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



[[Page 41725]]

Vol. 89

Monday,

No. 93

May 13, 2024

Part VI





 Department of Health and Human Services





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42 CFR Part 71





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

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

[[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. https://www.cdc.gov/media/pressrel/2007/r070907.htm. Accessed June 1, 2023.
    \2\ World Bank (2012). People, Pathogens and Our Planet: The 
Economics of One Health. Retrieved from https://openknowledge.worldbank.org/handle/10986/11892. Accessed December 
19, 2023.
    \3\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \4\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment 
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
    \5\ Fooks AR, Banyard AC, Horton DL, Johnson N, McElhinney LM, 
Jackson AC. Current status of rabies and prospects for elimination. 
Lancet 2014;384:1389-99.
    \6\ A complete list of countries with high risk of DMRVV is 
available at ``High-Risk Countries for Dog Rabies.'' https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html. Accessed June 8, 2023.
    \7\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \8\ Centers for Disease Control and Prevention (2022). Rabies 
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/index.html.
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    Through this final rule, HHS/CDC also seeks to prevent and deter 
the importation of dogs with falsified or fraudulent rabies vaccine 
documentation. In 2020, CDC observed a 52 percent increase in the 
number of dogs that were ineligible for admission due to falsified or 
fraudulent documentation, as compared to 2018 and 2019 (450 dogs 
compared to the previous baseline of 300 dogs per year out of an 
estimated 32,530 foreign-vaccinated dogs arriving annually from DMRVV 
high-risk countries as reported in Section VIIA).9 10 This 
troubling trend continued from January through June 2021, prior to the 
implementation of the temporary suspension in July 2021,\11\ with an 
additional 24 percent increase of dogs ineligible for admission in just 
the first half of the year, compared to the full 2020 calendar year 
(January-December) (approximately 560 dogs with falsified or fraudulent 
documentation).\12\ This final rule will also support CDC's efforts to 
improve data collection related to dog importation, including tracking 
the total number of dog importations which CDC has been unable to do 
previously across all ports and for all importations.
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    \9\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: 15 February 2021.
    \10\ Pieracci EG, Wallace R, Maskery B, Brouillette C, Brown C, 
Joo H. Dogs on the move: Estimating the risk of rabies in imported 
dogs in the United States, 2015-2022. Zoonoses and Public Health 
2024; 00:1-9 DOI: 10.1111/zph.13122.
    \11\ Temporary Suspension of Dogs Entering the United States 
from High-Risk Rabies Countries. Federal Register, 86 FR 32041 (June 
16, 2021).
    \12\ Centers for Disease Control and Prevention. Port Health 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, January 1, 2021-July 14, 2021. Accessed: 01 October 2021.
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    The use of a single false rabies vaccination certificate (RVC) \13\ 
or other rabies vaccination document as part of a larger shipment of 
multiple dogs raises suspicion that the rabies vaccination documents 
for the remaining dogs may also be false. This is not an uncommon 
occurrence \14\ and creates an additional

[[Page 41727]]

burden on CDC and State health departments to track, test, and evaluate 
the remaining dogs in the shipment.
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    \13\ Centers for Disease Control and Prevention. What is a valid 
rabies vaccination certificate? Available at: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html.
    \14\ Centers for Disease Control and Prevention. Port Health 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2021. Accessed: 26 March 2024.
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    CDC has documented numerous importations every year in which flight 
parents 15 16 transport dogs for the purpose of resale, 
adoption, or transfer of ownership that do not meet CDC's entry 
requirements. These flight parents often claim the dogs are their 
personal pets to avoid U.S. Department of Agriculture (USDA) Animal 
Care \17\ entry requirements and potential tariffs or fees under CBP 
regulations. Even when well-meaning, these importers jeopardize public 
health, as many of them do not know the history of the animals they are 
transporting. Deterring individuals who serve as flight parents from 
supporting fraudulent dog importations has proven difficult despite the 
existence of CBP penalties relating to aiding unlawful importations and 
fraudulent conduct. See 19 U.S.C. 1592 and 19 U.S.C. 1595a.
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    \15\ ``Flight parent'' means any person transporting one or more 
animals on behalf of an importer for purposes of resale, adoption, 
or to transfer ownership. A flight parent is typically solicited 
through social media and may be compensated (including through goods 
and services, e.g., complimentary airplane ticket, paid baggage 
fees, other paid fees) or be uncompensated. Flight parents must 
possess all required Federal licenses or registrations to transport 
animals.
    \16\ Centers for Disease Control and Prevention. Port Health 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2021. Accessed: 15 April 2024.
    \17\ https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/usda-animal-care-overview.
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    The documented increase in fraudulent vaccine documentation and 
importers circumventing dog import regulations was shortly followed by 
the emergence of the coronavirus disease 2019 (COVID-19) pandemic. Many 
public health resources were redirected to the COVID-19 response, 
reducing the availability of resources to respond to dog importation 
issues. In light of this confluence of events, in June 2021, CDC 
published a temporary suspension of dogs entering the United States 
from DMRVV high-risk countries.\18\ The temporary suspension created a 
system that, among other things, implemented the use of standardized 
forms, required test results demonstrating the presence of rabies 
antibodies in dogs, and developed a network of animal care facilities 
authorized by CDC for the purpose of allowing for the immediate 
quarantine of dogs from DMRVV high-risk countries arriving with 
inadequate proof of test results. During the temporary suspension, CDC 
has documented decreased instances of fraud, fewer dogs being denied 
admission into the country, and fewer sick and dead dogs arriving in 
the United States from both DMRVV high-risk and DMRVV-free and low-risk 
countries, all of which have resulted in fewer Federal and State agency 
resources devoted to addressing issues related to inadequate rabies 
vaccination and/or documentation. This final rule implements a similar 
regulatory framework, expanded to dogs from DMRVV-free and low-risk 
countries, based on the documented successes of the temporary 
suspension.
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    \18\ Temporary Suspension of Dogs Entering the United States 
from High-Risk Rabies Countries. Federal Register, 86 FR 32041 (June 
16, 2021).
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B. Summary of Major Provisions

    In this final rule, HHS/CDC aligns U.S. import requirements for 
dogs with the importation requirements of other DMRVV-free countries by 
requiring proof of rabies vaccination and adequate serologic test 
results from a CDC-approved laboratory. The final rule requires for all 
dog imports: a microchip, six-month minimum age requirement for 
admission, and importer submission of a CDC import form (CDC Dog Import 
Form). The rule requires airlines to confirm documentation, provide 
safe housing for animals, and assist public health officials in 
determining cause of animal illness or death.

B.i. Requirements for All Dogs

    Per this final rule, HHS/CDC requires that all dogs arriving from 
any country, including dogs returning to the United States after 
traveling abroad, be microchipped with an International Standards 
Organization (ISO)-compatible microchip prior to travel into the United 
States. The microchip information must be included on importation 
documents to help ensure that dogs presented for admission are the same 
dogs as those listed on the rabies vaccination records or other 
documents. CDC has documented several instances of importers attempting 
to present records of vaccinated dogs as the vaccination records for 
dogs that lacked appropriate veterinary paperwork in an attempt to 
import the unvaccinated dogs into the United States without 
detection.\19\ Because microchips were not required for entry into the 
United States at that time and the dogs in question were not 
microchipped, the public health investigations to confirm the identity 
of those dogs were both resource-intensive and challenging. Microchips 
are used frequently by pet owners and required for international 
transit by many foreign countries, including for importation in many 
DMRVV-free countries. Microchips are also recommended by the 
international veterinary community and animal rescue and welfare 
organizations to reunite lost animals with their owners and ensure that 
the veterinary records for an animal can be linked to the animal.\20\ 
Further, during CDC's temporary suspension of dogs entering the United 
States from DMRVV high-risk countries, CDC documented that 99 percent 
(>20,000) of permit applications received were for dogs that had 
microchips implanted prior to the announcement of the suspension. 
Therefore, CDC's requirement has minimal impact on dog importations, 
although costs to some importers may still be incurred.
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    \19\ Centers for Disease Control and Prevention. Port Health 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
    \20\ American Veterinary Medical Association. Microchipping FAQ. 
https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq. Accessed June 1, 2023.
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    To address concerns about importations of puppies that are too 
young to be properly vaccinated against rabies, through this final 
rule, HHS/CDC requires that any dog arriving in the United States be at 
least six months of age. Dogs cannot be vaccinated effectively against 
rabies before 12 weeks of age and are not considered fully vaccinated 
until 28 days after vaccination.\21\ Establishing a six-month minimum 
age requirement for the import of dogs aligns with current USDA 
requirements for commercial dog imports under the Animal Welfare Act 
and will better protect the public's health from rabies.\22\
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    \21\ National Association of State Public Health Veterinarians. 
Compendium of animal rabies prevention and control, 2016. JAVMA 
2016; 248 (5):505-517.
    \22\ 7 U.S.C. 2148.
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    In this final rule, HHS/CDC also requires all dog importers to 
submit a CDC Dog Import Form (i.e., an online form that includes the 
importers' contact information and information related to each dog 
being imported) via a CDC-approved system prior to travel to the United 
States. This requirement would apply to all imported dogs (including 
dogs arriving from DMRVV-free and DMRVV low-risk countries) arriving in 
the United States by air, land, or sea. Upon arrival at a U.S. port, 
importers must present a receipt confirming they submitted a completed 
CDC Dog Import Form; additionally, importers arriving by air must 
present the receipt to the airline prior to boarding. The receipt 
contains the information submitted on the CDC Dog

[[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. www.aphis.usda.gov/pet-travel/us-to-another-country-export.
    \24\ International Pet and Animal Transportation Association. 
www.ipata.org.
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    All dogs arriving by air are required to have an air waybill (AWB). 
An AWB is a legally binding document issued by a carrier to a shipper 
or importer that details the type, quantity, and destination of the 
goods (i.e., dogs) being carried. It serves as a tracking number that 
can assist Federal agencies in monitoring the dog throughout the 
lifecycle of the dog's travel from the point of origin to the final 
destination. Additionally, a bill of lading serves as undisputed proof 
of shipment, and it represents the agreed upon terms and conditions for 
the transportation of the goods. All commercial airlines and many 
private cargo aircraft are capable of generating AWB. Additionally, CDC 
has successfully piloted the generation of AWB for dogs transported as 
hand-carried or excess baggage with several foreign air carriers during 
the temporary suspension to ensure air carriers can generate AWB for 
dogs transported as hand-carried or excess baggage.
B.ii. Requirements for Dogs From DMRVV-Free or DMRVV Low-Risk Countries
    This final rule further permits dogs imported from DMRVV-free or 
DMRVV low-risk countries to arrive at any U.S. port.\25\ In lieu of a 
CDC vaccination form, which is required for dogs imported from DMRVV 
high-risk countries, these importers may instead provide proof 
(examples outlined in paragraph (u)) that the dogs have been in DMRVV-
free or DMRVV low-risk countries only during the six months prior to 
arriving in the United States.
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    \25\ U.S. Port means any seaport, airport, or border crossing 
point under the control of the United States. 42 CFR 71.1(b).
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TB.iii. Requirements for Dogs From DMRVV High-Risk Countries
    Per this final rule, HHS/CDC requires all importers of dogs that 
have been in a DMRVV high-risk country within the last six months, 
regardless of whether foreign- or U.S.-vaccinated, to submit a 
standardized vaccination form verifying the rabies vaccination status 
of the dog. This final rule permits dogs that have been in a DMRVV 
high-risk country in the past six months and have a valid U.S.-issued 
rabies vaccination form to arrive at any U.S. port. For dogs that have 
been in a DMRVV high-risk country in the past six months, and were 
vaccinated in a foreign country, this final rule requires that the dog 
arrive at a U.S. airport with a CDC quarantine station (also known as a 
port health station) and a CDC-registered animal care facility (ACF).
    HHS/CDC is removing the current requirement for a valid RVC in 42 
CFR 71.51(c) and replacing it with new rabies vaccination forms for 
dogs imported from DMRVV high-risk countries. The rabies vaccination 
forms include the rabies vaccination status of the dog and other 
required information similar to the previous valid RVC requirement. 
However, unlike the previous requirement for a valid RVC, the rabies 
vaccination forms are standardized.
    The rabies vaccination form for foreign-vaccinated dogs from DMRVV 
high-risk countries must also be endorsed by a government official in 
the exporting country, as an added measure to prevent falsification. 
The name for the rabies vaccination form to fulfill this requirement 
for foreign-vaccinated dogs from DMRVV high-risk countries was 
shortened from CDC Import Certification of Rabies Vaccination and 
Microchip Required for Live Dog Importations into the United States as 
proposed in the notice of proposed rulemaking (NPRM) to Certification 
of Foreign Rabies Vaccination and Microchip. The requirement for this 
standardized form helps ensure that foreign-vaccinated dogs imported 
from DMRVV high-risk countries meet CDC entry requirements prior to 
traveling to the United States and allows for follow-up with the 
exporting country's government officials if repeated import violations 
occur.
    Under this final rule, importers of U.S.-vaccinated dogs, including 
dogs that have been in a DMRVV high-risk country within the last six 
months, may arrive at any U.S. port. Prior to traveling out of the 
United States with a U.S.-vaccinated dog that will be present in a 
DMRVV high-risk country, the dog owner must obtain a form titled 
Certification of U.S.-issued Rabies Vaccination that must be completed 
and signed by a USDA-Accredited Veterinarian. The name for this rabies 
vaccination form was shortened from Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States as proposed in 
the NPRM to Certification of U.S.-issued Rabies Vaccination. CDC is 
partnering with USDA to utilize the USDA export process to verify an 
animal was vaccinated in the United States. This form must be endorsed 
by a USDA Official Veterinarian prior to the dog's departing the United 
States and must be presented by the importer to the airline to board 
the dog on its return flight to the United States. The importer must 
also present this form when requested to do so by U.S. government 
officials upon arrival. By having USDA-accredited veterinarians certify 
documents before export from the United States, CDC can confirm the 
dogs were previously vaccinated in the United States. The use of this 
form decreases the likelihood of missing or incomplete vaccination 
documentation because it includes all required information in a 
standardized format and relies on USDA's existing veterinary 
accreditation system for animal exportation. This form will also reduce 
instances of fraud or falsification because it can be verified by any 
U.S. government agency online through USDA's website after the USDA 
official veterinarian certifies the document. Dogs from DMRVV high-risk 
countries arriving with this form are not subject to the requirement 
for veterinary examination (unless ill, injured, or exposed), 
revaccination, confirmation of adequate rabies serologic tests, and/or 
post-vaccination quarantine at a CDC-registered ACF.
    HHS/CDC is requiring importers of foreign-vaccinated dogs that have 
been in a DMRVV high-risk country within the last six months to enter 
the United States through an airport with a CDC quarantine station and 
a CDC-registered ACF. The importer must have a reservation at the CDC-
registered ACF and have their dog(s) undergo a veterinary exam and 
revaccination with a USDA-licensed rabies vaccine at the CDC-registered 
ACF. The importer must obtain a rabies serologic test from a CDC-
approved laboratory for their foreign-vaccinated dogs demonstrating 
adequate titer levels. Importers of foreign-vaccinated dogs that have 
been

[[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. https://www.transportation.gov/individuals/aviation-consumer-protection/service-animals, last updated June 9, 2021.
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B.vi. Requirements for Airlines
    The final rule further requires that an airline, prior to accepting 
a dog for transport, confirm that the dog possess all required import 
documentation based on the country of origin. Airlines must also ensure 
that foreign-vaccinated dogs from DMRVV high-risk countries are 
entering the United States only through a designated U.S. airport with 
both a CDC quarantine station and a CDC-registered ACF and that the 
importer possesses a reservation with the CDC-registered ACF for 
examination, vaccination, and quarantine (if required). Air carriers 
are required to create bill of lading (e.g., air waybill (AWB)) for all 
dogs entering the United States via air, including dogs

[[Page 41730]]

transported as cargo, hand-carried and checked-baggage. As needed, CDC 
will coordinate with the airline regarding transport of the dog to the 
CDC-registered ACF. These regulatory actions help ensure that dogs 
arriving in the United States from DMRVV high-risk countries are 
adequately protected against rabies and do not pose a public health 
threat.
    The final rule requires that airlines return dogs or cats denied 
admission to the country of departure within 72 hours after arrival, 
unless the animal is ill or injured and CDC has approved delaying the 
return of the animal. The responsibility for a dog or cat pending 
admission into the United States or awaiting return to the country of 
departure has been a point of confusion for many airlines, resulting in 
delayed care and improper housing for numerous animals. Delays in 
returning dogs to their countries of departure also potentially 
threaten U.S. public health by exposing people to dogs with unknown 
rabies vaccination status. HHS/CDC requires that the airline that flew 
a dog or cat to the United States must arrange for and ensure 
transportation, housing, and care until the animal is either returned 
to the county of departure or cleared for entry into the United States.
    This final rule also includes a provision regarding dogs and cats 
that die en route to the United States or that die while detained 
pending determination of their admissibility. This provision is 
primarily directed at airlines and requires that they arrange for 
transportation of deceased dogs and cats and for necropsy requiring 
gross and histopathologic examination and any subsequent infectious 
disease testing based on the findings. The importer is responsible for 
all costs associated with transportation, necropsy and testing and 
providing the CDC quarantine station \29\ with the final necropsy 
report and all test results. The airline is also required to notify the 
CDC quarantine station of jurisdiction \30\ prior to transporting a 
dead dog or cat for a necropsy to determine whether rabies testing is 
required. These measures will help CDC rule out foreign animal diseases 
of public health concern \31\ as a potential cause of death, enable CDC 
to take responsive measures as needed, and will protect both animal and 
human health. The provisions of this paragraph may also be applied to 
other carriers transporting such dogs and cats in the very rare event 
when the death of a dog or cat occurs en route to the United States, or 
the animal dies while detained pending determination of admissibility.
---------------------------------------------------------------------------

    \29\ CDC quarantine stations are also known as U.S. Port Health 
Stations.
    \30\ CDC quarantine station jurisdictions, available at: 
www.cdc.gov/quarantine/quarantine-stations-us.html.
    \31\ U.S. Department of Agriculture. Notifiable Diseases and 
Conditions. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/Notifiable-Diseases-and-Conditions.
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    The final rule requires airlines to confirm prior to boarding a 
foreign-vaccinated dog from a DMRVV high-risk country that the dog is 
scheduled to arrive at an approved U.S. airport and the importer has 
documentation confirming a reservation at the CDC-registered ACF. This 
ensures that CDC and USDA can follow up with airlines more easily to 
confirm animals are being properly handled (e.g., not left in cargo 
warehouses for prolonged periods of time that endanger the health of 
the animal). Additionally, to address concerns relating to the movement 
of dogs or cats that are sick or dead upon arrival, HHS/CDC requires 
airlines to arrange transportation of all sick or dead animals 
(regardless of vaccination status and country of origin) to a CDC-
registered ACF or, under certain conditions, to another CDC-approved 
veterinary clinic as soon as possible.
    The final rule requires airlines to transport healthy-appearing 
animals that are denied admission and awaiting return to their country 
of departure, or are awaiting a determination as to their 
admissibility, to a CDC-registered ACF within 12 hours. CDC 
acknowledges that extraordinary circumstances, such as extreme weather, 
may delay the transport of animals beyond the 12-hour window. Under 
such circumstances, CDC will work closely with airlines to address 
these rare and unforeseen events while ensuring the safe handling of 
animals. CDC also will work with importers who arrive at unapproved 
U.S. ports based on circumstances beyond their control (e.g., re-
routing of their flight due to extreme weather). CDC quarantine station 
staff are available 24 hours a day to assist streamlined coordination 
and processing of dog and cat importation at U.S. ports and provide 
coverage for geographic areas beyond the U.S. port in which the CDC 
quarantine station is located.
B.vii. Other Requirements and Summary
    HHS/CDC is establishing requirements for businesses that wish to 
become CDC-registered ACF. Requirements include a USDA intermediate 
handlers registration and approved by CBP to act as a CBP-bonded 
facility with an active Facilities Information and Resource Management 
System (FIRMS) code. This ensures dogs and cats receive appropriate 
veterinary care and are housed in a way that prevents the spread of 
infectious diseases while protecting the safety of the animals. CDC-
registered ACF must be located within 35 miles of a CDC quarantine 
station.
    The requirements HHS/CDC is finalizing for dog importation into the 
United States are summarized below in Table E1. Since HHS/CDC is not 
substantially changing cat importation requirements, Table E1 does not 
apply to cats.
BILLING CODE 4163-18-P

[[Page 41731]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.000


[[Page 41732]]


[GRAPHIC] [TIFF OMITTED] TR13MY24.001

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

[[Page 41733]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.002

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

[[Page 41734]]

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


[[Page 41735]]


BILLING CODE 4163-18-C

C. Costs and Benefits

    CDC conducted an analysis to estimate the distributions of costs 
and benefits incurred with the final rule relative to regulatory 
baseline. The provisions of this final rule are not likely to have an 
effect on the economy of $200 million or more in any one year, although 
there is considerable uncertainty around the number of dogs imported at 
baseline, including the number of dogs imported from DMRVV high-risk 
countries.
    The requirements of this final rule will address the market 
inefficiency in which dog importers do not account for the potential 
detrimental impacts to public health that may result from the 
importation of ill dogs, especially dogs infected with DMRVV. The 
worst-case scenario would include the reintroduction of DMRVV into the 
United States. Federal regulation is necessary to mitigate the risk of 
importing infected dogs. Federal action allows this risk to be 
addressed prior to dogs' arrival in the United States and for dogs to 
be evaluated, revaccinated, and possibly quarantined (if required) in 
controlled conditions after their arrival in the United States. The 
primary public health benefit is a reduction in the risk of importing 
dogs infected with DMRVV. The regulatory changes in this final rule are 
expected to affect the following categories of interested parties and 
implementing partners:
     Importers of dogs from countries that are DMRVV-free or 
are low risk for DMRVV;
     Importers of dogs from countries that are at high risk of 
DMRVV;
     Airlines and other carriers;
     CBP;
     CDC;
     USDA; and
     State and local public health and animal health 
departments.
    The provisions in the final rule incorporate different requirements 
for dogs imported from DMRVV high-risk countries than those imported 
from DMRVV-free or DMRVV low-risk countries. The annualized and present 
value estimates of monetized costs and benefits over the 10-year period 
from 2024 through 2033 using three percent and seven percent discount 
rates are summarized below. The annualized, monetized costs (2020 USD) 
of the final rule are estimated to be $59 million (range: $13.1 to $207 
million) using a three percent discount rate; the estimated monetized 
costs using a seven percent discount rate are largely the same.
    Most monetized costs are expected to be incurred by importers (87 
percent of costs is the most likely estimate). The estimated monetized 
costs are about three times greater for importers of dogs from DMRVV 
high-risk countries compared to importers of dogs from DMRVV-free or 
low-risk countries. The requirements in the final rule estimated to 
result in the greatest increase in costs for importers of dogs are 
those associated with the veterinary examination and revaccination 
against rabies at a CDC-registered ACF for foreign-vaccinated dogs from 
DMRVV high-risk countries in section 71.51(k), costs for titer testing 
of foreign-vaccinated dogs from DMRVV high-risk countries, additional 
costs associated with the CDC Dog Import Form requirement, the minimum 
age for imported dogs, and the microchip requirements for all imported 
dogs. Other costs include (1) an expected reduction in the number of 
dogs imported from DMRVV high-risk countries, (2) the requirement to 
arrive at one of six U.S. airports with CDC-registered ACF (required 
for foreign-vaccinated dogs arriving from DMRVV high-risk countries), 
and (3) the requirement to obtain a Certification of Foreign Rabies 
Vaccination and Microchip form or a Certification of U.S.-issued Rabies 
Vaccination form with certification by an official government 
veterinarian for all dogs from DMRVV high-risk countries. Dogs imported 
from DMRVV-free or low-risk countries would also require a document 
certified by an official government veterinarian, but HHS/CDC will 
allow a greater number of potential documents as specified in 42 CFR 
71.51(u).
    Airlines are estimated to incur about 7.0 percent of the estimated 
annualized costs associated with the final rule. Most airline costs 
would result from ensuring that all transported dogs comply with the 
new requirements in the final rule, the costs associated with creating 
bills of lading or a CDC-approved alternative for all imported dogs, 
and from a small reduction in the number of dogs transported. Airline 
costs may be passed along to dog importers.
    HHS/CDC is estimated to incur about 3.3 percent of the annualized, 
monetized costs (most likely estimate) associated with the provisions 
of this final rule. Most CDC costs would be associated with the 
oversight of animal care facilities, which must be approved by and 
registered with CDC, and the establishment of a laboratory proficiency 
testing program to support serologic testing for foreign-vaccinated 
dogs imported from DMRVV high-risk countries.
    CBP is expected to incur about 3.0 percent of the annualized costs 
(most likely estimate) associated with the provisions of this final 
rule. Most CBP costs would result from additional screening time at 
U.S. ports for dogs from DMRVV-free or low-risk countries.
    The annualized monetized benefits of the provisions in the final 
rule are estimated to be about $1.8 million (range: $0.75 to $3.6 
million) using a three percent or seven percent discount rate. Most 
benefits will accrue to importers (47 percent of the most likely 
estimates) and to CBP (30 percent of the most likely estimate). Some of 
the benefits estimated for both importers and CBP will result from 
reduced time spent on screening dogs from high-risk countries at U.S. 
ports because fewer dogs will be imported with the requirements 
included in the final rule. The requirements in the final rule are 
estimated to reduce the amount of time required to verify admissibility 
per U.S.-vaccinated dog from DMRVV high-risk country at U.S. ports 
because rabies vaccination documentation forms will be standardized. 
The provisions in this final rule are also estimated to reduce the 
number of dogs arriving ill or dead and the number of dogs denied 
entry, with benefits estimated for importers, airlines, and CDC. USDA 
is expected to receive payments commensurate with its cost to provide 
the Certification of U.S.-issued Rabies Vaccination form for U.S.-
vaccinated dogs traveling internationally.
    The wide range between the lower-bound and upper-bound cost and 
benefit estimates demonstrates that there is considerable uncertainty 
in these results. At present, the number of dogs imported into the 
United States is neither accurately nor completely tracked by any data 
system, and the uncertainty in the cost and benefit estimates reflect 
uncertainty in both the total number of dogs imported and the number of 
dogs imported from DMRVV high-risk countries, as well as the cost of 
the new requirements in the final rule. The net annualized, monetized 
costs (total cost estimate - total benefit estimate) were estimated to 
be about $57 million per year (range: $12 to $203 million) using a 
three percent discount rate. The annualized estimates were relatively 
unaffected by using a seven percent discount rate.
    Because the estimated costs for foreign-vaccinated dogs from DMRVV 
high-risk countries are much higher than costs for other dog imports, 
importers may choose to import dogs from DMRVV-free or low-risk 
countries instead of from DMRVV high-risk countries. In addition, 
individuals who

[[Page 41736]]

travel from the United States to DMRVV high-risk countries with their 
pet dogs for long-term visits may take the additional step to have 
their dogs revaccinated with a three-year rabies vaccine prior to 
departure, which would allow up to three years for return to the United 
States with a Certification of U.S.-issued Rabies Vaccination. These 
changes should result in lower overall costs than the above estimates 
for the final rule in which HHS/CDC assumed individuals would be unable 
to change the countries from which dogs are imported into the United 
States.
    The importation of just one dog infected with DMRVV risks 
reintroduction of the virus into the United States, which could result 
in loss of human and animal life and substantial public health response 
costs. The social cost of the consequences associated with the 
importation of a single DMRVV-infected dog is estimated to be $270,000 
(range: $210,000 to $510,000) for conducting public health 
investigations and administering rabies PEP to exposed persons. The 
primary public health benefit of the provisions in the final rule is 
the reduced risk that a dog with DMRVV will be imported from a DMRVV 
high-risk country. The above estimate of the cost of importation of a 
dog with DMRVV does not account for the worst-case outcomes, which 
include (1) transmission of rabies to a person who dies from the 
disease, and (2) ongoing transmission to other domestic and wildlife 
species in the United States. The cost of reintroduction could be 
especially high if DMRVV spreads to other species of U.S. wildlife. Re-
establishment of DMRVV in the United States could result in costly 
efforts over several years to eliminate the virus again. The costs to 
contain any reintroduction would depend on the time period before the 
reintroduction was detected, the wildlife species in which DMRVV was 
transmitted, and the geographic area over which reintroduction 
occurred.
    An increase in human deaths from DMRVV could occur following the 
reintroduction of DMRVV to the United States, as the risk of exposure 
would increase. Human deaths from rabies continue to occur in the 
United States after exposures to wild animals, and there have been 
eight deaths among U.S. residents bitten by rabid dogs while traveling 
abroad in DMRVV high-risk countries since 2009. HHS/CDC uses the value 
of statistical life (VSL) to support quantifying benefits for 
interventions that can result in mortality risk reductions. HHS 
recommends using a central estimate of $11.6 million and a range of 
$5.5 to $17.7 million (2020 USD). HHS/CDC is unable to estimate the 
potential magnitude of the mortality risk reduction associated with the 
final rule. Based on the central VSL, averting five human deaths per 
year would mean the benefits of the final rule would exceed its costs.
    HHS/CDC and other Federal government agencies do not know with 
precision the number of dogs imported each year or the countries from 
which the dogs originate. More comprehensive data on where dogs are 
imported from may benefit public health investigations. Arrival data on 
animals exposed to a dog with DMRVV on U.S.-bound flights, for example, 
would expedite follow-up of exposed dogs in the United States. The lack 
of data received from implementing the current regulation also inhibits 
the Federal government's ability to target interventions for dogs 
imported from specific countries. Of note, the COVID-19 pandemic 
diverted resources from and weakened rabies control programs in some 
DMRVV high-risk countries, increasing the risk that imported dogs may 
be infected with DMRVV. The provisions of this final rule will be of 
particular public health benefit in light of the ongoing resource 
concerns for global rabies vaccination campaigns in the wake of the 
pandemic.
    These data would also benefit agencies such as USDA's Animal and 
Plant Health Inspection Service (APHIS), which have an interest in 
regulating dog imports with the intent of reducing the risk of 
introduction of diseases that may affect U.S. livestock. For example, 
in 2021, APHIS issued a Federal Order that established additional post-
entry requirements on dogs for resale imported from countries with 
ongoing African swine fever transmission, which poses a significant 
risk to U.S. pork producers. The potential economic benefits of 
reducing the risk of the importation of African swine fever could be 
significant; in fact, a 2019 outbreak in China was estimated to have 
total economic losses equivalent to 0.78 percent of China's gross 
domestic product. Thus, some of the requirements in this final rule may 
mitigate the risks of introduction and transmission of diseases that 
impact livestock in addition to reducing the risk of importing dogs 
infected with DMRVV.
    The monetized cost estimate has increased considerably relative to 
the estimates included in the NPRM. The primary reasons for the 
increase in cost include:
     The fees charged by ACF have increased relative to CDC's 
preliminary estimates.
     Some U.S. ports require that dogs needing follow-up care 
at ACF arrive as cargo. This requirement was not anticipated by HHS/CDC 
and will increase costs for importers of foreign-vaccinated dogs from 
DMRVV high-risk countries who otherwise would have chosen to transport 
their dogs as hand-carried or checked baggage. The fee charged for 
cargo shipments are highly variable.32 33 The future costs 
associated with this rule will depend on U.S. port policies that are 
subject to change. The average cost for the follow-up visit at ACF is 
estimated to be $900 (range: $500 to $1,300 per dog). The average costs 
associated with shipping dogs as cargo is estimated to be $2,000 
(range: $1,500 to $2,500) \34\ compared to an average of $300 (range: 
$200 to $400) for dogs shipped as hand-carried or checked baggage.\35\ 
Under the regulatory baseline, HHS/CDC assumes 25%, range: 17% to 50% 
of dogs going to ACF are shipped as cargo. With the final rule, HHS/CDC 
assumes that 60% of dogs going to ACF, range: 60% to 70% of dogs will 
be shipped as cargo.
---------------------------------------------------------------------------

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

     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.
     CDC increased the estimated costs associated with shipping 
blood samples to CDC-approved laboratories for serological testing 
based on a number of comments from individuals suggesting their 
shipping costs were higher.
     CDC changed the requirement for importing dogs from DMRVV-
free or low-risk countries such that no dogs less than six months may 
be imported at land borders. This will increase costs for individuals 
who wish to travel with their young dogs to or from Canada and Mexico.
     CDC increased the estimated costs to airlines by 100% for 
dogs imported from DMRVV-free or low-risk countries and by 50% for dogs 
imported from DMRVV high-risk countries to account for a number of 
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:
     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.
     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.
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    \39\ Centers for Disease Control. DMRVV high-risk country list. 
Available at: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html.
    \40\ The Program for Monitoring Emerging Diseases (ProMED) is a 
program of the International Society for Infectious Diseases and is 
available at https://promedmail.org/.
    \41\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K, 
et al. A country classification system to inform rabies prevention 
guidelines and treatment. Journal of Travel Medicine, 
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
    \42\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis 
of available animal testing data to propose peer-derived 
quantitative thresholds for determining adequate surveillance 
capacity for rabies. Scientific Reports 2023; 13: 3986.
    \43\ Extension of Temporary Suspension of Dogs Entering the 
United States from High-Risk Rabies Countries. Federal Register, 88 
FR 43570 (July 10, 2023).
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III. Summary of the Final Rule

Changes to 71.50

    Section 71.50(b) contains definitions applicable to animal 
importations under subpart F of 42 CFR part 71. The definitions 
contained in paragraph (b) are of general scientific applicability and 
thus would apply to different animal imports, not just dogs and cats. 
After considering public comment received to the NPRM, HHS/CDC is 
adding the following definitions to 42 CFR 71.50(b): Authorized 
veterinarian, cat, dog, histopathology, in-transit shipments, 
microchip, necropsy, official government veterinarian. CDC is replacing 
the definition for ``in-transit'' with the definition ``in-transit 
shipments,'' as proposed in the NRPM.
    This final rule also adds a new paragraph at 42 CFR 71.50(c) that 
addresses the legal severability of provisions found in 42 CFR part 71 
subpart F--Importations. Because the provisions relating to 
importations under subpart F are designed to protect the public's 
health from various communicable disease threats, HHS/CDC intends that 
these provisions have maximum legal effect. Accordingly, HHS/CDC is 
adding language to ensure that, if this subpart is held by a reviewing 
court of law to be invalid or unenforceable by its terms, or as applied 
to any person or circumstance, the provision be construed so as to 
continue to give the maximum effect to the provision permitted by law. 
If a reviewing court should hold that a provision is utterly invalid or 
unenforceable, then HHS/CDC intends that the provision be severable 
from Subpart F and not affect the remainder or the application of the 
provision to persons not similarly situated or to dissimilar 
circumstances.

Changes to 71.51

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

[[Page 41739]]

DMRVV Low-risk Country, conditional release, confinement, DMRVV, DMRVV-
free countries, DMRVV high-risk countries, DMRVV low-risk countries, 
DMRVV-restricted countries, flight parent, importer, SAFE TraQ, 
serologic testing, USDA-Accredited Veterinarian, and USDA Official 
Veterinarian. In response to public comment, CDC has modified the 
definition of importer and added definitions for ``flight parent'' and 
``Certification of Dog Arriving from DMRVV-free or DMRVV Low-risk 
Country,'' definitions that were not in the NPRM. CDC has also added a 
definition for CDC Dog Import Permit, and modified and shortened the 
names of the required rabies vaccination forms. CDC is removing the 
current definition for Valid rabies vaccination certificate in 42 CFR 
71.51 because other rabies vaccination forms will now be required. CDC 
is also moving the definitions for cat and dog from 71.51(a) to 
71.50(a).
    In 71.51(b) through 71.51(d), HHS/CDC is finalizing the section as 
proposed with the exception that U.S.-vaccinated dogs may enter through 
any U.S. port. CDC has a high degree of confidence in USDA-licensed 
rabies vaccines administered in the United States; therefore, the risk 
of a U.S.-vaccinated dog importing rabies when returning to the United 
States is very low. CDC also has confidence in DMRVV-free countries 
that have declared themselves to be free of canine rabies using WOAH's 
self-declared validation process in which their surveillance and 
vaccination data are available for external review.\44\ Additionally, 
CDC has confidence in DMRVV-free and low-risk countries which 
demonstrate adequate surveillance capacity and vaccination control 
measures in accordance with CDC published metrics, but have not pursued 
a WOAH self-declaration status.45 46 HHS/CDC is reducing the 
burden on importers of U.S.-vaccinated dogs by allowing greater 
flexibility to be admitted through any U.S. port and is finalizing as 
proposed the ability of importers of cats and dogs from DMRVV-free and 
low-risk countries to be admitted through any U.S. port.
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    \44\ World Organisation for Animal Health. Self-declared Disease 
Status. Available at: www.woah.org/en/what-we-offer/self-declared-disease-status/.
    \45\ Minhaj, F.S., Bonaparte, S.C., Boutelle, C. et al. Analysis 
of available animal testing data to propose peer-derived 
quantitative thresholds for determining adequate surveillance 
capacity for rabies. Sci Rep 13, 3986 (2023). https://doi.org/10.1038/s41598-023-30984-3.
    \46\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K, 
et al. A country classification system to inform rabies prevention 
guidelines and treatment. Journal of Travel Medicine, 
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
---------------------------------------------------------------------------

    (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:
     Veterinary health examination by a USDA-Accredited 
Veterinarian for signs of disease. Suspected or confirmed communicable 
or foreign animal diseases would be required to be reported to CDC and 
may delay release of the animals.
     Confirmation of microchip number.
     Confirmation of age through dental examination by a USDA-
Accredited Veterinarian.
     Vaccination against rabies with a USDA-licensed rabies 
vaccine and administered by a USDA-Accredited Veterinarian.
     Verification of adequate rabies serologic test from a CDC-
approved laboratory. To be considered valid, serologic tests must be 
drawn prior to arrival within an established timeframe and display 
results within parameters as specified in CDC technical 
instructions.\50\ Dogs that arrive without an adequate rabies serologic 
test results from a CDC-approved laboratory will be housed at the ACF 
for a 28-day quarantine following administration of the USDA-licensed 
rabies vaccine or until an adequate rabies serologic test from a CDC-
approved laboratory is confirmed.
---------------------------------------------------------------------------

    \50\ CDC technical instructions are posted on CDC's website at 
www.cdc.gov/dogtravel.
---------------------------------------------------------------------------

    (l) Registration or renewal of CDC-registered animal care 
facilities.
    HHS/CDC is finalizing section 71.51(l) as proposed with the 
exception that CDC may conduct inspections of ACF which will be guided 
by the USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 
3) and other standards outlined in CDC's Technical Instructions for 
CDC-registered Animal Care Facilities. Failure to adhere to standard 
operating procedures (SOP) requirements as outlined in USDA Animal 
Welfare regulation standards or CDC's Technical Instructions for CDC-
registered Animal Care Facilities would constitute grounds for not 
registering or renewing an ACF's registration.
    Per this final rule, HHS/CDC is requiring that an animal care 
facility register with and receive written approval from CDC, USDA, and 
CBP to submit their facility application before housing any imported 
live dog in the United States. The applicant must provide written SOP 
outlining how CDC's regulatory requirements will be met and the health 
and safety of animals and staff will be ensured. A copy of all Federal, 
State, or local registrations, licenses, or permits will also be 
required to be submitted to CDC. Additionally, HHS/CDC requires the 
facility to have a USDA intermediate handlers registration (and any 
other licenses or

[[Page 41741]]

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

    (o) CDC-registered animal care facility standard operating 
procedures, requirements, and equipment standards for crating, caging, 
and transporting live animals.
    Section 71.51(o) is finalized as proposed and requires that 
equipment standards for crating, caging, and transporting live animals 
must be in accordance with USDA Animal Welfare regulation standards (9 
CFR parts 1, 2, and 3) and International Air Transport Association 
standards.\54\ Animals must not be removed from crates during 
transport, and used PPE, bedding, and other potentially contaminated 
material must be removed from the ground transport vehicle upon arrival 
at the ACF and disposed of or disinfected in a manner that would 
destroy potential pathogens of concern.
---------------------------------------------------------------------------

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

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

[[Page 41742]]

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

    \55\ International Air Transport Association. Live Animals. 
https://www.iata.org/en/programs/cargo/live-animals. Accessed June 
7, 2023.
---------------------------------------------------------------------------

    If a facility's response is timely, the Director will review the 
registration, the notice of revocation, and the response. As soon as 
practicable after completing the written record review, the Director 
will issue a decision in writing that shall constitute final agency 
action, unless the Secretary, within one business day, decides to 
review the Director's decision. The Director will provide the facility 
with a copy of the written decision. The Director, in the Director's 
discretion, may reinstate a revoked registration after inspecting the 
facility, examining its records, conferring with the facility, and 
receiving information and assurance from the facility of compliance 
with the requirements of this section.
    (s) Requirement for the Certification of Foreign Rabies Vaccine and 
Microchip form to import a foreign-vaccinated dog from DMRVV high-risk 
countries.
    Section 71.51(s) is finalized as proposed with the exception that 
HHS/CDC shortened the name of the form to the Certification of Foreign 
Rabies Vaccine and Microchip (OMB Control Number 0920-1383; expiration 
date 04/30/2027). Through this final rule, HHS/CDC is requiring a new, 
standardized rabies vaccination form for all foreign-vaccinated dogs 
that have been in any DMRVV high-risk countries within the last six 
months. In addition to details about the dog, importer, and 
veterinarian, the form must be completed by an Authorized Veterinarian 
that examined the dog in the exporting country and certified by an 
official government veterinarian attesting that the authorized 
veterinarian is licensed or authorized to practice veterinary medicine 
in the exporting country. The authorized veterinarian and the official 
government veterinarian must further attest that the information listed 
on the form is true and correct.
    (t) Requirement for Certification of U.S.-Issued Rabies Vaccination 
Form for importers seeking to import U.S.-vaccinated dogs from DMRVV 
high-risk countries.
    Section 71.51(t) is finalized as proposed with the exception that 
HHS/CDC shortened the name of the form to the Certification of U.S.-
Issued Rabies Vaccination (OMB Control Number 0920-1383; expiration 
date 04/30/2027). HHS/CDC now requires that U.S.-vaccinated dogs re-
entering the United States from DMRVV high-risk countries be 
accompanied by a Certification of U.S.-issued Rabies Vaccination Form. 
The form must be completed by a USDA-Accredited Veterinarian and 
endorsed by a USDA Official Veterinarian prior to the dog departing the 
United States. People who leave the United States with their dogs 
without first obtaining this form will be required to have their dogs 
re-enter the United States as if they are foreign-vaccinated dogs and 
be required to meet all the requirements as outlined in section (s) for 
the dogs to be eligible for re-entry from a DRMVV high-risk country.
    (u) Requirement for proof that a dog has been only in DMRVV low-
risk or DMRVV-free countries.
    Section 71.51(u) is finalized as proposed with the exception that, 
based on public comment, CDC is now including a list of acceptable 
documents importers may provide to confirm a dog has been only in DMRVV 
low-risk or DMRVV-free countries during the last six months before 
arriving in the United States. This list includes a valid USDA export 
certificate, a valid foreign export certificate, a valid Certification 
of Dog Arriving from DMRVV-free or DMRVV Low-risk Country form, or 
other records or documents satisfactory to the Director. Importers may 
also provide proof of rabies vaccination, which is recommended but not 
required for dogs arriving from DMRVV-free or DMRVV low-risk countries, 
using the Certification of Foreign Rabies Vaccination and Microchip 
form or the Certification of U.S.-Issued Rabies Vaccination form. All 
forms must be endorsed by an official government veterinarian to be 
considered valid.

[[Page 41743]]

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

[[Page 41744]]

ACF is not available. Airlines are required to return animals denied 
admission to the country of departure within 72 hours of arrival, 
regardless of carrier or route. This is to ensure airlines do not leave 
animals in warehouses unattended for prolonged periods of time. 
Airlines are able to request extensions for an animal's return in the 
event the animal is not medically fit for travel. This operational 
framework provides that importers are responsible for all associated 
costs relating to the housing, care, and treatment of a dog or cat 
denied admission pending return to its country of departure. However, 
if an importer fails to pay any costs or fails to comply with any 
requirements, the animal will be considered abandoned, and the relevant 
carrier would be required to assume responsibility.
    Under this framework, in instances where a dog or cat is fatally 
ill or injured, the importer or airline may choose a humane euthanasia 
option in accordance with the standards of the American Veterinary 
Medical Association \58\ performed by a licensed veterinarian. The 
importer or airline must notify CDC and CBP in writing of this 
decision. This decision does not relieve the importer or airline of the 
obligation to obtain and report results of necropsy or diagnostic 
testing required by CDC.
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    \58\ https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals.
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    In the case of dogs and cats denied admission to the United States 
upon arrival at a U.S. seaport, the vessel's master or operator would 
be required to reembark the animal immediately and return it to its 
country of departure on the next voyage. In the case of dogs and cats 
denied admission to the United States upon arrival at a U.S. land port, 
the importer or carrier would be required to immediately return it to 
its country of departure.
    HHS/CDC does not expect the above operational framework relating to 
housing, care, and treatment of a dog or cat denied admission to be 
applied on a routine basis to carriers or importers arriving with dogs 
or cats at U.S. land or seaports because the circumstances leading to a 
delay in returning a dog or cat to its country of departure are not 
typically present at these U.S. ports. However, HHS/CDC acknowledges 
that there may be rare and unforeseen circumstances where it may be 
necessary to apply such procedures. Accordingly, HHS/CDC has added 
language authorizing it to apply these provisions in circumstances 
where a dog or cat is denied entry at a U.S. land or seaport and cannot 
be immediately returned to its country of departure (e.g., because it 
is unfit to travel). Section 71.51(x) is finalized as proposed.
    (y) Appeals of CDC denials to admit a dog or a cat upon arrival 
into the United States.
    Section 71.51(y) is finalized as proposed with the exception that 
it explicitly references the ability of the Secretary to review a CDC 
decision to deny admission to dogs and cats if the Secretary so 
chooses. The Secretary has authority to act as final arbiter and review 
the CDC Director's decisions relating to animal importations if the 
Secretary so chooses. This section outlines the appeal process for 
importers of dogs and cats in the event their animals are denied 
admission to the United States upon arrival.
    Because denial of admission to dogs and cats under these limited 
circumstances is likely to occur at a port, HHS/CDC requires that any 
appeal be submitted to CDC within one business day so as not to 
unnecessarily prolong the appeal process and allow for expedited 
decision-making regarding whether an animal should be returned to its 
country of departure. Instructions on how to submit an appeal are 
included in the regulatory text. Pending a determination regarding the 
appeal the animal will remain the legal responsibility of the carrier. 
The Director will issue a written response to the appeal, which shall 
constitute final agency action, unless the Secretary, within one 
business day, decides to review the Director's decision.
    (z) Record of death of dogs and cats while en route to the United 
States and disposition of dead animals.
    Section 71.51(z) is finalized as proposed. The requirement that 
carriers maintain a record of sickness or death for any animals that 
die during transit is longstanding. Through this final rule, HHS/CDC 
will now require necropsy and diagnostic testing for any dog or cat 
that dies en route to the United States or at a U.S. port prior to 
admission to determine the cause of death. Consistent with current 
requirements, carriers would be required to report deaths to the CDC 
quarantine station of jurisdiction. HHS/CDC is including these 
amendments to ensure it can detect, provide referrals to appropriate 
agencies, and respond to potential communicable disease importation 
risks in a timely manner. Importers are responsible for the costs 
unless they abandon the animal, in which case the airline or master or 
operator of a vessel will assume responsibility for the costs.
    (aa) Abandoned shipments of dogs and cats.
    Section 71.51(aa) is finalized as proposed. Through this final 
rule, HHS/CDC is providing an operational framework primarily 
applicable to airlines for when a dog or cat would be considered 
abandoned prior to admission and thus require the carrier to assume 
responsibility for the shipment.
    The provisions of Section 71.51(aa) may also be applied to other 
carriers transporting such dogs and cats in the rare circumstances 
where the dog or cat is abandoned by the importer at a U.S. land port 
or seaport and other options are not available.
    (bb) Sanitation of cages and containers of dogs and cats.
    Section 71.51(bb) is finalized as proposed. This section requires 
that cages or other containers of animals arriving in the United States 
be cleaned and disinfected or the animals removed and placed in clean 
containers if the cages or other containers constitute a communicable 
disease risk.
    (cc) Requirements for in-transit shipments of dogs and cats.
    Section 71.51(cc) is finalized as proposed. Under today's final 
rule, CDC's definition of an ``in-transit shipment'' now aligns with 
that of the USDA. This provision further clarifies that dogs and cats 
can only be considered in-transit if they are transported as cargo and 
not as hand-carried baggage or checked baggage. In-transit shipments 
may only be transported as cargo. HHS/CDC is also clarifying that a 
microchip is not required for dogs that are transported by aircraft and 
are being transited through the United States if retained in the 
custody of the airline.
    (dd) Bill of lading and other airline requirements for dogs.
    Section 71.51(dd) has been finalized as proposed with the exception 
that airlines that lack the technical ability to generate a bill of 
lading (including an air waybill (AWB)) to transport dogs may request a 
waiver from CDC and provide a SOP outlining how they will ensure care 
for any ill, injured, or abandoned animals or animals denied entry in 
the absence of an AWB. This final rule requires that airlines create a 
bill of lading accounting for all live dog imports through a U.S. 
airport, regardless of whether the dogs are transported as cargo, 
checked baggage, or hand-carried baggage, or otherwise accompany a 
traveler arriving in the United States on their person.
    As a condition of granting a waiver to the bill of lading 
requirement, HHS/CDC may require the airline to work with a broker to 
file the appropriate paperwork and identify suitable housing

[[Page 41745]]

accommodations (such as an ACF or a local kennel approved by CDC and 
CBP) for any dogs detained pending admissibility. The SOP must include 
the location of an ACF or other suitable alternative approved by CBP 
and CDC prior to transport of animals. HHS/CDC may require the airline 
to submit documentation outlining a timetable and steps that will be 
taken to develop the technical capacity to generate an AWB (or another 
suitable alternative to an AWB) to transport dogs. CDC has provided 
additional details for airlines seeking exemption for the AWB 
requirement in technical instructions available on CDC's website at 
www.cdc.gov/dogtravel.
    Section 71.51(dd) also requires that airlines confirm that all 
importers have a receipt of a completed CDC Dog Import Form prior to 
boarding. For U.S.-vaccinated dogs that have been in a DMRVV high-risk 
country within the last six months, CDC requires that airlines confirm 
that importers have a valid Certification of U.S.-issued Rabies 
Vaccination form. For foreign-vaccinated dogs that have been in a DMRVV 
high-risk country within the last six months, airlines must confirm 
that importers have a reservation at an ACF. For dogs from DMRVV-free 
or DMRVV low-risk countries, HHS/CDC will require that airlines confirm 
that the importer has documentation as outlined in paragraph (u) 
showing that the dog is over six months of age, has a microchip, and 
has been only in DMRVV-free or DMRVV low-risk countries within the last 
six months.
    Finally, section 71.51(dd) requires that a representative of an 
airline transporting live dogs into the United States be on-site at the 
U.S. airport and available to coordinate the entry/clearance of the 
dogs with Federal government officials until all live dogs transported 
on an arriving flight into the United States have either been cleared 
for admission, arrangements have been made to transport the dogs to an 
ACF or other facility (e.g., veterinary clinic or kennel) approved by 
CDC pending admissibility determination, or arrangements have been made 
for return of dogs not meeting CDC entry requirements.
    (ee) Order prohibiting carriers from transporting dogs and cats.
    Section 71.51(ee) is finalized as proposed. This final rule 
outlines procedures for the CDC Director to issue an order revoking a 
carrier's permission to transport live dogs and cats into the United 
States if a carrier has endangered the public health of the United 
States by acting or failing to act to prevent the introduction of 
DMRVV, as would occur by failing to comply with the provisions of this 
section.
    (ff) Prohibition on imports of dogs from DMRVV-restricted 
countries.
    Section 71.51(ff) is finalized as proposed. This section of the 
final rule explicitly states that HHS/CDC may prohibit or otherwise 
restrict the import of dogs into the United States from certain 
countries that have repeatedly exported rabid dogs to any country or 
that lack adequate controls to monitor and prevent the export of dogs 
to the United States with falsified or fraudulent rabies vaccine 
credentials, invalid rabies vaccination forms, or other fraudulent, 
inaccurate, or invalid exportation/importation documents. Such a 
prohibition or other restriction will remain in place until there is 
sufficient evidence for CDC to be assured that adequate controls have 
been established to prevent the reintroduction of DMRVV into the United 
States, including preventing the use of falsified or fraudulent vaccine 
credentials. To implement this provision HHS/CDC will maintain a list 
of DMRVV-restricted countries. The list will be maintained on CDC's 
website at www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html and updated annually. Amendments to the list of 
DMRVV-restricted countries will be published as a notice in the Federal 
Register. HHS/CDC may allow the importation of certain categories of 
dogs from DMRVV-restricted countries, such as service animals or 
government-owned animals.
    (gg) Request for issuance of additional fines or penalties.
    Section 71.51(gg) is finalized as proposed with the exception that 
CDC is adding language informing the public that it may also refer 
potential violations of Federal law to the U.S. Department of Justice 
for investigation, and based on the results of such investigation, 
prosecution. Specifically, CDC may refer a matter to the U.S. 
Department of Justice if the Director has reason to believe that an 
individual or organization has violated Federal law, including by 
forcibly assaulting, resisting, opposing, impeding, intimidating, or 
interfering with a U.S. government employee while engaged in or on 
account of the performance of their official duties in violation of 18 
U.S.C. 111, by obstructing an agency proceeding in violation of 18 
U.S.C. 1505, or by otherwise engaging in conduct contrary to law. This 
provision also serves to inform the public of actions that CDC may take 
to request DHS/CBP assistance in enforcing HHS/CDC's dog and cat 
importation requirements. HHS/CDC stresses that it does not administer 
Title 19, and decisions regarding whether to pursue enforcement actions 
under Title 19 would be entirely at the discretion of DHS/CBP and 
subject to its policies and procedures.

IV. Alternatives Considered

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

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

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

[[Page 41753]]

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

VI. Summary of Public Comments and Responses

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

A. Comments on Necessity of the Rule

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

[[Page 41754]]

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

    \67\ World Health Organization (2018). WHO Expert Consultation 
on Rabies (WHO Technical Report Series 1012). Retrieved from https://www.who.int/publications/i/item/WHO-TRS-1012.
    \68\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance 
for Rabies Control Partners for Rabies Prevention. Estimating the 
global burden of endemic canine rabies. PloS Negl Trop Dis 
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
    \69\ Fooks, A.R., Banyard, A.C., Horton, D.L., Johnson, N., 
McElhinney, L.M., and Jackson, A.C. (2014) Current status of rabies 
and prospects for elimination. Lancet, 384(9951), 1389-1399. Doi: 
10.1016/S0140-6736(13)62707-5.
    \70\ Velasco-Villa A, Mauldin MR, Shi M, et al. The history of 
rabies in the Western Hemisphere. Antiviral Res. 2017;146:221-232. 
Doi:10.1016/j.antiviral.2017.03.013.
---------------------------------------------------------------------------

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

    \71\ Pieracci EG, Wallace R, Maskery B, Brouillette, Brown C, 
Joo H. Dogs on the move: Estimating the risk of rabies in imported 
dogs in the United States, 2015-2022. Zoonoses and Public Health 
2024; 00:1-9 DOI: 10.1111/zph.13122.
---------------------------------------------------------------------------

    DMRVV is still a serious public health threat in the more than 100 
countries where it remains enzootic.\72\ Although the U.S. Government 
does not track the precise total number of dogs imported each year, CDC 
previously estimated that approximately 1 million dogs are imported 
into the United States annually, of which 100,000 dogs are from DMRVV 
high-risk countries.\73\ This estimate was based on information 
provided by airlines, CBP, and a public health study conducted at a 
U.S.-Mexico land border crossing.\74\ The re-establishment of DMRVV in 
the United States would near certainly result in human death, cost 
millions of dollars, and require years of dedicated State and Federal 
efforts to eliminate the virus again.
---------------------------------------------------------------------------

    \72\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance 
for Rabies Control Partners for Rabies Prevention. Estimating the 
global burden of endemic canine rabies. PloS Negl Trop Dis 
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
    \73\ HHS/CDC. Guidance Regarding Agency Interpretation of 
``Rabies-Free'' as It Relates to the Importation of Dogs Into the 
United States. 84 FR 724,724-730 (Jan. 31, 2019).
    \74\ McQuiston, J.H., et al., Importation of dogs into the 
United States: risks from rabies and other zoonotic diseases. 
Zoonoses Public Health, 2008. 55(8-10): p. 421-6.
---------------------------------------------------------------------------

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

    \75\ Thomas, S., Wilson, P., Moore, G., Oertli, E., Hicks, B., 
Rohde, R., Johnston, D. (2005). Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association, 227(5),785-92. Doi: 10.2460/javma.2005.227.785.
    \76\ Sterner, R., Meltzer, M., Shwiff, S., Slate, D. (2009). 
Tactics and Economics of Wildlife Oral Rabies Vaccination, Canada 
and the United States. Emerging Infectious Diseases, 15(8), 1176-
1184. Doi: 10.3201/eid1508.081061.
    \77\ Sarawak records 9 rabies deaths so far this year. The 
Straits Times. May 16,2023.
---------------------------------------------------------------------------

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

    \78\ Velasco-Villa A, Mauldin MR, Shi M, et al. The history of 
rabies in the Western Hemisphere. Antiviral Res. 2017;146:221-232. 
Doi:10.1016/j.antiviral.2017.03.013.
---------------------------------------------------------------------------

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

[[Page 41755]]

States should not update its regulations to ensure the continued 
effectiveness of its dog importation requirements.
    Specifically, updates to dog importation requirements are necessary 
to (1) adapt to increased fraud in importations of dogs; (2) avoid the 
severe disruptions and health risks posed by the re-introduction of 
DMRVV into the United States; and (3) stay ahead of growing gaps in 
rabies control efforts, both abroad and in the United States.
Addressing Increasing Fraud
    HHS/CDC continues to document a marked increase in fraud committed 
by importers of dogs from DMRVV high risk countries.79 80 81 
82 83 84 85 Internationally, there has been significant 
growth within the companion animal breeding industry with increasing 
international trade.\86\ Multiple international and U.S. investigations 
have identified importations of puppies that were too young to meet 
rabies vaccination requirements.87 88 89 90 There is growing 
evidence that criminal networks are becoming involved in the lucrative 
dog trade, and the illegal puppy trade was reported to have increased 
during the pandemic.91 92 93
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    \79\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2021-2024. Accessed: 26 March 2024.
    \80\ Centers for Disease Control and Prevention. Dog Import 
Permit Application System. Dog permit importation data, 2021-2024. 
Accessed: 26 March 2024.
    \81\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PloS ONE,16(9), e0254287. Doi: 10.1371/
journal.pone.0254287.
    \82\ Kaila M, Marjoniemi J, Nokireki T. Comparative study of 
rabies antibody titers of dogs vaccinated in Finland and imported 
street dogs vaccinated abroad. Acta Vet Scand 2019; 61:15.
    \83\ Maher J, Wyatt T. European illegal puppy trade and 
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
    \84\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \85\ Cocchi M, Danesi P, DeZan G, Leati M, Gagliazzo L, et al. A 
three-year biocrime sanitary surveillance on illegally imported 
companion animals. Pathogens. 2021; 10(80):1-12.
    \86\ Maher J, Wyatt T. European illegal puppy trade and 
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
    \87\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PloS ONE,16(9), e0254287. Doi: 10.1371/
journal.pone.0254287.
    \88\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \89\ Cocchi M, Danesi P, DeZan G, Leati M, Gagliazzo L, et al. A 
three-year biocrime sanitary surveillance on illegally imported 
companion animals. Pathogens. 2021; 10(80):1-12.
    \90\ Houle MK. Perspective from the field: Illegal puppy imports 
uncovered at JFK airport. 2017. Available at: www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html.
    \91\ Maher J, Wyatt T. Rural-urban dynamics in the UK illegal 
puppy trade: trafficking and trade in man's best friend. 
International Journal of Rural Law and Policy. 2019; 9 (2): 1-20.
    \92\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \93\ British Broadcasting Corporation. Illegal puppy trade 
warning as sales boom during the COVID pandemic. 18 NOV 2020. 
British Broadcasting Corporation News.
---------------------------------------------------------------------------

    Additionally, reports of international movement of animals with 
missing microchips, no proof of rabies vaccination, or underage dogs 
with fraudulent vaccination records have been documented in the United 
States and abroad.94 95 A rabies serological (antibody) 
titer is an estimation of an immune response against rabies virus 
(either through exposure or vaccination). While there is no 
``protective'' titer against rabies virus, survival against rabies 
virus infection is often more likely to occur the higher the animal's 
titer at the time of infection.\96\ The World Organisation for Animal 
Health considers a level of 0.5 IU/mL a ``passing'' antibody titer 
level. A 2015 study found that 53% of imported rescue dogs arriving in 
Norway with rabies vaccinations administered at least 21 days before 
arrival had titers less than 0.5 IU/mL.\97\ Nineteen percent of dogs in 
the study had titers less than 0.1 IU/mL, ``raising concerns as to 
whether they had been vaccinated against rabies at all.'' \98\ A study 
of over 20,000 dogs imported into Italy between 2006 and 2012 found 13% 
of imported dogs had titers less than 0.5 IU/mL, raising similar doubts 
about compliance with vaccination requirements.\99\ A Canadian study 
conducted between October 2021 and November 2022 found that nearly half 
(32/67; 47.8%) of imported rescue dogs had titers less than 0.5 IU/mL 
and 34% (23/67) had no detectable rabies titer, despite all dogs having 
been imported within one month with a current rabies vaccination 
certificate.\100\ Importers are increasingly resorting to falsifying 
the ages of dogs and submitting certificates for other animals while 
also submitting titer results from other animals or changing the titer 
results of the dogs being imported. This increase in instances of 
fraudulent rabies vaccination documents combined with increases in 
international dog movement presents an ongoing and significant risk of 
importation of DMRVV.
---------------------------------------------------------------------------

    \94\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PloS ONE,16(9), e0254287. Doi: 10.1371/
journal.pone.0254287.
    \95\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \96\ CDC. Rabies Serology. Available at: www.cdc.gov/rabies/specific_groups/hcp/serology.html#What%20Does%20A%20Rabies%20Virus%20Titer%20Mean?
    \97\ Klevar S, Hogasen HR, Davidson RK, Hammes IS, Treiberg 
Berndtsson L, LundA. Cross-border transport of rescue dogs may 
spread rabies in Europe. The Veterinary Record. 2015; 176 (26): 672.
    \98\ Id.
    \99\ Rota Modari E, Alonso S, Mancin M, De Nardi M, Hudson-Cooke 
S, Veggiato C, et al. Rabies vaccination: higher failure rates in 
imported dogs than those vaccinated in Italy. Zoonoses and Public 
Health 2022; 64 (2): 146-55.
    \100\ Weese S. Rabies titers in dogs imported into Ontario, 
Canada (2021-2022). Abstract submitted to Canadian Association of 
Veterinary Epidemiology and Preventative Medicine (CAVEPM) 
Conference 2023.
---------------------------------------------------------------------------

    For instance, in 2015 a rabid dog was part of a group of eight dogs 
and 27 cats imported from Egypt by an animal rescue group. The dog had 
an unhealed leg fracture and began showing signs of rabies four days 
after arrival. Following the DMRVV diagnosis, animal rescue workers in 
Egypt admitted that the dog's rabies vaccination documentation had been 
intentionally falsified to evade CDC entry requirements.\101\ As a 
result of this single importation, public health officials recommended 
that 18 people receive rabies PEP, seven dogs underwent a six-month 
quarantine, and eight additional dogs housed in the same home as the 
rabid dog had to receive rabies booster vaccinations and undergo a 45-
day monitoring period.\102\
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    \101\ Sinclair JR, Wallace RM, Gruszynski K, et al. Rabies in a 
dog imported from Egypt with a falsified rabies vaccination 
certificate--Virginia, 2015. MMWR Morb Mort Wkly Rep 2015;64:1359-
62. https://doi.Org/10.15585/mmwr.mm6449a2.
    \102\ Quarantine periods for animals exposed to rabies can vary 
between 30 days to six months based on several factors, including 
vaccination history, serologic titers or prospective serologic 
monitoring results, or jurisdictional requirements.
---------------------------------------------------------------------------

    In 2017, a flight parent imported four dogs from Egypt on behalf of 
an animal rescue organization. One of the dogs appeared agitated and 
bit the flight parent prior to the flight. A U.S.

[[Page 41756]]

veterinarian examined the dog one day after its arrival and tested the 
dog for rabies. A rabies test showed that the dog was positive for 
DMRVV.\103\ Public health officials recommended that at least four 
people receive rabies PEP, and the remaining three dogs underwent 
quarantine periods ranging from 30 days to six months. An investigation 
revealed the likelihood of falsified rabies vaccination documentation 
presented on entry to the United States.\104\
---------------------------------------------------------------------------

    \103\ The diagnosis of rabies requires laboratory confirmation 
on the basis of a positive result for the direct fluorescent 
antibody test performed on CNS tissue collected post-mortem. 
National Association of State Public Health Veterinarians. 
Compendium of animal rabies prevention and control, 2016. JAVMA 
2016; 248 (5):505-517.
    \104\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a dog 
imported from Egypt--Connecticut, 2017. MMWR Morb Mort Wkly Rep 
2018;67:1388-91. https://doi.org/10.15585/mmwr.mm6750a3.
---------------------------------------------------------------------------

    In 2019, 26 dogs were imported into the United States from Egypt by 
a rescue organization. All dogs had rabies vaccination documentation 
and serologic documentation indicating the presence of rabies 
antibodies in response to immunization, based on results from an 
Egyptian government-affiliated rabies laboratory. However, one dog 
developed signs of rabies three weeks after arrival and later tested 
positive for DMRVV. The resulting public health investigation raised 
suspicions that the rabies vaccination documents and serological test 
results had been falsified for all 26 dogs in the shipment, because 18 
dogs in the shipment lacked serologic evidence of vaccination when re-
tested in the United States. As a result, 44 people were required to 
receive PEP and the 25 other dogs imported on the same flight underwent 
re-vaccination and quarantines that ranged from four to six months. The 
rabid dog had been released into an individual's home because of its 
false paperwork and subsequently had contact with an additional 12 
dogs, all of which had to be revaccinated and undergo quarantine 
periods ranging from 45 days to six months.\105\ The public health 
investigations and administration of rabies PEP to exposed persons in 
this case cost more than $400,000 in State resources.106 107 
As a result of the rabid dog importations that occurred in 2015, 2017, 
and 2019, CDC issued a temporary suspension for dogs entering the 
United States from Egypt.108 109
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    \105\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \106\ Id.
    \107\ Centers for Disease Control and Prevention (2022). Rabies 
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/index.html.
    \108\ 84 FR 20628 (May 10, 2019).
    \109\ CDC implemented this suspension because of the lack of 
veterinary controls available in Egypt to prevent the exportation of 
rabid dogs. With limited exceptions, CDC began requiring a CDC Dog 
Import Permit and documentation of the dog's rabies serologic tests 
from World Organisation for Animal Health (WOAH)-approved 
laboratories for eligible importers. Since these permit and 
serologic test requirements were implemented, no rabid dogs have 
been imported from Egypt.
---------------------------------------------------------------------------

    In June 2021, 33 dogs and one cat were imported into the United 
States from Azerbaijan by an animal rescue organization. All dogs had 
rabies vaccination documents that appeared valid upon arrival in the 
United States. Three days after arrival, one dog developed signs of 
rabies. CDC confirmed the dog was infected with DMRVV known to 
circulate in the Caucasus Mountains region of Azerbaijan. The remaining 
rescue animals exposed to the rabid dog during travel were quickly 
dispersed across nine states, leading to what is believed to be the 
largest, multi-state, imported rabid dog investigation in U.S. 
history.\110\ Eighteen people received PEP to prevent rabies because of 
exposure to the rabid dog. CDC performed the test known as the 
``Prospective Serologic Monitoring'' test on the remaining dogs and the 
public health investigation revealed that improper vaccination 
practices by the veterinarian in Azerbaijan likely contributed to the 
inadequate vaccination response documented in 48 percent of the 
imported animals, including the rabid dog.\111\ The 33 exposed animals 
were revaccinated and placed in quarantine for periods ranging from 45 
days to six months.\112\
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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 
https://www.cdc.gov/worldrabiesday/disease-detectives/rabies-imported-dog.html.
    \112\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan- Pennsylvania, 2021. MMWR Morb Mort 
Wkly Rep 2022; 71: 686-689.
---------------------------------------------------------------------------

Avoiding Disruption of DMRVV Re-Introduction
    The disruption to public health associated with even a single rabid 
dog importation can be significant. For every imported rabid dog, an 
average of 20 people and 21 animals receive post-exposure prophylaxis 
(PEP) or undergo vaccination and quarantine, respectively, resulting in 
a substantial disruption to State and local public health services, a 
considerable cost burden to states, and a significant toll on the 
physical and mental health of exposed persons and animals.
    To manage even one instance of DMRVV exposure, State public health 
officials must immediately pivot from routine or less life-threatening 
responses and initiate multiple actions, some of which are extensive. 
First, the State health department must initiate an in-depth 
investigation to locate all persons and animals who were exposed to the 
rabid dog from the 10 days prior to the dog showing symptoms until the 
dog dies or is euthanized. In many instances, multiple health 
departments are involved and, based on the results of the 
investigation, CDC may be required to notify the World Health 
Organization pursuant to the International Health Regulations. Next, 
State health departments must conduct a rabies risk assessment of all 
individuals affected to determine if they need post-exposure 
prophylaxis (PEP), and if they are determined to be at risk, to 
administer post-exposure prophylaxis. Finally, if any of the 
individuals were scratched or bitten, they may also need wound care, 
tetanus boosters, and/or antibiotics.
    CDC estimates a range of costs for public health investigations and 
subsequent cost of care for people exposed to rabid dogs to be between 
$210,00 and $510,000 per importation event, as summarized in Section 
VI.113 114 This cost estimate does not include the cost to 
evaluate, vaccinate, test, and quarantine exposed animals. This cost 
estimate also does not account for the worst-case outcomes, which 
include: (1) transmission of rabies to a person who dies from the 
disease; and (2) ongoing transmission to other domestic and wildlife 
species in the United States. Finally, these costs do not include the 
cost of re-eliminating DMRVV if it were to be re-established in the 
United States, making this estimate an underestimate of the total cost 
associated with an imported rabid dog.
---------------------------------------------------------------------------

    \113\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \114\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

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

[[Page 41757]]

site of the wound) and protracted; DMRVV is 99% fatal in humans, a 
statistic certain to engender fear and anxiety; and the need to 
quarantine exposed pets can create a sense of great disruption and 
concern.
    Finally, DMRVV becoming re-established in the United States would 
result in costly efforts over many years to eliminate the virus again. 
The extraordinary cost of re-introduction of DMRVV is demonstrated by 
an instance of reintroduction that occurred in Texas, where DMRVV had 
been previously eliminated. The reintroduction resulted in several 
human deaths; the subsequent re-elimination of DMRVV cost $56 million 
(in 2023 USD) and required over 10 years of effort.115 116
---------------------------------------------------------------------------

    \115\ Thomas, S., Wilson, P., Moore, G., Oertli, E., Hicks, B., 
Rohde, R., Johnston, D. (2005). Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association, 227(5),785-92. Doi: 10.2460/javma.2005.227.785.
    \116\ Sterner, R., Meltzer, M., Shwiff, S., Slate, D. (2009). 
Tactics and Economics of Wildlife Oral Rabies Vaccination, Canada 
and the United States. Emerging Infectious Diseases, 15(8), 1176-
1184. Doi: 10.3201/eid1508.081061.
---------------------------------------------------------------------------

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

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

    The COVID-19 pandemic also negatively impacted global canine rabies 
vaccination campaigns, which have yet to recover. Successful canine 
rabies control requires canine mass vaccination coverage equal to or 
greater than 70% of a country's dog population.118 119 
Achieving pre-pandemic vaccination rates for countries that were moving 
toward canine rabies control and elimination prior to the COVID-19 
pandemic could take years to recover, and some countries may require 
even longer periods of time to attain pre-pandemic vaccination levels. 
During the COVID-19 pandemic, canine rabies vaccination campaigns were 
disrupted in many high-risk countries, which resulted in an increase in 
canine and human rabies cases.120 121 This disruption to 
canine vaccination campaigns has been contemporaneous with other 
factors, including: a high volume of dogs being imported into the 
United States, insufficient veterinary controls in DMRVV high-risk 
countries to prevent the export of inadequately vaccinated dogs, 
inadequate global veterinary supply chains for vaccines and related 
materials, and persistent workforce capacity shortages, particularly in 
DMRVV high-risk countries that export dogs to the United States.
---------------------------------------------------------------------------

    \118\ Coleman PG, Dye C. Immunization coverage required to 
prevent outbreaks of dog rabies. Vaccine. 1996 Feb;14(3):185-6. Doi: 
10.1016/0264-410x(95)00197-9. PMID: 8920697.
    \119\ Zinsstag J, D[uuml]rr S, Penny MA, Mindekem R, Roth F, 
Menendez Gonzalez S, Naissengar S, Hattendorf J. Transmission 
dynamics and economics of rabies control in dogs and humans in an 
African city. Proc Natl Acad Sci U S A. 2009 Sep 1;106(35):14996-
5001. Doi: 10.1073/pnas.0904740106. Epub 2009 Aug 17. PMID: 
19706492; PMCID: PMC2728111.
    \120\ Kunkel, A., Jeon, S., Joseph, H., Dilius, P., Crowdis, K., 
Meltzer, M., Wallace, R. (2021). The urgency of resuming disrupted 
dog rabies vaccination campaigns: a modeling and cost-effectiveness 
analysis. Scientific Reports, 11, 12476. Doi:10.1038/s41598-021-
92067-5.
    \121\ Raynor, B., D[iacute]az, E., Shinnick, J., Zegarra, E., 
Monroy, Y., Mena. C., . . . Castillo-Neyra, R. (2021). The impact of 
the COVID-19 pandemic on rabies reemergence in Latin America: The 
case of Arequipa, Peru. PLoS Neglected Tropical Diseases, 15(5), 
e0009414. doi:10.1371/journal.pntd.0009414.
---------------------------------------------------------------------------

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

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

    Global veterinary workforce capacity and veterinary supply chain 
shortages that have led to delayed or disrupted care for dogs (and 
other pets), and that were exacerbated by the COVID-19 pandemic, still 
remain today. The lack of veterinarians, veterinary technicians, and 
other animal care staff who are available to provide care for dogs 
prior to travel, combined with a lack of veterinary supplies such as 
drugs and vaccines, increase the likelihood dogs imported into the 
United States may pose a public health 
threat.124 125 126 127 Challenges with rabies vaccine 
administration, distribution, potency, quality, and storage in many 
countries also contribute to inadequate protection against rabies prior 
to the pandemic; these challenges continue as public health 
infrastructure recovers post-pandemic.128 129 130 131
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    \124\ https://www.theatlantic.com/health/archive/2022/07/not-enough-veterinarians-animals/ 661497/.
    \125\ https://www.agcanada.com/2021/07/is-the-veterinarian-
shortage-real-or-
regional#:~:text=A%20perceived%20global%20shortage%20of%20veterinaria
ns%20is%20creating,for%20the%20quality%20of%20care%20they%20can%20off
er.
    \126\ https://www.thebusinessresearchcompany.com/report/companion-animal-veterinary-vaccines-global-market-report.
    \127\ https://7news.com.au/lifestyle/pets/aussie-dog-owners-warned-of-national-vaccine-shortage-as-deadly-bacterial-disease-spreads-c-8568550.
    \128\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies 
vaccine quality and low immunization coverage in dogs in China. 
Epidemiol Infect. 2008; 136: 1556-63.
    \129\ Yale G, Sudarshan S, Taj S, Patchimuthu GI, Mangalanathan 
BV, et al. Investigation of protective level of rabies antibodies in 
vaccinated dogs in Chennai, India. VetRecord. 2021; 8: e8.
    \130\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan- Pennsylvania, 2021. MMWR Morb Mortal 
Wkly Rep 2022; 71: 686-689.
    \131\ Rota Modari E, Alonso S, Mancin M, De Nardi M, Hudson-
Cooke S, Veggiato C, et al. Rabies vaccination: higher failure rates 
in imported dogs than those vaccinated in Italy. Zoonoses and Public 
Health 2022; 64 (2): 146-55.

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[[Page 41758]]

    Comment: CDC received comments stating that the current regulation 
for dogs and cats is sufficient or that CDC should keep its current 
importation system in place. Because the commenter did not elaborate on 
what they meant by the term ``current importation system,'' CDC assumes 
that this refers to requirements under the temporary suspension.
    Response: CDC disagrees that current regulations are sufficient to 
prevent the reintroduction of DMRVV into the United States. CDC notes 
that its Federal quarantine regulations (currently found at 42 CFR 
71.51) controlling the entry of dogs and cats into the United States 
have not been substantively updated in decades. The final rule includes 
many improvements in terms of public health protection against the 
reintroduction of DMRVV over the current regulations. Among other 
things, the final rule removes the current requirement for a valid 
rabies vaccine certificate in 42 CFR 71.51(c) and replaces it with 
standardized rabies vaccination forms that better prevents importers 
from submitting fraudulent rabies documentation. The use of 
standardized forms also helps ensure that foreign-vaccinated dogs 
imported from DMRVV high-risk countries meet CDC entry requirements 
prior to traveling to the United States and allows for follow-up with 
the exporting country's government officials if needed. The final rule 
further requires pre-arrival rabies serologic testing, as well as 
revaccination, examination, and, in some cases, quarantine upon arrival 
at a CDC-registered ACF for foreign-vaccinated dogs from DMRVV high-
risk countries. Additionally, the final rule requires that all dogs be 
microchipped at the time of admission. Microchips are a widely used 
method of confirming the dogs' identity and help prevent importers from 
fraudulently presenting dogs for admission that do not match the dogs' 
accompanying health records. Finally, the provisions in this final rule 
are estimated to reduce the number of dogs arriving ill or dead, which 
should in turn conserve agency resources by diminishing the need for 
CDC to conduct public health investigations to rule out whether the 
dogs may have died of a zoonotic disease of public health concern, 
including DMRVV.
    CDC also disagrees that it should maintain the same system in place 
as it used during the temporary suspension. Beginning in June 2021, CDC 
published a temporary suspension of dogs entering the United States 
from DMRVV high-risk countries. The temporary suspension created a 
system that, among other things, implemented the use of standardized 
forms, required titer test results demonstrating the presence of rabies 
antibodies in dogs, and authorized a private network of ACF allowing 
for the immediate quarantine of dogs from DMRVV high-risk countries 
arriving with inadequate proof of titers. Although this final rule 
implements a similar regulatory framework based on the documented 
successes of the temporary suspension, there are important differences. 
Unlike during the temporary suspension, the final rule does not rely on 
CDC issuing CDC Dog Import Permits for foreign-vaccinated dogs from 
DMRVV high-risk countries. Rather, the final rule relies on the network 
of private ACF to examine, revaccinate, and quarantine (if necessary) 
foreign-vaccinated dogs from DMRVV high-risk countries. The final rule 
adopts this system instead of the permit system used during the 
temporary suspension because issuing permits costs CDC more in terms of 
personnel and IT services. By replacing the permitting system for 
foreign-vaccinated dogs from DMRVV high-risk countries with a system of 
ACF, CDC anticipates a reduction in costs and staff time associated 
with dog importation because the importer will bear the costs of 
examination, revaccination, and quarantine (if needed) at an ACF.
    During the temporary suspension CDC also continued to document 
attempts by importers to submit fraudulent documentation to receive a 
CDC Dog Import Permit. CDC recognized there is limited value in 
reviewing paperwork alone because physical inspection of animals in 
combination with a review of paperwork submitted by importers has a 
greater likelihood of allowing CDC to detect both fraudulent paperwork 
and communicable diseases of concern in dogs. For example, in 2002-
2023, ACF found several ticks on imported dogs. Investigation by CDC 
and USDA determined these were novel, exotic ticks that had never been 
found in the Western hemisphere. The health impacts of these ticks on 
people, livestock, wildlife, and pets are unknown because they have not 
been studied previously. Physical examination of dogs, which is crucial 
for rabies detection, at the ACF was also instrumental in detecting and 
preventing the introduction of these novel ticks in the United States.
    Comment: HHS/CDC received comments that the NPRM is not needed 
because U.S. states already regulate rabies control within the United 
States.
    Response: HHS/CDC disagrees with these comments. Although U.S. 
States establish requirements relating to rabies vaccination and 
control within their own jurisdictions, it is HHS/CDC's role to 
regulate the importation of dogs into the United States from foreign 
countries. The final rule should reduce the burden on state, local, and 
territorial public health and animal health agencies and support U.S. 
State requirements. As noted above, a single importation of a DMRVV-
infected dog can cost affected State governments hundreds of thousands 
of dollars for the ensuing public health investigations and rabies 
post-exposure prophylaxis (PEP) treatments administered to exposed 
persons. The cost to State and local governments can balloon 
significantly in the case of worst-case outcomes, which include: (1) 
transmission of rabies to a person who dies from the disease; and (2) 
ongoing transmission to other domestic and wildlife species in the 
United States.
    There have been significant challenges for State and Federal 
agencies in enforcing or verifying vaccination requirements in 
internationally imported animals. In 2021, the importation of a rabid 
dog resulted in a ten-state multi-agency investigation to locate all 
people and animals exposed to the rabid dog. It was the largest 
investigation of an imported rabid dog, to date, and required immense 
resources and time from multiple states to complete. Furthermore, HHS/
CDC received comments from Federal, State, and Local government 
agencies in support of this rule. State and local government agencies 
expressed support for requiring veterinary examination, revaccination, 
and quarantine (if needed) of dogs on arrival to reduce the burden on 
these agencies. These commenters also noted that these practices would 
also reduce the public health risk that imported dogs pose to U.S. 
communities, domestic pets, and wildlife and would improve the 
government's ability to identify dogs with diseases or external 
parasites before they enter the United States.
    This final rule will reduce the enforcement burden on jurisdictions 
and help to ensure all foreign-vaccinated dogs are vaccinated with a 
USDA-licensed vaccine on arrival, thereby reducing the public health 
risk of these dogs and bringing the dogs into

[[Page 41759]]

compliance with rabies control requirements.
    Comment: One commenter asserted the rule was unnecessary because 
the increase in numbers of imported dogs was due to the COVID-19 
pandemic and the pandemic has now ended.
    Response: CDC disagrees with this comment because demand for dogs 
from abroad has remained high since the pandemic. Further, the pandemic 
disrupted rabies control programs in high-risk countries, a trend that 
persists today and increases the risk of DMRVV importations.
    Since 2021, the demand for puppies and rescue dogs has remained 
high. The trend in purchasing and rescuing dogs from abroad has been 
noted in many countries, including the United 
States.132 133 134 135 Internationally, there has been 
significant growth within the companion animal breeding industry with 
increasing international trade.\136\ Multiple international and U.S. 
investigations have identified importations of puppies that were too 
young to meet rabies vaccination 
requirements.137 138 139 140 In addition, there is growing 
evidence that criminal networks are becoming involved in the lucrative 
dog trade, and the illegal puppy trade was reported to have increased 
during the pandemic.141 142 143 Because imported dogs will 
typically encounter multiple people, pets, and other animals throughout 
their journey--beginning at the airport in the country of departure and 
continuing with the airline, through the U.S. port, and pet adoption 
and pet socialization process--an increase in inadequately vaccinated 
dogs likewise increases the risk of human and animal exposure.\144\
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    \132\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PloS ONE,16(9), e0254287. Doi: 10.1371/
journal.pone.0254287.
    \133\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. 20 May 
2021.
    \134\ Morgan L, Protopopova A, Birkler RID, Itin-Shwatz B, 
Sutton G, Gamliel A, et al. Human-dog relationships during the 
COVID-19 pandemic: booming dog adoption during social isolation. 
Humanities and Social Science Communications. 2021; 7(150): 1-11.
    \135\ Velez M. I adopted my dog Cannoli from overseas. It's 
easier than you think. 9/20/2020. Available at: http://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think.
    \136\ Maher J, Wyatt T. European illegal puppy trade and 
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
    \137\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
    \138\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \139\ Cocchi M, Danesi P, DeZan G, Leati M, Gagliazzo L, et al. 
A three-year biocrime sanitary surveillance on illegally imported 
companion animals. Pathogens. 2021; 10(80):1-12.
    \140\ Houle MK. Perspective from the field: Illegal puppy 
imports uncovered at JFK airport. 2017. Available at: www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html.
    \141\ Maher J, Wyatt T. Rural-urban dynamics in the UK illegal 
puppy trade: trafficking and trade in man's best friend. 
International Journal of Rural Law and Policy. 2019; 9 (2): 1-20.
    \142\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \143\ British Broadcasting Corporation. Illegal puppy trade 
warning as sales boom during the COVID pandemic. 18 NOV 2020. 
British Broadcasting Corporation News.
    \144\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------

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

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

B. General Comments on Burden

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

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

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

[[Page 41760]]

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

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

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

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

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

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

C. Comments on Exemptions for Certain Groups

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

    \150\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a dog 
imported from Egypt--Connecticut, 2017. MMWR Morb Mort Wkly Rep 
2018;67:1388-91. https://doi.org/10.15585/mmwr.mm6750a3.
---------------------------------------------------------------------------

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

[[Page 41761]]

implementing the temporary suspension on importation of dogs from DMRVV 
high-risk countries. On June 16, 2021, HHS/CDC announced that temporary 
suspension to protect the public's health. Through the temporary 
suspension, CDC implemented requirements for importers of dogs from 
DMRVV high-risk countries. From July 14, 2021, to June 9, 2022, CDC 
issued CDC Dog Import Permits on a limited basis, for persons 
permanently relocating to the United States, importers of government-
owned working dogs, or owners of service animals to alleviate the 
potential burden of the temporary suspension for these categories of 
importers.
    On June 10, 2022, HHS/CDC modified the temporary suspension to 
allow commercial importations of dogs from DMRVV high-risk countries 
through ACF. On July 10, 2023, HHS/CDC extended the temporary 
suspension without modifications through July 31, 2024, because of a 
continued risk of reintroduction of DMRVV due to insufficient 
veterinary controls in DMRVV high-risk countries to prevent the export 
of inadequately vaccinated dogs and veterinary supply chain and 
workforce capacity shortages that have persisted since the global 
COVID-19 pandemic.
    During the period of the temporary suspension, HHS/CDC attempted to 
differentiate between personal pets and commercial dog imports and 
received hundreds of applications from commercial importers claiming to 
be importing dogs as personal pets. Although CDC was able to identify 
some of these cases and revoke dog import permits for ineligible 
importers, doing so was difficult and required extensive communication 
between CDC and other port partners such as CBP and USDA. As this 
experience shows, the stronger approach provided for in this final rule 
is to tailor importation requirements based on factors with a 
relationship to DMRVV risk, namely the country of origin and the dog's 
vaccination status (U.S.-versus foreign-vaccinated), as opposed to the 
category of importer (e.g., commercial importer) or type of dog (e.g., 
personal pet). Further, this approach conserves Federal agency 
resources that would otherwise be used in investigating and responding 
to potential instances of fraud.
    In sum, basing importation requirements on a dog's vaccination 
status and its potential exposure to DMRVV (i.e., whether it has been 
recently been in a high-risk DMRVV country) is the best way to evaluate 
the DMRVV risk of an imported dog; basing requirements on the purpose 
of the importation, occupation or nationality of the importer, or the 
breed or working status of the dog would be an ineffective means for 
evaluating DMRVV risk, would increase incentives for fraud in the ways 
mentioned above, and be difficult to implement. Because HHS/CDC is not 
basing importation requirements on the type of importer, there is no 
reason for the final rule to define specific categories of importer 
(e.g., pet owner, rescue organization, commercial importer).
    Comment: HHS/CDC received over 400 comments from U.S. Government 
(USG) employees and members of the U.S. military objecting to the 
proposed rule. Some of these commenters stated that these groups should 
be given special exemption to import dogs without meeting some or all 
of the proposed requirements. Other commenters stated that they 
believed that the proposed rule was specifically targeting USG 
employees. Some of these commenters asserted that the proposed rule is 
unnecessary because USG employees and military members are less likely 
to commit fraud and purportedly provide a higher standard of care for 
their dogs when compared to other dog owners, thereby negating the 
rabies risk. Commenters noted potential financial burdens and hardships 
when having to route through ports with ACF or having to pay for 
titers.
    Response: HHS/CDC disagrees that USG employees and members of the 
U.S. military should be exempt from any or all importation 
requirements. CDC has no data to support the proposition that dogs 
owned by USG employees or members of the U.S. military are better cared 
for than other dogs or that individuals in these groups are less likely 
to attempt to import dogs with falsified documents or fraudulent or 
insufficient titers. CDC has documented multiple instances of falsified 
documents, including intentionally altered import permits, forged titer 
results, and falsified rabies vaccination records, submitted by U.S. 
government employees and military service members both during and prior 
to CDC's temporary suspension of dogs entering the United States from 
high-risk countries. CDC reported violations to the USDA, the 
Department of Defense, and the State Department for internal 
investigation. Additionally, CDC has documented numerous reports of 
U.S. government employees, including military service members, adopting 
stray dogs while stationed overseas. CDC supports the human-animal bond 
and recognizes the important role these animals play in the lives of 
government employees and service members stationed overseas; however, 
the employment status of the importer does not affect the dog's 
potential risk of carrying DMRVV. Adopted stray dogs often have unknown 
rabies exposure history, have received little or no veterinary care or 
vaccines, and can present a risk of DMRVV just like any other dog that 
has been in a high-risk country with an unconfirmed vaccination status. 
Vaccination, titer, and quarantine requirements are essential to 
protect USG employees, service members, and their families as well as 
the U.S. communities these dogs are being introduced into when they 
arrive in the United States. Furthermore, HHS/CDC strongly disagrees 
that this final rule specifically targets USG employees. This rule 
bases its importation requirements on the risk profile of the dog's 
country of origin and the dog's vaccination status (U.S.-versus 
foreign-vaccinated), and not the type of importer. It imposes no 
additional requirements on USG employees or members of the U.S. 
military compared to any other importers. Finally, the State Department 
has made relocation funds available to U.S. government staff for 
quarantine fees or titer services. Additionally, there are CDC-approved 
laboratories providing discounted services for USG employees. In sum, 
the risk of DMRVV importation is best determined based on a dog's 
vaccination status and its recent presence in a DMRVV high-risk country 
rather than the employer of the importer. Thus HHS/CDC declines to 
create a specific exemption for USG employees and military members.
    Comment: HHS/CDC received comments noting that USG employees, 
members of the U.S. military, U.S. citizens, and U.S. permanent 
residents often need to return to the United States quickly with their 
families when an unexpected crisis develops in a foreign country, and 
that exemptions should be provided in these instances. Some comments 
said exceptions should be made or requirements should be different for 
emergency situations without specifying a category of importer that 
should be exempted.
    Response: HHS/CDC recognizes that USG employees, members of the 
U.S. military, U.S. citizens, and U.S. permanent residents often need 
to return to the United States quickly with their families when an 
unexpected crisis develops in a foreign country. In these scenarios, 
CDC works closely with the U.S. State Department on a case-by-case 
basis regarding emergency departures from foreign countries. CDC has 
assisted the U.S. State Department with more than ten evacuations 
during the

[[Page 41762]]

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

[[Page 41763]]

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

D. Comments on Specific Provisions of the Proposed Rule

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

[[Page 41764]]

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

[[Page 41765]]

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

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

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

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

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

[[Page 41766]]

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

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

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

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

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

[[Page 41767]]

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

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

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

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

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

    \158\ Personal communication with C. Williams, CDC. October 
24,2023.
    \159\ American Veterinary Medical Association. Microchipping 
FAQ. https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq. Accessed June 1, 
2023.
---------------------------------------------------------------------------

    The microchip requirement will also promote greater confidence in 
the information recorded on the rabies vaccination records and prevent 
fraud. CDC has documented several instances of importers attempting to 
import an unvaccinated dog using the vaccination paperwork for another 
dog.\160\ By requiring microchips, which will be verified by the ACF 
during revaccination and examination, CDC can ensure the paperwork for 
foreign-vaccinated dogs from DMRVV high-risk countries matches the 
microchip implanted in the dog.
---------------------------------------------------------------------------

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

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

[[Page 41768]]

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

    \161\ American Veterinary Medical Association. Microchipping 
FAQ. https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq. Accessed June 1, 
2023.
---------------------------------------------------------------------------

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

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

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

[[Page 41769]]

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

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

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

[[Page 41770]]

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

[[Page 41771]]

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

    \164\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies 
vaccine quality and low immunization coverage in dogs in China. 
Epidemiol Infect 2008;136: 1556-1563.
    \165\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M, 
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines 
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi: 
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
    \166\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan--Pennsylvania, 2021. MMWR Morb Mortal 
Wkly Rep 2022; 71: 686-689
---------------------------------------------------------------------------

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

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

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

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

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

[[Page 41772]]

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

    \172\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies 
vaccine quality and low immunization coverage in dogs in China. 
Epidemiol Infect 2008;136: 1556-1563.
    \173\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M, 
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines 
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi: 
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
    \174\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M, 
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines 
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5).
    \175\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan- Pennsylvania, 2021. MMWR Morb Mortal 
Wkly Rep 2022; 71: 686-689.
---------------------------------------------------------------------------

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

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

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

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

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

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

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

[[Page 41773]]

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

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

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

[[Page 41774]]

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

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

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

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

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

[[Page 41775]]

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

[[Page 41776]]

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

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

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

[[Page 41777]]

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

[[Page 41778]]

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

[[Page 41779]]

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

[[Page 41780]]

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

[[Page 41781]]

transport abandoned, ill, or injured dogs and dogs denied entry 
awaiting return to their country of origin to an HHS/CDC-approved 
facility. The commenter suggested that the six-hour window is arbitrary 
and not supported by corroborative evidence and requested 24 hours to 
transport these dogs from cargo warehouses to veterinary clinics or 
kennel facilities, and six hours to notify HHS/CDC of the abandoned, 
ill, or injured dogs. HHS/CDC also received many comments from public 
health partners, animal welfare groups, importers, and rescue groups 
supporting the six-hour timeframe for airlines to transport abandoned, 
ill, or injured dogs or dogs awaiting return to their country of origin 
to a veterinary or kennel facility for examination or care.
    Response: HHS/CDC appreciates these comments and notes that it has 
carefully considered the proposed 6-hour timeframe based on concerns 
relating to the burden on the carrier and to the health and safety of 
animals detained pending a determination as to their admissibility and 
workers who may interact with these animals. HHS/CDC anticipates that 
significantly increasing the time airlines are allowed to keep dogs in 
cargo warehouses (from 6 hours to 24 hours) would result in an increase 
in illness and deaths in dogs. An increase in ill dogs and dogs dead on 
arrival would negatively impact Federal and State public health 
resources because CDC would need to conduct a public health 
investigation into the cause of the illness or death. CDC conducted an 
average of 38 animal health investigations per year between 2019-2023. 
Each illness/death investigation can cost between $100-$5,500 per event 
($3,800-$209,000 per year in public health costs to State or Federal 
agencies).\188\
---------------------------------------------------------------------------

    \188\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk 
factors for death and illness in dogs imported into the United 
States, 2010-2018. Transboundary and Emerging Diseases, 2022; 1-9.
---------------------------------------------------------------------------

    Additionally, CDC notes that cargo warehouse staff are not trained 
to feed/water/care for animals and that detaining animals for long 
periods of time increases the health risks to the animals as well as 
the potential risk of injury or expose to workers. Expanding the 
timeframe for airlines to house dogs in cargo warehouses necessitates 
additional care from cargo warehouse staff, thereby increasing the risk 
of bites, scratches, and other injuries from dogs. Additionally, the 
stress dogs experience during transport could exacerbate the risk of 
injury to cargo warehouse workers. CDC has documented instances of 
cargo warehouse staff leaving animals unattended in their crates 
without food, water, or access to elimination areas outside their 
crates for prolonged periods of time. Prolonged wait times in cargo 
warehouses have also led to illness and death in multiple animals (five 
illnesses and one death in 2019; and two deaths in 2023).
    Consistent with USDA regulations, animals should receive food at a 
minimum every 24 hours and water every 12 hours during 
transport.\189\Additionally, animals must have their enclosures and 
food and water receptacles cleaned every 24 hours. CDC and USDA have 
documented numerous shipments of animals that did not have adequate 
food and water during transport, nor were their cages cleaned as 
required. Lengthy international flights, which can begin for a crated 
animal up to 4 hours before the flight departs and includes the flight 
time (6-16 hours) plus a 24-hour wait in a cargo hold, will leave many 
animals exceeding this feeding/watering/cleaning period leading to 
dehydration, hypoglycemia, illness, or death. Neglect of basic animal 
care, such as feeding and watering, has a direct public health impact 
on CDC as noted above because CDC must investigate every report of 
illness or death in an imported animal to determine the public health 
risk.
---------------------------------------------------------------------------

    \189\ USDA. Animal Welfare Act and Animal Welfare Regulations. 
Title 9, Chapter 1, Subpart A, Part 3.9, 3.10, 3.14, 3.17). https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_version.pdf.
---------------------------------------------------------------------------

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

[[Page 41782]]

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

[[Page 41783]]

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

    \190\ CDC. Extension of temporary suspension of dogs entering 
the United States from countries with a high risk of rabies. 88 FR 
43570 (July 10, 2023): 43570-43581.
---------------------------------------------------------------------------

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

E. General Comments Relating to DMRVV High-Risk Countries

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

    \191\ World health Organization. www.who.int/news-room/fact-sheets/detail/rabies.
---------------------------------------------------------------------------

    The robust rabies control programs present in the United States do 
not exist in many other countries due to a variety of factors, such as 
access to veterinary care, sufficient infrastructure to support 
adequate vaccination, and lack of veterinarians or animal support staff 
trained to vaccinate animals.\192\ Many DMRVV high-risk countries do 
not have adequate rabies surveillance and testing capacity and 
therefore do not report cases to WOAH even though rabies is widespread 
within their country. For example, in 2021 only 35 countries reported 
rabies case data to WHO and none reported on the number of suspected 
cases that underwent testing. Until countries report complete data 
routinely, relying on international organizations' data to make risk 
determinations will remain problematic. A lack of rabies surveillance 
data is more likely to reflect a poor public health infrastructure for 
rabies case detection within a country than the absence of rabies.
---------------------------------------------------------------------------

    \192\ Wallace RM, Undurraga EA, Blanton JD, Cleaton J, Franka R. 
Elimination of Dog-Mediated Human Rabies Deaths by 2030: Needs 
Assessment and Alternatives for Progress Based on Dog Vaccination. 
Front Vet Sci. 2017 Feb 10;4:9. doi: 10.3389/fvets.2017.00009. PMID: 
28239608; PMCID: PMC5300989.
---------------------------------------------------------------------------

    CDC evaluates and updates the DMRVV high-risk country list every 
year and posts the updated list on CDC's website by April 1. For this 
annual country risk assessment, CDC subject matter experts review 
publicly available data, including data from international 
organizations (including the World Health Organization (WHO); the WHO 
Rabies Bulletin--Europe; the Pan-American Health Organization, and 
WOAH); published government reports; scientific publications; and 
outbreak report alerts such as ProMED,\193\ as well as information 
provided by national and international rabies experts. HHS/CDC will 
also review the information and re-assess a country's status when 
presented with additional substantial data to support canine rabies-
free status by a foreign country's officials. Lastly, CDC has published 
the criteria for how it determines a country's classification as a 
high-risk, low-risk and DMRVV-free country in a peer-reviewed journal 
which is publicly available.194 195
---------------------------------------------------------------------------

    \193\ The Program for Monitoring Emerging Diseases (ProMED) is a 
program of the International Society for Infectious Diseases and is 
available at https://promedmail.org/.
    \194\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K, 
et al. A country classification system to inform rabies prevention 
guidelines and treatment. Journal of Travel Medicine, 
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
    \195\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis 
of available animal testing data to propose peer-derived 
quantitative thresholds for determining adequate surveillance 
capacity for rabies. Scientific Reports 2023; 13: 3986.
---------------------------------------------------------------------------

    Comment: HHS/CDC received questions asking why HHS/CDC's DMRVV 
high-risk country list differs from those used by other countries, 
including the European Union.
    Response: HHS/CDC notes that it is not unusual for different 
countries to use different methods, criteria, or data for determining a 
country's rabies risk level. CDC's list is very similar and closely 
aligns with the lists used by the EU, Australia, New Zealand, and 
Canada. However, HHS/CDC notes that the entry requirements for dogs 
from DMRVV high-risk countries differ significantly for the EU and 
Australia because those countries having stricter entry requirements 
than those outlined in this final rule. CDC's method for developing the 
high-risk country list is described in detail above.
    Comment: HHS/CDC received questions asking why CDC's list of 
approved laboratories differs from the laboratories on the EU list. 
Commenters also noted there were limited or no laboratories in certain 
regions of the world, or that shipping samples was cost prohibitive and 
challenging. Commenters noted the lack of CDC-approved laboratories in 
Asia, Africa, and South America was discriminatory toward U.S. citizens 
and tourists from those regions.
    Response: CDC acknowledges that there are limited or no 
laboratories in certain regions of the world. For this reason, CDC has 
included the option to quarantine at an ACF if they cannot obtain a 
titer for their dog. Prior to 2022, the Nancy Laboratory for Rabies and 
Wildlife which is part of the French Agency for Food, Environmental and 
Occupational Health Safety (ANSES) conducted the global proficiency 
testing

[[Page 41784]]

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

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

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

[[Page 41785]]

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

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

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

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

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

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

[[Page 41786]]

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

[[Page 41787]]

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

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

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

    \206\ CDC. Human Rabies--Alabama, Tennessee, and Texas, 1994. 
MMWR 1995; 44(14): 269-272.
    \207\ Sidwa, T., Wilson, P., Moore, G., Oertli, E., Hicks, B., 
Rohde, R., Johnston, D. (2005). Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association, 227(5),785-92. doi: 10.2460/javma.2005.227.785.
    \208\ Sterner, R., Meltzer, M., Shwiff, S., Slate, D. (2009). 
Tactics and Economics of Wildlife Oral Rabies Vaccination, Canada 
and the United States. Emerging Infectious Diseases, 15(8), 1176-
1184. doi: 10.3201/eid1508.081061.
---------------------------------------------------------------------------

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

    \209\ Tuah L., Sabri MSM, Hashim M, Hashim M. (Dec. 8, 2022) 
Spatial Risk Assessment on Spread of Dog-Mediated Rabies in Sarawak. 
SEACFMD Joint EpiNet and LabNet Virtual meeting. https://rr-asia.woah.org/wp-content/uploads/2022/12/4-seacfmd__mcda-spatial-risk-assessment-on-rabies-in-sarawak.pdf. Accessed November 9, 2023.
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    While the estimated monetized costs of this final rule 
significantly exceed estimated monetized benefits, HHS/CDC was not able 
to monetize the potential benefits associated with reducing the risk of 
re-introduction of DMRVV in the United States. This could increase 
costs for dogs traveling from the United States to DMRVV-free countries 
for all dogs leaving the United States. This would include dogs that 
later return to the United States. These costs would be in addition to 
any public health response efforts as discussed above when DMRVV was 
re-introduced from Mexico to Texas.
    HHS/CDC also disagrees that the final rule is overly burdensome on 
importers

[[Page 41788]]

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

G. Other Comments

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

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

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

[[Page 41789]]

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

[[Page 41790]]

final rule were implemented during the temporary suspension and are 
therefore, already in place and are general, widespread knowledge. 
Importers were able to adapt quickly under the temporary suspension and 
CDC anticipates the same will be true of the final rule given the 
similarities with the requirements already in place through the 
temporary suspension.
    Comment: HHS/CDC received comments that the proposed requirements 
infringe on individuals' rights and freedoms. The commenter did not 
specify further which individual rights and freedoms they believed 
would be infringed by the final rule.
    Response: Because the commenter did not specify further, HHS/CDC 
assumes that the commenter meant to refer to due process rights that 
may be protected by the Fifth and Fourteenth Amendments to the U.S. 
Constitution. However, HHS/CDC disagree that the final rule implicates 
any rights or interests protected by the Due Process Clause. Where 
applicable, the Due Process Clause ``imposes procedural constraints on 
governmental decisions that deprive individuals of liberty or property 
interests.'' Nozzi v. Hous. Auth. of City of Los Angeles, 806 F.3d 
1178, 1190 (9th Cir. 2015). However, ``[d]ue process protections extend 
only to deprivations of protected interests.'' Shinault v. Hawks, 782 
F.3d 1053, 1057 (9th Cir. 2015). Because individuals have no protected 
property or liberty interest in importing dogs or other animals into 
the United States, the final rule does not infringe upon any due 
process rights protected by the U.S. Constitution. See Ganadera Ind. v. 
Block, 727 F.2d 1156, 1160 (D.C. Cir. 1984) (``no constitutionally-
protected right to import into the United States''); see also Arjay 
Assoc. v. Bush, 891 F.2d. 894, 896 (Fed. Cir. 1989) (``It is beyond 
cavil that no one has a constitutional right to conduct foreign 
commerce in products excluded by Congress.'').
    Comment: CDC received a comment stating that ``CDC is a quasi-
governmental agency, it's difficult to understand the authority allowed 
for this proposed rule (and current rules on the books).''
    Response: CDC is a U.S. government agency within HHS. The primary 
legal authority supporting this final rule is section 361 of the Public 
Health Service Act (PHS Act) (42 U.S.C. 264). Under section 361, the 
Secretary of HHS (Secretary) may make and enforce such regulations as 
in the Secretary's judgment are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the United States and from one State or possession into any other 
State or possession. It also authorizes the Secretary to promulgate and 
enforce a variety of public health regulations to prevent the spread of 
communicable diseases, including through inspection, fumigation, 
disinfection, sanitation, pest extermination, destruction of animals or 
articles found to be sources of dangerous infection to human beings, 
and other measures. Since at least 1956, Federal quarantine regulations 
(currently found at 42 CFR 71.51) have controlled the entry of dogs and 
cats into the United States.
    In addition to section 361, other sections of the PHS Act relevant 
to this final rule are section 362 (42 U.S.C. 265), section 365 (42 
U.S.C. 268), section 367 (42 U.S.C. 270), and section 368 (42 U.S.C. 
271). Section 362, among other things, authorizes the Secretary to 
promulgate regulations prohibiting, in whole or in part, the 
introduction of property from foreign countries or places, for such 
period of time and as necessary for such purpose, to avert the serious 
danger of introducing communicable disease into the United States.
    Comment: HHS/CDC received several comments that proposed CDC issue 
fines or citations against importers who violate U.S. entry 
requirements, present fraudulent documentation, or import rabid dogs.
    Response: HHS/CDC appreciates this comment, but notes that it must 
rely on other U.S. Federal agencies, such as the U.S. Department of 
Justice, to seek criminal penalties for individuals who violate 
quarantine regulations, including those relating to the importation of 
dogs into the United States. Under section 368 of the PHS Act (42 
U.S.C. 271) any person who violates regulations implementing sections 
361 (42 U.S.C. 264) or 362 (42 U.S.C. 265) is subject to imprisonment 
of not more than one year, a fine, or both. Pursuant to 18 U.S.C. 3559 
and 3571, an individual may face a fine of up to $100,000 for a 
violation not resulting in death and up to $250,000 for a violation 
resulting in death. Because these penalties are criminal in nature, to 
implement section 368, HHS/CDC would refer potential violators to the 
U.S. Department of Justice for criminal prosecution.
    Through this final rule, HHS/CDC is also including new language 
advising individuals and organizations that it may request that DHS/CBP 
take additional action pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a. 
Specifically, CDC may request that DHS/CBP issue additional fines, 
citations, or penalties to importers, brokers, or carriers whenever the 
CDC Director (Director) has reason to believe that an importer, broker, 
or carrier has violated any of the provisions of this section or 
otherwise engaged in conduct contrary to law. HHS/CDC stresses that it 
does not administer Title 19, and decisions regarding whether to issue 
such fines, citations, or other penalties would be entirely at the 
discretion of DHS/CBP and subject to its policies and procedures. 
Notwithstanding, HHS/CDC believes it important to include this language 
to advise individuals and organizations that it may request that DHS/
CBP pursue such actions.
    Comment: HHS/CDC received comments that funding should not be spent 
implementing the provisions in this final rule as well as comments that 
the final rule will increase CDC costs and require additional staff. 
Another comment stated, ``I do not see the CDC having staff to 
coordinate this quarantine process and how will it be funded? This 
seems like tax payers will pay the burden.''
    Response: This final rule implements an importation system relying 
on a network of privately operating ACF for the examination, 
revaccination, and quarantine (if necessary) of foreign-vaccinated dogs 
from DMRVV high-risk countries. During the temporary suspension, CDC 
was issuing CDC Dog Import Permits for foreign-vaccinated dogs from 
DMRVV high-risk countries. Issuing permits required costs to CDC in the 
form of personnel and IT services. By replacing the permitting system 
for foreign-vaccinated dogs from DMRVV high-risk countries with a 
system of ACF, CDC anticipates a reduction in costs and staff time 
associated with dog importation. CDC will not bear any costs for 
quarantining dogs. The costs of examination, revaccination, and 
quarantine at ACF will be paid for by the importer.
    Comment: HHS/CDC also received comments suggesting that HHS/CDC 
should spay and neuter animals or consider spaying and neutering 
animals in lieu of euthanizing animals.
    Response: The final rule also contains no requirements relating to 
imported animals being spayed or neutered because HHS/CDC does not 
typically regulate the control of animal populations. HHS/CDC 
reiterates that the rule does not require that animals be euthanized if 
they do not meet HHS/CDC import requirements. If an animal is not fit 
to travel, poses a public health risk, or would pose a risk to other 
animals, then the carrier must arrange for the animal to be transported 
to an ACF or a CDC-approved veterinary

[[Page 41791]]

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

VII. Required Regulatory Analyses

A. Executive Orders 12866, 13563, and 14094

    Under Executive Order 12866 (E.O. 12866), Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), HHS/CDC is required to determine 
whether this regulatory action would be ``significant'' and therefore 
subject to review by the Office of Management and Budget (OMB) and the 
requirements of the Executive Order. E.O. 12866, as amended by 
Executive Order 14094, defines ``significant regulatory action'' as an 
action that is likely to result in a rule:
     Having an annual effect on the economy of $200 million or 
more (adjusted every 3 years by the Administrator of OIRA for changes 
in gross domestic product), or adversely affect in a material way the 
economy, a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, territorial, or 
Tribal governments or communities;
     Creating a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency;
     Materially altering the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or
     Raising legal or policy issues for which centralized 
review would meaningfully further the President's priorities, or the 
principles set forth in E.O. 12866, as specifically authorized in a 
timely manner by the Administrator of OIRA in each case.
    OMB's Office of Information and Regulatory Affairs has determined 
that this rulemaking is ``significant'' under E.O. 12866.
    The provisions of this rule are not likely to have an annual effect 
on the economy of $200 million or more, although there is considerable 
uncertainty around the number of dogs imported at baseline, including 
the number of dogs imported from DMRVV high-risk countries. HHS/CDC 
conducted an analysis to estimate the costs and benefits of the 
provisions of this rule relative to a regulatory baseline without any 
change in requirements. HHS/CDC also reports the costs and benefits of 
the set of lower-cost alternatives and higher-cost alternatives 
relative to the same regulatory baseline. HHS/CDC requested public 
comment on costs associated with these changes to importers, airlines, 
and State and local health departments to improve the accuracy of cost 
and benefit estimates. More details on the assumptions used to develop 
this analysis are included in an Appendix found in the Supplemental 
Materials tab of the docket.
    The economic regulatory baseline is based on the provisions 
included in the existing 42 CFR 71.51. The baseline analysis does not 
incorporate the impact of the temporary suspension of dogs imported 
from DMRVV high-risk countries that has been in effect since July 14, 
2021.\214\ The economic baseline does not account for the temporary 
suspension but does account for a change to the definition of DMRVV-
free country published in 2019.\215\ This baseline is used as a 
comparator to assess the impact of the provisions of the final rule. 
The summary of the regulatory baseline is defined further in Appendix 
Section A3 found in the Supplemental Materials tab of the docket.
---------------------------------------------------------------------------

    \214\ On June 14, 2021, CDC published the ``Notice of Temporary 
Suspension of Dogs Entering the United States from High-Risk Rabies 
Countries.'' Through that notice, CDC informed the public that, 
effective July 14, 2021, it was temporarily suspending the 
importation of dogs from: countries classified by CDC as having high 
risk for DMRVV; AND countries that are NOT at high risk if the dogs 
have been in high-risk countries during the previous six months. See 
86 FR 32041 (June 16, 2021). The suspension was extended effective 
June 10, 2022. See 87 FR 33158 (June 1, 2022).
    \215\ HHS/CDC. Guidance Regarding Agency Interpretation of 
``Rabies-Free'' as It Relates to the Importation of Dogs Into the 
United States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    The rule addresses the market inefficiency in which dog importers 
do not consider or bear the potential detrimental impacts to the 
public's health that may result from the importation of ill dogs, 
especially dogs infected with DMRVV. At the societal level, this could 
include the reintroduction of DMRVV into the United States. Regulation 
at the Federal level is necessary to address the public health risk of 
infectious diseases from the importation of ill or unhealthy dogs. 
Federal action allows risks to be addressed and mitigated prior to 
dogs' arrival in the United States. The rule is expected to affect the 
following categories of interested parties and implementing partners:
     Importers of dogs from countries that are DMRVV-free or at 
low risk for DMRVV;
     Importers of dogs from countries that are at high risk of 
DMRVV;
     Airlines and other carriers;
     CBP;
     CDC;
     USDA; and
     State and local public health and animal health 
departments.
    As discussed above, the rule incorporates different requirements 
depending on whether dogs are imported from DMRVV high-risk countries 
compared to countries that are DMRVV-free or DMRVV low-risk. 
Requirements for dogs from DMRVV high-risk countries are further 
differentiated depending on whether imported dogs have received their 
rabies vaccines in the United States or in another country. Foreign-
vaccinated dogs imported from DMRVV high-risk countries would have to 
arrive at one of currently six airports with a CDC-registered Animal 
Care Facility. Importers of foreign-vaccinated dogs

[[Page 41792]]

from DMRVV high-risk countries would make reservations prior to arrival 
with a CDC-registered ACF for a veterinary examination and 
revaccination. As part of the entry requirements, importers would 
either agree to a 28-day post-arrival quarantine period for the dog or 
prior to arrival submit samples of the dog's blood to a CDC-approved 
laboratory for serologic testing at a time interval specified in CDC 
technical instructions to demonstrate immunity to rabies virus. CDC 
assumes that most importers would choose serologic testing in lieu of 
the quarantine period. All importers of dogs from DMRVV high-risk 
countries need a Certification of Foreign Rabies Vaccination and 
Microchip form or Certification of U.S.-issued Rabies Vaccination form, 
which require certification by an Official Government Veterinarian in 
the country of origin or a USDA Official Veterinarian, respectively. 
However, dogs imported from DMRVV-free or DMRVV low-risk countries and 
importers of U.S.-vaccinated dogs from DMRVV high-risk countries do not 
require examination at CDC-registered Animal Care Facilities and are 
eligible to arrive at any U.S. port.
    In lieu of the Certification of Foreign Rabies Vaccination and 
Microchip form or Certification of U.S.-issued Rabies Vaccination form, 
importers may provide documentation that the dogs have been only in 
DMRVV-free or DMRVV low-risk countries during the six months prior to 
arriving in the United States (i.e., to demonstrate the dog had not 
been in a high-risk country). This documentation must be certified by 
an official government veterinarian, but many importers must already 
obtain a foreign export certificate from a DMRVV-free or DMRVV low-risk 
country that has been certified by an official government veterinarian 
in that country prior to importing dogs into the United States. In 
addition, importers who make multiple trips to and from the United 
States (e.g., across land borders) may use the Certification of U.S.-
issued Rabies Vaccination form for U.S.-vaccinated dogs, which will 
remain valid for three years after a dog receives a three-year rabies 
vaccine in the United States. Thus, the additional costs will only be 
incurred for a subset of dogs imported from DMRVV-free or low-risk 
countries.
    All dog imports arriving on aircraft conveyances, regardless of 
whether they arrive from countries that are DMRVV-free or at low- or 
high-risk for DMRVV, are subject to a six-month minimum age 
requirement. In addition, all dogs, other than those in transit, need 
to be implanted with microchips for identification purposes. All dogs, 
regardless of country of origin, must be listed on a bill of lading or 
CDC-approved alternative by the airline, if entering the U.S. via air. 
All importers of dogs arriving at an air, land, or seaport must submit 
a CDC Dog Import Form to CDC via a CDC-approved system prior to the 
dog's departure from the foreign country. The form must be presented to 
the airline or other carrier prior to boarding and to Federal officials 
upon arrival in the United States.
    The annualized and present value estimates of monetized costs and 
benefits over the 10-year period from 2024 through 2033 using three 
percent and seven percent discount rates are summarized in Tables 2 and 
3. The annualized, monetized costs (2020 USD) of the provisions in the 
final rule are estimated to be $59 million (range: $13 to $207 million) 
using a three percent discount rate, and the results were almost 
unchanged using a seven percent discount rate. Most monetized costs are 
expected to be incurred by importers (87 percent for the most likely 
estimate). The estimated monetized costs are expected to be less for 
importers of dogs from DMRVV-free or DMRVV low-risk countries compared 
to importers of dogs from DMRVV high-risk countries. The provisions 
estimated to result in the greatest increase in costs for importers of 
dogs imported from DMRVV-free or low-risk countries were associated 
with the additional costs associated with the documentation 
requirements to show that the dogs have not been in a DMRVV high-risk 
country, minimum age, and with the microchip requirements, and 
completing the new CDC Dog Import Form.
    The provisions estimated to result in the greatest increase in 
costs for importers of dogs from DMRVV high-risk countries were 
associated with the requirements regarding use of a CDC-registered 
Animal Care Facility for foreign-vaccinated dogs from DMRVV high-risk 
countries in section 71.51(k). Other costs included: (1) laboratory 
testing, (2) an expected reduction in the number of dogs imported from 
DMRVV high-risk countries, (3) the need for some travelers to reroute 
travel to an airport with a CDC quarantine station (also known as a CDC 
port health station) and CDC-registered Animal Care Facility, and (4) 
the costs with providing a CDC Import Certification of Rabies 
Vaccination and Microchip Record form or Certification of U.S.-issued 
Rabies Vaccination form (certified by an Official Government 
Veterinarian or USDA Official Veterinarian, respectively). Most of 
these requirements are specific to foreign-vaccinated dogs from DMRVV 
high-risk countries.
    Airlines are expected to incur the greatest costs among carriers 
and their costs are estimated to comprise about 7.0 percent of the 
estimated annualized, monetized costs, with most of their costs 
associated with ensuring that all transported dogs comply with the bill 
of lading or CDC-approved alternative requirements of the final rule 
and a reduction in the number of dogs transported. HHS/CDC was unable 
to estimate costs from other types of carriers of dogs arriving by land 
or sea. Specifically, CDC does not have any data on how the six-month 
age requirement may impact surface transportation conveyances importing 
dogs from Canada or Mexico (although CDC notes that importation of dogs 
less than six months of age for resale is already prohibited by USDA 
regulations). CDC is estimated to incur about 3.3 percent of the 
annualized, monetized costs (most likely estimate) associated with the 
provisions of this final rule. Most CDC costs would be associated with 
the oversight of animal care facilities and laboratory proficiency 
testing programs for dogs imported from high-risk countries. CBP is 
expected to incur about 3.0 percent of the annualized costs (most 
likely estimate) associated with the provisions of this final rule. 
Most CBP costs would result from the additional time spent on reviewing 
documentation for importers of dogs from DMRVV-free or low-risk 
countries and for training personnel to enforce the requirements. USDA 
is expected to receive payments commensurate with its cost to provide 
Certification of U.S.-issued Rabies Vaccination forms for U.S.-
vaccinated dogs traveling internationally.
    The annualized monetized benefits of the provisions in the final 
rule are estimated to be about $1.8 million (range: $0.75 to $3.6 
million) using a three percent or seven percent discount rate, with 
most of the benefits accruing to importers (47 percent of the most 
likely estimates) and to CBP (30 percent of the most likely estimates). 
Some of the benefits estimated for both importers and CBP would result 
from reduced time spent on screening dogs from high-risk countries at 
U.S. ports. The amount of time required per dog at U.S. ports would be 
reduced because it is assumed that the CDC standardized vaccination 
forms would be easier to review compared to non-standardized 
documentation for dogs arriving from DMRVV high-risk countries. The 
provisions in this final rule are also estimated to reduce the number 
of dogs

[[Page 41793]]

denied entry or arriving ill or dead, with benefits estimates for 
importers, airlines, CBP, and CDC.
    The wide range between the lower-bound and upper-bound cost and 
benefit estimates demonstrates that there is considerable uncertainty 
in these results. More details on the input parameters and assumptions 
used to generate these estimates may be found in the Appendix under the 
Supplemental Materials tab of the docket. At present, the number of 
dogs imported into the United States is neither accurately nor 
completely tracked by any data system, and the uncertainty in the cost 
and benefit estimates reflect uncertainty in both the total number of 
dogs imported and the number of dogs imported from DMRVV high-risk 
countries, as well as the cost of the new requirements included in the 
final rule. The net annualized, monetized costs (total cost estimate--
total benefit estimate) are estimated to be about $57 million per year 
(range: $12 to $203 million) using a three percent discount rate.
    Since the estimated costs for foreign-vaccinated dogs from DMRVV 
high-risk countries are much higher than costs for other dog imports, 
importers may choose to import dogs from DMRVV-free or low-risk 
countries instead of from DMRVV high-risk countries. In addition, 
individuals who travel from the United States to DMRVV high-risk 
countries with their pet dogs for long-term visits may take the 
additional step to have their dogs revaccinated with a three-year 
rabies vaccine prior to departure (e.g., many deployed Federal 
employees may obtain the Certification of U.S.-issued Rabies 
Vaccination, which would allow up to three years for return to the 
United States). These changes should result in lower overall costs than 
the above estimates for the final rule in which HHS/CDC assumed 
individuals would be unable to change the countries from which dogs are 
imported into the United States.
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    The present value of the estimated monetized cost over a 10-year 
period for the provisions in the final rule is estimated to be $502 
million (range: $111 to $1,750 million) using a three percent discount 
or $416 million (range: $91 to $1,450 million) using a seven percent 
discount rate. The present value of monetized benefits over a 10-year 
period of the provisions in the final rule is estimated at $15 million 
(range: $6.4 to $30 million) using a three percent discount rate or $13 
million (range: $5.2 to $25 million) using a seven percent discount 
rate. The net annualized monetized cost (total costs-total benefits) is 
estimated at $486 million (range: $104 to $1,720 million) using a three 
percent discount rate and $403 million per year (range: $86 to $1,430 
million) using a seven percent discount rate.

[[Page 41796]]

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BILLING CODE 4163-18-C
    As discussed in the response to public comments section of the 
preamble above, the estimated monetized cost estimate has increased 
considerably

[[Page 41798]]

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

[[Page 41799]]

second change is that HHS/CDC is eliminating the exemption for 
importers of dogs from DMRVV-free or low-risk countries to import three 
or fewer dogs less than six months of age at land borders. Both of 
these changes will increase costs to importers of dogs from DMRVV-free 
or low-risk countries and these changes are reflected in the higher-
cost estimates.
    The United States was declared DMRVV-free in 2007. Importing dogs 
from DMRVV high-risk countries involves a significant public health 
risk. The provisions of this final rule would better align U.S. dog 
importation requirements with those of other countries that have been 
declared DMRVV-free. Further, the serologic testing requirements are 
consistent with standards in the WOAH Terrestrial Manual for dogs 
imported from DMRVV high-risk countries to DMRVV-free countries.\220\ 
One DMRVV-infected dog may cause transmission to humans, domestic pets, 
livestock, or wildlife. The social cost of the consequences associated 
with the importation of a DMRVV-infected dog was estimated to be 
$270,000 (range: $210,000 to $510,000) to conduct public health 
investigations and administer rabies PEP to exposed persons.
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    \220\ WOAH Terrestrial Animal Health Code. Chapter 5.11. 
Available at: Access online: WOAH--World Organisation for Animal 
Health https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&;L=0&htmfile=chapitre_certif_rabies.htm.
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    Historically, CDC has denied entry to approximately 200 dogs 
annually due to fraudulent, incomplete, or inaccurate paperwork.\221\ 
However, between January 2020 and July 2021 (i.e., during the COVID-19 
pandemic, prior to the temporary suspension), CDC documented more than 
1000 instances of incomplete, inadequate, or fraudulent rabies 
vaccination certificates for dogs arriving from DMRVV high-risk 
countries.\222\ The diversion of public health resources globally to 
COVID-19 response activities contributed to a lapse in dog rabies 
vaccination efforts and a related increase in the prevalence of dogs 
infected with DMRVV in some high-risk countries. The combination of an 
increasing number of dogs imported without adequate documentation of 
rabies vaccination,\223\ in addition to the potential increase in the 
prevalence of DMRVV in high-risk countries,\224\ would increase the 
risk of importation of dogs that are infected with DMRVV. This 
combination of factors would increase the likelihood of DMRVV-
importation events relative to the time-period before the COVID-19 
pandemic.
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    \221\ Centers for Disease Control and Prevention (2021). 
Quarantine Activity Reporting System (version 4.9.8.8.2.2A). Dog 
Importation data, 2010-2019. Accessed: October 1, 2022.
    \222\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C., U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PloS ONE,16(9), e0254287. Doi: 10.1371/
journal.pone.0254287.
    \223\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: 15 February 2021.
    \224\ A. Kunkel, Jeon S., Haim, Dilius C.J.P., Crowdis K., 
Meltzer M.I., Wallace R. (2021). The urgency of resuming disrupted 
dog rabies vaccination campaigns: a modeling and cost-effectiveness 
analysis. Scientific Reports; 11:12476. https://doi.org/10.1038/s41598-021-92067-5.
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    CDC is unable to predict future trends with or without the 
provisions included in this final rule to estimate how many dogs 
infected with DMRVV may be imported. Two rabid dog imports (both from 
Iran) have been reported in Canada within a seven-month period 
(specifically July 2021 and January 2022) at around the same time the 
United States implemented a temporary suspension of dogs imported from 
DMRVV high-risk countries. Prior to these two imports, Canada had not 
reported a dog infected with DMRVV since the 1960s.\225\ Given the 
limited number of reported dogs with DMRVV, this observation may be 
indicative of a higher risk for dogs imported from DMRVV high-risk 
countries during the COVID-19 pandemic or could be anomalous 
occurrences in Canada. However, the provisions included in the final 
rule are expected to substantively reduce the risk of importation of 
dogs infected with DMRVV relative to baseline.
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    \225\ Outbreak News Today (Feb. 10, 2022) Rabies case reported 
in Toronto in a dog imported from Iran. http://outbreaknewstoday.com/rabies-case-reported-in-toronto-in-a-dog-imported-from-iran-46958. Accessed: February 14, 2022.
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    The primary public health benefit of this final rule is the reduced 
risk that a dog infected with DMRVV will be imported from a DMRVV high-
risk country. Using the most likely estimates of the net monetized cost 
estimate ($57.0 million) and the most likely estimate of the potential 
benefit of averting the social cost of the consequences associated with 
an importation of one dog with DMRVV from a high-risk country 
($270,000), it is possible to calculate the change in the number of 
imported dogs infected with DMRVV with the provisions of the final rule 
relative to the baseline such that the benefit would equal cost. The 
most likely estimate of the net cost ($57.0 million) divided by the 
most likely estimate of the social cost of the consequences associated 
with an importation of a dog infected with DMRVV ($270,000) suggests 
that the provisions of the final rule relative to baseline would have 
to avert the importation of 211 dogs infected with DMRVV for the 
benefit to exceed the cost. This would require an increase in the 
number of dogs imported into the United States while infected with 
DMRVV, which could only occur because of widespread failures of rabies 
control programs in multiple countries. However, this analysis does not 
consider the potential for fatal rabies cases in people or the risk of 
reintroduction of DMRVV in the United States, as analyzed below.
    The above estimate of the cost of an importation of a dog with 
DMRVV does not account for the worst-case outcomes, which include (1) 
transmission of rabies to a person who dies from the disease, or (2) 
ongoing transmission to other domestic and wildlife species in the 
United States. The cost of reintroduction could be especially high if 
DMRVV spreads to other species of U.S. wildlife. Re-establishment of 
DMRVV in the United States could result in costly efforts over several 
years to eliminate the virus again. Both worst-case outcomes may be 
more likely to occur after the COVID-19 pandemic because public health 
resources were diverted to COVID-19 response activities and disruptions 
in rabies control programs in high-risk countries. Disruptions to 
rabies control programs in DMRVV high-risk countries may contribute to 
elevated risks even as the COVID-19 pandemic wanes. Human deaths from 
rabies continue to occur in the United States after exposure to wild 
animals; however, no U.S. resident has died after exposure to an 
imported dog with DMRVV in over 20 years. CDC uses the value of 
statistical life (VSL) to assign a value to interventions that can 
result in mortality risk reductions. For fatal cases, HHS recommends 
the use of the value of statistical life to estimate the potential 
benefits of averted deaths, an estimate of $11.6 million in 2020 USD 
and a range of $5.5 to $17.7 million.\226\ However, CDC is unable to 
estimate the potential magnitude of the mortality risk reduction 
associated with the final rule. Based on the central VSL, the 
provisions of the final rule would need to avert 4.9 or more human 
deaths per year, on average, for the benefits to exceed costs.
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    \226\ U.S. Department of Health and Human Services, 2016. Office 
of the Assistant Secretary for Planning and Evaluation. Guidelines 
for Regulatory Impact Analysis. https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf. Accessed: April 20, 2020.
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    Efforts to eliminate DMRVV if re-established in the United States 
would also prove costly. A previous campaign

[[Page 41800]]

to eliminate domestic dog-coyote rabies virus variant jointly with gray 
fox (Texas fox) rabies virus variant in Texas over the period from 1995 
through 2003 cost $34 million,227 228 or $56 million in 2023 
USD. The costs to contain any reintroduction would depend on the time-
period before the reintroduction was realized, the wildlife species in 
which DMRVV was transmitted, and the geographic area over which 
reintroduction occurs. The above estimate is limited to the cost of 
rabies vaccination programs for targeted wildlife and does not include 
the costs to administer PEP to any persons exposed after the 
reintroduction has been identified. Human deaths from DMRVV could 
increase following the reintroduction of DMRVV to the United States as 
the risk of exposure would increase.
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    \227\ TJ Sidwa et al. (2005) Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association; 227(5):785-92.
    \228\ R.T. Sterner et al. (2009) Tactics and Economics of 
Wildlife Oral Rabies Vaccination, Canada and the United States. 
Emerging Infectious Diseases; 15(8), 1176-1184.
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    At the same time, hesitancy towards vaccinating dogs may be 
increasing in the United States. In a recent survey, about half of 
survey respondents reported skepticism toward dog vaccination; however, 
84% of these survey respondents reported that their dogs were up to 
date with required vaccinations.\229\ If this skepticism leads to 
reduced coverage rates for U.S. dog rabies vaccination, the United 
States would become more vulnerable to the reintroduction of DMRVV. In 
the worst-case scenario, a large-scale reintroduction of DMRVV could 
result in much greater costs than were reported for the elimination of 
the fox variant discussed previously.
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    \229\ Motta M, Motta G, Stecula D. Sick as a dog? The 
prevalence, politicization, and health policy consequences of canine 
vaccine hesitancy (CVH). Vaccine2023 41 (2023): 5946-5950.
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    Malaysia had been declared DMRVV-free, but the virus was 
reintroduced around 2017. Despite a large public health response, DMRVV 
has not yet been eliminated in Malaysia and 45 people have died after 
having been infected between 2017 and 2022.\230\ The probability of 
DMRVV reintroduction in the United States is likely to be much less 
than in Malaysia, which shares a land border with Indonesia, which is a 
DMRVV high-risk country. However, the potential risk for the United 
States would increase if the U.S. dog rabies vaccination rates were to 
decrease or if the number of imported DMRVV-infected dogs from DMRVV 
high-risk countries were to increase. The requirements included in this 
final rule would reduce the risk of importations of DMRVV-infected 
dogs.
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    \230\ Tuah L., Sabri MSM, Hashim M, Hashim M. (Dec. 8, 2022) 
Spatial Risk Assessment on Spread of Dog-Mediated Rabies in Sarawak. 
SEACFMD Joint EpiNet and LabNet Virtual meeting. https://rr-asia.woah.org/wp-content/uploads/2022/12/4-seacfmd__mcda-spatial-risk-assessment-on-rabies-in-sarawak.pdf. Accessed November 9, 2023.
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    The provisions of the final rule would also ensure that dogs that 
are denied admission or arrive ill will be housed appropriately and 
receive the care needed to protect their health and safety. This will 
reduce the likelihood that dogs may be left in unsafe conditions in 
cargo warehouses for extended periods of time with the potential to 
expose workers who are not trained to handle live animals safely.\231\
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    \231\ https://www.cbsnews.com/chicago/news/dog-dies-at-ohare-airport-warehouse-17-others-saved-after-being-left-without-food-or-water-for-3-days/.
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    Under the current baseline, the number of dogs imported into the 
United States is neither accurately nor completely tracked. The more 
comprehensive data collection in this final rule through the CDC Dog 
Import Form will benefit public health investigations and enable better 
and more timely contact tracing of all animals exposed to an imported 
dog with DMRVV. The current lack of data also inhibits the Federal 
government's ability to target interventions for dogs imported from 
specific countries. The collection of data from the CDC Dog Import Form 
as required in this final rule may also benefit other agencies such as 
USDA/Animal and Plant Health Inspection Service (APHIS) that may want 
to regulate dog imports based on the risk of introduction of diseases 
that may affect U.S. livestock. For example, in 2021, APHIS regulated 
importers of dogs for resale based on whether the dogs were imported 
from countries where African swine fever exists.\232\ The potential 
economic benefits of reducing the risk of the importation of African 
swine fever could be significant. For example, a recent African swine 
fever outbreak in China was estimated to have total economic losses 
equivalent to 0.78 percent of China's gross domestic product in 
2019.\233\ The requirement in the final rule to report all dogs to CDC 
via a CDC-approved system would reduce the risk of importation of 
infected dogs from countries with ongoing disease outbreaks that may 
affect livestock.
---------------------------------------------------------------------------

    \232\ Animal and Plant Health Inspection Service (Aug. 4, 2021) 
USDA Announces Requirements for Importing Dogs from Countries 
Affected with African Swine Fever. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed: 05 
February 2022.
    \233\ Shibing You, Tingyi Liu, Miao Zhang, Xue Zhao, Yizhe Dong, 
Bi Wu, Yanzhen Wang, Juan Li, Xinjie Wei and Baofeng Shi (2021) 
African swine fever outbreaks in China led to gross domestic product 
and economic losses. Nature Food; 2: 802-808.
---------------------------------------------------------------------------

    Viruses exploiting new host species have led to some of the most 
devastating disease epidemics, such as influenza, Ebola, and the HIV/
AIDS pandemic.\234\ Viruses continually evolve in their animal hosts. 
This has been observed in viruses such as avian and swine influenza 
viruses, constituting a permanent pandemic threat to humans.\235\ 
Although CDC cannot predict when future zoonotic diseases may emerge or 
whether future zoonotic diseases may be associated with transmission 
from dogs to humans, such events remain a possibility. Future dog-
mediated communicable diseases may pose an acute risk to the public's 
health because, in contrast to other animal imports, most dogs are 
imported as pets and will be in close contact with their owners.
---------------------------------------------------------------------------

    \234\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the 
epidemiology and evolution of species jumps. Trends in Ecology & 
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
    \235\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the 
epidemiology and evolution of species jumps. Trends in Ecology & 
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
---------------------------------------------------------------------------

    During the COVID-19 pandemic a variant of the SARS-CoV-2 virus was 
detected in mink populations in Europe and entered human populations 
from this animal host. Between February 18, 2020, and December 15, 
2021, 457 mink farms in 12 countries experienced SARS-CoV-2 outbreaks 
\236\ and mink-to-human transmission of the SARS-CoV-2 virus was 
documented on mink farms in the Netherlands, Denmark, Poland, and the 
United States.237 238 239 In August and September of 2020, 
Denmark documented a mink-associated SARS-CoV-2 variant strain found in 
12

[[Page 41801]]

people, eight of whom had links to the mink farming industry. Due to 
concerns about transmissibility, immunity, and potential impacts on 
vaccine efficacy, the Danish government ordered that all 15-17 million 
minks in the country be culled. Following a risk assessment of live 
mink importations from the Western European region to the United States 
using data from U.S. Fish and Wildlife Service who regulate and track 
mink importations, it was determined additional regulatory action to 
prohibit live mink importations was unnecessary due to public health 
prevention measures taken by mink importers and the low numbers of 
imported mink. In comparison, CDC would not have the same data 
available to conduct a risk assessment for dog imports in the event of 
a future dog-mediated communicable disease outbreak because dog imports 
are neither accurately nor completely tracked in any government data 
system in the absence of the CDC Dog Import Form requirement included 
in this final rule. This would limit HHS/CDC's ability to accurately 
quantify the risks presented from specific countries because the United 
States does not have data on the number of dogs imported from each 
country.
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    \236\ Koopmans M. SARS-CoV-2 and the human-animal interface: 
outbreaks on mink farms. The Lancet Infectious Diseases 2021; 21 
(1): 18-19.
    \237\ Hammer AS, Quaade ML, Rasmussen TB, et al. SARS-CoV-2 
Transmission between Mink (Neovison vison) and Humans, Denmark. 
Emerg Infect Dis. 2021 Feb;27(2):547-551. doi: 10.3201/
eid2702.203794. Epub 2020 Nov 18. PMID: 33207152; PMCID: PMC7853580.
    \238\ Oude Munnink BB, Sikkema RS, Nieuwenhuijse DF, et al. 
Transmission of SARS-CoV-2 on mink farms between humans and mink and 
back to humans. Science. 2021 Jan 8;371(6525):172-177. doi: 10.1126/
science.abe5901. Epub 2020 Nov 10. PMID: 33172935; PMCID: 
PMC7857398.
    \239\ Rabalski L, Kosinki M, Mazur-Panasiuk N, et al. Zoonotic 
spillover of SARS-CoV-2: mink-adapted virus in humans. Available at: 
https://www.biorxiv.org/content/10.1101/2021.03.05.433713v1.full.pdf.
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    The reporting of dog import volumes by country in an approved CDC 
import submission data system provides an opportunity to target 
interventions for dogs imported from specific countries. Such reporting 
as now required in 42 CFR 71.51(h) would allow CDC or other Federal 
agencies to more easily implement preventive measures to mitigate the 
risk of introductions of new zoonotic diseases or foreign animal 
diseases targeted to specific countries of concern. The import 
submission data requirement may also help CDC and other Federal 
agencies, as well as State and local health departments, 
retrospectively inspect shipments from specific countries. This would 
reduce the costs of future interventions; however, CDC is not able to 
quantify future savings.
    The provisions of the final rule are expected to reduce the risk of 
dogs arriving ill. If an animal arrives in the United States and 
appears ill or is dead, a public health investigation is required to 
ensure the ill or dead animal does not present a public health threat. 
The overall health of an animal can play a significant role in whether 
it can maintain core body functions (i.e., body temperature regulation 
and glucose levels) during prolonged flights. Stressed, malnourished, 
and young animals are more likely to become ill and can transmit 
communicable diseases that can affect humans; 240 241 
therefore, safety and welfare concerns for the transport of dogs have a 
public health impact that requires a degree of oversight from public 
health agencies to ensure human and animal health is protected.\242\
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    \240\ Galanis E et al. Brucellosis and other diseases imported 
with dogs. BCMJ 2019; 61 (4): 177-190. Available at: https://bcmj.org/bccdc/brucellosis-and-other-diseases-imported-dogs.
    \241\ Denstedt E. Echinococcus multilocularis as an emerging 
public health threat in Canada: A knowledge synthesis and needs 
assessment. Accessed: February 28, 2019. Available at: www.ncceh.ca/
sites/default/files/Guelph-Denstedt-2017.pdf.
    \242\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk 
factors for death and illness in dogs imported into the United 
States, 2010-2018. Transbound Emerg Dis. 2022 Mar 15. doi: 10.1111/
tbed.14510.
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    The required veterinarian examinations of foreign-vaccinated dogs 
from DMRVV high-risk countries should lead to the earlier detection of 
other exotic pathogens. A recent study from the United Kingdom 
performed additional screening for Babesia canis, Ehrlichia canis, 
Hepatozoon canis, Leishmania infantum, Brucella canis, and Dirofilaria 
immitis among 133 recently imported rescue dogs. They identified one or 
more of these pathogens in 24% (32/133) of the fully tested dogs.\243\ 
Although the authors found no significant association between infected 
dogs and presenting clinical signs, this study helps demonstrate how 
the mandatory veterinarian examination of foreign-vaccinated dogs from 
DMRVV high-risk countries may lead to early detection of other diseases 
prior to spreading into the U.S. dog population.
---------------------------------------------------------------------------

    \243\ Wright I, Whitfield V, Hanaghan R, et al. (2023) Analysis 
of exotic pathogens found in a large group of imported dogs 
following an animal welfare investigation. Vet Rec 4;193(9):e2996. 
doi: 10.1002/vetr.2996.
---------------------------------------------------------------------------

    In addition to the unmonetized benefits described above, there may 
be additional unmonetized costs. CDC plans to monitor countries with 
high risk of DMRVV and may suspend entry of dogs from countries with 
repeated instances of falsified or fraudulent dog vaccine credentials 
or invalid rabies vaccination documents (defined as DMRVV-restricted 
countries in this final rule). The lost value of imports from DMRVV-
restricted countries would impact some U.S. businesses and dog 
purchasers. However, the duration of any suspensions for these 
countries is highly uncertain and may be ended in the event of 
improvement of those countries' export controls.
    HHS/CDC will have the authority to issue orders to revoke a 
carrier's permission to transport live dogs and cats if a carrier has 
endangered the public's health; however, CDC does not have plans to 
suspend any carriers at this time.
    CDC lacks data on the cost to airlines of ensuring that a 
representative be on-site at the U.S. airport and available to 
coordinate the entry/clearance of dogs with Federal government 
officials. The representative must remain on site until all live 
imported dogs have either been cleared for entry or arrangements have 
been made to transport the dogs to a facility (either a CDC-registered 
ACF or other veterinary facility approved by CDC) pending admissibility 
determination. CDC believes this will only incur additional costs on 
occasion since airline staff are typically available on-site.
Analysis of the Costs and Benefits of the Alternatives
    The summary costs and benefits of the lower and higher-cost 
alternatives are presented assuming that either all of the lower-cost 
alternatives or all of the higher-cost alternatives are selected. The 
annualized monetized costs and benefits are calculated relative to the 
same regulatory baseline used to evaluate the impacts of the final 
rule. The alternatives are presented above in Table 1. More detail on 
the impacts of each section is presented in the appendix in the 
supplemental materials tab of this docket. Some of the key assumptions 
for the lower-cost alternative include:
     If the age limit were reduced from six months to four 
months for dogs arriving by air, the estimated reduction in the number 
of dogs arriving by air would decrease by two percent relative to the 
regulatory baseline. This is less than the five percent reduction 
assumed for the six-month age requirement included in the final rule. 
Also, there would be no reduction in dogs arriving at land borders if 
there were no age limit for dog imports arriving by land (or sea).
     If dogs were allowed to have either a microchip or tattoo 
(instead of allowing only microchips), the cost of implementation is 
assumed to be reduced by 25%. Since dog tattoos usually cost more than 
microchips,\244\ the benefit is mostly due to some importers preferring 
the tattoo to the microchip. Thus, the additional cost of the tattoo 
would have to be offset by the utility to dog owners from owners who 
strongly prefer to have the option of choosing either a tattoo or 
microchip.

[[Page 41802]]

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

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

    \245\ Hardy J. Physiology of temperature regulation. Physiologic 
reviews 1961: 41; 521-606.
    \246\ Jahn K, Ley J, DePorter T, Seksel K. How Well Do Dogs Cope 
with Air Travel? An Owner-Reported Survey Study. Animals (Basel). 
2023 Oct 4;13(19):3093. doi: 10.3390/ani13193093. PMID: 37835699; 
PMCID: PMC10571552.
---------------------------------------------------------------------------

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

[[Page 41805]]

obtain these documents (with an assumed cost of $35 per document on 
average).
     If importers of U.S.-vaccinated dogs from DMRVV high-risk 
countries were required to visit a CDC-registered ACF, their costs 
would increase commensurate with estimates for foreign-vaccinated dogs. 
CDC also assumed that five percent fewer U.S.-vaccinated dogs would be 
imported from DMRVV high-risk countries due to the additional cost 
associated with this requirement.
     If CDC required a 90-day waiting period from the time a 
dog blood sample was drawn to perform a serological titer test (instead 
of 30 days as required in CDC technical instructions), there would be 
additional costs to some importers who would be unable to plan further 
in advance. These costs could range from staying in the country for an 
extra 60 days to no cost if importers could arrange to have the blood 
sample taken earlier relative to when they plan to enter the United 
States. CDC assumed that it would cost an extra $200 on average, 
although this cost would vary considerably according to importer 
circumstances.
     If CDC required all dogs imported from DMRVV high-risk 
countries (including U.S.-vaccinated dogs) to arrive at U.S. ports with 
CDC-registered ACF instead of limiting this requirement to foreign-
vaccinated dogs, the costs to importers of U.S.-vaccinated dogs would 
increase commensurately and 60% of all imported dogs from DMRVV high-
risk countries would have to re-route their travel plans to a U.S. port 
with a CDC-registered ACF instead of their preferred U.S. port.
    The total annualized monetized costs associated with the higher-
cost alternative are summarized in Table 5. The costs to importers 
would increase considerably relative to the requirements included in 
the final rule ($108 million versus $51.0 million for annualized 
monetized importer costs). The total costs for these alternatives are 
$122 million (range: $31 to $320 million, 3% discount rate). The 
annualized monetized benefits this set of higher-cost alternatives is 
$1.3 million (range: $0.51 to $3.0 million).
    CDC did not select any of these higher-cost alternatives because 
most of these alternatives do not address the highest-risk category of 
imported dogs, i.e., foreign-vaccinated dogs from DMRVV high-risk 
countries. As a result, the public health benefits associated with 
these higher-cost alternatives would not decrease the risk to the 
public health sufficiently to balance the costs of these alternatives. 
CDC has not observed any DMRVV infections among U.S.-vaccinated dogs 
imported from DMRVV high-risk countries or among dogs imported from 
DMRVV-free or low-risk countries. In addition, CDC can obtain the data 
it needs from the lower-cost CDC import data submission system and does 
not require a tattoo in addition to a microchip to confirm the identity 
of imported dogs. Because of the limited public health benefit and 
excessive costs, HHS/CDC believes the requirements in the final rule 
address the risks associated with imported dogs infected with DMRVV or 
other exotic pathogens more cost effectively than the alternatives.
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[[Page 41807]]

Impact of the Final Rule on Dog Import Volumes
    CDC did not receive any additional data to update its estimates of 
the number of imported dogs and used the same set of estimates 
presented in the NPRM analysis. In total, CDC estimates that under the 
current regulatory baseline, about 800,000 imported dogs would arrive 
in the United States each year and that about 500 dogs from DMRVV high-
risk countries would be denied admission (Table 6). The number denied 
entry is based on CDC data from 2020 and the first six months of 2021 
prior to the suspension of dog imports from DMRVV high-risk countries. 
This approach may overestimate the number of dogs denied entry in the 
future if the COVID-19 pandemic was associated with a significant 
increase in dogs denied admission due to pandemic-associated factors. 
Since dog rabies vaccine certificates are not currently required for 
dogs from DMRVV-free or DMRVV low-risk countries, CDC did not assume 
any dogs from these countries would be denied admission under the 
baseline.
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    \247\ Id.
    \248\ Id.
    [GRAPHIC] [TIFF OMITTED] TR13MY24.019
    
    The provisions of the final rule that are expected to reduce the 
number of dog imports include: (1) age restrictions on air travel for 
all dogs under six months of age, including dogs from both DMRVV high-
risk and DMRVV low-risk or DMRVV-free countries; and (2) the additional 
costs of fulfilling the requirements for follow-up and revaccination at 
CDC-registered Animal Care Facilities for foreign-vaccinated dogs from 
DMRVV high-risk countries. At the same time, HHS/CDC believes that the 
number of dogs denied admission and returned to their countries of 
origin would decrease with the provisions included in the final rule 
because the standardized forms, requirements for carriers to confirm 
required documentation, and the requirement for foreign-vaccinated dogs 
from DMRVV-high-risk countries to have reservations at and arrive at 
U.S. ports with CDC-registered ACF should reduce the number of dogs 
denied entry.
    The estimated impact of the final rule on the number of dog imports 
is summarized in Table 7a. HHS/CDC lacks data on what fraction of dogs 
arriving by air or land are less than six months old under the 
baseline. In the absence of this information, HHS/CDC assumes five 
percent (range: three to eight percent) of imported dogs currently are 
less than six months of age and would not be eligible to be imported 
into the United States under the final rule. HHS/CDC notes that these 
provisions should primarily impact individuals traveling with their 
personal pets because the importation of dogs for resale or adoption 
(including transfer of ownership) that are less than six months of age 
is already prohibited by USDA regulations (7 CFR 2148). Another 
provision of the final rule requires importers of dogs from DMRVV-free 
or low-risk countries to submit verified documentation that the animal 
has been in a DMRVV low-risk or DMRVV-free country for the six months 
prior to importation into the United States. CDC does not anticipate 
denying admission to dogs that may arrive from DMRVV-free or low-risk 
countries without such documentation when the final rule goes into 
effect, but there may be delays at U.S. ports while HHS/CDC confirms 
dogs from DMRVV-free or low-risk countries have not been in a DMRVV 
high-risk country within the last six months.
    HHS/CDC assumes that the additional costs associated with importing 
dogs from DMRVV high-risk countries with foreign-issued rabies 
vaccination documentation would reduce the number of imports by about 
20 percent (range: 10 to 30 percent) with the final rule. In addition, 
CDC believes the number of dogs from DMRVV high-risk

[[Page 41808]]

countries that are denied entry will decrease with the provisions of 
the final rule because CDC will be able to require the use of 
standardized forms to confirm rabies vaccination and CDC-registered ACF 
follow-up requirements should be clear to importers. The number of dogs 
denied entry after arriving by air in calendar year 2022 was 96. Based 
in part on the number of dogs denied entry during HHS/CDC's temporary 
suspension and assuming that number would continue to decrease with a 
final rule in place, HHS/CDC estimates that about 50 dogs per year from 
DMRVV high-risk countries would be denied entry under the final rule. 
Overall, the final rule is expected to have a small impact on the total 
number of dogs imported (from about 799,000 [range: 652,000 to 946,000] 
at baseline to 755,000 [range: 630,000 to 872,000] with the provisions 
of the final rule in effect).
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    \249\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
    \250\ Id.
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    The estimated numbers of imported dogs arriving in the United 
States with lower-cost alternatives and the higher-cost alternatives 
are summarized in Tables 7b and 7c. With the set of lower-cost 
alternatives, the reduction in the

[[Page 41811]]

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

[[Page 41812]]

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[[Page 41813]]


[GRAPHIC] [TIFF OMITTED] TR13MY24.023


[[Page 41814]]


[GRAPHIC] [TIFF OMITTED] TR13MY24.024


[[Page 41815]]


[GRAPHIC] [TIFF OMITTED] TR13MY24.025

    HHS/CDC has not attempted to project future changes to the volume 
of dogs imported annually because of insufficient data. HHS/CDC 
believes that introducing another factor to project future volumes is 
not prudent. While HHS/CDC observed an increase in the number of dogs 
arriving with fraudulent paperwork prior to implementing the temporary 
suspension, this may not correspond to changes in the total number of 
dogs imported, of which only a small fraction arrives with fraudulent 
paperwork.
    The most likely estimates of the annual monetized costs and 
benefits for each interested party or implementing partner with the 
final rule relative to the regulatory baseline are summarized in Table 
8a over a 10-year period from 2024 through 2033 using the estimated 
values presented in Sections B2 through B9 of the Appendix found in the 
Supplemental Materials tab of the docket. The most likely estimate of 
monetized costs across interested parties is $79 million in the first 
year and $56 million in subsequent years for the final rule relative to 
the regulatory baseline. The most likely estimate of monetized benefits 
across interested parties is estimated to be $1.8 million each year.
    The annual costs and benefits for importers are split into 
importers of dogs from DMRVV-free or DMRVV low-risk countries versus 
importers of dogs from DMRVV high-risk countries. However, it is likely 
that some importers of dogs from DMRVV high-risk countries may also be 
importers of dogs from DMRVV-free or low-risk countries. In addition, 
the provisions of the final rule may result in some importers switching 
from importing dogs from DMRVV high-risk countries to dogs from DMRVV-
free or low-risk countries.
    As a percentage of total costs, importers were estimated to incur 
85 to 87 percent of the total costs (most likely estimates), with a 
higher fraction of total costs incurred in the subsequent years after 
the first year of implementation. Total costs are approximately 3.2 to 
3.3 times greater for dogs imported from DMRVV high-risk countries 
compared to dogs from DMRVV-free or low-risk countries. In addition, it 
is important to note that more than 10 times as many dogs are estimated 
to be imported from DMRVV-free or low-risk countries. Thus, the cost 
per dog for importers of dogs from DMRVV high-risk countries is 
significantly greater than for importers of dogs from DMRVV-free or 
low-risk countries. This is especially true for foreign-vaccinated dogs 
from DMRVV high-risk countries.

[[Page 41816]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.026

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

[[Page 41817]]

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

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

[[Page 41818]]

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

BILLING CODE 4163-18-C

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, as amended by the Small 
Business Regulatory Enforcement Fairness Act, agencies are required to 
analyze regulatory options to minimize the significant economic impact 
of a rule on small businesses, small governmental units, and small not-
for-profit organizations. CDC examined the potential impact of the rule 
on small entities, including small businesses that may import dogs for 
commercial purposes as well as airlines that transport dogs 
internationally. HHS/CDC lacks key data on the number of dogs imported. 
In the absence of data on the number of dogs imported, CDC made several 
assumptions to estimate revenues from small businesses for different 
categories of businesses that may import dogs and used these revenue 
estimates to calculate how many dogs could be imported such that the 
costs associated with the rule would be less than two percent of 
estimated revenues. HHS/CDC published an initial regulatory flexibility 
analysis with the NPRM, invited public comments, but did not receive 
any comments on the RFA. HHS/CDC did receive some comments from 
breeders, some of which identified as hobbyists, indicating that the 
six-month age requirements would impact their ability to import dogs 
for breeding purposes. HHS/CDC received some comments from breeders and 
breed enthusiasts reporting that the

[[Page 41819]]

costs to import dogs from DMRVV-free or low-risk countries would 
increase as a result of the six-month age requirement. Other breeders 
and enthusiasts did not mention an increase in costs, but suggested the 
change in regulations would reduce the number of exporters willing to 
send dogs to the United States, which would decrease genetic diversity.
    USDA prohibits the importation of dogs under six-months of age for 
commercial purposes, which includes any transfer of ownership; 
therefore, importing dogs under six months of age is already 
prohibited. Thus, HHS/CDC did not consider this as a change to the 
regulatory baseline. Additionally, HHS/CDC believes that the six-month 
age requirement for importation helps protect the health and safety of 
all dog breeds. Since dogs under six months of age are sexually 
immature and cannot be used for breeding, delaying their importation 
may not negatively impact their use as breeding animals. Additionally, 
waiting until a dog is six months of age to import the dog will help 
ensure the safety and welfare of the dog during international travel 
when they are subjected to the stresses of international travel (e.g., 
long travel times, temperature fluctuations, oxygen or altitude 
changes, and food/water deprivation). Any time a dog becomes ill or 
dies during international travel, regardless of country of import, 
Federal and State government agencies must conduct public health 
investigations to ensure the animal is not infected with a zoonotic 
disease that could be transmitted to people (or did not die from a 
zoonotic disease). These investigations take a tremendous amount of 
resources. HHS/CDC believes that the six-month age requirement for 
importation helps protect the health and safety of all dogs and will 
result in a reduced burden on Federal and State government agencies.
    Based on these analyses, CDC believes that the only small entities 
for which this rule would have significant impacts would be those that 
specialize in importing dogs from DMRVV high-risk countries. The 
provisions of this rule would probably not have a significant economic 
impact on small airlines and probably would not have a significant 
impact on small entities that import dogs from DMRVV-free or DMRVV low-
risk countries. The requirement most likely to impact small airlines is 
Sec.  71.51(dd), which requires airlines to provide bills of lading for 
all imported dogs. However, there is a waiver process for airlines to 
have an alternative process while preparing to provide bills of lading. 
CDC notes that the importation of dogs less than six months of age for 
resale or adoption in the United States is already prohibited by USDA 
regulations (7 CFR 2148). Thus, the minimum age requirements in this 
rule should not impact entities that sell or resell imported dogs but 
may impact entities that import very young dogs for commercial purposes 
other than resale assuming no transfer of ownership.
    As part of the economic impact analysis, CDC calculated the 
marginal cost associated with the rule per dog imported from DMRVV-free 
or DMRVV low-risk countries ($23, range: $7.74 to $48 per imported 
dog). The marginal cost associated with the requirements in the final 
rule per dog imported from DMRVV high-risk countries was further 
subdivided between foreign-vaccinated dogs (vaccinated outside the 
United States) ($1,910, range: $910 to $3,800) compared to U.S.-
vaccinated dogs ($41, range: $15 to $73). These estimates cover the 
first year of implementation after a final rule is published. Marginal 
costs in the second year and later are estimated to be about 25 percent 
less per dog compared to the first year of implementation.
    As discussed in the response to public comments section of the 
preamble above, the estimated monetized cost estimate has increased 
considerably relative to the estimates included in the NPRM. The 
primary reasons for the increase in cost include:
     The fees charged by CDC-registered ACF have increased 
relative to CDC's preliminary estimates.
     Some U.S. ports require that dogs that need follow-up care 
at CDC-registered ACF arrive as cargo. This requirement was not 
anticipated by CDC and will increase costs for importers of foreign-
vaccinated dogs from DMRVV high-risk countries who otherwise would have 
chosen to transport their dogs as hand-carried or checked baggage. The 
fee charged for cargo shipments are highly variable.251 252 
The future costs associated with this rule will depend on U.S. port 
policies that are subject to change. The average cost for the follow up 
visit at CDC-registered ACF is estimated to be $900 (range: $500 to 
$1,300 per dog). The average costs associated with shipping dogs as 
cargo is estimated to be $2,000 (range: $1,500 to $2,500) \253\ 
compared to an average of $300 (range: $200 to $400) for dogs shipped 
as hand-carried or checked baggage.\254\ Under the regulatory baseline, 
HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped 
as cargo. With the final rule, HHS/CDC assumes that 60%, range: 60% to 
70% of dogs going to ACF will be shipped as cargo.
---------------------------------------------------------------------------

    \251\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
    \252\ Katie Morrell (March 3, 2021) How Much Does It Cost To Fly 
With Your Dog on a Plane? Dailypaws.com https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane. Accessed: 06 February 2022.
    \253\ Feathers and Fur Express (2023) How much does it cost to 
fly a pet/s internationally? International Pet Shipping Costs--
Feathers & Fur Express (ffexpresspets.com). Accessed November 10, 
2023. Note that the costs reported in this reference include cargo 
shipping costs to Germany, the United Kingdom, Japan, and Australia. 
The reference includes costs for small and large dogs shipped to 
each country. Costs are much higher for larger dogs or for dogs 
shipped over longer distances. The highest costs were for Australia, 
which may be more representative of shipping costs from DMRVV high-
risk countries in Africa. The European costs may be similar to 
shipping costs for dogs imported from DMRVV high-risk countries in 
Europe or Central America or South America. The costs for Japan may 
be similar to costs for DMRVV high-risk countries in Asia. The 
simple average cost across the four countries and dog sizes is 
$1,931 in 2023 USD. This would correspond to $1,622 in 2020 after 
adjustment with the consumer price index: CPI Inflation Calculator 
(bls.gov). The most likely estimate is increased to $2,000 in case 
the costs to importers from DMRVV high-risk countries would be 
higher than for the countries for which data are available. This 
increase from $1,600 to $2,000 would also allow some importers to 
choose to hire shippers to facilitate the importation process or 
brokers to support customs clearance. The need to hire shippers may 
be reduced by the need to visit CDC-registered ACF, who may be able 
to review documentation in advance of arrival when reservations are 
made.
    \254\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
---------------------------------------------------------------------------

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

[[Page 41820]]

documents may be used as long as they specify travel to or from the 
country from which a dog is imported. Individuals who frequently travel 
to and from Canada and Mexico (or any other country) can obtain a valid 
Certification of U.S.-Issued Rabies Vaccination form, which will remain 
valid for multiple trips for up to three years corresponding to the 
duration of protection for dog rabies vaccines.
     CDC increased the estimated costs associated with shipping 
blood samples to CDC-approved laboratories for serological testing 
based on a number of comments from individuals suggesting their 
shipping costs were higher.
     CDC changed the requirement for importing dogs from DMRVV-
free or low-risk countries such that no dogs less than six months may 
be imported at land borders. This will increase costs for individuals 
who wish to travel with their young dogs to or from Canada and Mexico.
     CDC increased the estimated costs to airlines by 100% for 
dogs imported from DMRVV-free or low-risk countries and by 50% for dogs 
imported from DMRVV high-risk countries to account for a number of 
commenters who suggested that costs to airlines should be higher than 
the estimates included in the NPRM analysis.
    Some of the cost estimates for the final rule have also decreased 
due to changes made between the NPRM and the final rule. These include:
     The costs to importers of U.S.-vaccinated dogs from DMRVV 
high-risk countries were reduced because the final rule will not 
require that such dogs arrive at U.S. ports with CDC quarantine 
stations (also known as CDC port health stations).
     The costs for serological testing for foreign-vaccinated 
dogs from DMRVV high-risk countries were reduced because CDC plans to 
implement a policy that only one serological test will be required 
during the lifetime of such dogs as long as they remain current with 
their rabies vaccinations.
    The most significant increase in estimated costs is for importers 
of foreign-vaccinated dogs from high-risk countries, because the 
expected fees charged by CDC-registered ACF have increased and because 
some U.S. ports or ACF now require dogs who need to visit to CDC-
registered ACF to be shipped as cargo. HHS/CDC did not anticipate that 
some U.S. ports would require that dogs going to ACF be shipped as 
cargo in analyzing costs for the NPRM. Other U.S. ports do not require 
dogs going to ACF to be shipped as cargo. U.S. port-specific policies 
may change in the future, which, in conjunction with the uncertainty 
around the number of dogs imported, significantly complicates the 
project of future costs for the requirements in the final rule. As of 
March 2024, one U.S. port requires dogs going to ACF to be shipped as 
cargo, one U.S. port recommends dogs be shipped as cargo to avoid 
clearance delays and four U.S. ports do not have requirements or 
recommendations for shipping dogs as cargo. In total six U.S. ports 
have CDC-registered ACF.
    The next key change, which will increase the costs for importers of 
dogs from DMRVV-free or low-risk countries. In response to public 
comment, HHS/CDC further defined the required documentation needed for 
importers to prove that a dog has been only in DMRVV low-risk or DMRVV-
free countries. For the NPRM, HHS/CDC had assumed that veterinary 
records from DMRVV-free or low-risk countries would be sufficient. 
However, after observing a number of importers using fraudulent 
documentation to circumvent requirements for DMRVV high-risk countries 
by moving dogs to DMRVV-free or low-risk countries prior to entering 
the United States. As a result, HHS/CDC is requiring at least one 
record certified by an official veterinarian in Sec.  71.51(u). A 
second change is that HHS/CDC is eliminating the exemption for 
importers of dogs from DMRVV-free or low-risk countries to import three 
or fewer dogs less than six months of age at land borders. Both of 
these changes will increase costs to importers of dogs from DMRVV-free 
or low-risk countries and these changes are reflected in the higher-
cost estimates. More information regarding these cost estimates is 
available in the Appendix found in the Supplemental Materials tab in 
the docket.
    The estimates summarized below are subject to a great degree of 
uncertainty. CDC does not know how many dogs any small individual 
entity currently imports or the average number of imported dogs across 
entities. However, based on the relative estimates of annual revenues 
by type of entity and subdivided by the number of employees, CDC 
calculated how many dogs each entity could import before this final 
rule would have a significant economic impact on their businesses.
Small Entities That Import Dogs for Commercial Purposes
    The estimated revenues of small businesses likely to import and 
resell dogs are summarized in Table 9. Since there are no specific 
codes in the North American Industry Classification System (NAICS) 
specific to dog importers, CDC used the codes 115210, 423820, 424990, 
485991, 812910, and 813312 to estimate the revenue of the small 
businesses that may import and resell dogs. The businesses affected by 
the final rule would be a fraction of the firms summarized in Table 9, 
as CDC does not know how many dog importers are in these categories. 
Small business status was determined based on either firms' revenue or 
the numbers of employees, according to the Small Business Association's 
(SBA) table of small business size standards.\255\ The revenue of firms 
in each business category subdivided by the number of employees was not 
available. Using annual payroll data from the Statistics of U.S. 
Businesses (SUSB),\256\ CDC estimated the revenue based on the 
assumption that each firm's payroll expense would be approximately 15 
to 30 percent.\257\
---------------------------------------------------------------------------

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

[[Page 41821]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.029

    CDC assumes that the costs associated with the provisions of the 
final rule would be significant if the additional costs would exceed 
two percent of the estimated revenue shown in Table 9 by category. 
Unless a small entity only specializes in importing dogs for resale or 
adoption, the costs associated with dog importation would only 
constitute a portion of each firm's operational costs. Other 
operational costs by an entity should be unaffected by the provisions

[[Page 41822]]

included in this final rule. CDC is unaware of the proportion of dog 
import costs relative to all the other activities for each type of 
entity. Thus, CDC is not able to directly estimate the impact of the 
final rule as a fraction of total revenue. Instead, CDC calculates a 
threshold for each category representing the number of imported dogs at 
which the cost of the provisions in the final rule to importers would 
begin to exceed two percent of the revenue of firms in each category. 
To calculate the number of dogs at which point the costs associated 
with the final rule would be likely to exceed two percent of revenue 
for each category of the firm, the category-specific revenue per firm 
in Table 9 (most likely estimate, lower bound, and upper bound) were 
multiplied by 2 percent and then divided by the marginal cost per 
foreign-vaccinated dog from high-risk countries ($1,910, range: $910 to 
$3,800 per dog). This was repeated for U.S.-vaccinated dogs from DMRVV 
high-risk countries ($41, range: $15 to $73) and dogs from DMRVV-free 
or DMRVV low-risk countries ($23, range: $7.70 to $48).
    The estimated thresholds for the number of Imported dogs per firm 
for each small business category are summarized in Tables 10a and 10b. 
For example, if a wildlife organization (NAICS code 813312) with fewer 
than five employees imports more than 3.9 foreign-vaccinated dogs (most 
likely final rule cost estimate and midpoint revenue estimate) from 
high-risk countries, the costs associated with the final rule would be 
expected to exceed two percent of revenue. For U.S.-vaccinated dogs, 
the threshold would increase from about four dog imports to 182 dog 
imports using the most likely cost estimate and midpoint revenue 
estimate. This NAICS category may include dog rescue organizations that 
are likely to work with dogs imported from DMRVV high-risk countries, 
most or all of which would be foreign vaccinated. Because the marginal 
cost estimate per dog imported from DMRVV-free or DMRVV low-risk 
countries is much less than per dog imported from DMRVV high-risk 
countries, the threshold numbers of dogs that may be imported from 
DMRVV-free or DMRVV low-risk countries are much greater than for DMRVV 
high-risk countries.
    The values shown in Tables 10a and 10b are estimated by assuming 
that all dogs imported by each firm are either from DMRVV-free or DMRVV 
low-risk countries or, alternatively, from DMRVV high-risk countries. 
Some firms may import dogs from both types of countries, in which case, 
the threshold values would be in between the two sets of estimates. The 
difference in costs may also cause some entities to shift from 
importing dogs from DMRVV high-risk countries to dogs imported from 
DMRVV-free or DMRVV low-risk countries. In this case, for a business 
with NAICS code of 813312, the estimated threshold number of dogs would 
increase from four imported foreign-vaccinated dogs from DMRVV high-
risk countries to 327 dogs imported from DMRVV-free or DMRVV low-risk 
countries (both thresholds calculated using most likely final rule cost 
estimate and midpoint revenue estimate).

[[Page 41823]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.030


[[Page 41824]]


[GRAPHIC] [TIFF OMITTED] TR13MY24.031

    The marginal cost per dog imported for the final rule relative to 
the reported commercial values of imported dogs are estimated using 
data from CBP for dogs imported under Harmonized Tariff Schedule code 
0106.19.91.20, Other live animals, Other, Other, Dogs is shown in Table 
11. The estimated ratio of the marginal cost of final rule requirements 
relative to the reported value of the commercially imported dogs from 
DMRVV-free or DMRVV low-risk countries is 2.9 percent (range: 1.0 
percent to 6.1 percent). Based on this ratio, the expected marginal 
increase in cost per dog imported should not change much for dogs 
imported from DMRVV-free or low-risk countries.
    However, for the foreign-vaccinated dogs imported from DMRVV high-
risk countries, the estimated ratio is 536 percent (range: 256 percent 
to 1059 percent). This ratio is much larger both because the marginal 
cost per dog imported for the final rule is much greater and because 
the reported commercial value of dogs imported from DMRVV high-risk 
countries is lower compared to dogs imported from DMRVV-free or low-
risk countries. Since CBP's commercial values of imported dogs only 
provide a comparison of the estimated marginal cost of the final rule 
to reported commercial value, these ratios cannot be directly compared 
to the revenue

[[Page 41825]]

estimates by firm since the costs associated with dog imports would 
only be a portion of each firm's operational cost. However, it does 
provide an estimate of the potential increase in cost per dog imported 
from either DMRVV-free or low-risk countries or from DMRVV high-risk 
countries for the final rule. For this analysis, CDC assumes that most 
of the dogs imported from DMRVV high-risk countries for commercial 
purposes would have been vaccinated outside the United States.
[GRAPHIC] [TIFF OMITTED] TR13MY24.032


[[Page 41826]]


U.S. Airlines
    The provisions of this final rule would affect U.S. airlines 
conducting international flight operations arriving in the United 
States. Of the 60 U.S. airlines with international flights in 2020, 35 
airlines can be identified as small business entities. This is based on 
the size standard of ``fewer than 1,500 employees'' from the SBA for 
small businesses within NAICS Code 481111, Scheduled Passenger Air 
Transportation, and those within NAICS Code 481211, Nonscheduled 
Chartered Passenger Air Transportation in 2019.\258\ For the analysis, 
airline employee counts were estimated from the U.S. Department of 
Transportation's Bureau of Transportation Statistics.\259\ Monthly 
average numbers of employees in 2019, including part- and full-time 
employment, were used for U.S. airlines.
---------------------------------------------------------------------------

    \258\ Small Business Association (SBA), Table of small business 
size standards. Effective August 19, 2019. https://www.sba.gov/document/support-table-size-standards. Accessed: February 21, 2022.
    \259\ Bureau of Transportation Statistics. Air Carrier Financial 
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1(a) Employees. Bureau of Transportation Statistics. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GEF&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny. Accessed: February 21, 2022.
---------------------------------------------------------------------------

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

    \260\ Bureau of Transportation Statistics. Air Carrier Financial 
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1.1, and P-1.2 Operating revenues. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMD&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny; and https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMI&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny. Accessed: February 21, 2022.
    \261\ Air Carriers: T-100 International Market (U.S. Carriers 
Only) https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GDJ&QO_fu146_anzr=Nv4percent20Pn44vr45. 
Accessed: February 21, 2022.

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[[Page 41827]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.033

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

[[Page 41828]]

the number of international passengers reported in 2019 and, in most 
cases, greater than the total estimated number of dogs estimated to be 
imported into the United States each year.
    CDC did not separately estimate marginal costs to airlines for dogs 
imported from DMRVV-free or DMRVV low-risk countries versus dogs 
imported from DMRVV high-risk countries. The estimated marginal cost 
per dog is higher for airlines to transport dogs imported from DMRVV 
high-risk countries because dogs from these countries are more likely 
to be denied entry and abandoned by importers. Thus, marginal costs 
will be higher for airlines that specialize in travel to DMRVV high-
risk countries. However, the general finding still holds that the 
provisions of this final rule should not have a significant impact on 
airlines. Smaller airlines will also be eligible to receive a waiver 
for the bill of lading requirements included in Sec.  71.51(dd). This 
should help to reduce the costs of this requirement during the period 
shortly after the final rule goes into effect since it would allow 
smaller airlines more time to comply.

[[Page 41829]]

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BILLING CODE 4163-18-C

[[Page 41830]]

C. Paperwork Reduction Act of 1995

    HHS/CDC has determined that this rule includes information 
collections and recordkeeping requirements that are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). A description of 
these provisions is given below, with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information. Comments are invited on the following 
subjects:
     Whether the collection of information is necessary for the 
proper performance of the functions of CDC, including whether the 
information will have practical utility.
     The accuracy of CDC's estimate of the burden of the 
collection of information.
     Ways to enhance the quality, utility, and clarity of the 
information to be collected.
     Ways to minimize the burden of the collection of 
information on respondents, including by using information technology.
    Under the PRA, Federal agencies must obtain approval from OMB for 
each collection of information they conduct or sponsor. In the NPRM, 
HHS/CDC published a 60-day notice in the Federal Register concerning 
the collection of information related to proposed updates to 42 CR 
71.50 and 71.51. HHS/CDC addressed all comments above in Section VI. To 
comply with this requirement, OMB is publishing a notice of a revised 
data collection in conjunction with this final rule.
Data Collection
    Importation Regulations (42 CFR 71 Subpart F) OMB Control No. 0920-
1383, Exp. 1/31/2026)--Revision--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).
Background and Brief Description
    This information collection is a Revision to OMB Control No. 0920-
1383 related to the importation of animals, animal products, and human 
remains. Section 361 of the PHS Act (42 U.S.C. 264) authorizes the 
Secretary of HHS to make and enforce regulations necessary to prevent 
the introduction, transmission, or spread of communicable diseases from 
foreign countries into the United States. The existing regulations 
governing foreign quarantine activities (42 CFR 71) authorize 
quarantine officers (also known as port health officers) and other U.S. 
government personnel to inspect and undertake necessary control 
measures with respect to conveyances, persons, shipments of animals, 
articles, and other items to protect the public's health.
    CDC regulations govern the importation of animals and animal 
products capable of causing human disease. Animals that are regulated 
by CDC include dogs, cats, turtles, nonhuman primates (NHPs), civets 
(and other animals in Family Viverridae), African rodents, and bats. 
CDC controls the importation of these animals to ensure that these 
animals, or animal products, imported into the United States meet 
requirements of CDC regulations. CDC does this through a permitting 
process for certain animals.
    HHS/CDC is adding or amending the following information collection 
instruments:
     CDC is adding a form titled Certification of Foreign 
Rabies Vaccination and Microchip form. This form will capture the 
rabies vaccination and microchip information for foreign-vaccinated 
dogs and it must be completed by an authorized veterinarian and 
certified by a government official from the exporting country. CDC is 
including certification by an exporting country to prevent fraud and 
falsification of documentation.
     CDC is adding a new form titled Certification of U.S.-
issued Rabies Vaccination. This is a standardized form to capture 
rabies vaccination information for U.S-vaccinated dogs. It must be 
completed by a USDA-accredited veterinarian and endorsed by USDA during 
the exportation process to prevent fraud and falsification of 
documentation. CDC is creating this standardized form to assist 
importers in ensuring they provide all required information and to 
prevent fraud and falsification of documentation.
     CDC is adding the new form titled Certification of Dog 
Arriving from DMRVV-free or DMRVV low-risk Country form. The form can 
be used to demonstrate that a dog has not been in a DMRVV high-risk 
country within the last six months if accompanied by veterinary records 
or proof of payment for veterinary services establishing that 
veterinary services were performed in a DMRVV-free or DMRVV low-risk 
country at least six months before traveling to the United States. This 
form must be completed by an Authorized Veterinarian and must be 
certified by an Official Government Veterinarian in the exporting 
country. This is one option among multiple options that importers of 
dogs from DMRVV-free or DMRVV low-risk countries can use to certify 
that their dog has not been in a DMRVV high-risk country within the 
last six months. Since this is one of multiple options, CDC is 
estimating that only a small percentage of importers of dogs from these 
countries will use this form. Additional options for these importers 
are outlined in technical instructions.
     CDC will continue using the Application for Special 
Exemption for a Permitted Dog Import until the expiration of the 
temporary suspension on July 31, 2024. Applicants complete this form to 
apply for a CDC Dog Import Permit. CDC has been issuing CDC Dog Import 
Permits to importers of foreign-vaccinated personal pet dogs with a 
valid rabies vaccine and serologic titer results during the temporary 
suspension. CDC will discontinue issuing permits to that category of 
importer once this final rule goes into effect on August 1, 2024. 
Starting August 1, 2024, CDC will instead use this form to issue 
permits to importers of dogs from DMRVV-restricted countries. Since CDC 
is not adding any countries to the DMRVV-restricted country in 
concurrence with the publication of this rule, CDC does not anticipate 
using this form in 2024.
     CDC is adding a new form--CDC Dog Import Form--which will 
collect information similar to what is currently approved to be 
collected on the Application for Special Exemption for a Permitted Dog 
Import form. The CDC Dog Import Form is an online form that all 
importers must complete for each dog imported. It collects contact 
information for the importer and details about the dog being imported. 
CDC has added this form to gather data on the number of annual 
importations of dogs as well as where they originate. This information 
will assist CDC in its public health investigations related to imported 
dogs with communicable diseases.
     CDC is adding four new forms related to CDC-registered 
animal care facilities. Per this final rule, CDC-registered animal care 
facilities are facilities that are registered with CDC for the 
revaccination, examination, and quarantine (if applicable) of foreign-
vaccinated dogs from DMRVV high-risk countries. In order to register 
with CDC, representatives of the facility need to complete and sign the 
following documents to attest to their understanding of the 
requirements and recommendations for CDC-registered Animal Care 
Facilities.


[[Page 41831]]


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

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

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

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

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BILLING CODE 4163-18-C

D. National Environmental Policy Act (NEPA)

    HHS/CDC has determined that amendments to 42 CFR part 71 will not 
have a significant impact on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
needed.

E. Executive Order 12988: Civil Justice Reform

    HHS/CDC has reviewed this final rule under Executive Order 12988 on 
Civil Justice Reform and determines that this

[[Page 41837]]

rule meets the standard in the Executive Order.

F. Executive Order 13132: Federalism

    Under Executive Order 13132, if the rulemaking would limit or 
preempt State, local, or Tribal authorities, then a federalism analysis 
is required. The agency must consult with State, local, and Tribal 
officials to determine whether the rule would have a substantial direct 
effect on State or local governments, as well as whether it would 
either preempt State law or impose a substantial direct cost of 
compliance on them. HHS/CDC has determined that this final rule will 
not have sufficient federalism implications to warrant the preparation 
of a federalism summary impact statement.

G. Plain Language Act of 2010

    Under 63 FR 31883 (June 10, 1998), Executive Departments and 
Agencies are required to use plain language in all proposed and final 
rules. HHS/CDC has attempted to use plain language in this regulation 
to make our intentions and rationale clear.

List of Subjects in 42 CFR Part 71

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

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 71 as follows:

PART 71--FOREIGN QUARANTINE

0
1. The authority citation for part 71 continues to read as follows:

    Authority: Secs. 215 and 311 of Public Health Service (PHS) Act. 
as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended 
(42 U.S.C. 264-272).


0
2. Amend Sec.  71.50 by:
0
a. In paragraph (b); adding in alphabetical order definitions for 
``Authorized veterinarian'', ``Cat'', ``Dog'', ``Histopathy'', and 
``In-transit shipment'';
0
b. Adding in alphabetical order definitions for ``Microchip'', 
``Necropsy'', and ``Official government veterinarian;'' and
0
c. Adding paragraph (c).
    The revision and additions read as follows:


Sec.  71.50  Scope and definitions.

* * * * *
    (b) * * *
    Authorized veterinarian means an individual who has an advanced 
degree relevant to the practice of veterinary medicine, has a valid 
license or accreditation, and is authorized to practice animal medicine 
in the exporting country.
    Cat means any domestic cat (Felis catus).
* * * * *
    Dog means any domestic dog (Canis familiaris).
* * * * *
    Histopathology means the study of changes in human or animal 
tissues caused by disease.
* * * * *
    In-Transit Shipment means a cargo shipment originating in a foreign 
country that is moved through one or more U.S. ports while transiting 
through the United States to a third-country destination. In-transit 
shipments pass through a U.S. port of entry and a U.S. port of exit, 
which may be in the same location, or which may involve numerous 
stopping points.
* * * * *
    Microchip means an implanted radio-frequency device placed under 
the skin of an animal that contains a unique identification tag that 
meets the International Standards Organization (ISO) compatibility 
through ISO 11784 or ISO 11785, or similar technologies as approved by 
the Director.
    Necropsy means an animal autopsy in which the cause of death may be 
determined through the examination and collection, post-mortem, of 
tissues, organs, or bodily fluids.
    Official government veterinarian means a veterinarian who performs 
work on behalf of an exporting country's government and can verify the 
license or credentials of an authorized veterinarian.
* * * * *
    (c) Any provision of this subpart held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this subpart and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.

0
3. Amend Sec.  71.51 by:
0
a. In paragraph (a), adding in alphabetical order the definition for 
``Animal'',
0
b. Removing the definition for ``Cat'';
0
c. Adding in alphabetical order definitions for ``Certification of 
foreign rabies vaccination and microchip'', ``CDC dog import form'', 
``CDC dog import permit'', ``CDC-registered animal care facility'', 
``Certification of dog arriving from DMRVV-free or DMRVV low-risk 
country'', ``Certification of U.S.-issued rabies vaccination'', and 
``Conditional release'',
0
d. Revising the definition of ``Confinement'';
0
e. Removing the definition for ``Dog'';
0
f. Adding in alphabetical order definitions for ``DMRVV'', ``DMRVV-free 
country'', ``DMRVV high-risk country'', ``DMRVV low-risk country'', and 
``DMRVV-restricted country'', ``Flight parent'', ``Importer'', ``SAFE 
TraQ'', ``Serologic testing'', ``USDA-accredited veterinarian'', and 
``USDA official veterinarian'';
0
g. Removing the definition for ``Valid rabies vaccination 
certificate'';
0
h. Removing paragraphs (b) through (g);
0
i. Adding new paragraphs (b) through (g); and
0
j. Adding paragraphs (h) through (ff).
    The revision and additions read as follows:


Sec.  71.51  Dogs and cats.

    (a) * * *
    Animal means, for purposes of this section, any domestic cat (Felis 
catus) or domestic dog (Canis familiaris).
    Certification of foreign rabies vaccination and microchip means the 
Office of Management and Budget (OMB)-approved form that must be:
    (i) completed by an authorized veterinarian, which may include an 
official government veterinarian, in the exporting country; and
    (ii) reviewed and signed by an official government veterinarian in 
the exporting country attesting that the information listed is true and 
correct.
    CDC dog import form means an OMB-approved form submitted to CDC 
through an online portal that includes the importer's name and contact 
information; description of the dog, including microchip number and 
current photographs of the dog's face and body; purpose of importation; 
travel information, including dates of departure and arrival, country 
of departure, countries the dog has been physically present in within 
the last six months, and U.S. port of entry; and other information as 
described in CDC technical instructions.
    CDC dog import permit means a document issued by CDC granting 
approval to import a dog into the United States from a DMRVV-restricted 
country. To receive a permit, eligible

[[Page 41838]]

importers submit information to CDC that includes the importer's name 
and contact information; description of the dog, including microchip 
number and current photographs of the dog's face and body; purpose of 
importation; travel information, including dates of departure and 
arrival, country of departure, countries the dog has been physically 
present in within the last six months, and U.S. port of entry; and 
other information as described in CDC technical instructions.
    CDC-registered animal care facility means a facility registered by 
CDC for the purpose of providing veterinary care and housing to animals 
imported into the United States.
    Certification of dog arriving from DMRVV-free or DMRVV low-risk 
country means the OMB-approved form that together with other records 
may be used by an importer to demonstrate that a dog has been only in 
DMRVV-free or DMRVV low-risk countries during the six months before the 
dog's arrival in the United States.
    Certification of U.S.-issued rabies vaccination means the OMB-
approved form that must be completed by a U.S. Department of 
Agriculture (USDA)-Accredited Veterinarian and endorsed by a USDA 
Official Veterinarian prior to a dog's departure from the United States 
in order to demonstrate compliance with admissibility requirements upon 
the dog's return to the United States from a DMRVV high-risk country.
    Conditional release, when applied to an animal, means the temporary 
release of an animal from the custody of a carrier or a CDC-registered 
animal care facility into the care of a licensed veterinarian approved 
by the Director, for the purpose of receiving emergency medical care or 
a public health evaluation, pending an admissibility determination or 
removal of the animal from the United States. The licensed veterinarian 
must return conditionally released animals immediately to the custody 
of the carrier or the CDC-registered animal care facility upon the 
conclusion of such medical care or evaluation.
    Confinement, when applied to an animal, means restriction to a 
building or other enclosure at a U.S. port or other location approved 
by the Director, including en route to a destination, separate from 
other animals, and from persons except for contact necessary for its 
care. If the animal is allowed out of the enclosure, it must be muzzled 
and kept on a leash.
    DMRVV means dog-maintained rabies virus variant and includes any 
rabies virus variant that is known or suspected to have an enzootic 
transmission cycle in which dogs are essential for the maintenance of 
the viral variant. This includes epidemiologic situations in which dogs 
are the only recognized reservoir species, as well as situations in 
which dogs and other species (typically wildlife) both play 
epidemiologically relevant roles in maintaining enzootic transmission.
    DMRVV-free country means a country determined by the Director as 
not having DMRVV present based on internationally accepted standards.
    DMRVV high-risk country means a country determined by the Director 
as having high risk for DMRVV transmission based on factors such as the 
presence and geographic distribution of the virus, or low quality of or 
low confidence in rabies surveillance systems or dog vaccination 
programs. A list of the DMRVV high-risk countries is available on CDC's 
website.
    DMRVV low-risk country means a country determined by the Director 
as having low risk for DMRVV transmission based on factors such as the 
virus being limited to a localized area, adequacy of surveillance and 
dog vaccination programs to prevent further geographic distribution of 
the virus, and the virus being in a controlled status with the 
country's heading toward eventual DMRVV-free status.
    DMRVV-restricted country means a country from which the import of 
dogs into the United States has been prohibited or otherwise 
restricted. Designation of a DMRVV-restricted country may be based on 
the country's export of dogs infected with DMRVV to any other country 
within a timeframe determined by the Director or based on the country's 
lacking adequate controls, as determined by the Director, to monitor 
and prevent the export of dogs to the United States with falsified or 
fraudulent rabies vaccination credentials, inaccurate or invalid rabies 
vaccination documentation, or other fraudulent, inaccurate, or invalid 
importation documents.
    Flight parent means any person transporting one or more animals on 
behalf of an importer for purposes of resale, adoption, or transfer of 
ownership. A flight parent is typically solicited through social media 
and may be compensated (including through goods and services, e.g., 
complimentary airplane ticket, paid baggage fees, other paid fees) or 
be uncompensated. If required by USDA, flight parents must possess all 
required Federal licenses or registrations to transport animals.
    Importer for purposes of this section means any person importing or 
attempting to import an animal into the United States, including an 
owner or a person acting on behalf of an importer, such as a broker 
registered with U.S. Customs and Border Protection (CBP) or a flight 
parent. If required by USDA, an individual transporting an animal on 
behalf of an importer, including a flight parent must possess all 
required Federal licenses or registrations to transport animals.
* * * * *
    SAFE TraQ means CDC's System for Animal Facility Electronic 
Tracking of Quarantine or other system as approved by the Director for 
tracking pre-clearance management (e.g., quarantine, medical 
examinations, vaccinations, diagnostic testing, screening, and travel 
information) of animals arriving in the United States through a CDC-
registered animal care facility.
    Serologic Testing, when applied to an imported animal, means a 
rabies antibody titration test performed by a CDC-approved rabies 
laboratory using a CDC-approved technique. The serology sample must be 
drawn, submitted, and tested in accordance with CDC technical 
instructions. The current list of CDC-approved laboratories is 
available online on CDC's website. CDC will update its website as 
needed.
    USDA-Accredited Veterinarian shall have the same definition as 
Accredited Veterinarian under 9 CFR 160.1.
    USDA Official Veterinarian means the Animal and Plant Health 
Inspection Service (APHIS) veterinarian who is assigned by the USDA 
Administrator to supervise and perform the official work of APHIS in 
any U.S. State or several U.S. States.
    (b) Authorized U.S. airports for dogs and cats. (1) Cats may arrive 
at and be admitted into the United States through any U.S. airport.
    (2) Dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries and with documentation confirming that they have 
been only in DMRVV low-risk or DMRVV-free countries during the last six 
months may arrive at and be admitted into the United States through any 
U.S. airport.
    (3) Dogs that have a valid certification of U.S.-Issued rabies 
vaccination form may arrive at and be admitted into the United States 
through any U.S. airport.
    (4) Dogs that have been in a DMRVV high-risk country within the 
last six months and have a valid certification of foreign rabies 
vaccination and microchip form must arrive at and may be admitted only 
through a U.S. airport with a CDC quarantine station (also known as a 
U.S. port health station) and a CDC-registered animal care facility.
    (5) Dogs that have been in a DMRVV high-risk country within the 
last six

[[Page 41839]]

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

[[Page 41840]]

vessel's owner or operator may require reimbursement from an importer 
for any associated costs incurred by the vessel's owner or operator on 
the importer's behalf.
    (5) Dogs arriving by land without a receipt confirming submission 
of a CDC dog import form shall be denied admission and returned 
immediately to the dogs' country of departure, but such denial does not 
prevent the importer from reapplying for admission of the dogs after 
the form is filed.
    (6) A receipt confirming submission of the CDC dog import form must 
accompany all dogs departing foreign locations for travel to the United 
States. For dogs departing from foreign airports to the United States, 
the airline must deny boarding to dogs unless the importer has 
presented this receipt prior to boarding.
    (7) Airlines, unless granted a waiver in accordance with paragraph 
(dd) of this section, are required to create a bill of lading for all 
dogs arriving in the United States prior to the dogs' arrival. This 
includes dogs transported as cargo, checked-baggage, or hand-carried 
baggage. If granted a waiver to the bill of lading requirement, the 
airline's handling and transport of the dogs must be consistent with 
the terms of that waiver.
    (8) Unless being transported by an airline for which a waiver to 
the bill of lading requirement has been granted pursuant to paragraph 
(dd) of this section, dogs arriving by air for which a bill of lading 
has not been filed prior to their arrival in the United States (or if 
the airline's handling and transport of the dogs is inconsistent with 
the terms of the waiver) shall be denied admission and returned to 
their country of departure pursuant to paragraph (v) of this section.
    (i) Inspection requirements for admission of all dogs and cats. (1) 
All animals arriving at a U.S. port shall be inspected upon arrival, 
and only those animals that show no signs of communicable disease as 
defined in 42 CFR 71.1 shall be admitted into the United States.
    (2) All animals presented for admission into the United States may 
be subject to additional examination and disease surveillance screening 
for the purpose of communicable disease surveillance. Ill animals may 
be required to undergo additional diagnostic testing prior to release 
of the animal; such testing is not considered surveillance screening.
    (3) The Director may require confinement of an animal and 
examination by a veterinarian when necessary to determine whether the 
animal is admissible into the United States, for instance, if dental 
examination would assist in determining the animal's age.
    (4) Importers who refuse to consent to inspection, examination, 
disease surveillance screening, or diagnostic testing of the animal 
upon arrival shall have the animal denied admission and returned to its 
country of departure pursuant to paragraph (v) of this section.
    (j) Examination by a USDA-accredited veterinarian and confinement 
of exposed dogs and cats or those that appear unhealthy. (1) If an 
animal, upon inspection, does not appear to be in good health (e.g., it 
has signs such as emaciation, lesions of the skin, discharge of the 
eyes or nose, coughing, sneezing, nervous system disturbances, 
inability to stand or walk, difficulty breathing, jaundice, vomiting, 
or diarrhea), or appears healthy but, during shipment, may have been 
exposed to a sick or dead animal (including an animal other than a dog 
or cat) suspected of having a communicable disease, the Director may 
require prompt confinement and veterinary examination.
    (2) In the case of animals that appear unhealthy or those that were 
potentially exposed and arriving by air or sea, the Director may 
require the airline or vessel's master or operator to arrange for a 
licensed veterinarian to examine the animal and give or arrange for any 
tests or treatment indicated. In the case of animals that appear 
unhealthy or those that were potentially exposed and arriving by land, 
the Director may deny admission, but such denial does not prevent the 
importer from reapplying for admission after providing the Director 
with satisfactory evidence that a licensed veterinarian has examined 
the animal and administered any tests or treatment as needed to ensure 
the animal does not have a communicable disease.
    (3) Carriers shall maintain a record of sickness of animals 
occurring while en route to the United States and shall submit the 
record to the CDC quarantine station with jurisdiction for the U.S. 
port.
    (4) Animals that become sick while en route or on arrival shall be 
separated from other animals (including animals other than dogs or 
cats) as soon as the sickness is discovered and shall be held in 
confinement pending any necessary examination as determined by the 
Director.
    (5) Airlines (in the case of arrivals by air) or the masters or 
operators of vessels (in the case of arrivals by sea) shall immediately 
arrange for confinement and medical evaluation of any ill or injured 
animals at a CDC-registered animal care facility or CDC-approved 
veterinary facility (if a CDC-registered animal care facility is not 
available) which, in the judgment of the Director, affords protection 
against transmission of any communicable disease, and suitable housing 
in accordance with the Animal Welfare Act (7 U.S.C. 2131 et seq., as 
may be amended). In the case of ill or injured animals arriving by 
land, the Director may deny admission, but such denial does not prevent 
the importer from reapplying for admission after providing the Director 
with satisfactory evidence of confinement (as needed) and examination 
by a licensed veterinarian.
    (6) The airline or vessel's master or operator shall immediately 
thereafter arrange for transportation of any ill or injured animals by 
a CBP-bonded transporter to the CDC-registered animal care facility or 
other CDC-approved veterinary facility (if a CDC-registered animal care 
facility is not available) for confinement and medical evaluation. The 
airline or vessel's master or operator shall arrange to have ill or 
injured animals transported in a way that does not expose 
transportation personnel or the public to communicable diseases.
    (7) The Director will consider the findings of the examination and 
tests in determining whether the animal may have a communicable 
disease.
    (8) The importer shall bear the expenses of transportation, 
confinement, examination, tests, and treatment under this paragraph. If 
an importer fails to arrange for or pay for such expenses or cooperate 
with any CDC-mandated public health evaluations, then the animal will 
be considered abandoned, and the carrier shall assume financial 
responsibility pursuant to paragraph (aa) of this section.
    (9) Confinement shall be subject to conditions specified by the 
Director to protect the public's health.
    (10) CDC may request that CBP conditionally release animals for 
medical evaluation and treatment in emergency or exigent circumstances. 
Animals eligible for conditional release shall remain under the legal 
custody of the carrier or CDC-registered animal care facility for the 
purpose of receiving veterinary medical care. If such animals are 
conditionally released to a CDC-approved veterinary facility (if a CDC-
registered animal care facility is not available or cannot provide the 
level of care needed), then the animal must be immediately returned to 
the custody of the carrier or CDC-registered animal care facility once 
medical treatment is

[[Page 41841]]

no longer required or upon request by either CDC or CBP.
    (11) If an importer (or carrier if the animal is abandoned by the 
importer) opts to have an animal euthanatized (e.g., under 
circumstances where the animal is fatally ill or injured), the importer 
or carrier shall promptly communicate this decision to CDC in writing 
and prior to euthanasia. Euthanasia does not relieve importers or 
carriers of the obligation to arrange and pay for testing and necropsy 
required by CDC.
    (k) Veterinary examination, revaccination against rabies, and 
quarantine at a CDC-registered animal care facility for foreign-
vaccinated dogs from DMRVV high-risk countries. (1) All dogs arriving 
into the United States that have been in DMRVV high-risk countries 
within the last six months and that do not have a valid certification 
of U.S.-issued rabies vaccination form shall undergo veterinary 
examination and revaccination against rabies at a CDC-registered animal 
care facility upon arrival.
    (2) The importer is responsible for making all arrangements 
relating to the examination, revaccination, and quarantine (if 
applicable) at a CDC-registered animal care facility prior to the dog's 
arrival in the United States. The costs of examination, vaccination, 
and quarantine (if applicable) shall be borne by the importer and not 
at the government's expense.
    (3) Prior to granting a reservation, CDC-registered animal care 
facilities must ensure they have received the following:
    (i) The completed certification of foreign rabies vaccination and 
microchip form;
    (ii) Serologic test results (if applicable) obtained from a CDC-
approved laboratory on a blood sample drawn, submitted, and tested in 
accordance with CDC's technical instructions;
    (iii) Photos of the dogs' teeth to assist with age verification;
    (iv) The travel itinerary for the dogs confirming that the dogs 
will be arriving only at a U.S. airport with a CDC-registered animal 
care facility and will not be arriving at any other U.S. port; and
    (v) A receipt confirming submission of the CDC dog import form.
    (4) Importers must present documentation to airlines confirming 
their reservation at a CDC-registered animal care facility prior to 
their dogs boarding a flight to the United States. Airlines must deny 
boarding to dogs if the importer fails to present such documentation.
    (5) Airlines must deny boarding to any foreign-vaccinated dog that 
has been in a DMRVV high-risk country within the last six months for 
which the importer has not presented a receipt confirming submission of 
the CDC dog import form and proof of a reservation at a CDC-registered 
animal care facility, or that is being presented for travel to an 
unauthorized U.S. airport.
    (6) The airline shall arrange for dogs to be transported by a CBP-
bonded transporter to the CDC-registered animal care facility 
immediately upon arrival at the U.S. airport.
    (7) The dogs shall remain in the custody of the CDC-registered 
animal care facility until the following requirements are met:
    (i) Veterinary health examination by a USDA-accredited veterinarian 
for signs of illness. All illnesses must be documented in SAFE TraQ. 
CDC will review these illness case reports and determine admissibility 
prior to the dog's release. Suspected or confirmed communicable 
diseases, including the presence of ectoparasites (i.e., ticks and 
fleas), must be reported to CDC prior to release of the dog;
    (ii) Confirmation of microchip number;
    (iii) Confirmation of age through dental examination by a USDA-
accredited veterinarian;
    (iv) Vaccination against rabies with a USDA-licensed rabies vaccine 
that is administered by a USDA-accredited veterinarian; and
    (v) Confirmation of adequate rabies serologic titer from a CDC-
approved laboratory. Blood samples for serologic tests must be drawn 
within a timeframe as specified in CDC technical instructions. Dogs 
that arrive without an adequate rabies serologic test results from a 
CDC-approved laboratory, or with a serologic test result drawn outside 
the acceptable timeframe, or with serologic test results outside 
acceptable parameters, shall be housed at the CDC-registered animal 
care facility for a 28-day quarantine period following administration 
of the USDA-licensed rabies vaccine.
    (l) Registration or renewal of CDC-registered animal care 
facilities. (1) A facility must register with and receive written 
approval from the Director to function as a CDC-registered animal care 
facility before housing any live dog imported into the United States. 
Applications and all required documents must be submitted to 
[email protected].
    (2) The CDC-registered animal care facility must be located within 
35 miles of a CDC quarantine station.
    (3) To register or renew a registration certificate, a facility 
must submit the following documents to CDC:
    (i) A completed registration/application form;
    (ii) A statement of intent that describes the number and types of 
animals the facility can safely house at any one time, including the 
number of animals that can be housed in the quarantine area;
    (iii) Written standard operating procedures that include all 
elements required in paragraphs (k) through (q) of this section;
    (iv) A copy of all required Federal, State, or local registrations, 
licenses, and/or permits; a facility must have a USDA Class H 
intermediate handlers registration (and any additional class licenses 
or registrations as deemed appropriate by USDA) and a CBP Facilities 
Information and Resource Management System (FIRMS) code; and
    (v) A self-certification signed by the owner or manager of the CDC-
registered animal care facility stating that the facility is in 
compliance and agrees to continue to comply with the regulations in 
this section.
    (3) Upon receiving the documentation required by this section, the 
Director will review the application and either grant or deny the 
application for registration as a CDC-registered animal care facility. 
Applications that are denied may be appealed under paragraph (r) of 
this section.
    (i) Before issuing a registration, the Director may inspect any 
animal health record, facility, vehicle, or equipment to be used in 
management, examination, and clearance of imported animals. Thereafter, 
animal health records, facilities, vehicles, and equipment used in 
importing animals may be inspected during annual site inspection visits 
or when otherwise needed to protect the public's health.
    (ii) CDC may conduct unannounced inspections of facilities seeking 
to register or renew their status as a CDC-registered animal care 
facility or when otherwise needed to protect the public's health.
    (iii) CDC inspections will be based on USDA Animal Welfare 
regulation standards (9 CFR parts 1, 2, and 3) and other standards as 
outlined in CDC's Technical Instructions for CDC-registered Animal Care 
Facilities.
    (iv) Unless revoked in accordance with paragraph (r) of this 
section, a registration certificate issued under this section is 
effective for two years beginning from the date CDC issues the 
registration certificate.
    (v) A CDC-registered animal care facility must apply to CDC for 
renewal

[[Page 41842]]

of the registration certificate not less than 60 days and not more than 
90 days before the existing registration expires.
    (4) The Director may deny an application to register, renew, or 
reinstate a facility as a CDC-registered animal care facility if the 
registrant has had a previous registration revoked in accordance with 
paragraph (r) within the last five years.
    (5) All CDC-registered animal care facilities must comply with the 
requirements of paragraphs (k) through (q) of this section.
    (m) Record-keeping requirements at CDC-registered animal care 
facilities. (1) A CDC-registered animal care facility must retain 
records regarding each imported animal for three years after the 
release or return of the animal. Each record must include:
    (i) the bill of lading (or other alternative documentation if the 
airline has been granted a waiver under paragraph (dd) of this section) 
for the shipment;
    (ii) the name, address, phone number, and email address of the 
importer and owner (if different from the importer);
    (iii) the number of animals in the shipment;
    (iv) the identity of each animal in each shipment, including name, 
microchip number, date of birth, sex, breed, and coloring;
    (v) the airline, flight number, date of arrival, and port of 
arrival of the shipment; and
    (vi) veterinary medical records for the animal, including:
    (A) Certification of foreign rabies vaccination and microchip form 
and rabies serology obtained before arrival in the United States (if 
applicable);
    (B) the USDA-licensed rabies vaccine administered upon arrival;
    (C) veterinary examination records upon arrival and while in 
quarantine;
    (D) rabies serology performed while in quarantine in the United 
States (if applicable);
    (E) all diagnostic test results performed during quarantine; and
    (F) necropsy reports for imported animals that die while in the 
care of the CDC-registered animal care facility.
    (2) A CDC-registered animal care facility must maintain records 
electronically in SAFE TraQ.
    (i) Copies of all records must be entered directly into or uploaded 
into SAFE TraQ;
    (ii) Records must be uploaded and complete prior to the animal's 
release from the facility (or for necropsy results within 30 days of an 
animal's death); and
    (iii) CDC will audit records remotely as needed and in-person 
during site inspection visit(s) at the facility.
    (n) Worker protection plan and personal protective equipment (PPE). 
(1) A CDC-registered animal care facility must establish and maintain a 
worker protection plan with standards comparable to those in the 
Occupational Safety and Health Administration's Recommended Practices 
for Safety and Health Programs and the National Association of Public 
Health Veterinarians (NASPHV) Compendium of Veterinary Standard 
Precautions for Zoonotic Disease Prevention in Veterinary Personnel.
    (2) In addition to complying with the requirements of this section, 
a facility must comply with all relevant Federal and State requirements 
relating to occupational health and safety.
    (3) Rabies pre-exposure prophylaxis is required for workers who 
handle imported animals with signs of illness or in quarantine, and for 
staff who perform necropsies of imported animals. Rabies pre-exposure 
prophylaxis must be administered in accordance with the Advisory 
Committee on Immunization Practices guidelines for pre-exposure 
prophylaxis vaccination to prevent human rabies.
    (4) Post-exposure procedures that provide potentially exposed 
workers with direct and rapid access to a medical consultant are 
required.
    (5) Procedures for documenting the frequency of worker training, 
including for those working in the quarantine area, are required.
    (6) As part of the worker protection plan, a facility must 
establish, implement, and maintain hazard evaluation and worker 
communication procedures that include the following:
    (i) Descriptions of known communicable disease and injury hazards 
associated with handling animals;
    (ii) The need for PPE when handling animals and training in the 
proper use of PPE, including re-training and reinforcement of 
appropriate use;
    (iii) Procedures for disinfection or safe disposal of garments, 
supplies, equipment, and waste; and
    (iv) Procedures for reporting to CDC within 48 hours suspected or 
confirmed communicable diseases in facility workers associated with 
handling imported animals.
    (o) CDC-registered animal care facility standard operating 
procedures, requirements, and equipment standards for crating, caging, 
and transporting live animals. (1) Equipment standards for crating, 
caging, and transporting live animals must be in accordance with USDA 
Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and 
International Air Transport Association standards.
    (2) Animals must not be removed from crates during transport.
    (3) Used PPE, bedding, and other potentially contaminated material 
must be removed from the ground transport vehicle upon arrival at the 
animal care facility and disinfected in a manner that would destroy 
potential pathogens of concern or safely disposed of in a manner that 
prevents the spread of communicable disease.
    (p) Health reporting and veterinary service requirements for 
animals at CDC-registered animal fare facilities. (1) A CDC-registered 
animal care facility must provide the following services for each 
animal upon arrival and ensure that each animal meets CDC entry 
requirements prior to release from the facility:
    (i) veterinary examination by a USDA-accredited veterinarian within 
one business day of arrival;
    (ii) verification of microchip and confirmation that the microchip 
number matches the animal's health records;
    (iii) verification of an animal's age via a dental examination or, 
if dental examination cannot be reliably performed, verification 
through another CDC-approved diagnostic method (e.g., ocular lens 
examination, radiographs);
    (iv) revaccination against rabies using a USDA-licensed vaccine; 
and
    (v) confirmation of a valid serology test from a CDC-approved 
laboratory on a sample drawn from a dog prior to arrival within a 
timeframe and results within parameters as specified in CDC technical 
instructions, or completion of a 28-day quarantine at the CDC-
registered animal care facility after administration of the USDA-
licensed rabies vaccine.
    (2) A CDC-registered animal care facility must provide the 
following services upon the occurrence of any morbidity or mortality in 
an imported animal in the facility:
    (i) Immediate isolation of the animal and implementation of 
infection prevention and control measures in accordance with industry 
standards and CDC technical instructions if a communicable disease is 
suspected.
    (ii) Notification to CDC within 24 hours of the arrival of an ill 
animal or occurrence of any illness or death occurring in an animal.
    (iii) Examination by a USDA-accredited veterinarian immediately 
upon detection of illness and diagnostic testing to determine the cause 
of illness. All costs associated with examination and diagnostics are 
the responsibility of the importer.

[[Page 41843]]

    (iv) For any animal that dies or is euthanized due to fatal illness 
or injury, necropsy (gross and histopathologic examination are 
required), and any subsequent infectious disease testing based on gross 
or histopathology findings or as determined by CDC, to determine the 
cause of death. The importer is responsible for all costs associated 
with necropsy and testing.
    (v) Suspected or confirmed communicable diseases, including the 
presence of ectoparasites (i.e., ticks and fleas), must be reported to 
CDC within 24 hours of identification.
    (3) Upon completion of the quarantine period and before a facility 
releases any animal from quarantine, the facility must ensure that the 
facility's USDA-accredited veterinarian has verified the health status 
of the animal.
    (4) Any report required under this paragraph must be uploaded to 
SAFE TraQ prior to the release of the animal.
    (q) Quarantine requirements for animals at CDC-registered animal 
care facilities. (1) A CDC-registered animal care facility must 
maintain a quarantine area for holding animals when quarantine is 
required. Foreign-vaccinated dogs that have been in a DMRVV high-risk 
country within six months of arrival must be quarantined for 28 days 
after revaccination with a USDA-licensed rabies vaccine at the facility 
if they do not have a valid rabies serologic test from a CDC-approved 
laboratory. CDC may also require quarantine or extend the quarantine 
period if a facility or CDC finds or suspects that an animal is 
infected with, or has been exposed to, a communicable disease or if CDC 
determines that additional diagnostic testing is warranted.
    (2) For any quarantine area established or maintained under this 
section, a facility must establish, implement, maintain, and adhere to 
standard operating procedures that meet the following physical security 
requirements:
    (i) The CDC-registered animal care facility must be locked and 
secure, with access limited to authorized and trained personnel.
    (ii) A CDC-registered animal care facility must limit access to 
animal quarantine areas to authorized personnel responsible for the 
transport, care, or treatment of the animals.
    (3) During the quarantine period, a CDC-registered animal care 
facility must monitor animals for signs of any communicable disease, 
including, but not limited to, signs consistent with rabies, 
brucellosis, leptospirosis, leishmaniasis, or ecto- or endoparasites.
    (4) If any animals appear ill during quarantine, the CDC-registered 
animal care facility must, in accordance with paragraphs (p)(2)(i) 
through (v) of this section, ensure appropriate evaluation, monitoring, 
and treatment. Suspected or confirmed communicable diseases in animals 
must be reported to CDC within 24 hours.
    (5) A CDC-registered animal care facility must not knowingly 
release any ill animal from quarantine under paragraph (q)(3) of this 
section without prior consultation with and written approval from CDC.
    (6) Quarantined animals must be housed in such a manner that they 
do not expose other quarantined animals or non-quarantined animals 
(including animals other than dogs or cats) to potentially infectious 
materials, including soiled bedding, caging, and other potentially 
contaminated items. Animals in quarantine may not be housed together.
    (7) If CDC notifies a CDC-registered animal care facility of any 
evidence that animals have been exposed to a communicable disease, the 
facility must, at the facility's expense (subject to reimbursement by 
the importer or carrier (in case of abandonment)), implement or 
cooperate in the CDC's implementation of additional measures to rule 
out the spread of suspected communicable disease before releasing an 
animal or shipment of animals from quarantine, including examination, 
additional diagnostic procedures, treatment, detention, extended 
quarantine, isolation, seizure, or destruction of exposed animals.
    (8) A CDC-registered animal care facility must establish, 
implement, and adhere to standard operating procedures for safe 
handling and necropsy of any animal that dies in quarantine.
    (r) Revocation and reinstatement of a CDC-registered animal care 
facility's registration. (1) The Director may revoke a CDC-registered 
animal care facility's registration if the Director determines that the 
facility has failed to comply with any applicable provisions of this 
section, the facility's standard operating procedures, USDA Animal 
Welfare standards (9 CFR parts 1, 2, and 3), or other standards as 
outlined in CDC's Technical Instructions for CDC-registered Animal Care 
Facilities.
    (2) CDC will send the CDC-registered animal care facility a notice 
of revocation stating the grounds upon which the proposed revocation is 
based.
    (3) If the CDC-registered animal care facility wishes to contest 
the revocation, the facility must file a written response to the notice 
within five business days after receiving the notice.
    (4) As part of the response, a CDC-registered animal care facility 
may request that the Director review the written record.
    (5) If a CDC-registered animal care facility fails to file a 
response within five business days, all of the grounds listed in the 
proposed revocation will be deemed admitted, in which case the notice 
shall constitute final agency action, unless the Secretary, within one 
business day, decides to excuse the facility's failure to respond on a 
timely basis.
    (6) If a CDC-registered animal care facility's response is timely, 
the Director will review the registration, the notice of revocation, 
the response, and make a decision in writing based on the written 
record.
    (7) As soon as practicable after completing the written record 
review, the Director will issue a decision in writing that shall 
constitute final agency action, unless the Secretary, within one 
business day, decides to review the Director's decision. The Director 
will provide the facility with a copy of the written decision.
    (8) The Director may reinstate a revoked registration after 
inspecting the facility, examining its records, conferring with the 
facility, and receiving information and assurance from the facility of 
compliance with the requirements of this section.
    (s) Requirement for the certification of foreign rabies vaccination 
and microchip form to import foreign-vaccinated dogs from DMRVV high-
risk countries. (1) Importers of foreign-vaccinated dogs from DMRVV 
high-risk countries must submit the certification of foreign rabies 
vaccination and microchip form to the CDC-registered animal care 
facility in order to make a reservation at that facility.
    (2) Importers must present documentation confirming the dog's 
reservation at a CDC-registered animal care facility to the airline 
prior to boarding and to CBP upon arrival at a U.S. port for admission 
of foreign-vaccinated dogs from DMRVV high-risk countries.
    (3) The certification of foreign rabies vaccination and microchip 
form must be truthful and accurate, completed in English, and include:
    (i) The name of the person importing the dog (consignee), physical 
address, phone number, email address, passport number, and date of 
birth;
    (ii) The owner's name, phone number, and email address;
    (iii) The destination address (physical address) where the dog will 
reside upon arrival in the United States;

[[Page 41844]]

    (iv) The dog's name, breed, sex, date of birth or approximate age 
if the date of birth is unknown, and color or markings of the dog;
    (v) Rabies vaccination information for the dog administered within 
a timeframe and in accordance with the vaccination schedule as 
specified in CDC technical instructions;
    (vi) Rabies vaccine product information (product name, 
manufacturer, lot number, and product expiration date);
    (vii) Rabies vaccine expiration date (date when next vaccine is 
due), which must be after the dog's date of arrival at a U.S. port;
    (viii) Microchip number and microchip implant date, which must be 
on or before the date of administration of the most recent rabies 
vaccination included on this form;
    (ix) The name, license number or official stamp, address, telephone 
number, email address, and signature of the authorized veterinarian or 
official government veterinarian that examined the dog in the exporting 
country; and
    (x) The name, address, official seal or stamp, and signature of an 
official government veterinarian attesting that the authorized 
veterinarian is licensed or authorized to practice veterinary medicine 
in the exporting country and further attesting that the information 
listed on the form is true and correct.
    (4) Importers who fail or refuse to present the certification of 
foreign rabies vaccination and microchip form or present a form that is 
untruthful, inaccurate, and incomplete may result in the dog being 
denied admission and returned to the country of departure pursuant to 
paragraph (v) of this section.
    (t) Requirement for Certification of U.S.-Issued Rabies Vaccination 
form for importers seeking to import U.S.-vaccinated dogs from DMRVV 
high-risk countries. (1) Importers returning to the United States with 
a U.S.-vaccinated dog that has been in a DMRVV high-risk country within 
the last six months may present their dog for admission without a 
rabies serologic test from a CDC-approved laboratory, without the dog 
undergoing veterinary examination (unless ill, injured, or exposed), 
and without revaccination against rabies or quarantine at a CDC-
registered animal care facility upon arrival under the following 
circumstances:
    (i) The importer presents a certification of U.S.-issued rabies 
vaccination form that is truthful, complete, and accurate.
    (ii) The importer presents a valid certification of U.S.-issued 
rabies vaccination form that sufficiently and reliably demonstrates 
that a USDA-licensed rabies vaccine was administered within a timeframe 
and age parameters as specified in CDC technical instructions.
    (2) The certification of U.S.-issued rabies vaccination form must 
have been completed and endorsed prior to the dog leaving the United 
States and cannot be completed upon arrival at a U.S. port or after the 
dog has left the United States.
    (3) Importers returning to the United States from a DMRVV high-risk 
country with their U.S.-vaccinated dog that are unable to meet the 
requirements of this paragraph shall have the dog treated as if it was 
vaccinated in a foreign country in accordance with the provisions of 
paragraphs (k) and (s) of this section or, alternatively, have the dog 
denied admission and returned to the country of departure pursuant to 
the paragraph (v) of this section.
    (4) If an importer fails to immediately (within 24 hours of 
arrival) arrange for the dog's return to the country of departure, then 
the animal will be considered abandoned pursuant to paragraph (aa) of 
this section.
    (u) Requirement for proof that a dog has been only in DMRVV low-
risk or DMRVV-free countries. (1) Dogs arriving, including those 
returning to the United States, from a DMRVV low-risk or DMRVV-free 
country may be admitted into the United States subject to the 
requirements in this section if the importer submits written 
documentation satisfactory to the Director that for the six months 
before arrival, the dog has been only in DMRVV low-risk or DMRVV-free 
countries.
    (2) For purposes of paragraph (u)(1) of this section, written 
documentation satisfactory to the Director shall include any one of the 
following:
    (i) A valid certification of foreign rabies vaccination and 
microchip form if completed in a DMRVV-free or DMRVV low-risk country 
and the dogs are arriving into the United States from the same DMRVV-
free or DMRVV low-risk country as that listed on the form. This form 
must be completed by an authorized veterinarian, which may include an 
official government veterinarian, and must be certified by an official 
government veterinarian in the exporting country;
    (ii) A valid certification of U.S.-issued rabies vaccination form 
completed by a USDA-accredited veterinarian and endorsed by a USDA 
official veterinarian;
    (iii) A valid USDA export certificate if the certificate is issued 
to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country 
and the dogs are returning to the United States from the same DMRVV-
free or DMRVV low-risk country as that listed on the export 
certificate. The form must be completed by a USDA-accredited 
veterinarian and endorsed by a USDA official veterinarian;
    (iv) A valid foreign export certificate from a DMRVV-free or DMRVV 
low-risk country that has been certified by an official government 
veterinarian in that country. The export certificate must be 
accompanied by veterinary records (such as the European Union pet 
passport) or proof of payment for veterinary services establishing that 
veterinary services were performed in the exporting country at least 
six months before traveling to the United States;
    (v) A certification of dog arriving from DMRVV-free or DMRVV low-
risk country form if accompanied by veterinary records or proof of 
payment for veterinary services establishing that veterinary services 
were performed in the same DMRVV-free or DMRVV low-risk country at 
least six months before travel to the United States. This form must be 
completed by an authorized veterinarian, which may include an official 
government veterinarian, and must be certified by an official 
government veterinarian in the exporting country; or
    (vi) Other records or documents satisfactory to the Director that 
CDC may establish through technical instructions and publish on its 
website.
    (v) Denial of admission of dogs and cats. (1) The following 
categories of animals are inadmissible to the United States:
    (i) Any dog arriving from a DMRVV low-risk or DMRVV-free country 
without written documentation satisfactory to the Director that the dog 
has been only in DMRVV low-risk or DMRVV-free countries during the six 
months prior to the attempted entry, or if the Director reasonably 
suspects fraud.
    (ii) Any dog that is not accompanied by a receipt confirming that a 
CDC dog import form has been submitted to CDC through a CDC-approved 
system.
    (iii) Any dog arriving by air for which a bill of lading, including 
an air waybill, has not been created by the airline prior to the dog's 
arrival in the United States (regardless of the value of the shipment) 
unless the airline transporting the dog has been granted a waiver 
pursuant to paragraph (dd) of this section and the airline's handling 
and transport of the dog is consistent with the terms of that waiver.
    (iv) Any unvaccinated or foreign-vaccinated dog arriving by land to 
the

[[Page 41845]]

United States if the dog has been in a DMRVV high-risk countries within 
the last six months.
    (v) Any unvaccinated or foreign-vaccinated dog arriving by sea to 
the United States if the dog has been in a DMRVV high-risk country 
within the last six months, except for a foreign-vaccinated dog 
qualifying as a service animal and meeting the standards set forth in 
paragraph (d)(5) of this section.
    (vi) Any animal imported by an importer who refuses to comply with 
the requirements (if applicable) for disease surveillance screening, 
microchip scanning, veterinary examination, diagnostics tests to rule 
out communicable diseases, revaccination, providing proof of sufficient 
rabies serologic tests, or quarantine (if applicable) at a CDC-
registered animal care facility or other CDC-approved facility (if a 
CDC-registered animal care facility is not available) upon arrival.
    (vii) Any dog that has been in a DMRVV high-risk country within the 
last six months and arrives without a valid certification of U.S.-
issued rabies vaccination form or a valid certification of foreign 
rabies vaccination and microchip form.
    (viii) Any foreign-vaccinated dog that has been in a DMRVV high-
risk country within the last six months and does not arrive via air at 
a U.S. airport with a CDC quarantine station and a CDC-registered 
animal care facility, except for a foreign-vaccinated dog arriving by 
sea that qualifies as a service animal and meets the standards set 
forth in paragraph (d)(5) of this section.
    (ix) Any dog imported from a DMRVV high-risk country that arrives 
without a reservation at a CDC-registered animal care facility (if 
applicable).
    (x) Any dog from a DMRVV-restricted country that arrives without a 
valid CDC dog import permit.
    (xi) Any dog, regardless of country of departure, if the Director 
reasonably suspects fraud in any documentation required for admission 
or if such documentation is otherwise untruthful, inaccurate, or 
incomplete.
    (xii) Any animal, regardless of country of departure, that poses a 
public health risk, including animals that appear unhealthy upon 
arrival or demonstrate signs or symptoms of communicable disease.
    (xiii) Any dog under six months of age that arrives in the United 
States.
    (xiv) Any dog that arrives in the United States without a microchip 
or without its microchip number documented on the importation paperwork 
required by CDC.
    (2) An importer must meet the admission requirements of all U.S. 
government agencies for the admission of an animal into the United 
States. Satisfaction of CDC's requirements for the admission of animals 
does not fulfill the admission requirements of other U.S. government 
agencies.
    (w) Dogs and cats awaiting an admissibility determination or return 
to their country of departure. (1) Animals arriving by air that are 
denied admission and awaiting return to their country of departure or 
awaiting a determination as to their admissibility must be held in a 
CDC-registered animal care facility or other CDC-approved facility (if 
a CDC-registered animal care facility is not available) in such a way 
as to prevent the potential spread of communicable diseases.
    (2) An airline must arrange to transport an animal arriving by air 
to a CDC-registered animal care facility (or other boarding, kennel, or 
veterinary clinic approved by CDC if a CDC-registered animal care 
facility is not available) if the animal is denied admission and is 
awaiting return to its country of departure or is awaiting a 
determination of its admissibility. If the animal is apparently 
healthy, the airline must transport the animal (by a CBP-bonded 
transporter) within 12 hours of its arrival.
    (3) An airline must immediately report an obviously ill or injured 
animal (e.g., the animal is unable to stand, has difficulty breathing, 
is bleeding, has broken bones or disfigured limbs, or is experiencing 
seizures, vomiting, or discharge from the nose, mouth, or eyes) 
arriving into the United States to the CDC quarantine station of 
jurisdiction. The airline must immediately arrange to transport an 
obviously ill or injured animal by a CBP-bonded transporter to a CDC-
registered animal care facility or veterinary clinic as directed by 
CDC.
    (4) Animals arriving by sea that are denied admission must remain 
on the vessel while awaiting return to the country of departure.
    (x) Disposal or disposition of dogs and cats denied admission to 
the United States. (1) Animals shall be subject to such additional 
requirements as authorized under this part or 42 CFR part 70 as may be 
deemed necessary by the Director to protect the public's health, 
including suspension of entry under Sec.  71.63.
    (2) Animals denied admission to the United States that were 
transported to the United States via air must be returned by the 
airline to the country of departure at the importer's expense on the 
next available outbound flight (no later than 72 hours after arrival), 
regardless of airline or route, if fit to travel. Pending the animal's 
return, the animal shall be detained at the importer's expense in the 
custody of the carrier at a CDC-registered animal care facility (or 
other boarding, kennel, or veterinary clinic approved by CDC if a CDC-
registered animal care facility is not available).
    (3) Animals denied admission to the United States that were 
transported to the United States via sea shall be reembarked 
immediately by the vessel's master or operator and returned to their 
country of departure on the next voyage.
    (4) Animals denied admission to the United States that were 
transported to the United States via land shall be returned immediately 
by importer or carrier to their country of departure.
    (5) If an animal is not fit to travel, poses a public health risk, 
or would pose a risk to other animals, then the carrier shall arrange 
for the animal to be transported to a CDC-registered animal care 
facility or a CDC-approved veterinary clinic (if a CDC-registered 
animal care facility is not available) for housing and treatment by a 
licensed veterinarian until approved for travel by CDC or humanely 
euthanized (e.g., under circumstances where the animal is fatally ill 
or injured) by a licensed veterinarian. The importer shall be 
responsible for all costs associated with the denial, veterinary 
evaluation, care, or disposal of the animal. If the importer refuses to 
pay for any costs associated with the denial, evaluation, care, or 
disposal of the animal, then it will be considered abandoned, and the 
carrier shall assume custody and financial responsibility for these 
costs.
    (6) If humane euthanasia is recommended by a veterinarian or chosen 
by an importer or carrier (e.g., under circumstances where the animal 
is fatally ill or injured), the animal must be euthanized by a U.S.-
licensed veterinarian in accordance with American Veterinary Medical 
Association guidelines. Euthanasia does not relieve carriers or 
importers of the obligation to arrange and pay for testing and necropsy 
required by CDC.
    (7) The Director may grant temporary extensions of returns for 
animals that are not fit for travel as determined by a CDC 
veterinarian, but the importer (or carrier in the case of abandonment) 
must arrange for the return of the animal to its country of departure 
as soon as CDC notifies the carrier that the animal is fit for travel.
    (8) The requirements of this paragraph shall additionally apply to 
dogs or cats abandoned by the importer prior to the dogs' or cats' 
admission into the United States. A dog or cat may be deemed

[[Page 41846]]

abandoned pursuant to the provisions of paragraph (aa) of this section.
    (9) Carriers must provide transportation to/from and holding at a 
CDC-registered animal care facility or another CDC-approved facility 
(if a CDC-registered animal care facility is not available) while the 
animal is pending an admissibility determination, undergoing veterinary 
evaluation or care, or upon denial of entry. Carriers may require 
reimbursement from an importer for any costs incurred on behalf of the 
importer.
    (10) Importers must comply with CDC requirements for the return of 
an animal or for the veterinary assessment of an animal. Refusal to 
cooperate, including refusal to pay any associated veterinary fees, 
will result in the animal being considered abandoned by the importer, 
and custody of the animal will be transferred to the carrier who will 
assume financial responsibility for costs relating to the denial, 
evaluation, care, or disposal of the animal.
    (11) A carrier may enter into contractual arrangements with an 
importer or a third party relating to the expenses of returning an 
animal to its country of departure, for veterinary care, or otherwise 
disposing of an animal, provided that no government costs are incurred. 
The return of an animal to its country of departure or the initiation 
of veterinary care shall not be delayed while the carrier attempts to 
enter into or negotiate contractual arrangements.
    (12) The provisions of this paragraph may be applied to importers 
of animals and to carriers transporting such animals in circumstances 
where an animal is denied entry at a land port or seaport of the United 
States and the animal cannot be immediately returned to its country of 
departure (e.g., because it is unfit to travel).
    (y) Appeals of CDC denials to admit a dog or a cat upon arrival 
into the United States. (1) If CDC denies admission to an animal upon 
arrival, then the importer may appeal that denial to the Director.
    (2) The importer must submit the appeal in writing to the Director, 
stating the reasons for the appeal and demonstrating that there is a 
genuine and substantial issue of fact in dispute.
    (3) The importer must submit the appeal within one (1) business day 
of the denial by emailing [email protected].
    (4) Submitting an appeal will not delay the return of the animal to 
the country of departure.
    (5) The Director will issue a written response to the appeal, which 
shall constitute final agency action, unless the Secretary, within one 
(1) business day, decides to review the Director's decision.
    (z) Record of death of dogs and cats en route to the United States 
and disposition of dead animals. (1) Carriers shall maintain a record 
of the death of animals occurring while en route to the United States 
and shall submit the record to the CDC quarantine station of 
jurisdiction for the U.S. port upon arrival.
    (2) Animals that become sick or die en route or are identified as 
sick or dead upon arrival shall be separated from other animals 
(including animals other than dogs or cats) as soon as the sickness or 
death is discovered and shall be held in confinement pending any 
necessary examination as determined by the Director. Sick animals shall 
be examined pursuant to the provisions of paragraph (j) of this section 
or disposed of pursuant to the provisions of paragraph (x) of this 
section.
    (3) The carrier shall arrange for any animals that die en route to 
the United States or that die while detained pending determination of 
their admissibility to undergo a necropsy (gross and histopathologic 
examination are required), and any subsequent infectious disease 
testing based on gross or histopathology findings or as determined by 
CDC. The carrier or CDC-registered animal care facility must contact 
the CDC quarantine station of jurisdiction prior to transporting an 
animal for necropsy to determine whether rabies testing is required. In 
the event an importer abandons an animal, the carrier will become the 
owner and shall assume responsibility for all expenses described in 
this paragraph.
    (4) The carrier shall send copies of the final necropsy report and 
all test results to the CDC quarantine station of jurisdiction.
    (5) Pursuant to paragraphs (p) and (x) of this section, the 
importer is responsible for costs associated with the necropsy, 
testing, and disposal of the body. In the event an importer abandons an 
animal, then pursuant to paragraph (aa) of this section, the carrier 
will become the owner and shall assume responsibility for all expenses 
described in this paragraph.
    (aa) Abandoned shipments of dogs and cats. (1) In the event an 
importer abandons an animal under this section, the carrier will become 
the owner and shall assume responsibility for all expenses described in 
this section.
    (2) An animal shipment will be deemed abandoned under the following 
circumstances:
    (i) when explicitly stated by the importer verbally or in writing 
to the carrier, CDC, or CBP; or
    (ii) if the importer fails to cooperate with or respond to the 
carrier's attempts to comply with the provisions of this section within 
24 hours; or
    (iii) if the importer refuses payment within 24 hours for CDC-
mandated examinations, testing, holding, or treatment needed to ensure 
the safe importation of dogs and cats into the United States.
    (bb) Sanitation of cages and containers of dogs and cats. When the 
Director finds that the cages or other containers of animals arriving 
in the United States are in an unsanitary or other condition that may 
constitute a communicable disease risk, the animals shall not be 
admitted in such containers unless the carrier has the containers 
cleaned and disinfected or the animals are removed and placed in clean 
containers in accordance with USDA and, in the case of airlines, the 
International Air Transport Association shipping requirements. 
Discarded containers must be cleaned and disinfected or destroyed in 
accordance with carrier policies. CDC may require documentation of 
container disinfection or destruction by the carrier.
    (cc) Requirements for in-transit shipments of dogs and cats. (1) 
In-transit shipments of live animals are not eligible for release into 
the United States and may only be transported as cargo and not as hand-
carried baggage or checked/excess baggage.
    (2) In-transit shipments must be maintained under continuous 
confinement with USDA APHIS oversight on board a conveyance until 
export, or off-loaded and maintained under continuous confinement and 
APHIS oversight at a USDA APHIS-preapproved holding facility with a 
CBP-issued FIRMS code while awaiting a connecting conveyance, and then 
loaded and maintained under USDA APHIS oversight on board the 
connecting conveyance until export.
    (3) The provisions of this section shall apply to animals 
transiting through the United States from one foreign country to 
another, except as provided below:
    (i) Animals that appear healthy but have been exposed to a sick or 
dead animal (including an animal other than a dog or cat) suspected of 
having a communicable disease are not required to undergo examination 
or tests as provided in paragraph (j) of this section if the Director 
determines that the conditions under which the animals are being 
transported afford adequate protection against introduction of

[[Page 41847]]

communicable disease into the United States.
    (ii) The certification of foreign rabies vaccination and microchip 
form, certification of U.S.-issued rabies vaccination form, 
certification of dog arriving from DMRVV-free or DMRVV low-risk country 
form, or CDC dog import form is not required for dogs that are 
transported by aircraft and are being transited through the United 
States if retained in the custody of the airline under conditions that 
would prevent transmission of communicable diseases.
    (iii) There is no minimum age requirement for dogs that are 
transported by aircraft and are being transited through the United 
States if retained in the custody of the airline under conditions that 
would prevent transmission of communicable diseases.
    (iv) A microchip is not required for dogs that are transported by 
aircraft and are being transited through the United States if retained 
in the custody of the airline under conditions that would prevent 
transmission of communicable diseases.
    (dd) Bill of lading and other airline requirements for dogs. (1) 
Airlines are required to create a bill of lading, which includes air 
waybills (AWB), for all dogs arriving in the United States prior to 
arrival. This includes dogs transported as cargo, checked-baggage, or 
hand-carried baggage.
    (2) Airlines that lack the technical ability to generate a bill of 
lading to transport dogs as checked baggage or as hand-carried baggage 
may request a waiver from CDC by emailing [email protected].
    (i) The airline's request for a waiver must be accompanied by a 
written standard operating procedure (SOP) describing how the airline 
will ensure care, transportation, and housing for any ill, injured, or 
abandoned animals in the absence of a bill of lading. The SOP must also 
identify and provide the location of a CDC-registered animal care 
facility or other suitable alternative approved by CBP and CDC that 
will provide care and suitable housing for any ill, injured, or 
abandoned animals prior to any animals being transported to the United 
States.
    (ii) As a condition of granting a waiver, CDC may require the 
airline to obtain the services of a licensed U.S. customs broker who 
will be responsible for coordinating on behalf of the airline the entry 
and clearance of any dogs imported into the United States, including 
compliance with CDC's requirements relating to the admission of dogs.
    (iii) As a condition of granting a waiver, CDC may require the 
airline to provide a timetable and identify steps that the airline will 
take to develop the technical capacity to generate an AWB (or another 
suitable alternative to an AWB) to transport dogs as cargo, checked-
baggage, or hand-carried baggage.
    (iv) The Director may revoke a waiver granted to an airline upon 
notice to the airline and a finding that an airline has acted 
inconsistent with the terms of the waiver, including any provision of 
its SOP.
    (v) CDC may publish additional technical instructions on its 
website for airlines seeking a waiver from the bill of lading 
requirement.
    (3) Any dog arriving by air for which a bill of lading, including 
an AWB, has not been created by the airline prior to the dog's arrival 
in the United States will be denied admission and returned to the 
country of departure pursuant to paragraph (v) of this section, unless 
the airline transporting the dog has been granted a waiver and the 
airline's handling and transport of the dog are consistent with the 
terms of that waiver.
    (4) Airlines must deny boarding to any dogs for which the importer: 
has not presented to the airline before boarding a receipt confirming 
submission of the CDC dog import form; if the dogs are scheduled to 
arrive at a different U.S. port than the one listed on the receipt of 
the CDC dog import form; or if the dogs presented for travel do not 
match the description on the receipt of the CDC dog import form.
    (5) For U.S.-vaccinated dogs that have been in a DMRVV high-risk 
country within the last six months, airlines must deny boarding unless 
the importer presents prior to boarding a valid certification of U.S.-
issued rabies vaccination form or if the dogs presented for travel do 
not match the description on the certification of U.S.-issued rabies 
vaccination form.
    (6) For foreign-vaccinated dogs that have been in a DMRVV high-risk 
country within the last six months, airlines must deny boarding unless 
the importer presents documentation to the airline before boarding of a 
reservation at a CDC-registered animal care facility and the dog is 
scheduled to arrive in the United States at the U.S. airport where the 
CDC-registered animal care facility is located.
    (7) For dogs from DMRVV-free or DMRVV low-risk countries, airlines 
must deny boarding unless the importer before boarding presents 
documentation as described in paragraphs (g)(2) and (u)(2) 
demonstrating that the dog is over six months of age, has a microchip, 
and has been only in DMRVV low-risk or DMRVV-free countries during the 
last six months. Airlines must also deny boarding if the dog presented 
for travel does not match the description on the documents presented by 
the importer for travel.
    (8) A representative of an airline transporting live dogs into the 
United States must be on-site at the U.S. airport and available to 
coordinate the entry/clearance of the dogs with Federal government 
officials until all live dogs transported on an arriving flight into 
the United States have either been cleared for entry or arrangements 
have been made to transport the dogs to a CDC-registered animal care 
facility or other facility (e.g., veterinary clinic or kennel) approved 
by CDC pending an admissibility determination.
    (ee) Order prohibiting carriers from transporting dogs and cats. 
(1) If the Director determines that a carrier has endangered the public 
health of the United States by acting or failing to act to prevent the 
introduction of DMRVV, as would occur through failure to comply with 
any applicable provisions of this section, the Director may issue an 
order revoking the carrier's permission to transport live animals into 
the United States, which shall be served on the carrier's owner or 
operator.
    (2) The Director may rescind the order after inspecting the 
carrier's facilities; examining its records; conferring with the 
carrier's owners or operators, its contractors, or staff; or receiving 
information and written assurances from the carrier owner or operator 
that it has taken remedial steps to ensure future compliance with the 
requirements of this section.
    (3) A carrier owner or operator may appeal a revocation of a 
carrier's permission to transport live animals into the United States. 
The appeal shall be in writing, addressed to the Director, state the 
reasons for the appeal, and demonstrate that there is a genuine and 
substantial issue of fact in dispute. The appeal must be submitted via 
email to [email protected].
    (4) As soon as practicable after completing the written record 
review, the Director will issue a decision in writing that shall 
constitute final agency action, unless the Secretary, within one 
business day, decides to review the Director's decision. The Director 
will serve the carrier with a copy of the written decision.
    (ff) Prohibition on imports of dogs from DMRVV-restricted 
countries. (1) The Director may prohibit or otherwise restrict the 
import of dogs into the United States from certain countries designated 
as DMRVV-restricted countries. CDC will maintain a list of DMRVV-
restricted countries based on

[[Page 41848]]

the countries' prior export of dogs infected with DMRVV to any other 
countries within a time frame determined by CDC or based on inadequate 
controls, as determined by CDC, in the countries to monitor and prevent 
the export of dogs to the United States with falsified or fraudulent 
rabies vaccine credentials, invalid rabies vaccination certificates, or 
other fraudulent, inaccurate, or invalid exportation/importation 
documents.
    (2) DMRVV-restricted countries may be subject to additional 
restrictions, including a complete prohibition on the importation of 
dogs into the United States from those countries as needed to prevent 
the reintroduction of DMRVV.
    (3) The Director may maintain such additional restrictions or 
prohibitions in place until the Director is satisfied that the DMRVV-
restricted country has established sufficient controls to prevent the 
reintroduction of DMRVV into the United States, including measures to 
prevent the use of falsified or fraudulent vaccine credentials or 
invalid rabies vaccination certificates.
    (4) The addition or removal of DMRVV-restricted countries from the 
list shall be announced through notice in the Federal Register, and a 
list will be maintained on CDC's website.
    (5) Notwithstanding the prohibition on imports of dogs from DMRVV-
restricted countries, the Director may allow the importation of dogs 
for scientific purposes, when used as service animals (as defined in 14 
CFR 382.3) for individuals with disabilities, or in furtherance of an 
important government interest. In such instances CDC will issue a CDC 
dog import permit for the importation of dogs from DMRVV-restricted 
countries. Instructions for how to apply for a permit will be included 
in CDC technical instructions.
    (gg) Request for issuance of additional fines or penalties. (1) CDC 
may request that CBP, pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a, 
issue additional fines, citations, or penalties to importers, brokers, 
or carriers when the Director has reason to believe that an importer, 
broker, or carrier has violated any of the provisions of this section 
or otherwise engaged in conduct contrary to law.
    (2) CDC may request that the U.S. Department of Justice 
investigate, and if determined appropriate based on the outcome of such 
investigation, prosecute any person who the Director has reason to 
believe may have violated Federal law, including by forcibly 
assaulting, resisting, opposing, impeding, intimidating, or interfering 
with a U.S. government employee while engaged in or on account of the 
performance of their official duties in violation of 18 U.S.C. 111, by 
obstructing an agency proceeding in violation of 18 U.S.C. 1505, or by 
otherwise engaging in conduct contrary to law.

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