[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Proposed Rules]
[Pages 43978-44029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14343]



[[Page 43977]]

Vol. 88

Monday,

No. 130

July 10, 2023

Part VI





Department of Health and Human Services





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42 CFR Part 71





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

  Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / 
Proposed Rules  

[[Page 43978]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[CDC Docket No. CDC-2023-0051]
RIN 0920-AA82


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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the 
Department of Health and Human Services (HHS), proposes to amend its 
foreign quarantine regulation to provide additional clarity and 
safeguards to address the public health risk of dog-maintained rabies 
virus variant (DMRVV) associated with the importation of dogs into the 
United States. The United States has been DMRVV-free since 2007, and 
reintroduction poses significant risk to human and animal health. The 
close relationship between dogs and people means there is a direct 
public health risk to individuals that interact with inadequately 
vaccinated dogs imported from countries at high risk of DMRVV (high-
risk countries). The notice of proposed rulemaking (NPRM) also 
addresses the importation of cats because both dogs and cats are 
included in the current regulation. Cats are not required to have proof 
of rabies vaccination and CDC is not proposing new substantive changes 
relating to the importation of cats.

DATES: Written or electronic comments on the NPRM must be received by 
September 8, 2023.
    Written comments on the proposed data collection requirements under 
the Paperwork Reduction Act must be received by September 8, 2023.

ADDRESSES: 
    For the NPRM: You may submit comments, identified by Docket No. 
CDC-2023-0051 or RIN 0920-AA82, by either of the following ways:
     Federal Rulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Global Migration and Quarantine, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4, 
Atlanta, GA 30329.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
action. All relevant comments received, including any personal 
information provided, will be posted without change to https://www.regulations.gov/. Do not submit comments by email. CDC does not 
accept comments by email.
    To request more information on the proposed project or to obtain a 
copy of the information collection plan and instruments, contact 
Jeffrey M. Zirger, Information Collection Review Office Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, 
Atlanta, Georgia 30329; Telephone: 404-639-7570; Email: [email protected].

FOR FURTHER INFORMATION CONTACT: Ashley C. Altenburger, J.D., Division 
of Global Migration and Quarantine, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329. 
Telephone: 1-800-232-4636. For information regarding CDC operations and 
importations related to this NPRM, please contact Dr. Emily Pieracci, 
D.V.M., Division of Global Migration and Quarantine, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4, 
Atlanta, GA 30329; Telephone: 1-800-232-4636.

SUPPLEMENTARY INFORMATION: The NPRM is organized as follows:

I. Executive Summary
    A. Purpose of This Regulatory Action
    B. Summary of Major Provisions
    C. Costs and Benefits
II. Public Participation
III. Background
    A. Legal Authority
    B. Historical Background
    C. Current Process
IV. Summary of Proposed Changes
V. Alternatives Considered
VI. Required Regulatory Analyses
    A. Executive Orders 12866 and 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act of 1995
    D. National Environmental Policy Act (NEPA)
    E. Executive Order 12988: Civil Justice Reform
    F. Executive Order 13132: Federalism
    G. Plain Language Act of 2010

I. Executive Summary

A. Purpose of This Regulatory Action

    Through this NPRM, HHS/CDC proposes to revise its regulation at 42 
CFR 71.51 to prevent the reintroduction and spread of dog-maintained 
rabies virus variant (DMRVV) in the United States. HHS/CDC also 
proposes amendments to 42 CFR 71.50, which contains definitions 
applicable to animal importations under 42 CFR part 71, subpart F. The 
United States was declared DMRVV-free in 2007.\1\ The importation of 
just one dog infected with DMRVV risks re-introduction of the virus 
into the United States; such a public health threat could result in the 
loss of human and animal life and consequential economic 
impact.2 3 4 The rabies virus can infect any mammal, and, 
once clinical signs appear, the disease is almost always fatal.\5\ A 
DMRVV-infected dog can transmit the virus to humans, domestic pets, 
livestock, or wildlife. Importing inadequately vaccinated dogs from 
countries at high risk of DMRVV (high-risk countries) \6\ involves a 
significant public health risk to people who directly interact with 
those dogs. In 2019, the importation of a DMRVV-infected dog cost the 
affected State governments more than $400,000 U.S. dollars (USD) for 
the ensuing public health investigations and rabies post-exposure 
prophylaxis (PEP) treatments administered to exposed 
persons.7 8
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    \1\ Centers for Disease Control and Prevention. US Declared 
Canine-Rabies Free. https://www.cdc.gov/media/pressrel/2007/r070907.htm. Accessed June 1, 2023.
    \2\ World Bank (2012). People, Pathogens and Our Planet: The 
Economics of One Health. Retrieved from https://openknowledge.worldbank.org/handle/10986/11892.
    \3\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \4\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment 
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
    \5\ Fooks AR, Banyard AC, Horton DL, Johnson N, McElhinney LM, 
Jackson AC. Current status of rabies and prospects for elimination. 
Lancet 2014;384:1389-99.
    \6\ A complete list of countries with high risk of DMRVV is 
available at ``High-Risk Countries for Dog Rabies.'' https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html. Accessed June 8, 2023.
    \7\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \8\ Centers for Disease Control and Prevention (2022). Rabies 
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/index.html.
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    Through this proposed rulemaking, HHS/CDC also seeks to prevent and 
deter the importation of dogs with falsified or fraudulent rabies 
vaccine documentation. In 2020, CDC observed a 52 percent increase in 
the number of dogs that were ineligible for admission due to falsified 
or fraudulent documentation, as compared to 2018 and 2019 (450 dogs 
compared to the previous baseline of 300 dogs per year).\9\ This 
troubling trend continued in 2021, with an additional 24 percent 
increase of dogs ineligible for admission in just

[[Page 43979]]

the first half of the year, compared to the full 2020 calendar year 
(January-December) (approximately 560 dogs with falsified or fraudulent 
documentation).\10\
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    \9\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: 15 February 2021.
    \10\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, January 1, 2021-July 14, 2021. Accessed: 01 October 2021.
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    The use of a single false rabies vaccination certificate (RVC) \11\ 
or rabies vaccination documents as part of a larger shipment of 
multiple dogs raises suspicion that the other rabies vaccination 
documents for the remaining dogs may also be false and creates an 
additional burden on CDC and State health departments to track, test, 
and evaluate the remaining dogs in the shipment. CDC and U.S. Customs 
and Border Protection (CBP) have documented numerous importations every 
year in which flight parents \12\ transport dogs for the purpose of 
resale, adoption, or transfer of ownership that do not meet CDC's entry 
requirements. These flight parents often claim the dogs are their 
personal pets to avoid U.S. Department of Agriculture (USDA) Animal 
Care entry requirements and potential tariffs or fees under CBP 
regulations. Even when well-meaning, these importers jeopardize public 
health, as many of them do not know the history of the animals they are 
transporting. Deterring individuals who serve as flight parents from 
supporting fraudulent dog importations has proven difficult despite the 
existence of CBP penalties relating to aiding unlawful importations and 
fraudulent conduct. See 19 U.S.C. 1592 and 19 U.S.C. 1595a.
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    \11\ Centers for Disease Control and Prevention. What is a valid 
rabies vaccination certificate? Available at: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html.
    \12\ A flight parent refers to a person accompanying an animal 
into the country. Flight parents are often solicited through social 
media, not affiliated with the sponsoring dog rescue organization, 
and usually compensated with an airline ticket or other funds.
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    The documented increase in fraudulent vaccine documentation and 
importers circumventing dog import regulations was shortly followed by 
the advent of the coronavirus disease 2019 (COVID-19) pandemic. Many 
public health resources were redirected to the COVID-19 response, 
reducing the availability of resources to respond to dog importation 
issues. In light of this confluence of events, in June 2021, CDC 
published a temporary suspension of dogs entering the United States 
from DMRVV high-risk countries.\13\ The temporary suspension created a 
system that, among other things, implemented the use of standardized 
forms, required titer test results demonstrating the presence of rabies 
antibodies in dogs, and developed a reservation system allowing for the 
rapid quarantine of dogs from DMRVV high-risk countries arriving with 
inadequate proof of titers. During the temporary suspension, CDC has 
documented decreased instances of fraud, fewer dogs being denied 
admission into the country, fewer sick and dead dogs arriving in the 
United States, and fewer federal and state agency resources devoted to 
addressing issues related to inadequately vaccinated dogs upon arrival. 
This NPRM proposes a similar regulatory framework based on the 
documented successes of the temporary suspension.
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    \13\ Temporary Suspension of Dogs Entering the United States 
from High-Risk Rabies Countries. Federal Register, 86 FR 32041 (June 
16, 2021).
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    In parallel with the publication of this NPRM, CDC has published an 
extension of the temporary suspension through July 31, 2024. A 
suspension remains necessary to protect the public's health against the 
reintroduction of DMRVV into the United States because there is a 
continued threat posed by dogs from DMRVV high-risk countries that are 
unvaccinated or inadequately vaccinated against rabies. This continued 
threat is due to various factors, including: a high volume of dogs 
being imported into the United States contemporaneous with insufficient 
veterinary controls in DMRVV high-risk countries to prevent the export 
of inadequately vaccinated dogs, inadequate veterinary supply chains 
for vaccines and related materials, and persistent workforce capacity 
shortages, particularly in DMRVV high-risk countries that export dogs 
to the United States.
    This NPRM proposes to incorporate practices used during the 
temporary suspension period that CDC found effective to better protect 
the public's health from introductions of DMRVV from high-risk 
countries and reduce potential instances of fraudulent documentation. 
The NPRM outlines a framework and set of operations that CDC believes 
would mitigate the need for suspending dog imports from high-risk 
countries should these procedures be adopted. We welcome feedback from 
the public on all proposals contained within this NRPM.

B. Summary of Major Provisions

    In this NPRM, HHS/CDC proposes to align U.S. import requirements 
for dogs with the importation requirements of other DMRVV-free 
countries by requiring proof of rabies vaccination and adequate 
serologic test results from a CDC-approved laboratory. This NPRM 
proposes for all dog imports: a microchip, six-month minimum age 
requirement for admission, importer submission of a CDC import form 
(CDC Import Submission Form), and requirements for airlines to confirm 
documentation, provide safe housing, and assist public health officials 
in determining animal cause of death.
    HHS/CDC proposes all importers of dogs that have been in a DMRVV 
high-risk country in the past six months, regardless of whether 
foreign- or U.S.-vaccinated, would be required to submit a standardized 
vaccination form verifying the rabies vaccination status of dogs. For 
dogs that have been in a DMRVV high-risk country in the past six months 
and have a valid U.S.-issued rabies vaccination certificate, this NPRM 
proposes that the dog be required to arrive at a U.S. airport with a 
CDC quarantine station. For dogs that have been in a DMRVV high-risk 
country in the past six months, and were vaccinated in a foreign 
country, this NPRM proposes that the dog be required to arrive a U.S. 
airport with a CDC quarantine station and a CDC-registered Animal Care 
Facility. This NPRM further proposes that dogs imported from DMRVV-free 
or DMRVV low-risk countries be eligible to arrive at any U.S. port. In 
lieu of a CDC vaccination form, which would be required for dogs 
imported from DMRVV high-risk countries, these importers may instead 
provide proof that the dogs have only been in DMRVV-free or DMRVV low-
risk countries during the previous six months prior to arriving in the 
United States.
    HHS/CDC also proposes to require that all dogs arriving from any 
country, including dogs returning to the United States after traveling 
abroad, be properly microchipped with an International Standards 
Organization (ISO)-compatible microchip prior to travel into the United 
States. The microchip information would be included on importation 
documents to help ensure that dogs presented for admission are the same 
dogs as those listed on the rabies vaccination records. Microchips are 
already used globally and required for importation in many DMRVV-free 
countries. Microchips are recommended by the international veterinary 
community and animal rescue and welfare organizations to reunite lost 
animals with their owners and ensure the veterinary records for an 
animal can be linked to the animal.\14\
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    \14\ American Veterinary Medical Association. Microchipping FAQ. 
https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq. Accessed June 1, 2023.
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    The microchip requirement will also promote greater confidence in 
the

[[Page 43980]]

information recorded on the rabies vaccination records. CDC has 
documented several instances of importers attempting to present records 
of vaccinated dogs that became ill or died before travel as the 
vaccination records for dogs that lacked appropriate veterinary 
paperwork, presenting the original dogs' vaccination records for the 
replacement dogs and attempting to import the unvaccinated dogs into 
the United States without detection.\15\ Because microchips are not 
currently required for entry into the United States and the dogs in 
question were not microchipped, the public health investigation to 
confirm the identity of these dogs was both resource intensive and 
challenging. Further, during CDC's temporary suspension of dogs 
entering the United States from DMRVV high-risk countries, CDC 
documented that 99 percent (>20,000) of permit applications received 
were for dogs that had microchips implanted prior to the announcement 
of the suspension. Microchips are frequently used by pet owners and 
required for international transit by many foreign countries. 
Therefore, CDC's proposed requirement would have minimal impact on dog 
importations, although costs to some importers would still be incurred. 
We welcome feedback on this proposal.
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    \15\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
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    To address concerns about importations of puppies that are too 
young to be properly vaccinated against rabies, through this NPRM, HHS/
CDC proposes requiring that any dog arriving in the United States be at 
least six months of age. Dogs cannot be vaccinated effectively against 
rabies before 12 weeks of age and are not considered fully vaccinated 
until 28 days after vaccination.\16\ Establishing a six-month minimum 
age requirement for the import of dogs aligns with current USDA 
requirements for commercial dog imports under the Animal Welfare Act 
\17\ and will better protect the public's health from rabies. Under 
this proposal, an exception would be included to permit an owner to 
import a maximum of three individual (personal pet) dogs under six 
months of age in the same calendar year (January-December) if arriving 
in the United States via a U.S. land port through Canada or Mexico, 
provided the dogs have not been in a DMRVV high-risk or DMRVV-
restricted country since birth. CDC notes that both Canada and Mexico 
are currently DMRVV-free countries, and a limited exception to 
accommodate personal pet owners who travel by land between the U.S. and 
Canada or Mexico is unlikely to threaten the public's health. HHS/CDC 
specifically welcomes public comment this proposal.
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    \16\ National Association of State Public Health Veterinarians. 
Compendium of animal rabies prevention and control, 2016. JAVMA 
2016; 248 (5):505-517.
    \17\ 7 U.S.C. 2148.
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    In this NPRM, HHS/CDC also proposes to require all dog importers to 
submit a CDC Import Submission Form (i.e., an online form that includes 
the importers' contact information and information related to each dog 
being imported) via a CDC-approved system prior to travel to the United 
States. This proposed requirement would apply to all imported dogs 
(including dogs arriving from DMRVV-free and DMRVV low-risk countries) 
arriving in the United States by air, land, or sea. Upon arrival at a 
U.S. port,\18\ importers will present a receipt confirming they 
submitted a completed CDC Import Submission Form; additionally, 
importers arriving by air will present the receipt to the airline prior 
to boarding. The receipt will contain the information submitted on the 
CDC Import Submission Form, which will allow government officials to 
verify that the details from the CDC Import Submission Form match the 
dog being presented for entry. CDC's import submission system would 
operate as a free online system. Requiring documentation for all 
imported dogs would allow CDC to track the total number of dog 
importations (including the number imported from DMRVV high-risk 
countries), something CDC is unable to do currently.
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    \18\ U.S. Port means any seaport, airport, or border crossing 
point under the control of the United States. 42 CFR 71.1(b).
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    HHS/CDC further proposes that an airline, prior to accepting a dog 
for transport, must confirm that the dog possess all required import 
documentation based on the country of origin. Airlines must also ensure 
dogs from DMRVV high-risk countries will only be entering the United 
States through a designated U.S. airport with a CDC quarantine station 
(if U.S.-vaccinated) or a U.S. airport with both a CDC quarantine 
station and a CDC-registered Animal Care Facility (if foreign-
vaccinated) and that the importer possesses a reservation with the CDC-
registered Animal Care Facility for examination, vaccination, and 
quarantine (if required). As needed, CDC will coordinate with the 
airline regarding transport of the dog to the CDC-registered Animal 
Care Facility. These regulatory actions (if finalized as proposed) 
would help ensure that dogs arriving in the United States from DMRVV 
high-risk countries are adequately protected against rabies and do not 
pose a public health threat. We welcome feedback from the public on 
this proposal.
    HHS/CDC proposes to require that airlines return dogs or cats 
denied admission to the country of departure within 72 hours after 
arrival. The responsibility for a dog or cat pending admission into the 
United States or awaiting return to the country of departure has been a 
point of confusion for many airlines, resulting in delayed care and 
improper housing for numerous animals. Delays in returning dogs to 
their countries of departure also potentially threaten U.S. public 
health by exposing people to dogs with unknown rabies vaccination 
status. HHS/CDC proposes that the airline on which a dog or cat is 
brought to the United States must arrange for and ensure transportation 
and care until the animal is either returned to the county of departure 
or cleared for entry into the United States.
    HHS/CDC also proposes a provision regarding dogs and cats that die 
en route to the United States or that die while detained pending 
determination of their admissibility. This provision is primarily 
directed at airlines and would require that they transport deceased 
dogs and cats and arrange for necropsy requiring gross and 
histopathologic examination and any subsequent infectious disease 
testing based on the findings. The importer is responsible for all 
costs associated with necropsy and testing. The airline would also be 
required to notify the CDC quarantine station of jurisdiction \19\ 
prior to transporting a dead dog or cat for a necropsy to determine 
whether rabies testing is required and provide the quarantine station 
with the final necropsy report and all test results. These measures 
will help CDC rule out foreign animal diseases of public health concern 
\20\ as a potential cause of death and will protect both animal and 
human health. The provisions of this paragraph may also be applied to 
other carriers transporting such dogs and cats in the very rare event 
when the death of a dog or cat occurs en route to the United

[[Page 43981]]

States, or the animal dies while detained pending determination of 
their admissibility. HHS/CDC welcomes public comment specifically on 
these proposed requirements.
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    \19\ CDC quarantine station jurisdictions, available at: 
www.cdc.gov/quarantine/quarantinestationsjurisdictionscounties.html.
    \20\ U.S. Department of Agriculture. Notifiable Diseases and 
Conditions. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/Notifiable-Diseases-and-Conditions.
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    Through this NPRM, HHS/CDC proposes to remove the current 
requirement for a valid RVC in 42 CFR 71.51(c) and replace it with new 
rabies vaccination forms for dogs imported from DMRVV high-risk 
countries. The proposed rabies vaccination forms would include the 
rabies vaccination status of the dog and other required information 
similar to the current valid RVC requirement. However, unlike the 
current requirement for a valid RVC, the proposed rabies vaccination 
forms would be standardized.
    The rabies vaccination form for foreign-vaccinated dogs would also 
be certified by a government official in the exporting country, as an 
added measure to prevent falsification. The acceptable rabies 
vaccination form to fulfill this requirement for foreign-vaccinated 
dogs from DMRVV high-risk countries would be titled ``CDC Import 
Certification of Rabies Vaccination and Microchip Required for Live Dog 
Importations into the United States.'' This proposed change would help 
ensure that foreign-vaccinated dogs imported from DMRVV high-risk 
countries meet CDC entry requirements prior to traveling to the United 
States and allow for follow-up with the exporting country's government 
officials if repeated import violations occur. HHS/CDC welcomes public 
comment on this proposed requirement.
    Under the proposed rule, importers of U.S.-vaccinated dogs 
presenting for re-entry into the United States from countries at high 
risk for DMRVV would be required to arrive at a U.S. airport with a CDC 
quarantine station. Additionally, prior to traveling out of the United 
States, a USDA-Accredited Veterinarian would need to complete and sign 
a form titled ``Certification of U.S.-issued Rabies Vaccination for 
Live Dog Re-entry into the United States.'' This form would then be 
certified by a USDA Official Veterinarian prior to departing the United 
States and would need to be presented by the importer to the airline to 
board the dog on its return flight to the United States. The importer 
would also need to present this form when requested to do so by U.S. 
government officials upon arrival. The use of this form would decrease 
the likelihood of falsification or fraud because it would include 
information in a standardized format and rely on USDA's existing 
veterinary accreditation system. Dogs arriving with this form would not 
be subject to the requirement for veterinary examination (unless ill, 
injured, or exposed), revaccination, verification of adequate rabies 
serologic tests, and/or post-vaccination quarantine at a CDC-registered 
Animal Care Facility.
    In this NPRM, CDC/HHS proposes to require importers of foreign-
vaccinated dogs from DMRVV high-risk countries to enter the United 
States through an airport with a CDC quarantine station and a CDC-
registered Animal Care Facility. The importer would also need to obtain 
a rabies serologic test from a CDC-approved laboratory for their 
foreign-vaccinated dogs demonstrating adequate titer levels. In 
addition, the importer would also need to have a reservation at the 
CDC-registered Animal Care Facility and have their dog(s) undergo a 
veterinary exam and revaccination with a USDA-licensed rabies vaccine 
at the CDC-registered Animal Care Facility. Importers of foreign-
vaccinated dogs who cannot obtain serologic test results prior to 
importation would be required to have their dog remain under quarantine 
at the facility for 28 days after revaccination or until verification 
of adequate rabies serologic test from a CDC-approved laboratory is 
obtained, whichever occurs first. HHS/CDC is requesting comment on this 
proposed process.
    HHS/CDC proposes a narrow exception for both U.S.- and foreign-
vaccinated service dogs that have been in a DMRVV high-risk country 
within the last six months. This exception would allow such dogs to 
enter the U.S. at a U.S. seaport if the dog is at least six months of 
age, has a microchip, has either a complete, accurate, and valid 
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry 
into the United States form or a complete, accurate, and valid CDC 
Import Certification of Rabies Vaccination and Microchip Required for 
Live Dog Importations into the United States form, as appropriate, and 
has sufficient and valid titer results from a CDC-approved laboratory 
(if the dog is foreign-vaccinated). To be considered a valid service 
dog, the dog would need to meet the definition of a ``service animal'' 
under 14 CFR 382.3, be accompanied by an ``individual with a 
disability'' as defined under 14 CFR 382.3, and work or perform tasks 
directly related to that individual's disability. HHS/CDC is requesting 
comment on this proposed exception. HHS/CDC also proposes to prohibit 
or otherwise restrict importation of dogs into the United States from 
certain countries that have a history of exporting dogs infected with 
DMRVV to other countries or have demonstrated a lack of appropriate 
veterinary controls to prevent the exportation of rabid dogs. To 
implement this provision, HHS/CDC proposes to maintain a ``List of 
DMRVV-Restricted Countries'' from which the importation of dogs into 
the United States would be prohibited. The list of DMRVV-restricted 
countries would be maintained on CDC's website. Additions or removals 
of countries would also be announced in notices published in the 
Federal Register. Under this proposal, CDC would retain the ability to 
issue a special exemption on an extremely limited basis for dogs that 
have been in a DMRVV-restricted country in the six months prior to 
their importation into the United States (e.g., for dogs imported for 
scientific purposes, for use as a trained service animal for 
individuals with disabilities,\21\ or in furtherance of an important 
government interest). HHS/CDC welcomes public comment on public health 
standards and evidence used to maintain a list of DMRVV-restricted 
countries and the length of time or conditions to be met before a 
country is added or eligible for removal from the list. Additionally, 
HHS/CDC welcomes public comment on how the list will be maintained and 
whether publication on CDC's website and through Federal Register 
notices would be sufficient to adequately inform importers.
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    \21\ Emotional support animals are not recognized as service 
animals. U.S. Department of Transportation. Service Animals. https://www.transportation.gov/individuals/aviation-consumer-protection/service-animals, last updated June 9, 2021.
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    HHS/CDC proposes that airlines be required to confirm prior to 
boarding that the dog is scheduled to arrive at an approved U.S. 
airport and, if foreign-vaccinated, that the importer has documentation 
confirming a reservation at the CDC-registered Animal Care Facility. 
This will ensure that CDC and USDA can follow up with airlines more 
easily to ensure animals are being properly handled (e.g., not left in 
cargo warehouses for prolonged periods of time that endanger the health 
of the animal). Additionally, to address concerns relating to the 
movement of dogs or cats that are sick or dead upon arrival, HHS/CDC 
proposes to require that airlines transport all sick or dead animals 
(regardless of vaccination status and country of origin) to a CDC-
registered Animal Care Facility or, under certain conditions, to other 
CDC- or USDA-approved veterinary clinic within six hours of arrival. 
CDC acknowledges that extraordinary circumstances, such as extreme 
weather, may delay the transport of animals beyond the six-hour window. 
Under

[[Page 43982]]

such circumstances, CDC will work closely with airlines to address 
these rare and unforeseen events while ensuring the safe handling of 
animals. CDC also will work with importers who arrive at unapproved 
U.S. ports based on circumstances beyond their control (e.g., re-
routing of their flight due to extreme weather). CDC quarantine station 
staff are available 24 hours a day to assist streamlined coordination 
and processing of dog and cat importation at U.S. ports and provide 
coverage for geographic areas beyond the U.S. port in which the CDC 
quarantine station is located.
    HHS/CDC also proposes establishing requirements for businesses that 
wish to become CDC-registered Animal Care Facilities. Requirements 
would include a USDA intermediate handlers license and approval by CBP 
to act as a CBP-bonded facility with an active Facilities Information 
and Resource Management System (FIRMS) code. This will ensure dogs and 
cats receive appropriate veterinary care and are housed in a way that 
prevents the spread of infectious diseases while protecting the safety 
of the animals.
    The requirements HHS/CDC is proposing in this NPRM for dog 
importation into the United States are summarized below in Table 1. 
Since HHS/CDC is not proposing substantial changes to cat importation 
requirements, Table 1 does not apply to cats.

 Table 1--Summary Table of Proposed Importation Requirements for Dogs Based on Vaccination Status and Country of
                                                     Origin
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                                                            Requirements for admission
                                 -------------------------------------------------------------------------------
                                                        ISO- compatible                          Approved U.S.
                                          Age              microchip         Documentation           ports
----------------------------------------------------------------------------------------------------------------
U.S.-Vaccinated Dog from DMRVV    At least six months  Yes..............  Valid               Only U.S. airports
 High-Risk Country.                of age.                                 Certification of    with a CDC
                                                                           U.S.-issued         quarantine
                                                                           Rabies              station.*
                                                                           Vaccination for
                                                                           Live Dog Re-entry
                                                                           into the United
                                                                           States Form and
                                                                           CDC Import
                                                                           Submission Form
                                                                           receipt.
Foreign-Vaccinated Dog from       At least six months  Yes..............  Reservation with a  Only U.S. airports
 DMRVV High-Risk Country.          of age.                                 CDC-registered      with a CDC
                                                                           Animal Care         quarantine
                                                                           Facility, CDC       station and a CDC-
                                                                           Import              registered Animal
                                                                           Certification of    Care Facility.*
                                                                           Rabies
                                                                           Vaccination and
                                                                           Microchip
                                                                           Required for Live
                                                                           Dog Importations
                                                                           into the United
                                                                           States Form, CDC
                                                                           Import Submission
                                                                           Form receipt,
                                                                           titer results
                                                                           from a CDC-
                                                                           approved
                                                                           laboratory (dogs
                                                                           without titer
                                                                           results will be
                                                                           required to
                                                                           quarantine).
Dog from Rabies-Free or DMRVV     At least six months  Yes..............  There are no        All U.S. ports.
 Low-Risk Country.                 of age **.                              vaccination
                                                                           requirements,
                                                                           however, written
                                                                           documentation
                                                                           that the dog has
                                                                           resided or
                                                                           otherwise been
                                                                           only in a DMRVV
                                                                           low-risk or
                                                                           rabies-free
                                                                           country for the
                                                                           six months prior
                                                                           to the attempted
                                                                           entry and CDC
                                                                           Import Submission
                                                                           Form receipt.
U.S.- or Foreign-Vaccinated Dog   At least six months  Yes..............  CDC Dog Import      Only U.S. airports
 from DMRVV-Restricted Country.    of age.                                 Permit for          with a CDC
                                                                           limited groups of   quarantine
                                                                           dogs (i.e.,         station and a CDC-
                                                                           service animals,    registered Animal
                                                                           government-owned    Care Facility.
                                                                           animals).
----------------------------------------------------------------------------------------------------------------
* Dogs arriving at U.S. land ports that have been in DMRVV high-risk countries within the last six months will
  be denied admission. All service dogs entering at U.S. seaports must be six months of age, have an ISO-
  compatible microchip, and have a receipt confirming submission of a CDC Import Submission Form. Service dogs
  that have been in DMRVV high-risk countries within the last six months may enter the United States at U.S.
  seaports if they have either a valid Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry
  into the United States Form or both a valid CDC Import Certification of Rabies Vaccination and Microchip
  Required for Live Dog Importations into the United States Form and sufficient and valid titer results from a
  CDC-approved laboratory.
** Dogs arriving at U.S. land ports are subject to the six-month minimum age requirement. However, an importer
  may import up to three dogs younger than six months of age in a calendar year if the dogs have not been in a
  DMRVV high-risk country since birth.

    The forms HHS/CDC is proposing be required in this NPRM for dog 
importation into the United States are summarized below in Table 2. 
Since HHS/CDC is not proposing substantial changes to cat importation 
requirements, Table 2 does not apply to cats.

               Table 2--Summary Table of Proposed Forms Required From Importers of Dogs Based on Vaccination Status and Country of Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Dog from rabies-free or      U.S.-vaccinated dog from   Foreign-vaccinated dog from    U.S.-vaccinated dog from
                Form                     DMRVV low-risk country      DMRVV high-risk country      DMRVV high-risk country      DMRVV-restricted country
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDC Import Submission Form..........  Required...................  Required...................  Required...................  Required.
Certification of U.S.-issued Rabies   Not Required...............  Required...................  N/A........................  Required.
 Vaccination for Live Dog Re-entry
 into the United States Form.
CDC Import Certification of Rabies    Not Required...............  N/A........................  Required...................  N/A.
 Vaccination and Microchip Required
 for Live Dog Importations into the
 United States Form.
Application for Special Exemption     Not Required...............  Not Required...............  Not Required...............  Required.
 for a Permitted Dog Import Form.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Importers of foreign-vaccinated dogs from DMRVV high-risk countries will also be required to provide additional information to the CDC-registered
  Animal Care Facilities to make a reservation for their dog prior to arrival in the United States.

    The documentation HHS/CDC is proposing in this NPRM be presented at 
the U.S. port upon arrival for dog importation into the United States 
is summarized below in Table 3. Since HHS/CDC is not proposing 
substantial changes to cat importation requirements, Table 3 does not 
apply to cats.

[[Page 43983]]



 Table 3--Summary Table of Proposed Required Documentation To Be Presented at U.S. Port Upon Arrival for Dogs Based on Vaccination Status and Country of
                                                                         Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Documentation to be presented at      Dog from rabies-free or      U.S.-vaccinated dog from   Foreign-vaccinated dog from    U.S.-vaccinated dog from
       U.S. port upon arrival            DMRVV low-risk country      DMRVV high-risk country      DMRVV high-risk country      DMRVV-restricted country
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDC Import Submission Form Receipt..  Required...................  Required...................  Required...................  Required.
Written documentation that the        Required...................  N/A........................  N/A........................  N/A.
 animal has resided or otherwise
 been only in a rabies-free or DMRVV
 low-risk country for the six months
 prior to the attempted entry.
Certification of U.S.-issued Rabies   Not Required...............  Required...................  N/A........................  Not Required.
 Vaccination for Live Dog Re-entry
 into the United States Form.
Reservation with a CDC-registered     Not Required...............  Not Required...............  Required...................  May be required.
 Animal Care Facility.
CDC Dog Import Permit...............  N/A........................  N/A........................  N/A........................  Required.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Costs and Benefits

    CDC conducted an analysis to estimate the distributions of costs 
and benefits that may be incurred if a final rule is published in the 
future with the requirements proposed in this NPRM. The provisions of 
this NPRM (if finalized as proposed) are not likely to have an effect 
on the economy of $200 million or more in any one year, although there 
is considerable uncertainty around the number of dogs imported at 
baseline, including the number of dogs imported from DMRVV high-risk 
countries. HHS/CDC is soliciting public comment on costs to importers, 
airlines and other carriers, and State and local health departments of 
the proposed requirements in this NPRM to improve the accuracy of cost 
and benefit estimates for a future final rule.
    The provisions of this NPRM (if finalized as proposed) will address 
the market inefficiency in which dog importers do not account for the 
potential detrimental impacts to public health that may result from the 
importation of ill dogs, especially dogs infected with DMRVV. Federal 
regulation is necessary to mitigate the risk of importing infected 
dogs. Federal action allows risks to be addressed prior to dogs' 
arrival in the United States and for dogs to be evaluated, 
revaccinated, and possibly quarantined (if required) in controlled 
conditions after their arrival in the United States. The regulatory 
changes proposed in this NPRM (if finalized as proposed) are expected 
to affect the following categories of interested parties and 
implementing partners:
     Importers of dogs from countries that are DMRVV-free or 
are low risk for DMRVV;
     Importers of dogs from countries that are at high risk of 
DMRVV;
     Airlines and other carriers;
     CBP;
     CDC;
     USDA; and
     State and local public health and animal health 
departments.
    The changes proposed in the NPRM incorporate different requirements 
for dogs imported from DMRVV high-risk countries than those imported 
from DMRVV-free or DMRVV low-risk countries. The annualized and present 
value estimates of monetized costs and benefits over the 10-year period 
from 2023 through 2032 using three percent and seven percent discount 
rates are summarized below. The annualized, monetized costs (2020 USD) 
of the provisions in the NPRM (if finalized as proposed) are estimated 
to be $29 million (range: $7.7 to $87 million) using a three percent 
discount rate; the estimated monetized costs using a seven percent 
discount rate are largely the same.
    Most monetized costs are expected to be incurred by importers (84 
percent of costs is the most likely estimate). The estimated monetized 
costs are about 3.8 times greater for importers of dogs from DMRVV 
high-risk countries compared to importers of dogs from DMRVV-free or 
low-risk countries. The provisions proposed in the NPRM estimated to 
result in the greatest increase in costs for importers of dogs are 
those associated with the veterinary examination and revaccination 
against rabies at a CDC-registered Animal Care Facility for foreign-
vaccinated dogs from DMRVV high-risk countries in proposed section 
71.51(k), costs for titer testing of foreign-vaccinated dogs from DMRVV 
high-risk countries, additional costs associated with the proposed CDC 
Import Submission Form requirements and including the information from 
the form for all dogs in CDC data systems prior to or upon entry, the 
proposed minimum age for imported dogs, and the proposed microchip 
requirements for all imported dogs. Other costs include (1) an expected 
reduction in the number of dogs imported from DMRVV high-risk 
countries, (2) the proposed requirements to arrive at one of 18 U.S. 
airports with a CDC quarantine station such that some travelers would 
need to arrange their travel plans to arrive at these approved U.S. 
airports (required for U.S.-vaccinated dogs arriving from DMRVV high-
risk countries) or a more limited number of U.S. airports with CDC-
registered Animal Care Facilities (required for foreign-vaccinated dogs 
arriving from DMRVV high-risk countries) rather than other airports 
without CDC staff, and (3) the proposed requirement of obtaining a CDC 
Import Certification of Rabies Vaccination and Microchip Required for 
Live Dog Importations into the United States Form or a Certification of 
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United 
States Form with certification by an Official Government Veterinarian 
for all dogs from DMRVV high-risk countries.
    Airlines are estimated to absorb about 8.7 percent of the estimated 
annualized costs associated with the NPRM (if finalized as proposed). 
Most airline costs would result from ensuring that all transported dogs 
comply with the new requirements in the NPRM (if finalized as proposed) 
and from a small reduction in the number of dogs transported.
    CDC is estimated to incur about 6.9 percent of the annualized, 
monetized costs (most likely estimate) associated with the provisions 
of this NPRM (if finalized as proposed). Most CDC costs would be 
associated with the oversight of animal care facilities, which must be 
approved by and registered with CDC, and the establishment of a 
laboratory proficiency testing program to support serologic testing for 
foreign-vaccinated dogs imported from DMRVV high-risk countries. CBP is 
expected to incur about 0.5 percent of the annualized costs (most 
likely estimate) associated with the provisions of this NPRM (if 
finalized as proposed). Most CBP costs would result from training on 
the proposed new requirements.
    The annualized monetized benefits of the provisions in the NPRM (if 
finalized as proposed) are estimated to be about $1.9 million (range: 
$0.80 to $4.2 million) using a three percent or seven percent discount 
rate. Most benefits would accrue to importers (46 percent of the most 
likely estimates) and to CBP

[[Page 43984]]

(41 percent of the most likely estimate). Some of the benefits 
estimated for both importers and CBP would result from reduced time 
spent on screening dogs from high-risk countries at U.S. ports. The 
requirements in the NPRM (if finalized as proposed) are estimated to 
reduce the amount of time required to verify admissibility per dog at 
U.S. ports because it is assumed that rabies vaccination documentation 
will be included in standardized forms for importers of dogs from DMRVV 
high-risk countries. The provisions in this NPRM (if finalized as 
proposed) are also estimated to reduce the number of dogs arriving ill 
or dead and the number of dogs denied entry, with benefits estimated 
for importers, airlines, and CDC.
    The wide range between the lower-bound and upper-bound cost and 
benefit estimates demonstrates that there is considerable uncertainty 
in these results. At present, the number of dogs imported into the 
United States is neither accurately nor completely tracked by any data 
system, and the uncertainty in the cost and benefit estimates reflect 
uncertainty in both the total number of dogs imported and the number of 
dogs imported from DMRVV high-risk countries, as well as the cost of 
the new requirements in the NPRM (if finalized as proposed). The net 
annualized, monetized costs (total cost estimate - total benefit 
estimate) were estimated to be about $26 million per year (range: $6.9 
to $83 million) using a three percent discount rate. The annualized 
estimates were relatively unaffected by using a seven percent discount 
rate.
    The importation of just one dog infected with DMRVV risks 
reintroduction of the virus into the United States, which could result 
in loss of human and animal life and substantial public health response 
costs.22 23 24 The average cost per importation of a single 
DMRVV-infected dog is estimated to be $320,000 (range: $220,000 to 
$520,000) for conducting public health investigations and administering 
rabies PEP to exposed persons. The primary public health benefit of the 
provisions in the NPRM (if finalized as proposed) is the reduced risk 
that a dog with DMRVV will be imported from a DMRVV high-risk country. 
The above estimate of the cost of importation of a dog with DMRVV does 
not account for the worst-case outcomes, which include (1) transmission 
of rabies to a person who dies from the disease, and (2) ongoing 
transmission to other domestic and wildlife species in the United 
States. The cost of re-introduction could be especially high if DMRVV 
spreads to other species of U.S. wildlife. Re-establishment of DMRVV in 
the United States could result in costly efforts over several years to 
eliminate the virus again. The costs to contain any reintroduction 
would depend on the time period before the reintroduction was realized, 
the wildlife species in which DMRVV was transmitted, and the geographic 
area over which reintroduction occurs.
---------------------------------------------------------------------------

    \22\ Smith J, le Gall F, Stephenson S, et al. People, pathogens 
and our planet. The Economics of One Health 2012;2.
    \23\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \24\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment 
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
---------------------------------------------------------------------------

    An increase in human deaths from DMRVV could occur following the 
re-introduction of DMRVV to the United States, as the risk of exposure 
would increase. Human deaths from rabies continue to occur in the 
United States after exposures to wild animals, and there have been 
eight deaths among U.S. residents bitten by rabid dogs while traveling 
abroad in DMRVV high-risk countries since 2009.\25\ CDC uses the value 
of statistical life (VSL) to support quantifying benefits for 
interventions that can result in mortality risk reductions. HHS 
recommends using a median estimate of $11.6 million and a range of $5.5 
to $17.7 million (2020 USD).\26\ CDC is unable to estimate the 
potential magnitude of the mortality risk reduction associated with the 
proposed rule. Based on the median VSL, averting three human deaths per 
year would mean the benefits of the NPRM (if finalized as proposed) 
would exceed its costs.
---------------------------------------------------------------------------

    \25\ Human Rabies. https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html.
    \26\ U.S. Department of Health and Human Services, 2016. Office 
of the Assistant Secretary for Planning and Evaluation. Guidelines 
for Regulatory Impact Analysis. https://aspe.hhs.gov/sites/default/files/private/pdf/242926/HHS_RIAGuidance.pdf. Accessed: April 20, 
2020.
---------------------------------------------------------------------------

    CDC and other Federal government agencies do not know with 
precision the number of dogs imported each year or the countries from 
which the dogs originate. More comprehensive data on where dogs are 
imported from may benefit public health investigations. Arrival data on 
animals exposed to a dog with DMRVV on U.S.-bound flights, for example, 
would expedite follow-up of exposed dogs in the United States. The lack 
of data received from implementing the current regulations also 
inhibits the Federal government's ability to target interventions for 
dogs imported from specific countries. Of note, the COVID-19 pandemic 
weakened rabies control programs in some DMRVV high-risk countries, 
increasing the risk that imported dogs may be infected with DMRVV.\27\ 
The provisions of this NPRM (if finalized as proposed) would be of 
particular public health benefit in light of the ongoing resource 
concerns for global rabies vaccination campaigns in the wake of the 
pandemic.
---------------------------------------------------------------------------

    \27\ A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis K, Meltzer MI, 
Wallace R (2021) The urgency of resuming disrupted dog rabies 
vaccination campaigns: a modeling and cost-effectiveness analysis. 
Scientific Reports (2021) 11:12476. https://doi.org/10.1038/s41598-021-92067-5.
---------------------------------------------------------------------------

    These data would also benefit agencies such as USDA's Animal and 
Plant Health Inspection Service (APHIS), which have an interest in 
regulating dog imports with the intent of reducing the risk of 
introduction of diseases that may affect U.S. livestock. For example, 
in 2021, APHIS issued a Federal Order \28\ that established additional 
post-entry requirements on dogs for resale imported from countries with 
ongoing African swine fever transmission, which poses a significant 
risk to U.S. pork producers.\29\ The potential economic benefits of 
reducing the risk of the importation of African swine fever could be 
significant; in fact, a recent outbreak in China in 2019 was estimated 
to have total economic losses equivalent to 0.78 percent of China's 
gross domestic product.\30\ Thus, some of the requirements in this NPRM 
(if finalized as proposed) may mitigate the risks of introduction and 
transmission of diseases that impact livestock in addition to reducing 
the risk of dogs being imported while infected with DMRVV.
---------------------------------------------------------------------------

    \28\ USDA/APHIS (2021) Federal Order for Importation of Live 
Dogs for Resale from Regions Where African Swine Fever Exists or is 
Reasonably Believed to Exist. https://www.aphis.usda.gov/import_export/downloads/vs-federal-order-asf.pdf and https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed June 5, 2023.
    \29\ Animal and Plant Health Inspection Service (Aug. 4, 2021) 
USDA Announces Requirements for Importing Dogs from Countries 
Affected with African Swine Fever. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed: February 
5, 2022.
    \30\ Shibing You, Tingyi Liu, Miao Zhang, Xue Zhao, Yizhe Dong, 
Bi Wu, Yanzhen Wang, Juan Li, Xinjie Wei and Baofeng Shi (2021). 
African swine fever outbreaks in China led to gross domestic product 
and economic losses. Nature Food; 2: 802-808.
---------------------------------------------------------------------------

II. Public Participation

    Interested persons or organizations are invited to participate in 
this proposed rulemaking by submitting written views, recommendations, 
and

[[Page 43985]]

data on all aspects of the proposed rule notice. Comments received 
should reference a specific portion of the notice. Attachments and 
other supporting materials are part of the public record and subject to 
public disclosure. Submitters should not include any information in 
their comments or supporting materials that they consider confidential 
or inappropriate for public disclosure. HHS/CDC welcome comments on all 
aspects of this proposed rule, including the use of any forms or 
information collected and whether proposed requirements should be 
modified in any way.
    HHS/CDC will carefully review, consider, and address all comments 
submitted and may revise the content of the rule as appropriate at the 
final rulemaking stage. HHS/CDC will publish a final rule after the 
comment period that reflects any content changes made because of 
comments received.

III. Background

A. Legal Authority

    HHS/CDC has reviewed this rule under Executive Order 12988 on Civil 
Justice Reform and determines that this proposed rule meets the 
standard in the Executive Order. In this action, HHS/CDC proposes to 
revise 42 CFR 71.50 and 71.51.
    The primary legal authority supporting this proposed rulemaking is 
section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). 
Under section 361, the Secretary of HHS (Secretary) may make and 
enforce such regulations as in the Secretary's judgment are necessary 
to prevent the introduction, transmission, or spread of communicable 
diseases from foreign countries into the United States and from one 
State or possession into any other State or possession.\31\ It also 
authorizes the Secretary to promulgate and enforce a variety of public 
health regulations to prevent the spread of communicable diseases, 
including through inspection, fumigation, disinfection, sanitation, 
pest extermination, destruction of animals or articles found to be 
sources of dangerous infection to human beings, and other measures. 
Since at least 1956, Federal quarantine regulations (currently found at 
42 CFR 71.51) have controlled the entry of dogs and cats into the 
United States.\32\
---------------------------------------------------------------------------

    \31\ Although the statute assigns authority to the Surgeon 
General, all statutory powers and functions of the Surgeon General 
were transferred to the Secretary of HHS in 1966, 31 FR 8855, 80 
Stat. 1610 (June 25, 1966), see also Public Law 96-88, 509(b), 
October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)). The 
Secretary has retained these authorities despite the reestablishment 
of the Office of the Surgeon General in 1987.
    \32\ See 21 FR 9870 (Dec. 12, 1956).
---------------------------------------------------------------------------

    In addition to section 361, other sections of the PHS Act relevant 
to this proposed rulemaking are section 362 (42 U.S.C. 265), section 
365 (42 U.S.C. 268), section 367 (42 U.S.C. 270), and section 368 (42 
U.S.C. 271). Section 362, among other things, authorizes the Secretary 
to promulgate regulations prohibiting, in whole or in part, the 
introduction of property from foreign countries or places, for such 
period of time and as necessary for such purpose, to avert the serious 
danger of introducing communicable disease into the United States. 
Section 365 provides that it shall be the duty of customs officers and 
of Coast Guard officers to aid in the enforcement of quarantine rules 
and regulations.\33\ Through this statutory provision, CBP provides 
critical assistance in enforcing Federal quarantine regulations at U.S. 
ports. Section 367 (42 U.S.C. 270) also authorizes the application of 
certain sections of the PHS Act to air navigation and aircraft to such 
extent and upon such conditions as deemed necessary for safeguarding 
public health and authorizes the promulgation of regulations, including 
provisions for penalties and forfeitures for violations.
---------------------------------------------------------------------------

    \33\ 42 U.S.C. 268(b). The terms ``officer of the customs'' and 
``customs officer'' are defined by statute to mean, ``any officer of 
the United States Customs Service of the Treasury Department (also 
hereinafter referred to as the ``Customs Service'') or any 
commissioned, warrant, or petty officer of the Coast Guard, or any 
agent or other person, including foreign law enforcement officers, 
authorized by law or designated by the Secretary of the Treasury to 
perform any duties of an officer of the Customs Service.'' 19 U.S.C. 
1401(i). Although this provision refers to the Secretary of the 
Treasury, the Homeland Security Act transferred to the Secretary of 
Homeland Security all ``the functions, personnel, assets, and 
liabilities of . . . the United States Customs Service of the 
Department of the Treasury, including the functions of the Secretary 
of the Treasury relating thereto . . . [,]'' 6 U.S.C. 203(1), such 
that reference to the Secretary of the Treasury should be read to 
reference the Secretary of Homeland Security.
---------------------------------------------------------------------------

    Section 368 of the PHS Act provides that any person who violates 
regulations implementing sections 361 or 362 is subject to imprisonment 
of not more than one year, a fine, or both. Pursuant to 18 U.S.C. 3559 
and 3571, an individual may face a fine of up to $100,000 for a 
violation not resulting in death and up to $250,000 for a violation 
resulting in death. Under section 368, HHS/CDC may refer violators to 
the U.S. Department of Justice for criminal prosecution. HHS/CDC does 
not have independent authority under section 368 to impose criminal 
fines or imprison violators.
    Through this NPRM, HHS/CDC proposes new language advising 
individuals and organizations that it may request that DHS/CBP take 
additional action pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a. 
Specifically, CDC may request that DHS/CBP issue additional fines, 
citations, or penalties to importers or carriers whenever the CDC 
Director (Director) has reason to believe that an importer or carrier 
has violated any of the provisions of this section or otherwise engaged 
in conduct contrary to law. HHS/CDC stresses that it does not 
administer Title 19, and decisions regarding whether to issue such 
fines, citations, or other penalties would be entirely at the 
discretion of DHS/CBP and subject to its policies and procedures. 
Notwithstanding, HHS/CDC believes it important to include this language 
to advise individuals and organizations that it may request that DHS/
CBP pursue such actions.
    Through this NPRM, HHS/CDC further clarifies that there is no 
agency policy of using the ``least restrictive means'' (as that concept 
is typically understood and applied in cases involving interests 
protected by the U.S. Constitution) in regard to animal importations 
under 42 CFR part 71. ``The Due Process Clause of the Fourteenth 
Amendment imposes procedural constraints on governmental decisions that 
deprive individuals of liberty or property interests.'' Nozzi v. Hous. 
Auth. of City of Los Angeles, 806 F.3d 1178, 1190 (9th Cir. 2015). 
However, ``[d]ue process protections extend only to deprivations of 
protected interests.'' Shinault v. Hawks, 782 F.3d 1053, 1057 (9th Cir. 
2015). Because individuals have no protected property or liberty 
interest in importing dogs or other animals into the United States, it 
is HHS/CDC's policy to not employ a constitutional analysis of ``least 
restrictive means'' in regard to animal imports under 42 CFR part 71. 
See Ganadera Ind. v. Block, 727 F.2d 1156, 1160 (D.C. Cir. 1984) (``no 
constitutionally-protected right to import into the United States''); 
see also Arjay Assoc. v. Bush, 891 F.2d. 894, 896 (Fed. Cir. 1989) 
(``It is beyond cavil that no one has a constitutional right to conduct 
foreign commerce in products excluded by Congress.''). Members of the 
public are invited to comment regarding this clarification to HHS/CDC's 
animal import policy.

B. Historical Background

    Rabies is one of the deadliest zoonotic diseases and accounts for 
an estimated 59,000 human deaths globally each

[[Page 43986]]

year.\34\ Over 98 percent of those deaths are due to DMRVV.\35\ The 
rabies virus can infect any mammal and, once clinical signs appear, the 
disease is almost always fatal.\36\ In September 2007, at the Inaugural 
World Rabies Day Symposium, HHS/CDC declared the United States to be 
free of DMRVV.\37\ While bat rabies lyssaviruses and multiple 
terrestrial variants of rabies continue circulating in wildlife species 
(e.g., fox, raccoon, and skunk) in the United States, the country has 
been free of DMRVV since 2007 and focuses its regulatory efforts on 
preventing the reintroduction of this rabies virus variant. The close 
relationship between dogs and people means there is a direct public 
health risk to individuals that interact with inadequately vaccinated 
dogs imported from countries at high risk of DMRVV. One of CDC's 
principal goals is to prevent the reintroduction and spread of DMRVV in 
the United States.
---------------------------------------------------------------------------

    \34\ World Health Organization (2018). WHO Expert Consultation 
on Rabies (WHO Technical Report Series 1012). Retrieved from https://www.who.int/publications/i/item/WHO-TRS-1012.
    \35\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance 
for Rabies Control Partners for Rabies Prevention. Estimating the 
global burden of endemic canine rabies. PLoS Negl Trop Dis 
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
    \36\ Fooks, A.R., Banyard, A.C., Horton, D.L., Johnson, N., 
McElhinney, L.M., and Jackson, A.C. (2014) Current status of rabies 
and prospects for elimination. Lancet, 384(9951), 1389-1399. doi: 
10.1016/S0140-6736(13)62707-5.
    \37\ Velasco-Villa, A., Mauldin, M., Shi, M., Escobar, L., 
Gallardo-Romero, N., Damon, I., Emerson, G. (2017) The history of 
rabies in the Western Hemisphere. Antiviral Res, 146, 221-232. 
doi:10.1016/j.antiviral.2017.03.013.
---------------------------------------------------------------------------

    DMRVV is still a serious public health threat in the more than 100 
countries where it remains enzootic.\38\ DMRVV has been highly 
successful at adapting to new host species, particularly wildlife, that 
can further transmit the virus.\39\ Although the U.S. Government does 
not precisely track the total number of dogs imported each year, CDC 
previously estimated that approximately 1 million dogs are imported 
into the United States annually, of which 100,000 dogs are from DMRVV 
high-risk countries.\40\ This estimate was based on information 
provided by airlines, CBP, and a public health study conducted at a 
U.S.-Mexico land border crossing.\41\
---------------------------------------------------------------------------

    \38\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance 
for Rabies Control Partners for Rabies Prevention. Estimating the 
global burden of endemic canine rabies. PLoS Negl Trop Dis 
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
    \39\ Velasco-Villa A, Mauldin MR, Shi M, et al. The history of 
rabies in the Western Hemisphere. Antiviral Res. 2017;146:221-232. 
doi:10.1016/j.antiviral.2017.03.013.
    \40\ HHS/CDC. Guidance Regarding Agency Interpretation of 
``Rabies-Free'' as It Relates to the Importation of Dogs Into the 
United States. 84 FR 724,724-730 (Jan. 31, 2019).
    \41\ McQuiston, J.H., et al., Importation of dogs into the 
United States: risks from rabies and other zoonotic diseases. 
Zoonoses Public Health, 2008. 55(8-10): p. 421-6.
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    Preventing the entry of animals infected with DMRVV into the United 
States is a public health priority. When it is discovered that a rabid 
dog has been imported into the United States, a multi-agency response 
is required. This can involve CDC, USDA, CBP, State and local health 
departments and animal health officials, and veterinarians in the local 
community. Local, State, and Federal government agencies primarily 
incur the costs of investigation, testing, and response efforts. Since 
2015 there have been four known rabid dogs imported into the United 
States. Each of the dogs was imported by a different animal rescue 
organization for the purposes of U.S. adoption. These four cases, 
discussed in detail below, highlight the vast amount of public health 
resources that are required to investigate, respond to, and mitigate 
the public health threat posed by the importation of a rabid dog.
    In 2015, a rabid dog was part of a group of eight dogs and 27 cats 
imported from Egypt by an animal rescue group. The dog had an unhealed 
leg fracture and began showing signs of rabies four days after arrival. 
Following the DMRVV diagnosis, animal rescue workers in Egypt admitted 
that the dog's rabies vaccination documentation had been intentionally 
falsified to evade CDC entry requirements.\42\ As a result of this 
single importation, public health officials recommended that 18 people 
receive rabies PEP, seven dogs underwent a six-month quarantine, and 
eight additional dogs housed in the same home as the rabid dog had to 
receive rabies booster vaccinations and undergo a 45-day monitoring 
period.\43\
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    \42\ Sinclair JR, Wallace RM, Gruszynski K, et al. Rabies in a 
dog imported from Egypt with a falsified rabies vaccination 
certificate--Virginia, 2015. MMWR Morb Mort Wkly Rep 2015;64:1359-
62. https://doi.org/10.15585/mmwr.mm6449a2.
    \43\ Quarantine periods for animals exposed to rabies can vary 
between 30 days to six months based on several factors, including 
vaccination history, serologic titers or prospective serologic 
monitoring results, or jurisdictional requirements.
---------------------------------------------------------------------------

    In 2017, a flight parent imported four dogs from Egypt on behalf of 
an animal rescue organization. One of the dogs appeared agitated and 
bit the flight parent prior to the flight. A U.S. veterinarian examined 
the dog one day after its arrival and then euthanized and tested the 
dog for rabies. A post-mortem rabies test showed that the dog was 
positive for DMRVV.\44\ Public health officials recommended that at 
least four people receive rabies PEP, and the remaining three dogs 
underwent quarantine periods ranging from 30 days to six months. An 
investigation revealed the possibility of falsified rabies vaccination 
documentation presented on entry to the United States.\45\
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    \44\ The diagnosis of rabies requires laboratory confirmation on 
the basis of a positive result for the direct fluorescent antibody 
test performed on CNS tissue collected post-mortem. National 
Association of State Public Health Veterinarians. Compendium of 
animal rabies prevention and control, 2016. JAVMA 2016; 248 (5):505-
517.
    \45\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a dog 
imported from Egypt--Connecticut, 2017. MMWR Morb Mort Wkly Rep 
2018; 67:1388-91. https://doi.org/10.15585/mmwr.mm6750a3.
---------------------------------------------------------------------------

    Another example in 2019 involved 26 dogs that were imported into 
the United States from Egypt by a rescue organization. All dogs had 
rabies vaccination documentation and serologic documentation indicating 
the presence of rabies antibodies in response to immunization, based on 
results from an Egyptian government-affiliated rabies laboratory. 
However, one dog developed signs of rabies three weeks after arrival 
and, when euthanized, tested positive for DMRVV. The resulting public 
health investigation raised suspicions that the rabies vaccination 
documents and serological test results were falsified for all 26 dogs 
in the shipment because 18 dogs in the shipment lacked serologic 
evidence of vaccination when re-tested in the United States. Due to 
this event, 44 people were required to receive PEP and the 25 other 
dogs imported on the same flight underwent re-vaccination and 
quarantines that ranged from four to six months. The rabid dog had been 
released into an individual's home because of its false paperwork and 
subsequently had contact with an additional 12 dogs, all of which had 
to be revaccinated and undergo quarantine periods ranging from 45 days 
to six months.\46\ The public health investigations and administration 
of rabies PEP to exposed persons in this case cost more than $400,000 
in state resources.47 48 As a result of the rabid dog 
importations that occurred in 2015, 2017, and 2019, CDC issued a 
temporary suspension for dogs entering the United States from 
Egypt.49 50
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    \46\ Raybern, C et al. Rabies in a dog imported from Egypt--
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \47\ Id.
    \48\ Centers for Disease Control and Prevention (2022). Rabies 
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/index.html.
    \49\ 84 FR 20628 (May 10, 2019).
    \50\ CDC implemented this suspension because of the lack of 
veterinary controls available in Egypt to prevent the exportation of 
rabid dogs. With limited exceptions, CDC began requiring a CDC Dog 
Import Permit and documentation of the dog's rabies serologic tests 
from World Organisation for Animal Health (WOAH)-approved 
laboratories for eligible importers. Since these permit and 
serologic test requirements were implemented, no rabid dogs have 
been imported from Egypt.

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[[Page 43987]]

    In June 2021, 33 dogs and one cat were imported into the United 
States from Azerbaijan by an animal rescue organization. All dogs had 
rabies vaccination documents that appeared valid upon arrival in the 
United States. Three days after arrival, one dog developed signs of 
rabies and was euthanized. CDC confirmed the dog was infected with 
DMRVV known to circulate in the Caucasus Mountains region of 
Azerbaijan. The remaining rescue animals exposed to the rabid dog 
during travel were quickly dispersed across nine states, leading to 
what is believed to be the largest, multi-state, imported rabid dog 
investigation in U.S. history.\51\ Eighteen people received PEP to 
prevent rabies because of exposure to the rabid dog. CDC performed the 
test known as the ``Prospective Serologic Monitoring'' test on the 
remaining dogs and the public health investigation revealed that 
improper vaccination practices by the veterinarian in Azerbaijan likely 
contributed to the inadequate vaccination response documented in 48 
percent of the imported animals, including the rabid dog.\52\ The 33 
exposed animals were revaccinated and placed in quarantine for periods 
ranging from 45 days to six months.\53\
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    \51\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan--Pennsylvania, 2021. MMWR Morb Mortal 
Wkly Rep 2022; 71: 686-689.
    \52\ Centers for Disease Control and Prevention (2021). CDC 
responds to a case of rabies in an imported dog. Retrieved from 
https://www.cdc.gov/worldrabiesday/disease-detectives/rabies-imported-dog.html.
    \53\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a 
Dog Imported from Azerbaijan--Pennsylvania, 2021. MMWR Morb Mort 
Wkly Rep 2022; 71: 686-689.
---------------------------------------------------------------------------

    CDC estimates a range of costs for public health investigations and 
subsequent cost of care for people exposed to rabid dogs to be between 
$220,00 and $520,000 per importation event, as summarized in Section 
VI.54 55 This cost estimate does not include the cost to 
evaluate, vaccinate, test, and quarantine exposed animals. This cost 
estimate also does not account for the worst-case outcomes, which 
include: (1) transmission of rabies to a person who dies from the 
disease; and (2) ongoing transmission to other domestic and wildlife 
species in the United States.
---------------------------------------------------------------------------

    \54\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
    \55\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    DMRVV becoming re-established in the United States would result in 
costly efforts over several years to eliminate the virus again. The 
extraordinary cost of re-introduction of DMRVV is demonstrated by an 
instance of reintroduction that occurred in Texas, where DMRVV had been 
previously eliminated. The reintroduction resulted in several human 
deaths; the subsequent re-elimination of DMRVV cost $60 million (in 
2022 USD) and required over 10 years of effort.56 57
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    \56\ Thomas, S., Wilson, P., Moore, G., Oertli, E., Hicks, B., 
Rohde, R., Johnston, D. (2005). Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association, 227(5),785-92. doi: 10.2460/javma.2005.227.785.
    \57\ Sterner, R., Meltzer, M., Shwiff, S., Slate, D. (2009). 
Tactics and Economics of Wildlife Oral Rabies Vaccination, Canada 
and the United States. Emerging Infectious Diseases, 15(8), 1176-
1184. doi: 10.3201/eid1508.081061.
---------------------------------------------------------------------------

    Historically, approximately 60 to 70 percent of CDC's dog entry 
denials (or about 200 cases annually) have been based on fraudulent, 
incomplete, or inaccurate paperwork.\58\ However, between January 2020 
and July 2021 (i.e., during the COVID-19 pandemic, prior to the 
temporary suspension), CDC documented more than 1,000 instances of 
incomplete, inadequate, or fraudulent rabies vaccination certificates 
for dogs arriving from DMRVV high-risk countries.\59\ These cases 
resulted in dogs being denied entry into the United States and 
ultimately returned to their country of origin.
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    \58\ Centers for Disease Control and Prevention (2021). 
Quarantine Activity Reporting System (version 4.9.8.8.2.2A). Dog 
Importation data, 2010-2019. Accessed 1 October 2022.
    \59\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
---------------------------------------------------------------------------

    The significant increase in the number of dogs from DMRVV high-risk 
countries arriving with incomplete, inadequate, or fraudulent rabies 
vaccination documentation observed in 2020 and 2021 coincided with 
increased interest in purchasing dogs from the international rescues 
and breeders during the COVID-19 pandemic.60 61 62 Since 
2021, the demand for puppies and rescue dogs has remained high. The 
trend in purchasing and rescuing dogs from abroad has been noted in 
many countries, including the United States.63 64 65 66 
Internationally, there has been significant growth within the companion 
animal breeding industry with increasing international trade.\67\ 
Multiple international and U.S. investigations have identified 
importations of puppies that were too young to meet rabies vaccination 
requirements.68 69 70 71 In addition, there is growing 
evidence that criminal networks are becoming involved in the lucrative 
dog trade, and the illegal puppy trade was reported to have increased 
during the pandemic.72 73 74

[[Page 43988]]

Because imported dogs will typically encounter multiple people, pets, 
and other animals throughout their journey--beginning at the airport in 
the country of departure and continuing with the airline, through the 
U.S. port, and pet adoption and pet socialization process--an increase 
in inadequately vaccinated dogs likewise increases the risk of human 
and animal exposure.\75\
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    \60\ Id.
    \61\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. May 20, 
2021.
    \62\ Morgan L, Protopopova A, Birkler RID, Itin-Shwatz B, Sutton 
G, Gamliel A, et al. Human-dog relationships during the COVID-19 
pandemic: booming dog adoption during social isolation. Humanities 
and Social Science Communications. 2021; 7(150): 1-11.
    \63\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
    \64\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. May 20, 
2021.
    \65\ Morgan L, Protopopova A, Birkler RID, Itin-Shwatz B, Sutton 
G, Gamliel A, et al. Human-dog relationships during the COVID-19 
pandemic: booming dog adoption during social isolation. Humanities 
and Social Science Communications. 2021; 7(150): 1-11.
    \66\ Velez M. I adopted my dog Cannoli from overseas. It's 
easier than you think. 9/20/2020. Available at: https://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think.
    \67\ Maher J, Wyatt T. European illegal puppy trade and 
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
    \68\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
    \69\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \70\ Cocchi M, Danesi P, DeZan G, Leati M, Gagliazzo L, et al. A 
three-year biocrime sanitary surveillance on illegally imported 
companion animals. Pathogens. 2021; 10(80):1-12.
    \71\ Houle MK. Perspective from the field: Illegal puppy imports 
uncovered at JFK airport. 2017. Available at: www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html.
    \72\ Maher J, Wyatt T. Rural-urban dynamics in the UK illegal 
puppy trade: trafficking and trade in man's best friend. 
International Journal of Rural Law and Policy. 2019; 9 (2): 1-20.
    \73\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P, 
Haifsl J, et al. The `bio-crime model' of cross-border cooperation 
among veterinary public health, justice, law enforcements, and 
customs to tackle the illegal animal trade/bio-terrorism and to 
prevent the spread of zoonotic diseases among human population. 
Frontiers in Veterinary Science. 2020; 7: 1-13.
    \74\ British Broadcasting Corporation. Illegal puppy trade 
warning as sales boom during the COVID pandemic. 18 NOV 2020. 
British Broadcasting Corporation News.
    \75\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
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Temporary Suspension of the Importation of Dogs From DMRVV High-Risk 
Countries
    In light of these concerns, on June 16, 2021, CDC announced a 
temporary suspension of the importation of dogs from DMRVV high-risk 
countries to protect the public's health. The temporary suspension was 
issued because public health resources were being diverted to the 
response to the COVID-19 pandemic, which limited the availability of 
resources to respond to dog importation issues. This diversion of 
resources coincided with the documented increase in fraudulent vaccine 
documentation and importers circumventing dog import regulations. To 
address these concerns, CDC developed a framework for dog importation 
requiring importers to apply for special permission to import a dog 
into the United States. Importers were required to submit an 
Application for Special Exemption for a Permitted Dog Import form \76\ 
and obtain a CDC Dog Import Permit prior to importing a dog into the 
United States. To obtain a permit, an importer had to demonstrate that 
the dog was at least six months old, had a microchip, had proof of 
rabies vaccination, and had obtained a serologic titer test from a CDC-
approved laboratory if the dog was vaccinated outside the United 
States.
---------------------------------------------------------------------------

    \76\ Approved under OMB Control Number 0920-1383 Importation 
Regulations (42 CFR 71 Subpart F) (exp. 1/31/2026, or as revised).
---------------------------------------------------------------------------

    From July 14, 2021, to June 9, 2022, CDC issued CDC Dog Import 
Permits on a limited basis, for persons permanently relocating to the 
United States, importers of government-owned working dogs, or owners of 
service animals \77\ to alleviate the potential burden of the temporary 
suspension for these categories of importers. On December 1, 2021, 
consistent with public health standards of practice, CDC eased some of 
the temporary suspension restrictions. CDC allowed dogs six months of 
age or older that were microchipped and accompanied by valid U.S. RVCs 
to re-enter the United States without a CDC Dog Import Permit. Because 
these dogs were vaccinated in the United States, CDC determined that 
allowing them to enter without a CDC Dog Import Permit would be 
unlikely to endanger the public's health. To provide additional 
resources for importers of foreign-vaccinated dogs, CDC expanded the 
number of approved rabies serologic testing laboratories from five to 
60 laboratories.\78\ CDC also reduced the wait time following 
collection of a serologic sample to permit dogs to be eligible to enter 
the United States after only 45 days, rather than the previous 90-day 
waiting period. In addition, based on data from the latter part of 2021 
showing a significant decrease in the arrival of ill dogs and dogs 
being denied entry, CDC allowed imported dogs from DMRVV high-risk 
countries to enter through any of the 18 U.S. airports with a CDC 
quarantine station.79 80
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    \77\ A service dog must meet the definition of a ``service 
animal'' under 14 CFR 382.3, be accompanied by an ``individual with 
a disability'' as defined under 14 CFR 382.3, and work or perform 
tasks directly related to that individual's disability.
    \78\ List of CDC-approved labs can be found at www.cdc.gov/importation/bringing-an-animal-into-the-United-States/approved-labs.html.
    \79\ List of U.S. ports with a CDC quarantine station available 
at: www.cdc.gov/quarantine/quarantinestationcontactlistfull.html.
    \80\ At the time the Federal Register announcing the temporary 
suspension was published, dogs imported from high-risk countries 
were only allowed to enter the United States through the one port of 
entry with an animal care facility. However, CDC's review of dog 
importation data from July 14-November 30, 2021, noted a significant 
decrease in the arrival of ill dogs and dogs denied entry, reducing 
the need for dogs to enter only through U.S. ports with an animal 
care facility.
---------------------------------------------------------------------------

    Even with the temporary suspension in place, CDC documented 
multiple instances of importers attempting to circumvent entry 
requirements by using fraudulent rabies vaccination documents that had 
been fabricated to make them appear as if they had been issued in the 
United States. CDC also documented instances of importers presenting 
fraudulent rabies vaccination documents purporting to be from DMRVV-
free countries to import young puppies from DMRVV high-risk countries 
into the United States, presumably for resale. These factors highlight 
the need for rabies vaccination documentation to be standardized for 
all dogs arriving from DMRVV high-risk countries to reduce the 
likelihood of falsified documentation in the future.
    On June 1, 2022, CDC announced that effective June 10, 2022, it 
would modify and extend the temporary suspension through January 31, 
2023.\81\ The suspension was extended based on the continued risk of 
the reintroduction of DMRVV into the United States and the ongoing need 
to commit global public health resources towards the COVID-19 pandemic. 
Between the temporary suspension going into effect on July 14, 2021, 
and June 1, 2022, CDC documented a decrease in dog importation issues 
that existed prior to the suspension (e.g., the number of suspected 
fraudulent rabies vaccination documents, the number of dogs that were 
sick or dead upon arrival). CDC's ability to track and monitor dog 
imports from DMRVV high-risk countries also improved during this 
timeframe. For these reasons, CDC modified the terms of the temporary 
suspension to allow more dog imports into the United States by a wider 
range of importers building upon the requirements that had already been 
in place and had been successful in reducing dog importation issues. On 
February 1, 2023, CDC extended the temporary suspension without 
modifications through July 31, 2023, because of a continued risk of 
reintroduction of DMRVV due to insufficient veterinary controls in 
DMRVV high-risk countries to prevent the export of inadequately 
vaccinated dogs and veterinary supply chain and workforce capacity 
shortages that have persisted since the global COVID-19 pandemic.\82\
---------------------------------------------------------------------------

    \81\ Notice of Extension and Modification of Temporary 
Suspension of Dogs Entering the United States From High-Risk Rabies 
Countries. 87 FR 33158 (June 1, 2022).
    \82\ 88 FR 5348 (Jan. 27, 2023).
---------------------------------------------------------------------------

    In parallel with the publication of this NPRM, CDC has published an 
extension of the temporary suspension through July 31, 2024. A 
suspension remains necessary to protect the public's health against the 
reintroduction of DMRVV into the United States because there is a 
continued threat posed by dogs from high-risk countries that are 
unvaccinated or inadequately vaccinated against rabies. This continued 
threat is due to various factors, including: a high volume of dogs 
being imported into the United States contemporaneous with insufficient 
veterinary controls in high-risk countries to prevent the export of 
inadequately vaccinated dogs, inadequate veterinary supply chains for 
vaccines and related materials, and persistent workforce capacity 
shortages, particularly in high-risk countries that export dogs to the 
United States. Through this NPRM, HHS/CDC proposes to address the 
various concerns with the importation of dogs

[[Page 43989]]

observed in recent years by establishing a regulatory framework based 
on the documented successes of the temporary suspension. In addition, 
the requirements and standards proposed in the rule would help ensure 
the health and safety of imported animals while also protecting the 
public's health and preventing the reintroduction of DMRVV into the 
United States.
    There are numerous challenges associated with reviewing rabies 
vaccination documentation from around the world, including the lack of 
a standardized rabies vaccination documents, different required 
elements on a rabies vaccination documents, differences in who can 
vaccinate and issue rabies vaccination documents, and limited to no 
accountability for unlicensed or unauthorized vaccinators. CDC has 
documented numerous instances of fraudulent or erroneous paperwork for 
dogs based on various factors. These include:
     Dogs that were younger than the age indicated on their 
rabies vaccination paperwork (based on dental examination by U.S. 
veterinarians);
     Differences between the breed, sex, color, or microchip 
number listed on the rabies vaccination documents and the dog presented 
for admission;
     Suspicious veterinary stamps and inconsistent signatures 
across veterinary paperwork;
     Inconsistent dates of rabies vaccination between different 
veterinary documents; and
     Vaccines administered after the expiration date of the 
vaccine lot.
    The international public health community has recognized that 
rabies vaccination documentation alone is no longer sufficient to 
ensure adequate protection against rabies.83 84 Numerous 
DMRVV-free countries, including Australia, New Zealand, and European 
Union member states, already require a two-step verification of rabies 
vaccination status for dogs imported from DMRVV high-risk countries 
(when direct importation is allowed), by which a valid RVC and proof of 
adequate rabies serologic test are required for importation. The 
international standard is to capture any required information for 
movement of animals via an ``import (movement) certificate.'' Import 
certificates can be standardized, which helps to ensure all required 
information is included and the information is verified by an Official 
Government Veterinarian in the exporting country prior to the animal's 
shipment to the United States. Implementing the use of standardized 
import certificates, which have long been used for the international 
movement of animals and are well understood by foreign governments, 
would enhance compliance with CDC entry requirements and ensure that 
follow-up with the exporting country can occur if import violations are 
noted.\85\
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    \83\ World Organisation for Animal Health. Terrestrial Code 
Online Access--WOAH--World Organisation for Animal Health, Chapter 
2.1.17 and 8.14. https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=1&htmfile=chapitre_certif_rabies.htm.
    \84\ World Health Organization. Expert Consultation on Rabies, 
Third Report. Geneva, Switzerland. 2018.
    \85\ https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/iregs-for-animal-exports/ct_iregs_animal_exports_home.
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    In addition to issues with fraudulent or incomplete rabies 
vaccination documents, CDC has observed in recent years a number of 
practices that raised concerns relating to how airlines transport and 
house animals. Some airlines have chosen to leave dogs denied admission 
or pending determination of admissibility in cargo warehouses, which 
can create an unsafe environment for workers exposed to dogs with 
zoonotic diseases (such as rabies, brucellosis, leptospirosis, and 
numerous intestinal or external parasites). Workers also risk bites, 
scratches, and other injuries, as they are not trained to handle live 
animals and are required to feed, water, and provide breaks or cage 
cleaning for the animals in accordance with USDA Animal Welfare Act 
standards. As a result, many animals are left in crates for extended 
periods of time without immediate supervision while warehouse workers 
conduct routine duties. These conditions are often unsafe for dogs due 
to the prolonged periods of time between flights, inadequate cooling 
and heating, non-compliant cleaning and sanitization of crates, and the 
inability to physically separate the animals from areas of the 
warehouse where other equipment, machinery, and goods are used and 
stored.
    CDC has documented numerous instances of dogs housed under 
inadequate conditions while in the care of airlines. For example, 
during the COVID-19 pandemic, fewer international flights worldwide 
86 87 resulted in delayed returns for dogs denied admission 
to the United States. In August 2020, a dog died in the custody of an 
airline at Chicago O'Hare International Airport after CDC denied 
admission to a group of dogs based on falsified rabies vaccination 
documentation. Despite CDC's request to find appropriate housing at a 
local kennel or veterinary clinic, the airline left 18 dogs in a cargo 
warehouse without food and water for more than 48 hours contributing to 
the death of one dog.\88\ In March 2023, a dog arrived at a U.S airport 
without a CDC-registered Animal Care Facility. The dog was later found 
dead in the airline's cargo warehouse.\89\
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    \86\ https://www.cnbc.com/2020/04/02/coronavirus-update-american-airlines-cuts-summer-international-flights-by-60percent-as-demand-suffers.html.
    \87\ https://news.aa.com/news/news-details/2020/American-Airlines-Announces-Additional-Schedule-Changes-in-Response-to-Customer-Demand-Related-to-COVID-19-031420-OPS-DIS-03/default.aspx.
    \88\ https://www.cbsnews.com/chicago/news/dog-dies-at-ohare-airport-warehouse-17-others-saved-after-being-left-without-food-or-water-for-3-days/.
    \89\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System. March 2023.
---------------------------------------------------------------------------

    Because there are insufficient numbers of animal care facilities 
with a USDA intermediate handlers license and a CBP-issued FIRMS code 
available to house dogs that are denied admission, CDC worked with 
USDA, CBP, and local businesses to identify and approve five new animal 
care facilities in 2021 and 2022 as part of the strategic shift towards 
safer importation controls. As of June 1, 2023, there are five CDC-
registered Animal Care Facilities with a USDA intermediate handlers 
license and a FIRMS code issued by CBP. The five facilities are located 
at Atlanta Hartsfield-Jackson International Airport, John F. Kennedy 
International Airport (New York), Los Angeles International Airport, 
Miami International Airport, and Washington Dulles International 
Airport (Washington DC Metropolitan Area).
    While airlines are ultimately responsible for finding appropriate 
housing for dogs denied admission, the inadequate number of facilities 
with a CBP-issued FIRMS code and USDA intermediate handlers license for 
holding and providing care for live animals creates significant 
administrative and financial burdens for Federal, State, and local 
governments. To address these concerns, this NPRM proposes that if a 
CDC-registered Animal Care Facility with a CBP-issued FIRMS code and 
USDA intermediate handlers license is not available to hold a dog while 
the U.S. Government determines admissibility, the airline that has 
transported the dog would be required to, at a minimum, arrange 
transfer of the animal to a veterinary clinic or kennel that meets USDA 
Animal Welfare Act standards \90\ and is approved by CDC.
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    \90\ U.S. Department of Agriculture. Animal Welfare Regulations; 
Part 3, Subpart A: Transportation Standards. Sections 3.14-3.20. 
July 2020. Available at: https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_version.pdf.

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[[Page 43990]]

    While costs associated with housing, caring for dogs, and returning 
dogs are the responsibility of the importer (or airline if the importer 
abandons the dog), some importers and airlines have been reluctant to 
pay these costs, requiring the Federal government to find appropriate 
interim housing facilities, and veterinary care. The cost to house, 
care for, and return inadequately vaccinated dogs ranges between $1,000 
and $4,000 per dog, depending on the location and time required until 
the next available return flight. The Federal government has been 
required to find individualized solutions to ensure appropriate 
accommodations for prolonged periods of time for these animals pending 
return to their countries of departure and has been left to bear the 
costs for such housing, care, and return of dogs when airlines and 
importers have not. The increasing demand to vaccinate and quarantine 
dogs that have been denied admission presents an increasing burden to 
Federal, State, and local public health agencies.91 92 The 
increased need for inspections, veterinary medical care, and 
appropriate quarantine of dogs inadequately vaccinated against rabies 
has financially burdened Federal and State agencies while also putting 
the public's health at risk.
---------------------------------------------------------------------------

    \91\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk 
factors for death and illness in dogs imported into the United 
States, 2010-2018. Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
    \92\ Pieracci EG, Williams CE, Wallace RM, Kalapura CR, Brown CM 
(2021) U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE 16(9): e0254287. https://doi.org/10.1371/journal.pone.0254287.
---------------------------------------------------------------------------

    Additionally, an increasing number of dogs being imported do not 
meet age requirements of multiple agencies. CDC has noted that 61 
percent (890/1463) of dogs denied admission and 46 percent of ill or 
dead dogs arriving in the United States from 2019 to 2021 were under 
six months of age. During the first six months of 2021, CDC 
investigated 35 instances of sick or dead puppies under six months of 
age. CDC has also documented an increase in fraudulent rabies 
vaccination documentation from importers claiming the dogs were over 
four months of age.\93\ Many of these dogs were imported into the 
United States for resale or adoption. USDA requires any dog entering 
the United States for resale or adoption to be six months of age; 
however, many importers claim the animals as personal pets to avoid the 
age requirement because younger dogs may be sold for more money.\94\ 
This has led to multiple instances where young puppies, some as young 
as six weeks of age, were transported in violation of the Animal 
Welfare Act, which requires dogs to be at least eight weeks of age to 
be eligible to fly, in an attempt to circumvent the entry requirements 
of multiple agencies. Updated and standardized vaccination information 
collection and minimum age requirements will help address these issues.
---------------------------------------------------------------------------

    \93\ Pieracci, EG; Williams, CE; Wallace, RM; Kalapura, CR; 
Brown CM. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE 2021;16 (9): e0254287.
    \94\ Id.
---------------------------------------------------------------------------

    The requirements proposed in this NPRM, if adopted, would also help 
address public health concerns regarding sick or dead animals being 
imported to the United States. If an animal arrives in the United 
States and appears ill or is dead, a public health investigation is 
required to ensure the ill or dead animal does not present a public 
health threat. The overall health of an animal can play a significant 
role in whether it can maintain core body functions (i.e., body 
temperature regulation and glucose levels) during prolonged flights. 
Stressed, malnourished, and young animals are more likely to become ill 
and can transmit communicable diseases that can affect humans; 
95 96 therefore, safety and welfare concerns for the 
transport of dogs have a public health impact that requires a degree of 
oversight from public health agencies to ensure human and animal health 
is protected.\97\ Additionally, diagnostic testing or necropsy of ill 
or dead animals, respectively, is critical to understand the underlying 
cause of illness or death and ensure the animals do not pose a public 
health risk.
---------------------------------------------------------------------------

    \95\ Galanis E et al. Brucellosis and other diseases imported 
with dogs. BCMJ 2019; 61 (4): 177-190. Available at: https://bcmj.org/bccdc/brucellosis-and-other-diseases-imported-dogs.
    \96\ Denstedt E. Echinococcus multilocularis as an emerging 
public health threat in Canada: A knowledge synthesis and needs 
assessment. Accessed: 28 February 2019. Available at: www.ncceh.ca/
sites/default/files/Guelph-Denstedt-2017.pdf.
    \97\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk 
factors for death and illness in dogs imported into the United 
States, 2010-2018. Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
---------------------------------------------------------------------------

    The creation of standards for CDC-registered Animal Care 
Facilities; the requirement that all foreign-vaccinated dogs be 
examined, vaccinated, and quarantined (when applicable) at one of these 
facilities prior to entry into the United States; and the prevention 
measures in this proposed rule will mitigate the need for future 
broadly applied suspensions and help ensure the health and safety of 
imported animals while also serving to protect public health and 
prevent the reintroduction of DMRVV into the United States.

C. Current Process

    Currently, per regulation at 42 CFR 71.51(c), there is no standard 
form used to capture rabies vaccination information. However, importers 
must present valid RVCs which must include all of the following 
information to be valid:
     Identifies a dog on the basis of breed, sex, age, color, 
markings, and other identifying information.
     Specifies a date of rabies vaccination at least 30 days 
before the date of arrival of the dog at a U.S. port.
     Specifies a date of expiration which is after the date of 
arrival of the dog at a U.S. port. If no date of expiration is 
specified, then the date of vaccination shall be no more than 12 months 
before the date of arrival at a U.S. port.
     Bears the signature of a licensed veterinarian.
    Upon the dog's arrival in the United States, Federal officials 
examine the RVC and ensure the description of the dog listed on the 
paperwork matches the dog presented. For a rabies vaccine to be 
effective, the dog must be at least 12 weeks (84 days) of age at the 
time of administration. A dog's initial vaccine must also be 
administered at least four weeks (28 days) before arrival in the United 
States.
    Under HHS/CDC's regulatory authority, dogs arriving from DMRVV 
high-risk countries without appropriate RVCs are denied admission and 
returned to the country of departure on the next available flight.\98\ 
CDC currently recommends that airlines house dogs awaiting return to 
their country of departure at a USDA-accredited facility that meets the 
USDA's Animal Welfare Act standards during transit. However, these 
facilities are often cargo warehouses that are not equipped to house 
live animals for more than several hours.
---------------------------------------------------------------------------

    \98\ Guidance Regarding Agency Interpretation of ``Rabies-Free'' 
as it Relates to the Importation of Dogs into the United States, 84 
FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    The transportation, care, and payment for sick or dead animals are 
highly variable and depend on whether the animal is suspected of having 
rabies. Ideally, local veterinarians are consulted

[[Page 43991]]

immediately to provide care for sick animals; however, importers and 
owners frequently refuse to pay for the care of sick animals resulting 
in confusion and delayed care for often critically ill animals. When 
owners have refused to pay for the care of their sick animals, the 
responsibility has been transferred to the airline that transported the 
animals into the United States, but some airlines have been reluctant 
to pay costs associated with the care and housing of animals. While 
State health departments and CDC will test blood samples free of charge 
when rabies is suspected, in some instances, CDC has been left to cover 
the costs of animal care.
    HHS/CDC believes that clarifying the regulatory requirements 
delineating importer and carrier responsibilities would streamline the 
animal importation process and help ensure sick animals receive timely 
veterinary care upon arrival in the United States if needed. We welcome 
input from the public on all proposals contained herein.

IV. Summary of Proposed Changes

Proposed Changes to 71.50

    Section 71.50(b) contains definitions applicable to animal 
importations under subpart F of 42 CFR part 71. The definitions 
contained in paragraph (b) are of general scientific applicability and 
thus would apply to different animal imports, not just dogs and cats. 
HHS/CDC proposes adding the following definitions to 42 CFR 71.50(b): 
Authorized Veterinarian, histopathology, in-transit shipments, 
microchip, necropsy, Official Government Veterinarian.
    Authorized Veterinarian means an individual who has obtained both 
an advanced degree and valid license and is authorized to practice 
animal medicine in the exporting country.
    Histopathology means the study of changes in animal tissue caused 
by disease.
    In-Transit Shipment means a cargo shipment originating in a foreign 
country that is moved through one or more U.S. ports while transiting 
through the United States to a third-country destination.
    Microchip means an implanted radio-frequency device placed under 
the skin of an animal that contains a unique identification tag that 
meets the International Standards Organization (ISO) compatibility 
through ISO 11784 or ISO 11785, or similar technologies as approved by 
the Director.
    Necropsy means an animal autopsy in which the cause of death may be 
determined through the examination and collection of tissues, organs, 
or bodily fluids post-mortem.
    Official Government Veterinarian means a veterinarian who performs 
work on behalf of an exporting country's government and can verify the 
license or credentials of an Authorized Veterinarian.
    HHS/CDC also proposes adding a new subsection at 42 CFR 71.50(c) 
addressing the legal severability of provisions found in 42 CFR part 71 
Subpart F--Importations. Because the provisions relating to 
importations under Subpart F are designed to protect the public's 
health from various zoonotic disease threats, HHS/CDC intends that 
these provisions have maximum legal effect. Accordingly, HHS/CDC 
proposes adding language that in the event any provision of this 
subpart is held by a reviewing court of law to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, that the provision be construed so as to continue to give 
the maximum effect to the provision permitted by law. If a reviewing 
court should hold that a provision is utterly invalid or unenforceable, 
then HHS/CDC intends that the provision be severable from Subpart F and 
not affect the remainder or the application of the provision to persons 
not similarly situated or to dissimilar circumstances. HHS/CDC seeks 
public comment regarding this and other proposed changes to 71.50.

Proposed Changes to 71.51

    (a) Definitions.
    Section 71.51(a) contains definitions specifically applicable to 
importations of dogs and cats under this section. Among other things, 
HHS/CDC proposes definitions for animal, CDC-registered Animal Care 
Facility, CDC Import Submission Form, conditional release, confinement, 
DMRVV-free countries, DMRVV high-risk countries, DMRVV low-risk 
countries, DMRVV-restricted countries, importer, SAFE TraQ, serologic 
testing, USDA-Accredited Veterinarian, and USDA Official Veterinarian. 
Some of these definitions were previously published in guidance.\99\
---------------------------------------------------------------------------

    \99\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    Animal means all domestic cats (Felis catus) or domestic dogs 
(Canis familiaris).
    CDC-registered Animal Care Facility means a facility registered by 
CDC for the purpose of providing veterinary care and housing to animals 
imported into the United States.
    CDC Import Submission Form means an OMB-approved declaration \100\ 
submitted to CDC through an online portal that includes the importer's 
name and contact information; description of the dog, including 
microchip number, current photographs of the dog's face and body; 
purpose of importation; travel information, including dates of 
departure and arrival, country of departure, countries visited in the 
past six months, and U.S. port of entry; and other information as 
described in CDC technical instructions. A receipt confirming 
successful submission of this form must accompany all dogs departing 
foreign locations for travel to the United States. For dogs departing 
from airports overseas with a U.S. final destination, the responsible 
airline must confirm the receipt prior to dogs being loaded onto 
departing aircraft.
---------------------------------------------------------------------------

    \100\ Current OMB approval no. 0920-1383 (exp. 1/31/26).
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    Conditional release, when applied to a dog or cat, means the 
temporary release of a dog or cat from the custody of a carrier into 
the care of a licensed veterinarian approved by CDC for the purpose of 
receiving emergency medical care or a public health evaluation, pending 
removal of the dog or cat from the United States. Dogs and cats must be 
returned immediately to the carrier's custody upon the conclusion of 
such medical care or evaluation for removal from the United States.
    Confinement, when applied to a dog or cat, means restriction to a 
building or other enclosure at a U.S. port or other location approved 
by CDC, including en route to a destination, in isolation from other 
dogs and cats, and from persons except for contact necessary for its 
care. If the animal is allowed out of the enclosure, it must be muzzled 
and kept on a leash.
    DMRVV-free countries means countries assessed by CDC based on 
internationally accepted standards as not having DMRVV present.
    DMRVV low-risk countries means countries assessed by CDC as low 
risk for DMRVV transmission based on factors such as the virus being 
limited to a localized area, adequacy of surveillance and dog 
vaccination programs to prevent further geographic distribution of the 
virus, and the virus being in a controlled status with the country or 
countries heading toward eventual DMRVV-free status.
    DMRVV high-risk countries means countries assessed by CDC as high 
risk for DMRVV transmission based on factors such as the presence and

[[Page 43992]]

geographic distribution of the virus or low quality of or low 
confidence in rabies surveillance systems or dog vaccination programs.
    DMRVV-restricted countries means countries for which the export of 
dogs into the United States has been prohibited or otherwise restricted 
based on the countries' export of dogs infected with DMRVV to any other 
countries within a period determined by CDC or based on evidence of 
lacking adequate controls, as determined by CDC, to monitor and prevent 
the export of dogs to the United States with falsified or fraudulent 
vaccine credentials, invalid rabies vaccination forms, or other 
fraudulent, inaccurate, or invalid importation documents.
    Importer of dogs or cats means any person importing or attempting 
to import a dog or cat into the United States, including the animal's 
legal owner or a person acting on behalf of the importer, such as a 
broker licensed with CBP. Individuals compensated or hired to transport 
animals on behalf of the importer must have a valid USDA license or 
registration. CDC believes that requiring that individuals who are 
compensated or hired to transport animals have a valid USDA license or 
registration pursuant to the Animal Welfare Act would help deter 
fraudulent conduct.
    HHS/CDC is also providing a new definition for what constitutes 
proof of rabies vaccination. These definitions are needed to provide 
clarity regarding HHS/CDC's proposed admission requirements.
    CDC Import Certification of Rabies Vaccination and Microchip 
Required for Live Dog Importations into the United States Form means 
the OMB-approved form \101\ that must be: (1) completed by an 
Authorized Veterinarian in the exporting country, which may include an 
Official Government Veterinarian in the exporting country; and (2) 
reviewed and certified by an Official Government Veterinarian in the 
exporting country attesting that the information listed is true and 
correct.
---------------------------------------------------------------------------

    \101\ OMB approval no. 0920-1383 (exp. 1/31/26).
---------------------------------------------------------------------------

    Certification of U.S.-issued Rabies Vaccination for Live Dog Re-
entry into the United States Form means the OMB-approved form \102\ 
that must be completed by a USDA-Accredited Veterinarian and certified 
by a USDA Official Veterinarian prior to exporting a dog from the 
United States in order to demonstrate compliance with admissibility 
requirements upon returning to the United States.
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    \102\ OMB approval no. 0579-0020, 0036, 0048, 0101, 0156, 0278, 
0432.
---------------------------------------------------------------------------

    SAFE TraQ means the System for Animal Facilities Electronic 
Tracking of Quarantine or other system as approved by the Director for 
tracking the quarantine of animals approved for admission into the 
United States.
    Serologic Testing, when applied to an imported animal, means an 
antibody titration test performed by a CDC-approved rabies laboratory 
using a CDC-approved technique. The serology sample must be drawn and 
submitted in accordance with CDC technical instructions. The current 
list of CDC-approved laboratories is available online.
    USDA-Accredited Veterinarian is defined in 9 CFR 160.1 and is an 
Accredited Veterinarian who has completed formal training from the 
National Veterinary Accreditation Program in the State in which they 
are licensed to practice as a veterinarian.
    USDA Official Veterinarian is a USDA/APHIS veterinarian who is 
assigned by the USDA Administrator to supervise and perform official 
work of APHIS in a State or group of states.
    (b) Authorized U.S. airports for dogs and cats.
    Dogs from DMRVV-free or DMRVV low-risk countries that have not been 
in any DMRVV high-risk country within the last six months and all cats 
may continue to enter through any U.S. port. CDC does not currently 
have any restrictions on the U.S. ports for dogs arriving in the United 
States from DMRVV high-risk countries. Through this NPRM, HHS/CDC 
proposes that if a U.S.-vaccinated dog has been in a DMRVV high-risk 
country in the previous six months, the dog must arrive at an airport 
with a CDC quarantine station. The importer would also be required to 
have a USDA-Accredited Veterinarian complete the Certification of U.S.-
Issued Rabies Vaccination For Live Dog Re-entry into the United States 
Form and present this form to the airline prior to boarding. All 
foreign-vaccinated dogs that have been in a DMRVV high-risk country in 
the previous six months would be required to enter the United States at 
a U.S. airport with a CDC quarantine station and a CDC-registered 
Animal Care Facility. The importer would also be required to have an 
Authorized Veterinarian complete the CDC Import Certification of Rabies 
Vaccination and Microchip Required for Live Dog Importations into the 
United States Form and present this form to the airline prior to 
boarding.
    This requirement that dogs from DMRVV high-risk countries arrive at 
specified airports is being proposed to ensure dogs can be evaluated by 
CDC quarantine station staff or a USDA-Accredited Veterinarian upon 
arrival to confirm they have all required documentation for admission 
and do not appear ill. Visual examinations of animals may be conducted 
by CDC quarantine station staff to look for overt signs of illness 
(i.e., vomiting, diarrhea, bleeding, seizures, or ocular or nasal 
discharge). Animals showing signs of illness will not be released for 
entry until a USDA-Accredited Veterinarian completes a physical exam 
and administers a USDA-licensed rabies vaccine (if applicable). As of 
June 1, 2023, five U.S. airports have CDC-registered Animal Care 
Facilities. The CDC-registered Animal Care Facilities will help to 
ensure animals that arrive ill, or must be detained, will be held in a 
facility that meets CDC requirements, USDA Animal Welfare Act 
Standards,\103\ and maintains an active CBP FIRMS code. This 
requirement would further help ensure that facilities have staff who 
are properly trained to provide food, water, shelter, and veterinary 
care to animals if needed. CDC will continue to register live-animal 
care facilities at the remaining 13 U.S. airports with CDC quarantine 
stations to protect the health and safety of airline and warehouse 
staff, as well as the health and safety of animals arriving in the 
United States at these ports.
---------------------------------------------------------------------------

    \103\ 7 U.S.C. 2148.
---------------------------------------------------------------------------

    (c) Authorized U.S. land ports for dogs and cats.
    HHS/CDC is not proposing any changes to the authorized U.S. land 
ports for dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries that have not been in a DMRVV high-risk country 
within the last six months. There are also no proposed changes for 
cats; cats may continue to enter through any U.S. port, including land 
ports. CDC is proposing to prohibit entry into the United States 
through any U.S. land port for dogs that have been in a DMRVV high-risk 
country within the last six months. There are no CDC-registered Animal 
Care Facilities along the U.S-Mexico and U.S.-Canada borders that can 
safely house or quarantine dogs arriving from DMRVV high-risk 
countries. Additionally, local and State animal and public health 
authorities do not have capacity on a routine basis to house and 
quarantine dogs arriving from DMRVV high-risk countries without 
additional burdens being placed on local public health resources.

[[Page 43993]]

    (d) Authorized U.S. seaports for dogs and cats.
    HHS/CDC is not proposing any changes to the authorized U.S. 
seaports for dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries that have not been in any DMRVV high-risk country 
within the last six months. There are also no proposed changes for 
cats; cats may continue to enter through any U.S. port, including 
seaports. HHS/CDC is proposing to prohibit entry into the United States 
through any U.S. seaport for dogs that have been in a DMRVV high-risk 
country within the last six months. There are no CDC-registered Animal 
Care Facilities at U.S. seaports that can safely house or quarantine 
dogs arriving from DMRVV high-risk countries. Additionally, local and 
State animal and public health authorities do not have capacity on a 
routine basis to house and quarantine dogs arriving from DMRVV high-
risk countries without additional burdens being placed on local public 
health resources.
    However, HHS/CDC is proposing an exception for dogs meeting the 
definition of a ``service animal'' under 14 CFR 382.3 that have been in 
a DMRVV high-risk country within the last six months. HHS/CDC would 
permit entry if the dog is accompanied by an ``individual with a 
disability'' as defined under 14 CFR 382.3 and the dog does work or 
performs tasks that are directly related to the individual's 
disability. CDC believes this exception would apply to a small number 
of individuals who require that their service dog accompany them on 
cruise ships with U.S. destination ports. The dog must be otherwise 
admissible under this section and would be allowed entry if:
    1. The dog was vaccinated against rabies in the United States and 
is accompanied by a valid Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States Form; or
    2. The dog was vaccinated against rabies in a foreign country and 
is accompanied by both a valid foreign-issued CDC Import Certification 
of Rabies Vaccination and Microchip Required for Live Dog Importations 
into the United States Form and a valid serologic titer from a CDC-
approved laboratory.
    (e) Limitation on U.S. ports for dogs and cats.
    HHS/CDC is proposing to explicitly authorize the Director to limit 
the times, U.S. ports, and/or conditions under which dogs or cats may 
arrive at and be admitted to the United States based on an importer's 
or carrier's failure to comply with the provisions of this section or 
as needed to protect the public's health. If the Director determines 
such a limitation is required, the Director will notify importers or 
carriers in writing of the specific times, U.S. ports, and/or 
conditions under which dogs and cats may be permitted to arrive at and 
be admitted to the United States.
    (f) Age requirement for all dogs.
    Through this NPRM, HHS/CDC proposes that all dogs arriving into the 
United States (regardless of whether from DMRVV-free, DMRVV low-risk, 
or DMRVV high-risk countries) be, at minimum, six months of age. HHS/
CDC currently requires dogs to be at least four months of age to enter 
the United States if arriving from a DMRVV high-risk country because 
this is the age at which a dog can be considered adequately vaccinated 
for rabies. Verification of a dog's age is made via dental examination, 
with dogs six months of age or older being easily identified by the 
presence of adult incisors and canine teeth. HHS/CDC is proposing to 
require imported dogs be at least six months of age, which would allow 
veterinarians to more easily estimate the ages of young dogs to ensure 
adequate DMRVV vaccination.
    The proposed requirement that all dogs arriving into the United 
States be at least six months of age will align with USDA/APHIS Animal 
Care requirements for the importation of dogs that are being imported 
for rescue or resale and will help ensure pet dogs can be safely 
transported without risk to their health and welfare. HHS/CDC is 
proposing as an exception to allow an importer to import a maximum of 
three personal pet dogs under six months of age in a calendar year if 
arriving via a U.S. land port from Canada or Mexico if the dog has not 
been in a DMRVV high-risk country in the previous six months.
    Based on communication with Federal partner agencies and data in 
CDC's quarantine activity reporting system, persons importing three or 
more dogs in a calendar year are less likely to be doing so in 
connection with their personal pet ownership and more likely to be 
associated with commercial importations of animals, including importers 
attempting to circumvent HHS/CDC entry requirements by transporting 
dogs from DMRVV high-risk countries through Canada and Mexico for 
resale or adoption in the United States. Therefore, HHS/CDC proposes 
this age requirement to protect public health, as well as the health 
and safety of young puppies being purchased and sold internationally.
    (g) Microchip requirements for all dogs.
    HHS/CDC does not currently require a microchip for importation of 
dogs into the United States. Requiring a microchip for all dogs would 
help ensure that veterinary paperwork and animal identification can be 
verified. It will also align with the admission requirements of other 
DMRVV-free countries and bring the United States into international 
alignment with the World Organisation for Animal Health (WOAH) 
standards that all dogs have permanent identification or marking for 
international movement.\104\ HHS/CDC proposes to require that all dogs 
have an Individual Standards Organization (ISO)-compliant microchip 
prior to arrival in the United States or prior to traveling out of the 
United States and returning.
---------------------------------------------------------------------------

    \104\ World Organisation for Animal Health. Terrestrial Code 
Online Access--WOAH--World Organisation for Animal Health: https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=1&htmfile=chapitre_certif_rabies.htm.
---------------------------------------------------------------------------

    (h) CDC Import Submission Form for all dogs.
    CDC and Federal partners have documented numerous instances of 
importers moving dogs from DMRVV high-risk countries through DMRVV low-
risk country to circumvent U.S. dog entry 
requirements.105 106 HHS/CDC proposes requiring that 
importers submit a CDC Import Submission Form via a CDC-approved system 
for each imported dog to help mitigate the risk of importers presenting 
dogs from DMRVV high-risk countries at U.S. ports that have traveled 
through DMRVV low-risk countries for short periods of time (less than 
six months) and do not meet CDC entry requirements. The CDC Import 
Submission Form must be submitted to CDC prior to a dog's departure 
from the foreign country.
---------------------------------------------------------------------------

    \105\ The importer of the rabid dog into the United States in 
2019 first flew into Canada before crossing a land border into the 
United States. See Raybern, C et al. Rabies in a dog imported from 
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-
1377.
    \106\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------

    (i) Inspection requirements for admission of dogs and cats.
    HHS/CDC currently requires that all dogs and cats arriving in the 
United States be inspected to ensure they appear healthy. While the 
requirement for inspection of dogs and cats is not new, HHS/CDC 
proposes clarifying that dogs and cats may be denied admission if an 
importer refuses to consent to the required screening. HHS/CDC believes 
that this additional clarification is

[[Page 43994]]

needed because of numerous documented instances of confusion among 
importers and some carriers regarding CDC's ability to mandate a public 
health evaluation of a dog or cat prior to admission. Additionally, CDC 
may coordinate with other federal and state partners to engage in 
routine disease surveillance of animals arriving in the United States.
    (j) Examination by a USDA-Accredited Veterinarian and confinement 
of exposed dogs and cats or those that appear unhealthy.
    HHS/CDC currently requires examination by a veterinarian and 
confinement if, upon examination, a dog or cat appears unhealthy upon 
arrival, and such measures are needed to protect the public's health. 
While the requirement for examination and confinement are not new, this 
proposed provision is primarily intended to require airlines to assume 
responsibility for housing and caring for dogs and cats that arrive 
sick in the event the importer abandons the shipment. CDC has 
documented numerous instances of sick animals not receiving care in a 
timely manner and animals denied admission being left by airlines in 
unacceptable housing conditions.
    HHS/CDC proposes, in the event a dog or cat arrives ill, is denied 
admission, or is exposed to a sick animal in transit,107 108 
that the airline arrange for confinement in a CDC-approved veterinary 
clinic and that the importer bears the expenses of such confinement, 
examination, testing, and treatment. If an importer fails to pay for 
such expenses, then the animal may be considered abandoned, and the 
airline will be required to assume financial responsibility. This 
provision is needed to help ensure airlines assume responsibility for 
sick or exposed dogs and cats and that such animals do not remain in 
unsafe conditions for prolonged periods of time (e.g., longer than six 
hours). The proposed rule further clarifies an airline's 
responsibilities in the event an importer abandons a dog or cat. This 
provision may also be applied to other carriers transporting dogs and 
cats in the rare circumstances where it is necessary for public health 
reasons to require that the carrier arrange for examination and 
confinement.
---------------------------------------------------------------------------

    \107\ National Association of State Public Health Veterinarians. 
Compendium of animal rabies prevention and control, 2016. JAVMA 
2016; 248 (5):505-517.
    \108\ Manning SE, Rupprecht CE, Fishbein D, et al. Human rabies 
prevention--United States, 2008: recommendations of the Advisory 
Committee on Immunization Practices. MMWR Recomm Rep 2008;57(RR-
3):1-28.
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    (k) Veterinary examination and revaccination against rabies at a 
CDC-registered Animal Care Facility for foreign-vaccinated dogs.
    HHS/CDC proposes to require all dogs arriving from DMRVV high-risk 
countries without a valid Certification of U.S.-Issued Rabies 
Vaccination for Live Dog Re-entry into the United States Form to have a 
valid CDC Import Certification of Rabies Vaccination and Microchip 
Required for Live Dog Importations into the United States Form and 
undergo veterinary examination and revaccination against rabies at a 
CDC-registered Animal Care Facility upon arrival.
    The importer would be responsible for making a reservation and all 
arrangements relating to the examination, revaccination, and quarantine 
(if quarantine is required) of dogs with a CDC-registered Animal Care 
Facility prior to the dogs' arrival in the United States. Airlines must 
deny boarding to dogs if the importer fails to present a receipt of the 
completed CDC Import Certification of Rabies Vaccination and Microchip 
Required for Live Dog Importations into the United States Form. The 
costs of examination, vaccination, and quarantine (if required) would 
be borne by the importer and not the United States Government. Animals 
that are abandoned before meeting requirements outlined below become 
the legal responsibility of the airline.
    HHS/CDC proposes that the dogs remain in the custody of a CDC-
registered Animal Care Facility until all of the following requirements 
are met:
    (i) Veterinary health examination by a USDA-Accredited Veterinarian 
for signs of disease. Suspected or confirmed zoonotic or foreign animal 
diseases would be required to be reported to CDC, USDA, the State or 
County Public Health Veterinarian, and the State Veterinarian prior to 
release of the animals.
    (ii) Vaccination against rabies with a USDA-licensed rabies vaccine 
and administered by a USDA-Accredited Veterinarian.
    (iii) Confirmation of microchip number.
    (iv) Confirmation of age through dental examination by a USDA-
Accredited Veterinarian.
    (v) Verification of adequate rabies serologic test from a CDC-
approved laboratory. To be considered valid, serologic tests must be 
drawn prior to arrival within an established timeframe and display 
results within parameters as specified in CDC technical 
instructions.\109\ Currently, this means that serologic tests must be 
drawn 45 to 365 days before arrival and have a result greater than or 
equal to 0.5 IU/mL. Dogs that arrive without an adequate rabies 
serologic test results from a CDC-approved laboratory would be housed 
at the CDC-registered Animal Care Facility for a 28-day quarantine 
following administration of the U.S. rabies vaccine or until an 
adequate rabies serologic test from a CDC-approved laboratory is 
confirmed.
---------------------------------------------------------------------------

    \109\ CDC Technical Instructions will be posted to CDC's website 
(www.cdc.gov/dogtravel) upon publication of the final rule.
---------------------------------------------------------------------------

    (l) Registration or renewal of CDC-registered Animal Care 
Facilities.
    Through this NPRM, HHS/CDC proposes to establish a registration 
mechanism for CDC-registered Animal Care Facilities used in the 
importation of foreign-vaccinated dogs arriving in the United States 
from DMRVV high-risk countries. Before housing any imported live dog in 
the United States, an animal care facility would be required to 
register with and receive written approval from CDC, USDA, and CBP to 
submit their facility application. The applicant would need to provide 
written standard operating procedures outlining how CDC's regulatory 
requirements will be met and the health and safety of animals and staff 
will be ensured. A copy of all Federal, State, or local registrations, 
licenses, or permits would also be required to be submitted to CDC. 
Additionally, CDC would require the facility to have a USDA 
intermediate handlers license and a FIRMS code issued by CBP. The 
facility would be subject to inspection by CDC at least annually and 
required to renew their registration every two years. Animal health 
records, facilities, vehicles, or equipment to be used in receiving, 
examining, and processing imported animals would also be subject to 
inspection.
    (m) Record-keeping requirements at CDC-registered Animal Care 
Facilities.
    HHS/CDC proposes to require that any CDC-registered Animal Care 
Facilities retain records regarding each imported animal for three 
years after the distribution or transfer of the animal. Each record 
must include:
    (i) The bill of lading for each shipment;
    (ii) The name, address, phone number, and email address of the 
importer and owner (if different from the importer);
    (iii) The number of animals in each shipment;
    (iv) The identity of each animal in each shipment, including name,

[[Page 43995]]

microchip number, date of birth, sex, breed, and coloring;
    (v) The airline, flight number, date of arrival, and port of each 
shipment; and
    (vi) Veterinary medical records for each animal, including:
    (a) CDC Import Certification of Rabies Vaccination and Microchip 
Required for Live Dog Importations into the United States Form and 
rabies serology obtained before arrival in the United States (if 
applicable);
    (b) The USDA-licensed rabies vaccine administered upon arrival;
    (c) Veterinary exam records upon arrival and while in quarantine;
    (d) Rabies serology performed while in quarantine in the United 
States (if applicable); and
    (e) All diagnostic test, histopathology and necropsy results 
performed during quarantine (if applicable).
    The facility would be required to maintain these records 
electronically and allow CDC to inspect the records.
    (n) Worker protection plan and personal protective equipment (PPE).
    HHS/CDC proposes to require that a CDC-registered Animal Care 
Facility establish and maintain a worker protection plan with standards 
comparable to those in CDC's National Institute for Occupational Safety 
and Health (NIOSH) Veterinary Safety and Health guidelines \110\ and 
the National Association of Public Health Veterinarians (NASPHV) 
Compendium of Veterinary Standard Precautions for Zoonotic Disease 
Prevention in Veterinary Personnel.\111\ Such a worker protection plan 
must include rabies pre-exposure prophylaxis for workers handling 
imported animals in quarantine, post-exposure procedures that provide 
potentially exposed workers with direct and rapid access to a medical 
consultant, and procedures for documenting the frequency of worker 
training, including for those working in the quarantine area. As part 
of the worker protection plan, a facility would also need to establish, 
implement, and maintain hazard evaluation and worker communication 
procedures that include descriptions of the known zoonotic disease and 
injury hazards associated with handling animals, the need for PPE when 
handling animals and training in the proper use of PPE, and procedures 
for disinfection of garments, supplies, equipment, and waste.
---------------------------------------------------------------------------

    \110\ https://www.cdc.gov/niosh/topics/veterinary/biological.html.
    \111\ http://www.nasphv.org/Documents/VeterinaryStandardPrecautions.pdf.
---------------------------------------------------------------------------

    (o) CDC-registered Animal Care Facility standard operating 
procedures, requirements, and equipment standards for crating, caging, 
and transporting live animals.
    HHS/CDC proposes to outline equipment standards for crating, 
caging, and transporting live animals for CDC-registered Animal Care 
Facilities. The standards must be in accordance with USDA Animal 
Welfare regulation standards \112\ (9 CFR parts 1, 2, and 3) and 
International Air Transport Association standards.\113\ Violations of 
the USDA Animal Welfare Act may result in immediate revocation of an 
animal care facility's status as a CDC-registered Animal Care Facility.
---------------------------------------------------------------------------

    \112\ U.S. Department of Agriculture. Animal Welfare Act. 
https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa. 
Accessed June 7, 2023.
    \113\ International Air Transport Association. Live Animals. 
https://www.iata.org/en/programs/cargo/live-animals. Accessed June 
7, 2023.
---------------------------------------------------------------------------

    (p) Health reporting requirements for animals at CDC-registered 
Animal Care Facilities.
    HHS/CDC proposes to establish health reporting requirements for all 
dogs being evaluated at a CDC-registered Animal Care Facility. A 
facility would need to provide the following services for each dog from 
a DMRVV high-risk country with a foreign-issued rabies vaccine upon 
arrival and ensure each animal meets CDC, USDA, and state and local 
entry requirements prior to release from the facility:
    (i) Veterinary examination by a USDA-Accredited Veterinarian within 
one business day of arrival;
    (ii) Verification of microchip and confirmation that the microchip 
number matches the animal's health records;
    (iii) Verification of animal's age via a dental examination;
    (iv) Vaccination against rabies using a USDA-licensed vaccine; and
    (v) Verification of an adequate serologic test from a CDC-approved 
laboratory OR 28-day quarantine after administration of the USDA-
licensed rabies vaccine.
    HHS/CDC further proposes that the facility notify CDC within 24 
hours of the occurrence of any morbidity or mortality of animals in the 
facility. Any animal that dies at a CDC-registered Animal Care Facility 
would be required to undergo a necropsy and diagnostic testing to 
determine the cause of death. An animal that arrives ill or becomes ill 
while at the CDC-registered Animal Care Facility would need to be 
examined by a USDA-Accredited Veterinarian immediately and undergo 
diagnostic testing to determine the cause of illness prior to release 
from the facility. Suspected or confirmed zoonotic diseases would need 
to be reported to CDC and the State or County Public Health 
Veterinarian within 24 hours of identification. Suspected or confirmed 
foreign animal diseases or infectious animal diseases would be reported 
to USDA and the State or County Veterinarian within 24 hours of 
identification.\114\
---------------------------------------------------------------------------

    \114\ Zoonotic disease are diseases that can spread from animals 
to people; infectious animal diseases spread only between animals; 
foreign animal diseases are not present in the United States and may 
or may not be zoonotic.
---------------------------------------------------------------------------

    (q) Quarantine requirements for CDC-registered Animal Care 
Facilities.
    HHS/CDC proposes to establish requirements for the quarantine area 
at CDC-registered Animal Care Facilities to ensure animals are safely 
housed and do not present a public health risk to humans or other 
animals. The proposed requirements include building security to prevent 
unintended public exposure to quarantined animals, cleaning and 
disinfection standards, and diagnostic testing or necropsy for ill or 
deceased animals.
    (r) Revocation and reinstatement of a CDC-registered Animal Care 
Facility's registration.
    HHS/CDC proposes procedures to revoke a CDC-registered Animal Care 
Facility's registration if the Director determines that it has failed 
to comply with any applicable provisions of this section. CDC would 
send the facility a notice of revocation stating the grounds upon which 
the proposed revocation is based. If the facility contested the 
revocation, the facility would be required to file a written response 
to the notice within five business days after receiving the notice. All 
the grounds listed in the proposed revocation would be deemed admitted 
if the facility failed to respond.
    If a facility's response is timely, the Director will review the 
registration, the notice of revocation, and the response. The Director 
would then decide whether to revoke the facility's registration based 
on the written record and communicate this decision in writing to the 
facility. The Director could reinstate a revoked registration after 
inspecting the facility, examining its records, conferring with the 
facility, and receiving information and assurance from the facility of 
compliance with the requirements of this section.
    (s) Requirement for the CDC Import Certification of Rabies 
Vaccination and Microchip Required for Live Dog Importations into the 
United States Form to import a foreign-vaccinated dog from DMRVV high-
risk countries.
    HHS/CDC currently requires in 42 CFR 71.51(c) that importers of 
dogs

[[Page 43996]]

arriving from DMRVV high-risk countries provide a valid RVC, as defined 
in 42 CFR 71.51(a), upon arrival; this includes proof of vaccination 
but importers are not required to use a standardized form. Without a 
standardized form, there is tremendous variation among countries in 
documenting proof of vaccination. This lack of standardization creates 
confusion for port staff who are responsible for reviewing the rabies 
proof of vaccination.
    Through this NPRM, HHS/CDC proposes to require a new, standardized 
rabies vaccination form for all foreign-vaccinated dogs arriving from 
DMRVV high-risk countries. This rabies vaccination form will be 
standardized and help importers and Federal agencies ensure dogs being 
imported from DMRVV high-risk countries are imported with all the 
required information on one form. This requirement will reduce 
confusion and ensure Official Government Veterinarians in the exporting 
country have reviewed the veterinary records and examined dogs prior to 
travel. HHS/CDC proposes that this form replace the current valid RVC 
requirement, which was not aligned with internationally accepted 
standards for the international movement of animals. This form will 
also permit CDC and other U.S. Government agencies to confirm the 
accuracy of documentation with exporting country officials if 
discrepancies in the forms are noted.
    All foreign-vaccinated dogs from DMRVV high-risk countries will be 
required to be examined by a USDA-Accredited Veterinarian and 
revaccinated with a USDA-licensed vaccine at a CDC-registered Animal 
Care Facility upon arrival to align with State rabies vaccination 
requirements and recommendations from the NASPHV.\115\ Dogs arriving 
without a Certification of U.S.-issued Rabies Vaccination for Live Dog 
Re-entry into the United States form will be required to present the 
CDC Import Certification of Rabies Vaccination and Microchip Required 
for Live Dog Importations into the United States form to the CDC-
registered Animal Care Facility along with a valid serologic test from 
a CDC-approved laboratory (if applicable).
---------------------------------------------------------------------------

    \115\ National Association of State Public Health Veterinarians. 
Compendium of Animal Rabies Prevention and Control, 2016. JAVMA 
2016; 248 (5): 505-517.
---------------------------------------------------------------------------

    To be considered valid, serologic tests must be drawn prior to 
arrival within a timeframe and display results within parameters as 
specified in CDC technical instructions. Currently, to be considered 
valid, serologic tests must be drawn within a timeframe of 45 to 365 
days before arrival and have a result greater than or equal to 0.5 IU/
ml. Dogs that arrive without an adequate rabies serologic test from a 
CDC-approved laboratory will be subject to a mandatory 28-day 
quarantine after revaccination at a CDC-registered Animal Care Facility 
at the importer's expense. HHS/CDC is requesting public comments on all 
aspects of this proposal as it relates to persons traveling abroad with 
their dogs.
    (t) Requirement for Certification of U.S.-Issued Rabies Vaccination 
for Live Dog Re-entry into the United States Form for importers seeking 
to import U.S.-vaccinated dogs from DMRVV high-risk countries.
    HHS/CDC proposes to require that U.S.-vaccinated dogs re-entering 
the United States from DMRVV high-risk countries arrive at a U.S. 
airport with a CDC quarantine station and be accompanied by a 
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry 
into the United States Form. The form must be completed by a USDA-
Accredited Veterinarian and signed by a USDA Official Veterinarian 
prior to the animal departing the United States. Importers returning to 
the United States from a DMRVV high-risk country with this form may 
present their dog for admission without a rabies serologic test from a 
CDC-approved laboratory, without the dog undergoing veterinary 
examination (unless ill, injured, or exposed), and without 
revaccination against rabies at a CDC-registered Animal Care Facility. 
People who leave the United States with their dogs without first 
obtaining this form will be required to have their dogs re-enter the 
United States as if they are foreign-vaccinated dogs and be required to 
meet all the requirements as outlined in section (s) for the dogs to be 
eligible for re-entry from a DRMVV high-risk country. HHS/CDC solicits 
feedback on this proposed process.
    (u) Requirement for proof that a dog has only been in a DMRVV low-
risk or DMRVV-free country.
    HHS/CDC proposes to require that dogs being imported from DMRVV 
low-risk or DMRVV-free countries be accompanied by appropriate written 
documentation demonstrating that they have not been in any DMRVV high-
risk country during the past six months. An importer would need to 
provide written documentation, such as veterinary medical records, upon 
request confirming that the dog is at least six months of age, is 
microchipped, and has been only in a DMRVV low-risk or DMRVV-free 
country for the six months prior to importation into the United States. 
There are no proposed changes for cat rabies vaccination importation 
requirements. CDC recommends importers comply with State or Territorial 
requirements for rabies vaccination in cats. The CDC Import 
Certification of Rabies Vaccination and Microchip Required for Live Dog 
Importations into the United States form would not be required for 
importers able to meet the requirements of this paragraph. HHS/CDC is 
requesting public comment on whether a standardized form should be 
required for dogs arriving from DMRVV-free and DMRVV low-risk countries 
in order to avoid potential fraud. HHS/CDC is requesting public comment 
on all aspects of this proposal as it relates to cats and dogs.
    (v) Denial of admission of dogs and cats.
    This proposed section outlines the circumstances under which CDC 
can deny admission to a dog or cat being presented for admission into 
the United States. CDC shall notify CBP in writing to enforce this 
action. This includes:
     Any dog arriving from a DMRVV low-risk or DMRVV-free 
country without written documentation that the dog has resided in a 
DMRVV low-risk or rabies-free country for the six months prior to the 
attempted entry, or if the Director reasonably suspects fraud.
     Any dog that is not accompanied by a receipt confirming 
that a CDC Import Submission Form has been submitted to CDC through a 
CDC-approved system.
     Any dog arriving at a U.S. airport for which a bill of 
lading has not been created by the airline prior to arrival.
     Any dog arriving at a U.S. land port that has been in a 
DMRVV high-risk country within the last six months prior to the 
attempted entry.
     Any dog arriving at a U.S. seaport that has been in a 
DMRVV high-risk country within the last six months prior to the 
attempted entry, except for a dog qualifying as a service animal that 
is otherwise admissible under this section.
     Any dog imported by an importer who refuses to comply with 
the requirement (if applicable) for the dog to undergo disease 
surveillance screening, veterinary examination, revaccination, provide 
proof of sufficient rabies serologic tests, or quarantine at a CDC-
registered Animal Care Facility upon arrival.
     Any dog that has been in a DMRVV high-risk country in the 
previous six months and arrives without a valid Certification of U.S.-
Issued Rabies Vaccination for Live Dog Re-entry into the United States 
Form or a valid CDC Import Certification of Rabies

[[Page 43997]]

Vaccination and Microchip Required for Live Dog Importations into the 
United States Form.
     Any dog that has been in a DMRVV high-risk country in the 
previous six months and does not arrive via air at a U.S. airport with 
a CDC quarantine station or via air at a U.S. airport with a CDC-
registered Animal Care Facility (if applicable).
     Any dog imported from a DMRVV high-risk country that 
arrives without a reservation at a CDC-registered Animal Care Facility 
(if applicable).
     Any dog from a DMRVV-restricted country that arrives 
without a valid CDC Dog Import Permit.
     Any dog imported from a DMRVV high-risk country if the 
Director reasonably suspects fraud in any documentation required for 
admission or if such documentation is otherwise untruthful, inaccurate, 
or incomplete.
     Any dog or cat, regardless of country of departure, that 
poses a public health risk, including dogs or cats that appear 
unhealthy upon arrival or demonstrate signs or symptoms of communicable 
disease.
     Any dog under six months of age that is arriving at a U.S. 
airport or seaport, or any dog under six months of age that is arriving 
at a U.S. land port if the importer has imported three or more 
individual dogs under six months of age in the same calendar year 
(January-December).
    HHS/CDC solicits public comment regarding this proposed paragraph, 
including whether the grounds for the proposed denial of admission are 
sufficient to protect the public's health.
    (w) Disposal or disposition of dogs and cats denied admission or 
abandoned prior to admission that were transported to the United 
States.
    Through this NPRM, HHS/CDC proposes an operational framework 
primarily applicable to airlines regarding how dogs denied admission 
would be handled by carriers and importers. HHS/CDC clarifies that 
airlines must provide housing for animals awaiting return to their 
country of departure at a CDC-registered Animal Care Facility or a CDC-
approved animal facility if a CDC-registered Animal Care Facility is 
not available. Airlines are required to return animals denied admission 
to the country of departure within 72 hours of arrival, regardless of 
carrier or route. This is to ensure airlines do not leave animals in 
warehouses unattended for prolonged periods of time. As proposed, 
airlines would be able to request extensions for an animal's return in 
the event the animal is not medically fit for travel. This proposed 
operational framework provides that importers are responsible for all 
associated costs relating to the housing, care, and treatment of a dog 
or cat denied admission pending return to its country of departure. 
However, if an importer fails to pay any costs or fails to comply with 
any requirements, the animal will be considered abandoned, and the 
relevant carrier would be required to assume responsibility.
    In instances where a dog or cat is fatally ill or injured, the 
importer or airline may choose a humane euthanasia option in accordance 
with the standards of the American Veterinary Medical Association \116\ 
performed by a licensed veterinarian. The importer or airline must 
notify CDC and CBP in writing of this decision. This decision does not 
relieve the importer or airline of the obligation to obtain and report 
results of necropsy or diagnostic testing required by CDC.
---------------------------------------------------------------------------

    \116\ https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals.
---------------------------------------------------------------------------

    In the case of dogs and cats denied admission to the United States 
upon arrival at a U.S. seaport, the vessel's master or operator would 
be required to reembark the animal immediately and return it to its 
country of departure on the next voyage. In the case of dogs and cats 
denied admission to the United States upon arrival at a U.S. land port, 
the importer or carrier would be required to immediately return it to 
its country of departure.
    CDC does not expect the above operational framework relating to 
housing, care, and treatment of a dog or cat denied admission to be 
applied on a routine basis to carriers or importers arriving with dogs 
or cats at U.S. land or seaports because the circumstances leading to a 
delay in returning a dog or cat to its country of departure are not 
typically present at these U.S. ports. However, CDC acknowledges that 
there may be rare and unforeseen circumstances where it may be 
necessary to apply such procedures. Accordingly, CDC has added language 
authorizing it to apply these provisions in circumstances where a dog 
or cat is denied entry at a U.S. land or seaport and cannot be 
immediately returned to its country of departure (e.g., because it is 
unfit to travel). HHS/CDC specifically solicits public comment 
regarding the possible application of these measures to dogs and cat 
arriving in the United States at U.S. land or seaports.
    (x) Appeals of CDC denials to admit a dog or a cat upon arrival 
into the United States.
    This section proposes an appeal process for importers of dogs and 
cats in the event their animals are denied admission to the United 
States upon arrival.
    If CDC denies admission to a dog or cat under this section, the 
importer may appeal that denial to the Director. The importer must 
submit the appeal in writing to the Director that states the reasons 
for the appeal and demonstrates that there is a genuine and substantial 
issue of fact in dispute. The importer must submit the appeal within 
one business day of the denial. Submitting an appeal will not delay the 
return of the animal to the country of departure. CDC will issue a 
written response, which shall constitute final agency action.
    Because denial of admission to dogs and cats under these limited 
circumstances is likely to occur at a port, HHS/CDC proposes that any 
appeal be submitted within one business day so as not to unnecessarily 
prolong the appeal process and allow for expedited decision-making 
regarding whether an animal should be returned to its country of 
departure. Pending a determination regarding the appeal the animal will 
remain the legal responsibility of the carrier. HHS/CDC solicits public 
comment regarding this proposal.
    (y) Record of death of dogs and cats while en route to the United 
States and disposition of dead animals.
    The requirement that carriers maintain a record of sickness or 
death for any animals that die during transit is longstanding. Through 
this NPRM, HHS/CDC proposes to require necropsy and diagnostic testing 
for any dog or cat that dies en route to the United States or at a U.S. 
port prior to admission to determine the cause of death. Consistent 
with current requirements, carriers would be required to report deaths 
to the CDC quarantine station of jurisdiction. HHS/CDC proposes these 
amendments to ensure it can detect, provide referrals to appropriate 
agencies, and respond to potential zoonotic disease importation risks 
in a timely manner. Importers would be responsible for the costs unless 
they abandon the animal, in which case the airline or master or 
operator of a vessel would assume responsibility for the costs.
    (z) Abandoned shipments of dogs and cats.
    Through this NPRM, HHS/CDC proposes an operational framework 
primarily applicable to airlines for when a dog or cat would be 
considered abandoned prior to admission and thus require the carrier to 
assume responsibility for the shipment. CDC has documented several 
instances in which importers have chosen to abandon dogs.

[[Page 43998]]

Federal and State public health agencies have incurred financial costs 
because of importers abandoning dogs and the subsequent refusal by 
airlines to provide safe housing and return for dogs. HHS/CDC proposes 
that an animal shipment be deemed abandoned under the following 
circumstances:
     When explicitly stated by the importer verbally or in 
writing to the carrier, CDC, or CBP; or
     If the importer fails to cooperate with or respond to the 
carrier's attempts to comply with the regulations listed in 42 CFR 
71.51 within 24 hours; or
     If the importer refuses payment within 24 hours for CDC-
mandated examinations, testing, holding, or treatment needed to ensure 
the safe importation of animals into the United States.
    The provisions of this paragraph may also be applied to other 
carriers transporting such dogs and cats in the rare circumstances 
where the dog or cat is abandoned by the importer at a U.S. land port 
or seaport and other options are not available.
    (aa) Sanitation of cages and containers of dogs and cats.
    The requirement that animal cages and containers be kept in a 
sanitary condition is long-standing. This language appears as a 
separate paragraph in the proposed regulation, but HHS/CDC is not 
proposing any changes to the existing language, which requires that 
animals be transported in clean crates or cages. CDC is republishing 
this section to provide context and for the convenience of the reader.
    (bb) Requirements for in-transit shipments of dogs and cats.
    HHS/CDC proposes to clarify the definition of an in-transit 
shipment and outlines the requirements for dogs and cats that transit 
the United States as part of an in-transit shipment. CDC's definition 
would align with that of the USDA, and HHS/CDC clarifies that dogs and 
cats cannot be considered in transit if they are transported as hand-
carried baggage or checked baggage. In-transit shipments may only be 
transported as cargo.
    (cc) Bill of lading and other airline requirements for dogs.
    To help mitigate the risk of importers presenting dogs from DMRVV 
high-risk countries at U.S. airports that have traveled through DMRVV 
low-risk countries for short periods of time (less than six months) and 
do not meet CDC entry requirements, this NPRM proposes to require that 
airlines create a bill of lading accounting for all live dog imports 
through a U.S. airport, regardless of whether the dogs are transported 
as cargo, checked baggage, or hand-carried baggage, or otherwise 
accompany a traveler arriving in the United States on their person. 
Requiring airlines to create a bill of lading specifically for all live 
dog imports arriving at a U.S. airport will also help ensure airlines 
are accountable for the safety of the dog upon arrival in the United 
States. Dogs that do not have bills of lading by an airline are more 
likely to be left by the airline in unsafe conditions, and airlines 
often refuse to take responsibility for the safety and entry 
requirements for dogs flown as checked-baggage or hand-carried 
baggage.\117\
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    \117\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------

    CDC also proposes to require that airlines confirm that all 
importers have a receipt of a completed CDC Import Submission Form 
prior to boarding. For U.S.-vaccinated dogs, CDC proposes that airlines 
confirm that importers have a valid Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States Form. For 
foreign-vaccinated dogs, CDC proposes that airlines confirm that 
importers have a reservation at a CDC-registered Animal Care Facility. 
For dogs from DMRVV-free or low-risk countries, CDC proposes that 
airlines confirm that the importer has documentation showing that the 
dog is over six months of age, has a microchip, and has not been in a 
DMRVV high-risk country in the previous six months.
    CDC is also proposing that a representative of an airline 
transporting live dogs into the United States be on-site at the U.S. 
airport and available to coordinate the entry/clearance of the dogs 
with federal government officials until all live dogs transported on an 
arriving flight into the United States have either been cleared for 
admission or arrangements have been made to transport the dogs to a 
CDC-registered Animal Care Facility or other facility (e.g., veterinary 
clinic or kennel) approved by CDC pending admissibility determination.
    HHS/CDC is seeking public comment on whether airline staff should 
be required to present dogs for entry and be available until all dogs 
have been cleared for entry or arrangements have been made to transport 
the dogs to a CDC-registered Animal Care Facility or other facility 
(e.g., veterinary clinic or kennel) approved by CDC pending an 
admissibility determination. HHS/CDC is also seeking public comment on 
how airlines can present dogs for inspection in the cargo area, except 
dogs meeting the definition of a ``service animal'' under 14 CFR 382.3.
    (dd) Order prohibiting carriers from transporting dogs and cats.
    HHS/CDC proposes procedures for the Director to issue an order 
revoking a carrier's permission to transport live dogs and cats into 
the United States if a carrier has endangered the public health of the 
United States by acting or failing to act to prevent the introduction 
of DMRVV, as would occur by failing to comply with the provisions of 
this section. HHS/CDC believes that the circumstances giving rise to 
such an order would be exceedingly rare, such that HHS/CDC would issue 
an order only after repeated attempts to consult with and obtain 
voluntary compliance and remedial action from the carrier have failed. 
The Director would rescind the order after working with the carrier to 
obtain remedial action, such as: inspecting the carrier's facilities; 
examining its records; conferring with the carrier's owners or 
operators, contractors, or staff; or after receiving information and 
written assurances from the carrier owner or operator that it has taken 
remedial steps to ensure future compliance with HHS/CDC dog and cat 
importation requirements. Such an order would be subject to an 
administrative appeal. The appeal must be in writing, addressed to the 
Director, state the reasons for the appeal, and demonstrate that there 
is a genuine and substantial issue of fact in dispute. As soon as 
practicable after completing the appeal review, the Director will issue 
a decision in writing that would constitute final agency action. The 
Director will serve the carrier owners or operators with a copy of the 
written decision.
    (ee) Prohibition on imports of dogs from DMRVV-restricted 
countries.
    Through this NPRM, HHS/CDC proposes to prohibit or otherwise 
restrict the import of dogs into the United States from certain 
countries that have repeatedly exported rabid dogs to any other country 
or that lack adequate controls to monitor and prevent the export of 
dogs to the United States with falsified or fraudulent vaccine 
credentials. Such a prohibition or other restriction would remain in 
place until CDC was satisfied that sufficient controls had been 
established to prevent the reintroduction of DMRVV into the United 
States, including preventing the use of falsified or fraudulent vaccine 
credentials. To implement this provision, this NPRM proposes that HHS/
CDC maintain a list of DMRVV-restricted countries. The list would be 
maintained on CDC's website and

[[Page 43999]]

updated annually. Amendments to the list of DMRVV-restricted countries 
would be published as a notice in the Federal Register. Under this 
proposal, CDC may allow the importation of certain categories of dogs 
from DMRVV-restricted countries, such as service animals or government-
owned animals. HHS/CDC solicits comment as to whether such Federal 
Register notices would be sufficient to inform the public.
    (ff) Request for issuance of additional fines or penalties.
    Under 42 U.S.C. 268(b), CBP and Coast Guard officers may aid in the 
enforcement of HHS/CDC's quarantine rules and regulations. HHS/CDC is 
proposing to add a paragraph recognizing that HHS/CDC may request that 
CBP pursue enforcement actions using CBP's existing authorities under 
19 U.S.C. 1592 and 19 U.S.C. 1595a against importers, brokers, or 
carriers who violate HHS/CDC's dog and cat importation requirements. 
This provision does not create new authority. Its purpose is to inform 
the public of actions that CDC may take to request CBP assistance in 
enforcing HHS/CDC's dog and cat importation requirements. HHS/CDC 
stresses that it does not administer Title 19, and decisions regarding 
whether to pursue enforcement actions under Title 19 would be entirely 
at the discretion of DHS/CBP and subject to its policies and 
procedures.

V. Alternatives Considered

    In developing this NPRM, HHS/CDC considered more and less 
restrictive policy alternatives. The provisions included in the NPRM 
were determined to minimize the cost and burden of the proposed 
regulatory provisions while protecting and reducing risks to the 
public's health. To reduce the costs associated with the provisions of 
the NPRM, many proposed requirements only apply to dogs imported from 
DMRVV high-risk countries, and some apply only to dogs vaccinated 
outside the United States imported from DMRVV high-risk countries.
    Table 4 summarizes alternatives to selected proposed requirements 
expected to be associated with most of the monetized costs and benefits 
for this NPRM (if finalized as proposed) relative to the current status 
quo. A semi-quantitative analysis of the costs and benefits is 
available in Section F of an Appendix found in the Supplemental 
Materials tab of the docket.
---------------------------------------------------------------------------

    \118\ The current requirements do not take account of the 
temporary suspension of dogs from DMRVV high-risk countries, because 
it is a temporary measure.

 Table 4--Summary Table of Important Changes to Regulatory Requirements Based on the Provisions of This NPRM and
                                             Alternatives Considered
----------------------------------------------------------------------------------------------------------------
                                        Current
   NPRM requirement (proposed)    requirements \118\    Option 1--more      Option 2--less       Justification
                                      (baseline)          restrictive         restrictive
----------------------------------------------------------------------------------------------------------------
Proposed 71.51(f)...............  DMRVV High-risk     Dogs must be at     Dogs must be at     The increased age
Dogs must be at least six months   countries: Dogs     least six months    least four months   requirement will
 of age to be imported from a      must be at least    of age regardless   of age to arrive    improve health
 DMRVV high-risk country.          four months of      of country of       via aircraft        and safety for
Dogs must be at least six months   age (based on the   origin or type of   regardless of       dogs being
 of age to arrive via aircraft     earliest age at     conveyance.         country of          transported and
 regardless of country origin.     which a dog could                       origin, which is    result in fewer
Only three or fewer dogs less      be considered                           the youngest age    public health
 than six months of age may be     fully vaccinated                        a dog may be        investigations of
 imported at land ports by an      against rabies).                        considered fully    dogs found to be
 importer/owner (per calendar     No requirement for                       vaccinated          ill or to have
 year). Dogs that have been in     DMRVV-free or                           against rabies.     died during air
 DMRVV high-risk countries are     DMRVV low-risk                         No limit to the      travel. The 6-
 not eligible to arrive at land    countries since                         number of dogs      month versus 4-
 ports.                            rabies                                  that may be         month age
                                   vaccination                             imported at land    requirement will
                                   documentation is                        ports.              also make it
                                   not currently                                               easier to
                                   required for                                                estimate the age
                                   these dogs.                                                 of dogs based on
                                                                                               examination of
                                                                                               their teeth. This
                                                                                               age requirement
                                                                                               will also improve
                                                                                               alignment with
                                                                                               USDA import
                                                                                               requirements (7
                                                                                               CFR 2148) for
                                                                                               dogs imported for
                                                                                               resale.
Proposed section 71.51(g).......  No dog-             All dogs must be    Either no           This requirement
All dogs must have a microchip     identification      implanted with      identification      is needed to
 regardless of country of origin.  requirement other   microchips and      requirement or      confirm that the
                                   than a              have tattoos for    allow use of        arriving dogs
                                   description on      identification      tattoos or other    match their
                                   the rabies          purposes.           dog-identifying     paperwork because
                                   vaccination                             technology          CDC has
                                   documentation.                          instead of          documented a
                                                                           requiring           dramatic increase
                                                                           microchips.         in the number of
                                                                                               dogs arriving
                                                                                               with falsified
                                                                                               rabies
                                                                                               vaccination
                                                                                               documentation.
                                                                                               The microchip
                                                                                               requirement will
                                                                                               allow for
                                                                                               matching
                                                                                               microchip
                                                                                               information
                                                                                               (obtained by
                                                                                               scanning the dog)
                                                                                               with the
                                                                                               microchip number
                                                                                               documented on the
                                                                                               dog's proof of
                                                                                               rabies
                                                                                               vaccination.

[[Page 44000]]

 
Proposed section 71.51(h).......  No requirement for  Require importers   Only require dogs   This requirement
Require importers to submit        dog importers to    to use the more     from DMRVV high-    will help Federal
 advance data for each dog via a   submit data with    complicated and     risk countries to   agencies detect
 CDC-approved system and require   CDC and no          costly CBP formal   submit data via a   dogs that move
 airlines to create bill of        requirement for     entry               CDC-approved        from DMRVV high-
 lading for all live dog imports.  airlines to         requirements.       system and          risk to DMRVV low-
                                   create a bill of                        require airlines    risk countries to
                                   lading for all                          to create a bill    avoid U.S.
                                   live dog imports.                       of lading for all   requirements.
                                                                           live dog imports.  This requirement
                                                                                               will also support
                                                                                               Federal agencies'
                                                                                               targeting of
                                                                                               interventions for
                                                                                               dogs arriving
                                                                                               from countries
                                                                                               presenting
                                                                                               significant risks
                                                                                               to human or
                                                                                               animal health.
Proposed 71.51 (t)..............  Rabies vaccine      Require             Require             At present, the
Require standardized rabies        certificates are    Certification of    veterinarians to    information on
 vaccination information using a   required for dogs   U.S.-issued         fill out the        rabies
 CDC form: Certification of U.S.-  imported from       Rabies              Certification of    vaccination
 issued Rabies Vaccination for     DMRVV high-risk     Vaccination for     U.S.-issued         documents is not
 Live Dog Re-entry into the        countries and do    Live Dog Re-entry   Rabies              standardized;
 United States Form for dogs       not need to be      into the United     Vaccination for     different formats
 originating in the United         entered into a      States form be      Live Dog Re-entry   are used in
 States and wanting to re-enter    standardized form   certified by a      into the United     different
 the U.S. after traveling to a     or certified by     USDA Official       States Form, but    countries and
 DMRVV high-risk country.          an Official         Veterinarian for    do not require      even within the
                                   Government          all dogs leaving    certification by    U.S. Lack of a
                                   Veterinarian.       the U.S. with       an Official         standardized
                                                       planned re-entry    Government          format may lead
                                                       into the U.S.       Veterinarian.       to dogs from
                                                                                               DMRVV high-risk
                                                                                               countries
                                                                                               arriving at a
                                                                                               U.S. port with
                                                                                               rabies
                                                                                               vaccination
                                                                                               documentation s
                                                                                               that does not
                                                                                               align with
                                                                                               current CDC
                                                                                               requirements and
                                                                                               subsequent entry
                                                                                               denials. This
                                                                                               provision will
                                                                                               also align the
                                                                                               United States
                                                                                               with import/
                                                                                               export
                                                                                               requirements
                                                                                               commonly required
                                                                                               in other
                                                                                               countries.
Proposed 71.51(k)...............  No follow-up        Require veterinary  In lieu of          This process will
Requirement for veterinary         examination or      examination and     requiring follow-   better align U.S.
 examination and revaccination     revaccination       revaccination for   up at a CDC-        requirements with
 against rabies at a CDC-          required.           all dogs imported   registered Animal   existing
 registered Animal Care Facility                       from DMRVV high-    Care Facility,      requirements of
 for foreign-vaccinated dogs                           risk countries,     allow dogs          other DMRVV-free
 from DMRVV high-risk countries,                       including dogs      imported from       countries
 no requirement for dogs                               with valid U.S.-    DMRVV high-risk    This requirement
 imported from DMRVV-free or                           issued rabies       countries that      for veterinary
 DMRVV low-risk countries or                           vaccinations.       were vaccinated     examination and
 U.S.-vaccinated dogs from DMRVV                                           outside the         revaccination
 high-risk countries if U.S.-                                              United States to    will reduce the
 vaccinated dogs are healthy and                                           visit any           risk of dogs
 meet all other requirements.                                              licensed U.S.       potentially
The laboratory testing                                                     veterinarian for    infecting people
 requirements in proposed                                                  examination and     or wildlife with
 71.51(k)(4)(v) are addressed                                              revaccination.      DMRVV and
 separately below.                                                                             potentially other
                                                                                               zoonotic diseases
                                                                                               or diseases which
                                                                                               impact livestock
                                                                                               in the United
                                                                                               States.

[[Page 44001]]

 
Proposed 71.51(k)(4)............  No laboratory       Serologic test      Allow serologic     This laboratory
Foreign-vaccinated dogs from       testing             from a CDC-         test results for    testing provision
 DMRVV high-risk countries must    requirement for     approved            dogs imported       will better align
 have serologic test results       dog imports from    laboratory with a   from DMRVV high-    U.S. requirements
 from a CDC-approved laboratory    any country.        longer, e.g., 90-   risk countries      with existing
 with a waiting period, or such                        day waiting         with foreign-       requirements of
 time period as specified in CDC                       period before       issued rabies       other DMRVV-free
 technical instructions, before                        entry for dogs      vaccinations from   countries that
 entry or be quarantined for 28                        vaccinated          any laboratory      require
 days after revaccination with a                       outside the         (i.e., not          laboratory
 USDA-licensed rabies vaccine.                         United States and   limited to CDC-     confirmation
                                                       arriving from       approved            because rabies
                                                       DMRVV high-risk     laboratories).      vaccination
                                                       countries or all                        documentation
                                                       dogs imported                           alone is
                                                       from DMRVV high-                        considered
                                                       risk countries                          insufficient as
                                                       require serologic                       proof of rabies
                                                       test results.                           immunity.
                                                                                               However, this
                                                                                               requirement is
                                                                                               still less
                                                                                               restrictive than
                                                                                               many DMRVV-free
                                                                                               countries because
                                                                                               there is no
                                                                                               serologic test
                                                                                               requirement for
                                                                                               U.S.-vaccinated
                                                                                               dogs.
Proposed 71.51(b)...............  No U.S. port        For all dogs from   Allow foreign-      This requirement
U.S.-vaccinated dogs imported      requirement.        DMRVV high-risk     vaccinated dogs     will ensure dogs
 from DMRVV high-risk countries                        countries, limit    imported from       denied entry or
 must enter through one of 18                          entry to U.S.       DMRVV high-risk     placed on hold
 U.S. airports with a CDC                              port with CDC-      countries to        have safe housing
 quarantine station. Foreign-                          registered Animal   enter at any U.S.   locations
 vaccinated dogs from DMRVV high-                      Care Facilities.    port with a CDC     available and/or
 risk countries must arrive at a                       Five U.S. ports     quarantine          CDC oversight.
 U.S. port with a CDC-registered                       currently have      station and allow   This will reduce
 Animal Care Facility. Such                            facilities that     U.S.-vaccinated     the risk that
 facilities must have an active                        meet this           dogs from any       dogs pending or
 custodial bond and a FIRMS code                       standard.           country to enter    denied entry will
 issued by CBP, and a USDA                                                 at any U.S. port.   be placed in
 intermediate handlers license.                                                                cargo warehouses
 Five U.S. ports currently have                                                                or other unsafe
 facilities that meet this                                                                     locations while
 standard.                                                                                     awaiting CDC
                                                                                               determination or
                                                                                               return to their
                                                                                               countries of
                                                                                               origin. This
                                                                                               would ensure
                                                                                               appropriate
                                                                                               veterinary follow
                                                                                               up for foreign-
                                                                                               vaccinated dogs
                                                                                               from DMRVV high-
                                                                                               risk countries.
----------------------------------------------------------------------------------------------------------------

VI. Required Regulatory Analyses

A. Executive Orders 12866 and 13563

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

[[Page 44002]]

CFR 71.51. The baseline analysis does not incorporate the impact of the 
temporary suspension of dogs imported from DMRVV high-risk countries 
that has been in effect since July 14, 2021.\119\ The economic baseline 
does not account for the temporary suspension but does account for a 
change to the definition of rabies-free country published in 2019.\120\ 
This baseline is used as a comparator to assess the impact of the 
provisions of the NPRM if finalized as proposed.
---------------------------------------------------------------------------

    \119\ On June 14, 2021, CDC published the ``Notice of Temporary 
Suspension of Dogs Entering the United States from High-Risk Rabies 
Countries.'' Through this notice, CDC informed the public that, 
effective July 14, 2021, it was temporarily suspending the 
importation of dogs from: countries classified by CDC as high risk 
for DMRVV; AND countries that are NOT at high risk if the dogs have 
been in high-risk countries during the previous six months. See 86 
FR 32041 (June 16, 2021). The suspension was extended effective June 
10, 2022. See 87 FR 33158 (June 1, 2022).
    \120\ HHS/CDC. Guidance Regarding Agency Interpretation of 
``Rabies-Free'' as It Relates to the Importation of Dogs Into the 
United States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    The provisions of this NPRM (if finalized as proposed) would 
address the market inefficiency in which dog importers do not consider 
the potential detrimental impacts to the public's health that may 
result from the importation of ill dogs, especially dogs infected with 
DMRVV. Regulation at the Federal level is necessary to address the risk 
of unhealthy dog imports upon entry to the United States. Federal 
action allows risks to be addressed prior to dogs' arrival in the 
United States. The provisions of this NPRM (if finalized as proposed) 
are expected to affect the following categories of interested parties 
and implementing partners:
     Importers of dogs from countries that are DMRVV-free or at 
low risk for DMRVV;
     Importers of dogs from countries that are at high risk of 
DMRVV;
     Airlines and other carriers;
     CBP;
     CDC;
     USDA; and
     State and local public health and animal health 
departments.
    As discussed above, the changes proposed in the NPRM incorporate 
different requirements depending on whether dogs are imported from 
DMRVV high-risk countries compared to countries that are DMRVV-free or 
DMRVV low-risk. Proposed requirements for dogs from DMRVV high-risk 
countries are further differentiated depending on whether imported dogs 
have received their rabies vaccines in the United States or in another 
country. Dogs imported from DMRVV high-risk countries would have to 
arrive at one of five airports with a CDC-registered Animal Care 
Facility (foreign-vaccinated dogs) or at one of 18 airports with a CDC 
quarantine station (U.S.-vaccinated dogs). Importers of foreign-
vaccinated dogs from DMRVV high-risk countries would make reservations 
with a CDC-registered Animal Care Facility for a veterinary examination 
and revaccination prior to arrival. As part of the proposed entry 
requirements in the NPRM (if finalized as proposed), importers would 
either agree to a 28-day quarantine period for the dog or submit 
samples of the dog's blood to a CDC-approved laboratory for serologic 
testing to demonstrate immunity to rabies virus. CDC assumes that most 
importers would choose serologic testing in lieu of the quarantine 
period. All importers of dogs from DMRVV high-risk countries would 
submit the CDC Import Certification of Rabies Vaccination and Microchip 
Required for All Live Dog Importations into the United States Form or 
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry 
into the United States Form, which require certification by an Official 
Government Veterinarian. However, dogs imported from DMRVV-free or 
DMRVV low-risk countries do not require evaluation at CDC-registered 
Animal Care Facilities and are eligible to arrive at any U.S. port. In 
lieu of the CDC Import Certification of Rabies Vaccination and 
Microchip Required for All Live Dog Importations into the United States 
Form or Certification of U.S.-issued Rabies Vaccination for Live Dog 
Re-entry into the United States Form, importers may provide proof that 
the dogs have only been in DMRVV-free or DMRVV low-risk countries 
during the six months prior to arriving in the United States (i.e., to 
demonstrate the dog had not been in a high-risk country).
    All dog imports arriving on aircraft conveyances, regardless of 
whether they arrive from countries that are DMRVV-free or at low- or 
high-risk for DMRVV, are subject to a six-month minimum age 
requirement. Dog imports arriving at land ports are only subject to the 
six-month minimum age requirement if an importer needs to import three 
or more dogs younger than six months of age in a calendar year. In 
addition, all dogs would need to be implanted with microchips for 
identification purposes (if the NPRM is finalized as proposed). All 
dogs, regardless of country of origin, would be listed on a bill of 
lading by the airline, if entering the U.S. via air. All importers of 
dogs arriving at an air, land, or seaport would have to submit a CDC 
Import Submission Form to CDC via a CDC-approved system prior to the 
dog's departure from the foreign country. The form would need to be 
presented to the airline or other carrier prior to boarding and upon 
arrival in the United States.
    The annualized and present value estimates of monetized costs and 
benefits over the 10-year period from 2023 through 2032 using three 
percent and seven percent discount rates are summarized in Tables 5 and 
6. The annualized, monetized costs (2020 USD) of the provisions in the 
NPRM (if finalized as proposed) are estimated to be $29 million (range: 
$7.8 to $88 million) using a three percent discount rate, and the 
results were almost unchanged using a seven percent discount rate. Most 
monetized costs are expected to be incurred by importers (84 percent 
for the most likely estimate). The estimated monetized costs are 
expected to be less for importers of dogs from DMRVV-free or DMRVV low-
risk countries compared to importers of dogs from DMRVV high-risk 
countries. The proposed provisions estimated to result in the greatest 
increase in costs for importers of dogs imported from DMRVV-free 
countries were associated with the additional costs associated with the 
minimum age, and with the microchip requirements, and completing the 
new CDC Import Submission Form.
    The provisions estimated to result in the greatest increase in 
costs for importers of dogs from DMRVV high-risk countries were 
associated with the requirements regarding use of a CDC-registered 
Animal Care Facility for foreign-vaccinated dogs from DMRVV high-risk 
countries in proposed section 71.51(k). Other costs included: (1) 
laboratory testing, (2) an expected reduction in the number of dogs 
imported from DMRVV high-risk countries, (3) the need for some 
travelers to re-route travel to an airport with a CDC quarantine 
station or airport with a CDC-registered Animal Care Facility, and (4) 
the costs with providing a CDC Import Certification of Rabies 
Vaccination and Microchip Required for All Live Dog Importations into 
the United States Form or Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States Form 
(certified by an Official Government Veterinarian). Airlines are 
expected to incur the greatest costs among carriers and their costs are 
estimated to comprise about 8.7 percent of the estimated annualized, 
monetized costs, with most of their costs associated with ensuring that 
all transported dogs comply with the bill of

[[Page 44003]]

lading requirements of the NPRM (if finalized as proposed) and a 
reduction in the number of dogs transported. HHS/CDC was unable to 
estimate costs from other types of carriers of dogs arriving by land or 
sea and welcomes public comment on their potential costs. CDC is 
estimated to incur about 6.9 percent of the annualized, monetized costs 
(most likely estimate) associated with the provisions of this NPRM (if 
finalized as proposed). Most CDC costs would be associated with the 
oversight of animal care facilities and laboratory proficiency testing 
programs for dogs imported from high-risk countries. CBP is expected to 
incur about 0.5 percent of the annualized costs (most likely estimate) 
associated with the provisions of this NPRM (if finalized as proposed). 
Most CBP costs would result from training personnel to implement the 
proposed requirements.
    The annualized monetized benefits of the provisions in the NPRM (if 
finalized as proposed) are estimated to be about $1.9 million (range: 
$0.80 to $4.0 million) using a three percent or seven percent discount 
rate, with most of the benefits accruing to importers (46 percent of 
the most likely estimates) and to CBP (33 percent of the most likely 
estimates). Some of the benefits estimated for both importers and CBP 
would result from reduced time spent on screening dogs from high-risk 
countries at U.S. ports. The amount of time required per dog at U.S. 
ports would be reduced because it is assumed that the CDC standardized 
vaccination forms would be easier to review compared to non-
standardized documentation for dogs arriving from DMRVV high-risk 
countries. The provisions in this NPRM (if finalized as proposed) are 
also estimated to reduce the number of dogs denied entry or arriving 
ill or dead, with benefits estimated for importers, airlines, CBP, and 
CDC.
    The wide range between the lower-bound and upper-bound cost and 
benefit estimates demonstrates that there is considerable uncertainty 
in these results. More details on the input parameters and assumptions 
used to generate these estimates may be found in the Appendix under the 
Supplemental Materials tab of the docket. At present, the number of 
dogs imported into the United States is neither accurately nor 
completely tracked by any data system, and the uncertainty in the cost 
and benefit estimates reflect uncertainty in both the total number of 
dogs imported and the number of dogs imported from DMRVV high-risk 
countries, as well as the cost of the new requirements included in the 
NPRM (if finalized as proposed). The net annualized, monetized costs 
(total cost estimate-total benefit estimate) are estimated to be about 
$26 million per year (range: $6.9 to $83 million) using a three percent 
discount rate.

                         Table 5--Annualized, Monetized Costs and Benefits Summary Table
   [In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent
                                                 discount rate]
----------------------------------------------------------------------------------------------------------------
                                        Most likely
                                         estimate       Lower bound     Upper bound      Source (RIA section)
----------------------------------------------------------------------------------------------------------------
                                 Annualized, monetized benefits (reduced costs)
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
    Importer benefits...............           $0.89           $0.37            $1.8  B1, B2, B3.
    Airline benefits................            0.18           0.038            0.59  B4.
    DHS/CBP benefits................            0.65            0.30            0.95  B5.
    HHS/CDC benefits................            0.22           0.090            0.59  B6.
    State and local health                      0.05             0.0           0.022  B7.
     department benefits.
                                     ---------------------------------------------------------------------------
        Total benefits (A1).........             1.9             0.8             4.0
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
    Importer benefits...............            0.89            0.37             1.8  B1, B2, B3.
    Airline benefits................            0.18           0.038            0.59  B4.
    DHS/CBP benefits................            0.65            0.30            0.95  B5.
    HHS/CDC benefits................            0.22           0.090            0.59  B6.
    State and local health                     0.005             0.0           0.022  B7.
     department benefits.
                                     ---------------------------------------------------------------------------
        Total benefits (A2).........             1.9            0.80             4.0
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized,          The response costs associated with a dog        C1.
 benefits.                            imported while infected with DMRVV were
                                      estimated to be about $320,000, ranging from
                                      $220,000 to $520,000. The requirements in the
                                      NPRM (if finalized as proposed) reduce the
                                      risk of imported dogs arriving with DMRVV, and
                                      the costs associated with rabies response
                                      activities will decrease.
----------------------------------------------------------------------------------------------------------------

[[Page 44004]]

 
Qualitative (unquantified) benefits.  With each importation of a dog infected with    D1.
                                      DMRVV, there is a risk that a person may
                                      become infected and die or that DMRVV may be
                                      re-introduced in the U.S. wildlife population,
                                      which could dramatically increase costs
                                      relative to the public health response cost
                                      summarized above. In addition, by obtaining
                                      high-quality data on the number of dogs
                                      imported by country, CDC and other Federal
                                      agencies, including USDA, will improve
                                      preparedness for outbreaks of new and emerging
                                      infectious disease threats to humans (e.g.,
                                      DMRVV) and animals (e.g., African swine
                                      fever). The provisions of the NPRM (if
                                      finalized as proposed) will also ensure that
                                      dogs that are denied entry or arrive ill will
                                      receive the veterinary care needed to protect
                                      their health and safety.
----------------------------------------------------------------------------------------------------------------
                                           Annualized, monetized costs
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
    Importer costs..................            23.8             5.2            79.1  B1, B2, B3.
    Airline costs...................             2.5             1.0             5.2  B4.
    DHS/CBP costs...................             0.1            0.05             0.3  B5.
    HHS/CDC costs...................             1.9             1.4             2.5  B6.
                                     ---------------------------------------------------------------------------
        Total costs (B1)............            28.3             7.7            87.1
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
    Importer costs..................            23.9             5.3            79.6  B1, B2, B3.
    Airline costs...................             2.5             1.0             5.2  B4.
    DHS/CBP costs...................             0.2            0.06             0.4  B5.
    HHS/CDC costs...................             2.0             1.4             2.6  B6.
                                     ---------------------------------------------------------------------------
        Total costs (B2)............            28.6             7.8            87.8
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized, costs..  Not applicable.                                 C2.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) costs....  CDC would monitor countries and may suspend     D2.
                                      entry of dogs from countries with repeated
                                      instances of dogs with falsified or fraudulent
                                      rabies vaccination documentation. The lost
                                      value of these imports would impact some U.S.
                                      businesses and dog purchasers. In addition,
                                      the duration of any suspensions for these
                                      countries is highly uncertain and may be ended
                                      in the event of improvement of those
                                      countries' dog export controls. CDC is
                                      proposing the authority to issue orders to
                                      revoke a carrier's or importer's permission to
                                      transport live dogs and cats if either has
                                      endangered the public's health; however, CDC
                                      does not have any plans to suspend any
                                      carriers or importers at this time. Owners of
                                      dogs that undergo a 28-day quarantine period
                                      may suffer qualitative costs from being
                                      separated from their dogs during quarantine.
----------------------------------------------------------------------------------------------------------------
                                              Net annualized costs
----------------------------------------------------------------------------------------------------------------
Total (three percent discount rate),            26.4             6.9            83.1
 (B1)-(A1).
Total (seven percent discount rate),            26.6             7.0            83.8
 (B1)-(A1).
----------------------------------------------------------------------------------------------------------------

    The present value of the estimated monetized cost over a 10-year 
period for the provisions in the NPRM (if finalized as proposed) is 
estimated to be $240 million (range: $65 to $740 million) using a three 
percent discount or $200 million (range: $53 to $610 million) using a 
seven percent discount rate. The present value of monetized benefits 
over a 10-year period of the provisions in the NPRM (if finalized as 
proposed) is estimated at $17 million (range: $6.9 to

[[Page 44005]]

$34 million) using a three percent discount rate or $14 million (range: 
$5.7 to $28 million) using a seven percent discount rate. The net 
annualized monetized cost (total costs-total benefits) is estimated at 
$230 million per year (range: $58 to $700 million) using a three 
percent discount rate and $190 million per year (range: $48 to $580 
million) using a seven percent discount rate.

                           Table 6--Present Value of Costs and Benefits Summary Table
   [In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent
                                                 discount rate]
----------------------------------------------------------------------------------------------------------------
                                        Most likely
                                         estimate       Lower bound     Upper bound      Source (RIA section)
----------------------------------------------------------------------------------------------------------------
                               Present value of monetized benefits (reduced costs)
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
    Importer benefits...............            $7.6            $3.2             $16  B1, B2, B3.
    Airline benefits................             1.5            0.32             5.0  B4.
    DHS/CBP benefits................             5.5             2.6             8.1  B5.
HHS/CDC benefits....................             1.9            0.77             5.0  B6.
    State and local health                     0.042             0.0            0.19  B7.
     department benefits.
                                     ---------------------------------------------------------------------------
        Total benefits (A)..........              17             6.9              34
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
    Importer benefits...............             6.3             2.6              13  B1, B2, B3.
    Airline benefits................             1.2            0.27             4.1  B4.
    DHS/CBP benefits................             4.6             2.1             6.7  B5.
    HHS/CDC benefits................             1.6            0.63             4.1  B6.
    State and local health                     0.034             0.0            0.16  B7.
     department benefits.
                                     ---------------------------------------------------------------------------
        Total benefits..............              14             5.7              28
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized,          The response costs associated with a dog        C1.
 benefits.                            imported while infected with DMRVV were
                                      estimated to be about $320,000, ranging from
                                      $220,000 to $520,000. The requirements in the
                                      NPRM (if finalized as proposed) reduce the
                                      risk of imported dogs arriving with DMRVV, and
                                      the costs associated with rabies response
                                      activities will decrease.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) benefits.  With each importation of a dog infected with    D1.
                                      DMRVV, there is a risk that a person may
                                      become infected and die or that DMRVV may be
                                      re-introduced in the U.S. wildlife population,
                                      which could dramatically increase costs
                                      relative to the public health response cost
                                      summarized above. In addition, by obtaining
                                      high-quality data on the number of dogs
                                      imported by country, CDC and other Federal
                                      agencies, including USDA, will improve
                                      preparedness for outbreaks of new and emerging
                                      infectious disease threats to humans (e.g.,
                                      DMRVV) and animals (e.g., African swine
                                      fever). The provisions of the NPRM (if
                                      finalized as proposed) will also ensure that
                                      dogs that are denied entry or arrive ill will
                                      receive the veterinary care needed to protect
                                      their health and safety.
----------------------------------------------------------------------------------------------------------------
                                        Present value of monetized costs
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
    Importer costs..................             203              45             675  B1, B2, B3.
    Airline costs...................              21               8              41  B4.
    DHS/CBP costs...................             1.1             0.4             2.6  B5.
    CDC costs.......................              17              11              18  B6.
                                     ---------------------------------------------------------------------------
        Total costs (B).............             242              64             737
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
    Importer costs..................             168              37             559  B1, B2, B3.
    Airline costs...................              17             6.6              33  B4.
    DHS/CBP costs...................             1.1             0.4             2.4  B5.
    CDC costs.......................              14             9.3              14  B6.
                                     ---------------------------------------------------------------------------
        Total costs.................             200              53             608
----------------------------------------------------------------------------------------------------------------

[[Page 44006]]

 
Quantified, but unmonetized, costs..  Not applicable.                                 C2.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) costs....  CDC would monitor countries and may suspend     D2.
                                      entry of dogs from countries with repeated
                                      instances of dogs with falsified or fraudulent
                                      vaccine credentials or invalid rabies
                                      vaccination documentation. The lost value of
                                      these imports would impact some U.S.
                                      businesses and dog purchasers. In addition,
                                      the duration of any suspensions for these
                                      countries is highly uncertain and may be ended
                                      in the event of improvement of those
                                      countries' dog export controls. CDC is
                                      proposing the authority to issue orders to
                                      revoke a carrier's or importer's permission to
                                      transport live dogs and cats if either has
                                      endangered the public's health; however, CDC
                                      does not have any plans to suspend any
                                      carriers or importers at this time. Owners of
                                      dogs that undergo a 28-day quarantine period
                                      may suffer qualitative costs from being
                                      separated from their dogs during quarantine.
----------------------------------------------------------------------------------------------------------------
                                              Net annualized costs
----------------------------------------------------------------------------------------------------------------
Total (three percent discount rate),             225              58             702
 (B1)-(A1).
Total (seven percent discount rate),             187              48             581
 (B1)-(A1).
----------------------------------------------------------------------------------------------------------------

    The United States was declared DMRVV-free in 2007. Importing dogs 
from DMRVV high-risk countries involves a significant public health 
risk. The proposed provisions of this NPRM (if finalized as proposed) 
would better align U.S. dog importation requirements with those of 
other countries that have been declared DMRVV-free. Further, the 
serologic testing requirements are consistent with recommendations in 
the WOAH Terrestrial Manual for dogs imported from DMRVV high-risk 
countries to DMRVV-free countries.\121\ One DMRVV-infected dog may 
cause transmission to humans, domestic pets, livestock, or wildlife. 
The average cost per importation of a DMRVV-infected dog was estimated 
to be $320,000 (range: $220,000 to $520,000) to conduct public health 
investigations and administer rabies PEP to exposed persons.
---------------------------------------------------------------------------

    \121\ WOAH Terrestrial Animal Health Code. Chapter 5.11. 
Available at: Access online: WOAH--World Organisation for Animal 
Health https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=0&htmfile=chapitre_certif_rabies.htm.
---------------------------------------------------------------------------

    Historically, CDC's has denied entry to approximately 200 dogs 
annually due to fraudulent, incomplete, or inaccurate paperwork.\122\ 
However, between January 2020 and July 2021 (i.e., during the COVID-19 
pandemic, prior to the temporary suspension), CDC documented more than 
1000 instances of incomplete, inadequate, or fraudulent rabies 
vaccination certificates for dogs arriving from DMRVV high-risk 
countries.\123\ The diversion of public health resources globally to 
COVID-19 response activities has contributed to a lapse in canine 
rabies vaccination efforts and a related increase in the prevalence of 
dogs infected with DMRVV in some high-risk countries. The combination 
of an increasing number of dogs imported without adequate documentation 
of rabies vaccination,\124\ in addition to the potential increase in 
the prevalence of DMRVV in high-risk countries,\125\ would increase the 
risk of importation of dogs that are infected with DMRVV. This 
combination of factors would increase the likelihood of DMRVV-
importation events relative to the time-period before the COVID-19 
pandemic.
---------------------------------------------------------------------------

    \122\ Centers for Disease Control and Prevention (2021). 
Quarantine Activity Reporting System (version 4.9.8.8.2.2A). Dog 
Importation data, 2010-2019. Accessed October 1, 2022.
    \123\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C., 
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we 
have an erupting problem? PLoS ONE, 16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
    \124\ Centers for Disease Control and Prevention. Quarantine 
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation 
data, 2018-2020. Accessed: 15 February 2021.
    \125\ A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis K, Meltzer MI, 
Wallace R. (2021) The urgency of resuming disrupted dog rabies 
vaccination campaigns: a modeling and cost-effectiveness analysis. 
Scientific Reports; 11:12476. https://https://doi.org/10.1038/s41598-021-92067-5.
---------------------------------------------------------------------------

    CDC is unable to predict future trends with or without the proposed 
provisions included in this NPRM to estimate how many dogs infected 
with DMRVV may be imported. Two rabid dog imports (both from Iran) have 
been reported in Canada within a seven-month period (specifically July 
2021 and January 2022) at around the same time the United States 
implemented a temporary suspension of dogs imported from DMRVV high-
risk countries. Prior to these two imports, Canada had not reported a 
dog infected with DMRVV since the 1960s.\126\ Given the limited number 
of reported dogs with DMRVV, this observation may be indicative of a 
higher risk for dogs imported from DMRVV high-risk countries during the 
COVID-19 pandemic or could be anomalous occurrences in Canada. However, 
the provisions included in the NPRM (if finalized as proposed) is 
expected to substantively reduce the risk of importation of dogs 
infected with DMRVV relative to baseline.
---------------------------------------------------------------------------

    \126\ Outbreak News Today (Feb. 10, 2022) Rabies case reported 
in Toronto in a dog imported from Iran. http://outbreaknewstoday.com/rabies-case-reported-in-toronto-in-a-dog-imported-from-iran-46958. Accessed: February 14, 2022.
---------------------------------------------------------------------------

    The primary public health benefit of this NPRM (if finalized as 
proposed) is

[[Page 44007]]

the reduced risk that a dog infected with DMRVV will be imported from a 
high-risk country. Using the most likely estimates of the net monetized 
cost estimate ($26.4 million) and the most likely estimate of the 
potential benefit of averting the importation of one dog with DMRVV 
from a high-risk country ($320,000), it is possible to calculate the 
change in the number of imported dogs infected with DMRVV if the 
provisions of the NPRM are finalized as proposed relative to the 
baseline such that the benefit would equal cost. The net cost ($26.4 
million) divided by the cost per importation ($320,000) suggests that 
the provisions of the NPRM (if finalized as proposed) relative to 
baseline would have to avert the importation of 82 dogs infected with 
DMRVV for the benefit to exceed the cost. This would require an 
increase in the number of dogs imported into the United States while 
infected with DMRVV, which could only occur because of widespread 
failures of rabies control programs in multiple countries. However, 
this analysis does not consider the potential for fatal rabies cases in 
people or the risk of reintroduction of DMRVV in the United States, as 
analyzed below.
    The above estimate of the cost of an importation of a dog with 
DMRVV does not account for the worst-case outcomes, which include (1) 
transmission of rabies to a person who dies from the disease, or (2) 
ongoing transmission to other domestic and wildlife species in the 
United States. The cost of re-introduction could be especially high if 
DMRVV spreads to other species of U.S. wildlife. Re-establishment of 
DMRVV in the United States could result in costly efforts over several 
years to eliminate the virus again. Both worst-case outcomes may be 
more likely to occur after the COVID-19 pandemic because public health 
resources were diverted to COVID-19 response activities and disruptions 
in rabies control programs in high-risk countries. Disruptions to 
rabies control programs in DMRVV high-risk countries may contribute to 
elevated risks even as the COVID-19 pandemic wanes.
    Human deaths from rabies continue to occur in the United States 
after exposure to wild animals; however, no U.S. resident has died 
after exposure to an imported dog with DMRVV in at least 20 years. CDC 
uses the value of statistical life (VSL) to assign a value to 
interventions that can result in mortality risk reductions. For fatal 
cases, HHS recommends the use of the value of statistical life to 
estimate the potential benefits of averted deaths, an estimate of $11.6 
million in 2020 USD and a range of $5.5 to $17.7 million.\127\ However, 
CDC is unable to estimate the potential magnitude of the mortality risk 
reduction associated with the proposed rule. Based on the median VSL, 
the provisions of the NPRM (if finalized as proposed) would need to 
help avert three or more human deaths per year for the benefits to 
exceed costs (or an average of 2.3 deaths per year over multiple 
years).
---------------------------------------------------------------------------

    \127\ U.S. Department of Health and Human Services, 2016. Office 
of the Assistant Secretary for Planning and Evaluation. Guidelines 
for Regulatory Impact Analysis. https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf. Accessed: April 20, 2020.
---------------------------------------------------------------------------

    Efforts to eliminate DMRVV if re-established in the United States 
would also prove costly. A previous campaign to eliminate domestic dog-
coyote rabies virus variant jointly with gray fox (Texas fox) rabies 
virus variant in Texas over the period from 1995 through 2003 cost $34 
million,128 129 or $55 million in 2022 USD. The costs to 
contain any reintroduction would depend on the time-period before the 
reintroduction was realized, the wildlife species in which DMRVV was 
transmitted, and the geographic area over which reintroduction occurs. 
The above estimate is limited to the cost of rabies vaccination 
programs for targeted wildlife and does not include the costs to 
administer PEP to any persons exposed after the reintroduction has been 
identified. Human deaths from DMRVV could increase following the re-
introduction of DMRVV to the United States as the risk of exposure 
would increase.
---------------------------------------------------------------------------

    \128\ TJ Sidwa et al. (2005) Evaluation of oral rabies 
vaccination programs for control of rabies epizootics in coyotes and 
gray foxes: 1995-2003. Journal of the American Veterinary Medicine 
Association; 227(5):785-92.
    \129\ R.T. Sterner et al. (2009) Tactics and Economics of 
Wildlife Oral Rabies Vaccination, Canada and the United States. 
Emerging Infectious Diseases; 15(8), 1176-1184.
---------------------------------------------------------------------------

    The provisions of the NPRM (if finalized as proposed) would also 
ensure that dogs that are denied admission or arrive ill will be housed 
appropriately and receive the veterinary care needed to protect their 
health and safety. This will reduce the likelihood that dogs may be 
left in unsafe conditions in cargo warehouses for extended periods of 
time (i.e., longer than six hours) with the potential to expose workers 
who are not trained to handle live animals safely.\130\
---------------------------------------------------------------------------

    \130\ https://www.cbsnews.com/chicago/news/dog-dies-at-ohare-airport-warehouse-17-others-saved-after-being-left-without-food-or-water-for-3-days/.
---------------------------------------------------------------------------

    Under the current baseline, the number of dogs imported into the 
United States is neither accurately nor completely tracked. The more 
comprehensive data collection proposed in this NPRM through the CDC 
Import Submission Form would benefit public health investigations and 
enable better and more timely contact tracing of all animals exposed to 
an imported dog with DMRVV. The current lack of data also inhibits the 
Federal government's ability to target interventions for dogs imported 
from specific countries. The collection of data from the CDC Import 
Submission Form as proposed in this NPRM may also benefit other 
agencies such as USDA/APHIS that may want to regulate dog imports based 
on the risk of introduction of diseases that may affect U.S. livestock. 
For example, in 2021, APHIS regulated importers of dogs for resale 
based on whether the dogs were imported from countries where African 
swine fever exists.\131\ The potential economic benefits of reducing 
the risk of the importation of African swine fever could be 
significant. For example, a recent African swine fever outbreak in 
China was estimated to have total economic losses equivalent to 0.78 
percent of China's gross domestic product in 2019.\132\ The requirement 
in the NPRM (if finalized as proposed) to report all dogs to CDC via a 
CDC-approved system would reduce the risk of importation of infected 
dogs from countries with ongoing disease outbreaks that may affect 
livestock.
---------------------------------------------------------------------------

    \131\ Animal and Plant Health Inspection Service (Aug. 4, 2021) 
USDA Announces Requirements for Importing Dogs from Countries 
Affected with African Swine Fever. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed: 05 
February 2022.
    \132\ Shibing You, Tingyi Liu, Miao Zhang, Xue Zhao, Yizhe Dong, 
Bi Wu, Yanzhen Wang, Juan Li, Xinjie Wei and Baofeng Shi (2021) 
African swine fever outbreaks in China led to gross domestic product 
and economic losses. Nature Food; 2: 802-808.
---------------------------------------------------------------------------

    Viruses exploiting new host species have led to some of the most 
devastating disease epidemics, such as influenza, Ebola, and the HIV/
AIDS pandemic.\133\ Viruses continually evolve in their animal hosts. 
This has been observed in viruses such as avian and swine influenza 
viruses, constituting a permanent pandemic threat to humans.\134\ 
Although CDC cannot predict when future zoonotic diseases may emerge or 
whether future zoonotic diseases may be associated with transmission 
from dogs to humans, such events remain a possibility. Future dog-

[[Page 44008]]

mediated zoonotic diseases may pose an acute risk to the public's 
health because, in contrast to other animal imports, most dogs are 
imported as pets and will be in close contact with their owners.
---------------------------------------------------------------------------

    \133\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the 
epidemiology and evolution of species jumps. Trends in Ecology & 
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
    \134\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the 
epidemiology and evolution of species jumps. Trends in Ecology & 
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
---------------------------------------------------------------------------

    During the COVID-19 pandemic a variant of the SARS-CoV-2 virus was 
detected in mink populations in Europe and entered human populations 
from this animal host. Between February 18, 2020, and December 15, 
2021, 457 mink farms in 12 countries experienced SARS-CoV-2 outbreaks 
\135\ and mink-to-human transmission of the SARS-CoV-2 virus was 
documented on mink farms in the Netherlands, Denmark, Poland, and the 
United States.136 137 138 In August and September of 2020, 
Denmark documented a mink-associated SARS-CoV-2 variant strain found in 
12 people, eight of whom had links to the mink farming industry. Due to 
concerns about transmissibility, immunity, and potential impacts on 
vaccine efficacy, the Danish government ordered that all 15-17 million 
minks in the country be culled. Following a risk assessment of live 
mink importations from the Western European region to the United 
States, CDC determined additional regulatory action to prohibit live 
mink importations was unnecessary due to public health prevention 
measures taken by mink importers and the low numbers of imported mink. 
In comparison, CDC would not have the same data available to conduct a 
risk assessment for dog imports in the event of a future dog-mediated 
zoonotic disease outbreak because dog imports are neither accurately 
nor completely tracked in any government data system in the absence of 
the dog import submission data requirement proposed in this NPRM.
---------------------------------------------------------------------------

    \135\ Koopmans M. SARS-CoV-2 and the human-animal interface: 
outbreaks on mink farms. The Lancet Infectious Diseases 2021; 21 
(1): 18-19.
    \136\ Hammer AS, Quaade ML, Rasmussen TB, et al. SARS-CoV-2 
Transmission between Mink (Neovison vison) and Humans, Denmark. 
Emerg Infect Dis. 2021 Feb;27(2):547-551. doi: 10.3201/
eid2702.203794. Epub 2020 Nov 18. PMID: 33207152; PMCID: PMC7853580.
    \137\ Oude Munnink BB, Sikkema RS, Nieuwenhuijse DF, et al. 
Transmission of SARS-CoV-2 on mink farms between humans and mink and 
back to humans. Science. 2021 Jan 8;371(6525):172-177. doi: 10.1126/
science.abe5901. Epub 2020 Nov 10. PMID: 33172935; PMCID: 
PMC7857398.
    \138\ Rabalski L, Kosinki M, Mazur-Panasiuk N, et al. Zoonotic 
spillover of SARS-CoV-2: mink-adapted virus in humans. Available at: 
https://www.biorxiv.org/content/10.1101/2021.03.05.433713v1.full.pdf.
---------------------------------------------------------------------------

    The proposed reporting of dog import volumes by country in an 
approved CDC import submission data system provides an opportunity to 
target interventions for dogs imported from specific countries. Such 
reporting as proposed in 42 CFR 71.51(h) would allow CDC or other 
Federal agencies to more easily implement preventive measures to 
mitigate the risk of introductions of new zoonotic diseases targeted to 
specific countries of concern. The import submission data requirement 
may also help CDC and other Federal agencies, as well as State and 
local health departments, retrospectively inspect shipments from 
specific countries. This would reduce the costs of future 
interventions; however, CDC is not able to quantify future savings.
    The provisions of the NPRM (if finalized as proposed) are expected 
to reduce the risk of dogs arriving while ill. If an animal arrives in 
the United States and appears ill or is dead, a public health 
investigation is required to ensure the ill or dead animal does not 
present a public health threat. The overall health of an animal can 
play a significant role in whether it can maintain core body functions 
(i.e., body temperature regulation and glucose levels) during prolonged 
flights. Stressed, malnourished, and young animals are more likely to 
become ill and can transmit communicable diseases that can affect 
humans; 139 140 therefore, safety and welfare concerns for 
the transport of dogs have a public health impact that requires a 
degree of oversight from public health agencies to ensure human and 
animal health is protected.\141\
---------------------------------------------------------------------------

    \139\ Galanis E et al. Brucellosis and other diseases imported 
with dogs. BCMJ 2019; 61 (4): 177-190. Available at: https://bcmj.org/bccdc/brucellosis-and-other-diseases-imported-dogs.
    \140\ Denstedt E. Echinococcus multilocularis as an emerging 
public health threat in Canada: A knowledge synthesis and needs 
assessment. Accessed: February 28, 2019. Available at: www.ncceh.ca/
sites/default/files/Guelph-Denstedt-2017.pdf.
    \141\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk 
factors for death and illness in dogs imported into the United 
States, 2010-2018. Transbound Emerg Dis. 2022 Mar 15. doi: 10.1111/
tbed.14510.
---------------------------------------------------------------------------

    In addition to the unmonetized benefits described above, there may 
be additional unmonetized costs. CDC plans to monitor countries and may 
suspend entry of dogs from countries with repeated instances of 
falsified or fraudulent dog vaccine credentials or invalid rabies 
vaccination documents. The lost value of imports from DMRVV-restricted 
countries would impact some U.S. businesses and dog purchasers. 
However, the duration of any suspensions for these countries is highly 
uncertain and may be ended in the event of improvement of those 
countries' export controls.
    HHS/CDC is proposing the authority to issue orders to revoke a 
carrier's permission to transport live dogs and cats if a carrier has 
endangered the public's health; however, CDC does not have plans to 
suspend any carriers at this time.
    CDC lacks data on the cost to airlines of ensuring that a 
representative of an airline transporting live dogs into the United 
States be on-site at the U.S. port and available to coordinate the 
entry/clearance of the dogs with Federal government officials until all 
live dogs on an arriving flight into the United States have either been 
cleared for entry or arrangements have been made to transport the dogs 
to a CDC-registered Animal Care Facility or other facility (e.g., 
veterinary clinic or kennel) approved by CDC pending admissibility 
determination. CDC believes this will only incur additional costs on 
occasion since airline staff are typically available on-site. However, 
HHS/CDC requests public comment to provide more data to estimate costs 
associated with this proposed requirement.
Impact of the NPRM (if Finalized as Proposed) on Dog Import Volumes
    Although the U.S. Government does not precisely track the total 
number of dogs imported each year, it was previously estimated that 
approximately 1 million dogs are imported into the United States 
annually, of which 100,000 dogs are from DMRVV high-risk 
countries.\142\ This estimate was based on information provided by 
airlines, CBP, and a zoonoses public health study conducted at a U.S.-
Mexico land border crossing.\143\
---------------------------------------------------------------------------

    \142\ HHS/CDC. Guidance Regarding Agency Interpretation of 
``Rabies-Free'' as It Relates to the Importation of Dogs Into the 
United States. 84 FR 724 (Jan. 31, 2019).
    \143\ McQuiston, J.H., et al., Importation of dogs into the 
United States: risks from rabies and other zoonotic diseases. 
Zoonoses Public Health, 2008. 55(8-10): p. 421-6.
---------------------------------------------------------------------------

    CBP does record, by country, the number of dogs imported with 
formal entry under Harmonized Tariff Schedule (HTS) code 0106.19.91.20 
and HTS Description: Other live animals, other, other, dogs. CDC used 
these data from CBP to update its estimates of the annual number of 
imported dogs. The total number of dogs imported into the United States 
from all countries under this HTS category varied from 25,232 in 2018 
to 58,540 in 2020. The number of dogs from DMRVV high-risk countries 
under this HTS category averaged 16,390 and varied from 9,966 to 24,031 
over this three-year period. Over the three-year period, 43,000 dogs on 
average were imported per year, with

[[Page 44009]]

about 38 percent arriving from DMRVV high-risk countries. The number of 
dogs reported under this HTS category does not include dogs imported as 
checked baggage, hand-carried in airplane cabins, or crossing land 
borders without formal entry. Thus, the number underestimates the true 
number of dogs imported into the United States. The fraction of dogs 
with this HTS code arriving from DMRVV high-risk countries (38 percent) 
is much greater than the fraction estimated by CBP field staff (15 
percent) in a previous data collection.\144\ This could result if the 
composition of dogs imported for resale or adoption under the HTS code 
is different than the full distribution of imported dogs. In other 
words, more individuals may travel internationally with their personal 
pets or relocate to the United States from DMRVV-free or DMRVV low-risk 
countries. CDC adjusted for the difference in the fraction of dogs 
imported from DMRVV-free or DMRVV low-risk countries based on estimates 
from CBP field staff of this fraction and then re-estimated the number 
of imported dogs arriving at airports, as summarized in Section A2 of 
the Regulatory Impact Analysis.
---------------------------------------------------------------------------

    \144\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------

    CDC used previously reported estimates of the number of dogs 
arriving at the land ports with Canada and Mexico.\145\ The updated 
estimates for dog imports under the baseline are summarized in Table 7. 
In total, CDC estimated that under the current regulatory baseline, 
about 800,000 imported dogs would arrive in the United States each year 
and that about 500 dogs from DMRVV high-risk countries would be denied 
admission. The number denied entry is based on CDC data from 2020 and 
the first six months of 2021 prior to the suspension of dog imports 
from DMRVV high-risk countries. This approach may overestimate the 
number of dogs denied entry in the future if the COVID-19 pandemic was 
associated with a significant increase in dogs denied admission due to 
pandemic-associated factors. Since dog rabies vaccine certificates are 
not currently required for dogs from DMRVV-free or DMRVV low-risk 
countries, CDC did not assume any dogs from these countries would be 
denied admission under the baseline.
---------------------------------------------------------------------------

    \145\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).

 Table 7--Estimated Annual Numbers of Dogs Imported Into the United States Under the Current Regulatory Baseline
----------------------------------------------------------------------------------------------------------------
                                                                    Most likely
                                                                     estimate       Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                        Baseline estimate of dog imports
----------------------------------------------------------------------------------------------------------------
From DMRVV-free or DMRVV low-risk countries under baseline,              733,787         619,229         848,344
 total..........................................................
    Airports....................................................         371,507         297,205         445,808
    Land ports..................................................         362,280         322,024         402,536
        Canada-U.S. land ports \146\............................         120,780          96,624         144,936
        Mexico-U.S. land ports \147\............................         241,500         225,400         257,600
Dogs temporarily denied admission...............................               0               0               0
From DMRVV high-risk countries..................................          65,560          32,780          98,340
    Dogs approved entry with adequate rabies vaccination                  65,060          32,480          97,590
     documentation..............................................
    Dogs denied admission.......................................             500             300             750
                                                                 -----------------------------------------------
            Total dog imports at baseline.......................         798,847         651,709         945,934
----------------------------------------------------------------------------------------------------------------

    The provisions of the NPRM (if finalized as proposed) that are 
expected to reduce the number of dog imports include: (1) age 
restrictions on air travel for all dogs under six months of age, 
including dogs from both DMRVV high-risk and DMRVV low-risk countries; 
(2) restricting the number of dogs under six months of age allowed to 
enter the United States at land ports to three or fewer; and (3) the 
additional costs of fulfilling the requirements for follow-up and 
revaccination at CDC-registered Animal Care Facilities for foreign-
vaccinated dogs from DMRVV high-risk countries. At the same time, CDC 
believes that the number of dogs denied admission and returned to their 
countries of origin would decrease if the provisions included in the 
NPRM are finalized as proposed.
---------------------------------------------------------------------------

    \146\ Id.
    \147\ Id.
---------------------------------------------------------------------------

    The estimated impact of the NPRM (if finalized as proposed) on the 
number of dog imports is summarized in Table 8. CDC lacks data on what 
fraction of dogs arriving by air are less than six months old under the 
baseline. In the absence of this information, CDC assumes five percent 
(range: three to eight percent) of dogs currently arriving by air are 
less than six months and would not be eligible to be imported into the 
United States under the NPRM (if finalized as proposed). CDC also lacks 
data on the importers who would want to bring in more than three dogs 
less than six months of age within a calendar year, which would no 
longer be allowed with the NPRM (if finalized as proposed). CDC notes 
that these provisions should primarily impact individuals traveling 
with their personal pets because the importation of dogs for resale or 
adoption that are less than six months of age is already prohibited by 
USDA regulations (7 CFR 2148). Another provision of the NPRM (if 
finalized as proposed) would require importers of dogs from DMRVV low-
risk countries to submit written documentation, such as veterinary 
medical records, documenting that the animal has been in a DMRVV low-
risk or DMRVV-free country for the six months prior to importation into 
the United States. CDC does not anticipate denying admission to dogs 
that may arrive from DMRVV low-risk countries without such 
documentation if the NPRM is finalized as proposed, but there may be 
delays at U.S. ports while CDC confirms dogs from DMRVV low-risk 
countries have not been in a DMRVV high-risk country within the 
previous six months.
    CDC assumes that the additional costs associated with importing 
dogs from DMRVV high-risk countries with foreign-issued rabies 
vaccination documentation would reduce the

[[Page 44010]]

number of imports by about 20 percent (range: 10 to 30 percent) if the 
NPRM is finalized as proposed. In addition, CDC believes the number of 
dogs from DMRVV high-risk countries that are denied entry will decrease 
if the provisions of the NPRM are finalized as proposed because CDC 
will be able to require the use of standardized forms to confirm rabies 
vaccination and animal care facility follow-up requirements should be 
clear to importers. Based in part on the number of dogs denied entry 
during CDC's temporary suspension, CDC estimated that about 50 dogs 
from DMRVV high-risk countries would be denied entry under the 
provisions of the NPRM (if finalized as proposed). Overall, the 
provisions in the NPRM (if finalized as proposed) are expected to have 
a small impact on the total number of dogs imported (from about 799,000 
at baseline to 770,000 with the provisions of the NPRM in effect and 
finalized as proposed).
---------------------------------------------------------------------------

    \148\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United 
States. 84 FR 724 (Jan. 31, 2019).
    \149\ Id.

   Table 8--Estimated Average Annual Numbers of Dog Imports by DMRVV Risk Category and by Immunization Status
----------------------------------------------------------------------------------------------------------------
                                                                                   Lower  bound    Upper  bound
                                                                  Best  estimate        \b\             \c\
----------------------------------------------------------------------------------------------------------------
                                        Baseline estimate of dog imports
                From rabies-free, DMRVV-free, or DMRVV low-risk countries under previous guidance
----------------------------------------------------------------------------------------------------------------
Total...........................................................         733,787         619,229         848,344
  Airports......................................................         371,507         297,205         445,808
  Land ports....................................................         362,280         322,024         402,536
      Canada-U.S. land ports \148\..............................         120,780          96,624         144,936
      Mexico-U.S. land ports \149\..............................         241,500         225,400         257,600
  Dogs denied entry from rabies-free, DMRVV-free, or low-risk...               0               0               0
----------------------------------------------------------------------------------------------------------------
                                    Dogs from countries at high risk of DMRVV
----------------------------------------------------------------------------------------------------------------
Total...........................................................          65,560          32,780          98,340
  Dogs approved entry with rabies vaccination documentation.....          65,060          32,480          97,590
      Estimated fraction of imported dogs from DMRVV high-risk               50%             65%             35%
       countries that are U.S.-vaccinated.......................
      Estimated U.S.-vaccinated dogs............................          32,530          21,112          34,157
      Estimated foreign-vaccinated dogs.........................          32,530          11,368          63,434
  Dogs denied entry \a\.........................................             500             300             750
Total imported dogs \a\.........................................         798,847         651,709         945,934
----------------------------------------------------------------------------------------------------------------
                                      With NPRM (if finalized as proposed)
                               From rabies-free, DMRVV-free, or low-risk countries
----------------------------------------------------------------------------------------------------------------
Fraction of dogs who are unable to be imported with NPRM (if                  5%              3%              8%
 finalized as proposed) at airports (due to age restrictions)...
  Airports......................................................         352,931         288,289         410,143
      Dogs approved entry.......................................         352,578         288,145         409,528
      Dogs temporarily denied entry.............................             353             144             615
Fraction of dogs unable to be imported with NPRM (if finalized              1.0%            0.5%            1.5%
 as proposed) at land ports (due to age restrictions)...........
  Land ports....................................................         358,657         320,414         396,498
      Canada-U.S. land ports....................................         119,572          96,141         142,762
          Dogs approved entry...................................         119,453          96,093         142,548
          Dogs temporarily denied entry.........................             120              48             214
      Mexico-U.S. land ports....................................         239,085         224,273         253,736
          Dogs approved entry...................................         238,846         224,161         253,355
          Dogs temporarily denied entry.........................             239             112             381
  Dogs temporarily denied entry from rabies-free, DMRVV-free, or             712             304           1,210
   low-risk (total).............................................
----------------------------------------------------------------------------------------------------------------
                                    Dogs from countries at high risk of DMRVV
----------------------------------------------------------------------------------------------------------------
Fraction of dog imports that would not occur under the                       20%             30%             10%
 provisions of the NPRM (if finalized as proposed) due to the
 higher costs associated with importing foreign-vaccinated dogs
 from DMRVV high-risk countries.................................
Total...........................................................          58,554          29,070          91,247
  Number of U.S.-vaccinated dogs approved entry.................          32,530          21,112          34,157
  Number of foreign-vaccinated dogs approved entry..............          25,974           7,928          57,090
Total dogs approved entry.......................................          58,504          29,040          91,172
  Dogs denied entry and returned to country-of-origin \a\.......              50              30              75
Total imported dogs (with NPRM, if finalized as proposed) \a\...         770,093         637,743         897,813
Total imported dogs (Baseline) \a\..............................         798,847         651,709         945,934
----------------------------------------------------------------------------------------------------------------
\a\ Since these dogs are denied entry and returned to their countries of origin, they are not included in the
  total number of imports.


[[Page 44011]]

    CDC did not attempt to project future changes to the volume of dogs 
imported annually because of insufficient data. CDC believed that 
introducing another factor to project future volumes was not prudent. 
HHS/CDC requests public comment from airlines on whether the number of 
imported dogs has increased, decreased, or remained relatively constant 
in recent years. Such data may be available to airlines if they track 
the number of dogs transported each year. While CDC observed an 
increase in the number of dogs arriving with fraudulent paperwork prior 
to implementing the temporary suspension, this may not correspond to 
changes in the total number of dogs imported, of which only a small 
fraction arrive with fraudulent paperwork.
    The most likely estimates of the annual monetized costs and 
benefits for each interested party or implementing partner are 
summarized in Table 9 over a 10-year period from 2023 through 2032 
using the estimated values presented in Sections B1 through B8 of the 
Appendix found in the Supplemental Materials tab of the docket. The 
most likely estimate of monetized costs across interested parties is 
$39 million in the first year and $27 million in subsequent years. The 
most likely estimate of monetized benefits across interested parties 
was estimated to be $1.9 million each year.
    The annual costs and benefits for importers are split into 
importers of dogs from DMRVV-free or DMRVV low-risk countries versus 
importers of dogs from DMRVV high-risk countries. However, it is likely 
that some importers of dogs from DMRVV high-risk countries may also be 
importers of dogs from DMRVV-free or low-risk countries. In addition, 
the provisions of the NPRM (if finalized as proposed) may result in 
some importers switching from importing dogs from DMRVV high-risk 
countries to those from DMRVV-free or low-risk countries.
    As a percentage of total costs, importers were estimated to incur 
79 to 85 percent of the total costs (most likely estimates), with a 
higher fraction of total costs incurred in the subsequent years after 
the first year of implementation. Importer costs are approximately 3.8 
times greater for dogs imported from DMRVV high-risk countries compared 
to dogs from DMRVV-free or low-risk countries. In addition, it is 
important to note that more than 10 times as many dogs are estimated to 
be imported from DMRVV-free or low-risk countries. Thus, the cost per 
dog for importers of dogs from DMRVV high-risk countries is 
significantly greater than for importers of dogs from DMRVV-free or 
low-risk countries. This is especially true for foreign-vaccinated dogs 
from DMRVV high-risk countries.
    The costs to airlines are expected to comprise 8.0 to 8.8 percent 
of total costs. Among Federal government agency costs for the 
provisions included in the NPRM (if finalized as proposed), CBP's 
additional costs (0.5 to 2.8 percent of the total) are expected to be 
less than CDC's additional costs (6.2 to 10.4 percent of the total).

 Table 9--Most Likely Estimates of Annual Monetized Costs and Benefits by Affected Party or Implementing Partner From 2023-2032 Relative to Baseline in
                                                                        2020 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Importers    Importers of                                            State/local
                                                           of dogs       dogs from                 Customs and  Centers for   public health
                          Year                            from DMRVV   DMRVV-free or    Airlines      Border      Disease      and animal       Total
                                                          high-risk      low-risk                   Protection  Control and      health
                                                          countries      countries                               Prevention    departments
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual monetized costs (million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023...................................................        $24.6            $6.5         $3.2         $1.1         $4.1              $0          $39
2024...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2025...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2026...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2027...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2028...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2029...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2030...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2031...................................................         18.1             4.8          2.4        0.004          1.7               0           27
2032...................................................         18.1             4.8          2.4        0.004          1.7               0           27
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Annual monetized benefits (million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2024...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2025...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2026...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2027...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2028...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2029...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2030...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2031...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
2032...................................................         0.81           0.088         0.18         0.65         0.22          0.0049          1.9
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The greatest fractions of the most likely estimates of the 
monetized benefits associated with the provisions in the NPRM (if 
finalized as proposed) would accrue to importers of dogs from DMRVV 
high-risk countries (41 percent) and to CBP (33 percent). For both 
groups, the costs of screening dogs at U.S. ports would be reduced 
since documentation of rabies vaccination would be standardized. This 
would result in cost savings for both groups at U.S. ports, although 
costs for importers to obtain the standardized forms would increase (as 
documented in the cost estimates). Additional benefits are estimated to 
accrue to importers of dogs from DMRVV high-risk countries, airlines, 
CBP, and CDC from a reduction in the number of dogs denied entry and 
returned to their countries of origin.

[[Page 44012]]

    The estimates included in this economic impact analysis are highly 
uncertain. HHS/CDC requests comments on several parameter estimates and 
assumptions in the Appendix found in the Supplemental Materials tab of 
the docket. Specifically, HHS/CDC is requesting comment from the public 
on the topics listed below:
     Procedures applicable at U.S. land and seaports and 
whether and how procedures for U.S. land or seaports should differ from 
procedures for U.S. airports.
     The numbers of dogs imported each year and the numbers of 
dogs imported from DMRVV high-risk countries. Such data may be 
available from airline operating data for air imports. Public comment 
about dogs imported at land or seaports could help to improve 
estimates.
     The impact of the requirements of this NPRM (if finalized 
as proposed) to reduce the number of dogs imported from DMRVV high-risk 
countries.
     The fraction of imported dogs arriving on air conveyances 
that are less than six months of age.
     The number of importers that bring in more than three dogs 
at land or seaports that are less than six months of age during a 
calendar year.
     Data showing whether the number of imported dogs has 
increased, decreased, or remained relatively constant in recent years. 
Such data may be available to airlines if they track the number of dogs 
transported each year.
     The number of dogs imported at one time or as part of one 
shipment on average and if the requirements of this NPRM (if finalized 
as proposed) would impact how dogs are imported (e.g., would importers 
wait to import a larger group of dogs in a single shipment).
     The number of times individuals who travel internationally 
with their dogs enter the United States each year.
     How this proposed rulemaking would impact the ability of 
individuals with foreign-vaccinated service dogs to enter the United 
States.
     How frequently importers of dogs for adoption or resale 
import dogs (i.e., among businesses that import dogs for commercial 
purposes, how many shipments are received each year on average). This 
information would be used to improve CDC's estimate of the number of 
repeat importers.
     Costs to owners of young dogs who would have to forego 
international travel with their pets.
     The additional travel costs and travel time associated 
with re-routing travel through an airport with a CDC quarantine station 
or an airport with a CDC-registered Animal Care Facility.
     The average cost to return a dog to the country of 
departure after denial of entry and the cost to importers whose dogs 
have been denied entry.
     The appropriate range of estimates from airlines for the 
profit margin per dog imported on international flights.
     The cost to airlines if they were prevented from 
transporting dogs on flights in the future.
     The cost to CDC-registered Animal Care Facilities to 
comply with proposed CDC requirements for these facilities.

B. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, as amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA), agencies are 
required to analyze regulatory options to minimize the significant 
economic impact of a rule on small businesses, small governmental 
units, and small not-for-profit organizations. CDC examined the 
potential impact of the provisions of this NPRM (if finalized as 
proposed) on small entities, including small businesses that may import 
dogs for commercial purposes as well as airlines that transport dogs 
internationally. HHS/CDC lacks key data on the number of dogs imported 
and requests public comment from airlines and small businesses on the 
number of dogs imported and the impact of the provisions of the NPRM 
(if finalized as proposed) on their standard practices. In the absence 
of data on the number of dogs imported, CDC made several assumptions to 
estimate revenues from small businesses for different categories of 
businesses that may import dogs and used these revenue estimates to 
calculate how many dogs could be imported such that the costs 
associated with the provisions of this NPRM (if finalized as proposed) 
would be less than two percent of estimated revenues.
    Based on these analyses, CDC believes that the only small entities 
for which this NPRM (if finalized as proposed) would have significant 
impacts would be those that specialize in importing dogs from DMRVV 
high-risk countries. The provisions of this NPRM (if finalized as 
proposed) would not have a significant economic impact on small 
airlines and probably would not have a significant impact on small 
entities that import dogs from DMRVV-free or DMRVV low-risk countries. 
CDC notes that the importation of dogs less than six months of age for 
resale or adoption in the United States is already prohibited by USDA 
regulations (7 CFR 2148). Thus, the minimum age requirements in this 
proposed NPRM (if finalized as proposed) should not impact entities 
that sell or resell imported dogs but may impact entities that import 
young dogs for commercial purposes other than resale. The NPRM (if 
finalized as proposed) does not include provisions that would reduce 
costs for small entities relative to other categories of importers.
    As part of the economic impact analysis, CDC calculated the 
marginal cost associated with the proposed provisions in the NPRM per 
dog imported from DMRVV-free or DMRVV low-risk countries ($9.10, range: 
$2.60 to $25 per imported dog). The marginal cost associated with the 
proposed provisions in the NPRM per dog imported from DMRVV high-risk 
countries was further subdivided between foreign-vaccinated dogs 
(vaccinated outside the United States) ($810, range: $550 to $1,180) 
compared to U.S.-vaccinated dogs ($110, range: $44 to $510). These 
estimates cover the first year of implementation after a final rule is 
published, assuming the NPRM requirements are finalized as proposed. 
Marginal costs in the second year and later are estimated to be about 
25 percent less per dog compared to the first year of implementation.
    The estimates summarized below are subject to a great degree of 
uncertainty. CDC does not know how many dogs any small individual 
entity currently imports or the average number of imported dogs across 
entities. However, based on the relative estimates of annual revenues 
by type of entity and subdivided by the number of employees, CDC 
calculated how many dogs each entity could import before this NPRM (if 
finalized as proposed) would have a significant economic impact on 
their businesses. HHS/CDC welcomes public comments to improve and 
refine these estimates.
Small Entities That Import Dogs for Commercial Purposes
    The estimated revenues of small businesses likely to import and 
resell dogs are summarized in Table 10. Since there are no specific 
codes in the North American Industry Classification System (NAICS) 
specific to dog importers, CDC used the codes 115210, 423820, 424990, 
485991, 812910, and 813312 to estimate the revenue of the small 
businesses that may import and resell dogs. The businesses affected by 
the NPRM (if finalized as proposed) would be a fraction of the firms 
summarized in Table 10, as CDC does not know how many dog importers are 
in these categories. Small business status was determined based on 
either firms' revenue or the numbers of employees, according to the 
Small Business Association's (SBA) table of

[[Page 44013]]

small business size standards.\150\ The revenue of firms in each 
business category subdivided by the number of employees was not 
available. Using annual payroll data from the Statistics of U.S. 
Businesses (SUSB),\151\ CDC estimated the revenue based on the 
assumption that each firm's payroll expense would be approximately 15 
to 30 percent.\152\
---------------------------------------------------------------------------

    \150\ SBA, Table of small business size standards. Effective 
August 19, 2019. https://www.sba.gov/document/support-table-size-standards.
    \151\ 2019 SUSB Annual Data Tables by Establishment Industry. 
https://www.census.gov/data/tables/2019/econ/susb/2019-susb-annual.html.
    \152\ How to figure the gross percent of payroll. https://smallbusiness.chron.com/figure-gross-percent-payroll-66395.html.

                         Table 10--Estimated Revenue of Small Businesses That May Import Dogs for Commercial Purposes, 2020 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Annual     Revenue per firm  (thousand USD) \a\
                                                                                                      payroll per --------------------------------------
               NAICS code                            Description             Number of      Firms         firm     Lower bound  Upper bound  Most likely
                                                                             employees                 (thousand    (payroll/    (payroll/     estimate
                                                                                                          USD)         30%)         15%)      (midpoint)
--------------------------------------------------------------------------------------------------------------------------------------------------------
115210..................................  Support Activities for Animal              <5        3,633          $48         $161         $321         $241
                                           Production.                              5-9          585          181          605        1,210          907
                                                                                  10-19          238          406        1,355        2,709        2,032
                                                                                  20-99          118        1,259        4,197        8,394        6,296
423820..................................  Farm and Garden Machinery and              <5        1,808           90          300          599          450
                                           Equipment Merchant Wholesalers.          5-9          958          308        1,026        2,053        1,539
                                                                                  10-19          835          693        2,309        4,619        3,464
                                                                                  20-99          820        2,094        6,980       13,960       10,470
424990..................................  Other Miscellaneous Nondurable             <5        7,068           75          249          499          374
                                           Goods Merchant Wholesalers.              5-9        1,493          299          996        1,992        1,494
                                                                                  10-19          791          657        2,191        4,383        3,287
                                                                                  20-99          670        1,755        5,850       11,700        8,775
485991..................................  Special Needs Transportation....           <5        1,553           55          184          368          276
                                                                                    5-9          554          148          493          986          740
                                                                                  10-19          500          338        1,127        2,254        1,691
                                                                                  20-99          611        1,050        3,500        6,999        5,249
812910..................................  Pet Care (except Veterinary)               <5       12,257           43          142          283          213
                                           Services.                                5-9        4,026          140          466          931          698
                                                                                  10-19        2,580          280          932        1,863        1,398
                                                                                  20-99        1,213          663        2,210        4,421        3,316
813312..................................  Environment, Conservation and              <5        3,575           75          249          498          373
                                           Wildlife Organizations.                  5-9        1,262          263          875        1,751        1,313
                                                                                  10-19          922          516        1,720        3,441        2,580
                                                                                  20-99          745        1,551        5,169       10,338        7,754
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Revenue was estimated from the annual payroll reported in the 2019 SUSB Annual Data Tables by Establishment Industry (https://www.census.gov/data/tables/2019/econ/susb/2019-susb-annual.html). Estimated were updated to 2020 USD using the Consumer Price Index for All Urban Consumers (CPI-U).

    CDC assumes that the costs associated with the proposed provisions 
of the NPRM (if finalized as proposed) would be significant if the 
additional costs would exceed two percent of the estimated revenue 
shown in Table 10 by category. Unless a small entity only specialized 
in importing dogs for resale or adoption, the costs associated with dog 
importation would only constitute a portion of each firm's operational 
costs. Other operational costs by an entity should be unaffected by the 
proposed provisions included in this NPRM (if finalized as proposed). 
CDC is unaware of the proportion of dog import costs relative to all 
the other activities for each type of entity. Thus, CDC was not able to 
directly estimate the impact of the NPRM (if finalized as proposed) as 
a fraction of total revenue. Instead, CDC calculated a threshold for 
each category representing the number of imported dogs at which the 
cost of the provisions in the NPRM to importers (if finalized as 
proposed) would begin to exceed two percent of the revenue of firms in 
each category. To calculate the number of dogs at which point the costs 
associated with the NPRM (if finalized as proposed) would be likely to 
exceed two percent of revenue for each category of the firm, the 
category-specific revenue per firm in Table 10 (most likely estimate, 
lower bound, and upper bound) were multiplied by 2 percent and then 
divided by the marginal cost per foreign-vaccinated dog from high-risk 
countries ($810, range: $550 to $1,180). This was repeated for U.S.-
vaccinated dogs from DMRVV high-risk countries ($110, range: $44 to 
$510) and dogs from DMRVV-free or DMRVV low-risk countries ($9.10, 
range: $2.60 to $25). The estimated thresholds for the number of 
imported dogs per firm for each small business category are summarized 
in Tables 11a and 11b. For example, if a Wildlife Organization (NAICS 
code 813312) with fewer than five employees import more than ten 
foreign-vaccinated dogs (most likely NPRM cost estimate and midpoint 
revenue estimate) from high-risk countries, the costs associated with 
the NPRM (if finalized as proposed) would be expected to exceed two 
percent of revenue. For U.S.-vaccinated dogs, the threshold would 
increase from about ten dog imports to 68 dog imports using the most 
likely cost estimate and midpoint revenue estimate. This NAICS category 
may include dog rescue organizations that are likely to work with dogs 
imported from DMRVV high-risk countries, most or all of which would be 
foreign-vaccinated. Because the marginal cost estimate per dog imported 
from DMRVV-free or DMRVV low-risk countries (assuming the NPRM is 
finalized as proposed) is much less than per dog imported from DMRVV 
high-risk countries, the threshold numbers of dogs that may be imported 
from DMRVV-free or DMRVV low-risk countries are much greater than for 
DMRVV high-risk countries. The values shown in Tables 11a and 11b are 
estimated by assuming that all dogs imported by each firm are either 
from DMRVV-free or DMRVV low-risk

[[Page 44014]]

countries or, alternatively, from DMRVV high-risk countries. Some firms 
may import dogs from both types of countries, in which case, the 
threshold values would be in between the two sets of estimates. The 
difference in costs may also cause some entities to shift from 
importing dogs from DMRVV high-risk countries to dogs imported from 
DMRVV-free or DMRVV low-risk countries if the NPRM is finalized as 
proposed. In this case, for a business with NAICS code of 813312, the 
estimated threshold number of dogs would increase from ten imported 
foreign-vaccinated dogs from DMRVV high-risk countries to 823 dogs 
imported from DMRVV-free or DMRVV low-risk countries (both thresholds 
calculated using most likely NPRM cost estimate and midpoint revenue 
estimate). HHS/CDC welcomes public comments from the dog importation 
industry to improve these threshold estimates.

  Table 11a--Estimated Threshold for the Number of Imported Dogs From DMRVV High-Risk Countries Per Firm at Which NPRM Costs (if Finalized as Proposed)
                        Would Exceed Two Percent of Revenue During the First Year of Implementation of the Proposed Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Foreign-vaccinated dogs from high-risk       U.S.-vaccinated dogs from high-risk countries
                                                                             countries                   -----------------------------------------------
               NAICS code                    Number of   ------------------------------------------------
                                             employees      Most likely                                     Most likely     Lower bound     Upper bound
                                                             estimate       Lower bound     Upper bound      estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (USD, if finalized as                    $810            $553          $1,178            $110             $44            $507
 proposed)..............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Number of imported dogs per year at which NPRM cost 2 percent of revenue
--------------------------------------------------------------------------------------------------------------------------------------------------------
115210, Support Activities for Animal                 <5               6               6               6              44              72              13
 Production.............................             5-9              23              22              21             164             271              48
                                                   10-19              51              49              46             366             606             106
                                                   20-99             156             152             143           1,132           1,876             328
423820, Farm and Garden Machinery and                 <5              12              11              11              81             134              24
 Equipment Merchant Wholesalers.........             5-9              38              37              35             277             459              81
                                                   10-19              86              84              79             623           1,032             181
                                                   20-99             259             252             237           1,882           3,119             545
424990, Other Miscellaneous Nondurable                <5              10               9               9              68             112              20
 Goods Merchant Wholesalers.............             5-9              37              36              34             269             445              78
                                                   10-19              82              79              75             591             979             172
                                                   20-99             217             211             199           1,577           2,614             457
485991, Special Needs Transportation....              <5               7               7               7              50              83              15
                                                     5-9              19              18              17             133             221              39
                                                   10-19              42              41              39             304             504              88
                                                   20-99             130             127             119             944           1,564             274
812910, Pet Care (except Veterinary)                  <5               6               6               5              39              64              12
 Services...............................             5-9              18              17              16             126             208              37
                                                   10-19              35              34              32             252             417              73
                                                   20-99              82              80              75             596             988             173
813312, Environment, Conservation and                 <5              10               9               9              68             112              20
 Wildlife Organizations.................             5-9              33              32              30             236             392              69
                                                   10-19              64              62              59             464             769             135
                                                   20-99             192             187             176           1,394           2,310             404
--------------------------------------------------------------------------------------------------------------------------------------------------------


 Table 11b--Estimated Threshold for the Number of Imported Dogs from DMRVV-Free or DMRVV Low-Risk Countries per
Firm at Which NPRM Costs (if Finalized as Proposed) Would Exceed Two Percent of Revenue During the First Year of
                                   Implementation of the Proposed Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                   Foreign-vaccinated dogs from
                                                                                        high-risk countries
                             NAICS code                               Number of  -------------------------------
                                                                      employees    Most likely   Lower    Upper
                                                                                    estimate     bound    bound
----------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (if finalized as proposed, USD)......................         $9.10    $2.60      $25
----------------------------------------------------------------------------------------------------------------
             Number of imported dogs per year at which NPRM cost  two percent of revenue
----------------------------------------------------------------------------------------------------------------
115210, Support Activities for Animal Production...................           <5           531    1,257      258
                                                                             5-9         1,999    4,736      973
                                                                           10-19         4,476   10,605    2,177
                                                                           20-99        13,867   32,856    6,744
423820, Farm and Garden Machinery and Equipment Merchant                      <5           991    2,347      482
 Wholesalers.......................................................          5-9         3,391    8,034    1,649
                                                                           10-19         7,630   18,079    3,711
                                                                           20-99        23,061   54,641   11,215
424990, Other Miscellaneous Nondurable Goods Merchant Wholesalers..           <5           824    1,953      401
                                                                             5-9         3,291    7,797    1,601
                                                                           10-19         7,240   17,155    3,522
                                                                           20-99        19,327   45,794    9,400

[[Page 44015]]

 
485991, Special Needs Transportation...............................           <5           608    1,441      296
                                                                             5-9         1,630    3,860      793
                                                                           10-19         3,725    8,825    1,812
                                                                           20-99        11,562   27,396    5,623
812910, Pet Care (except Veterinary) Services......................           <5           469    1,110      228
                                                                             5-9         1,539    3,645      749
                                                                           10-19         3,079    7,294    1,497
                                                                           20-99         7,303   17,305    3,552
813312, Environment, Conservation and Wildlife Organizations.......           <5           823    1,949      401
                                                                             5-9         2,893    6,853    1,407
                                                                           10-19         5,684   13,468    2,765
                                                                           20-99        17,078   40,466    8,306
----------------------------------------------------------------------------------------------------------------

    The marginal cost per dog imported (if the NPRM is finalized as 
proposed) relative to the reported commercial values of imported dogs 
were estimated using data from CBP for dogs imported under Harmonized 
Tariff Schedule code 0106.19.91.20, Other live animals, other, other, 
dogs is shown in Table 12. The estimated ratio of the marginal cost of 
NPRM requirements (if finalized as proposed) relative to the reported 
value of the commercially imported dogs from DMRVV-free or DMRVV low-
risk countries is 1.2 percent (range: 0.33 percent to 3.2 percent). 
Based on this ratio, the expected marginal increase in cost per dog 
imported should not change much for dogs imported from DMRVV-free or 
low-risk countries.
    However, for the foreign-vaccinated dogs imported from DMRVV high-
risk countries, the estimated ratio is 227 percent (range: 155 percent 
to 330 percent). This ratio is much larger both because the marginal 
cost per dog imported (assuming the NPRM is finalized as proposed) is 
much greater and because the reported commercial value of dogs imported 
from DMRVV high-risk countries is lower compared to dogs imported from 
DMRVV-free or low-risk countries. Since CBP's commercial values of 
imported dogs only provide a comparison of the estimated marginal cost 
of the NPRM (if finalized as proposed) to reported commercial value, 
these ratios cannot be directly compared to the revenue estimates by 
firm since the costs associated with dog imports would only be a 
portion of each firm's operational cost. However, it does provide an 
estimate of the potential increase in cost per dog imported from either 
DMRVV-free or low countries or from DMRVV high-risk countries if the 
NPRM is finalized as proposed. For this analysis, CDC assumes that most 
of the dogs imported from DMRVV high-risk countries for commercial 
purposes would have been vaccinated outside the United States.

Table 12--Estimated Impact of the NPRM (if Finalized as Proposed) on the
          Cost per Dog Imported for Commercially Imported Dogs
                               [2020 USD]
------------------------------------------------------------------------
                                 Most likely
                                  estimate     Lower bound   Upper bound
------------------------------------------------------------------------
             Importers from DMRVV-free or low-risk countries
------------------------------------------------------------------------
Baseline: \a\
  --Total dogs imported (A)...        57,860  ............  ............
  --Average commercial value            $777  ............  ............
   per dog (B)................
  --Total commercial value (C)   $44,957,220  ............  ............
   = (A) x (B)................
With NPRM (if finalized as
 proposed):
  --Estimated marginal NPRM            $9.08         $2.55        $24.89
   cost per dog imported (if
   finalized as proposed) (D).
  --Total marginal NPRM costs       $525,369      $147,543    $1,440,135
   for dogs imported for
   commercial purposes (if
   finalized as proposed) (E)
   = (D) x (A)................
Estimated ratio of marginal            1.17%         0.33%         3.20%
 NPRM costs to commercial
 value of imported dogs (E)/
 (C)..........................
------------------------------------------------------------------------
      Importers from high-risk countries of foreign-vaccinated dogs
------------------------------------------------------------------------
Baseline: \a\
  --Total dogs imported (F)...        43,382  ............  ............
  --Average commercial value            $357  ............  ............
   per dog (G)................
  --Total commercial value (H)   $15,487,374  ............  ............
   = (F) x (G)................
With NPRM (if finalized as
 proposed):
  --Estimated marginal NPRM             $810          $553        $1,178
   costs per dog imported (if
   finalized as proposed) (I).
  --Total marginal NPRM costs    $35,139,420   $23,990,246   $51,103,996
   for dogs imported for
   commercial purposes (if
   finalized as proposed) (J)
   = (I) x (F)................

[[Page 44016]]

 
Estimated ratio of marginal             227%          155%          330%
 NPRM costs to commercial
 value of imported dogs (J)/
 (H)..........................
------------------------------------------------------------------------
\a\ Baseline values were based on the data received from CBP, not
  publicly available (HTS code 0106.19.91.20).

U.S. Airlines
    The provisions of this NPRM (if finalized as proposed) would affect 
U.S. airlines conducting international flight operations arriving in 
the United States. Of the 60 U.S. airlines with international flights 
in 2020, 35 airlines can be identified as small business entities. This 
is based on the size standard of ``fewer than 1,500 employees'' from 
the SBA for small businesses within NAICS Code 481111, Scheduled 
Passenger Air Transportation, and those within NAICS Code 481211, 
Nonscheduled Chartered Passenger Air Transportation in 2019.\153\ For 
the analysis, airline employee counts were estimated from the U.S. 
Department of Transportation's Bureau of Transportation 
Statistics.\154\ Monthly average numbers of employees in 2019, 
including part- and full-time employment, were used for U.S. airlines.
---------------------------------------------------------------------------

    \153\ Small Business Association (SBA), Table of small business 
size standards. Effective August 19, 2019. https://www.sba.gov/document/support-table-size-standards. Accessed: February 21, 2022.
    \154\ Bureau of Transportation Statistics. Air Carrier Financial 
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1(a) Employees. Bureau of Transportation Statistics. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GEF&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny Accessed: February 21, 2022.
---------------------------------------------------------------------------

    The annual revenue per U.S. airline was estimated based on the 2019 
revenue of each airline.\155\ Lower-bound and upper-bound estimates 
were calculated by multiplying by 75 and 125 percent (Table 13). Among 
the selected 35 airlines, seven had zero U.S. international arrivals in 
2019.\156\
---------------------------------------------------------------------------

    \155\ Bureau of Transportation Statistics. Air Carrier Financial 
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1.1, and P-1.2 Operating revenues. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMD&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny; and https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMI&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny. Accessed: February 21, 2022.
    \156\ Air Carriers: T-100 International Market (U.S. Carriers 
Only) https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GDJ&QO_fu146_anzr=Nv4percent20Pn44vr45. 
Accessed: February 21, 2022.

                       Table 13--Estimated Annual Revenue of Small Business U.S. Airlines
----------------------------------------------------------------------------------------------------------------
                                                           Total revenue  (million USD)
                                                 ------------------------------------------------    2019 U.S.
                     Airline                        Most likely                                      arrivals
                                                     estimate       Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
1...............................................            $290            $218            $363             317
2...............................................              78              58              97             279
3...............................................             112              84             140             169
4...............................................             241             181             301             136
5...............................................              38              28              47             116
6...............................................              44              33              55             114
7...............................................             230             173             288             113
8...............................................             541             406             677             111
9...............................................             218             164             273              96
10..............................................             115              87             144              86
11..............................................             558             419             698              80
12..............................................           1,296             972           1,620              75
13..............................................              42              31              52              73
14..............................................              52              39              66              57
15..............................................             169             127             212              57
16..............................................              37              28              46              55
17..............................................             104              78             130              49
18..............................................             147             110             183              46
19..............................................             265             199             331              45
20..............................................               7               6               9              41
21..............................................              40              30              50              40
22..............................................               2               1               2              31
23..............................................             105              79             131              18
24..............................................              59              44              74              13
25..............................................              20              15              25              12
26..............................................              19              14              23               6
27..............................................               9               7              12               2
28..............................................             313             235             391               1
29..............................................              12               9              14               0
30..............................................             115              86             143               0
31..............................................             117              88             146               0
32..............................................              13              10              16               0
33..............................................              10               7              12               0
34..............................................              21              16              27               0

[[Page 44017]]

 
35..............................................              19              14              23               0
----------------------------------------------------------------------------------------------------------------

    The threshold numbers of dogs that may be transported by each 
airline such that the costs associated with the provisions of this NPRM 
(if finalized as proposed) to airlines would be less than two percent 
of annual revenue were estimated using the same methodology as for the 
dog importers above. However, the annualized marginal cost per dog 
transported by airlines was only estimated to be about $6.00 per dog 
(range: $3.20 to $10.30 per dog) if the requirements in the NPRM are 
finalized as proposed. This was calculated based on the annualized 
costs to airlines divided by the number of dogs transported. However, 
costs were estimated to be higher in the first year of implementation 
and some airlines may be disproportionately affected if their customers 
are proportionally more likely to reduce the number of dogs transported 
to the United States. The estimated number of dogs was calculated by 
multiplying the revenue per airline in Table 13 by 2 percent and then 
dividing by the marginal airline cost per dog imported if the NPRM is 
finalized as proposed. As shown in Table 14, the estimated numbers of 
dogs that each airline could transport were significantly greater than 
the number of international passengers reported in 2019 and, in most 
cases, greater than the total estimated number of dogs estimated to be 
imported into the United States each year. CDC did not separately 
estimate marginal costs to airlines for dogs imported from DMRVV-free 
or DMRVV low-risk countries versus dogs imported from DMRVV high-risk 
countries. The estimated marginal cost per dog may be higher for 
airlines to transport dogs imported from DMRVV high-risk countries 
because dogs from these countries are more likely to be denied entry 
and abandoned by importers. Thus, marginal costs may be slightly higher 
for airlines that specialize in travel to DMRVV high-risk countries. 
However, the general finding still holds that the provisions of this 
NPRM (if finalized as proposed) should not have a significant impact on 
airlines.

 Table 14--Estimated Threshold of the Annual Number of Imported Dogs per Airline at Which the Marginal Costs of
                 the NPRM (if Finalized as Proposed) Begin To Exceed 2 Percent of Annual Revenue
----------------------------------------------------------------------------------------------------------------
                                                              Most likely                             2019 U.S.
                           Airline                              estimate   Lower bound  Upper bound    arrivals
----------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (if finalized as proposed).......        $6.00        $3.20       $10.30  ...........
----------------------------------------------------------------------------------------------------------------
           Annual number of transported dogs at which NPRM cost 2 percent of annual revenue
----------------------------------------------------------------------------------------------------------------
1...........................................................   48,333,333   68,125,000   35,242,718          317
2...........................................................   13,000,000   18,125,000    9,417,476          279
3...........................................................   18,666,667   26,250,000   13,592,233          169
4...........................................................   40,166,667   56,562,500   29,223,301          136
5...........................................................    6,333,333    8,750,000    4,563,107          116
6...........................................................    7,333,333   10,312,500    5,339,806          114
7...........................................................   38,333,333   54,062,500   27,961,165          113
8...........................................................   90,166,667  126,875,000   65,728,155          111
9...........................................................   36,333,333   51,250,000   26,504,854           96
10..........................................................   19,166,667   27,187,500   13,980,583           86
11..........................................................   93,000,000  130,937,500   67,766,990           80
12..........................................................  216,000,000  303,750,000  157,281,553           75
13..........................................................    7,000,000    9,687,500    5,048,544           73
14..........................................................    8,666,667   12,187,500    6,407,767           57
15..........................................................   28,166,667   39,687,500   20,582,524           57
16..........................................................    6,166,667    8,750,000    4,466,019           55
17..........................................................   17,333,333   24,375,000   12,621,359           49
18..........................................................   24,500,000   34,375,000   17,766,990           46
19..........................................................   44,166,667   62,187,500   32,135,922           45
20..........................................................    1,166,667    1,875,000      873,786           41
21..........................................................    6,666,667    9,375,000    4,854,369           40
22..........................................................      333,333      312,500      194,175           31
23..........................................................   17,500,000   24,687,500   12,718,447           18
24..........................................................    9,833,333   13,750,000    7,184,466           13
25..........................................................    3,333,333    4,687,500    2,427,184           12
26..........................................................    3,166,667    4,375,000    2,233,010            6
27..........................................................    1,500,000    2,187,500    1,165,049            2
28..........................................................   52,166,667   73,437,500   37,961,165            1
29..........................................................    2,000,000    2,812,500    1,359,223            0
30..........................................................   19,166,667   26,875,000   13,883,495            0
31..........................................................   19,500,000   27,500,000   14,174,757            0
32..........................................................    2,166,667    3,125,000    1,553,398            0
33..........................................................    1,666,667    2,187,500    1,165,049            0

[[Page 44018]]

 
34..........................................................    3,500,000    5,000,000    2,621,359            0
35..........................................................    3,166,667    4,375,000    2,233,010            0
----------------------------------------------------------------------------------------------------------------

C. Paperwork Reduction Act of 1995

    HHS/CDC has determined that this NPRM includes proposed information 
collections and recordkeeping requirements that are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). A description of 
these proposed provisions is given below, with an estimate of the 
annual reporting and recordkeeping burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information. Comments are invited on the following 
subjects:
     Whether the proposed collection of information is 
necessary for the proper performance of the functions of CDC, including 
whether the information will have practical utility.
     The accuracy of CDC's estimate of the burden of the 
collection of information.
     Ways to enhance the quality, utility, and clarity of the 
information to be collected.
     Ways to minimize the burden of the collection of 
information on respondents, including by using information technology.
    Under the PRA, Federal agencies must obtain approval from OMB for 
each collection of information they conduct or sponsor. In addition, 
the PRA also requires Federal agencies to provide a 60-day notice in 
the Federal Register concerning each proposed collection of 
information, including each new proposed collection, each proposed 
extension of an existing collection of information, and each 
reinstatement of previously approved information collection before 
submitting the collection to OMB for approval. To comply with this 
requirement, we are publishing this notice of a revised data collection 
as described below.
    OMB is particularly interested in comments that will help:
    1. Evaluate whether the revised collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology (e.g., permitting electronic 
submissions of responses); and,
    5. Assess information collection costs.
Proposed Project
    Importation Regulations (42 CFR 71 Subpart F)--Revised Information 
Collection--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
    This information collection is a revision to OMB Control Number 
0920-1383 related to the importation of animals, animal products, and 
human remains. HHS/CDC is amending the CDC Import Certification of 
Rabies Vaccination and Microchip Record Form and renaming it CDC Import 
Certification of Rabies Vaccination and Microchip Required for Live Dog 
Importations into the United States Form. HHS/CDC is instituting a new 
import submission system that will collect information similar to what 
is currently approved to be collected for the Application for Special 
Exemption for a Permitted Dog Import form. CDC is also proposing to 
require per 42 CFR 71.51 that importers of dogs have either a CDC 
Import Certification of Rabies Vaccination and Microchip Required for 
Live Dog Importations into the United States Form or a Certification of 
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United 
States Form, which is a form approved under OMB Control No. 0579- 0020, 
0036, 0048, 0101, 0156, 0278, and 0432. The Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States 
Form will be revised as part of information collection OMB Control No. 
0579-0020, 0036, 0048, 0101, 0156, 0278, and 0432.
    Section 361 of the PHS Act (42 U.S.C. 264) authorizes the Secretary 
of HHS to make and enforce regulations necessary to prevent the 
introduction, transmission, or spread of communicable diseases from 
foreign countries into the United States. The existing regulations 
governing foreign quarantine activities (42 CFR 71) authorize 
quarantine officers and other personnel to inspect and undertake 
necessary control measures with respect to conveyances, persons, 
shipments of animals, articles, and other items to protect the public's 
health.
    CDC regulations govern the importation of animals and animal 
products capable of causing human disease. Animals that are regulated 
by CDC include dogs, cats, turtles, nonhuman primates (NHPs), civets, 
African rodents, and bats. CDC controls the importation of these 
animals to ensure that these animals, or animal products, being 
imported into the United States meet CDC regulations. CDC does this 
through a permitting process for certain animals.
    The currently approved form (Application for Special Exemption for 
a Permitted Dog Import) for individuals to apply for a CDC Dog Import 
Permit is an online form that includes a series of questions. It also 
requires applicants to upload proof of eligibility to import under the 
current requirements, serology results, a proof of rabies vaccination, 
and photos of their dog's teeth.
    The process for dog importation under the provisions of the NPRM 
(if finalized as proposed) will require issuing far fewer CDC Dog 
Import Permits compared to the currently approved information 
collection, since only people seeking approval to import dogs from 
DMRVV-restricted countries would need to apply. Under the currently 
approved information collection, importers of foreign-vaccinated dogs 
from high-risk countries can apply for a CDC Dog Import Permit in lieu 
of making a reservation with a CDC-approved animal care facility. The 
option to apply for a CDC Dog Import Permit for

[[Page 44019]]

importers of foreign-vaccinated dogs from high-risk countries, however, 
is not being proposed in this NPRM. At this time, CDC is not including 
any countries on the DMRVV-restricted countries list; therefore, the 
annual burden in the burden table reflects a change in burden hours to 
zero hours for the Application for Special Exemption for a Permitted 
Dog Import form. The most significant changes to the current 
information collection will be the requirement to complete a 
standardized form for U.S.-vaccinated dogs (Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States; 
approved under OMB Control No. 0579-0020, 0036, 0048, 0101, 0156, 0278, 
and 0432) or an amended standardized form for foreign-vaccinated dogs 
(CDC Import Certification of Rabies Vaccination and Microchip Required 
for Live Dog Importations into the United States) and a new CDC Import 
Submission Form. The CDC Import Submission Form will contain similar 
information to the current Application for Special Exemption for a 
Permitted Dog Import form and is proposed to be required for all dog 
importations.
    The standardized rabies vaccination forms will be completed by the 
importers' veterinarian to ensure all required information is on the 
form and signed by a government official. Currently, to be valid, 
rabies vaccination documentation must include the name and address of 
the owner; dog's breed, sex, date of birth, color, and markings; 
microchip number; date of vaccination and vaccine product information, 
including product expiration date; date the vaccination expires; and 
name, license number, address, and signature of the veterinarian who 
administered the vaccination. CDC found that despite these being 
requirements for importation, many people submitted incomplete rabies 
vaccination documentation, which both delayed the issuance of the 
requestor's permit and used staff time for multiple communications with 
requestors to ensure they obtained complete rabies vaccination 
documentation. It also meant some requestors made multiple requests to 
their veterinarian, increasing the time burden on them as well. CDC is 
attempting to solve this issue by requiring that importers have their 
veterinarian complete one of the standardized CDC forms that contains 
all the required information and have it verified by a government 
official, making the form harder to falsify.
    Additionally, CDC proposes to require importers to submit a CDC 
Import Submission Form online via a new CDC import submission system 
for each dog being imported. Importers would submit contact information 
and details about the dog similar to what is currently collected in the 
Application for Special Exemption for a Permitted Dog Import form. The 
new information that would be collected in this system compared to what 
is currently approved to be collected in the Application for Special 
Exemption for a Permitted Dog Import form is: whether the submission is 
a new CDC submission or a change to an existing submission; the method 
by which someone is traveling to the United States (air, sea, or land); 
and, if they marked change to an existing submission, an explanation of 
that change. It would also not require that an importer upload their 
rabies vaccination documentation.
    The burden table below has been updated to reflect the burden hours 
on veterinarians to complete the rabies vaccination forms and the total 
amount of time it will take an importer to complete the online import 
submission form.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                          Average
                                                            Number of      Number of     burden per     Total
        Type of respondents               Form name        respondents   responses per    response    burden (in
                                                                          respondent     (in hours)     hours)
----------------------------------------------------------------------------------------------------------------
Dog Importers with Foreign-         CDC Import                  13,671               1        15/60        3,418
 vaccinated dogs.                    Certification of
                                     Rabies Vaccination
                                     and Microchip
                                     Required for Live
                                     Dog Importations
                                     into the United
                                     States.
Veterinarians for Foreign-          CDC Import                  13,671               1        15/60        3,418
 vaccinated dogs.                    Certification of
                                     Rabies Vaccination
                                     and Microchip
                                     Required for Live
                                     Dog Importations
                                     into the United
                                     States.
Official Government Veterinarian    CDC Import                  13,671               1        15/60        3,418
 in Exporting Country.               Certification of
                                     Rabies Vaccination
                                     and Microchip
                                     Required for Live
                                     Dog Importations
                                     into the United
                                     States.
Importers of U.S.-vaccinated dogs.  Certification of U.S.-      17,121               1        15/60        4,280
                                     issued Rabies
                                     Vaccination for Live
                                     Dog Re-entry into
                                     the United States.
Veterinarians for U.S.-vaccinated   Certification of U.S.-      17,121               1        15/60        4,280
 dogs.                               issued Rabies
                                     Vaccination for Live
                                     Dog Re-entry into
                                     the United States.
Importers of Dogs from DMRVV-       Application for                  0               0        60/60            0
 restricted Countries.               Special Exemption
                                     for a Permitted Dog
                                     Import.
All dog importers.................  CDC Import Submission      800,000               1         7/60       93,333
                                     Form.
Animal Care Facilities............  Application..........           10               1        60/60           10
                                                          ------------------------------------------------------
    Total.........................  .....................  ...........  ..............  ...........      112,157
----------------------------------------------------------------------------------------------------------------

D. National Environmental Policy Act (NEPA)

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

E. Executive Order 12988: Civil Justice Reform

    HHS/CDC has reviewed this rule under Executive Order 12988 on Civil 
Justice Reform and determines that this NPRM meets the standard in the 
Executive Order.

F. Executive Order 13132: Federalism

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

[[Page 44020]]

preparation of a federalism summary impact statement.

G. Plain Language Act of 2010

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

List of Subjects in 71.50, 71.51

    Airline, animal, border, canine rabies virus variant, carrier, cat, 
communicable diseases, confinement, DMRVV, Director, dog, exemption, 
importation, importer, microchip, necropsy, permit, public health, 
quarantine, rabies, rabies vaccination, rabies virus, serologic 
testing, valid rabies vaccination certificate, zoonotic diseases.

    For the reasons discussed in the preamble, we propose to amend 42 
CFR part 71 as follows:

PART 71--FOREIGN QUARANTINE

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

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

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


Sec.  71.50   Scope and definitions.

* * * * *
    (b) * * *
    Authorized veterinarian means an individual who has obtained both 
an advanced degree and valid license and is authorized to practice 
animal medicine in the exporting country.
* * * * *
    Cat means all domestic cats (Felis catus).
* * * * *
    Dog means all domestic dogs (Canis familiaris).
* * * * *
    Histopathology means the study of changes in human or animal tissue 
caused by disease.
* * * * *
    In-transit shipment means a cargo shipment originating in a foreign 
country that is moved through one or more U.S. ports of entry while 
transiting through the United States to a third-country destination. 
In-transit shipments pass through a U.S. port of entry and a U.S. port 
of exit, which may be in the same location, or which may involve 
numerous stopping points.
* * * * *
    Microchip means an implanted radio-frequency device placed under 
the skin of an animal that contains a unique identification tag that 
meets the International Standards Organization (ISO) compatibility 
through ISO 11784 or ISO 11785, or similar technologies as approved by 
the Director.
    Necropsy means an animal autopsy in which the cause of death may be 
determined through the examination and collection of tissues, organs, 
or bodily fluids post-mortem.
    Official government veterinarian means a veterinarian who performs 
work on behalf of an exporting country's government and can verify the 
license or credentials of an Authorized Veterinarian.
* * * * *
    (c) Any provision of this subpart held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this subpart and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.
0
3. Amend Sec.  71.51:
0
a. In paragraph (a) by:
0
i. Adding in alphabetical order definitions for ``Animal'', CDC-
registered animal care facility'', ``CDC import submission form'', 
``CDC Import Certification of Rabies Vaccination and Microchip Required 
for Live Dog Importations into the United States'', ``Certification of 
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United 
States'', and ``Conditional release'';
0
ii. Revising the definition of ``Confinement'';
0
iii. Adding in alphabetical order definitions for ``DMRVV'', ``DMRVV-
free countries'', ``DMRVV high-risk countries'', ``DMRVV low-risk 
countries'', ``DMRVV-restricted countries'', ``Importer'', ``SAFE 
TraQ'', ``Serologic testing'', ``USDA-accredited veterinarian'', and 
``USDA official veterinarian''; and
0
iv. Redesignating paragraphs (1) through (4) in the definition of 
``Valid rabies vaccination certificate'' as paragraphs (i) through 
(iv);
0
d. By revising paragraphs (b) through (g); and
0
e. By adding paragraphs (h) through (ff).
    The additions and revisions read as follows:


Sec.  71.51   Dogs and cats.

    (a) * * *
    Animal means, for purposes of this section, all domestic cats 
(Felis catus) or domestic dogs (Canis familiaris).
* * * * *
    CDC-registered animal care facility means a facility registered by 
CDC for the purpose of providing veterinary care and housing to animals 
imported into the United States.
    CDC import submission form means an OMB-approved declaration 
submitted to CDC through an online portal that includes the importer's 
name and contact information; description of the dog, including 
microchip number and current photographs of the dog's face and body; 
purpose of importation; travel information, including dates of 
departure and arrival, country of departure, countries visited in the 
past six months, and U.S. port of entry; and other information as 
described in CDC technical instructions.
    CDC Import Certification of Rabies Vaccination and Microchip 
Required for Live Dog Importations into the United States means the 
OMB-approved form that must be:
    (i) Completed by an authorized veterinarian in the exporting 
country, which may include an official government veterinarian in the 
exporting country; and
    (ii) Reviewed and signed by an official government veterinarian in 
the exporting country attesting that the information listed is true and 
correct.
    Certification of U.S.-issued Rabies Vaccination for Live Dog Re-
entry into the United States means the OMB-approved form that must be 
completed by a U.S. Department of Agriculture (USDA)-accredited 
veterinarian and certified by a USDA official veterinarian prior to 
exporting the dog from the United States in order to demonstrate 
compliance with admissibility requirements upon returning to the United 
States.
    Conditional release, when applied to an animal, means the temporary 
release of an animal from the custody of a carrier into the care of a 
licensed veterinarian approved by the Director for the purpose of 
receiving emergency medical care or a public health evaluation, pending 
removal of the animal from the United States. The

[[Page 44021]]

licensed veterinarian must return animals immediately to the carrier's 
custody upon the conclusion of such medical care or evaluation for 
removal from the United States.
    Confinement, when applied to an animal, means restriction to a 
building or other enclosure at a U.S. port or other location approved 
by the Director, including en route to a destination, separate from 
other animals, and from persons except for contact necessary for its 
care. If the animal is allowed out of the enclosure, it must be muzzled 
and kept on a leash.
    DMRVV means dog-maintained rabies virus variant and includes any 
rabies virus variant that is known or suspected to have an enzootic 
transmission cycle in which dogs are essential for the maintenance of 
the viral variant. This includes epidemiologic situations in which dogs 
are the only recognized reservoir species, as well as situations in 
which dogs and other species (typically wildlife) both play an 
epidemiologically relevant role in maintaining enzootic transmission.
    DMRVV-free countries mean countries determined by the Director as 
not having DMRVV present based on internationally accepted standards.
    DMRVV high-risk countries mean countries determined by the Director 
as having high risk for DMRVV transmission based on factors such as the 
presence and geographic distribution of the virus or low quality of or 
low confidence in rabies surveillance systems or dog vaccination 
programs.
    DMRVV low-risk countries mean countries determined by the Director 
as having low risk for DMRVV transmission based on factors such as the 
virus being limited to a localized area, adequacy of surveillance and 
dog vaccination programs to prevent further geographic distribution of 
the virus, and the virus being in a controlled status with the country 
or countries heading toward eventual DMRVV-free status.
    DMRVV-restricted countries means countries for which the export of 
dogs into the United States has been prohibited or otherwise restricted 
based on the countries' export of dogs infected with DMRVV to any other 
countries within a timeframe determined by the Director or based on the 
countries' lacking adequate controls, as determined by the Director, to 
monitor and prevent the export of dogs to the United States with 
falsified or fraudulent vaccine credentials, invalid rabies vaccination 
documentation, or other fraudulent, inaccurate, or invalid importation 
documents.
* * * * *
    Importer for purposes of this section means any person importing or 
attempting to import an animal into the United States, including an 
owner or a person acting on behalf of an importer, such as a broker 
registered with U.S. Customs and Border Protection (CBP). Individuals 
compensated or hired to transport animals must have a valid USDA 
license or registration.
* * * * *
    SAFE TraQ means the System for Animal Facilities Electronic 
Tracking of Quarantine or other system as approved by the Director for 
tracking the quarantine of animals approved for admission into the 
United States.
    Serologic testing, when applied to an imported animal, means a 
rabies antibody titration test performed by a CDC-approved rabies 
laboratory using a CDC-approved technique. The serology sample must be 
drawn, submitted and tested in accordance with CDC technical 
instructions. The current list of CDC-approved laboratories is 
available online on CDC's website. CDC will update its website as 
needed.
    USDA-accredited veterinarian shall have the same definition as 
accredited veterinarian under 9 CFR 160.1.
    USDA official veterinarian means the Animal and Plant Health 
Inspection Service (APHIS) veterinarian who is assigned by the USDA 
Administrator to supervise and perform the official work of APHIS in 
any U.S. State or several U.S. States.
* * * * *
    (b) Authorized U.S. airports for dogs and cats. (1) Cats may arrive 
at and be admitted into the United States through any U.S. airport.
    (2) Dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries that have not been in any DMRVV high-risk country 
within the last six months may arrive at and be admitted into the 
United States through any U.S. airport.
    (3) Dogs that have been in a DMRVV high-risk country within the 
last six months and were vaccinated against rabies in the United States 
must arrive at and may only be admitted through a U.S. airport with a 
CDC quarantine station.
    (4) Dogs that have been in a DMRVV high-risk country within the 
last six months and were vaccinated against rabies in a foreign country 
must arrive at and may only be admitted through a U.S. airport with a 
CDC quarantine station and a CDC-registered Animal Care Facility.
    (5) Dogs that have been in a DMRVV high-risk country within the 
last six months that arrive at an unauthorized U.S. airport shall be 
denied admission and returned to their countries of departure via air 
pursuant to paragraph (v) of this section.
    (6) The current list of U.S. airports with CDC quarantine stations 
is available on CDC's website. CDC also maintains a list of U.S. 
airports with CDC-registered Animal Care Facilities on its website. CDC 
will update these lists as needed.
    (c) Authorized U.S. land ports for dogs and cats. (1) Cats may 
arrive at and be admitted into the United States through any U.S. land 
port.
    (2) Dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries that have not been in any DMRVV high-risk country 
within the last six months may arrive at and be admitted into the 
United States through any U.S. land port.
    (3) Dogs that have been in a DMRVV high-risk country within the 
last six months are not authorized to enter the United States through 
any U.S. land port and shall be denied admission into the United 
States.
    (d) Authorized U.S. seaports for dogs and cats. (1) Cats may arrive 
at and be admitted into the United States through any U.S. seaport.
    (2) Dogs arriving to the United States from DMRVV low-risk or 
DMRVV-free countries that have not been in any DMRVV high-risk country 
within the last six months may arrive at and be admitted into the 
United States through any U.S. seaport.
    (3) Dogs that have been in a DMRVV high-risk country within the 
last six months are not authorized to enter the United States through 
any U.S. seaport and shall be denied admission into the United States.
    (4) Notwithstanding paragraph (d)(3) of this section, a dog meeting 
the definition of a ``service animal'' under 14 CFR 382.3 that has been 
in a DMRVV high-risk country within the last six months may be admitted 
through a U.S. seaport if:
    (i) The dog is accompanied by an ``individual with a disability'' 
as defined under 14 CFR 382.3 and the dog does work or performs tasks 
that are directly related to the individual's disability; and
    (ii) The dog was vaccinated against rabies in the United States and 
is accompanied by a valid Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States form; or
    (iii) The dog was vaccinated against rabies in a foreign country 
and is accompanied by a valid foreign-issued CDC Import Certification 
of Rabies Vaccination and Microchip Required for

[[Page 44022]]

Live Dog Importations into the United States form and a valid serologic 
titer from a CDC-approved laboratory.
    (e) Limitation on U.S. ports for dogs and cats. The Director may 
limit the times, U.S. ports, or conditions under which dogs or cats may 
arrive at and be admitted to the United States based on an importer's 
or carrier's failure to comply with the provisions of this section or 
as needed to protect the public's health. If the Director determines a 
limitation is required, the Director will notify importers or carriers 
in writing of the specific times, U.S. ports, or conditions under which 
dogs and cats may be permitted to arrive at and be admitted to the 
United States.
    (f) Age requirement for all dogs. All dogs presented for admission 
into the United States must be at least six (6) months old at the time 
of arrival into the United States. However, an importer may present for 
admission up to three (3) individual dogs within the same calendar year 
below the age of six (6) months if the dogs are arriving in the United 
States by land from Canada or Mexico and the dogs have not been in a 
DMRVV high-risk or DMRVV-restricted country since birth.
    (g) Microchip requirements for all dogs. (1) All dogs presented for 
admission into the United States must have a microchip implanted prior 
to arrival at the U.S. port.
    (2) The microchip number must be documented on the CDC Import 
Certification of Rabies Vaccination and Microchip Required for All Live 
Dog Importations into the United States form or the Certification of 
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United 
States form or documented on the veterinary health records of the dog 
if arriving from a DMRVV low-risk or DMRVV-free country. The microchip 
number must also be documented on the CDC import submission form.
    (3) The importer must consent to the scanning of the dog's 
microchip upon arrival by CDC quarantine public health officers or 
their representatives.
    (4) Dogs arriving in the United States without a microchip, with a 
microchip that cannot be detected, with a microchip that does not match 
the accompanying documentation, or if the importer refuses to have the 
dogs' microchip scanned, may be denied admission and returned to the 
country of departure pursuant to paragraph (v) of this section.
    (h) CDC Import Submission Form for all dogs. (1) All importers of 
dogs into the United States must submit a CDC Import Submission Form to 
CDC via a CDC-registered system prior to the dogs' arrival. This 
includes accompanied or unaccompanied dogs arriving by air, land, and 
sea regardless of whether arriving as cargo, checked-baggage, or hand-
carried baggage.
    (2) Dogs that arrive without a complete and accurate CDC import 
submission form filed prior to arrival may be denied admission and 
returned to the country of departure pursuant to paragraph (v) of this 
section, regardless of the value of the shipment.
    (3) Dogs arriving by air without a complete and accurate CDC import 
submission form may be held on a space-available basis for up to 24 
hours after arrival in the care of a CDC-registered animal care 
facility or a licensed veterinarian if the animal care facility cannot 
house the dog until the form is filed or if the dog arrives at an 
airport without a CDC-registered animal care facility. The importer (or 
airline if the importer abandons the animal) is responsible for making 
all necessary arrangements with a CDC-registered animal care facility 
or a veterinary clinic if the animal care facility cannot house the dog 
or is not available at the airport, including arranging transportation 
to the facility. The airline may require reimbursement from an importer 
for any associated costs incurred by the airline on the importer's 
behalf.
    (4) Dogs arriving by sea without a complete and accurate CDC import 
submission form may be held onboard the vessel until the form is filed. 
The vessel's owner or operator may require reimbursement from an 
importer for any associated costs incurred by the vessel on the 
importer's behalf.
    (5) Dogs arriving by land without a complete and accurate CDC 
import submission form shall be denied admission and returned 
immediately to the dogs' country of departure, but such denial does not 
prevent the importer from reapplying for admission of the dogs after 
the form is filed.
    (6) A receipt confirming submission of the form to CDC must 
accompany all dogs departing foreign locations for travel to the United 
States. For dogs departing from foreign airports to the United States, 
the airline must deny boarding to dogs unless the importer has 
presented this receipt prior to boarding.
    (7) Airlines are required to create a bill of lading for all dogs 
arriving in the United States prior to arrival. This includes dogs 
transported as cargo, checked-baggage, or hand-carried baggage.
    (8) Dogs arriving by air for which a bill of lading has not been 
filed prior to arrival in the United States may be denied admission and 
returned to the country of departure pursuant to paragraph (v) of this 
section.
    (i) Inspection requirements for admission of all dogs and cats. (1) 
All animals arriving at a U.S. port shall be inspected upon arrival, 
and only those animals that show no signs of communicable disease as 
defined in 42 CFR 71.1 shall be admitted into the United States.
    (2) All animals presented for admission into the United States may 
be subject to additional examination and disease surveillance screening 
for the purpose of communicable disease surveillance. Ill animals may 
be required to undergo additional diagnostic testing prior to release 
of the animal; such testing is not considered surveillance screening.
    (3) The Director may require confinement of an animal and 
examination by a veterinarian when necessary to determine whether the 
animal is admissible into the United States, for instance, if dental 
examination would assist in determining the animal's age.
    (4) Importers who refuse to consent to inspection, examination, or 
disease surveillance screening of the animal upon arrival may have the 
animal denied admission and returned to its country of departure 
pursuant to paragraph (v) of this section.
    (j) Examination by a USDA-accredited veterinarian and confinement 
of exposed dogs and cats or those that appear unhealthy. (1) If an 
animal, upon inspection, does not appear to be in good health (e.g., it 
has symptoms such as emaciation, lesions of the skin, discharge of the 
eyes or nose, coughing, sneezing, nervous system disturbances, 
inability to stand or walk, difficulty breathing, jaundice, vomiting, 
or diarrhea), or appears healthy but, during shipment, may have been 
exposed to a sick or dead animal (including an animal other than a dog 
or cat) suspected of having a communicable disease, the Director may 
require prompt confinement and veterinary examination.
    (2) In the case of animals that appear unhealthy or those that were 
potentially exposed and arriving by air or sea, the Director may 
require the airline or vessel's master or operator to arrange for a 
licensed veterinarian to examine the animal and give or arrange for any 
tests or treatment indicated. In the case of animals that appear 
unhealthy or those that were potentially exposed and arriving by land, 
the Director may deny admission, but such denial does not prevent the 
importer from reapplying for admission after providing the Director 
with satisfactory evidence that a licensed veterinarian has examined

[[Page 44023]]

the animal and administered any tests or treatment as needed.
    (3) Carriers shall maintain a record of sickness of animals 
occurring while en route to the United States and shall submit the 
record upon arrival to the CDC quarantine station with jurisdiction for 
the U.S. port.
    (4) Animals that become sick while en route or on arrival shall be 
separated from other animals (including an animal other than a dog or 
cat) as soon as the sickness is discovered and shall be held in 
confinement pending any necessary examination as determined by the 
Director.
    (5) Airlines (in the case of arrivals by air) or a vessel's master 
or operator (in the case of arrivals by sea) shall immediately arrange 
for medical evaluation by a licensed veterinarian of any animals that 
arrive sick and for transportation as needed to a facility for 
confinement or medical evaluation of any sick animals. In the case of 
sick animals arriving by land, the Director may deny admission, but 
such denial does not prevent the importer from reapplying for admission 
after providing the Director with satisfactory evidence of confinement 
(as needed) and examination by a licensed veterinarian.
    (6) The Director will consider the findings of the examination and 
tests in determining whether the animal may have a communicable 
disease.
    (7) The airline or vessel's master or operator shall arrange for 
confinement at a CDC-registered animal care facility or CDC-approved 
veterinary clinic which, in the judgment of the Director, affords 
protection against transmission of any communicable disease and 
suitable housing in accordance with the Animal Welfare Act (7 U.S.C. 
2131 et seq., as may be amended).
    (8) The importer shall bear the expenses of confinement, 
examination, tests, and treatment under this paragraph. If an importer 
fails to arrange for or pay for such expenses or cooperate with any 
CDC-mandated public health evaluations, then the animal will be 
considered abandoned, and the carrier shall assume financial 
responsibility pursuant to paragraph (z) of this section.
    (9) Confinement shall be subject to conditions specified by the 
Director to protect the public's health.
    (10) CDC may request that CBP conditionally release animals in need 
of medical evaluation or treatment. Animals eligible for conditional 
release shall remain under the legal custody of the carrier or CDC-
registered animal care facility for the purpose of receiving emergency 
veterinary medical care or examination. Such animals must be returned 
immediately to a CDC-registered animal care facility or other CDC-
approved kennel or veterinary facility (if a CDC-registered animal care 
facility is not available) once medical treatment is no longer required 
or upon request by either CDC or CBP.
    (11) If an importer (or carrier if the animal is abandoned by the 
importer) opts to have an animal euthanatized (e.g., under 
circumstances where the animal is fatally ill or injured), the importer 
or carrier shall promptly communicate this decision to CDC and CBP in 
writing and prior to euthanasia. Euthanasia does not relieve importers 
or carriers of the obligation to arrange and pay for testing and 
necropsy required by CDC.
    (k) Veterinary examination and revaccination against rabies at a 
CDC-registered animal care facility for foreign-vaccinated dogs. (1) 
All dogs arriving from DMRVV high-risk countries that do not have a 
valid certification of U.S.-issued rabies vaccination for live dog re-
entry into the United States form shall undergo veterinary examination 
and revaccination against rabies at a CDC-registered animal care 
facility upon arrival.
    (2) The importer is responsible for making all arrangements 
relating to the examination, revaccination, and quarantine of dogs with 
a CDC-registered animal care facility prior to arrival in the United 
States. The costs of examination, vaccination, or quarantine shall be 
borne by the importer and not at the government's expense.
    (3) Importers are required to present to airlines documentation 
confirming their reservation at a CDC-registered animal care facility 
prior to their dogs boarding a flight to the United States. Airlines 
must deny boarding to dogs if the importer fails to present such 
documentation.
    (4) Prior to granting a reservation, CDC-registered animal care 
facilities must ensure they have received the following:
    (i) The completed CDC Import Certification of Rabies Vaccination 
and Microchip Required for Live Dog Importations into the United States 
form;
    (ii) Serologic test results collected in accordance with CDC's 
technical instruction from a CDC-approved laboratory (if applicable);
    (iii) Photos of the dog's teeth to assist with age verification;
    (iv) The travel itinerary for the dog confirming that the dog will 
only be arriving at a U.S. airport with a CDC quarantine station and a 
CDC-registered animal care facility and will not be arriving at any 
other U.S. port; and
    (v) A receipt confirming submission of the CDC import submission 
form.
    (5) Airlines must deny boarding to any foreign-vaccinated dog for 
which the importer has not presented a receipt confirming submission of 
the CDC import submission form and proof of a reservation at a CDC-
registered animal care facility, or that is being presented for travel 
to an unauthorized U.S. airport.
    (6) The airline shall arrange for dogs to be transported by a CBP-
bonded transporter to a CDC-registered animal care facility immediately 
upon arrival at the U.S. airport.
    (7) The dog shall remain in the custody of the CDC-registered 
animal care facility until the following requirements are met:
    (i) Veterinary health examination by a USDA-accredited veterinarian 
for signs of illness. All illnesses must be documented in SAFE TraQ. 
CDC will review these illness case reports and determine admissibility 
prior to the animal's release. Suspected or confirmed zoonotic or 
foreign animal diseases, including the presence of ecto-parasites 
(i.e., ticks and fleas), must be reported to CDC, USDA, the State or 
county public health veterinarian, and the State veterinarian prior to 
release of the animal.
    (ii) Vaccination against rabies with a USDA-licensed rabies vaccine 
that is administered by a USDA-accredited veterinarian.
    (iii) Confirmation of microchip number.
    (iv) Confirmation of age through dental examination by a USDA-
accredited veterinarian.
    (v) Verification of adequate rabies serologic test from a CDC-
approved laboratory. Serologic tests must be drawn within a timeframe 
as specified in CDC technical instructions. Dogs that arrive without an 
adequate rabies serologic test results from a CDC-approved laboratory, 
or with a serologic test result drawn outside the acceptable timeframe, 
or with serologic test results outside acceptable parameters, shall be 
housed, at the CDC-registered animal care facility for a 28-day 
quarantine period following administration of the USDA-licensed rabies 
vaccine.
    (l) Registration or renewal of CDC-registered animal care 
facilities. (1) Before housing any live dog imported into the United 
States, a facility must register with and receive written approval from 
the Director to function as a CDC-registered animal care facility. 
Applications and all required

[[Page 44024]]

documents must be submitted to [email protected].
    (2) To register or to renew a registration certificate, a facility 
must submit the following documents to CDC:
    (i) A completed registration/application form;
    (ii) A statement of intent that describes the number and types of 
animals the facility can house at one time, including the number of 
animals that can be housed in the quarantine area;
    (iii) Written standard operating procedures that include all 
elements required in paragraphs (k) through (q) of this section;
    (iv) A copy of all Federal, State, or local registrations, 
licenses, and/or permits; a facility must have a USDA Class H 
intermediate handlers license (and any additional class licenses or 
registrations as deemed appropriate by USDA) and a CBP Facilities 
Information and Resource Management System (FIRMS) code.
    (v) A self-certification signed by the owner or manager of the CDC-
registered Animal Care Facility stating that the facility is in 
compliance and agrees to continue to comply with the regulations in 
this section.
    (3) Upon receiving the documentation required by this section, the 
Director will review the application and either grant or deny the 
application for registration as a CDC-registered Animal Care Facility. 
Applications that are denied may be appealed under paragraph (r) of 
this section.
    (i) Before issuing a registration, the Director may inspect any 
animal health record, facility, vehicle, or equipment to be used in 
management, examination, and clearance of imported animals. Thereafter, 
animal health records, facilities, vehicles, and equipment used in 
importing animals may be inspected during annual site inspection visits 
or when otherwise needed to protect the public's health.
    (ii) Unless revoked in accordance with paragraph (r) of this 
section, a registration certificate issued under this section is 
effective for two years beginning from the date CDC issues the 
registration certificate.
    (iii) A CDC-registered animal care facility must apply to CDC for 
renewal of the registration certificate not less than 60 days and not 
more than 90 days before the existing registration expires.
    (4) The Director may deny an application to register, renew, or 
reinstate a facility as a CDC-registered animal care facility if the 
registrant has had a previous registration revoked in accordance with 
paragraph (r) of this section within the last five years.
    (5) All CDC-registered animal care facilities must comply with the 
requirements of paragraphs (k) through (q) of this section.
    (m) Record-keeping requirements at CDC-registered animal care 
facilities. (1) A CDC-registered animal care facility must retain 
records regarding each imported animal for three years after the 
distribution or transfer of the animal. Each record must include:
    (i) The bill of lading for each shipment;
    (ii) The name, address, phone number, and email address of the 
importer and owner (if different from the importer);
    (iii) The number of animals in each shipment;
    (iv) The identity of each animal in each shipment, including name, 
microchip number, date of birth, sex, breed, and coloring;
    (v) The airline, flight number, date of arrival, and port of 
arrival of each shipment;
    (vi) Veterinary medical records for each animal, including:
    (A) CDC import certification of rabies vaccination and microchip 
required for live dog importations into the United States form and 
rabies serology obtained before arrival in the United States (if 
applicable);
    (B) The USDA-licensed rabies vaccine administered upon arrival;
    (C) Veterinary examination records upon arrival and while in 
quarantine;
    (D) Rabies serology performed while in quarantine in the United 
States (if applicable);
    (E) All diagnostic test results performed during quarantine; and
    (F) Necropsy reports for imported animals that die while in the 
care of the CDC-registered animal care facility.
    (2) A CDC-registered animal care facility must maintain these 
records electronically in SAFE TraQ.
    (i) Copies of all records must be entered directly into or uploaded 
into SAFE TraQ;
    (ii) Records must be uploaded and complete prior to the animal's 
release from the facility; and
    (iii) CDC will audit records remotely as needed and in-person 
during the annual site inspection visit(s) at the facility.
    (n) Worker protection plan and personal protective equipment (PPE). 
(1) A CDC-registered Animal Care Facility must establish and maintain a 
worker protection plan with standards comparable to those in the 
National Institute for Occupational Safety and Health (NIOSH) 
Veterinary Safety and Health guidelines and the National Association of 
Public Health Veterinarians (NASPHV) Compendium of Veterinary Standard 
Precautions for Zoonotic Disease Prevention in Veterinary Personnel.
    (2) In addition to complying with the requirements of this section, 
a facility must comply with all relevant Federal and State requirements 
relating to occupational health and safety.
    (3) Rabies pre-exposure prophylaxis is required for workers 
handling imported animals in rabies quarantine.
    (4) Post-exposure procedures that provide potentially exposed 
workers with direct and rapid access to a medical consultant.
    (5) Procedures for documenting the frequency of worker training, 
including for those working in the quarantine area.
    (6) As part of the worker protection plan, a facility must 
establish, implement, and maintain hazard evaluation and worker 
communication procedures that include the following:
    (i) Descriptions of the known zoonotic disease and injury hazards 
associated with handling animals;
    (ii) The need for PPE when handling animals and training in the 
proper use of PPE, including re-training and reinforcement of 
appropriate use; and
    (iii) Procedures for disinfection of garments, supplies, equipment, 
and waste.
    (o) CDC-registered animal care facility standard operating 
procedures, requirements, and equipment standards for crating, caging, 
and transporting live animals. (1) Equipment standards for crating, 
caging, and transporting live animals must be in accordance with USDA 
Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and 
International Air Transport Association standards.
    (2) Animals must not be removed from crates during transport.
    (3) Used PPE, bedding, and other potentially contaminated material 
must be removed from the ground transport vehicle upon arrival at the 
animal care facility and disposed of or disinfected in a manner that 
would destroy potential pathogens of concern.
    (p) Health reporting requirements for animals at CDC-registered 
animal care facilities. (1) A CDC-registered animal care facility must 
provide the following services for each animal upon arrival and ensure 
each animal meets CDC entry requirements prior to release from the 
facility:
    (i) Veterinary examination by a USDA-accredited veterinarian within 
one business day of arrival;
    (ii) Verification of microchip and confirmation that the microchip 
number matches the animal's health records;

[[Page 44025]]

    (iii) Verification of animal's age via a dental examination;
    (iv) Revaccination against rabies using a USDA-licensed vaccine; 
and
    (v) Verification of a valid serology test from a CDC-approved 
laboratory drawn from a dog prior to arrival within a timeframe and 
results within parameters as specified in CDC technical instructions or 
28-day quarantine after administration of the USDA-licensed rabies 
vaccine.
    (2) A CDC-registered animal care facility must provide the 
following services upon the occurrence of any morbidity or mortality in 
an imported animal in the facility:
    (i) Notification to CDC within 24 hours of the arrival of an ill 
animal or occurrence of any illness or death occurring in an animal.
    (ii) Examination by a USDA-accredited veterinarian immediately upon 
detection of illness and diagnostic testing to determine the cause of 
illness. All costs associated with examination and diagnostics are the 
responsibility of the importer.
    (iii) Reporting of suspected or confirmed zoonotic diseases and 
ecto-parasites to CDC and the State or county public health 
veterinarian within 24 hours of identification. Suspected or confirmed 
foreign animal diseases or infectious animal diseases must be reported 
to USDA and the State or county veterinarian within 24 hours of 
identification.
    (iv) Necropsy and diagnostic testing to determine the cause of 
death. The importer is responsible for all costs associated with 
necropsy and testing.
    (3) Upon completion of the quarantine period and before a facility 
releases any animal from quarantine, the facility must ensure that the 
facility's USDA- accredited veterinarian has verified the health status 
of the animal and all required paperwork is uploaded into SAFE TraQ.
    (4) Any report required under this paragraph must be uploaded to 
SAFE TraQ prior to the release of the animal.
    (q) Quarantine requirements for animals at CDC-registered animal 
care facilities. (1) A CDC-registered animal care facility must 
maintain a quarantine area for holding dogs during the required 
quarantine period. Dogs must be quarantined for 28 days after 
revaccination with a USDA-licensed rabies vaccine at the facility if 
they do not have a valid rabies serologic test from a CDC-approved 
laboratory. CDC may extend the quarantine period if a facility or CDC 
finds or suspects that a dog is infected with, or has been exposed to, 
a zoonotic disease or if a facility or CDC determines that additional 
diagnostic testing is warranted.
    (2) For any quarantine area established or maintained under this 
section, a facility must establish, implement, maintain, and adhere to 
standard operating procedures that meet the following physical security 
requirements:
    (i) The CDC-registered animal care facility must be locked and 
secure, with access limited to authorized, trained, and knowledgeable 
personnel.
    (ii) A CDC-registered animal care facility must limit access to 
animal quarantine areas to authorized personnel responsible for the 
transport, care, or treatment of the animals.
    (3) During the quarantine period, a CDC-registered animal care 
facility must monitor animals for signs of any zoonotic illness, 
including, but not limited to, signs consistent with rabies, 
brucellosis, leptospirosis, leishmaniasis, or ecto- or endo-parasites.
    (4) If any animals appear ill during quarantine, the CDC-registered 
animal care facility must notify CDC through SAFE TraQ and monitor that 
animal for signs of zoonotic illness and ensure appropriate treatment. 
Suspected or confirmed zoonotic diseases in animals or facility workers 
must be reported to CDC within 48 hours.
    (5) A CDC-registered animal care facility must not knowingly 
release any ill animal from quarantine under paragraph (q)(3) of this 
section without prior consultation with and written approval from CDC.
    (6) Quarantined animals must be housed in such a manner that they 
do not expose non-quarantined animals (including an animal other than a 
dog or cat) to other potentially infectious materials, including soiled 
bedding, caging, and other potentially contaminated items.
    (7) If CDC notifies a CDC-registered animal care facility of any 
evidence that animals have been exposed to a zoonotic disease, the 
facility must, at the facility's expense, implement or cooperate in the 
CDC's implementation of additional measures to rule out the spread of 
suspected zoonotic disease before releasing an animal or shipment of 
animals from quarantine, including examination, additional diagnostic 
procedures, treatment, detention, isolation, seizure, or destruction of 
exposed animals.
    (8) A CDC-registered animal care facility must establish, 
implement, and adhere to standard operating procedures for safe 
handling and necropsy of any animal that dies in quarantine.
    (r) Revocation and reinstatement of a CDC-registered animal care 
facility's registration. (1) If the Director determines that a CDC-
registered animal care facility has failed to comply with any 
applicable provisions of this section, including failure to abide by 
the facility's standard operating procedures, the Director may revoke 
the facility's registration.
    (2) CDC will send the CDC-registered animal care facility a notice 
of revocation stating the grounds upon which the proposed revocation is 
based.
    (3) If the CDC-registered animal care facility wishes to contest 
the revocation, the facility must file a written response to the notice 
within five business days after receiving the notice.
    (4) As part of the response, a CDC-registered animal care facility 
may request that the Director review the written record.
    (5) If a CDC-registered animal care facility fails to file a 
response within five business days, all of the grounds listed in the 
proposed revocation will be deemed admitted, in which case the notice 
shall constitute final agency action.
    (6) If a CDC-registered animal care facility's response is timely, 
the Director will review the registration, the notice of revocation, 
and the response, and make a decision in writing based on the written 
record.
    (7) As soon as practicable after completing the written record 
review, the Director will issue a decision in writing that shall 
constitute final agency action. The Director will provide the facility 
with a copy of the written decision.
    (8) The Director may reinstate a revoked registration after 
inspecting the facility, examining its records, conferring with the 
facility, and receiving information and assurance from the facility of 
compliance with the requirements of this section.
    (s) Requirement for the CDC Import Certification of Rabies 
Vaccination and Microchip Required for Live Dog Importations into the 
United States form to import foreign-vaccinated dogs from DMRVV high-
risk countries. (1) Importers of foreign-vaccinated dogs from DMRVV 
high-risk countries must submit the CDC Import Certification of Rabies 
Vaccination and Microchip Required for Live Dog Importations into the 
United States form to the CDC-registered animal care facility in order 
to make a reservation at that facility.
    (2) Importers must present documentation confirming the dog's 
reservation at a CDC-registered animal care facility to the airline 
prior to boarding and to CBP upon arrival at a U.S. port for admission 
of foreign-

[[Page 44026]]

vaccinated dogs from DMRVV high-risk countries.
    (3) The CDC Import Certification of Rabies Vaccination and 
Microchip Required for Live Dog Importations into the United States 
form must be truthful and accurate, completed in English, and include:
    (i) The name of person importing the dog (consignee), physical 
address, phone number, email address, passport number and date of 
birth;
    (ii) The owner's name, phone number, and email address;
    (iii) The destination address (physical address) where the dog will 
reside upon arrival in the United States;
    (iv) The dog's name, microchip number, microchip implant date, 
breed, sex, date of birth or approximate age if the date of birth is 
unknown, and color or markings of the dog;
    (v) Rabies vaccination information for the dog administered within 
a timeframe and in accordance with the vaccination schedule as 
specified in CDC technical instructions;
    (vi) Rabies vaccine product information (product name, 
manufacturer, lot number, and product expiration date);
    (vii) Rabies vaccine expiration date (date when next vaccine is 
due), which must be after the dog's date of arrival at a U.S. port;
    (viii) The name, license number or official stamp, address, 
telephone number, email address, and signature of the authorized 
veterinarian or official government veterinarian that examined the dog 
in the exporting country; and
    (ix) The name, address, official seal or stamp, and signature of an 
official government veterinarian attesting that the authorized 
veterinarian is licensed or authorized to practice veterinary medicine 
in the exporting country and further attesting that the information 
listed on the form is true and correct.
    (4) Importers who fail or refuse to present the CDC Import 
Certification of Rabies Vaccination and Microchip Required for Live Dog 
Importations into the United States form or present a form that is 
untruthful, inaccurate, and incomplete may result in the dog denied 
admission and returned to the country of departure pursuant to 
paragraph (v) of this section.
    (t) Requirement for Certification Of U.S.-Issued Rabies Vaccination 
for Live Dog Re-entry into the United States form for importers seeking 
to import U.S.-vaccinated dogs from DMRVV high-risk countries. (1) 
Importers returning to the United States from a DMRVV high-risk country 
with their U.S.-vaccinated dog may present their dog for admission 
without a rabies serologic test from a CDC-approved laboratory, without 
the dog undergoing veterinary examination (unless ill, injured, or 
exposed), and without revaccination against rabies at a CDC-registered 
animal care facility upon arrival under the following circumstances:
    (i) The importer presents a Certification of U.S.-issued Rabies 
Vaccination for Live Dog Re-entry into the United States form that is 
truthful, complete, and accurate.
    (ii) The dog must arrive by air and entry must be made through a 
U.S. airport with a CDC quarantine station.
    (iii) The importer presents a valid Certification of U.S.-issued 
Rabies Vaccination for Live Dog Re-entry into the United States form 
that sufficiently and reliably demonstrates that a USDA-licensed rabies 
vaccine was administered within a timeframe and age parameters as 
specified in CDC technical instructions.
    (2) The Certification of U.S.-issued Rabies Vaccination for Live 
Dog Re-entry into the United States form must be completed prior to the 
dog leaving the United States and cannot be completed upon arrival at a 
U.S. port or after the dog has left the United States.
    (3) Importers returning to the United States from a DMRVV high-risk 
country with their U.S.-vaccinated dog that are unable to meet the 
requirements of this paragraph (t) shall have the dog treated as if it 
was vaccinated in a foreign country in accordance with the provisions 
of paragraph (k) of this section and this paragraph (t) or, 
alternatively, have the dog denied admission and returned to the 
country of departure pursuant to the paragraph (v) of this section.
    (4) If an importer fails to immediately (within 24 hours of 
arrival) arrange for the dog's return to the country of departure, then 
the animal will be considered abandoned pursuant to paragraph (z) of 
this section.
    (u) Requirement for proof that a dog has only been in a DMRVV low-
risk or DMRVV-free country. Dogs arriving, including those returning to 
the United States, from a DMRVV low-risk or DMRVV-free country may be 
admitted into the United States subject to the requirements in this 
section if the importer submits written documentation (i.e., veterinary 
records, veterinary import/export certificate) satisfactory to the 
Director that for the six months before arrival, the dog has been only 
in a DMRVV low-risk or DMRVV-free country.
    (v) Denial of admission of dogs and cats. (1) The Director may deny 
admission to the following categories of animals:
    (i) Any dog arriving from a DMRVV low-risk or DMRVV-free country 
without written documentation (i.e., veterinary records, veterinary 
import/export certificate) that the dog has only been in a DMRVV low-
risk or DMRVV-free country for the six months prior to the attempted 
entry, or if the Director reasonably suspects fraud.
    (ii) Any dog that is not accompanied by a receipt confirming that a 
CDC import submission form has been submitted to CDC through a CDC-
approved system.
    (iii) Any dog arriving by air for which a bill of lading has not 
been created by the airline prior to arrival.
    (iv) Any dog arriving by land to the United States from DMRVV high-
risk countries.
    (v) Any dog arriving by sea to the United States from DMRVV high-
risk countries, except for a dog qualifying as a service animal and 
meeting the standards set forth in paragraph (d)(4) of this section.
    (vi) Any dog imported by an importer who refuses to comply with the 
requirement (if applicable) to undergo disease surveillance screening, 
microchip scanning, veterinary examination, revaccination, provide 
proof of sufficient rabies serologic tests, or quarantine at a CDC-
registered animal care facility or other CDC-approved facility (if a 
CDC-registered Animal Care Facility is not available) upon arrival.
    (vii) Any dog that has been in a DMRVV high-risk country in the 
previous six months and arrives without a valid Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States 
form or a valid CDC import certification of rabies vaccination and 
microchip required for live dog importations into the United States 
form.
    (viii) Any dog that has been in a DMRVV high-risk country in the 
previous six months and does not arrive via air at a U.S. airport with 
a CDC quarantine station and a CDC-registered animal care facility, 
except for a dog arriving by sea that qualifies as a service animal and 
meets the standards set forth in paragraph (d)(4) of this section.
    (ix) Any dog imported from a DMRVV high-risk country that arrives 
without a reservation at a CDC-registered animal care facility (if 
applicable).
    (x) Any dog from a DMRVV-restricted country that arrives without a 
valid CDC dog import permit.
    (xi) Any dog imported from a DMRVV high-risk country if the 
Director reasonably suspects fraud in any documentation required for 
admission or if such documentation is otherwise untruthful, inaccurate, 
or incomplete.

[[Page 44027]]

    (xii) Any animal, regardless of country of departure, that poses a 
public health risk, including animals that appear unhealthy upon 
arrival or demonstrate signs or symptoms of communicable disease.
    (xiii) Any dog under six months of age that is arriving via air or 
sea into the United States, or any dog under six months of age imported 
via a land port if the importer has imported more than three individual 
dogs under six months of age in the same calendar year (January-
December).
    (2) Animals arriving by air that are awaiting an admissibility 
determination or denied admission must be held in CDC-registered animal 
care facilities or other CDC- or USDA-approved veterinary clinics (if a 
CDC-registered animal care facility is not available) in such a way as 
to prevent the potential spread of communicable diseases.
    (3) Pursuant to 9 CFR 3.14(f), animals arriving by air that are 
denied admission must be transported to a CDC-registered animal care 
facility (or other boarding, kennel, or veterinary clinic approved by 
CDC if a CDC-registered animal care facility is not available) by the 
airline within six hours of denial of admission into the United States 
while awaiting return to the country of departure, excluding animals 
transiting through the United States. Animals arriving by sea that are 
denied admission must remain on the vessel while awaiting return to the 
country of departure.
    (4) An importer must meet the admission requirements of all U.S. 
Government agencies for the admission of an animal into the United 
States. Satisfaction of CDC's requirements for the admission of animals 
does not fulfill the admission requirements of other U.S. Government 
agencies.
    (w) Disposal or disposition of dogs and cats denied admission to 
the United States. (1) Animals shall be subject to such additional 
requirements, including denial of admission, as may be deemed necessary 
by the Director to protect the public's health or suspension of entry 
under 42 CFR 71.63.
    (2) Animals denied admission to the United States that were 
transported to the United States via air must be returned by the 
airline to the country of departure at the importer's expense on the 
next available outbound flight (no later than 72 hours after arrival), 
regardless of airline or route, if fit to travel. Pending the animal's 
return, the animal shall be detained at the importer's expense in the 
custody of the carrier at a CDC-registered animal care facility (or 
other boarding, kennel, or veterinary clinic approved by CDC if a CDC-
registered animal care facility is not available).
    (3) Animals denied admission to the United States that were 
transported to the United States via sea shall be reembarked 
immediately by the vessel's master or operator and returned to its 
country of departure on the next voyage.
    (4) Animals denied admission to the United States that were 
transported to the United States via land shall be returned immediately 
by importer or carrier to their country of departure.
    (5) If an animal is not fit to travel, poses a public health risk, 
or would pose a risk to other animals, then the carrier shall arrange 
for the animal to be transported to a CDC-registered animal care 
facility or a CDC- approved veterinary clinic (if a CDC-registered 
animal care facility is not available) for either housing and treatment 
by a licensed veterinarian until approved for travel by CDC or humanely 
euthanized (e.g., under circumstances where the animal is fatally ill 
or injured) by a licensed veterinarian. The importer shall be 
responsible for all costs associated with the denial, veterinary 
evaluation, care, or disposal of the animal. If the importer refuses to 
pay for any costs associated with the denial, evaluation, care, or 
disposal of the animal, then it will be considered abandoned, and the 
carrier shall assume custody and financial responsibility for these 
costs.
    (6) If humane euthanasia is recommended by a veterinarian or chosen 
by an importer or carrier (e.g., under circumstances where the animal 
is fatally ill or injured), the animal must be euthanized by a U.S.-
licensed veterinarian in accordance with American Veterinary Medical 
Association guidelines. Euthanasia does not relieve carriers or 
importers of the obligation to arrange and pay for testing and necropsy 
required by CDC.
    (7) The Director may grant temporary extensions of returns for 
animals that are not fit for travel as determined by a CDC 
veterinarian, but the importer (or carrier in the case of abandonment) 
must arrange for the return of the animal to its country of departure 
as soon as CDC notifies the carrier that the animal is fit for travel.
    (8) The requirements of this paragraph shall additionally apply to 
dogs or cats abandoned by the importer prior to the dogs' or cats' 
admission into the United States. A dog or cat may be deemed abandoned 
pursuant to the provisions of paragraph (z) of this section.
    (9) Carriers must provide transportation to/from and holding at a 
CDC-registered animal care facility (or other boarding, kennel, or 
veterinary clinic approved by CDC if a CDC-registered animal care 
facility is not available) while determining admissibility, undergoing 
veterinary evaluation or care, or upon denial of entry. Carriers may 
require reimbursement from an importer for any costs incurred on behalf 
of the importer.
    (10) Importers must comply with CDC requirements for the return of 
an animal or for the veterinary assessment of an animal. Refusal to 
cooperate, including refusal to pay any associated veterinary fees, 
will result in the animal being considered abandoned by the importer, 
and custody of the animal will be transferred to the carrier who will 
assume financial responsibility for costs relating to the denial, 
evaluation, care, or disposal of the animal.
    (11) A carrier may enter into contractual arrangements with an 
importer or a third party relating to the expenses of returning an 
animal to its country of departure, for veterinary care, or otherwise 
disposing of an animal, provided that no government costs are incurred. 
The return of an animal to its country of departure or the initiation 
of veterinary care shall not be delayed while the carrier attempts to 
enter into or negotiate contractual arrangements.
    (12) The provisions of this paragraph may be applied to importers 
of animals and to carriers transporting such animals in circumstances 
where an animal is denied entry at a land port or seaport of the United 
States and the animal cannot be immediately returned to its country of 
departure (e.g., because it is unfit to travel).
    (x) Appeals of CDC denials to admit a dog or a cat upon arrival 
into the United States. (1) If CDC denies admission to an animal upon 
arrival, then the importer may appeal that denial to the Director.
    (2) The importer must submit the appeal in writing to the Director, 
stating the reasons for the appeal and demonstrating that there is a 
genuine and substantial issue of fact in dispute.
    (3) The importer must submit the appeal within one (1) business day 
of the denial by emailing [email protected].
    (4) Submitting an appeal will not delay the return of the animal to 
the country of departure.
    (5) The Director will issue a written response to the appeal, which 
shall constitute final agency action.
    (y) Record of death of dogs and cats en route to the United States 
and disposition of dead animals. (1) Carriers shall maintain a record 
of the death of animals occurring while en route to the United States 
and shall submit the record to the CDC quarantine station of

[[Page 44028]]

jurisdiction for the U.S. port upon arrival.
    (2) Animals that become sick or die en route or are identified as 
sick or dead upon arrival shall be separated from other animals 
(including animals other than dogs or cats) as soon as the sickness or 
death is discovered and shall be held in confinement pending any 
necessary examination as determined by the Director. Sick animals shall 
be examined pursuant to the provisions of paragraph (j) of this section 
or disposed of pursuant to the provisions of paragraph (w) of this 
section.
    (3) The carrier shall arrange for any animals that die en route to 
the United States or that die while detained pending determination of 
their admissibility to undergo a necropsy (gross and histopathologic 
examination are required), and any subsequent infectious disease 
testing based on gross or histopathology findings or as determined by 
CDC. The carrier or CDC-registered animal care facility must contact 
the CDC quarantine station of jurisdiction prior to transporting an 
animal for necropsy to determine whether rabies testing is required. In 
the event an importer abandons an animal, the carrier will become the 
owner and shall assume responsibility for all expenses described in 
this paragraph (y)(3).
    (4) The carrier shall send copies of the final necropsy report and 
all test results to the CDC quarantine station of jurisdiction.
    (5) Pursuant to paragraphs (p) and (w) of this section, the 
importer is responsible for costs associated with the necropsy, 
testing, and disposal of the body. In the event an importer abandons an 
animal, then pursuant to paragraph (z) of this section, the carrier 
will become the owner and shall assume responsibility for all expenses 
described in paragraph (y)(3) of this section.
    (z) Abandoned shipments of dogs and cats. (1) In the event an 
importer abandons an animal under this section, the carrier will become 
the owner and shall assume responsibility for all expenses described in 
this section.
    (2) An animal shipment will be deemed abandoned under the following 
circumstances:
    (i) When explicitly stated by the importer verbally or in writing 
to the carrier, CDC, or CBP; or
    (ii) If the importer fails to cooperate with or respond to the 
carrier's attempts to comply with the provisions of this section within 
24 hours; or
    (iii) If the importer refuses payment within 24 hours for CDC-
mandated examinations, testing, holding, or treatment needed to ensure 
the safe importation of dogs and cats into the United States.
    (aa) Sanitation of cages and containers of dogs and cats. When the 
Director finds that the cages or other containers of animals arriving 
in the United States are in an unsanitary or other condition that may 
constitute a communicable disease risk, the animals shall not be 
admitted in such containers unless the carrier has the containers 
cleaned and disinfected or the animals are removed and placed in clean 
containers in accordance with USDA and, in the case of airlines, the 
International Air Transport Association (IATA) shipping requirements. 
Discarded containers must be cleaned and disinfected or destroyed in 
accordance with carrier policies. CDC may require documentation of 
crate disinfection or destruction by the carrier.
    (bb) Requirements for in-transit shipments of dogs and cats. (1) 
In-transit shipments of live animals are not eligible for release into 
the United States.
    (2) In-transit shipments must be maintained under continuous 
confinement with USDA APHIS oversight onboard a conveyance until export 
or off-loaded and maintained under continuous confinement and APHIS 
oversight at a USDA APHIS-preapproved holding facility with a CBP-
issued FIRMS code while awaiting a connecting conveyance, and then 
loaded and maintained under USDA APHIS oversight onboard the connecting 
conveyance until export.
    (3) The provisions of this section shall apply to animals 
transiting through the United States from one foreign country to 
another, except as provided in paragraphs (bb)(3)(i) and (ii) of this 
section:
    (i) Animals that appear healthy but have been exposed to a sick or 
dead animal (including an animal other than a dog or cat) suspected of 
having a communicable disease are not required to undergo examination 
or tests as provided in paragraph (j) of this section if the Director 
determines that the conditions under which the animals are being 
transported afford adequate protection against introduction of 
communicable disease into the United States.
    (ii) The CDC Import Certification of Rabies Vaccination and 
Microchip Required For Live Dog Importations into the United States 
form or Certification Of U.S.-Issued Rabies Vaccination For Live Dog 
Re-entry into the United States form is not required for dogs that are 
transported by aircraft and are being transited through the United 
States if retained in the custody of the airline under conditions that 
would prevent transmission of communicable diseases.
    (cc) Bill of lading and other airline requirements for dogs. (1) 
Airlines are required to create a bill of lading for all dogs arriving 
in the United States prior to arrival. This includes dogs transported 
as cargo, checked-baggage, or hand-carried baggage.
    (2) Dogs arriving by air for which a bill of lading has not been 
filed prior to arrival in the United States may be denied admission and 
returned to the country of departure pursuant to paragraph (v) of this 
section.
    (3) Airlines must deny boarding to any dogs for which the importer 
has not presented to the airline before boarding a receipt confirming 
submission of the CDC import submission form. Airlines must also deny 
boarding if the dog presented for travel does not match the description 
on the receipt of the CDC import submission form.
    (4) For U.S.-vaccinated dogs that have been in a DMRVV high-risk 
country within the last six months, airlines must deny boarding unless 
the importer presents prior to boarding a valid certification of U.S.-
issued rabies vaccination for live dog re-entry into the United States 
form. Airlines must also deny boarding if the dog presented for travel 
does not match the description on the Certification of U.S.-Issued 
Rabies Vaccination for Live Dog Re-entry into the United States form or 
if the dog is scheduled to arrive in the United States at a U.S. 
airport that does not have a CDC quarantine station.
    (5) For foreign-vaccinated dogs that have been in a DMRVV high-risk 
country within the last six months, airlines must deny boarding unless 
the importer presents documentation to the airline before boarding of a 
reservation at a CDC-registered animal care facility and the dog is 
scheduled to arrive in the United States at the U.S. airport where the 
CDC-registered animal care facility is located.
    (6) For dogs from DMRVV-free or low-risk countries, airlines must 
deny boarding unless the importer presents documentation to the airline 
before boarding by showing that the dog is over six months of age, has 
a microchip, and has not been in a DMRVV high-risk country in the 
previous six months. Airlines must also deny boarding if the dog 
presented for travel does not match the description on the documents 
presented by the importer for travel.
    (7) A representative of an airline transporting live dogs into the 
United States must be on-site at the U.S. airport and available to 
coordinate the entry/

[[Page 44029]]

clearance of the dogs with Federal Government officials until all live 
dogs transported on an arriving flight into the United States have 
either been cleared for entry or arrangements have been made to 
transport the dogs to a CDC-registered animal care facility or other 
facility (e.g., veterinary clinic or kennel) approved by CDC pending an 
admissibility determination.
    (dd) Order prohibiting carriers from transporting dogs and cats. 
(1) If the Director determines that a carrier has endangered the public 
health of the United States by acting or failing to act to prevent the 
introduction of DMRVV, as would occur through failure to comply with 
any applicable provisions of this section, the Director may issue an 
order revoking the carrier's permission to transport live animals into 
the United States, which shall be served on the carrier's owner or 
operator.
    (2) The Director may rescind the order after inspecting the 
carrier's facilities; examining its records; conferring with the 
carrier's owners or operators, its contractors, or staff; or receiving 
information and written assurances from the carrier owner or operator 
that it has taken remedial steps to ensure future compliance with the 
requirements of this section.
    (3) A carrier owner or operator may appeal a revocation of a 
carrier's permission to transport live animals into the United States. 
The appeal shall be in writing, addressed to the Director, state the 
reasons for the appeal, and demonstrate that there is a genuine and 
substantial issue of fact in dispute. The appeal must be submitted via 
email to [email protected]
    (4) As soon as practicable after completing the appeal review, the 
Director will issue a decision in writing that shall constitute final 
agency action. The Director will serve the carrier with a copy of the 
written decision.
    (ee) Prohibition on imports of dogs from DMRVV-restricted 
countries. (1) The Director may prohibit or otherwise restrict the 
import of dogs into the United States from certain countries designated 
as DMRVV-restricted countries. CDC will maintain a list of DMRVV-
restricted countries for which the import of dogs into the United 
States has been prohibited or otherwise restricted based on the 
countries' prior export of dogs infected with DMRVV to any other 
countries within a time frame determined by CDC or based on inadequate 
controls, as determined by CDC, in the countries to monitor and prevent 
the export of dogs to the United States with falsified or fraudulent 
rabies vaccine credentials, invalid rabies vaccination certificates, or 
other fraudulent, inaccurate, or invalid exportation/importation 
documents.
    (2) DMRVV-restricted countries may be subject to additional 
restrictions, including a complete prohibition on the importation of 
dogs into the United States from those countries as needed to prevent 
the reintroduction of DMRVV.
    (3) The Director may maintain such additional restrictions or 
prohibitions in place until the Director is satisfied that the DMRVV-
restricted country has established sufficient controls to prevent the 
reintroduction of DMRVV into the United States, including measures to 
prevent the use of falsified or fraudulent vaccine credentials or 
invalid rabies vaccination certificates.
    (4) The addition or removal of DMRVV-restricted countries from the 
list shall be announced through notification in the Federal Register, 
and a list will be maintained on CDC's website.
    (5) Notwithstanding the prohibition on imports of dogs from DMRVV-
restricted countries, the Director may allow the importation of dogs 
for scientific purposes, when used as a service animal (as defined in 
14 CFR 382.3) for individuals with disabilities, or in furtherance of 
an important government interest. In such instances CDC will issue a 
CDC dog import permit for the importation of dogs from DMRVV-restricted 
countries. Instructions for how to apply for a permit will be included 
in CDC technical instructions.
    (ff) Request for issuance of additional fines or penalties. CDC may 
request that U.S. Customs and Border Protection (CBP), pursuant to 19 
U.S.C. 1592 and 19 U.S.C. 1595a, issue additional fines, citations, or 
penalties to importers, brokers, or carriers when the Director has 
reason to believe that an importer, broker, or carrier has violated any 
of the provisions of this section or otherwise engaged in conduct 
contrary to law.

    Dated: June 30, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-14343 Filed 7-6-23; 4:15 pm]
BILLING CODE 4163-18-P