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

AGENCY:

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

ACTION:

Final rule.

SUMMARY:

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

DATES:

This final rule is effective August 1, 2024.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

This rule is organized as follows:

I. Executive Summary

a. Purpose of This Regulatory Action

b. Summary of Major Provisions

c. Costs and Benefits

II. Public Participation

III. Background

a. Legal Authority

b. Regulatory History

IV. Summary of the Final Rule

V. Alternatives Considered

VI. Summary of Public Comment and Responses

VII. Required Regulatory Analyses

a. Executive Orders 12866, 13563, and 14094

b. The Regulatory Flexibility Act

c. The Paperwork Reduction Act

d. National Environmental Policy Act (NEPA)

e. Executive Order 12988: Civil Justice Reform

f. Executive Order 13132: Federalism

g. The Plain Language Act of 2010

I. Executive Summary

A. Purpose of This Regulatory Action

Through this final rule, HHS/CDC is revising its regulation at 42 CFR 71.51 to prevent the reintroduction and spread of dog-maintained rabies virus variant (DMRVV) in the United States. HHS/CDC is also revising 42 CFR 71.50, which contains definitions applicable to animal importations under 42 CFR part 71, subpart F. The United States was declared DMRVV-free in 2007. 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. The rabies virus can infect any mammal, and, once clinical signs appear, the disease is almost always fatal. 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) involves a significant public health risk to people who directly interact with those dogs. This rule also includes requirements for dogs from DMRVV-free and low-risk countries to confirm that the dog has not been in a high-risk country during the six months before arriving in the United States. In 2019, the importation of a DMRVV-infected dog cost the affected State governments more than $400,000 U.S. dollars (USD) for the ensuing public health investigations and rabies post-exposure prophylaxis (PEP) treatments administered to exposed persons.

Through this final rule, HHS/CDC also seeks to prevent and deter the importation of dogs with falsified or fraudulent rabies vaccine documentation. In 2020, CDC observed a 52 percent increase in the number of dogs that were ineligible for admission due to falsified or fraudulent documentation, as compared to 2018 and 2019 (450 dogs compared to the previous baseline of 300 dogs per year out of an estimated 32,530 foreign-vaccinated dogs arriving annually from DMRVV high-risk countries as reported in Section VIIA). This troubling trend continued from January through June 2021, prior to the implementation of the temporary suspension in July 2021, with an additional 24 percent increase of dogs ineligible for admission in just the first half of the year, compared to the full 2020 calendar year (January-December) (approximately 560 dogs with falsified or fraudulent documentation). This final rule will also support CDC's efforts to improve data collection related to dog importation, including tracking the total number of dog importations which CDC has been unable to do previously across all ports and for all importations.

The use of a single false rabies vaccination certificate (RVC) or other rabies vaccination document as part of a larger shipment of multiple dogs raises suspicion that the rabies vaccination documents for the remaining dogs may also be false. This is not an uncommon occurrence and creates an additional burden on CDC and State health departments to track, test, and evaluate the remaining dogs in the shipment.

CDC has documented numerous importations every year in which flight parents 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. See19 U.S.C. 1592 and 19 U.S.C. 1595a.

The documented increase in fraudulent vaccine documentation and importers circumventing dog import regulations was shortly followed by the emergence of the coronavirus disease 2019 (COVID-19) pandemic. Many public health resources were redirected to the COVID-19 response, reducing the availability of resources to respond to dog importation issues. In light of this confluence of events, in June 2021, CDC published a temporary suspension of dogs entering the United States from DMRVV high-risk countries. The temporary suspension created a system that, among other things, implemented the use of standardized forms, required test results demonstrating the presence of rabies antibodies in dogs, and developed a network of animal care facilities authorized by CDC for the purpose of allowing for the immediate quarantine of dogs from DMRVV high-risk countries arriving with inadequate proof of test results. During the temporary suspension, CDC has documented decreased instances of fraud, fewer dogs being denied admission into the country, and fewer sick and dead dogs arriving in the United States from both DMRVV high-risk and DMRVV-free and low-risk countries, all of which have resulted in fewer Federal and State agency resources devoted to addressing issues related to inadequate rabies vaccination and/or documentation. This final rule implements a similar regulatory framework, expanded to dogs from DMRVV-free and low-risk countries, based on the documented successes of the temporary suspension.

B. Summary of Major Provisions

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

B.i. Requirements for All Dogs

Per this final rule, HHS/CDC requires that all dogs arriving from any country, including dogs returning to the United States after traveling abroad, be microchipped with an International Standards Organization (ISO)-compatible microchip prior to travel into the United States. The microchip information must be included on importation documents to help ensure that dogs presented for admission are the same dogs as those listed on the rabies vaccination records or other documents. CDC has documented several instances of importers attempting to present records of vaccinated dogs as the vaccination records for dogs that lacked appropriate veterinary paperwork in an attempt to import the unvaccinated dogs into the United States without detection. Because microchips were not required for entry into the United States at that time and the dogs in question were not microchipped, the public health investigations to confirm the identity of those dogs were both resource-intensive and challenging. Microchips are used frequently by pet owners and required for international transit by many foreign countries, including for importation in many DMRVV-free countries. Microchips are also recommended by the international veterinary community and animal rescue and welfare organizations to reunite lost animals with their owners and ensure that the veterinary records for an animal can be linked to the animal. Further, during CDC's temporary suspension of dogs entering the United States from DMRVV high-risk countries, CDC documented that 99 percent (>20,000) of permit applications received were for dogs that had microchips implanted prior to the announcement of the suspension. Therefore, CDC's requirement has minimal impact on dog importations, although costs to some importers may still be incurred.

To address concerns about importations of puppies that are too young to be properly vaccinated against rabies, through this final rule, HHS/CDC requires that any dog arriving in the United States be at least six months of age. Dogs cannot be vaccinated effectively against rabies before 12 weeks of age and are not considered fully vaccinated until 28 days after vaccination. Establishing a six-month minimum age requirement for the import of dogs aligns with current USDA requirements for commercial dog imports under the Animal Welfare Act and will better protect the public's health from rabies.

In this final rule, HHS/CDC also requires all dog importers to submit a CDC Dog Import Form ( i.e., an online form that includes the importers' contact information and information related to each dog being imported) via a CDC-approved system prior to travel to the United States. This requirement would apply to all imported dogs (including dogs arriving from DMRVV-free and DMRVV low-risk countries) arriving in the United States by air, land, or sea. Upon arrival at a U.S. port, importers must present a receipt confirming they submitted a completed CDC Dog Import Form; additionally, importers arriving by air must present the receipt to the airline prior to boarding. The receipt contains the information submitted on the CDC Dog Import Form, which allows government officials to verify that the details from the CDC Dog Import Form match the dog being presented for entry. CDC's import submission system is a free online system. Requiring documentation for all imported dogs allows CDC to track the total number of dog importations (including the number imported from DMRVV high-risk countries), something CDC has been unable to do previously.

To improve vaccination verification systems and deter fraud, CDC's required forms (not including the electronically submitted CDC Dog Import Form ) need to be endorsed by official government veterinarians in the country of export. Importers should contact their local veterinarian who can submit the required form to an official government veterinarian in the exporting country. Importers may also use the USDA pet travel website or IPATA website to contact a pet shipper to request assistance.

All dogs arriving by air are required to have an air waybill (AWB). An AWB is a legally binding document issued by a carrier to a shipper or importer that details the type, quantity, and destination of the goods ( i.e., dogs) being carried. It serves as a tracking number that can assist Federal agencies in monitoring the dog throughout the lifecycle of the dog's travel from the point of origin to the final destination. Additionally, a bill of lading serves as undisputed proof of shipment, and it represents the agreed upon terms and conditions for the transportation of the goods. All commercial airlines and many private cargo aircraft are capable of generating AWB. Additionally, CDC has successfully piloted the generation of AWB for dogs transported as hand-carried or excess baggage with several foreign air carriers during the temporary suspension to ensure air carriers can generate AWB for dogs transported as hand-carried or excess baggage.

B.ii. Requirements for Dogs From DMRVV-Free or DMRVV Low-Risk Countries

This final rule further permits dogs imported from DMRVV-free or DMRVV low-risk countries to arrive at any U.S. port. In lieu of a CDC vaccination form, which is required for dogs imported from DMRVV high-risk countries, these importers may instead provide proof (examples outlined in paragraph (u)) that the dogs have been in DMRVV-free or DMRVV low-risk countries only during the six months prior to arriving in the United States.

TB.iii. Requirements for Dogs From DMRVV High-Risk Countries

Per this final rule, HHS/CDC requires all importers of dogs that have been in a DMRVV high-risk country within the last six months, regardless of whether foreign- or U.S.-vaccinated, to submit a standardized vaccination form verifying the rabies vaccination status of the dog. This final rule permits dogs that have been in a DMRVV high-risk country in the past six months and have a valid U.S.-issued rabies vaccination form to arrive at any U.S. port. For dogs that have been in a DMRVV high-risk country in the past six months, and were vaccinated in a foreign country, this final rule requires that the dog arrive at a U.S. airport with a CDC quarantine station (also known as a port health station) and a CDC-registered animal care facility (ACF).

HHS/CDC is removing the current requirement for a valid RVC in 42 CFR 71.51(c) and replacing it with new rabies vaccination forms for dogs imported from DMRVV high-risk countries. The rabies vaccination forms include the rabies vaccination status of the dog and other required information similar to the previous valid RVC requirement. However, unlike the previous requirement for a valid RVC, the rabies vaccination forms are standardized.

The rabies vaccination form for foreign-vaccinated dogs from DMRVV high-risk countries must also be endorsed by a government official in the exporting country, as an added measure to prevent falsification. The name for the rabies vaccination form to fulfill this requirement for foreign-vaccinated dogs from DMRVV high-risk countries was shortened from CDC Import Certification of Rabies Vaccination and Microchip Required for Live Dog Importations into the United States as proposed in the notice of proposed rulemaking (NPRM) to Certification of Foreign Rabies Vaccination and Microchip. The requirement for this standardized form helps ensure that foreign-vaccinated dogs imported from DMRVV high-risk countries meet CDC entry requirements prior to traveling to the United States and allows for follow-up with the exporting country's government officials if repeated import violations occur.

Under this final rule, importers of U.S.-vaccinated dogs, including dogs that have been in a DMRVV high-risk country within the last six months, may arrive at any U.S. port. Prior to traveling out of the United States with a U.S.-vaccinated dog that will be present in a DMRVV high-risk country, the dog owner must obtain a form titled Certification of U.S.-issued Rabies Vaccination that must be completed and signed by a USDA-Accredited Veterinarian. The name for this rabies vaccination form was shortened from Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United States as proposed in the NPRM to Certification of U.S.-issued Rabies Vaccination. CDC is partnering with USDA to utilize the USDA export process to verify an animal was vaccinated in the United States. This form must be endorsed by a USDA Official Veterinarian prior to the dog's departing the United States and must be presented by the importer to the airline to board the dog on its return flight to the United States. The importer must also present this form when requested to do so by U.S. government officials upon arrival. By having USDA-accredited veterinarians certify documents before export from the United States, CDC can confirm the dogs were previously vaccinated in the United States. The use of this form decreases the likelihood of missing or incomplete vaccination documentation because it includes all required information in a standardized format and relies on USDA's existing veterinary accreditation system for animal exportation. This form will also reduce instances of fraud or falsification because it can be verified by any U.S. government agency online through USDA's website after the USDA official veterinarian certifies the document. Dogs from DMRVV high-risk countries arriving with this form are not subject to the requirement for veterinary examination (unless ill, injured, or exposed), revaccination, confirmation of adequate rabies serologic tests, and/or post-vaccination quarantine at a CDC-registered ACF.

HHS/CDC is requiring importers of foreign-vaccinated dogs that have been in a DMRVV high-risk country within the last six months to enter the United States through an airport with a CDC quarantine station and a CDC-registered ACF. The importer must have a reservation at the CDC-registered ACF and have their dog(s) undergo a veterinary exam and revaccination with a USDA-licensed rabies vaccine at the CDC-registered ACF. The importer must obtain a rabies serologic test from a CDC-approved laboratory for their foreign-vaccinated dogs demonstrating adequate titer levels. Importers of foreign-vaccinated dogs that have been in a DMRVV high-risk country within the last six months who cannot obtain serologic test results prior to importation are required to have their dog remain under quarantine at the facility for 28 days after revaccination or until confirmation of adequate rabies serologic test from a CDC-approved laboratory is obtained, whichever occurs first.

CDC is requiring the use of CDC-registered ACF as opposed to community veterinary clinics because (1) ACF are trained to quarantine animals, and to observe and report abnormalities in quarantined animals to CDC; (2) ACF undergo, at a minimum, an annual inspection to ensure compliance with CDC regulations; (3) ACF are experienced in pet transportation and trained to meet requirements established by airlines, exporting countries, and U.S. importation requirements; and (4) ACF are bonded facilities that have special equipment and insurance for goods ( i.e., dogs) that are awaiting clearance into the United States.

B.iv. Exemption for Foreign-Vaccinated Service Dogs at U.S. Seaports

In this final rule, HHS/CDC is allowing foreign-vaccinated service dogs that have been in a DMRVV high-risk country within the last six months to enter the U.S. at a U.S. seaport if the dog is at least six months of age; has a microchip; has a complete, accurate, and valid Certification of Foreign Rabies Vaccination and Microchip form; and has sufficient and valid titer results from a CDC-approved laboratory. To be considered a valid service dog, the dog must meet the definition of a “service animal” under 14 CFR 382.3 and accompany an “individual with a disability” as defined under 14 CFR 382.3. This exemption is limited to foreign-vaccinated service dogs entering the United States via seaports and is not available to foreign vaccinated dogs entering via air or at land ports. Under this final rule, airlines must confirm that foreign vaccinated dogs, including foreign vaccinated service dogs meet all CDC requirements prior to allowing dogs to board an aircraft. Therefore, CDC had determined that a special exemption for foreign-vaccinated service dogs arriving via air is not needed because airlines must confirm that these dogs meet all CDC requirements prior to arrival. Under such circumstances, an individual with a disability can choose to remain with their service animal and seek to rebook their flights after all CDC requirements have been met. Similarly, CDC has determined that a special exemption for foreign vaccinated service dogs is not needed at land ports because if the dogs do not meet all CDC requirements for entry, the dogs will be denied entry to the United States. Under these circumstances, the individual can choose to remain with their dogs on the non-U.S. side of the land border and then seek admission after all CDC requirements have been met. CDC further notes that there are fewer available ACFs close to land ports and allowing an exemption for foreign vaccinated service animals at land ports would be operationally impracticable. Regarding the exemption for service animals entering via seaports, CDC believes that this exemption would most likely be used by individuals with disabilities traveling with their service animals on board cruise ships and that these individuals would presumably be visiting the United States for a very short period of time before reboarding the ship ( e.g., under circumstances where an individual with a disability is participating on a shore excursion). Based on the limited amount of time that these service animals will be spending in the United States and the fact that cruise operators maintain their own vaccination requirements for service dogs, CDC believes that the rabies risk presented by foreign-vaccinated service dogs temporarily visiting the United States via cruise ship is low. The volume of foreign-vaccinated service dogs arriving from high-risk countries on board non-cruise sea vessels is also believed to be very small, compared to the number of foreign-vaccinated service dogs arriving from high-risk countries entering the US via land and air which presents a greater public health risk and the need for enforcement of the requirements without an exemption.

B.v. Requirements for Dogs From DMRVV-Restricted Countries

The final rule also authorizes HHS/CDC to prohibit or otherwise restrict the importation of dogs into the United States from certain countries that have a history of exporting dogs infected with DMRVV or have demonstrated a lack of appropriate veterinary controls to prevent the exportation of rabid dogs. HHS/CDC will maintain a “List of DMRVV-Restricted Countries” from which the importation of dogs into the United States would be prohibited on CDC's website; however, HHS/CDC is not including any countries on this list at this time. Additions or removals of countries will be announced in notices published in the Federal Register and would include a timeline for implementation. CDC retains the ability to allow certain importers to apply for and for CDC to issue CDC Dog Import Permit s on an extremely limited basis for dogs that have been in a DMRVV-restricted country in the six months prior to their importation into the United States ( e.g., for dogs imported for scientific purposes, for use as a service animal for individuals with disabilities, or in furtherance of an important government interest).

B.vi. Requirements for Airlines

The final rule further requires that an airline, prior to accepting a dog for transport, confirm that the dog possess all required import documentation based on the country of origin. Airlines must also ensure that foreign-vaccinated dogs from DMRVV high-risk countries are entering the United States only through a designated U.S. airport with both a CDC quarantine station and a CDC-registered ACF and that the importer possesses a reservation with the CDC-registered ACF for examination, vaccination, and quarantine (if required). Air carriers are required to create bill of lading ( e.g., air waybill (AWB)) for all dogs entering the United States via air, including dogs transported as cargo, hand-carried and checked-baggage. As needed, CDC will coordinate with the airline regarding transport of the dog to the CDC-registered ACF. These regulatory actions help ensure that dogs arriving in the United States from DMRVV high-risk countries are adequately protected against rabies and do not pose a public health threat.

The final rule requires that airlines return dogs or cats denied admission to the country of departure within 72 hours after arrival, unless the animal is ill or injured and CDC has approved delaying the return of the animal. The responsibility for a dog or cat pending admission into the United States or awaiting return to the country of departure has been a point of confusion for many airlines, resulting in delayed care and improper housing for numerous animals. Delays in returning dogs to their countries of departure also potentially threaten U.S. public health by exposing people to dogs with unknown rabies vaccination status. HHS/CDC requires that the airline that flew a dog or cat to the United States must arrange for and ensure transportation, housing, and care until the animal is either returned to the county of departure or cleared for entry into the United States.

This final rule also includes a provision regarding dogs and cats that die en route to the United States or that die while detained pending determination of their admissibility. This provision is primarily directed at airlines and requires that they arrange for transportation of deceased dogs and cats and for necropsy requiring gross and histopathologic examination and any subsequent infectious disease testing based on the findings. The importer is responsible for all costs associated with transportation, necropsy and testing and providing the CDC quarantine station with the final necropsy report and all test results. The airline is also required to notify the CDC quarantine station of jurisdiction prior to transporting a dead dog or cat for a necropsy to determine whether rabies testing is required. These measures will help CDC rule out foreign animal diseases of public health concern as a potential cause of death, enable CDC to take responsive measures as needed, and will protect both animal and human health. The provisions of this paragraph may also be applied to other carriers transporting such dogs and cats in the very rare event when the death of a dog or cat occurs en route to the United States, or the animal dies while detained pending determination of admissibility.

The final rule requires airlines to confirm prior to boarding a foreign-vaccinated dog from a DMRVV high-risk country that the dog is scheduled to arrive at an approved U.S. airport and the importer has documentation confirming a reservation at the CDC-registered ACF. This ensures that CDC and USDA can follow up with airlines more easily to confirm animals are being properly handled ( e.g., not left in cargo warehouses for prolonged periods of time that endanger the health of the animal). Additionally, to address concerns relating to the movement of dogs or cats that are sick or dead upon arrival, HHS/CDC requires airlines to arrange transportation of all sick or dead animals (regardless of vaccination status and country of origin) to a CDC-registered ACF or, under certain conditions, to another CDC-approved veterinary clinic as soon as possible.

The final rule requires airlines to transport healthy-appearing animals that are denied admission and awaiting return to their country of departure, or are awaiting a determination as to their admissibility, to a CDC-registered ACF within 12 hours. CDC acknowledges that extraordinary circumstances, such as extreme weather, may delay the transport of animals beyond the 12-hour window. Under such circumstances, CDC will work closely with airlines to address these rare and unforeseen events while ensuring the safe handling of animals. CDC also will work with importers who arrive at unapproved U.S. ports based on circumstances beyond their control ( e.g., re-routing of their flight due to extreme weather). CDC quarantine station staff are available 24 hours a day to assist streamlined coordination and processing of dog and cat importation at U.S. ports and provide coverage for geographic areas beyond the U.S. port in which the CDC quarantine station is located.

B.vii. Other Requirements and Summary

HHS/CDC is establishing requirements for businesses that wish to become CDC-registered ACF. Requirements include a USDA intermediate handlers registration and approved by CBP to act as a CBP-bonded facility with an active Facilities Information and Resource Management System (FIRMS) code. This ensures dogs and cats receive appropriate veterinary care and are housed in a way that prevents the spread of infectious diseases while protecting the safety of the animals. CDC-registered ACF must be located within 35 miles of a CDC quarantine station.

The requirements HHS/CDC is finalizing for dog importation into the United States are summarized below in Table E1. Since HHS/CDC is not substantially changing cat importation requirements, Table E1 does not apply to cats.

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

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

C. Costs and Benefits

CDC conducted an analysis to estimate the distributions of costs and benefits incurred with the final rule relative to regulatory baseline. The provisions of this final rule are not likely to have an effect on the economy of $200 million or more in any one year, although there is considerable uncertainty around the number of dogs imported at baseline, including the number of dogs imported from DMRVV high-risk countries.

The requirements of this final rule will address the market inefficiency in which dog importers do not account for the potential detrimental impacts to public health that may result from the importation of ill dogs, especially dogs infected with DMRVV. The worst-case scenario would include the reintroduction of DMRVV into the United States. Federal regulation is necessary to mitigate the risk of importing infected dogs. Federal action allows this risk to be addressed prior to dogs' arrival in the United States and for dogs to be evaluated, revaccinated, and possibly quarantined (if required) in controlled conditions after their arrival in the United States. The primary public health benefit is a reduction in the risk of importing dogs infected with DMRVV. The regulatory changes in this final rule are expected to affect the following categories of interested parties and implementing partners:

• Importers of dogs from countries that are DMRVV-free or are low risk for DMRVV;
• Importers of dogs from countries that are at high risk of DMRVV;
• Airlines and other carriers;
• CBP;
• CDC;
• USDA; and
• State and local public health and animal health departments.

The provisions in the final rule incorporate different requirements for dogs imported from DMRVV high-risk countries than those imported from DMRVV-free or DMRVV low-risk countries. The annualized and present value estimates of monetized costs and benefits over the 10-year period from 2024 through 2033 using three percent and seven percent discount rates are summarized below. The annualized, monetized costs (2020 USD) of the final rule are estimated to be $59 million (range: $13.1 to $207 million) using a three percent discount rate; the estimated monetized costs using a seven percent discount rate are largely the same.

Most monetized costs are expected to be incurred by importers (87 percent of costs is the most likely estimate). The estimated monetized costs are about three times greater for importers of dogs from DMRVV high-risk countries compared to importers of dogs from DMRVV-free or low-risk countries. The requirements in the final rule estimated to result in the greatest increase in costs for importers of dogs are those associated with the veterinary examination and revaccination against rabies at a CDC-registered ACF for foreign-vaccinated dogs from DMRVV high-risk countries in section 71.51(k), costs for titer testing of foreign-vaccinated dogs from DMRVV high-risk countries, additional costs associated with the CDC Dog Import Form requirement, the minimum age for imported dogs, and the microchip requirements for all imported dogs. Other costs include (1) an expected reduction in the number of dogs imported from DMRVV high-risk countries, (2) the requirement to arrive at one of six U.S. airports with CDC-registered ACF (required for foreign-vaccinated dogs arriving from DMRVV high-risk countries), and (3) the requirement to obtain a Certification of Foreign Rabies Vaccination and Microchip form or a Certification of U.S.-issued Rabies Vaccination form with certification by an official government veterinarian for all dogs from DMRVV high-risk countries. Dogs imported from DMRVV-free or low-risk countries would also require a document certified by an official government veterinarian, but HHS/CDC will allow a greater number of potential documents as specified in 42 CFR 71.51(u).

Airlines are estimated to incur about 7.0 percent of the estimated annualized costs associated with the final rule. Most airline costs would result from ensuring that all transported dogs comply with the new requirements in the final rule, the costs associated with creating bills of lading or a CDC-approved alternative for all imported dogs, and from a small reduction in the number of dogs transported. Airline costs may be passed along to dog importers.

HHS/CDC is estimated to incur about 3.3 percent of the annualized, monetized costs (most likely estimate) associated with the provisions of this final rule. Most CDC costs would be associated with the oversight of animal care facilities, which must be approved by and registered with CDC, and the establishment of a laboratory proficiency testing program to support serologic testing for foreign-vaccinated dogs imported from DMRVV high-risk countries.

CBP is expected to incur about 3.0 percent of the annualized costs (most likely estimate) associated with the provisions of this final rule. Most CBP costs would result from additional screening time at U.S. ports for dogs from DMRVV-free or low-risk countries.

The annualized monetized benefits of the provisions in the final rule are estimated to be about $1.8 million (range: $0.75 to $3.6 million) using a three percent or seven percent discount rate. Most benefits will accrue to importers (47 percent of the most likely estimates) and to CBP (30 percent of the most likely estimate). Some of the benefits estimated for both importers and CBP will result from reduced time spent on screening dogs from high-risk countries at U.S. ports because fewer dogs will be imported with the requirements included in the final rule. The requirements in the final rule are estimated to reduce the amount of time required to verify admissibility per U.S.-vaccinated dog from DMRVV high-risk country at U.S. ports because rabies vaccination documentation forms will be standardized. The provisions in this final rule are also estimated to reduce the number of dogs arriving ill or dead and the number of dogs denied entry, with benefits estimated for importers, airlines, and CDC. USDA is expected to receive payments commensurate with its cost to provide the Certification of U.S.-issued Rabies Vaccination form for U.S.-vaccinated dogs traveling internationally.

The wide range between the lower-bound and upper-bound cost and benefit estimates demonstrates that there is considerable uncertainty in these results. At present, the number of dogs imported into the United States is neither accurately nor completely tracked by any data system, and the uncertainty in the cost and benefit estimates reflect uncertainty in both the total number of dogs imported and the number of dogs imported from DMRVV high-risk countries, as well as the cost of the new requirements in the final rule. The net annualized, monetized costs (total cost estimate − total benefit estimate) were estimated to be about $57 million per year (range: $12 to $203 million) using a three percent discount rate. The annualized estimates were relatively unaffected by using a seven percent discount rate.

Because the estimated costs for foreign-vaccinated dogs from DMRVV high-risk countries are much higher than costs for other dog imports, importers may choose to import dogs from DMRVV-free or low-risk countries instead of from DMRVV high-risk countries. In addition, individuals who travel from the United States to DMRVV high-risk countries with their pet dogs for long-term visits may take the additional step to have their dogs revaccinated with a three-year rabies vaccine prior to departure, which would allow up to three years for return to the United States with a Certification of U.S.-issued Rabies Vaccination. These changes should result in lower overall costs than the above estimates for the final rule in which HHS/CDC assumed individuals would be unable to change the countries from which dogs are imported into the United States.

The importation of just one dog infected with DMRVV risks reintroduction of the virus into the United States, which could result in loss of human and animal life and substantial public health response costs. The social cost of the consequences associated with the importation of a single DMRVV-infected dog is estimated to be $270,000 (range: $210,000 to $510,000) for conducting public health investigations and administering rabies PEP to exposed persons. The primary public health benefit of the provisions in the final rule is the reduced risk that a dog with DMRVV will be imported from a DMRVV high-risk country. The above estimate of the cost of importation of a dog with DMRVV does not account for the worst-case outcomes, which include (1) transmission of rabies to a person who dies from the disease, and (2) ongoing transmission to other domestic and wildlife species in the United States. The cost of reintroduction could be especially high if DMRVV spreads to other species of U.S. wildlife. Re-establishment of DMRVV in the United States could result in costly efforts over several years to eliminate the virus again. The costs to contain any reintroduction would depend on the time period before the reintroduction was detected, the wildlife species in which DMRVV was transmitted, and the geographic area over which reintroduction occurred.

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

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

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

The monetized cost estimate has increased considerably relative to the estimates included in the NPRM. The primary reasons for the increase in cost include:

• The fees charged by ACF have increased relative to CDC's preliminary estimates.
• Some U.S. ports require that dogs needing follow-up care at ACF arrive as cargo. This requirement was not anticipated by HHS/CDC and will increase costs for importers of foreign-vaccinated dogs from DMRVV high-risk countries who otherwise would have chosen to transport their dogs as hand-carried or checked baggage. The fee charged for cargo shipments are highly variable. The future costs associated with this rule will depend on U.S. port policies that are subject to change. The average cost for the follow-up visit at ACF is estimated to be $900 (range: $500 to $1,300 per dog). The average costs associated with shipping dogs as cargo is estimated to be $2,000 (range: $1,500 to $2,500) compared to an average of $300 (range: $200 to $400) for dogs shipped as hand-carried or checked baggage. Under the regulatory baseline, HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped as cargo. With the final rule, HHS/CDC assumes that 60% of dogs going to ACF, range: 60% to 70% of dogs will be shipped as cargo.

• The cost estimate for foreign-vaccinated dogs from DMRVV high-risk countries to re-route travel destinations to arrive at authorized U.S. ports with ACF was increased.
• The costs associated with the requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries have increased because HHS/CDC added more examples of the types of proof required. Each type of document requires certification by a USDA or official government veterinarian in the exporting country. Examples include: (a) a valid foreign export certificate from a DMRVV-free or DMRVV low-risk country that has been certified by an official government veterinarian in that country; (b) a USDA export certificate if the certificate is issued to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c) a validCertification of Foreign Rabies Vaccination and Microchip form if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid Certification of U.S.-Issued Rabies Vaccination form. These documents are often required for individuals to travel internationally with their pets but are not required for travel to Canada or Mexico. These documents may be used as long as they specify travel to or from the country from which a dog is imported. Individuals who frequently travel to and from Canada and Mexico (or any other country) can obtain a valid Certification of U.S.-Issued Rabies Vaccination form, which will remain valid for multiple trips for up to three years corresponding to the duration of protection for dog rabies vaccines.
• CDC increased the estimated costs associated with shipping blood samples to CDC-approved laboratories for serological testing based on a number of comments from individuals suggesting their shipping costs were higher.
• CDC changed the requirement for importing dogs from DMRVV-free or low-risk countries such that no dogs less than six months may be imported at land borders. This will increase costs for individuals who wish to travel with their young dogs to or from Canada and Mexico.
• CDC increased the estimated costs to airlines by 100% for dogs imported from DMRVV-free or low-risk countries and by 50% for dogs imported from DMRVV high-risk countries to account for a number of comments suggesting that costs to airlines should be higher than the estimates included in the NPRM analysis.

Some of the cost estimates for the final rule have also decreased due to changes made between the NPRM and the final rule. These include:

• The costs to importers of U.S.-vaccinated dogs from DMRVV high-risk countries were reduced because the final rule will not require that such dogs arrive at U.S. ports with CDC quarantine stations.
• The costs for serological testing for foreign-vaccinated dogs from DMRVV high-risk countries were reduced because CDC plans to implement a policy that only one serological test will be required during the lifetime of such dogs as long as they remain current with their rabies vaccinations.

II. Background

a. Legal Authority

The primary legal authority supporting this final rule is section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under section 361, the Secretary of HHS (Secretary) may make and enforce such regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into any other State or possession. It also authorizes the Secretary to promulgate and enforce a variety of public health regulations to prevent the spread of communicable diseases, including through inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. Since at least 1956, Federal quarantine regulations (currently found at 42 CFR 71.51) have controlled the entry of dogs and cats into the United States.

In addition to section 361, other sections of the PHS Act relevant to this final rule are section 362 (42 U.S.C. 265), section 365 (42 U.S.C. 268), section 367 (42 U.S.C. 270), and section 368 (42 U.S.C. 271). Section 362, among other things, authorizes the Secretary to promulgate regulations prohibiting, in whole or in part, the introduction of property from foreign countries or places, for such period of time and as necessary for such purpose, to avert the serious danger of introducing communicable disease into the United States. 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. Through this statutory provision, U.S. Customs and Border Protection (CBP) within the Department of Homeland Security (DHS) provides critical assistance in enforcing Federal quarantine regulations at U.S. ports. Section 367 (42 U.S.C. 270) also authorizes the application of certain sections of the PHS Act to air navigation and aircraft to such extent and upon such conditions as deemed necessary for safeguarding public health and authorizes the promulgation of regulations.

Section 368 of the PHS Act provides that any person who violates regulations implementing sections 361 or 362 is subject to imprisonment of not more than one year, a fine, or both. Pursuant to 18 U.S.C. 3559 and 3571, an individual may face a fine of up to $100,000 for a violation not resulting in death and up to $250,000 for a violation resulting in death. HHS/CDC may refer violators to the U.S. Department of Justice for criminal prosecution. To implement section 368, HHS/CDC would request assistance from other departments and agencies to address violations.

Through this final rule, HHS/CDC is also including new language advising individuals and organizations that it may request that DHS/CBP take additional action pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a. Specifically, CDC may request that DHS/CBP issue additional fines, citations, or penalties to importers, brokers, or carriers whenever the CDC Director (Director) has reason to believe that an importer, broker, or carrier has violated any of the provisions of this section or otherwise engaged in conduct contrary to law. HHS/CDC stresses that it does not administer Title 19, and decisions regarding whether to issue such fines, citations, or other penalties would be entirely at the discretion of DHS/CBP and subject to its policies and procedures. Notwithstanding, HHS/CDC believes it important to include this language to advise individuals and organizations that it may request that DHS/CBP pursue such actions.

Through this final rule, HHS/CDC is also including new language advising individuals and organizations that it may request that the U.S. Department of Justice investigate, and based on the results of such investigation, prosecute, potential violations of Federal law arising under its dog importation regulations. This includes potential violations of 18 U.S.C. 111 which prohibits persons from forcibly assaulting, resisting, opposing, impeding, intimidating, or interfering with government employees in the conduct of or on account of their official government duties and 18 U.S.C. 1505 which prohibits disrupting agency proceedings. See, e.g., United States v. Schwartz, 924 F.2d 410, 423 (2d Cir. 1991) (holding that a U.S. Customs Service interview of defendants for purposes of determining whether to seize potentially illegal arms was an “agency proceeding” under 18 U.S.C. 1505).

HHS/CDC further clarifies that there is no agency policy of using the “least restrictive means” (as that concept is typically understood and applied in cases involving interests protected by the U.S. Constitution) regarding animal importations under 42 CFR part 71. “The Due Process Clause of the Fourteenth Amendment imposes procedural constraints on governmental decisions that deprive individuals of liberty or property interests.” Nozzi v. Hous. Auth. of City of Los Angeles, 806 F.3d 1178, 1190 (9th Cir. 2015). However, “[d]ue process protections extend only to deprivations of protected interests.” Shinault v. Hawks, 782 F.3d 1053, 1057 (9th Cir. 2015). Because individuals have no protected property or liberty interest in importing dogs or other animals into the United States, it is HHS/CDC's policy to not employ a constitutional analysis of “least restrictive means” in regard to animal imports under 42 CFR part 71. See Ganadera Ind. V. Block, 727 F.2d 1156, 1160 (D.C. Cir. 1984) (“no constitutionally-protected right to import into the United States”); see also Arjay Assoc. v. Bush, 891 F.2d. 894, 896 (Fed. Cir. 1989) (“It is beyond cavil that no one has a constitutional right to conduct foreign commerce in products excluded by Congress.”).

b. Regulatory Background

On July 10, 2023, HHS/CDC published an NPRM to update 42 CFR 71.50 and 71.51 within its Foreign Quarantine regulations to address the risk to public health from the importation of dogs and cats into the United States. The provisions contained within the NPRM were designed to enhance HHS/CDC's ability to prevent the importation and spread of dog-maintained rabies virus variant (DMRVV) into the United States and interstate by implementing requirements that are used throughout other rabies-free countries and are recommended by animal health organizations ( e.g., World Organisation for Animal Health). CDC evaluates and updates the DMRVV high-risk country list every year and generally posts the updated list on CDC's website by April 1. For this annual country risk assessment, CDC subject matter experts review publicly available data, including data from international organizations (including the World Health Organization (WHO); the WHO Rabies Bulletin—Europe; the Pan-American Health Organization, and the World Organisation for Animal Health (WOAH)); published government reports; scientific publications; and outbreak report alerts such as ProMED, as well as information provided by national and international rabies experts. HHS/CDC will also review the information and re-assess a country's status when presented with additional substantial data to support canine rabies-free status by a foreign country's officials. Lastly, CDC has published the criteria for how it determines a country's classification as a high-risk, low-risk and DMRVV-free country in peer-reviewed journal articles which are publicly available. Because of an ongoing risk of reintroduction of DMRVV due to insufficient veterinary controls in countries where DMRVV is still endemic and in parallel with the publication of the NPRM on July 10, 2023, CDC published an extension of the temporary suspension of dogs from DMRVV high-risk countries. Today's final rule has no effect on the temporary suspension, which expires on July 31, 2024. This final rule will go into effect August 1, 2024.

III. Summary of the Final Rule

Changes to 71.50

Section 71.50(b) contains definitions applicable to animal importations under subpart F of 42 CFR part 71. The definitions contained in paragraph (b) are of general scientific applicability and thus would apply to different animal imports, not just dogs and cats. After considering public comment received to the NPRM, HHS/CDC is adding the following definitions to 42 CFR 71.50(b): Authorized veterinarian, cat, dog, histopathology, in-transit shipments, microchip, necropsy, official government veterinarian. CDC is replacing the definition for “in-transit” with the definition “in-transit shipments,” as proposed in the NRPM.

This final rule also adds a new paragraph at 42 CFR 71.50(c) that addresses the legal severability of provisions found in 42 CFR part 71 subpart F—Importations. Because the provisions relating to importations under subpart F are designed to protect the public's health from various communicable disease threats, HHS/CDC intends that these provisions have maximum legal effect. Accordingly, HHS/CDC is adding language to ensure that, if this subpart is held by a reviewing court of law to be invalid or unenforceable by its terms, or as applied to any person or circumstance, the provision be construed so as to continue to give the maximum effect to the provision permitted by law. If a reviewing court should hold that a provision is utterly invalid or unenforceable, then HHS/CDC intends that the provision be severable from Subpart F and not affect the remainder or the application of the provision to persons not similarly situated or to dissimilar circumstances.

Changes to 71.51

Under this final rule, and after considering public comment received to the NPRM, Section 71.51(a) now contains definitions that are specifically applicable to the importation of dogs and cats under this section. HHS/CDC is adding the following definitions: animal, CDC-registered Animal Care Facility, Certification of Foreign Rabies Vaccination and Microchip, CDC Dog Import Form, Certification of U.S.-issued Rabies Vaccination, Certification of Dog Arriving from DMRVV-free or DMRVV Low-risk Country, conditional release, confinement, DMRVV, DMRVV-free countries, DMRVV high-risk countries, DMRVV low-risk countries, DMRVV-restricted countries, flight parent, importer, SAFE TraQ, serologic testing, USDA-Accredited Veterinarian, and USDA Official Veterinarian. In response to public comment, CDC has modified the definition of importer and added definitions for “flight parent” and “ Certification of Dog Arriving from DMRVV-free or DMRVV Low-risk Country, ” definitions that were not in the NPRM. CDC has also added a definition for CDC Dog Import Permit, and modified and shortened the names of the required rabies vaccination forms. CDC is removing the current definition for Valid rabies vaccination certificate in 42 CFR 71.51 because other rabies vaccination forms will now be required. CDC is also moving the definitions for cat and dog from 71.51(a) to 71.50(a).

In 71.51(b) through 71.51(d), HHS/CDC is finalizing the section as proposed with the exception that U.S.-vaccinated dogs may enter through any U.S. port. CDC has a high degree of confidence in USDA-licensed rabies vaccines administered in the United States; therefore, the risk of a U.S.-vaccinated dog importing rabies when returning to the United States is very low. CDC also has confidence in DMRVV-free countries that have declared themselves to be free of canine rabies using WOAH's self-declared validation process in which their surveillance and vaccination data are available for external review. Additionally, CDC has confidence in DMRVV-free and low-risk countries which demonstrate adequate surveillance capacity and vaccination control measures in accordance with CDC published metrics, but have not pursued a WOAH self-declaration status. HHS/CDC is reducing the burden on importers of U.S.-vaccinated dogs by allowing greater flexibility to be admitted through any U.S. port and is finalizing as proposed the ability of importers of cats and dogs from DMRVV-free and low-risk countries to be admitted through any U.S. port.

(b) Authorized U.S. airports for dogs and cats.

Section 71.51(b) is finalized as proposed with the exception that HHS/CDC is allowing U.S.-vaccinated dogs to enter through any U.S. airport if the dog is six months of age, microchipped, and accompanied by a valid Certification of U.S.-issued Rabies Vaccination form and CDC Dog Import Form receipt. Dogs that have been only in DMRVV-free or DRMVV low-risk countries during the last six months and all cats may also enter through any U.S. airport. Foreign-vaccinated dogs that have been in any DMRVV high-risk country within the last six months must enter through a U.S. airport with a CDC quarantine station and an ACF.

(c) Authorized U.S. land ports for dogs and cats.

Section 71.51(c) has been finalized as proposed with the exception that HHS/CDC is allowing U.S.-vaccinated dogs that have been in a DMRVV high-risk country in the past six months to enter through any U.S. land port if the dog is six months of age, microchipped, and accompanied by a valid Certification of U.S.-issued Rabies Vaccination form and CDC Dog Import Form receipt. Dogs that have been only in DMRVV-free or DRMVV low-risk countries during the last six months and all cats may enter through any U.S. land port.

(d) Authorized U.S. seaports for dogs and cats.

Section 71.51(d) has been finalized as proposed with the exception that HHS/CDC is allowing U.S.-vaccinated dogs that have been in a DMRVV high-risk country in the past six months to enter through any U.S. seaport if the dog is six months of age, microchipped, and is accompanied by a valid Certification of U.S.-issued Rabies Vaccination form and a CDC Dog Import Form receipt. Dogs that have been only in DMRVV-free or DRMVV low-risk countries during the last six months and all cats may enter through any U.S. seaport.

HHS/CDC is finalizing as proposed the prohibition of entry into the United States through a U.S. seaport for unvaccinated or foreign-vaccinated dogs that have been in a DMRVV high-risk country within the last six months with an exception for dogs meeting the definition of a “service animal” under 14 CFR 382.3. This final rule allows entry if a foreign-vaccinated dog that has been in a DMRVV high-risk country within the last six months accompanies an “individual with a disability” as defined under 14 CFR 382.3. The dog must meet all other CDC requirements for admission of a foreign vaccinated dog from a high-risk country, including that it be microchipped, at least six months of age, have a valid Certification of Foreign Rabies Vaccination and Microchip form, a valid serologic titer from a CDC-approved laboratory, and a CDC Dog Import Form receipt.

(e) Limitation on U.S. ports for dogs and cats.

Section 71.51(e) is finalized as proposed with the exception that HHS/CDC is clarifying that CBP will prescribe the time, place, and manner in which dogs are presented upon arrival at a port of entry, which may include prohibiting dogs from being presented within the Federal Inspection Station. This provision of the final rule also explicitly authorizes the CDC Director to limit the times, U.S. ports, and/or conditions under which dogs or cats may arrive at and be admitted to the United States based on an importer's or carrier's failure to comply with the provisions of this section or as needed to protect the public's health. If the CDC Director determines such a limitation is required, the CDC Director will notify importers or carriers in writing of the specific times, U.S. ports, and/or conditions under which dogs and cats may be permitted to arrive at and be admitted to the United States. This provision is applicable to all U.S. ports, including land, sea, and air.

(f) Age requirement for all dogs.

Section 71.51(f) is finalized as proposed with the exception that HHS/CDC removed the exemption for importers to import up to three dogs under six months of age at U.S. land borders if arriving from DMRVV-free or DMRVV low-risk countries. This provision of the final rule requires that all dogs arriving into the United States (regardless of whether from DMRVV-free, DMRVV low-risk, or DMRVV high-risk countries) at air-, land-, and seaports be, at minimum, six months of age. As explained in further detail below, HHS/CDC originally proposed a limited exemption for dogs under six months old primarily to reduce the burden on U.S. travelers who frequently travel across the U.S. and Canada/Mexico borders and choose to travel with young dogs. However, upon further consideration and careful evaluation of the comments received, HHS/CDC has removed the exemption proposed in the NPRM to create a uniform standard for all dogs, ensure U.S.-land borders are not overwhelmed with dog importations, and reduce the risk of importers fraudulently claiming that their dog has not been in DMRVV high-risk country.

(g) Microchip requirements for all dogs.

Section 71.51(g) is finalized as proposed with the exception that HHS/CDC is clarifying that an imported dog's microchip must have been implanted on or before the date the most recent rabies vaccine was administered. Rabies vaccines administered prior to the implantation of an imported dog's microchip are invalid. HHS/CDC is making this clarification to ensure that the dog receiving the rabies vaccine is properly identified by the microchip. Through this final rule, HHS/CDC is requiring that all dogs have an International Standards Organization (ISO)-compliant microchip prior to arrival in the United States or prior to traveling out of the United States and returning.

(h) CDC Dog Import Form for all dogs.

Section 71.51(h) is finalized as proposed. This provision of the final rule requires that importers submit a CDC Dog Import Form (OMB Control Number 0920-1383; expiration date 04/30/2027) (formerly referred to as the CDC Import Submission Form) via a CDC-approved system for each imported dog. The CDC Dog Import Form must be submitted to CDC prior to a dog's departure from the foreign country. The CDC Dog Import Form receipt must be presented to the airline prior to boarding and to Federal officials upon arrival.

(i) Inspection requirements for admission of dogs and cats.

Section 71.51(i) is finalized as proposed. This final rule requires that dogs and cats may be denied admission if an importer refuses to consent to required inspection, examination, diagnostic testing, or disease surveillance screening.

(j) Examination by a USDA-Accredited Veterinarian and confinement of exposed dogs and cats or those that appear unhealthy.

Section 71.51(j) is finalized as proposed with minor reorganization of the paragraph. This final rule requires that, in the event a dog or cat arrives ill, is denied admission, or is exposed to a sick animal in transit, the airline must arrange for confinement in an ACF or CDC-approved veterinary clinic (if an ACF is not available or is unable to adequately care for the ill or injured animal) and transport to the facility in a way that does not expose transportation personnel or the public to communicable diseases. This provision may also be applied to other carriers transporting dogs and cats in the rare circumstances where it is necessary for public health reasons to require that the carrier arrange for examination and confinement. The importer bears the expenses of transportation, confinement, examination, testing, and treatment. The final rule further clarifies an airline's responsibilities in the event an importer abandons a dog or cat. If an importer fails to pay for such expenses, then the animal may be considered abandoned, and the airline will be required to assume financial responsibility.

(k) Veterinary examination, revaccination against rabies, and quarantine at a CDC-registered animal care facility for foreign-vaccinated dogs.

Section 71.51(k) is finalized as proposed with the exception that the paragraph name has been modified to reflect all the required components of the paragraph. However, the requirements within the paragraph have not changed. HHS/CDC is clarifying that suspected or confirmed communicable diseases need only be reported to CDC. Additional notification of Federal, state, and local public health partners will be done by CDC. HHS/CDC now requires that all foreign-vaccinated dogs arriving from DMRVV high-risk countries have a valid Certification of Foreign Rabies Vaccination and Microchip form and undergo veterinary examination and revaccination against rabies at an ACF upon arrival. The importer is responsible for making a reservation and all arrangements relating to the examination, revaccination, and quarantine (if quarantine is required) of dogs with an ACF prior to the dogs' arrival in the United States.

Airlines must deny boarding to dogs if the importer fails to present a receipt of the completed CDC Dog Import Form (OMB Control Number 0920-1383; expiration date 04/30/2027) and confirmation of a reservation at an ACF. The costs of examination, vaccination, and quarantine (if required) are the responsibility of the importer and not the United States Government. Animals that are abandoned before meeting requirements outlined below become the legal responsibility of the airline.

This final rule further requires that the dogs remain in the custody of an ACF until all of the following requirements are met:

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

(l) Registration or renewal of CDC-registered animal care facilities.

HHS/CDC is finalizing section 71.51(l) as proposed with the exception that CDC may conduct inspections of ACF which will be guided by the USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and other standards outlined in CDC's Technical Instructions for CDC-registered Animal Care Facilities. Failure to adhere to standard operating procedures (SOP) requirements as outlined in USDA Animal Welfare regulation standards or CDC's Technical Instructions for CDC-registered Animal Care Facilities would constitute grounds for not registering or renewing an ACF's registration.

Per this final rule, HHS/CDC is requiring that an animal care facility register with and receive written approval from CDC, USDA, and CBP to submit their facility application before housing any imported live dog in the United States. The applicant must provide written SOP outlining how CDC's regulatory requirements will be met and the health and safety of animals and staff will be ensured. A copy of all Federal, State, or local registrations, licenses, or permits will also be required to be submitted to CDC. Additionally, HHS/CDC requires the facility to have a USDA intermediate handlers registration (and any other licenses or registrations required by USDA) and a FIRMS code issued by CBP.

This section has been finalized as proposed with the clarification that an ACF must be located within 35 miles of a CDC quarantine station. The facility is subject to inspection by CDC at least annually and required to renew their registration every two years. Animal health records, facilities, vehicles, or equipment to be used in receiving, examining, and processing imported animals are also subject to inspection.

(m) Record-keeping requirements at CDC-registered animal care facilities.

Section 71.51(m) is finalized as proposed with the exception that the section references a document other than a bill of lading if the airline has been granted a waiver to the bill of lading requirement under paragraph (dd). The waiver to the bill of lading requirement is discussed more fully in explanation text to section (dd). Per this final rule, HHS/CDC requires that any ACF retain records regarding each imported animal for three years after the distribution or transfer of the animal. Records must be uploaded into CDC's System for Animal Facility Tracking during Quarantine (SAFE TraQ) and completed prior to the animal's release from the facility. HHS/CDC is clarifying that records for necropsy results should be uploaded into SAFE TraQ within 30 days of an animal's death. Each record must include:

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

Certification of Foreign Rabies Vaccination and Microchip form (OMB Control Number 0920-1383; expiration date 04/30/2027) and rabies serology obtained before arrival in the United States (if applicable);

The USDA-licensed rabies vaccine administered upon arrival;

Veterinary exam records upon arrival and while in quarantine;

Rabies serology performed while in quarantine in the United States (if applicable); and

All diagnostic test, histopathology and necropsy results performed during quarantine (if applicable).

The facility is required to maintain these records electronically and allow CDC to inspect the records.

(n) Worker protection plan and personal protective equipment (PPE).

Section 71.51(n) is finalized as proposed with the exception that HHS/CDC is noting that procedures for reporting suspected or confirmed communicable diseases associated with handling animals in facility workers must be reported to CDC within 48 hours. This requirement was included in the NPRM in paragraph (q) and has been moved to paragraph (n) for clarity. Today's final rule requires that an ACF establish and maintain a worker protection plan with standards comparable to those in the Occupational Safety and Health Administration's Recommended Practices for Safety and Health Programs and the National Association of Public Health Veterinarians (NASPHV) Compendium of Veterinary Standard Precautions for Zoonotic Disease Prevention in Veterinary Personnel. Such a worker protection plan must include rabies pre-exposure prophylaxis consistent with CDC guidance for workers who handle imported animals with signs of illness or in quarantine, and for staff who perform necropsies of imported animals; post-exposure procedures that provide potentially exposed workers with direct and rapid access to a medical consultant; and procedures for documenting the frequency of worker training, including for those working in the quarantine area. As part of the worker protection plan, a facility must also establish, implement, and maintain hazard evaluation and worker communication procedures that include descriptions of the known communicable disease and injury hazards associated with handling animals, the need for PPE when handling animals and training in the proper use of PPE, and procedures for disinfection or safe disposal of garments, supplies, equipment, and waste.

(o) CDC-registered animal care facility standard operating procedures, requirements, and equipment standards for crating, caging, and transporting live animals.

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

(p) Health reporting and veterinary service requirements for animals at CDC-registered animal care facilities.

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

• Veterinary examination by a USDA-Accredited Veterinarian within one business day of arrival;
• Verification of microchip and confirmation that the microchip number matches the animal's health records;
• Verification of animal's age via a dental examination (or other CDC-approved method);
• Vaccination against rabies using a USDA-licensed vaccine; and
• Confirmation of an adequate serologic test from a CDC-approved laboratory OR completion of a 28-day quarantine after administration of the USDA-licensed rabies vaccine.

This provision also requires that the facility notify CDC within 24 hours of the occurrence of any morbidity or mortality of animals in the facility. Any animal that dies during transport or while in quarantine at a ACF is required to undergo a necropsy and diagnostic testing to determine the cause of death. An animal that arrives ill or becomes ill while at the ACF must be examined by a USDA-Accredited Veterinarian immediately and must undergo diagnostic testing to determine the cause of illness prior to release from the facility. Suspected or confirmed communicable diseases in animals must be reported to CDC within 24 hours of identification.

(q) Quarantine requirements for CDC-registered animal care facilities.Section 71.51(q) is finalized as proposed with the exception that HHS/CDC is clarifying that quarantined animals must be housed in such a manner that they do not expose other quarantined animals or non-quarantined animals (including animals other than dogs or cats). Additionally, animals in quarantine may not be housed together even if they were transported as part of the same shipment. After consideration of public comments, this final rule establishes requirements for the quarantine area at ACF to ensure animals are safely housed and do not present a public health risk to humans or other animals. These requirements include security measures within the facility to prevent unintended public exposure to quarantined animals, limited access to animal quarantine areas, monitoring animals for signs of any communicable illness, and timely notification of CDC of animals that becomes ill during quarantine. Additionally, suspected or confirmed communicable diseases in animals or facility workers must be reported to CDC. ACF must also establish standard operating procedures for safe handling and necropsy of any animal that dies in quarantine.

(r) Revocation and reinstatement of a CDC-registered animal care facility's registration. Section 71.51(r) is finalized as proposed with the exception that it explicitly references the ability of the Secretary to review a CDC revocation of an ACF registration if the Secretary so chooses. The Secretary has authority to act as final arbiter and review the CDC Director's decisions relating to animal importations if the Secretary so chooses.

Section 71.51(r) establishes procedures to revoke an ACF's registration if the Director determines that it has failed to comply with any applicable provisions of this section, including failure to abide by the facility's standard operating procedures, USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and 3), or the International Air Transport Association standards. Under the terms of this provision, CDC will send the facility a notice of revocation stating the grounds upon which the proposed revocation is based. If the facility contests the revocation, the facility may file a written response to the notice within five business days. All the grounds listed in the proposed revocation will be deemed admitted if the facility does not respond within five business days, in which case CDC's notice of revocation will constitute final agency action, unless the Secretary, within one business day, decides to excuse the facility's failure to respond on a timely basis.

If a facility's response is timely, the Director will review the registration, the notice of revocation, and the response. As soon as practicable after completing the written record review, the Director will issue a decision in writing that shall constitute final agency action, unless the Secretary, within one business day, decides to review the Director's decision. The Director will provide the facility with a copy of the written decision. The Director, in the Director's discretion, may reinstate a revoked registration after inspecting the facility, examining its records, conferring with the facility, and receiving information and assurance from the facility of compliance with the requirements of this section.

(s) Requirement for the Certification of Foreign Rabies Vaccine and Microchip form to import a foreign-vaccinated dog from DMRVV high-risk countries.

Section 71.51(s) is finalized as proposed with the exception that HHS/CDC shortened the name of the form to the Certification of Foreign Rabies Vaccine and Microchip (OMB Control Number 0920-1383; expiration date 04/30/2027). Through this final rule, HHS/CDC is requiring a new, standardized rabies vaccination form for all foreign-vaccinated dogs that have been in any DMRVV high-risk countries within the last six months. In addition to details about the dog, importer, and veterinarian, the form must be completed by an Authorized Veterinarian that examined the dog in the exporting country and certified by an official government veterinarian attesting that the authorized veterinarian is licensed or authorized to practice veterinary medicine in the exporting country. The authorized veterinarian and the official government veterinarian must further attest that the information listed on the form is true and correct.

(t) Requirement for Certification of U.S.-Issued Rabies Vaccination Form for importers seeking to import U.S.-vaccinated dogs from DMRVV high-risk countries.

Section 71.51(t) is finalized as proposed with the exception that HHS/CDC shortened the name of the form to the Certification of U.S.-Issued Rabies Vaccination (OMB Control Number 0920-1383; expiration date 04/30/2027). HHS/CDC now requires that U.S.-vaccinated dogs re-entering the United States from DMRVV high-risk countries be accompanied by a Certification of U.S.-issued Rabies Vaccination Form. The form must be completed by a USDA-Accredited Veterinarian and endorsed by a USDA Official Veterinarian prior to the dog departing the United States. People who leave the United States with their dogs without first obtaining this form will be required to have their dogs re-enter the United States as if they are foreign-vaccinated dogs and be required to meet all the requirements as outlined in section (s) for the dogs to be eligible for re-entry from a DRMVV high-risk country.

(u) Requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries.

Section 71.51(u) is finalized as proposed with the exception that, based on public comment, CDC is now including a list of acceptable documents importers may provide to confirm a dog has been only in DMRVV low-risk or DMRVV-free countries during the last six months before arriving in the United States. This list includes a valid USDA export certificate, a valid foreign export certificate, a valid Certification of Dog Arriving from DMRVV-free or DMRVV Low-risk Country form, or other records or documents satisfactory to the Director. Importers may also provide proof of rabies vaccination, which is recommended but not required for dogs arriving from DMRVV-free or DMRVV low-risk countries, using the Certification of Foreign Rabies Vaccination and Microchip form or the Certification of U.S.-Issued Rabies Vaccination form. All forms must be endorsed by an official government veterinarian to be considered valid. Certification of Foreign Rabies Vaccination and Microchip forms must be endorsed by an official government veterinarian in a DMRVV-free or DMRVV low-risk country to be used as proof that a dog has been only in DMRVV low-risk or DMRVV-free countries. Importers should contact their local veterinarian who can submit the required form to an official government veterinarian in the exporting country. Importers may also use the USDA pet travel website or IPATA website to contact a pet shipper to request assistance. The list of acceptable documents is also located on CDC's website. This final rule requires that dogs imported from DMRVV low-risk or DMRVV-free countries be accompanied by appropriate written documentation demonstrating that they have been only in DMRVV low-risk or DMRVV-free countries during the last six months. The documentation must also confirm that the dog is at least six months of age and is microchipped. There have been no changes made for cat rabies vaccination importation requirements. Instead, CDC continues to recommend that importers comply with State or Territorial requirements for rabies vaccination in cats and dogs from DMRVV-free or DMRVV low-risk countries.

(v) Denial of admission of dogs and cats.

Section 71.51(v) is finalized as proposed with the exception that HHS/CDC may additionally deny entry to an animal if an importer refuses to comply with CDC-required diagnostic tests to rule out communicable diseases. Diagnostic tests are crucial to determine the cause of an illness and ensure the animal does not pose a public health threat. This section also references alternative documentation to a bill of lading if the airline has been granted a waiver to the requirement that it create a bill of lading for dogs prior to the dogs' arrival in the United States.

This section outlines the categories of dogs and cats that are inadmissible to the United States. CDC will coordinate with CBP to enforce this action whenever CDC determines that an animal is inadmissible. This includes:

• Any dog arriving from a DMRVV low-risk or DMRVV-free country without written documentation that the dog has been only in DMRVV low-risk or DMRVV-free countries during the six months prior to the attempted entry, or if the CDC Director reasonably suspects fraud.
• Any dog that is not accompanied by a receipt confirming that aCDC Dog Import Form has been submitted to CDC through a CDC-approved system.
• Any dog arriving by air for which a bill of lading, including an air waybill, has not been created by the airline prior to the dog's arrival in the United States (regardless of the value of the shipment) unless the airline transporting the dog has been granted a waiver pursuant to paragraph (dd) and the airline's handling and transport of the dog is consistent with the terms of that waiver.
• Any unvaccinated or foreign-vaccinated dog arriving at a U.S. land port that has been in a DMRVV high-risk country within the last six months prior to the attempted entry.
• Any unvaccinated or foreign-vaccinated dog arriving at a U.S. seaport that has been in a DMRVV high-risk country within the last six months prior to the attempted entry, except for a dog qualifying as a service animal that is otherwise admissible under section (d).
• Any foreign-vaccinated dog that has been in a DMRVV high-risk country within the last six months and does not arrive at a U.S. airport with a CDC quarantine station and an ACF.
• Any animal imported by an importer who refuses to comply with the requirement (if applicable) for the animal to undergo disease surveillance screening, veterinary examination, revaccination, diagnostic testing, provide proof of sufficient rabies serologic tests, or quarantine at an ACF upon arrival.
• Any dog that has been in a DMRVV high-risk country within the last six months and arrives without a validCertification of U.S.-Issued Rabies Vaccination form or a valid Certification of Foreign Rabies Vaccination and Microchip form.
• Any foreign-vaccinated dog imported from a DMRVV high-risk country that arrives without a reservation at an ACF.
• Any dog from a DMRVV-restricted country that arrives without a validCDC Dog Import Permit.
• Any dog imported from a DMRVV high-risk, DMRVV low-risk, or DMRVV-free country if the CDC Director reasonably suspects fraud in any documentation required for admission or if such documentation is otherwise untruthful, inaccurate, or incomplete.
• Any dog or cat, regardless of country of departure, that poses a public health risk, including dogs or cats that appear unhealthy upon arrival or demonstrate signs or symptoms of communicable disease.
• Any dog arriving in the United States that is under six months of age.
• Any dogs arriving in the United States without a microchip or without their microchip number documented on the importation paperwork required by CDC.

(w) Dogs and cats awaiting an admissibility determination or return to their country of departure.

HHS/CDC has split section 71.51(v) as written in the NPRM into two sections for ease of reading and greater clarity. Section 71.51(w) is a new paragraph, but the final requirements in section 71.51(w) were included in the NPRM under section 71.51(v). These requirements are finalized as proposed with the exception that based on public comment CDC is changing the timeframe for airlines to transport a healthy animal to an ACF or another CDC-approved facility (if an ACF is not available) from 6 hours to 12 hours. However, airlines must arrange to transport an obviously ill or injured animal immediately.

Animals arriving by air must be held in an ACF or another CDC-approved facility (if an ACF is not available) pending an admissibility determination or pending return to their country of departure if denied admission. As finalized, airlines must transport healthy animals to a ACF or other CDC-approved facility (if an ACF is not available) within 12 hours of arrival.

An airline must immediately report an obviously ill or injured animal ( e.g., the animal is unable to stand, has difficulty breathing, is bleeding, has broken bones or disfigured limbs, or is experiencing seizures, vomiting, or discharge from the nose, mouth, or eyes) arriving into the United States to the CDC quarantine station of jurisdiction. As finalized, the airline must immediately arrange to transport an obviously ill or injured animal to an ACF or veterinary clinic as directed by HHS/CDC.

Animals arriving by sea that are denied admission must remain on the vessel while awaiting return to the country of departure.

(x) Disposal or disposition of dogs and cats denied admission or abandoned prior to admission that were transported to the United States.

Section 71.51(x) is finalized as proposed. HHS/CDC has developed an operational framework primarily applicable to airlines regarding how dogs denied admission will be handled by carriers and importers. HHS/CDC clarifies that airlines must provide housing for animals awaiting return to their country of departure at an ACF or a CDC-approved animal facility if an ACF is not available. Airlines are required to return animals denied admission to the country of departure within 72 hours of arrival, regardless of carrier or route. This is to ensure airlines do not leave animals in warehouses unattended for prolonged periods of time. Airlines are able to request extensions for an animal's return in the event the animal is not medically fit for travel. This operational framework provides that importers are responsible for all associated costs relating to the housing, care, and treatment of a dog or cat denied admission pending return to its country of departure. However, if an importer fails to pay any costs or fails to comply with any requirements, the animal will be considered abandoned, and the relevant carrier would be required to assume responsibility.

Under this framework, in instances where a dog or cat is fatally ill or injured, the importer or airline may choose a humane euthanasia option in accordance with the standards of the American Veterinary Medical Association performed by a licensed veterinarian. The importer or airline must notify CDC and CBP in writing of this decision. This decision does not relieve the importer or airline of the obligation to obtain and report results of necropsy or diagnostic testing required by CDC.

In the case of dogs and cats denied admission to the United States upon arrival at a U.S. seaport, the vessel's master or operator would be required to reembark the animal immediately and return it to its country of departure on the next voyage. In the case of dogs and cats denied admission to the United States upon arrival at a U.S. land port, the importer or carrier would be required to immediately return it to its country of departure.

HHS/CDC does not expect the above operational framework relating to housing, care, and treatment of a dog or cat denied admission to be applied on a routine basis to carriers or importers arriving with dogs or cats at U.S. land or seaports because the circumstances leading to a delay in returning a dog or cat to its country of departure are not typically present at these U.S. ports. However, HHS/CDC acknowledges that there may be rare and unforeseen circumstances where it may be necessary to apply such procedures. Accordingly, HHS/CDC has added language authorizing it to apply these provisions in circumstances where a dog or cat is denied entry at a U.S. land or seaport and cannot be immediately returned to its country of departure ( e.g., because it is unfit to travel). Section 71.51(x) is finalized as proposed.

(y) Appeals of CDC denials to admit a dog or a cat upon arrival into the United States.

Section 71.51(y) is finalized as proposed with the exception that it explicitly references the ability of the Secretary to review a CDC decision to deny admission to dogs and cats if the Secretary so chooses. The Secretary has authority to act as final arbiter and review the CDC Director's decisions relating to animal importations if the Secretary so chooses. This section outlines the appeal process for importers of dogs and cats in the event their animals are denied admission to the United States upon arrival.

Because denial of admission to dogs and cats under these limited circumstances is likely to occur at a port, HHS/CDC requires that any appeal be submitted to CDC within one business day so as not to unnecessarily prolong the appeal process and allow for expedited decision-making regarding whether an animal should be returned to its country of departure. Instructions on how to submit an appeal are included in the regulatory text. Pending a determination regarding the appeal the animal will remain the legal responsibility of the carrier. The Director will issue a written response to the appeal, which shall constitute final agency action, unless the Secretary, within one business day, decides to review the Director's decision.

(z) Record of death of dogs and cats while en route to the United States and disposition of dead animals.

Section 71.51(z) is finalized as proposed. The requirement that carriers maintain a record of sickness or death for any animals that die during transit is longstanding. Through this final rule, HHS/CDC will now require necropsy and diagnostic testing for any dog or cat that dies en route to the United States or at a U.S. port prior to admission to determine the cause of death. Consistent with current requirements, carriers would be required to report deaths to the CDC quarantine station of jurisdiction. HHS/CDC is including these amendments to ensure it can detect, provide referrals to appropriate agencies, and respond to potential communicable disease importation risks in a timely manner. Importers are responsible for the costs unless they abandon the animal, in which case the airline or master or operator of a vessel will assume responsibility for the costs.

(aa) Abandoned shipments of dogs and cats.

Section 71.51(aa) is finalized as proposed. Through this final rule, HHS/CDC is providing an operational framework primarily applicable to airlines for when a dog or cat would be considered abandoned prior to admission and thus require the carrier to assume responsibility for the shipment.

The provisions of Section 71.51(aa) may also be applied to other carriers transporting such dogs and cats in the rare circumstances where the dog or cat is abandoned by the importer at a U.S. land port or seaport and other options are not available.

(bb) Sanitation of cages and containers of dogs and cats.

Section 71.51(bb) is finalized as proposed. This section requires that cages or other containers of animals arriving in the United States be cleaned and disinfected or the animals removed and placed in clean containers if the cages or other containers constitute a communicable disease risk.

(cc) Requirements for in-transit shipments of dogs and cats.

Section 71.51(cc) is finalized as proposed. Under today's final rule, CDC's definition of an “in-transit shipment” now aligns with that of the USDA. This provision further clarifies that dogs and cats can only be considered in-transit if they are transported as cargo and not as hand-carried baggage or checked baggage. In-transit shipments may only be transported as cargo. HHS/CDC is also clarifying that a microchip is not required for dogs that are transported by aircraft and are being transited through the United States if retained in the custody of the airline.

(dd) Bill of lading and other airline requirements for dogs.

Section 71.51(dd) has been finalized as proposed with the exception that airlines that lack the technical ability to generate a bill of lading (including an air waybill (AWB)) to transport dogs may request a waiver from CDC and provide a SOP outlining how they will ensure care for any ill, injured, or abandoned animals or animals denied entry in the absence of an AWB. This final rule requires that airlines create a bill of lading accounting for all live dog imports through a U.S. airport, regardless of whether the dogs are transported as cargo, checked baggage, or hand-carried baggage, or otherwise accompany a traveler arriving in the United States on their person.

As a condition of granting a waiver to the bill of lading requirement, HHS/CDC may require the airline to work with a broker to file the appropriate paperwork and identify suitable housing accommodations (such as an ACF or a local kennel approved by CDC and CBP) for any dogs detained pending admissibility. The SOP must include the location of an ACF or other suitable alternative approved by CBP and CDC prior to transport of animals. HHS/CDC may require the airline to submit documentation outlining a timetable and steps that will be taken to develop the technical capacity to generate an AWB (or another suitable alternative to an AWB) to transport dogs. CDC has provided additional details for airlines seeking exemption for the AWB requirement in technical instructions available on CDC's website at www.cdc.gov/dogtravel.

Section 71.51(dd) also requires that airlines confirm that all importers have a receipt of a completed CDC Dog Import Form prior to boarding. For U.S.-vaccinated dogs that have been in a DMRVV high-risk country within the last six months, CDC requires that airlines confirm that importers have a valid Certification of U.S.-issued Rabies Vaccination form. For foreign-vaccinated dogs that have been in a DMRVV high-risk country within the last six months, airlines must confirm that importers have a reservation at an ACF. For dogs from DMRVV-free or DMRVV low-risk countries, HHS/CDC will require that airlines confirm that the importer has documentation as outlined in paragraph (u) showing that the dog is over six months of age, has a microchip, and has been only in DMRVV-free or DMRVV low-risk countries within the last six months.

Finally, section 71.51(dd) requires that a representative of an airline transporting live dogs into the United States be on-site at the U.S. airport and available to coordinate the entry/clearance of the dogs with Federal government officials until all live dogs transported on an arriving flight into the United States have either been cleared for admission, arrangements have been made to transport the dogs to an ACF or other facility ( e.g., veterinary clinic or kennel) approved by CDC pending admissibility determination, or arrangements have been made for return of dogs not meeting CDC entry requirements.

(ee) Order prohibiting carriers from transporting dogs and cats.

Section 71.51(ee) is finalized as proposed. This final rule outlines procedures for the CDC Director to issue an order revoking a carrier's permission to transport live dogs and cats into the United States if a carrier has endangered the public health of the United States by acting or failing to act to prevent the introduction of DMRVV, as would occur by failing to comply with the provisions of this section.

(ff) Prohibition on imports of dogs from DMRVV-restricted countries.

Section 71.51(ff) is finalized as proposed. This section of the final rule explicitly states that HHS/CDC may prohibit or otherwise restrict the import of dogs into the United States from certain countries that have repeatedly exported rabid dogs to any country or that lack adequate controls to monitor and prevent the export of dogs to the United States with falsified or fraudulent rabies vaccine credentials, invalid rabies vaccination forms, or other fraudulent, inaccurate, or invalid exportation/importation documents. Such a prohibition or other restriction will remain in place until there is sufficient evidence for CDC to be assured that adequate controls have been established to prevent the reintroduction of DMRVV into the United States, including preventing the use of falsified or fraudulent vaccine credentials. To implement this provision HHS/CDC will maintain a list of DMRVV-restricted countries. The list will be maintained on CDC's website at www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html and updated annually. Amendments to the list of DMRVV-restricted countries will be published as a notice in the Federal Register . HHS/CDC may allow the importation of certain categories of dogs from DMRVV-restricted countries, such as service animals or government-owned animals.

(gg) Request for issuance of additional fines or penalties.

Section 71.51(gg) is finalized as proposed with the exception that CDC is adding language informing the public that it may also refer potential violations of Federal law to the U.S. Department of Justice for investigation, and based on the results of such investigation, prosecution. Specifically, CDC may refer a matter to the U.S. Department of Justice if the Director has reason to believe that an individual or organization has violated Federal law, including by forcibly assaulting, resisting, opposing, impeding, intimidating, or interfering with a U.S. government employee while engaged in or on account of the performance of their official duties in violation of 18 U.S.C. 111, by obstructing an agency proceeding in violation of 18 U.S.C. 1505, or by otherwise engaging in conduct contrary to law. This provision also serves to inform the public of actions that CDC may take to request DHS/CBP assistance in enforcing HHS/CDC's dog and cat importation requirements. HHS/CDC stresses that it does not administer Title 19, and decisions regarding whether to pursue enforcement actions under Title 19 would be entirely at the discretion of DHS/CBP and subject to its policies and procedures.

IV. Alternatives Considered

In developing this final rule, HHS/CDC considered more and less costly policy alternatives. The provisions included in the final rule were determined to minimize the cost and burden of the regulatory provisions while protecting and reducing risks to the public's health. To reduce the costs associated with the provisions of the final rule, many requirements only apply to dogs imported from DMRVV high-risk countries, and some apply only to dogs vaccinated outside the United States imported from DMRVV high-risk countries.

Table I summarizes alternatives to selected requirements expected to be associated with most of the monetized costs and benefits for this rule relative to the current status quo. A quantitative analysis of the cost and benefits is available in an Appendix found in the Supplemental Materials tab of the docket and summarized in Section VII(A).

HHS/CDC determined that the set of lower-cost alternatives would likely not have a significant impact on reducing the risk of dogs being imported with DMRVV compared to the regulatory baseline. The requirements in the final rule would more effectively reduce this risk. If the age requirements were reduced, importers may be more likely to attempt to circumvent CDC rules to move dogs from DMRVV high-risk to DMRVV-free or low-risk countries prior to importation into the United States. It is difficult to age dogs under six months, and CDC has documented cases of fraud involving the movement of dogs under six months of age from DMRVV high-risk countries to DMRVV-free and DMRVV low-risk countries to avoid rabies vaccination requirements. By requiring all dogs to be at least six months of age, CDC can better confirm that the dog presented matches the documentation presented, particularly the age listed for the dog, and that it is old enough to be adequately vaccinated for rabies. This age requirement also more closely aligns with the WOAH standard for dogs from high-risk countries that states dogs should be imported 90 days after a serologic sample has been drawn.

In addition, transporting dogs under six months of age under conditions with unstable and fluctuating air temperatures, such as those present in the cargo area of a plane, may subject these young animals to adverse events (illness or death) because young animals cannot regulate their body temperature as efficiently as adult animals. International travel often results in prolonged time between feeding and watering of animals leading to potential adverse events (illness and death) in young animals due to physiologic stressors associated with or exacerbated by low blood glucose levels, low oxygen environments (such as the cargo area of a plane), dehydration, and the stress of travel. This could result in more ill and dead dogs arriving on flights (reducing the benefits estimated for the final rule). CDC would lack data on the total number of dogs imported into the United States and would have less data to conduct public health investigations in the event that a sick dog is imported from DMRVV-free or low-risk country. In the absence of official certification of the Certification of U.S.-issued Rabies Vaccination form, CDC believes it would be much easier for importers of dogs from DMRVV high-risk countries to present fraudulent documentation of U.S. rabies vaccination. It would be more difficult for CDC to verify the identity of dogs arriving with tattoos instead of microchips (increasing the risk of fraudulently imported dogs). Microchips are also already widely used throughout the world and are a WOAH standard for the international movement of animals.

Follow-up examination and revaccination of dogs by any U.S.-licensed veterinarian would be less costly in comparison to services provided by CDC-registered ACF; however, this would increase the public health risk associated with foreign-vaccinated dogs from DMRVV high-risk countries. CDC would have limited capacity to follow up with importers to ensure that the dogs had been appropriately examined and revaccinated in a timely manner. Prior to the examination, the dog could come into contact with additional people and potentially other pets or wildlife. Finally, staff at CDC-registered ACF will operate according to CDC regulations and guidance to minimize the risk of disease transmission to humans and other animals.

CDC would have very limited oversight of the laboratories conducting serological tests. Importers would also find it easier to obtain fraudulent serological tests from laboratories that are not approved by CDC or may get inaccurate test results from unapproved laboratories. If CDC allowed foreign-vaccinated dogs to arrive at any U.S. port with a CDC quarantine station (also known as a CDC port health station), the government ( i.e., CBP and CDC) would not be able to ensure that the dogs had been cleared by a CDC-registered ACF prior to admitting the dogs into the United States. In summary, the lower-cost alternatives would result in significantly less costs for importers and airlines but would also significantly limit the ability of CDC to prevent the importation of inadequately vaccinated dogs from DMRVV high-risk countries. CDC has observed that many importers have tried to circumvent CDC requirements for dog importation and the provisions in this final rule are chosen to mitigate these risks. The lower-cost alternatives would lead to a significantly increased risk that dogs infected with DMRVV would be imported.

CDC did not select any of the higher-cost alternatives described above because most of these alternatives do not address the highest-risk category of imported dogs, i.e., foreign-vaccinated dogs from DMRVV high-risk countries. As a result, the public health benefits associated with these higher-cost alternatives would not decrease the risk to the public health sufficiently to balance the costs of these alternatives. CDC has not observed any DMRVV infections among U.S.-vaccinated dogs imported from DMRVV high-risk countries or among dogs imported from DMRVV-free or low-risk countries. In addition, CDC can obtain the data it needs from the lower-cost CDC import data submission system and does not require a tattoo in addition to a microchip to confirm the identity of imported dogs. Because of the limited public health benefit relative to the additional costs, HHS/CDC believes the requirements in the final rule address the risks associated with imported dogs infected with DMRVV or other exotic pathogens more cost effectively than the alternatives.

VI. Summary of Public Comments and Responses

On July 10, 2023, HHS/CDC published a NPRM proposing to amend the current foreign quarantine regulations at 42 CFR 71.50 and 71.51 to provide additional clarity and safeguards to address the public health risk of DMRVV associated with the importation of dogs into the United States (88 FR 43978). In the NPRM, HHS/CDC specifically requested public comment on the following:

• A limited exception to accommodate personal pet owners who travel by land between the U.S. and Canada or Mexico.
• The proposed requirement that airlines transport and assume responsibility (if the importer abandons the animal) for necropsy of dogs and cats that dieen route to the United States or that die pending an admissibility determination. Necropsy would include gross and histopathologic examination and any subsequent infectious disease testing based on the findings.
• The proposed requirement for the rabies vaccination form for foreign-vaccinated dogs to be certified by a foreign government official in the exporting country, as an added measure to prevent falsification.
• The proposed public health standards and evidence used to maintain a list of DMRVV-restricted countries and the length of time or conditions to be met before a country is added to or eligible for removal from the list. Additionally, how the list will be maintained and whether publication on CDC's website and throughFederal Register notices would be sufficient to adequately inform importers.
• The potential costs to carriers of dogs arriving by land or sea (as opposed to airlines) to comply with the requirements proposed in the NPRM.
• Estimates of the number of dogs any small individual entity currently imports annually or the average number of imported dogs across entities.
• Estimated thresholds for the number of imported dogs from DMRVV high-risk countries per firm at which NPRM costs (if finalized as proposed) would exceed two percent of revenue during the first year of implementation of the proposed requirements.

During the public comment period, HHS/CDC received 2,106 comments from individuals, groups, organizations, and the airline industry. This included one comment from a group of organizations involved in animal rescue that included 118,312 signatures.

The following is a discussion of public comments received that are applicable and within the scope of the regulation.

A. Comments on Necessity of the Rule

Numerous commenters made general remarks either supporting or opposing the importation requirements. In the following paragraphs, we discuss and respond to such comments.

Comment: HHS/CDC received comments from several agencies and organizations that supported many of the provisions proposed in the NPRM and adopted in this final rule. These comments generally recognized the significant public health threat posed by the importation of rabid dogs. Most of the supportive comments were submitted as part of a write-in campaign, which stated that the proposals in the NPRM would “add much needed safeguards to protect animals and the public from the introduction of rabies via imported dogs.” These entities were particularly supportive of the six-month age minimum for dog importation, microchip requirement, greater veterinary oversight, and verification of animals' rabies documentation. Other commenters supported the proposals in the NPRM because they believe the requirements would help prevent imported dogs from introducing diseases into the U.S. dog population. Organizations involved in veterinary medicine supported the updated dog importation requirements outlined in the NPRM. Organizations and individuals involved in purebred dog activities ( e.g., breeding) generally supported many of the provisions in the NPRM except for the six-month age requirement. Associations and government entities involved in protecting public health and animal health generally supported the proposal.

Response: HHS/CDC agrees with the comments that suggest this action and specific requirements are necessary for continued control of DMRVV from imported dogs. This includes specific provisions including the six-month age minimum for dog importation, microchip requirement, greater veterinary oversight, and verification of animals' rabies documentation, which are discussed in further length below.

Comment: CDC received numerous comments that the rule was unnecessary because DMRVV was not a serious problem in the United States. Commenters noted that no person has died from rabies in the United States during the past 20 years, that CDC should instead focus on wildlife rabies which they considered a greater risk than DMRVV and is already present in the United States, and that the rule was overcompensating for rare events (citing the low number of imported rabid dogs and the uncommon occurrence of rabies in dogs in the United States).

Response: CDC disagrees with these comments and considers DMRVV a serious threat that requires effective controls to prevent its re-introduction into the United States. Rabies is one of the deadliest zoonotic diseases and accounts for an estimated 59,000 human deaths globally each year. Over 98 percent of those deaths are due to DMRVV. The rabies virus can infect any mammal and, once clinical signs appear, the disease is almost always fatal. The close relationship between dogs and people means there is a direct public health risk to individuals that interact with inadequately vaccinated dogs imported from countries at high risk of DMRVV. Of note, DMRVV has been highly successful at adapting to new host species, particularly wildlife, that can further transmit the virus.

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

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

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

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

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

Response: While DMRVV importations remain uncommon and thankfully no one in the United States has died from rabies following exposure to an imported dog in the last 20 years, HHS/CDC disagrees that the recent success in preventing deaths from imported rabies means that the United States should not update its regulations to ensure the continued effectiveness of its dog importation requirements.

Specifically, updates to dog importation requirements are necessary to (1) adapt to increased fraud in importations of dogs; (2) avoid the severe disruptions and health risks posed by the re-introduction of DMRVV into the United States; and (3) stay ahead of growing gaps in rabies control efforts, both abroad and in the United States.

Addressing Increasing Fraud

HHS/CDC continues to document a marked increase in fraud committed by importers of dogs from DMRVV high risk countries.^{79 80 81} Internationally, there has been significant growth within the companion animal breeding industry with increasing international trade. Multiple international and U.S. investigations have identified importations of puppies that were too young to meet rabies vaccination requirements. 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.

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

For instance, in 2015 a rabid dog was part of a group of eight dogs and 27 cats imported from Egypt by an animal rescue group. The dog had an unhealed leg fracture and began showing signs of rabies four days after arrival. Following the DMRVV diagnosis, animal rescue workers in Egypt admitted that the dog's rabies vaccination documentation had been intentionally falsified to evade CDC entry requirements. 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.

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

In 2019, 26 dogs were imported into the United States from Egypt by a rescue organization. All dogs had rabies vaccination documentation and serologic documentation indicating the presence of rabies antibodies in response to immunization, based on results from an Egyptian government-affiliated rabies laboratory. However, one dog developed signs of rabies three weeks after arrival and later tested positive for DMRVV. The resulting public health investigation raised suspicions that the rabies vaccination documents and serological test results had been falsified for all 26 dogs in the shipment, because 18 dogs in the shipment lacked serologic evidence of vaccination when re-tested in the United States. As a result, 44 people were required to receive PEP and the 25 other dogs imported on the same flight underwent re-vaccination and quarantines that ranged from four to six months. The rabid dog had been released into an individual's home because of its false paperwork and subsequently had contact with an additional 12 dogs, all of which had to be revaccinated and undergo quarantine periods ranging from 45 days to six months. The public health investigations and administration of rabies PEP to exposed persons in this case cost more than $400,000 in State resources. 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.

In June 2021, 33 dogs and one cat were imported into the United States from Azerbaijan by an animal rescue organization. All dogs had rabies vaccination documents that appeared valid upon arrival in the United States. Three days after arrival, one dog developed signs of rabies. CDC confirmed the dog was infected with DMRVV known to circulate in the Caucasus Mountains region of Azerbaijan. The remaining rescue animals exposed to the rabid dog during travel were quickly dispersed across nine states, leading to what is believed to be the largest, multi-state, imported rabid dog investigation in U.S. history. 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. The 33 exposed animals were revaccinated and placed in quarantine for periods ranging from 45 days to six months.

Avoiding Disruption of DMRVV Re-Introduction

The disruption to public health associated with even a single rabid dog importation can be significant. For every imported rabid dog, an average of 20 people and 21 animals receive post-exposure prophylaxis (PEP) or undergo vaccination and quarantine, respectively, resulting in a substantial disruption to State and local public health services, a considerable cost burden to states, and a significant toll on the physical and mental health of exposed persons and animals.

To manage even one instance of DMRVV exposure, State public health officials must immediately pivot from routine or less life-threatening responses and initiate multiple actions, some of which are extensive. First, the State health department must initiate an in-depth investigation to locate all persons and animals who were exposed to the rabid dog from the 10 days prior to the dog showing symptoms until the dog dies or is euthanized. In many instances, multiple health departments are involved and, based on the results of the investigation, CDC may be required to notify the World Health Organization pursuant to the International Health Regulations. Next, State health departments must conduct a rabies risk assessment of all individuals affected to determine if they need post-exposure prophylaxis (PEP), and if they are determined to be at risk, to administer post-exposure prophylaxis. Finally, if any of the individuals were scratched or bitten, they may also need wound care, tetanus boosters, and/or antibiotics.

CDC estimates a range of costs for public health investigations and subsequent cost of care for people exposed to rabid dogs to be between $210,00 and $510,000 per importation event, as summarized in Section VI. This cost estimate does not include the cost to evaluate, vaccinate, test, and quarantine exposed animals. This cost estimate also does not account for the worst-case outcomes, which include: (1) transmission of rabies to a person who dies from the disease; and (2) ongoing transmission to other domestic and wildlife species in the United States. Finally, these costs do not include the cost of re-eliminating DMRVV if it were to be re-established in the United States, making this estimate an underestimate of the total cost associated with an imported rabid dog.

It bears noting that while the cost of public health investigations and administering PEP is borne by public health departments, the individuals who are the subjects of the investigations and who may receive PEP will experience great disruption and physical and emotional burden: rabies PEP can be painful (specifically, rabies immunoglobulin administered at the site of the wound) and protracted; DMRVV is 99% fatal in humans, a statistic certain to engender fear and anxiety; and the need to quarantine exposed pets can create a sense of great disruption and concern.

Finally, DMRVV becoming re-established in the United States would result in costly efforts over many years to eliminate the virus again. The extraordinary cost of re-introduction of DMRVV is demonstrated by an instance of reintroduction that occurred in Texas, where DMRVV had been previously eliminated. The reintroduction resulted in several human deaths; the subsequent re-elimination of DMRVV cost $56 million (in 2023 USD) and required over 10 years of effort.

Addressing Potential Gaps in Rabies Control

The rule is further necessitated by two new threats to rabies control efforts domestically and abroad, which could increase the risk of the re-introduction of DMRVV in the United States—drops in vaccination coverage among U.S. dogs and disruptions to rabies control programs in high-risk countries.

The risk of re-introduction of DMRVV is compounded by potential gaps in rabies vaccine coverage among U.S. dogs. Researchers recently documented canine vaccine hesitancy, which is defined as “a dog owners' skepticism about the safety and efficacy of administering routine vaccinations to their dogs,” in 53% of the U.S. population. Rabies vaccination in pets creates a protective barrier between people and wildlife infected with rabies by disrupting the virus transmission chain. Declines in canine rabies vaccination rates increases the chance of people being exposed to and infected with the rabies virus.

This perspective among dog owners could lead to decreases in rabies vaccination coverage in pets, creating a potential susceptible pet population primed for DMRVV re-introduction. Canine vaccine hesitancy has specifically been associated with rabies non-vaccination. While existing importation regulations have been instrumental in decreasing and preventing the importation of rabid dogs, updates to these regulations, as provided for in the final rule, are necessary to sustain and advance effective control of DMRVV.

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

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

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

Comment: CDC received comments stating that the current regulation for dogs and cats is sufficient or that CDC should keep its current importation system in place. Because the commenter did not elaborate on what they meant by the term “current importation system,” CDC assumes that this refers to requirements under the temporary suspension.

Response: CDC disagrees that current regulations are sufficient to prevent the reintroduction of DMRVV into the United States. CDC notes that its Federal quarantine regulations (currently found at 42 CFR 71.51) controlling the entry of dogs and cats into the United States have not been substantively updated in decades. The final rule includes many improvements in terms of public health protection against the reintroduction of DMRVV over the current regulations. Among other things, the final rule removes the current requirement for a valid rabies vaccine certificate in 42 CFR 71.51(c) and replaces it with standardized rabies vaccination forms that better prevents importers from submitting fraudulent rabies documentation. The use of standardized forms also helps ensure that foreign-vaccinated dogs imported from DMRVV high-risk countries meet CDC entry requirements prior to traveling to the United States and allows for follow-up with the exporting country's government officials if needed. The final rule further requires pre-arrival rabies serologic testing, as well as revaccination, examination, and, in some cases, quarantine upon arrival at a CDC-registered ACF for foreign-vaccinated dogs from DMRVV high-risk countries. Additionally, the final rule requires that all dogs be microchipped at the time of admission. Microchips are a widely used method of confirming the dogs' identity and help prevent importers from fraudulently presenting dogs for admission that do not match the dogs' accompanying health records. Finally, the provisions in this final rule are estimated to reduce the number of dogs arriving ill or dead, which should in turn conserve agency resources by diminishing the need for CDC to conduct public health investigations to rule out whether the dogs may have died of a zoonotic disease of public health concern, including DMRVV.

CDC also disagrees that it should maintain the same system in place as it used during the temporary suspension. Beginning in June 2021, CDC published a temporary suspension of dogs entering the United States from DMRVV high-risk countries. The temporary suspension created a system that, among other things, implemented the use of standardized forms, required titer test results demonstrating the presence of rabies antibodies in dogs, and authorized a private network of ACF allowing for the immediate quarantine of dogs from DMRVV high-risk countries arriving with inadequate proof of titers. Although this final rule implements a similar regulatory framework based on the documented successes of the temporary suspension, there are important differences. Unlike during the temporary suspension, the final rule does not rely on CDC issuing CDC Dog Import Permits for foreign-vaccinated dogs from DMRVV high-risk countries. Rather, the final rule relies on the network of private ACF to examine, revaccinate, and quarantine (if necessary) foreign-vaccinated dogs from DMRVV high-risk countries. The final rule adopts this system instead of the permit system used during the temporary suspension because issuing permits costs CDC more in terms of personnel and IT services. By replacing the permitting system for foreign-vaccinated dogs from DMRVV high-risk countries with a system of ACF, CDC anticipates a reduction in costs and staff time associated with dog importation because the importer will bear the costs of examination, revaccination, and quarantine (if needed) at an ACF.

During the temporary suspension CDC also continued to document attempts by importers to submit fraudulent documentation to receive a CDC Dog Import Permit. CDC recognized there is limited value in reviewing paperwork alone because physical inspection of animals in combination with a review of paperwork submitted by importers has a greater likelihood of allowing CDC to detect both fraudulent paperwork and communicable diseases of concern in dogs. For example, in 2002-2023, ACF found several ticks on imported dogs. Investigation by CDC and USDA determined these were novel, exotic ticks that had never been found in the Western hemisphere. The health impacts of these ticks on people, livestock, wildlife, and pets are unknown because they have not been studied previously. Physical examination of dogs, which is crucial for rabies detection, at the ACF was also instrumental in detecting and preventing the introduction of these novel ticks in the United States.

Comment: HHS/CDC received comments that the NPRM is not needed because U.S. states already regulate rabies control within the United States.

Response: HHS/CDC disagrees with these comments. Although U.S. States establish requirements relating to rabies vaccination and control within their own jurisdictions, it is HHS/CDC's role to regulate the importation of dogs into the United States from foreign countries. The final rule should reduce the burden on state, local, and territorial public health and animal health agencies and support U.S. State requirements. As noted above, a single importation of a DMRVV-infected dog can cost affected State governments hundreds of thousands of dollars for the ensuing public health investigations and rabies post-exposure prophylaxis (PEP) treatments administered to exposed persons. The cost to State and local governments can balloon significantly in the case of worst-case outcomes, which include: (1) transmission of rabies to a person who dies from the disease; and (2) ongoing transmission to other domestic and wildlife species in the United States.

There have been significant challenges for State and Federal agencies in enforcing or verifying vaccination requirements in internationally imported animals. In 2021, the importation of a rabid dog resulted in a ten-state multi-agency investigation to locate all people and animals exposed to the rabid dog. It was the largest investigation of an imported rabid dog, to date, and required immense resources and time from multiple states to complete. Furthermore, HHS/CDC received comments from Federal, State, and Local government agencies in support of this rule. State and local government agencies expressed support for requiring veterinary examination, revaccination, and quarantine (if needed) of dogs on arrival to reduce the burden on these agencies. These commenters also noted that these practices would also reduce the public health risk that imported dogs pose to U.S. communities, domestic pets, and wildlife and would improve the government's ability to identify dogs with diseases or external parasites before they enter the United States.

This final rule will reduce the enforcement burden on jurisdictions and help to ensure all foreign-vaccinated dogs are vaccinated with a USDA-licensed vaccine on arrival, thereby reducing the public health risk of these dogs and bringing the dogs into compliance with rabies control requirements.

Comment: One commenter asserted the rule was unnecessary because the increase in numbers of imported dogs was due to the COVID-19 pandemic and the pandemic has now ended.

Response: CDC disagrees with this comment because demand for dogs from abroad has remained high since the pandemic. Further, the pandemic disrupted rabies control programs in high-risk countries, a trend that persists today and increases the risk of DMRVV importations.

Since 2021, the demand for puppies and rescue dogs has remained high. The trend in purchasing and rescuing dogs from abroad has been noted in many countries, including the United States. Internationally, there has been significant growth within the companion animal breeding industry with increasing international trade. Multiple international and U.S. investigations have identified importations of puppies that were too young to meet rabies vaccination requirements. 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. 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.

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

B. General Comments on Burden

Comment: Most of the 200 comments stating that the rule was unnecessary also made some type of assertion that the rule was generally excessive or too burdensome, without citing specific requirements of the rule that the commenters believed were excessive or too burdensome.

Response: HHS/CDC address comments about the burden of specific provisions of the rule ( e.g., titer and quarantine requirements) in more detail below. Regarding the claim that the rule is generally too burdensome, HHS/CDC disagrees. As noted above, the risk of DMRVV importation is a high-consequence event and increased fraud, the severe disruptions posed by DMRVV re-introduction, and new gaps in domestic and international rabies control efforts demand an update of U.S. dog importation requirements to ensure continued effective DMRVV control. Further, the requirements of the rule itself align U.S. importation requirements with the best practices advanced by WOAH, and the practices of member countries (including the United States). In fact, this final rule is less burdensome than WOAH standards and the requirements of many other DMRVV-free countries, which reflects HHS/CDC's considered efforts to reduce the burden of the rule on importers while advancing best public health and importation practices.

WOAH has long recognized the risk of rabies to human and animal health. WOAH has led the development of longstanding international animal movement standards to ensure that dogs imported from DMRVV high-risk countries are vaccinated, have an adequate antibody titer, appear healthy at the time of importation, and undergo a sufficient waiting period before importation (or quarantine after arrival) to ensure they do not develop signs of rabies. WOAH's Terrestrial Manual states that all dogs, cats, and ferrets from rabies-endemic countries should meet the following standards for international movement:

• Receive an international veterinary certificate prior to travel which confirms administration of a rabies vaccine and a rabies antibody titer collected and tested in accordance with the WOAH Terrestrial Manual;
• Undergo examination the day prior to shipment to ensure the animal is not showing signs of rabies;
• Are permanently identified (e.g., microchip) with the identification number listed on the certificate;
• Are vaccinated against rabies in accordance with manufacturer's recommendations with a vaccine that was produced in accordance with the WOAH Terrestrial Manual;
• Have a titer test conducted not less than 3 months and not more than 12 months prior to travel, with a titer test result ≥0.5 IU/mL; or
• Are kept in a Federal quarantine station for six months prior to shipment.

Seventy-one percent of rabies-free countries meet or exceed the WOAH standards for the international movement of dogs from rabies-endemic areas whereas the current HHS/CDC regulation for the importation of dogs and cats (42 CFR 71.51) does not align with WOAH standards. This final rule adopts many but not all WOAH standards. HHS/CDC carefully considered the WOAH standards when drafting the final rule. Consultation with rabies subject matter experts and review of peer-reviewed literature allowed HHS/CDC to identify several areas in which HHS/CDC could reduce the burden on importers while protecting public health.

The HHS/CDC requirements outlined in this final rule are less burdensome than WOAH standards in the following ways:

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

• HHS/CDC is not requiring a six-month quarantine prior to shipping an animal without a titer as most countries do not have this capacity. Instead, HHS/CDC has identified CDC-registered Animal Care Facilities that can provide quarantine services after arrival for dogs unable to receive a titer prior to shipment.

HHS/CDC is not requiring a quarantine period of six months and is instead requiring 28-days based on peer-reviewed findings, if the importer does not have rabies serologic test results. This represents a significantly lower time and cost burden for importers.

C. Comments on Exemptions for Certain Groups

Comment: HHS/CDC received various comments suggesting that certain categories of importers or types of dogs should not be subject to specific provisions of this rule, referenced as “exemptions” here. These commenters proposed that the final rule should exempt (1) U.S. government (USG) employees and military members (both routinely and during emergencies); (2) certain U.S. citizens; (3) certified rescue organizations; (4) U.S.-based rescue organizations; (5) breeders; and (6) certain types of dogs such as specific dog breeds, service dogs, government-owned dogs, dogs used in research, U.S.-vaccinated dogs, and personal pets. Many commenters noted that all of the rabid dogs imported into the United States since 2015 were imported by rescue organizations; thus they contended that imposing requirements on other types of importers was not necessary. Commenters suggested that HHS/CDC implement different import requirements for different importers and tailor its requirements based on the risk profile of the importer, and that CDC add definitional terms to distinguish between different types of importers ( e.g., pet owners, rescue groups). Other comments suggested creating a separate registration or inspection system for commercial importers or rescue organizations or limiting the number of dogs imported by rescue organizations.

Response: HHS/CDC disagrees with these comments. The final rule is designed to address and reduce the risk of the importation of a dog with DMRVV. That risk exists based on two factors: (1) the likelihood that an animal was exposed to DMRVV; and (2) whether the animal was sufficiently vaccinated to protect against infection. Based on these factors, available evidence, and CDC's experience with importations, a dog's recent presence in a high-risk DMRVV country and the dog's vaccination status (U.S.-versus foreign-vaccinated) are the best ways to evaluate the risk that an imported dog may have DMRVV. An importer's statement regarding the intended use of the dog ( e.g., show dog, personal pet); the dog's breed; whether it is a service animal or working dog; the nationality of the importer; and the importer's occupation do not provide useful evidence for evaluating the risk of DMRVV presented by that animal. While it is accurate that since 2015 dog rescue organizations have imported four dogs for adoption that were subsequently found to be rabid, differentiating between commercial dog importations and dogs imported as personal pets is operationally impracticable and increases opportunities for fraud. For example, CDC has documented many importers who claimed to own the dogs they were importing as personal pets, but upon further investigation by CBP, USDA, and CDC it was determined that they were transporting the dogs for resale or on behalf of a rescue organization. These importers admitted to being flight parents and misrepresented that they were the personal owners of the dogs. They confirmed that they were unable to verify the vaccination history or health status of the dogs they were transporting. Many had just met the dogs for the first time at the airport on the day the flight departed. In 2017, a dog with rabies was imported by a flight parent who was bitten during the flight and could not attest to the legitimacy of the dog's rabies vaccination paperwork. CDC suspected the paperwork was falsified because the dog developed rabies and died.

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

Differentiating importation requirements based on the type of importer has also proven impracticable based on CDC's recent experience implementing the temporary suspension on importation of dogs from DMRVV high-risk countries. On June 16, 2021, HHS/CDC announced that temporary suspension to protect the public's health. Through the temporary suspension, CDC implemented requirements for importers of dogs from DMRVV high-risk countries. From July 14, 2021, to June 9, 2022, CDC issued CDC Dog Import Permits on a limited basis, for persons permanently relocating to the United States, importers of government-owned working dogs, or owners of service animals to alleviate the potential burden of the temporary suspension for these categories of importers.

On June 10, 2022, HHS/CDC modified the temporary suspension to allow commercial importations of dogs from DMRVV high-risk countries through ACF. On July 10, 2023, HHS/CDC extended the temporary suspension without modifications through July 31, 2024, because of a continued risk of reintroduction of DMRVV due to insufficient veterinary controls in DMRVV high-risk countries to prevent the export of inadequately vaccinated dogs and veterinary supply chain and workforce capacity shortages that have persisted since the global COVID-19 pandemic.

During the period of the temporary suspension, HHS/CDC attempted to differentiate between personal pets and commercial dog imports and received hundreds of applications from commercial importers claiming to be importing dogs as personal pets. Although CDC was able to identify some of these cases and revoke dog import permits for ineligible importers, doing so was difficult and required extensive communication between CDC and other port partners such as CBP and USDA. As this experience shows, the stronger approach provided for in this final rule is to tailor importation requirements based on factors with a relationship to DMRVV risk, namely the country of origin and the dog's vaccination status (U.S.-versus foreign-vaccinated), as opposed to the category of importer ( e.g., commercial importer) or type of dog ( e.g., personal pet). Further, this approach conserves Federal agency resources that would otherwise be used in investigating and responding to potential instances of fraud.

In sum, basing importation requirements on a dog's vaccination status and its potential exposure to DMRVV ( i.e., whether it has been recently been in a high-risk DMRVV country) is the best way to evaluate the DMRVV risk of an imported dog; basing requirements on the purpose of the importation, occupation or nationality of the importer, or the breed or working status of the dog would be an ineffective means for evaluating DMRVV risk, would increase incentives for fraud in the ways mentioned above, and be difficult to implement. Because HHS/CDC is not basing importation requirements on the type of importer, there is no reason for the final rule to define specific categories of importer ( e.g., pet owner, rescue organization, commercial importer).

Comment: HHS/CDC received over 400 comments from U.S. Government (USG) employees and members of the U.S. military objecting to the proposed rule. Some of these commenters stated that these groups should be given special exemption to import dogs without meeting some or all of the proposed requirements. Other commenters stated that they believed that the proposed rule was specifically targeting USG employees. Some of these commenters asserted that the proposed rule is unnecessary because USG employees and military members are less likely to commit fraud and purportedly provide a higher standard of care for their dogs when compared to other dog owners, thereby negating the rabies risk. Commenters noted potential financial burdens and hardships when having to route through ports with ACF or having to pay for titers.

Response: HHS/CDC disagrees that USG employees and members of the U.S. military should be exempt from any or all importation requirements. CDC has no data to support the proposition that dogs owned by USG employees or members of the U.S. military are better cared for than other dogs or that individuals in these groups are less likely to attempt to import dogs with falsified documents or fraudulent or insufficient titers. CDC has documented multiple instances of falsified documents, including intentionally altered import permits, forged titer results, and falsified rabies vaccination records, submitted by U.S. government employees and military service members both during and prior to CDC's temporary suspension of dogs entering the United States from high-risk countries. CDC reported violations to the USDA, the Department of Defense, and the State Department for internal investigation. Additionally, CDC has documented numerous reports of U.S. government employees, including military service members, adopting stray dogs while stationed overseas. CDC supports the human-animal bond and recognizes the important role these animals play in the lives of government employees and service members stationed overseas; however, the employment status of the importer does not affect the dog's potential risk of carrying DMRVV. Adopted stray dogs often have unknown rabies exposure history, have received little or no veterinary care or vaccines, and can present a risk of DMRVV just like any other dog that has been in a high-risk country with an unconfirmed vaccination status. Vaccination, titer, and quarantine requirements are essential to protect USG employees, service members, and their families as well as the U.S. communities these dogs are being introduced into when they arrive in the United States. Furthermore, HHS/CDC strongly disagrees that this final rule specifically targets USG employees. This rule bases its importation requirements on the risk profile of the dog's country of origin and the dog's vaccination status (U.S.-versus foreign-vaccinated), and not the type of importer. It imposes no additional requirements on USG employees or members of the U.S. military compared to any other importers. Finally, the State Department has made relocation funds available to U.S. government staff for quarantine fees or titer services. Additionally, there are CDC-approved laboratories providing discounted services for USG employees. In sum, the risk of DMRVV importation is best determined based on a dog's vaccination status and its recent presence in a DMRVV high-risk country rather than the employer of the importer. Thus HHS/CDC declines to create a specific exemption for USG employees and military members.

Comment: HHS/CDC received comments noting that USG employees, members of the U.S. military, U.S. citizens, and U.S. permanent residents often need to return to the United States quickly with their families when an unexpected crisis develops in a foreign country, and that exemptions should be provided in these instances. Some comments said exceptions should be made or requirements should be different for emergency situations without specifying a category of importer that should be exempted.

Response: HHS/CDC recognizes that USG employees, members of the U.S. military, U.S. citizens, and U.S. permanent residents often need to return to the United States quickly with their families when an unexpected crisis develops in a foreign country. In these scenarios, CDC works closely with the U.S. State Department on a case-by-case basis regarding emergency departures from foreign countries. CDC has assisted the U.S. State Department with more than ten evacuations during the temporary suspension, including evacuations of USG staff from Ukraine, Ethiopia, Nigeria, Haiti, and China, and has ensured foreign services officers were able to evacuate safely with their pet dogs. However, HHS/CDC declines to create a specific exemption under these circumstances because dogs from high-risk rabies countries continue to present a potential DMRVV importation risk regardless of whether imported in emergent or non-emergent circumstances. HHS/CDC plans to continue to support importers during emergency situations by assisting them in making reservations at ACF and educating importers about the importance of maintaining their dog's current rabies vaccination. Potential importers of foreign-vaccinated dogs from DMRVV high-risk countries should also always maintain a valid rabies titer for their dogs from a CDC-approved laboratory in the event of an unplanned emergency. Additionally, HHS/CDC is reducing the burden on importers to maintain a valid titer from a CDC-approved laboratory by reducing the frequency with which titers must be drawn and tested compared to the annual titer requirement during the temporary suspension, which will assist importers in the event of an emergency (see CDC technical instructions available at www.cdc.gov/dogtravel ). Given the demonstrated and close effective working relationship between CDC and the U.S. Department of State, CDC does not believe a specific exemption for emergencies is necessary in the final rule.

Comment: HHS/CDC received five individual comments and one form letter from an organization representing foreign service officers stating that the proposed requirements in the NPRM on government employees with dogs would result in U.S. employees retiring from public service or would cause them to avoid working in DMRVV high-risk countries.

Response: HHS/CDC appreciates these comments but believes the updated regulation is necessary to protect the public's health and to prevent the reintroduction of DMRVV into the United States because there is a continued threat posed by dogs from high-risk countries that are unvaccinated or inadequately vaccinated against rabies. This continued threat is due to various factors, including: a high volume of dogs being imported into the United States contemporaneous with insufficient veterinary controls in high-risk countries to prevent the export of inadequately vaccinated dogs, inadequate veterinary supply chains for vaccines and related materials, and persistent workforce capacity shortages, particularly in high-risk countries that export dogs to the United States. HHS/CDC is addressing the various risks associated with the importation of dogs observed in recent years by establishing a regulatory framework based on the documented successes of the temporary suspension. In addition, the requirements and standards in the rule will help ensure the health and safety of the public while also protecting animal health and preventing the reintroduction of DMRVV into the United States.

HHS/CDC is easing the burden on all importers, including USG employees, by relaxing the entry requirements for U.S.-vaccinated dogs so they may enter through any U.S. port if they meet the criteria outlined in § 71.51(t) of the final rule. HHS/CDC is also revising the titer requirements for foreign-vaccinated dogs to reduce both the waiting period before entry into the United States, and the frequency with which titers must be collected.

Further, HHS/CDC's requirements remain less burdensome when compared to WOAH standards that are widely used in other rabies-free countries. As noted above, HHS/CDC carefully considered the WOAH standards when drafting the final rule, consulting with rabies subject matter experts and reviewing peer-reviewed literature. Based on these considerations and experience during the temporary suspension, HHS/CDC eased requirements on importers, including USG employees, relative to WOAH standards in several key areas, including but not limited to: (1) applying requirements only to dogs; (2) not requiring examination the day before travel; (3) not requiring use of vaccines manufactured in accordance with the WOAH Terrestrial Manual; (4) not requiring a six-month quarantine prior to shipping an animal without a titer; and (5) requiring only a 28-day quarantine rather than six months. The approach in this final rule represents an appropriate balance between flexibility for importers while protecting against importation of DMRVV from high-risk countries.

Additionally, HHS/CDC's requirements remain less burdensome when compared to other countries, such as European Union member states and Australia, that have strengthened their importation requirements for the international movement of dogs (even for animals merely transiting through such countries). The increased challenges that some government employees may face when stationed abroad reflect an international effort to reduce the spread of foreign animal diseases associated with the movement of animals and are not solely a result of this final rule.

Comment: HHS/CDC received a comment that USG-owned dogs (as distinguished from dogs owned by USG employees) should be exempt from HHS/CDC entry requirements.

Response: An exemption for USG-owned dogs is unnecessary because based on CDC's discussions with USG agencies that utilize government-owned working dogs the dogs owned by the USG are all over six months of age, are microchipped, and maintain a current and valid U.S. rabies vaccination prior to deployments. HHS/CDC does not consider the final rule to be overly burdensome in this regard such than any form of exemption is needed.

Comment: HHS/CDC received a comment stating that dogs imported for research purposes should be exempt from entry requirements.

Response: HHS/CDC has determined that a research exemption is not necessary given the infrequency with which dogs are imported for research purposes from DMRVV high-risk countries. For instance, in the past five years, CDC has not received any requests to import dogs for research purposes. Furthermore, during the more recent period of the temporary suspension, CDC has not documented any dogs imported for research from DMRVV high-risk countries. The final rule allows for the importation of unvaccinated dogs from DMRVV-free or DMRVV low-risk countries if the dogs have been only in those countries during the six months before arriving in the United States. Therefore, importers seeking to import unvaccinated dogs for research purposes may do so from DMRVV-free or DMRVV low-risk countries. Thus, considering the infrequency with which dogs are imported for research purposes and the availability of dogs from DMRVV-free or DMRVV low-risk countries that can be used for research, HHS/CDC does not believe an exemption for individuals seeking to import dogs for research purposes is needed.

Comment: HHS/CDC received comments that the rule may be detrimental to animal welfare and inhibit rescue organizations' ability to import dogs.

Response: While HHS/CDC acknowledges that the final rule will result in additional requirements for some rescue groups to operate from high-risk countries, these difficulties do not outweigh the benefits to U.S. public health. HHS/CDC believes that, in addition to protecting public health, the rule will likely better ensure the health of dogs prior to their release into the United States. This helps protect the domestic dog and animal populations, as well as people, from communicable diseases that imported dogs may carry and spread into U.S. communities. There is no clear reason why dogs imported by rescue organizations would be at a lower risk of DMRVV than other dogs from high-risk rabies country. Nothing in the rule prevents rescue dogs from being imported if they meet entry requirements. HHS/CDC further notes that commercial importers and rescue groups were adept at responding to changes in import requirements established during the period of the temporary suspension and that this rule adopts many of those same practices. Accordingly, HHS/CDC believes an exemption is not required.

Comment: HHS/CDC received comments that the proposed requirements for individual pet owners were excessive because there have been few rabid dog importations, and these were all from animal rescue organizations, and that personal pets should be exempt from the importation requirements.

Response: Although the final rule is more burdensome for individuals importing dogs as pets when compared to the current regulation, HHS/CDC believes it is less burdensome when compared to dog importation standards among other WOAH member countries. As more countries have strengthened their importation requirements for the international movement of dogs, the requirements in HHS/CDC's final rule remain less cumbersome than what other countries, such as European Union member states, Australia and New Zealand, require for the movement of animals, including for animals merely transiting through such countries. The increased challenges that some pet owners may face when traveling abroad reflects an international effort to reduce the spread of foreign animal diseases associated with the movement of animals and are not solely a result of this final rule.

Further and as noted above, although recent rabid dog importations have been associated with rescue groups, HHS/CDC has determined that the public health risk from dog imports is based primarily on the dog's country of origin and vaccination status (U.S.- vs. foreign-vaccinated), and not the type of importer. HHS/CDC further notes that attempting to distinguish between pet owners and rescue groups would be difficult to enforce and creates opportunities for fraud. In CDC's experience, as noted above, it is not unusual for importers to misrepresent the reasons why dogs are being imported. As noted above there has been an increase in fraudulent importations and importers misrepresenting that they were the personal owners of the dogs. Such an increase in importers misrepresenting the purpose for which dogs are being imported could increase the risk of a rabid dog being imported and also place importers at risk of exposure to rabies and other zoonotic diseases of concern.

Applying standardized importation requirements for all dogs regardless for the reasons why dogs are being imported ( i.e., rescue, resale, personal pet) helps minimize the risk of human exposure to rabies and ensure dogs are adequately protected against rabies. Therefore, HHS/CDC has decided to apply the rule's requirements equally to all importers to ensure imported dogs do not present a public health risk.

D. Comments on Specific Provisions of the Proposed Rule

Definitions

Comment: HHS/CDC received specific comments on the following sections and paragraphs of the proposed rule.

Paragraph (a) — Definitions.

HHS/CDC received comments on the following definitions:

Authorized Veterinarian

Comment: HHS/CDC received a comment requesting that CDC “define the term `Authorized Veterinarian' in order to establish a single documentation standard all carriers can follow.”

Response: HHS/CDC has finalized the definition for authorized veterinarian that was proposed in the NPRM with minor modifications for clarification. Per the final rule, authorized veterinarian means an individual who has an advance degree relevant to the practice of veterinary medicine, has a valid license or accreditation, and is authorized to practice animal medicine in the exporting country.

DMRVV Low-Risk Countries

Comment: HHS/CDC received a comment that instead of using the terms “low-risk countries” or “rabies-free countries” it should use the terms “countries free of canine rabies” and “countries with low risk of canine rabies.”

Response: HHS/CDC appreciates this comment but declines to incorporate the suggested changes. HHS/CDC notes that the commenter's concerns relate solely to grammar and the commenter has proposed terms conveying the same meaning as those used in the proposed rule. HHS/CDC has chosen the terms DMRVV-free and DMRVV low-risk because HHS/CDC believes these terms are easy to use and likely to be understood by stakeholders.

Importer

Comment: HHS/CDC received comments to define and clarify the term “flight parent.”

Response: In the proposed rule, HHS/CDC did not include a definition for “flight parent” but used this term in the preamble to describe a person that transports one or more dogs for the purpose of resale, adoption, or transfer of ownership. The flight parent may be compensated ( e.g., provided with a complimentary airplane ticket, baggage fees, or other paid fee) for the transport of the animal or agree to transport the animal as an uncompensated volunteer. CDC added a definition for “flight parent” to the final rule. Per this final rule, if required by CBP or USDA, flight parents transporting animals must have a valid license or registration to transport animals.

Comment: HHS/CDC received a comment stating that friends and family who transport dogs belonging to USG employees should be excepted from the definition of flight parent.

Response: HHS/CDC reiterates that flight parents are limited to those individuals transporting one or more dogs for purposes of resale, adoption, or transfer of ownership. If a friend or family member is transporting a dog for purposes of returning the dog to its owner, who was previously in physical possession of the dog, then the friend or family member would not be considered a flight parent. Alternatively, if the dog's owner in the United States merely purchased a dog from another owner or breeder in a foreign country and never previously physically possessed the animal, then the individual transporting the dog would be considered a flight parent regardless of their relationship to the U.S. owner.

Official Government Veterinarian

Comment: HHS/CDC received questions about how HHS/CDC defines a government veterinarian.

Response: HHS/CDC's definition of an official government veterinarian is outlined in 71.50 and states it is “a veterinarian who performs work on behalf of an exporting country's government and can verify the license or credentials of an Authorized Veterinarian.”

Forms

Comment: HHS/CDC received comments on the definitions of CDC Import Certification of Rabies Vaccination and Microchip Required for Live Dog Importations into the United States and Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United States.

Response: These comments are addressed below in our replies to paragraph (s) and paragraph (t). HHS/CDC notes that it has shortened the names of these forms in the final rule to Certification of Rabies Vaccination and Microchip and Certification of U.S.-issued Rabies Vaccination, respectively.

Importation

Comment: HHS/CDC received a comment that HHS/CDC “needs to better define what conditions they are considering when they are talking about `importation' and what activity they are trying to regulate.” The comment stated that U.S. government personnel bringing a pet dog or cat back to the United States are not “importing” an animal.

Response: HHS/CDC welcomes the opportunity to further explain what it means by “importation” but disagrees that individuals, including U.S. government personnel, bringing dogs or cats into the United States from foreign countries are not “importing” an animal just because the animal is returning to the United States from a foreign country. HHS/CDC considers an importation to occur whenever a dog or cat is entering the United States from a foreign country, regardless of whether the animal was in the United States previously and is seeking to reenter the United States. Through this final rule, HHS/CDC is seeking to regulate the importation of dogs and cats into the United States. Although HHS/CDC acknowledges that pets may have emotional value to their owners, animals are considered to be “goods” ( i.e., merchandise or property that can be moved) that are imported into the United States if arriving from foreign countries. Per the definition for importer in this final rule, importer means “any person importing or attempting to import an animal into the United States, including an owner, or a person acting on behalf of an importer, such as a broker registered with CBP or a flight parent. If required by USDA or CBP, an individual transporting an animal on behalf of an importer, including a flight parent must possess all required Federal licenses or registrations to transport animals.” U.S. government personnel bringing dogs or cats into the United States from foreign countries would be included under this definition of “importer.”

HHS/CDC did not receive comments on the following definitions proposed for 42 CFR 70.50: cat, dog, histopathology, in-transit shipment, microchip, and necropsy.

HHS/CDC also did not receive comments on the following definitions proposed for 42 CFR 71.51: animal, CDC-registered animal care facility, CDC Dog Import Form, conditional release, DMRVV, DMRVV-restricted countries, SAFE TraQ, serologic testing, USDA-accredited veterinarian, or USDA official veterinarian.

Paragraphs (b)— Authorized U.S. airports for dogs and cats and (c)— Authorized U.S. land ports for dogs and cats.;

Comment: HHS/CDC received several comments regarding permissible ports of entry. Some commenters opposed any restrictions on ports of entry for any dog being imported into the United States. Other commenters opposed restrictions only for U.S-vaccinated dogs, suggesting that these dogs should be able to enter through any U.S. port and/or be able to enter at U.S. land ports. Some comments suggested that entry be allowed for all personal pets at U.S. ports with CDC quarantine stations. Some comments suggested that entry be allowed at all U.S. ports for all dogs, at all U.S. ports for U.S.-vaccinated dogs, for all personal pets at ports with CDC quarantine stations, and for dogs from DMRVV high-risk countries at land-borders.

HHS/CDC also received comments acknowledging the need to limit the number of authorized ports to reduce fraud and provide greater government oversight to adequately regulate dog imports from DMRVV high-risk countries and inspect shipments of dogs on arrival.

Response: HHS/CDC disagrees with comments suggesting that there should be no restrictions on ports of entry for any dogs entering the United States from foreign countries. The port of entry requirements proposed in the NPRM and finalized through this rulemaking safeguard the public's health by ensuring that adequate staff and facilities are available to provide care for and evaluate foreign-vaccinated dogs from DMRVV high-risk countries for rabies and other diseases that may pose a public health risk. CDC has documented previous instances of dogs not meeting CDC requirements that arrived at U.S. ports that lack adequate facilities to care for and house abandoned dogs or dogs denied entry into the United States. In other instances, adequate housing facilities and care were arranged only with great difficulty, which potentially endangers the health of both dogs and animal handlers. The port of entry requirements are further designed to reduce the burden on airlines, CBP, state/local health departments, and the local veterinary community by ensuring foreign-vaccinated dogs from DMRVV high-risk countries arrive only at a U.S port with an ACF.

However, based on comments received and its review of available data, HHS/CDC has revised the requirements proposed in the NPRM regarding imports of U.S.-vaccinated dogs. CDC has a high degree of confidence in the safety and effectiveness of USDA-licensed rabies vaccines administered by U.S. veterinarians within the United States. Therefore, HHS/CDC is revising its proposal to allow dogs from DMRVV high-risk countries that are at least six months old, microchipped, and have a valid Certification of U.S.-issued Rabies Vaccination form and a CDC Dog Import Form receipt to re-enter the United States through any U.S. port (by air, land, or sea).

Comment: HHS/CDC received comments that there are too few U.S. ports with ACF for foreign-vaccinated dogs to enter the U.S.

Response: HHS/CDC believes there is an adequate number of ACF currently available for the volume of foreign-vaccinated dog importations into the United States (less than 1% of dogs imported into the United States require quarantine). CDC recognizes that more ACFs would further reduce the burden on travelers, and is working to expand the network of ACF to provide importers with greater flexibility for ports of arrival. ACF are able to receive, examine, vaccinate and release dogs within 1 business day of arrival, most of which are cleared the same day they arrive. Additional ACF would provide importers additional travel flexibility for ports of arrival, and CDC is dedicated to expanding the number of available ACF. CDC worked with USDA, CBP, and local businesses to identify and approve five ACF in 2021 and 2022 as part of the strategic shift towards safer importation controls. HHS/CDC notes that since the publication of the NPRM, it has registered two additional ACF at Los Angeles International Airport and Philadelphia International Airport. As of April 1, 2024, there are seven CDC-registered ACF with a USDA intermediate handlers registration and a FIRMS code issued by CBP. The facilities are located at Atlanta Hartsfield-Jackson International Airport, John F. Kennedy International Airport (New York), Los Angeles International Airport (2), Miami International Airport, Philadelphia International Airport, and Washington Dulles International Airport (Washington DC Metropolitan Area). The registration of new ACF at additional ports continues to be a priority for HHS/CDC.

Comment: Commenters noted travel with animals in cargo into certain ports of entry can be restricted during times of the year due to extreme temperatures.

Response: HHS/CDC acknowledges that some airlines may restrict dogs flying as cargo into certain ports during different times of the year but notes that this is an airline requirement put in place for the protection and safety of animals and is not a function of this rulemaking process. Transportation restrictions due to extreme temperatures is a component of the Animal Welfare Act which is enforced by USDA APHIS Animal Care. However, HHS/CDC acknowledges that international travel is stressful for animals and can result in illness and death in young or old animals, specialty breeds ( i.e., snub-nosed breeds, hairless breeds, etc.), or those with pre-existing medical conditions that cannot compensate for the stresses they undergo during travel, including extreme temperatures. Therefore, HHS/CDC defers to USDA APHIS AC to determine appropriate regulatory requirements for the movement of animals during extreme weather conditions and encourages all air carriers to comply with USDA APHIS AC standards.

Comment: Commenters recommended that HHS/CDC seek greater uniformity among U.S. ports handling dog imports. It was noted that each U.S. port has their own procedure, often with their own “job aid” document requirements, which can be unhelpful and lead to unnecessary confusion. It was suggested by a commenter that HHS/CDC's requirements should supersede and preclude duplicate data requirements or job aids at U.S. ports.

Response: HHS/CDC appreciates this comment but notes that several Federal agencies have authority over operations at U.S. ports and CDC does not establish procedures for how those agencies conduct their own operations. However, HHS/CDC does work closely with port partners to develop and disseminate standardized documents ( e.g., job aids, trainings, presentations) to promote consistency between ports and will continue to do so as the final rule is implemented. For example, during the temporary suspension, CDC worked closely with CBP and airlines to disseminate standardized job aids nationwide to streamline importation operations at the ports.

Paragraph (e)— Limitation on U.S. ports for dogs and cats.

HHS/CDC received no public comment on this provision of the rule.

Paragraph (f)— Age requirement for all dogs.

Comment: HHS/CDC received comments in support of the six-month age requirement from individuals concerned about animal welfare and from public health and animal health organizations and agencies. HHS/CDC also received numerous comments opposing the six-month age requirement for dogs as too high. Commenters, including representatives of the airline industry, breeders, breed enthusiasts, and trade groups, stated that dogs should be allowed entry at either 12 weeks of age (the earliest age at which dogs can be vaccinated against rabies), or 16 weeks of age (the earliest age at which the vaccine is considered effective), or at any age (if arriving from a DMRVV low-risk or DMRVV-free country).

Response: HHS/CDC agrees that establishing a six-month age requirement for all dogs will assist in protecting public health while simultaneously improving safety and welfare benefits for young animals subjected to stressful travel environments in which their health could be compromised.

HHS/CDC disagrees, however, with comments suggesting that dogs should be admitted into the United States if under six months of age. The purpose of an age requirement in the context of dogs arriving from DMRVV high-risk countries is to ensure (1) that imported dogs are old enough to be vaccinated for rabies; (2) that the vaccination has time to be effective and confer immunity on the dog; (3) that protection is verifiable; and (4) that there is an appropriate waiting period after drawing the titer to ensure the dog does not develop symptoms of rabies. In short, it is not sufficient that a dog be old enough to be vaccinated; there must be sufficient time for immunity to develop, and authorities must be able to verify the immunity. CDC has also documented cases of importers moving dogs too young to be vaccinated effectively from DMRVV high-risk countries to DMRVV-free or DMRVV low-risk countries to avoid rabies vaccination requirements. Therefore, CDC is also requiring that dogs from DMRVV-free or DMRVV low-risk countries be at least six months old to prevent importers from trying to circumvent CDC's requirements by moving dogs from DMRVV high-risk countries through DMRVV-free or DMRVV low-risk countries.

The WOAH established vaccine and titer standards set seven-months as the minimum age for importation of dogs from DMRVV high-risk countries. Countries following WOAH standards do not allow entry of dogs younger than seven months old if following vaccine and titer timeline recommendations. Many rabies vaccines are licensed for use in dogs on or after 12 weeks of age and laboratories suggest titer collection occur 30 days after initial rabies vaccination. WOAH's standards call for importation to occur a minimum of 90 days after titer collection ( i.e., earliest age for importation is seven months of age).

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

HHS/CDC is also establishing a six-month age requirement for all dogs because it can be difficult for veterinarians to determine with specificity whether a dog has reached the age at which it can be fully protected by the rabies vaccine before six months of age. Veterinarians rely on dental patterns to age dogs. However, it is difficult to accurately assess the age of dogs that are between four and six months old due to variability in an individual dog's dental eruption patterns (loss of baby teeth). Dogs lose all their deciduous (baby) teeth by six months of age making it easier to accurately assess the age of a dog. CDC has documented over 1000 cases of importers providing vaccine records that falsely stated the dog was over six months of age, but upon examination, the dog presented was much younger (often 6-8 weeks of age). Because the rabies vaccine is not considered effective in dogs under 12 weeks of age these puppies were not protected against rabies and presented a threat to the families that purchased or adopted them. By requiring all dogs to be at least six months of age, CDC can better confirm that the dog presented matches the documentation presented, particularly the age listed for the dog, and that the dog is old enough to have been adequately vaccinated for rabies.

The six-month requirement for all dogs also aligns with USDA importation rules, eases enforcement of the vaccination requirements, and reduces opportunities for fraud. USDA requires dogs imported for commercial purposes ( e.g., resale, rescue, or adoption) to be at least six months of age. Aligning with USDA requirements for commercial dog imports will help minimize confusion among travelers importing dogs from outside the United States, and among airlines and port partners that enforce HHS/CDC and USDA entry requirements for dogs.

Setting the minimum age for importation below six months would undermine the ability of authorities to ensure dogs are fully, effectively, and verifiably vaccinated. A 12- or 16-week age requirement for importation would require potentially compromising the full 28-day development of immunity and/or risk importation of a rabid dog because screening fully for signs of rabies was not done. Screening for rabies can be difficult in puppies because they can often exhibit dyskinetic or uncoordinated movement as part of their normal growth and development. These awkward movements can also be seen in rabid dogs and may be mistaken in young puppies for normal movement patterns. Contrary to some common misconceptions, puppies are susceptible to rabies and rabies has been diagnosed in young puppies. For these reasons, the final rule sets six months as the appropriate minimum age for dog importation.

Comment: HHS/CDC received comments opposing its proposal to allow importers to import up to three dogs under the age of six months if arriving into the United States from Mexico or Canada, contending that the requirements between land and air should be the same. Some commenters also opposed any limit on the number of dogs under six months of age that an importer could import through U.S. land ports. Specifically, HHS/CDC received a comment from the airline industry stating that requiring a six-month age limit for all dogs arriving by air, but not for all dogs arriving by land, was neither fair nor equitable. Additionally, commenters noted that allowing dogs under six months of age at the land border potentially created a loophole for importers from DMRVV high-risk countries to exploit.

Response: HHS/CDC agrees that dogs should be subject to the same age requirement regardless of whether arriving by air, land, or sea. Furthermore, HHS/CDC also agrees that allowing some dogs under six months of age to arrive via the land border potentially creates a loophole for unscrupulous importers to exploit. CDC and CBP have documented numerous instances in which importers transported dogs from a DMRVV high-risk country to Mexico (a DMRVV-free country) and who then made claims that their dogs had not been in a DMRVV high-risk country. CDC worked with CBP and airlines and were able to confirm the importers had traveled with the dogs from a DMRVV high-risk country and were attempting to avoid U.S. entry requirements. If CDC were to allow dogs under six months of age to enter via land border crossings, CBP and CDC believe this could create a significant burden on CBP officers at U.S.-Mexico border crossings as more importers would attempt to enter the United States through a land border crossing. This could potentially lead to dogs from DMRVV high-risk countries arriving in the United States via land borders to circumvent HHS/CDC entry requirements. Given that CDC has no ACF at land border crossings this creates a potentially dangerous situation for dogs that must be held pending determination of their admissibility since neither CBP nor CDC have safe housing options at land ports of entry.

HHS/CDC originally proposed a limited exemption for dogs under six months old primarily to reduce the burden on U.S. travelers who frequently travel across the U.S. and Canada/Mexico borders and choose to travel with young dogs. Although data suggests more dogs enter the United States by air each year, extrapolated data from 2006 estimated that 287,000 dogs entered the United States through land border crossings that year. CDC does not have recent data to confirm the volume of dogs crossing at land borders, but unofficial statements from CBP officers stationed at U.S.-Mexico land border crossings suggest the volume remains high. However, upon further consideration and careful evaluation of the comments received, HHS/CDC has removed the exemption proposed in the NPRM to create a uniform standard for all dogs, ensure U.S.-land borders are not overwhelmed with dog importations, and reduce the risk of importers fraudulently claiming that their dog has not been in DMRVV high-risk country.

HHS/CDC has documented many instances of young dogs under six months of age being routed from DMRVV high-risk countries through DMRVV-free countries, such as Canada or Mexico, to circumvent U.S. entry requirements. To prevent this type of fraud, HHS/CDC believes there is reasonable need to require a standardized age for all dogs, regardless of the purported country of origin or port of entry. Accordingly, HHS/CDC has removed from the final rule the exemption at land borders proposed in the NPRM for an importer to import up to three dogs under six months of age through Canada or Mexico via a U.S. land port if the dog has not been in a DMRVV high-risk country or DMRVV-restricted country since birth.

Comment: There were also comments that a six-month minimum age requirement for all imported dogs could lead to the decline of specialty breeds. Commenters stated that breeders in other countries would not want to house and care for dogs bred for resale for six months due to increased cost. Additional commenters said dogs need to be socialized with their owner prior to six months of age.

Response: HHS/CDC disagrees with these comments. First, USDA prohibits the importation of dogs under six-months of age for commercial purposes, which includes any transfer of ownership; therefore, the comment that breeders need to be able to import dogs under six months of age is invalid because it is already prohibited. CDC's age requirement is aligning with a currently existing regulatory requirement from a partner Federal agency. CDC's requirement is not new and therefore, there is no new or additional burden on commercial dog importations ( i.e., dogs imported for rescue, resale, or transfer of ownership). Additionally, CDC notes that a six-month age requirement aligns more closely with WOAH requirements for the international movement of dogs and that 67% of DMRVV-free countries require dogs to be at least six months of age for importation. Furthermore, because dogs under six months of age are sexually immature and cannot be used for breeding, delaying their importation will not negatively impact their use as breeding animals.

Second, although the primary public health reason for requiring a six-month age limitation for importation has been described above, HHS/CDC notes that socialization of puppies may be done overseas at the breeding facility or another overseas location such as a kennel or foster family prior to the dogs arriving in the United States. Additionally, the rule will likely better ensure the health of dogs during international travel to the United States, which is stressful for young animals and can result in illness and death. As noted above, the six-month age requirement for importation helps protect the health and safety of all dogs. HHS/CDC further notes that breeders and commercial importers effectively adapted to changing import requirements during the temporary suspension and that this rule adopts many of those same practices.

HHS/CDC further notes that separating puppies from the mother and littermates when they are too young may adversely impact dogs' behavior and socialization. In HHS/CDC's view, separating the puppies from their mothers and littermates has the potential to affect their social and mental development greatly and negatively. In HHS/CDC's view, this risk outweighs the possible associated costs. HHS/CDC has also documented hundreds of cases where puppies under eight weeks of age (who are not yet protected against rabies due to their age) have been imported for resale. Although HHS/CDC acknowledges that some overseas breeders may choose to change their operations based on HHS/CDC's dog import requirements, HHS/CDC believes that the public health benefits of this change outweigh the theoretical possibility of some specialty breeders choosing to import fewer dogs into the United States.

Comment: HHS/CDC received comments that there should be exemptions for service dogs under six months of age or that HHS/CDC should create an accreditation system for service dogs.

Response: HHS/CDC disagrees with these commenters. To be considered a valid service dog, a dog needs to meet the definition of a “service animal” under 14 CFR 382.3 and be accompanied by an “individual with a disability” as defined under 14 CFR 382.3. Most dogs under six months of age are not yet capable of being trained to work or perform tasks directly related to an individual's disability. Therefore, it is HHS/CDC's determination that the requirement for dogs to be at least six months of age is unlikely to impact importers with service dogs. Additionally, it is not operationally feasible for CDC to provide certification or accreditation of service dogs.

Paragraph (g)— Microchip requirements for all dogs.

Comment: HHS/CDC received comments that microchips are too expensive and that microchips may be difficult to obtain in some low-income countries. Some USG employees also opined that their dogs should be exempt from microchip requirements.

Response: HHS/CDC disagrees with these comments. HHS/CDC notes that microchips are already used and available globally for the international movement of animals. Microchips are required by 86% of DMRVV-free countries for the importation of dogs from DMRVV high-risk countries and microchips are a WOAH standard for the international movement of animals. Microchips are recommended by WOAH, the international veterinary community, and animal rescue and welfare organizations to reunite lost animals with their owners and ensure the veterinary records for an animal can be linked to the animal. HHS/CDC's rule aligns the United States with international standards and practice.

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

Further, during the period of CDC's temporary suspension of dogs entering the United States from DMRVV high-risk countries, CDC documented that 99 percent of permit applications received were for dogs that had microchips implanted prior to the announcement of the suspension. Microchips are frequently used by pet owners and required for international transit by many foreign countries. Given these existing practices and the ubiquity of microchipping of dogs, the microchip requirement is not likely to impose a burden on importers and would have minimal impact on dog importations.

CDC did not receive specific public comments on when a dog's microchip should be implanted. However, through this final rule, HHS/CDC is clarifying that a dog's microchip must have been implanted on or before the date the current rabies vaccine was administered. Rabies vaccines administered prior to the implantation of a microchip are invalid because without the microchip the identity of the dog that received the rabies vaccine cannot be properly verified. The microchip is required to be able to verify a rabies vaccine was administered to an individual dog.

Comment: One commenter stated microchipping their dog would run counter to their religious beliefs and requested an exemption based on religious grounds.

Response: The Religious Freedom Restoration Act (RFRA), 42 U.S.C 2000bb et seq., provides that the U.S. government shall not substantially burden a person's exercise of religion, even if the burden results from a rule of general applicability, unless it demonstrates that application of the burden to the person is in furtherance of a compelling governmental interest; and is the least restrictive means of furthering that compelling governmental interest. HHS/CDC complies with RFRA where applicable and will make determinations arising under RFRA on a case-by-case basis. If individuals believe they may be entitled to an exemption or accommodation based on religious beliefs under RFRA, they should contact CDC through cdcanimalimports@cdc.gov for additional guidance concerning how to submit their request. Requests for an exemption or accommodation under RFRA must be made 120 days prior to importing a dog into the United States.

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

Comment: Two comments asked that tattoos be permitted in lieu of microchips, with one comment stating, “Not everyone in the dog industry is comfortable with microchips.”

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

Comment: Some commenters expressed concerns that because “the proposed rule does not distinguish between personal and commercially imported dogs, requiring all dogs to be at least six months old, bear a microchip and submit a CDC import form prior to travel” would “dramatically increase[ ] [CDC's] regulatory volume.”

Response: CDC disagrees that it would be unable to handle an increase in regulatory volume based on requirements in the final rule relating to age, microchips, or submission forms, or that this regulatory volume would be alleviated by distinguishing between personally owned and commercially imported dogs. Many of the provisions of this final rule are designed to reduce instances of fraud and improve the ability of Federal agencies including CDC to ensure that dogs meet entry requirements. In particular, the six-month age requirement is designed to reduce instances of importers presenting dogs for import that are too young to be effectively vaccinated against rabies and will make it easier for veterinarians to appropriately age dogs based on dental eruptions. Microchips will reduce CDC's regulatory burden by providing an ability to confirm a dogs' identity. Importers can demonstrate that their dog has a microchip by including the number on their documentation. Importer documentation will be examined by government officials upon entry in the same manner that it was examined prior to this regulatory update. Microchips for foreign-vaccinated dogs from DMRVV high-risk countries will be scanned and confirmed by ACF; therefore, requiring microchips does not create an unmanageable burden on CDC. The final rule further replaces the current requirement for a valid RVC with standardized forms that will make it easier for CDC and CBP to process dogs for entry to the United States because there will be less variability in documentation. Furthermore, distinguishing between dogs imported for commercial reasons and those imported as personal pets would increase rather than decrease CDC's regulatory burden because importers often misrepresent the reasons why dogs are being imported into the United States.

Comment: One commenter stated that “CDC references `larger shipments' of dogs from importers as an issue not individual dog owners . . . Microchipping would not solve the alleged large shipment problem. It simply moves the problem while imposing additional cost and a new potential failure point. The idea of using trusted vaccination sites is far more workable and would yield higher confidence levels.”

Response: HHS/CDC disagrees. CDC will be able to verify the identity and vaccination status of the dogs in large shipments through the use of microchips. Previously, CDC has documented large shipments of dogs imported with fraudulent paperwork whereby one dog's paperwork was “swapped” with another dog's paperwork. Microchips are the safest and least expensive way to confirm a dog matches the paperwork presented by the importer. CDC is requiring microchips because it helps prevent fraud, particularly for the highest risk category of dogs—foreign-vaccinated dogs from DMRVV high-risk countries. These dogs will have their microchip scanned upon arrival at the ACF. The ACF will then be able to confirm that the scanned microchip number matches the number on the importer's documentation. Furthermore, CDC notes that this final rule does include trusted vaccination sites, which are ACF. ACF are facilities registered with CDC that will be revaccinating all foreign-vaccinated dogs from DMRVV high-risk countries upon entry.

Paragraph (h)— CDC Dog Import Form for all dogs.

Comment: Several commenters expressed support for the CDC Dog Import Form requirement. Commenters supported CDC improving its ability to track how many dogs enter the United States. Commenters also suggested CDC create a system whereby frequent travelers could login and pre-populate the form to reduce the time spent filling out the form.

Response: HHS/CDC agrees with these comments and believes use of the CDC Dog Import Form will improve CDC's ability to track the number of dogs being imported into the United States. HHS/CDC appreciates the suggestion to use a system with login capabilities for frequent travelers. CDC does not have the funding available to establish the suggested system at this time but will work in the future to establish a system that addressees the unique need of frequent travelers.

Comment: HHS/CDC received a number of comments regarding the CDC Dog Import Form (OMB approval number 0920-1383, exp 04/30/2027). Commenters requested clarification about the information to be collected, and whether foreign veterinarians will need to verify the form. One comment said the form should not become a requirement until it is available to the public. Another comment stated, “disabled individuals and veterans with US vaccinated service dog canines would be burdened with extra work due to the additional tracking systems.” CDC takes this to be referring to the CDC Dog Import Form. This commenter also stated, “Citizens in the US will be further burdened with extra work due to the additional tracking systems and . . . Citizens returning to their country are already tracked [and] should not need to submit further tracking data for data collection.” Additional commenters questioned the purpose of the CDC Dog Import Form and did not support its use due to cost and burden on importers.

Response: HHS/CDC seeks to clarify several points raised by commenters. The CDC Dog Import Form has been available to the public since the publication of the NPRM. It is available on www.reginfo.gov under the information collection review (ICR) number 0920-1383. Importers must submit the CDC Dog Import Form prior to travel via an online automated system that is accessible from a smartphone, tablet, or computer. It is free for importers to submit the form; therefore, there is no cost to importers. The form will collect identifying information about the importer, their dog, and the dog's travel itinerary. Importers will need to upload a photo of their dog as part of the submission. No U.S. government agency is currently collecting this information for all dog importations; therefore, it is not information that is already tracked. Neither veterinarians nor government officials will be asked to complete, verify, or submit any information as part of this form. The form is intended to help CDC capture the number of dogs imported, the locations from which these dogs arrive, and to provide assistance to CBP, USDA, CDC, and State government agencies in conducting contact tracing when there is a public health need. Upon successfully submitting the form, importers will immediately receive an automated receipt for presentation to their airline, if arriving by air, and CBP and the ACF (for foreign-vaccinated dogs from DMRVV high-risk countries), upon arrival at a U.S. port. CBP and the ACF, if applicable, will review and confirm that the information matches the animal presented. HHS/CDC estimates that an importer can complete the form in less than 15 minutes. HHS/CDC believes this new requirement places a small burden on importers and that the benefits of the requirement (the collection of data on all dog importations) outweighs the minimal burden being placed on importers. CDC also disagrees that these measures place an extra or disproportionate burden on disabled individuals and or U.S. veterans traveling with U.S. vaccinated service dogs.

Comment: Some comments asked how the CDC Dog Import Form will be reviewed and verified by CDC with some seeming to believe this form would be the same as the CDC Dog Import Permits CDC issued during the temporary suspension or some saying to require the CDC Dog Import Permit instead. Some of these comments also questioned whether CDC has the capacity to handle the volume of forms received. Comments from the airline industry asked how airlines would be expected to verify the CDC Dog Import Form. Another comment questioned why the “CDC import permit” should be required for U.S.-vaccinated dogs since it is not currently required for U.S.-vaccinated dogs. CDC understood this comment to mean that the commenter confused the CDC Dog Import Form with the CDC Dog Import Permit.

Response: The CDC Dog Import Form is not the same as the CDC Dog Import Permit application. CDC will discontinue issuing CDC Dog Import Permits when the temporary suspension expires and this final rule goes into effect. In the future, CDC will only issue CDC Dog Import Permits for importers of dogs from DMRVV-restricted countries; however, CDC is not including any countries on the DMRVV-restricted list at the time of publication of this final rule. Unlike the CDC Dog Import Permit, however, the CDC Dog Import Form does not require review by CDC staff prior to the issuance of the auto-generated receipt. CBP will confirm the information on the form upon arrival, along with other documents required for entry. Because the system is automated, the volume of forms submitted will not adversely impact CDC's workload nor will it impact the time that importers will need to wait for the receipt; whereas issuing CDC Dog Import Permits does require CDC staff time and requires importers to await review by CDC before receiving their permit. The wait time for a CDC Dog Import Permit can take anywhere from one to eight weeks, particularly if the importer did not submit all required information. CDC is also requiring that all importers use the CDC Dog Import Submission Form, including those importing U.S. vaccinated dogs, because the form includes important information such as the importer's contact information and information related to each dog being imported, and will allow CDC to more easily track the frequency and number of dog imports.

Additionally, CDC will not require that airlines verify information on the form. For example, airlines will not be required to scan dogs' microchips to ensure the microchip number matches the number listed on the form. Rather, airlines will only be required to confirm that the importer has a CDC Dog Import Form receipt and either a Certification of U.S.-Issued Rabies Vaccination form, a reservation at an ACF, or documentation the dog has resided only in a DMRVV-free or DMRVV low-risk country for the six months prior to boarding the dog on the plane.

Comment: One comment said the CDC Dog Import Form may infringe on privacy without stopping the reintroduction of rabies. The commenter did not elaborate further on how they believed the CDC Dog Import Form may infringe on privacy or why use of this form would not help mitigate the reintroduction of DMRVV into the United States.

Response: Although the commenter did not elaborate on how they believe the CDC Dog Import Form may infringe on privacy interests, HHS/CDC does not believe that requiring importers to complete this form will infringe on privacy. CDC notes that it will maintain and use the information collected via the CDC Dog Import Form in accordance with the Privacy Act of 1974 (5 U.S.C. 552a) and its applicable System of Records Notice. Personally identifiable information may be used and shared only for lawful purposes, including with authorized personnel of HHS, State and local government agencies, and other cooperating authorities, as authorized by law.

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

Comment: HHS/CDC received comments that the CDC Import Certificate should be certified by an official veterinarian. HHS/CDC interprets this to mean the Certification of Foreign Rabies Vaccination and Microchip form.

Response: HHS/CDC agrees with this comment. HHS/CDC is implementing requirements in this final rule that veterinary documentation be certified by official government veterinarians in order to reduce the use of fraudulent documentation by importers. Official government veterinarians are able to certify that an accredited veterinarian is authorized to practice veterinary medicine in the exporting country. Additionally, engaging foreign government official veterinarians in the exportation process of an animal provides a pathway to communicate with a foreign government when cases of fraud are detected by CDC. Currently, there is no recourse or follow-up that a foreign government can perform when CDC identifies fraudulent paperwork because CDC does not require foreign governments to certify the paperwork prior to export. Official government veterinarians currently review and certify dog exportation paperwork for most other countries in the world, but the United States does not have this requirement. The final rule will align the United States requirements more closely with other countries that already require official government certification of export documentation in order to prevent fraud and provide an official pathway to engage with foreign government officials when cases of fraud are detected.

Comment: HHS/CDC received comments from foreign government representatives requesting that the CDC Dog Import Form not require involvement from a licensed veterinarian or from an official government veterinarian.

Response: HHS/CDC agrees with these comments and does not think it is necessary to have this form certified by a veterinarian because a purpose of this form is to collect data on the number of dogs arriving into the United States and the proportion arriving from DMRVV high-risk countries which is something the U.S. government was previously unable to do. The form is administrative in nature and does not capture medical information about the dog; therefore, a veterinarian does not need to certify the form.

Comment: One comment stated it is illogical to require the CDC Dog Import Form for importations at the land borders and the commenter questioned the intended purpose of the form.

Response: HHS/CDC disagrees. The information that importers will submit to CDC via the CDC Dog Import Form will help CDC prevent the reintroduction of rabies. It allows CDC to track all dog importations, including those arriving at U.S. land ports, which helps CDC better determine the risk of human exposure incidence to DMRVV from imported dogs. It will allow CDC to better conduct contact tracing if a rabid dog were to be imported into the United States. It would also provide data to CDC about the countries from which dogs are being imported. This information helps CDC assess the DMRVV risk to the United States based on the level of DMRVV present in each country and the number of importations from DMRVV countries.

Paragraph (i)— Inspection requirements for admission of all dogs and cats.

Comment: HHS/CDC received comments that a health certificate or certificate of veterinary inspection (CVI) should be required in addition to rabies vaccine documentation because this is a basic protection adopted by other countries. A health certificate or CVI is a document used by some foreign countries for the export of animals from those countries.

Response: HHS/CDC declines to accept this suggestion. Although health certificates can contain valuable information regarding the dog's health status, health certificates often do not contain all the necessary information that would allow HHS/CDC to confirm valid rabies vaccination. Therefore, HHS/CDC has adopted its own documentation requirements for this final rule.

Comment: Commenters also noted that EU pet passports should be accepted or that CDC should create a passport that is compatible with or comparable to the EU pet passport.

Response: HHS/CDC declines to accept these suggestions. CDC has documented numerous instances of importers using falsified or fraudulent EU pet passports. EU pet passports are not certified by official government veterinarians. HHS/CDC is implementing requirements in this final rule that veterinary documentation be certified by official government veterinarians in order to reduce the use of fraudulent documentation by importers. Official government veterinarians are able to certify that an accredited veterinarian is authorized to practice veterinary medicine in the exporting country. Additionally, engaging foreign government official veterinarians in the exportation process of an animal provides a pathway to communicate with a foreign government when cases of fraud are detected by CDC. Currently, there is no recourse or follow-up that a foreign government can perform when CDC identifies fraudulent paperwork because CDC does not require foreign governments to certify the paperwork prior to export. Official government veterinarians currently review and certify dog exportation paperwork for most other countries in the world, but the United States does not have this requirement. The final rule will align the United States requirements more closely with other countries that already require official government certification of export documentation in order to prevent fraud and provide an official pathway to engage with foreign government officials when cases of fraud are detected.

Comment: HHS/CDC received comments that dogs and cats should have the same vaccination and entry requirements or that cats should have to be vaccinated for rabies to enter the United States. HHS/CDC also received comments asking that HHS/CDC not render it harder to import cats and exempt various groups ( e.g., military members and Foreign Service Officers) from the requirements for cats to be imported into the United States. Additional comments asked to clarify what the requirements are for cats or if there were proposed updates to cat requirements in the NPRM.

Response: HHS/CDC would like to clarify that this final rule does not substantively update requirements to import a cat into the United States. The NPRM did not propose, nor is this final rule establishing, vaccination requirements for importing cats into the United States. Although HHS/CDC recommends that cats be vaccinated against rabies prior to importation because cats can acquire rabies from other animals ( i.e., be an incidental host of the virus), this final rule does not require vaccination of cats because cats are not considered a reservoir of rabies. Additionally, HHS/CDC has never documented a report of an imported rabid cat. This final rule is updating the requirements for the care and transport of cats that appear unhealthy upon arrival, by requiring that any ill cat undergo a veterinary examination immediately upon arrival to ensure it receives timely care, and that CDC is notified of any potential zoonotic diseases that could be transmitted to people. The final rule is also updating requirements for necropsy of cats that arrive dead in order to determine the cause of death and ensure CDC is notified of any potential zoonotic diseases that could be transmitted to people. Because the final rule is not imposing new requirements to import cats, no exemption, including for specific groups such as military members and Foreign Service Officers, is not needed.

Paragraph (j)— Examination by a USDA-Accredited Veterinarian and confinement of exposed dogs and cats or those that appear unhealthy.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (k)— Veterinary examination, revaccination against rabies, and quarantine at a CDC-registered Animal Care Facility for foreign-vaccinated dogs from DMRVV high-risk countries.

Comment: Many State and local public health and animal health agencies expressed support for requiring veterinary examination, revaccination, and quarantine (if needed) of dogs on arrival to reduce the burden on these agencies. These commenters also noted that these practices would also reduce the public health risk that imported dogs pose to U.S. communities, domestic pets, and wildlife and would improve the government's ability to identify dogs with diseases or external parasites before they enter the United States.

Response: HHS/CDC agrees with the commenters regarding the public health benefit of these provisions in preventing rabies as well as additional zoonotic diseases. In drafting this final rule, HHS/CDC recognized that there is limited value in reviewing paperwork alone because physical inspection of animals in combination with a review of paperwork submitted by importers has a greater likelihood of allowing CDC to detect both fraudulent paperwork and communicable diseases of concern in dogs.

Comment: HHS/CDC received comments objecting to the revaccination requirements for foreign-vaccinated dogs from DMRVV high-risk countries because the dogs have already been vaccinated overseas.

Response: HHS/CDC disagrees with these comments. There is a high degree of variability in the quality and efficacy of rabies vaccines produced in some countries. Therefore, re-vaccination with a high-quality USDA-licensed vaccine is necessary to ensure adequate protection against rabies. CDC has also documented instances in DMRVV high-risk countries in which rabies vaccines have been improperly administered. USDA-licensed rabies vaccines undergo rigorous testing to ensure they are safe and effective. Requiring a rabies booster vaccine on arrival ensures dogs are adequately protected against rabies and do not pose a public health risk.

Comment: Some commenters expressed concerns regarding revaccinating dogs upon arrival that were already vaccinated overseas and the impact of multiple rabies vaccines on dogs' health.

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

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

Comment: HHS/CDC received comments objecting to the titer requirements for foreign-vaccinated dogs from DMRVV high-risk countries on the basis that only a rabies vaccine should be sufficient for entry into the United States. Some comments asked why CDC does not trust vaccines from other countries.

Response: HHS/CDC disagrees with these comments. WOAH and the international community have long recognized vaccination paperwork alone is not sufficient to ensure a dog is adequately vaccinated against rabies. There is a high degree of variability in the quality and efficacy of rabies vaccines produced in some countries. Therefore, re- vaccination with a high-quality USDA-licensed vaccine is necessary to ensure adequate protection against rabies. CDC has also documented instances in DMRVV high-risk countries in which rabies vaccines have been improperly administered. A titer provides supportive evidence that a dog has been adequately vaccinated against rabies. Rabies vaccination documentation can also be falsified. Requiring a titer in addition to rabies vaccination documentation makes it more difficult for importers to falsify documents.

Titers or quarantine are the WOAH recommended importation standards that should be implemented for dogs arriving from DMRVV high-risk countries. HHS/CDC has provided alternative entry pathways through an ACF with a 28-day quarantine if an importer is unable or unwilling to receive a titer prior to arriving in the United States.

Comment: HHS/CDC received comments objecting to the requirement for dogs with titers to go to an ACF because titers demonstrate the presence of rabies antibodies in dogs and that should be sufficient for entry. The comments stated that requiring these dogs to be revaccinated and examined at ACF is unnecessary.

Response: HHS/CDC disagrees with these comments. As noted above, there is a high degree of variability in the quality and efficacy of rabies vaccines produced in some countries, as well as evidence that some rabies vaccines administered in DMRVV high-risk countries contain an additive that may cause an initial robust immune response that quickly wanes and provides no protection against an exposure to the rabies virus. This can result in titer test results falsely demonstrating adequate antibodies for rabies. Additionally, elevated (or passing) titers suggest an animal has either been vaccinated against rabies or could be infected with the rabies virus. Re-vaccination with a high-quality USDA-licensed vaccine provided at an ACF is necessary to ensure adequate protection against rabies. USDA-licensed rabies vaccines undergo rigorous testing to ensure they are safe and effective. Requiring a rabies booster on arrival ensures dogs are adequately protected against rabies and do not pose a public health risk.

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

Comment: HHS/CDC received comments objecting to dogs undergoing quarantine even when there is a rabies vaccination document.

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

Foreign-vaccinated dogs arriving from DMRVV high-risk countries must undergo revaccination and, for dogs without a titer result from a CDC-approved laboratory, a quarantine period of 28 days. This quarantine period allows CDC to be confident the dog is not incubating rabies. Dogs that have been exposed to rabies and are subsequently vaccinated will either (1) adequately respond to vaccination and develop sufficient antibodies to prevent clinical infection and death; or (2) succumb to the virus within an accelerated timeframe (<28 days). Quarantining dogs ensures that if a dog is going to develop rabies and die, it will do so in an environment where no other animals are exposed, and where it is cared for by only a limited number of people who are trained to wear personal protective equipment and administer veterinary care as needed.

Comment: HHS/CDC received comments that unvaccinated dogs should be quarantined or vaccinated only upon arrival or that HHS/CDC should not require dogs to be vaccinated overseas if they have to undergo vaccination and/or quarantine upon arrival.

Response: HHS/CDC disagrees with these comments. It is critical that dogs from DMRVV high-risk countries be vaccinated overseas prior to their arrival in the United States to prevent the reintroduction of rabies into the United States and help prevent people and animals from being exposed to rabid dogs in transit and upon arrival. Additionally, HHS/CDC notes that if dogs were not vaccinated prior to arrival, then every dog from a DMRVV high-risk country would be required to undergo a 28-day quarantine. The cost to quarantine these dogs for 28 days on arrival would be a financial burden on importers. There is also limited space available for quarantine at the AFC, making this option unfeasible for many importers. HHS/CDC notes that the titer requirement combined with revaccination upon arrival would serve a similar purpose at a fraction of the cost for importers.

Comment: Some commenters said that HHS/CDC should not ban dogs and cats from being imported into the U.S. and instead allow quarantine and vaccination upon arrival.

Response: First, HHS/CDC would like to clarify it is not banning the importation of dogs and cats. Second, as mentioned above, to require quarantine for all dogs from DMRVV high-risk countries would increase costs for most importers. It is significantly less expensive for importers to have their dogs vaccinated prior to travel and provide rabies documentation and titer results, if applicable, for entry into the United States compared to quarantining their dogs upon arrival.

Comment: HHS/CDC received comments that in lieu of revaccination, examination, and quarantine (if required) at an ACF for foreign-vaccinated dogs from DMRVV high-risk countries, HHS/CDC should continue to issue the CDC Dog Import Permits, which were issued during the temporary suspension. HHS/CDC also received comments that in lieu of requiring that dogs go to an ACF, HHS/CDC should allow home quarantine and verify revaccination through compliance checks after a dog has been cleared for entry and released into the community.

Response: HHS/CDC disagrees. ACF visits are critical because physical examinations by a veterinarian who can identify signs of rabies in dogs and verify the microchip matches all rabies vaccination and titer paperwork presented for the dog have a greater public health benefit than review of paper-based forms or records (such as the permit system HHS/CDC used during the temporary suspension) that can be fraudulent or falsified. Home quarantine and verification of revaccination through random compliance checks also does not ensure that dogs have been physically examined by a veterinarian prior to their release into U.S. communities. HHS/CDC would also have to rely on states and localities to follow-up with home-quarantined dogs. Prior to 2018, HHS/CDC allowed home quarantine of dogs through the issuance of confinement agreements; however, this practice proved to be too burdensome for the states and localities. Therefore, HHS/CDC did not propose this option in the NPRM due to poor feasibility.

Because of the above-listed reasons, foreign-vaccinated dogs arriving from DMRVV high-risk countries must undergo revaccination and, for dogs without a titer result from a CDC-approved laboratory, a quarantine period of 28 days. This quarantine period allows HHS/CDC to be confident the dog is not incubating rabies. As discussed above, dogs that have been exposed to rabies and are subsequently vaccinated will either (1) adequately respond to vaccination and develop sufficient antibodies to prevent clinical infection and death; or (2) succumb to the virus within an accelerated timeframe (<28 days). Quarantining dogs ensures that if a dog is going to develop rabies and die, it will do so in an environment where no other animals are exposed, and where it is surrounded only by a limited number of people who are trained to wear personal protective equipment and administer veterinary care as needed.

Comment: HHS/CDC received comments that there are too few ACF and that ACF are too expensive. Some of these comments expressed concern about ACF' ability to accommodate all foreign-vaccinated dogs from DMRVV high-risk countries while other comments said the limited number of ACF places a burden on importers who are forced to arrive into the United States at a port with an ACF.

Response: HHS/CDC appreciates this comment and notes that it has registered two additional ACF since the publication of the proposed rule. The registration of new ACF at additional ports continues to be a priority for CDC; however, CDC believes there is an adequate number of ACF currently available to handle the volume of dogs being imported. CDC is making efforts to expand the network of CDC-registered ACF to additional ports of entry in order to provide greater flexibility for importers arriving from DMRVV high-risk countries with foreign-vaccinated dogs. CDC notes that the agency does not set prices charged by an ACF, which are privately owned and operated. Additionally, based on data during the temporary suspension, the vast majority of importers of foreign-vaccinated dogs from DMRVV high-risk countries chose to submit titer results in lieu of having their dogs complete a 28-day quarantine. These dogs were usually examined, re-vaccinated and released back to the owner the same day they arrived in the United States. The cost to importers of these dogs is significantly less than for dogs without titer results, which require quarantine. Only a small percentage (<3%) of importers are required to pay the highest cost of quarantine for 28 days.

Comment: HHS/CDC received comments requesting that HHS/CDC consider allowing a single titer for the lifetime of an animal instead of annual titers, and to consider new technologies that might be available in the future. HHS/CDC also received comments that the titer takes too long, is too expensive, or that it is difficult to ship blood samples from countries that do not have a CDC-approved laboratory.

Response: HHS/CDC notes that, as proposed in the NPRM, prior to granting a reservation, an ACF must ensure they have received serologic test results obtained from a CDC-approved laboratory on a blood sample collected in accordance with CDC's technical instructions (if applicable); otherwise, the dog will be required to quarantine for 28 days upon revaccination at an ACF. HHS/CDC intends to provide additional information relating to titers through technical instruction posted on CDC's website. HHS/CDC's current intent is to align the frequency of titer testing and waiting periods between the time of titer collection and date of importation with the most recent peer-reviewed literature, WOAH guidelines, and input from CDC rabies subject matter experts. During the temporary suspension, CDC has required titers to be drawn 45 days to 365 days prior to importation; however, CDC will periodically review its titer requirements and provide updates through technical instructions as needed and consistent with the best scientific practices.

Although no public comments were received, HHS/CDC is clarifying that suspected or confirmed communicable diseases need only be reported to CDC and not to other public health entities. Additional notification of Federal, State, and local public health partners will be done by CDC.

CDC is updating the name of this paragraph to reflect all the required components of the paragraph. However, the requirements within the paragraph have not changed.

Paragraph (l)— Registration or renewal of CDC-registered Animal Care Facilities.

HHS/CDC received no public comment on this paragraph of the proposed rule. However, HHS/CDC will be amending this provision of the final rule to require that an ACF be located within 35 miles of a CDC quarantine station. Although the NPRM did not propose that an ACF be located within a certain distance from a CDC quarantine station, HHS/CDC is confident that the public could infer that HHS/CDC would consider physical location, distance, and travel times when deciding to register a facility as an ACF. As explained extensively throughout the preamble to the NPRM (88 FR 43992) the rule is intended, in part, to address the difficulty that airlines encountered finding appropriate housing for dogs denied admission and the lack of facilities that maintain an active CBP FIRMS code. If an animal arriving at an airport is sick or injured, it will also need to be transported to an ACF which must, therefore, be located within a reasonable distance from the airport to ensure the animal's health and safety as well as the safety of transport personnel. Accordingly, it is reasonable for the public to have inferred that HHS/CDC would only approve and register facilities as an ACF that were located within a reasonable distance from an airport where a CDC quarantine station was located. HHS/CDC further notes that the 35-mile distance requirement for an ACF aligns with CBP's Bonded Warehouse Manual and ensures inspection of animals at the facility can occur in a timely manner when the ACF requests assistance from CDC.

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

Paragraph (m)— Record-keeping requirements at CDC-registered Animal Care Facilities.

HHS/CDC received no public comment on this section of the rule; however, HHS/CDC is clarifying that records for necropsy results should be uploaded into SAFE TraQ within 30 days of an animal's death.

Paragraph (n)— Worker protection plan and personal protective equipment (PPE).

HHS/CDC received no public comment on this paragraph of the proposed rule. HHS/CDC is noting that procedures for reporting suspected or confirmed communicable diseases associated with handling animals in facility workers must be reported to CDC within 48 hours. This requirement was included in the NPRM in proposed paragraph (q) and has been moved to paragraph (n) for clarity.

Paragraph (o)— CDC-registered Animal Care Facility standard operating procedures, requirements, and equipment standards for crating, caging, and transporting live animals.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (p)— Health reporting and veterinary service requirements for animals at CDC-registered Animal Care Facilities.

Comment: HHS/CDC received a comment from a veterinary professional organization stating, “if the animal requires veterinary care prior to export to its country of origin, the organization supports an exception if the animal is taken directly to a veterinary facility for treatment with appropriate quarantine.”

Response: HHS/CDC seeks to clarify that this is the current standard of care and HHS/CDC has no intent to change this current practice. Although protecting the public's health is CDC's chief priority, CDC takes reasonable steps to ensure the health and safety of ill or injured animals and will continue to work with airlines, the animal transportation industry, and port partners so that ill or injured animals arriving in the United States receive veterinary care in a timely manner. Further, HHS/CDC does not require the return of ill or injured animals to the country of departure until such animals are deemed fit to travel if that action would be in violation of USDA's Animal Welfare Act.

Additionally, although HHS/CDC did not receive public comment on this issue, HHS/CDC is clarifying that if an animal is suspected of having a communicable disease, it must be immediately isolated and CDC-registered Animal Care Facilities must implement infection prevention and control measures in accordance with industry standards and CDC technical instructions.

Although no public comments were received, HHS/CDC is clarifying that suspected or confirmed communicable diseases need only be reported to CDC and not to other public health entities. Additional notification of Federal, State, and local public health partners will be done by CDC.

HHS/CDC notes the paragraph name has been modified to reflect all the required components of the paragraph. However, the requirements within the paragraph have not changed.

Paragraph (q)— Quarantine requirements for animals at CDC-registered Animal Care Facilities.

HHS/CDC received no public comment on this paragraph of the proposed rule. However, HHS/CDC is clarifying that although implicit in its use of the term “quarantine” that quarantined animals must be housed in such a manner that they do not expose other quarantined animals. Additionally, animals in quarantine may not be housed together even if they were transported as part of the same shipment. This clarification is considered a veterinary industry standard of care.

Paragraph (r)— Revocation and reinstatement of a CDC-registered Animal Care Facility's registration.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (s)— Requirement for the CDC Import Certification of Rabies Vaccination and Microchip Required for Live Dog Importations into the United States form to import foreign-vaccinated dogs from DMRVV high-risk countries.

Comment: HHS/CDC received comments that importers should not be required to have an official government veterinarian certify rabies vaccination forms prior to travel.

Response: HHS/CDC disagrees with these comments. HHS/CDC has documented numerous instances of importers who falsify vaccination documents with the names of persons who are not authorized to practice veterinary medicine within their countries or who alter the vaccine records of animals unbeknownst to the veterinarian. Official government veterinarians are able to certify a veterinarian's authorization to practice veterinary medicine and can help detect cases of fraud before an animal is shipped to the United States. Additionally, engaging foreign government official veterinarians in the exportation process of an animal provides a pathway to communicate with a foreign government when cases of fraud are detected by CDC. Currently, there is no recourse or follow-up that a foreign government can perform when CDC identifies fraudulent paperwork because CDC does not require foreign governments to certify the paperwork prior to export. Official government veterinarians currently review and certify dog exportation paperwork for most other countries in the world, but the United States does not have this requirement. The final rule will align the United States' requirements more closely with other countries that already require official government certification of export documentation to prevent fraud and provide an official pathway to engage with foreign government officials when cases of fraud are detected. This is a critical public health intervention in the pre-departure phase of preparing an animal for travel.

Lastly, many DMRVV-free and DMRVV high-risk countries currently require importers to obtain health certificates or vaccination records certified by official government veterinarians in the exporting country as part of the importation requirements for those countries.

Comment: HHS/CDC received comments expressing concern that individuals in low-income countries (which tend to be DMRVV high-risk countries), may have trouble identifying government officials to certify paperwork and that issues of poor governance and bureaucracy in these countries may lead to bribery.

Response: Although issues of poor governance, including bribery and corruption, in foreign countries fall outside the scope of this final rule, HHS/CDC notes that through this rulemaking at § 71.51( ee), HHS/CDC will be able to prohibit exports of dogs to the United States from countries that are unable to prevent the export of dogs with fraudulent vaccination paperwork or other fraudulent documentation. In addition, through the use of the Certification of Rabies Vaccination and Microchip form, HHS/CDC will be utilizing an existing framework that already includes official government veterinarians that are trained and experienced in certifying standardized veterinary documentation for the international movement (import and export) of animals. HHS/CDC is updating U.S. importation requirements in a way that will more closely align with international practices and WOAH standards. By leveraging the current international animal movement system overseen by official government veterinarians in exporting countries, HHS/CDC will be streamlining documentation requirements while strengthening the validity of importer documentation. HHS/CDC defined official government veterinarian in § 71.50( a) of the final rule.

Comment: A commenter stated that veterinarians who vaccinate or falsify the rabies vaccination documentation of rabid dogs imported into the U.S. should be banned instead of restricting the importation of dogs from that country. Additionally, HHS/CDC received comments to consider creating a list of approved veterinarians abroad for tracking the administration of rabies vaccines in foreign countries.

Response: HHS/CDC appreciates these comments and notes that this is the purpose of having official government veterinarians certify the rabies vaccination form. Official government veterinarians are able to verify which veterinarians are authorized to vaccinate dogs against rabies in their country. Additionally, engaging foreign government official veterinarians in the exportation process of an animal provides a pathway to communicate with a foreign government when cases of fraud are detected by CDC. Currently, there is no recourse or follow-up that a foreign government can perform when CDC identifies fraudulent paperwork because CDC does not require foreign governments to certify the paperwork prior to export. Official government veterinarians currently review and certify dog exportation paperwork for most other countries in the world, but the United States does not have this requirement. The final rule will align the United States requirements more closely with other countries that already require official government certification of export documentation in order to prevent fraud and provide an official pathway to engage with foreign government officials when cases of fraud are detected. It is not feasible for HHS/CDC to maintain a list of veterinarians globally nor for USG officials to verify that an importer does not present documentation signed by a banned veterinarian; therefore, HHS/CDC is leveraging the existing international animal movement system that is overseen by official government veterinarians in each respective country.

Comment: HHS/CDC received a comment that having official government veterinarians verify vaccination forms may result in significant delays.

Response: HHS/CDC disagrees with the comment. The rabies vaccination form can be completed during an animal's health examination prior to export, and most official government veterinarians can certify paperwork within 3-10 days of submission. Owners and importers should plan ahead as wait times to have the forms certified can vary. However, HHS/CDC is utilizing the existing international animal movement system which already has a process in place for issuing travel documents for international pet movement, therefore, HHS/CDC does not anticipate significant delays in certifying paperwork prior to exportation.

Comment: HHS/CDC also received a comment that rather than provide the vaccination form, importers should be required to test tissue samples from dogs to prove they do not have rabies.

Response: HHS/CDC would like to clarify that testing tissue samples for rabies can only be done after an animal has died because the tissues are obtained from the animal's brain. There is no test that can be done to prove an animal does not have rabies while the animal is still alive. Serologic blood tests (titers) can be run to measure antibodies against rabies while an animal is alive, but titer tests do not prove an animal does not have rabies. In fact, elevated (or passing) titers suggest an animal has either been vaccinated against rabies or is infected with the rabies virus. This is why HHS/CDC requires a waiting period between the time a titer is collected and when an animal can be imported, or the time between ACF vaccination and the 28-day quarantine on arrival in the United States. The waiting period or quarantine period helps to ensure the animal is not infection with the rabies virus.

Paragraph (t)— Requirement for Certification of U.S.-Issued Rabies Vaccination for Live Dog Re-entry into the United States form for importers seeking to import U.S.-vaccinated dogs from DMRVV high-risk countries.

Of note: CDC has shortened the name of this form in the final rule to Certification of U.S.-Issued Rabies Vaccination.

Comment: HHS/CDC received comments that an importer should not be required to have USDA certify rabies vaccination forms prior to travel.

Response: HHS/CDC disagrees. As noted above, HHS/CDC has documented instances of importers who falsify vaccination documents with the names of persons who are not accredited to practice veterinary medicine in the United States, or who alter the U.S. vaccine records of animals unbeknownst to the veterinarian. USDA official veterinarians can certify a veterinarian's authority to practice veterinary medicine in the United States through an electronic system that is less susceptible to fraud. CDC, CBP and other government agencies can verify all documentation on USDA's website enhancing importer compliance and reducing risk of fraud.

Comment: HHS/CDC received questions from the public concerning how a U.S. person traveling abroad would be able to have the Certification of U.S.-issued Rabies Vaccination for Live Dog Reentry into the United States form completed by a U.S. veterinarian and endorsed by USDA if they have already left the country.

Of note: CDC has shortened the name of this form in the final rule to Certification of U.S.-Issued Rabies Vaccination.

Response: HHS/CDC has taken steps to address these concerns. HHS/CDC will plan for a transition period to allow personal pet owners to return to the U.S. with their U.S.-vaccinated dog without providing a titer or needing to quarantine at an ACF if they left the United States without obtaining the rabies vaccination form if they can provide a USDA-issued export health certificate that includes proof of a current, valid rabies vaccine. During this transition period, HHS/CDC will have additional guidance available on its website for U.S. veterinarians regarding how to document U.S. rabies vaccination in the event an importer has already left the United States with their U.S.-vaccinated dog.

Comment: HHS/CDC also received comments encouraging HHS/CDC to work with USDA to create joint documents, or to align with USDA requirements and documentation. Commenters also asked what coordination with USDA has occurred and how CDC plans to engage with USDA-accredited veterinarians to communicate the new requirements.

Response: HHS/CDC notes that it works closely with USDA regarding dog importation requirements and believes the current, close coordination is sufficient. CDC has engaged with USDA Veterinary Service to leverage the Veterinary Export Health Certification System already used by USDA-accredited veterinarians for the completion of CDC's Certification of U.S.-Issued Rabies Vaccination Form during a dog's export process. CDC plans to distribute website materials through CDC and USDA websites and communicate directly with veterinary organizations, such as the American Veterinary Medical Association, the National Association of State Public Health Veterinarians, and the U.S. Animal Health Association.

CDC is also aligning with USDA APHIS Animal Care's age requirement for the importation of commercial dog imports by requiring all dogs to be at least six-months of age for importation; partnering with USDA to ensure only USDA-accredited veterinarians complete the Certification of U.S.-Issued Rabies Vaccination form; and requiring the form be endorsed by USDA official veterinarians during the exportation process to reduce fraud. CDC and USDA also work closely with ACF to ensure all dogs meet both agencies importation requirements. However, CDC notes that current USDA APHIS Animal Care requirements do not apply to all dogs and USDA APHIS Veterinary Service's importation requirements do not focus on protecting human health, therefore, CDC requirements are needed in addition to USDA requirements to protect both human and animal health against the reintroduction of DMRVV.

Paragraph (u)— Requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries.

Comment: Commenters expressed various concerns relating to the ability of an importer, airline, or veterinarian to provide documentation confirming that a dog has been only in DMRVV low-risk or DMRVV-free countries during the six months before its arrival into the United States. Commenters also requested greater clarity regarding acceptable forms of documentation.

Response: HHS/CDC appreciates these comments. Based on these public comments, HHS/CDC has included a list of acceptable documents in the regulatory text that an importer may use to confirm that a dog has been only in DMRVV-free or DMRVV low-risk countries during the six months prior to its importation into the United States. Importers may provide proof of rabies vaccination, which is recommended but not required, using the Certification of Foreign Rabies Vaccination and Microchip form or the Certification of U.S.-Issued Rabies Vaccination form listed below.

All forms must be endorsed by an official government veterinarian to be considered valid. Importers should contact their local veterinarian who can submit the required form to an official government veterinarian in the exporting country. Importers may also use the USDA pet travel website or IPATA website to contact a pet shipper to request assistance. This list also appears on CDC's website at www.cdc.gov/dogtravel. These documents include, but are not limited to:

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

Regarding airlines, CDC does not require that airlines confirm that a dog has been only in DMRVV low-risk or DMRVV-free countries during the six months before its arrival into the United States. Rather, airlines must confirm that importers have presented required documentation to the airline before boarding the dog. CDC will specify in communication materials how airlines can confirm an importer has presented the required documentation.

HHS/CDC further notes that it is the importer and not the veterinarian who is responsible for providing documents to the airline confirming that a dog has been only in DMRVV low-risk or DMRVV-free countries during the six months before its arrival into the United States.

Comment: HHS/CDC also received comments from public health agencies expressing concern that allowing dogs from DMRVV-free countries to enter the United States without proof of vaccination creates potential loopholes for unscrupulous importers to exploit.

Response: HHS/CDC shares this concern. However, HHS/CDC believes there should be reduced importation requirements for countries that have eliminated canine rabies in order to encourage other countries to implement canine rabies elimination plans and to reduce the burden on importers traveling from DMRVV-free countries to the United States. HHS/CDC acknowledges that there have been numerous cases documented by CBP, CDC, and USDA of importers moving dogs from DMRVV high-risk countries through DMRVV-free countries to avoid U.S. entry requirements. HHS/CDC is attempting to address this issue by requiring documentation from importers arriving with dogs from DMRVV-free countries attesting that the dog has been in a DMRVV-free country for the six months before arrival. This documentation must be certified by an official government veterinarian in the exporting country. Through this rulemaking HHS/CDC has attempted to balance the needs of public health with the desire to not unnecessarily burden the vast majority of importers who enter the United States with dogs from DMRVV-free or DMRVV low-risk countries. HHS/CDC is not requiring proof of rabies vaccination, serologic titers, quarantine, or limiting ports of entry for dogs arriving from DMRVV-free or DMRVV low-risk countries with appropriate paperwork. HHS/CDC believes that this rule appropriately strikes this balance.

Paragraph (v)— Denial of admission of dogs and cats.

Comment: HHS/CDC received a comment from an airline industry organization stating that the proposed “six-hour window from which an animal denied admission into the United States should be relocated to a CDC-facility or a CDC-registered facility” was too short. The commenter suggested “that airlines notify the CDC within six (6) hours of an animal being denied admission into the U.S. with transport scheduled within 24 hours.”

Response: HHS/CDC has split § 71.51(v) as written in the NPRM into two paragraphs. Paragraph (w) is a new paragraph in the final rule. In response to public comment, under paragraph (w), HHS/CDC now requires airlines to transport healthy animals to a CDC-registered ACF or other CDC-approved facility (if a CDC-registered ACF is not available) within 12 hours of arrival. Ill or injured animals must be transported by the airline immediately to a CDC-registered Animal Care Facilities or other CDC-approved veterinary clinic as directed by CDC.

Animals arriving by air that are awaiting an admissibility determination or denied admission must be held in CDC-registered Animal Care Facilities or other CDC-approved facility (if a CDC-registered Animal Care Facility is not available).

An airline must immediately report an obviously ill or injured animal ( e.g., the animal is unable to stand, has difficulty breathing, is bleeding, has broken bones or disfigured limbs, or is experiencing seizures, vomiting, or discharge from the nose, mouth, or eyes) arriving into the United States to the CDC quarantine station (also known as the port health station) of jurisdiction. The airline must immediately arrange to transport an obviously ill or injured animal to a CDC-registered Animal Care Facility or veterinary clinic as directed by CDC.

Animals arriving by sea that are denied admission must remain on the vessel while awaiting return to the country of departure.

HHS/CDC is also clarifying that it may deny entry to an animal if an importer refuses to comply with CDC-required diagnostic tests to rule out communicable diseases. Diagnostic tests are crucial to determine the cause of an illness and ensure the animal does not pose a public health threat.

Paragraph (w)— Disposal or disposition of dogs and cats denied admission to the United States.

HHS/CDC addressed comments above in “General Comments” that inaccurately interpreted HHS/CDC's NPRM as proposing to euthanize dogs that do not meet HHS/CDC entry requirements. Additionally, comments noted in paragraph (z) may also be applicable to paragraph (w).

Paragraph ((x))— Appeals of CDC denials to admit a dog or a cat upon arrival into the United States.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (y)— Record of death of dogs and cats en route to the United States and disposition of dead animals.

Comment: HHS/CDC received a comment that charging importers for the cost of a necropsy is egregious because it imposes an extra burden on a grieving family. The comment stated that only, “if the autopsy revealed that the importer had falsified documentation then fines and any other action against the importer would be appropriate.”

Response: HHS/CDC disagrees with this comment. CDC acknowledges the important role pets play in the lives of people and their families; however, determining the cause of death of an imported dog or cat is crucial to ensuring an importer, their family members, and other people or animals were not exposed to a potential communicable disease that could threaten the health and safety of an importer, their family, or a community. Necropsies are performed by licensed veterinarians who can arrange for the remains or cremated ashes of an animal to be returned to the importer if the cause of death is determined not to be a communicable disease, which provides grieving families the ability to mourn their dog or cat while ensuring the safety of travelers and U.S. communities. Importers are financially responsible for the animals they import, including the cost of any diagnostic tests needed to ensure a dog or cat is not carrying a communicable disease, including post-mortem diagnostic tests. While the focus of this final rule is DMRVV, there are other communicable diseases that dogs and cats can spread to people, so requiring an importer to pay for a necropsy only if the rabies vaccination paperwork is falsified is not sufficient to protect public health.

Paragraph (z)— Abandoned shipments of dogs and cats.

Comment: HHS/CDC received numerous letters from public health partners, animal welfare groups, importers, and rescue groups that stated that HHS/CDC should identify resolutions for the issues of abandoned animals at ports of entry and the public health risks associated with delayed care or evaluation for sick or injured animals that arrive in the United States. However, other commenters, including an airline industry member organization, objected to airlines being identified as the responsible party for dogs they transport in the event an importer abandons the dog. An airline industry member organization suggested that CDC and CBP should be financially responsible for abandoned animals. Commenters stated the responsibility for finding appropriate housing for dogs denied admission should not be shifted to airlines. In their view, the care of a dog denied admission into the United States should be the responsibility of the Federal agency denying entry and/or the facility where entry is denied. Commenters argued there is no justification for shifting the consequences of enforcing Federal agency rules onto carriers, and that this was akin to an unfunded mandate for airlines.

Response: HHS/CDC notes that abandonment of animals arriving in the United States is a genuine, documented problem, which can create public health risks (exposures to sick or rabid animals), animal welfare concerns, and additional costs for housing and care. The final rule seeks to reduce the incidence of abandoned animals by requiring airlines to confirm entry requirements prior to boarding, which will likely reduce the number of dogs denied entry and abandoned on arrival. The final rule further provides that when an airline accepts an animal for boarding, whether in cargo or in the cabin, the airline must provide care for the animal in the event an importer abandons it or to transport the animal to a veterinary clinic on behalf of the importer if it becomes ill or injured prior to being cleared for entry into the United States. Such costs have never been borne by Federal agencies, and this requirement does not represent a shifting of this responsibility. This is consistent with existing practice, as carriers are already assigned responsibility for the goods they transport (if there is an AWB). For the rare occasions in which an animal is abandoned, carriers have the ability to use contractual provisions to ensure importers are responsible for associated costs, as discussed at more length below.

HHS/CDC would like to note that this requirement would not be considered an unfunded mandate, as that term is understood under the Unfunded Mandate Reform Act, 2 U.S.C. 1501 et seq., for several reasons. First, HHS/CDC is not imposing a cost of $177M USD or more onto airlines, as required to be an unfunded mandate under the 1995 Unfunded Mandate Reform Act of 1995. HHS/CDC estimated that between 300 and 750 dogs would be denied entry each year under the regulatory baseline ( i.e., under the dog importation requirements specified prior to this final rule going into effect and assuming the temporary suspension was not in effect). With the requirements in the final rule, CDC assumed that between 30 and 75 dogs would be denied entry because HHS/CDC believes that the standardization of rabies vaccination documentation will facilitate the ability of airlines to check this documentation is in place prior to boarding dogs for flights to the United States. Only a small portion of all imported dogs would be abandoned by importers such that the costs of the dogs' care and their return to their countries of origin would be incurred by airlines. CDC estimated that the costs to airlines under the regulatory baseline would range from $42,000 to $650,000. These costs would be further reduced by the requirements in the final rule. Second, the costs for transportation, care, and housing are not being shifted from the government to the airline because these costs have never been a government responsibility. Third, ensuring airlines are responsible for confirming entry requirements for dogs prior to boarding is likely to result in fewer dogs denied entry and abandoned at the U.S. port, reducing the number of abandoned animals that airlines may be responsible for and resulting in fewer costs to airlines for abandoned animals. HHS/CDC acknowledges that the need for airlines to review additional documents and create bills of lading (or other CDC-approved alternative) as required in this final rule will also increase costs for airlines to transport dogs to the United States. In addition, this final rule is expected to reduce the number of dogs flown into the United States, which would reduce the revenue and profit earned by airlines to transport dogs.

Comment: HHS/CDC received comments requesting that it require importers to either reimburse airlines for costs relating to care and transporting an animal to a veterinary clinic or require that the importer be the financially responsible if the animal is abandoned.

Response: HHS/CDC notes that the importation of animals and other goods involves multiple parties (importers, carriers, etc.), each with its own sets of responsibilities. The final rule outlines these responsibilities in ways that best protect public health. Airlines have responsibilities for the animals they carry, and the final rule is designed to minimize this burden where possible while protecting public health from the importation of rabid dogs. HHS/CDC agrees that an airline may pursue reimbursement from importers for any expenses incurred on behalf of the importer if an animal arrives ill, is denied admission, or is exposed to a sick animal in transit. Both the NPRM and the final rule include regulatory text that states that an airline may make “contractual arrangements with an importer or a third party relating to the expenses of returning an animal to its country of departure, for veterinary care, or otherwise disposing of an animal, provided that no government costs are incurred.” Airlines would also be able to include reimbursement for costs incurred relating to animal importations as part of their contract for carriage with an importer. To the extent that the commenters argue that HHS/CDC should directly reimburse carriers for costs incurred on behalf of an importer abandoning an animal, HHS/CDC notes that it would lack the legal authority to provide such indemnification. The cost of caring for a dog denied admission has never been a government responsibility. Long-standing regulations at 42 CFR 71.51(g) have provided that animals denied admission shall be detained at the owner's expense, and not at government expense. Although the rule may have the effect of transferring immediate responsibility from the owner to the carrier, this is to ensure that animals abandoned by their owners after import are housed appropriately pending return to their country of departure, and as noted above, contractual mechanisms are available to carriers to pursue reimbursement from importers for any expenses incurred on behalf of the importer if an animal arrives ill, is denied admission, or is exposed to a sick animal in transit. This shifting of responsibility is justified because airlines can establish the conditions by which they accept goods and cargo transported into the United States. It is also the airline, not the owner, that establishes flight schedules and can therefore arrange to return a dog denied admission quickly to its country of departure, thereby reducing potential housing costs, or otherwise disposing of an animal, provided that no government costs are incurred.

Comment: HHS/CDC also received comments that veterinary clinics should be acceptable housing alternatives for animals abandoned at ports of entry in the event an ACF is not available.

Response: HHS/CDC works closely with the airlines, USDA, and CBP when an animal is abandoned at a port of entry. In the event an ACF is not available, CDC may contact local veterinary clinics to determine whether there is available housing for an abandoned animal. Abandoned animals are the responsibility of the airline and the animal's ultimate disposition is determined in collaboration with the airline. CDC veterinarians will contact local veterinary clinics or veterinary teaching hospitals to determine whether they are equipped to house an imported dog. CDC may request verification from the clinic or hospital that it is equipped to handle a variety of scenarios, such as an isolation or quarantine, emergency surgery, diagnostic testing capabilities, or overnight (24 hours a day) monitoring to determine whether a hospital or clinic is suitable to house an animal pending admissibility determination. These determinations are made based on the health status of the dog and assessment of potential communicable disease risks. In the past, CDC has allowed dogs to be held at local veterinary clinics or veterinary teaching hospitals when ACF are not available for short periods of time. HHS/CDC agrees that if an ACF is not available, a CDC-approved alternative facility such as a veterinary clinic or kennel may be a suitable alternative for animals abandoned at ports of entry. The facility must be approved by HHS/CDC prior to transport.

Comment: HHS/CDC received a comment stating that an importer should not be allowed to abandon an animal if the animal has not been cleared to enter the United States with its importer.

Response: HHS/CDC notes that in practice it is very difficult to prevent importers from abandoning animals after the animals arrive in the United States. In general, there is a large amount of inanimate goods that are abandoned by importers upon arrival. Although HHS/CDC in theory could attempt to penalize importers from abandoning dogs upon arrival, to do so, HHS/CDC must request assistance from other departments and agencies to address violations which can be a time-consuming process. This process would also not address the immediate concern of port partners who would still need to find adequate housing and care for abandoned animals and determine their ultimate disposition on a timely basis. Considering the enforcement needs and practical difficulties in preventing an individual importer from abandoning a dog, HHS/CDC has sought alternative solutions as explained in this final rule.

Paragraph (aa)— Sanitation of cages and containers of dogs and cats.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (bb)— Requirements for in-transit shipments of dogs and cats.

Comment: HHS/CDC received a comment clarifying that in-transit shipments only include dogs transported as cargo.

Response: HHS/CDC confirms that this is accurate. HHS/CDC is aligning with the USDA's definition of in-transit which only applies to dogs in cargo. This is because animals in-transit must remain under the care of the airlines to minimize contact with members of the public or illegal entry into the United States. Dogs flown in the passenger environment (hand-carried or checked baggage) do not meet the definition of in-transit and must meet HHS/CDC entry requirements.

Comment: HHS/CDC received a comment that in-transit shipments should be required to contain an entry number on the in-bond form.

Response: HHS/CDC disagrees. In-transit shipments are, by definition, not entering the U.S.; therefore, an entry number is not needed. HHS/CDC believes that the addition of an entry number could lead to confusion and the accidental admission of animals that do not meet U.S. entry requirements.

Although HHS/CDC did not receive public comment about microchip requirements for dogs in-transit, HHS/CDC is clarifying that a microchip is not required for dogs that are transported by aircraft and are being transited through the United States if retained in the custody of the airline.

Paragraph (cc)— Bill of lading and other airline requirements for dogs.

Comment: HHS/CDC received comments from airlines that they should not be held responsible for confirming that importers meet entry requirements before boarding dogs. Other commenters requested more information on how they can confirm the CDC Dog Import Form has been completed.

Response: HHS/CDC is requiring airlines to confirm entry requirements in order to decrease the likelihood a dog will be denied entry and abandoned at upon arrival. Airlines can ensure importers have appropriate paperwork prior to departure, and airlines are best positioned to confirm required documentation at the point of departure. Additionally, these requirements align with other airline responsibilities in other contexts (verifying traveler passport and visa information, screening cargo and baggage). Airlines will be required to confirm all necessary paperwork is present and that the information on documents is consistent when multiple documents are presented to the airline. For example, airlines should deny boarding based on discrepancies in paperwork that would be obvious to a reasonable observer. CDC will issue guidance on how to confirm documentation. It will not be an onerous process for airlines to confirm importers have a CDC Dog Import Form receipt as importers will be able to present the emailed receipt digitally or a paper print-out of the receipt to an airline representative at check-in.

Comment: HHS/CDC received comments supporting the requirement that airlines should deny boarding dogs whose importer does not present required documentation to prevent inadmissible dogs from flying to the United States.

Response: HHS/CDC agrees with this comment. Federal agencies that work at ports strongly support airlines confirming importer documentation prior to the flight to limit the number of inadmissible dogs that arrive at ports in the United States. Many State agencies also voiced support for required document review and visual screening of dogs by airlines prior to accepting dogs for transport to prevent inadmissible dogs from flying to the United States and entering their jurisdictions. These requirements align with other airline responsibilities in other contexts (verifying traveler passport and visa information, screening cargo and baggage).

Comment: HHS/CDC received comments from airlines that they believed the proposed rule would require them to buy specialized equipment (microchip scanners) and opposed this requirement.

Response: HHS/CDC clarifies it is not asking airlines to scan dogs' microchips. Scanning is performed at the ACF or by the importer with assistance from CDC's quarantine station officers (also known as CDC port health station officers). Airlines will be required to confirm all necessary paperwork is present and that the information on documents is consistent when multiple documents are presented to the airline. For example, airlines should deny boarding based on discrepancies in paperwork that would be obvious to a reasonable observer. CDC will issue guidance on how to confirm documentation.

Comment: HHS/CDC received numerous comments from public health partners, animal welfare groups, importers, and rescue groups that airlines should be responsible for the animals they transport.

Response: HHS/CDC agrees with these comments and believes the best way to ensure airline responsibility for the animals they transport is through an existing process called a bill of lading. A bill of lading (including an AWB) is a legally binding document issued by a carrier to a shipper or importer that details the type, quantity, and destination of the goods ( i.e., dogs) being carried. A bill of lading serves as a shipment receipt when the carrier delivers the goods at a predetermined destination. A bill of lading is a key document to ensure theft or abandonment of goods does not occur while the goods are being shipped to the final destination. Additionally, a bill of lading serves as undisputed proof of shipment, and it represents the agreed upon terms and conditions for the transportation of the goods. Dogs that arrive ill, injured, or who are denied entry upon arrival in the United must have a bill of lading to ensure the animal receives timely care and can be tracked by Federal agencies and airlines throughout the clearance or return process. A bill of lading gives the Federal Government authority to leverage the carrier's bond in cases of noncompliance. HHS/CDC encourages airlines with limited cargo operations to work with sales supervisors in their local offices or partner airlines to create AWB. CDC and several foreign-based air carriers have successfully piloted the creation of AWB for dogs transported in the passenger environment.

Comment: HHS/CDC received a comment that the rule usurps the USDA's authority by treating all pets as imports and by forcing all dogs to travel by air as cargo.

Response: HHS/CDC disagrees because it is not unusual for different Federal agencies to possess overlapping legal authority and HHS/CDC's requirements complement and do not conflict with applicable USDA requirements. Additionally, dogs and cats are goods that are imported into the United States if entering from a foreign country regardless of whether the owner/importer considers the animal to be a personal pet. An importation occurs whenever a dog or cat is presented for admission at a U.S. port, regardless of whether the animal is being presented for admission for the first time or returning to the United States after traveling abroad. Dogs and cats must meet the United States' importation requirements to be eligible for entry or re-entry. HHS/CDC has authority to create requirements based on public health concerns for the importation of dogs into the United States. USDA is the competent authority for animal export and animal welfare during transport. HHS/CDC's final rule is focused on dog and cat importation and protecting the public health by establishing requirements specific to preventing the reintroduction of DMRVV into the United States. HHS/CDC's requirements for airlines to confirm documentation before boarding and create a bill of lading or record of transport serve a public health function by preventing inadmissible dogs from being transported to the United States. These requirements also allow HHS/CDC more easily track and identify dogs upon arrival that require further public health evaluation, such as examinations needed for sick or dead dogs or cats.

Additionally, HHS/CDC clarifies that the proposed rule and this final rule do not require that all dogs fly as cargo. HHS/CDC does note that some U.S. ports may require dogs to enter as cargo based on the ACF and CBP Port Director's authority. CBP Port Directors have authority to direct how dogs are processed and cleared at their ports. This is done at the CBP Port Director's discretion and is not a requirement of this final rule. HHS/CDC also notes that travelers can choose to import dogs through another port if they want to import their dog in the passenger environment (hand-carried or checked baggage). HHS/CDC's final rule requires airlines to create an Airway Bill (AWB) or other suitable bill of lading for the movement of dogs in the passenger environment.

Comment: Some commenters stated that the creation of AWB is not possible for dogs transported in the passenger environment (hand-carried or checked baggage). CDC also received comment from the public that flying with an AWB will force dogs to fly as cargo. One commenter requested that HHS/CDC require importers and dogs transported in the passenger environment be cleared together (which can only occur in the Federal Inspection Station) and multiple comments stated that importers should be able to continue to fly imported dogs as checked baggage or hand-carried or both because it is more expensive to fly a dog as cargo and because importers do not want to be separated from their dogs. Commenters also stated that some airlines do not have cargo operations so they cannot create an AWB.

Response: HHS/CDC disagrees with these comments. CDC has successfully piloted the creation of AWB for dogs transported in the passenger environment with several airlines, therefore, HHS/CDC believes this approach can be adopted by other air carriers so that dogs can continue to fly as hand carried or checked baggage. HHS/CDC has also revised the requirements in this final rule to allow greater flexibility for airlines that are unable for technical reasons to generate an AWB to transport dogs as cargo, checked baggage, or hand-carried baggage. Airlines that lack the technical ability to generate an AWB to transport dogs as checked baggage or as hand-carried must request a waiver from CDC and provide a standard operating procedure (SOP) outlining how they will ensure care for any ill, injured, or abandoned animals in the absence of an AWB. CDC may grant an annual waiver. As a condition of granting a waiver, CDC may require the airline to work with a broker to file the appropriate paperwork and identify suitable housing accommodations for any dogs detained pending admissibility (such as an ACF or local kennel). The SOP must include the location of a bonded facility or other suitable alternative approved by CBP and CDC prior to transport of animals. As a further condition of granting a waiver, CDC may require the airline to submit documentation outlining a timetable and steps that will be taken to develop the technical capacity to generate an AWB (or another suitable alternative to an AWB) to transport dogs. CDC will provide additional details for airlines seeking exemption for the AWB requirement in technical instructions available by emailing cdcanimalimports@cdc.gov.

Comment: One commenter noted that HHS/CDC should utilize CBP's Automated Commercial Environment (ACE) 2.0 system for dog importations.

Response: HHS/CDC carefully considered this comment but declines this option because using ACE would require importers to hire a broker which would significantly increase importer costs. Additionally, ACE is only accessible by CBP personnel as authorized by their respective agency role and provisioned for cargo environments, and would not be provisioned for use by CBP officers located in the FIS in verifying whether an owner has uploaded all required documentation prior to arrival. Instead, by requiring that dog importers use the CDC Dog Import Form, CDC is able to track dog imports in a manner similar to ACE through a web-based system that does not require importers to use brokers. Importers will present the paper-based CDC Dog Import Form receipt to CBP officers in the FIS, or the receipt can be uploaded into ACE for dogs traveling in cargo. This ensures the receipt is accessible by all Federal officers at ports of entry. Additionally, CDC does not currently have access to ACE and obtaining access would be costly for CDC at this time. CDC, however, may consider use of this system in the future.

Comment: HHS/CDC also received comments from the airline industry on the six-hour timeline for airlines to transport abandoned, ill, or injured dogs and dogs denied entry awaiting return to their country of origin to an HHS/CDC-approved facility. The commenter suggested that the six-hour window is arbitrary and not supported by corroborative evidence and requested 24 hours to transport these dogs from cargo warehouses to veterinary clinics or kennel facilities, and six hours to notify HHS/CDC of the abandoned, ill, or injured dogs. HHS/CDC also received many comments from public health partners, animal welfare groups, importers, and rescue groups supporting the six-hour timeframe for airlines to transport abandoned, ill, or injured dogs or dogs awaiting return to their country of origin to a veterinary or kennel facility for examination or care.

Response: HHS/CDC appreciates these comments and notes that it has carefully considered the proposed 6-hour timeframe based on concerns relating to the burden on the carrier and to the health and safety of animals detained pending a determination as to their admissibility and workers who may interact with these animals. HHS/CDC anticipates that significantly increasing the time airlines are allowed to keep dogs in cargo warehouses (from 6 hours to 24 hours) would result in an increase in illness and deaths in dogs. An increase in ill dogs and dogs dead on arrival would negatively impact Federal and State public health resources because CDC would need to conduct a public health investigation into the cause of the illness or death. CDC conducted an average of 38 animal health investigations per year between 2019-2023. Each illness/death investigation can cost between $100-$5,500 per event ($3,800-$209,000 per year in public health costs to State or Federal agencies).

Additionally, CDC notes that cargo warehouse staff are not trained to feed/water/care for animals and that detaining animals for long periods of time increases the health risks to the animals as well as the potential risk of injury or expose to workers. Expanding the timeframe for airlines to house dogs in cargo warehouses necessitates additional care from cargo warehouse staff, thereby increasing the risk of bites, scratches, and other injuries from dogs. Additionally, the stress dogs experience during transport could exacerbate the risk of injury to cargo warehouse workers. CDC has documented instances of cargo warehouse staff leaving animals unattended in their crates without food, water, or access to elimination areas outside their crates for prolonged periods of time. Prolonged wait times in cargo warehouses have also led to illness and death in multiple animals (five illnesses and one death in 2019; and two deaths in 2023).

Consistent with USDA regulations, animals should receive food at a minimum every 24 hours and water every 12 hours during transport. Additionally, animals must have their enclosures and food and water receptacles cleaned every 24 hours. CDC and USDA have documented numerous shipments of animals that did not have adequate food and water during transport, nor were their cages cleaned as required. Lengthy international flights, which can begin for a crated animal up to 4 hours before the flight departs and includes the flight time (6-16 hours) plus a 24-hour wait in a cargo hold, will leave many animals exceeding this feeding/watering/cleaning period leading to dehydration, hypoglycemia, illness, or death. Neglect of basic animal care, such as feeding and watering, has a direct public health impact on CDC as noted above because CDC must investigate every report of illness or death in an imported animal to determine the public health risk.

However, HHS/CDC recognizes that some airlines may need additional time to find suitable housing for animals; therefore, HHS/CDC is modifying the language in the final rule to allow airlines up to 12 hours to move dogs from cargo warehouses to an ACF or other CDC-approved location if the animal is healthy. Obviously ill or injured animals must be reported immediately to the CDC quarantine station of jurisdiction and must be transported immediately thereafter to a veterinary clinic or as directed by CDC. Notification to CDC should be made based on visual observation of illness in animals ( e.g., unable to stand, difficulty breathing, bleeding, broken bones or disfigured limbs, seizures, vomiting, or discharge from the nose, mouth, or eyes) by the airline employees or its agents (including contracted cargo warehouse staff) or by Federal government officials ( e.g., CDC or CBP staff). Delaying the care of ill or injured animals will likely result in more deaths, increased potential public health risks, and would be considered inhumane.

Comment: HHS/CDC received comments from the public that it will be difficult to ensure airlines comply with these requirements.

Response: HHS/CDC has outlined options for addressing noncompliant air carriers in § 71.51(ee) of the final rule. Failure to comply with CDC requirements can result in CDC prohibiting carriers from transporting animals. However, CDC will develop training materials for airline partners and animal shippers in the industry and work collaboratively with the animal transportation industry to ensure compliance. Diligence is needed from importers as well as the airlines to ensure compliance with U.S. entry requirements. CDC will continue to develop job aids, presentations, website information, and other materials to distribute to those in the animal transport industry.

Comment: HHS/CDC received a comment that “since airlines have transport registrations with USDA, it is the USDA's responsibility to set the rules and regulations for transportation of live animals.”

Response: Although HHS/CDC agrees that USDA's regulations govern many aspects of animal transportation, this final rule is authorized under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which authorizes the HHS Secretary to make and enforce such regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into any other State or possession. The final rule's provisions, among other things, are designed to prevent the importation of inadequately vaccinated, ill, or dead animals which can lead to communicable disease spread. This is both a public health issue and an animal health issue. HHS/CDC regulates public health risks and works closely with USDA to align requirements where possible; however, the agencies have different mandates, and the purpose of this final rule is to protect the public's health.

Comment: HHS/CDC also received comments that airline costs would increase or that airlines will stop transporting dogs.

Response: HHS/CDC appreciates these comments and notes that the comment from an airline industry organization did not state that HHS/CDC's proposed requirements would cause airlines to stop transporting dogs. For the NPRM, HHS/CDC attempted to estimate the costs to airlines but lacked data on the potential costs to airlines for additional document review and to create bills of lading. HHS/CDC did not receive data from commenters that would help refine these cost estimates, but HHS/CDC understands that commenters may believe the cost estimates for airlines are too low. In the NPRM, HHS/CDC estimated the costs to airlines would include an additional five minutes per dog from DMRVV-free or low-risk countries and 15 minutes per dog from DMRVV high-risk countries. This resulted in an estimate of about $3.2 million (range: $1.3 to $6.6 million) to airlines. On average, this would correspond to between $6.25 to $17.29 per dog transported. CDC could only assume how much time would be required for airlines to review documentation. However, based on comments from the airline industry about the potential difficulties for some airlines to produce bills of lading and other commenters expressing concern that the cost to airlines were underestimated, HHS/CDC increased the amount of time that would assume to be required for airlines to comply with the requirements of this final rule. In the analysis in the final rule, HHS/CDC assumed the amount of time per dog would be 50% more than the estimate for the NPRM for dogs from DMRVV high-risk countries and 100% more for dogs from DMRVV-free or low-risk countries. This amount should not significantly impact airlines' costs to transport dogs on international flights.

On an individual dog basis, the greatest costs to airlines would be incurred when dogs are denied entry and abandoned by an importer. However, this would only occur for a fraction of the dogs transported and HHS/CDC believes the additional requirements included in this final rule should reduce the number of dogs denied entry by standardizing the forms used to verify rabies vaccination documentation. As noted above, the annual costs to airlines for abandoned dogs was estimated to be between $42,000 and $650,000 per year. Assuming the number of dogs denied entry with the final rule is less than under the regulatory baseline, the costs to airlines for abandoned dogs should decrease.

In addition, HHS/CDC has included language in the final rule that allows airlines to seek reimbursement from importers that abandoned animals on arrival, thereby mitigating the potential cost burden on airlines and making it unlikely that airlines will stop transporting animals. They may modify their transportation process to ensure animals are healthy and meet CDC entry requirements prior to transporting the animal. Furthermore, the clearance process at airports may have to be modified to reflect CDC's requirements that are being put in place to control the public health risk of dogs arriving from DMRVV high-risk countries, but CDC will work with airlines and other port partners to continue the safe transportation of dogs from DMRVV high-risk countries.

Paragraph (dd)— Order prohibiting carriers from transporting dogs and cats.

HHS/CDC received no public comment on this paragraph of the proposed rule.

Paragraph (ee)— Prohibition on imports of dogs from DMRVV-restricted countries.

Comment: HHS/CDC received several comments and questions regarding DMRVV-restricted countries. The questions included how the list would be determined, whether data would be publicly available, and whether a country could appeal their status. Suggestions were offered to ban veterinarians instead of countries and to issue permits for dogs arriving from DMRVV-restricted countries. Some commenters expressed concern that people could get stuck overseas with pets when a country was added to the DMRVV-restricted list.

Response: HHS/CDC will maintain a “List of DMRVV-Restricted Countries” from which the importation of dogs into the United States would be prohibited. The list of DMRVV-restricted countries would be maintained on HHS/CDC's website. The addition of countries to the DMRVV-restricted country list will also be announced in notices published in the Federal Register and the data supporting the announcement will also be published in the Federal Register . HHS/CDC is aware of the risk of some travelers being unable to return with their dogs, and HHS/CDC will consider ways to provide adequate notice to importers of changes to the DMRVV-restricted country list, such as including as much time as possible between the announcement of a change to the list and the effective date. HHS/CDC will also retain the ability to issue, at its discretion, a special exemption permit on an extremely limited basis for certain dogs that have been in a DMRVV-restricted country in the six months prior to their importation into the United States.

Although there is no formal appeal process, a listed country's officials may submit additional information to CDC if they believe that the country has been added to the “List of DMRVV-Restricted Countries” in error or if they believe the listing is no longer current. However, HHS/CDC may maintain restrictions or prohibitions in place until the Director is satisfied that the DMRVV-restricted country has established sufficient controls to prevent the reintroduction of DMRVV into the United States, including measures to prevent the use of falsified or fraudulent vaccination credentials or invalid rabies vaccination certificates, or the use of expired, ineffective, or unapproved vaccine products within a country.

HHS/CDC notes that maintaining a list of individual veterinarians would be extremely cumbersome, operationally difficult to revise and maintain, and raise concerns regarding HHS/CDC's ability to effectively enforce such a restriction. Therefore, HHS/CDC declines to implement this proposal. HHS/CDC further notes that the goal of having an official government veterinarian certify the export documentation is to ensure that the exporting country is monitoring the activity of their veterinarians and not certifying any documents they deem suspicious or fraudulent. This also allows CDC to communicate concerns directly with exporting country officials if fraudulent paperwork is noted. Each country has its own rules and regulations governing veterinary medicine and it would be inappropriate and likely ineffective for HHS/CDC to focus on individual foreign veterinarians.

Paragraph (ff)— Request for issuance of additional fines or penalties.

HHS/CDC received no public comment on this paragraph of the proposed rule. However, CDC is adding language informing the public that it may also refer potential violations of Federal law to the U.S. Department of Justice for investigation, and based on the results of such investigation, prosecution. Specifically, CDC may refer a matter to the U.S. Department of Justice if the Director has reason to believe that an individual or organization has violated Federal law, including by forcibly assaulting, resisting, opposing, impeding, intimidating, or interfering with a U.S. government employee while engaged in or on account of the performance of their official duties in violation of 18 U.S.C. 111, by obstructing an agency proceeding in violation of 18 U.S.C. 1505, or by otherwise engaging in conduct contrary to law. CDC believes that this provision serves an important function in informing the public and potentially deterring bad actors from engaging in conduct that forcibly interferes with CDC and CBP's ability to carry out its official duties or obstructing an agency proceeding under this section.

Comment: HHS/CDC received public comment on matters that were not part of HHS/CDC's proposed changes to its regulations and thus are outside of the scope of this final rule. These comments included statements about saving wildlife and suggestions for the regulation of other animals such as nonhuman primates.

Response: HHS/CDC is not updating its regulations for species other than dogs and cats in this rule.

Comment: HHS/CDC also received comments asking to end the temporary suspension of dogs entering the United States from countries with a high risk of rabies.

Response: HHS/CDC notes that these comments are outside the scope of the proposed rulemaking which did not solicit any comments or propose changes to the temporary suspension. However, HHS/CDC clarifies that the purpose of this rulemaking is to mitigate the need for future suspensions by reducing the likelihood of DMRVV being reintroduced into the United States. HHS/CDC further intends to let the temporary suspension expire on July 31, 2024. These comments are beyond the scope of this final rule.

Comment: HHS/CDC received comments about focusing efforts on other areas rather than this rulemaking such as vaccinating immigrants or “illegal immigrants,” addressing drug trafficking, addressing human trafficking, and working to prevent the next pandemic.

Response: HHS/CDC notes that these comments are outside the scope of the proposed rulemaking, which is focused on dog and cat importation.

E. General Comments Relating to DMRVV High-Risk Countries

Comment: HHS/CDC received a number of comments stating that too many countries were on the DMRVV high-risk country list. Commenters also requested that HHS/CDC make publicly available the data used to determine the DMRVV high-risk list.

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

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

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

Comment: HHS/CDC received questions asking why HHS/CDC's DMRVV high-risk country list differs from those used by other countries, including the European Union.

Response: HHS/CDC notes that it is not unusual for different countries to use different methods, criteria, or data for determining a country's rabies risk level. CDC's list is very similar and closely aligns with the lists used by the EU, Australia, New Zealand, and Canada. However, HHS/CDC notes that the entry requirements for dogs from DMRVV high-risk countries differ significantly for the EU and Australia because those countries having stricter entry requirements than those outlined in this final rule. CDC's method for developing the high-risk country list is described in detail above.

Comment: HHS/CDC received questions asking why CDC's list of approved laboratories differs from the laboratories on the EU list. Commenters also noted there were limited or no laboratories in certain regions of the world, or that shipping samples was cost prohibitive and challenging. Commenters noted the lack of CDC-approved laboratories in Asia, Africa, and South America was discriminatory toward U.S. citizens and tourists from those regions.

Response: CDC acknowledges that there are limited or no laboratories in certain regions of the world. For this reason, CDC has included the option to quarantine at an ACF if they cannot obtain a titer for their dog. Prior to 2022, the Nancy Laboratory for Rabies and Wildlife which is part of the French Agency for Food, Environmental and Occupational Health Safety (ANSES) conducted the global proficiency testing program for rabies serology laboratories worldwide. CDC uses the ANSES-approved rabies laboratory list, excluding several laboratories that have been associated with fraudulent titers resulting in the importation of rabid dogs into rabies-free countries. Laboratory proficiency testing is an essential tool for helping to ensure that a laboratory gets its results right. Proficiency testing allows participating laboratories to compare their results and performance with their peers across the world. It helps to identify testing or measurement problems. A proficiency testing program is critical to ensure laboratories are qualified to test samples to ensure the results they produce are valid. In the case of rabies serology laboratories, it is imperative that an animal that receives a passing titer —which can suggest that an animal is protected against rabies virus infection—is truly protected from infection. CDC is working to establish a proficiency testing program to further expand the current list of CDC-approved laboratories. CDC intends to work with laboratories to enhance coverage and accessibility.

HHS/CDC will add laboratories that have successfully completed ANSES proficiency testing (or other CDC-approved proficiency testing equivalent) to the CDC-approved laboratory list (assuming they have not issued fraudulent titers). Additionally, HHS/CDC recognizes there are currently three ANSES-approved labs in the United States. Due to the limited availability of approved laboratories in some countries, CDC strongly encourages U.S. citizens have their dogs vaccinated against rabies while in the United States before traveling, and submit a titer to a U.S. laboratory while in the United States to minimize cost and shipping challenges, and ensure U.S. citizens can return to the United States with their dogs after traveling to a DMRVV high-risk country for a prolonged period of time ( i.e., when their U.S.-issued rabies vaccination may be expired). HHS/CDC notes that the requirement for titers is a WOAH standard for the international movement of any dog that has been in a DMRVV high-risk country; therefore, HHS/CDC disagrees that the final rule is discriminatory toward U.S. citizens and tourists.

Comment: Other commenters asked that HHS/CDC only use the number of cases of human and dog rabies for a country to determine the DMRVV high-risk list because only countries that report cases of rabies in humans and/or dogs should be considered high-risk.

Response: HHS/CDC disagrees with this request because many DMRVV high-risk countries do not have adequate rabies surveillance and testing capacity and therefore do not report cases to WOAH even though rabies is widespread within their country. For example, in 2021 only 35 countries reported rabies case data to WHO and none reported on the number of suspected cases that underwent testing. Until countries report complete data routinely, relying on international organizations' data to make risk determinations will remain problematic. A lack of rabies surveillance data is more likely to reflect a poor public health infrastructure for rabies case detection within a country than the absence of rabies.

As discussed above, there are over 100 countries currently on the DMRVV high-risk country list which reflects the fact that rabies is a neglected tropical disease. The robust rabies control programs present in the United States do not exist in many other countries due to a variety of factors, such as access to veterinary care, sufficient infrastructure to support adequate vaccination, and lack of veterinarians or animal support staff trained to vaccinate animals. CDC evaluates and updates the DMRVV high-risk country list every year and posts the updated list on CDC's website by April 1. For this annual country risk assessment, CDC subject matter experts review publicly available data, including data from international organizations (including the World Health Organization (WHO); the WHO Rabies Bulletin—Europe; the Pan-American Health Organization, and WOAH); published government reports; scientific publications; and outbreak report alerts such as ProMED, as well as information provided by national and international rabies experts. CDC has published the criteria for how it determines a countries classification as a high-risk, low-risk and DMRVV-free country in a peer-reviewed journal which is publicly available. HHS/CDC also believes that countries will be more motivated to share their rabies surveillance data to be removed from the DMRVV high-risk list, which will result in improved rabies global surveillance.

Comment: Some commenters expressed concerns that sudden changes to the DMRVV high-risk country list could result in animals being abandoned overseas.

Response: In HHS/CDC's experience, such concerns are unfounded. Since the inception of the list in 2018, only one country has been added to the list, which was based on a widespread outbreak of DMRVV along a porous international border. CDC has, however, removed multiple countries after they demonstrated improvement in their rabies control programs (moving the countries from DMRVV high-risk to DMRVV low-risk or DMRVV-free status). Additionally, if a country were to be added to the DMRVV high-risk country list, CDC would publish the information on its website and allow for a transition period which would provide importers sufficient time to come into compliance with new importation requirements for dogs arriving from that country. HHS/CDC further encourages people intending to travel to the United States to review the DMRVV high-risk list before traveling and maintain a valid rabies vaccination record and titer (if required) for the dog they wish to bring into the United States.

Comment: HHS/CDC also received comments that it should not maintain a list or differentiate between DMRVV-free, DMRVV low-risk and DMRVV high-risk countries because all imported dogs should be subject to the same requirements regardless of the endemicity of DMRVV within a country. Some comments included statements that any imported dog potentially poses a public health threat and could threaten the health of the U.S. domestic dog population.

Response: HHS/CDC appreciates these comments and recognizes there could be challenges in confirming whether a dog has been only in DMRVV-free or DMRVV low-risk rabies countries during the six months prior to the dog's arrival in the United States. HHS/CDC further acknowledges that some importers have, in the past, moved dogs from DMRVV high-risk countries to DMRVV-free countries solely to circumvent HHS/CDC entry requirements. HHS/CDC defines risk based on the dog's country of origin (or countries the dog has been present in during the previous six months), the risk of rabies within countries (based on endemicity and rabies control programs), and the dog's vaccination status (U.S.- vs. foreign-vaccinated). Although HHS/CDC acknowledges that holding all imported dogs to one standard could theoretically reduce the burden of confirming a dog's country of origin, the final rule does not adopt this approach because it would be unduly burdensome for importers arriving with dogs from countries that have demonstrated adequate control of DMRVV.

Comment: HHS/CDC received three comments specific to Ecuador's inclusion on the DMRVV high-risk list and one comment specific to Ukraine's inclusion on the DMRVV high-risk list.

Response: Ecuador and Ukraine are on the DMRVV high-risk list because they currently meet HHS/CDC's criteria for inclusion on the DMRVV high-risk list.

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

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

Comment: HHS/CDC received a number of comments stating the economic impact analysis underestimated the cost to importers. Some commenters reported facing higher costs relative to estimates included in the NPRM and provided additional cost information relevant to the analysis. HHS/CDC received a number of comments around the cost for post-arrival follow-up at ACF and the costs for transporting dogs as cargo, which is required by some U.S. ports with ACF.

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

Comment: HHS/CDC received a comment inquiring about the estimated costs incurred by different categories of importers with the final rule. HHS/CDC received a request to provide separate cost estimates for deployed Federal employees.

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

The average estimated marginal cost of the final rule to importers of dogs from DMRVV-free or low-risk countries is $23 per dog (range $7.70 to $48 per dog). In contrast, the average estimated marginal cost for dogs from DMRVV high-risk countries is $870 per dog (range $260 to $2,400 per dog). These cost estimates are net of the costs estimated under the regulatory baseline. Among dogs from DMRVV high-risk countries, the costs depend on whether the dog was vaccinated in the United States (estimated average marginal cost per dog range: $15 to $73 per dog) or another country (estimated average marginal cost per dog range: $910 to $3,800 per dog). Finally, among foreign-vaccinated dogs from DMRVV high-risk countries, the costs to importers are likely to vary considerably depending on the country from which dogs would be imported, which will influence costs associated with obtaining titer tests and shipping costs (especially for dogs arriving as cargo).

The estimates reported above represent the average cost per dog for each type of dog import in the first year of implementation. The estimated cost per dog is expected to decrease slightly in subsequent years depending on the introduction of more HHS/CDC-registered ACF and CDC-approved laboratories. However, the costs faced by any individual importer may be higher than these average cost estimates. The most complete data on the countries from which dogs were imported prior to the temporary suspension is for dogs shipped as cargo. HHS/CDC only has data for dogs that are imported as cargo. During 2018 through 2020, about 75% of these dogs arrived from four countries: Ukraine, Colombia, Russia, and China, in order. Almost of half (47%) of dogs arrived from two countries (Ukraine and Colombia) among dogs imported from DMRVV high-risk countries as cargo. The dogs imported from these countries may have lower costs than dogs imported from DMRVV high-risk countries because these countries either have a CDC-approved laboratory or share a border with a country with an approved laboratory.

In addition, HHS/CDC updated the cost estimates for importers from DMRVV-free or low-risk countries by accounting for the additional costs associated with being unable to import dogs younger than six months of age at land borders. The costs associated with the requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries have increased because HHS/CDC added more examples of the types of proof required. Each type of document requires certification by a USDA or foreign official government veterinarian. Examples include: (a) a valid foreign export certificate from a DMRVV-free or DMRVV low-risk country that has been certified by an official government veterinarian in that country; (b) a USDA export certificate if the certificate is issued to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c) a valid Certification of Foreign Rabies Vaccination and Microchip form if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid Certification of U.S.-Issued Rabies Vaccination form. These documents are often required for individuals to travel internationally with their pets but are not required for travel to Canada or Mexico. These documents may be used as long as they specify travel to or from the country from which a dog is imported. Individuals who frequently travel to and from Canada and Mexico (or any other country) can obtain a valid Certification of U.S.-Issued Rabies Vaccination form, which will remain valid for multiple trips for up to three years corresponding to the duration of protection for dog rabies vaccines.

HHS/CDC also accounted for the reduction in costs associated with a dog only needing one titer test during its lifetime if a dog is imported more than once from a DMRVV high-risk country and maintains a current rabies vaccination. HHS/CDC also accounted for the reduction in transportation costs for U.S.-vaccinated dogs imported from DMRVV high-risk countries, which will no longer have to arrive at U.S. ports with CDC quarantine stations. HHS/CDC did not revise estimates for titer shipment costs but notes that, per technical instructions being published in conjunction with this rule, a single titer test will be valid for a dog's lifetime (provided the dog remains current with rabies vaccinations). The cost for shipping may be reduced since importers may obtain the titer test at any time. This change may allow some importers to pool samples for shipment to HHS/CDC-approved laboratories to reduce their costs.

In general, importers of dogs originating from African countries may face higher costs to comply with the requirements finalized in this rule because there are fewer HHS/CDC-approved laboratories on this continent, which would increase the costs for importers to ship samples for titer testing or require quarantine if a titer test cannot be conducted. However, it is challenging to extrapolate costs from individual situations to the total costs for imported dogs from DMRVV high-risk countries because HHS/CDC lacks data on both the total number of dogs imported as well as the proportion of dogs imported from each DMRVV high-risk country. HHS/CDC acknowledges that individual importers may face higher costs than those estimated for the average cost estimates and that importers of foreign-vaccinated dogs from DMRVV high-risk countries will face higher costs than other importers. This group faces higher costs because the dogs they import present a greater risk of DMRVV importation and thus require more substantial and costly measures to mitigate that elevated risk.

HHS/CDC believes the cost per dog estimates presented above would apply to deployed Federal government employees and that their costs to import dogs would be similar as for other dog importers within each category ( i.e., importers of dogs from DMRVV-free or low-risk countries, importers of U.S.-vaccinated dogs from DMRVV high-risk countries, or importers of foreign-vaccinated dogs from DMRVV high-risk countries). Deployed Federal government employees may be able to reduce their costs by vaccinating their dogs in the United States and obtaining a Certification of U.S.-issued Rabies Vaccination form prior to departing the United States. As noted above, the costs for U.S.-vaccinated dogs imported from DMRVV high-risk countries are much less than for foreign-vaccinated dogs. The Certification of U.S.-issued Rabies Vaccination form will remain valid for three years after a dog receives a three-year rabies vaccine in the United States. Dog rescue organizations operating in DMRVV high-risk countries would face the highest costs assuming all of their dogs would be foreign-vaccinated (and not U.S.-vaccinated). However, as noted above, the last four dogs imported while infected with DMRVV were rescue dogs from DMRVV high-risk countries. Thus, this category of importer likely poses the greatest public health risk.

Comment: HHS/CDC received some comments that the changes proposed in the NPRM and finalized in this final rule underestimate the costs to airlines. The commenters did not provide further details regarding which specific costs they believed HHS/CDC had underestimated.

Response: In the NPRM, HHS/CDC attempted to estimate the costs to airlines but lacked data on the potential costs to airlines for additional document review and to create bills of lading. HHS/CDC did not receive specific comments requesting refinement of these cost estimates but understands that airlines may believe the cost estimates are too low. In the NPRM, HHS/CDC estimated that the costs to airlines for document review and processing would include an additional five minutes per dog from DMRVV-free or low-risk countries and 15 minutes per dog from DMRVV high-risk countries. This resulted in an estimate of about $3.2 million (range: $1.3 to $6.6 million) to airlines.

In the analysis in the final rule, CDC increased the estimated costs to airlines by 100% for dogs imported from DMRVV-free or low-risk countries and by 50% for dogs imported from DMRVV high-risk countries to account for a number of commenters who suggested that costs to airlines should be higher than the estimates included in the NPRM analysis. The average cost corresponds to between $7.12 to $20.42 per dog transported as a result of the provisions of this final rule. This amount should not significantly impact airlines' costs to transport dogs on international flights. On an individual dog basis, the greatest costs would be incurred when dogs are denied entry to the United States and abandoned by an importer. However, this would only occur for a small proportion of the dogs transported, and HHS/CDC believes the additional requirements included in this final rule should reduce the number of dogs denied entry by requiring airlines to confirm documentation before boarding dogs and by requiring government certification of rabies vaccination documentation. The use of standardized forms should facilitate and streamline review of rabies vaccination documentation. This will be the primary new requirement for U.S.-vaccinated dogs. The review of documentation for foreign-vaccinated dogs is greater, and CDC will develop guidance to support airlines in reviewing these new documentation requirements. Further, the final rule will provide stability to requirements relative to the temporary suspension. Finally, the annual costs to airlines for abandoned dogs was estimated to be between $42,000 and $650,000 per year. Assuming the number of dogs denied entry with the final rule is less than under the baseline, the costs to airlines for assuming responsibility for abandoned dogs should decrease.

Comment: One commenter stated $400,000 is not that much money to conduct a rabies investigation when HHS/CDC gave $455,151,295 in funding to the State of Kansas, for example, in fiscal year 2021.

Response: HHS/CDC disagrees with this statement and the characterization of State and local public health resources. With regard to the example of Kansas, the funding Kansas (and other states) received from HHS/CDC in 2021 was primarily for COVID-19 response efforts. Kansas only received $2.1M in core public health funding for 2021 which means a single imported rabid dog event could have a substantial adverse impact on the state's public health budget. States also have very limited funding dedicated to rabies control and response. In 2023, for instance, HHS/CDC awarded $200,000 in total to U.S jurisdictions, or approximately $3,500 per state, for rabies response activities, which is not enough to cover the cost of a typical rabies investigation. State health departments conduct a multitude of activities with HHS/CDC funds and the cost associated with a rabid dog investigation are additional costs for which the states do not receive routine funding. The funding limitations in local jurisdictions can be even more significant than those at the State level.

Comment: Some commenters suggested that the costs of this final rule exceed the potential benefits associated with mitigating the risk of DMRVV reintroduction to the United States. Specially, other commenters suggested that the costs to importers of personal pets were too high because the four most recent imports of dogs from DMRVV high-risk countries with rabies were by animal rescues.

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

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

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

HHS/CDC also disagrees that the final rule is overly burdensome on importers of personal pets considering the enforcement burden involved in attempting to distinguish between different types of importers. Although it appears that the risks associated with personal pets may be less than for dogs imported for adoption or resale, HHS/CDC has limited ability to verify which dogs are imported as personal pets versus which dogs are imported as rescue or for resale because it is not unusual for importers to misrepresent the reasons why they are importing a dog into the United States. As discussed above, owners of personal pet dogs who travel from the United States to a DMRVV high-risk country will incur significantly less cost if they obtain a three-year vaccine prior to departure and a Certification of U.S.-Issued Rabies Vaccination. This would reduce costs for some importers of personal pets.

Comment: HHS/CDC received many comments from breeders and breed enthusiasts reporting that the costs to import dogs from DMRVV-free or low-risk countries would increase as a result of the six-month age requirement. Other breeders and enthusiasts did not mention an increase in costs, but suggested the change in regulations would reduce the number of exporters willing to send dogs to the United States, which would decrease genetic diversity.

Response: HHS/CDC disagrees that costs for breeders and breed enthusiasts importing dogs from DMRVV-free or low-risk countries will increase as a result of the six-month age requirement because most breeders should already be complying with this requirement. Breeders frequently import dogs for resale, rescue, adoption, or transfer of ownership, which are defined by USDA as commercial importations. USDA regulations already require that commercially imported dogs be six months or older. In addition, because dogs under six months of age are sexually immature and cannot be used for breeding, delaying their importation will not negatively impact their use as breeding animals. Thus, HHS/CDC did not consider this as a change to the regulatory baseline.

HHS/CDC also believes that the six-month age requirement helps protect the health and safety of all dog breeds because dogs that are at least six months old or older are better able to endure the stresses of international travel ( e.g., long travel times, temperature fluctuations, oxygen or altitude changes, and food/water deprivation). The six-month age requirement for importation will further reduce the burden on Federal and State government agencies of conducing public health investigations. Any time a dog becomes ill or dies during international travel, regardless of country of import, Federal and State government agencies must conduct public health investigations to ensure the animal is not infected with a zoonotic disease that could be transmitted to people (or did not die from a zoonotic disease). These investigations take considerable resources away from other public health priorities. Therefore, because the six-month age requirement helps ensure that dogs are less stressed during international travel and arrive in a healthier state, the burden on Federal and State government agencies of conducting public health investigations should be reduced.

While HHS/CDC acknowledges that this comment was specific to dogs from DMRVV-free countries, HHS/CDC notes that breeders and commercial importers were adept at responding to changes in import requirements established during the period of the temporary suspension and that this rule adopts many of those same practices. HHS/CDC believes that the benefits in improved animal health and public health strongly support this rulemaking.

G. Other Comments

Comment: Some commenters suggested that the proposed rule would result in an increase in pet abandonment in foreign countries and/or at U.S. ports for dogs that do not meet HHS/CDC entry requirements.

Response: HHS/CDC disagrees with these commenters. Throughout the temporary suspension, which has had similar importation requirements in place, HHS/CDC did not document an increase in pets being abandoned by importers at U.S. ports. HHS/CDC does not track the number of dogs abandoned in foreign countries. Although HHS/CDC appreciates the efforts of animal rescue organizations in foreign countries, HHS/CDC's mandate is the protection of human lives and prevention of the consequences that the reintroduction of DMRVV could have on people, pets, and wildlife populations in the United States. Additionally, HHS/CDC has no reason to believe that the final rule will increase animals abandoned in foreign countries because it expects importers to adapt to the new regulatory requirements which align with, but are less burdensome than, WOAH standards. Thus, an exemption is not needed.

Comment: HHS/CDC received comments that the proposed rule seeks to enrich vaccine and microchip manufactures as well as the ACF, and that ACF fees are too high. One comment asked, “Who has shares in microchip companies and Rabies vaccine manufacturers?”

Response: HHS/CDC disagrees with this comment. The intent of this rulemaking is to protect public health—not to enrich private companies. Vaccination is broadly recognized by international health experts, including the World Health Organization and WOAH, as essential to the effective prevention and control of rabies. Microchips are one of the only ways to confirm the identity of a dog and match the vaccination and titer documents to the animal presented for importation. While other permanent identification methods, such as tattoos, do exist, they are subject to alteration and fading, creating opportunities for importers to falsify documents to circumvent entry requirements. Microchipping is a key component required for the international movement of animals, including livestock, zoo animals, wildlife, and pets. It is an international standard required by other countries for the importation of pets and is also a WOAH standard for the international movement of dogs, cats, and ferrets. Regarding fees, HHS/CDC does not set prices charged by privately owned and operated businesses, including manufacturers of vaccines, microchips, or ACF. Although HHS/CDC acknowledges some costs such as vaccination and examination of dogs at the ACF may be higher than those charged by other providers (U.S. average $86 vs. ACF average $208), it has found that other fees such as those for boarding (U.S. average $40-$280/night vs. ACF average $137/night) are comparable with those charged by other providers.

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

Response: Although HHS/CDC acknowledges that the final rule will result in additional requirements to import dogs from high-risk countries and will prevent breeders and breed enthusiasts from importing dogs under six months of age, these difficulties do not outweigh the benefits to U.S. public health. HHS/CDC believes that, in addition to protecting public health by ensuring all imported dogs are adequately protected against rabies, the rule will likely better ensure the health of dogs during international travel and prior to their release into the United States. As noted above, international travel is stressful for animals and can result in illness and death in young animals or specialty breeds ( e.g., snub-nosed breeds, hairless breeds) that cannot compensate for the stresses they undergo (length of travel time, temperature fluctuations, oxygen or altitude changes, food/water deprivation).

As noted above, the six-month age requirement for importation helps protect the health and safety of all dogs, including rare dog breeds. Since dogs under six months of age are sexually immature and cannot be used for breeding, delaying their importation will not negatively impact their use as breeding animals. Additionally, waiting until a dog is six months of age to import the dog will help ensure the safety and welfare of the dog during international travel when they are subjected to the stresses of international travel mentioned above ( e.g., long travel times, temperature fluctuations, oxygen or altitude changes, and food/water deprivation). Rare dog breeds may be imported under the final rule if they meet entry requirements. Although HHS/CDC acknowledges that it lacks data to quantify whether specific types of breeds of dogs imported into the United States will change, HHS/CDC believes that the final rule is not overly burdensome in regard to dog breeders and breed enthusiasts because the final rule has strong public health benefits and will help ensure the safety and welfare of dogs engaged in international travel. Thus, an exemption is not needed.

Comment: HHS/CDC received comments that the final rule will make it harder to travel abroad with pets.

Response: HHS/CDC does not believe that the final rule is overly burdensome with regard to individuals traveling abroad with their pets in large part because the rule does not apply to animals being exported from the United States. Other countries set their own importation requirements, separate from HHS/CDC's import requirements. Additionally, HHS/CDC does not believe travel will be more difficult for importers with U.S.-vaccinated dogs because HHS/CDC has amended the final rule to allow these importers to enter the United States at any U.S. port, rather than only at one of the 18 U.S. airports with a CDC quarantine station as proposed in the NPRM. Therefore, importers who maintain their dog's valid Certification of U.S.-issued Rabies Vaccination can easily return to the United States with their dog from any country through any U.S. port provided their dog is at least six months old, microchipped, and accompanied by a Certification of U.S.-issued Rabies Vaccination form and a CDC Dog Import Form receipt. Also, as noted more extensively above, the final rule aligns U.S. importation requirements with practices in other rabies-free countries while providing significant additional flexibilities relative to WOAH importation standards to alleviate unnecessary burden on pet owners and importers.

Comment: HHS/CDC received comments stating that the NPRM was unclear and suggesting that HHS/CDC reorganize the rule into different categories, such as “Family Pets,” “On-line Sales and/or Commercial Sales,” Service Animals,” and “Cats.”

Response: HHS/CDC declines to reorganize the final rule as suggested by the commenters because it believes that the final rule is sufficiently clear and that some of the proposed categories are unneeded and would be more difficult to enforce. HHS/CDC has determined that the public health risk from dog imports is based primarily on the dog's country of origin (high-risk DMRVV countries) and vaccination status (U.S.-vs. foreign-vaccinated) and has, through this final rule, established different requirements based on these factors.

In CDC's experience, because importers frequently misrepresent the reasons why a dog is being imported, CDC cannot reliably ensure that dogs presented as “personal pets” are not being imported for other reasons, including commercial resale after the dogs have been permitted to enter the United States. For instance, USDA APHIS Animal Care (AC) currently requires dogs imported for commercial purposes to apply for and receive a USDA AC dog import permit, however, over the past several years, USDA, CDC, and CBP have documented hundreds of instances of commercial importers attempting to avoid USDA entry requirements by misrepresenting the reasons why dogs are being imported. HHS/CDC also notes that service animals are subject to the same public health risk as other dogs from DMRVV high-risk countries and that the final rule already includes a separate provision for service animals entering through a U.S. seaport. For these reasons, HHS/CDC declines to reorganize the final rule as suggested in this comment.

Comment: HHS/CDC received a comment that the changes would make the process of dog importation more confusing, expensive, time consuming, and difficult for people without financial and educational resources.

Response: HHS/CDC acknowledges that animal transportation can be a confusing and frustrating process. However, CDC believes the changes it is implementing will reduce confusion among importers, government officials, airlines, and the animal transportation industry. For example, with CDC's implementation of standardized forms certified by official government veterinarians, CDC will be less likely to deny animals entry due to missing, incomplete, or fraudulent vaccination forms. Airline staff and CBP officers will no longer have to search through multiple documents to ascertain whether all required information for a dog is present for entry into the United States. Instead, a single form can be referenced and used to streamline the process, avoid confusion, and ensure entry requirements are met. The microchip requirement will reduce confusion and uncertainty about an animal's identity and vaccination history. Having ACF at multiple ports will provide a place for sick or injured pets to receive prompt veterinary care and will reduce an owner's stress in those unfortunate circumstances.

HHS/CDC also acknowledges there is an increased cost to importers under the final rule, however, CDC's requirements align more closely with WOAH standards, which have already been implemented by the majority of DMRVV-free countries around the world. The additional expense associated with international animal travel is not a U.S.-phenomenon due solely to CDC's updated final rule, but rather reflects an international commitment by numerous countries to prevent DMRVV importations through enhanced entry requirements, including microchipping, certified vaccination records, serologic titers, and quarantine. HHS/CDC notes that it is limiting costs to importers by not enacting all WOAH standards (as outlined above).

Finally, HHS/CDC plans to engage in a proactive education campaign for importers, government officials, U.S. and foreign-based veterinarians, airlines, and the animal transportation industry in order to ensure importers are aware of the new requirements. Many of the requirements under the final rule were implemented during the temporary suspension and are therefore, already in place and are general, widespread knowledge. Importers were able to adapt quickly under the temporary suspension and CDC anticipates the same will be true of the final rule given the similarities with the requirements already in place through the temporary suspension.

Comment: HHS/CDC received comments that the proposed requirements infringe on individuals' rights and freedoms. The commenter did not specify further which individual rights and freedoms they believed would be infringed by the final rule.

Response: Because the commenter did not specify further, HHS/CDC assumes that the commenter meant to refer to due process rights that may be protected by the Fifth and Fourteenth Amendments to the U.S. Constitution. However, HHS/CDC disagree that the final rule implicates any rights or interests protected by the Due Process Clause. Where applicable, the Due Process Clause “imposes procedural constraints on governmental decisions that deprive individuals of liberty or property interests.” Nozzi v. Hous. Auth. of City of Los Angeles, 806 F.3d 1178, 1190 (9th Cir. 2015). However, “[d]ue process protections extend only to deprivations of protected interests.” Shinault v. Hawks, 782 F.3d 1053, 1057 (9th Cir. 2015). Because individuals have no protected property or liberty interest in importing dogs or other animals into the United States, the final rule does not infringe upon any due process rights protected by the U.S. Constitution. See Ganadera Ind. v. Block, 727 F.2d 1156, 1160 (D.C. Cir. 1984) (“no constitutionally-protected right to import into the United States”); see also Arjay Assoc. v. Bush, 891 F.2d. 894, 896 (Fed. Cir. 1989) (“It is beyond cavil that no one has a constitutional right to conduct foreign commerce in products excluded by Congress.”).

Comment: CDC received a comment stating that “CDC is a quasi-governmental agency, it's difficult to understand the authority allowed for this proposed rule (and current rules on the books).”

Response: CDC is a U.S. government agency within HHS. The primary legal authority supporting this final rule is section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under section 361, the Secretary of HHS (Secretary) may make and enforce such regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into any other State or possession. It also authorizes the Secretary to promulgate and enforce a variety of public health regulations to prevent the spread of communicable diseases, including through inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. Since at least 1956, Federal quarantine regulations (currently found at 42 CFR 71.51) have controlled the entry of dogs and cats into the United States.

In addition to section 361, other sections of the PHS Act relevant to this final rule are section 362 (42 U.S.C. 265), section 365 (42 U.S.C. 268), section 367 (42 U.S.C. 270), and section 368 (42 U.S.C. 271). Section 362, among other things, authorizes the Secretary to promulgate regulations prohibiting, in whole or in part, the introduction of property from foreign countries or places, for such period of time and as necessary for such purpose, to avert the serious danger of introducing communicable disease into the United States.

Comment: HHS/CDC received several comments that proposed CDC issue fines or citations against importers who violate U.S. entry requirements, present fraudulent documentation, or import rabid dogs.

Response: HHS/CDC appreciates this comment, but notes that it must rely on other U.S. Federal agencies, such as the U.S. Department of Justice, to seek criminal penalties for individuals who violate quarantine regulations, including those relating to the importation of dogs into the United States. Under section 368 of the PHS Act (42 U.S.C. 271) any person who violates regulations implementing sections 361 (42 U.S.C. 264) or 362 (42 U.S.C. 265) is subject to imprisonment of not more than one year, a fine, or both. Pursuant to 18 U.S.C. 3559 and 3571, an individual may face a fine of up to $100,000 for a violation not resulting in death and up to $250,000 for a violation resulting in death. Because these penalties are criminal in nature, to implement section 368, HHS/CDC would refer potential violators to the U.S. Department of Justice for criminal prosecution.

Through this final rule, HHS/CDC is also including new language advising individuals and organizations that it may request that DHS/CBP take additional action pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a. Specifically, CDC may request that DHS/CBP issue additional fines, citations, or penalties to importers, brokers, or carriers whenever the CDC Director (Director) has reason to believe that an importer, broker, or carrier has violated any of the provisions of this section or otherwise engaged in conduct contrary to law. HHS/CDC stresses that it does not administer Title 19, and decisions regarding whether to issue such fines, citations, or other penalties would be entirely at the discretion of DHS/CBP and subject to its policies and procedures. Notwithstanding, HHS/CDC believes it important to include this language to advise individuals and organizations that it may request that DHS/CBP pursue such actions.

Comment: HHS/CDC received comments that funding should not be spent implementing the provisions in this final rule as well as comments that the final rule will increase CDC costs and require additional staff. Another comment stated, “I do not see the CDC having staff to coordinate this quarantine process and how will it be funded? This seems like tax payers will pay the burden.”

Response: This final rule implements an importation system relying on a network of privately operating ACF for the examination, revaccination, and quarantine (if necessary) of foreign-vaccinated dogs from DMRVV high-risk countries. During the temporary suspension, CDC was issuing CDC Dog Import Permits for foreign-vaccinated dogs from DMRVV high-risk countries. Issuing permits required costs to CDC in the form of personnel and IT services. By replacing the permitting system for foreign-vaccinated dogs from DMRVV high-risk countries with a system of ACF, CDC anticipates a reduction in costs and staff time associated with dog importation. CDC will not bear any costs for quarantining dogs. The costs of examination, revaccination, and quarantine at ACF will be paid for by the importer.

Comment: HHS/CDC also received comments suggesting that HHS/CDC should spay and neuter animals or consider spaying and neutering animals in lieu of euthanizing animals.

Response: The final rule also contains no requirements relating to imported animals being spayed or neutered because HHS/CDC does not typically regulate the control of animal populations. HHS/CDC reiterates that the rule does not require that animals be euthanized if they do not meet HHS/CDC import requirements. If an animal is not fit to travel, poses a public health risk, or would pose a risk to other animals, then the carrier must arrange for the animal to be transported to an ACF or a CDC-approved veterinary clinic (if an ACF is not available) for either housing and treatment by a licensed veterinarian until approved by CDC for entry or denied entry to the United States and returned to its country of departure. If the veterinarian recommends humane euthanasia ( e.g., under circumstances where the animal is fatally ill or injured), or if this option is chosen by the importer or carrier, then the animal must be euthanized by a U.S.-licensed veterinarian in accordance with American Veterinary Medical Association guidelines. Under these circumstances, the decision to euthanize an animal is made by the animal's custodian ( i.e., the importer or the carrier if the importer abandons the animal) and not HHS/CDC.

Comment: HHS/CDC received 29 comments stating support for “Option 2.” HHS/CDC believes “Option 2” referred to Table 4 in the NPRM, which is a “Summary Table of Important Changes to Regulatory Requirements Based on the Provisions of this NPRM and Alternatives Considered.” Option 2 is described as the less restrictive option and included no age requirement, no certification of rabies vaccination forms, acceptance of titers from any lab, follow-up vaccination performed by local veterinarian in the United States, and no port of entry restrictions.

Response: HHS/CDC disagrees with the request to adopt components of “Option 2” with the exception of providing additional flexibility regarding the ports of entry at which U.S.-vaccinated dogs may arrive in the United States. This final rule allows U.S-vaccinated dogs from DMRVV high-risk countries to enter at any U.S. port instead of only arriving via air at a U.S. airport with a CDC quarantine station as proposed in the NPRM. HHS/CDC addresses the justification for each of the remaining requirements outlined in Table 1. Additional details on the costs the lower cost and higher cost alternatives is provided in section (VIIA: Required Regulatory Analyses).

VII. Required Regulatory Analyses

A. Executive Orders 12866, 13563, and 14094

Under Executive Order 12866 (E.O. 12866), Regulatory Planning and Review (58 FR 51735, October 4, 1993), HHS/CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. E.O. 12866, as amended by Executive Order 14094, defines “significant regulatory action” as an action that is likely to result in a rule:

• Having an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of OIRA for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities;
• Creating a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
• Materially altering the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
• Raising legal or policy issues for which centralized review would meaningfully further the President's priorities, or the principles set forth inE.O. 12866, as specifically authorized in a timely manner by the Administrator of OIRA in each case.

OMB's Office of Information and Regulatory Affairs has determined that this rulemaking is “significant” under E.O. 12866.

The provisions of this rule are not likely to have an annual effect on the economy of $200 million or more, although there is considerable uncertainty around the number of dogs imported at baseline, including the number of dogs imported from DMRVV high-risk countries. HHS/CDC conducted an analysis to estimate the costs and benefits of the provisions of this rule relative to a regulatory baseline without any change in requirements. HHS/CDC also reports the costs and benefits of the set of lower-cost alternatives and higher-cost alternatives relative to the same regulatory baseline. HHS/CDC requested public comment on costs associated with these changes to importers, airlines, and State and local health departments to improve the accuracy of cost and benefit estimates. More details on the assumptions used to develop this analysis are included in an Appendix found in the Supplemental Materials tab of the docket.

The economic regulatory baseline is based on the provisions included in the existing 42 CFR 71.51. The baseline analysis does not incorporate the impact of the temporary suspension of dogs imported from DMRVV high-risk countries that has been in effect since July 14, 2021. The economic baseline does not account for the temporary suspension but does account for a change to the definition of DMRVV-free country published in 2019. This baseline is used as a comparator to assess the impact of the provisions of the final rule. The summary of the regulatory baseline is defined further in Appendix Section A3 found in the Supplemental Materials tab of the docket.

The rule addresses the market inefficiency in which dog importers do not consider or bear the potential detrimental impacts to the public's health that may result from the importation of ill dogs, especially dogs infected with DMRVV. At the societal level, this could include the reintroduction of DMRVV into the United States. Regulation at the Federal level is necessary to address the public health risk of infectious diseases from the importation of ill or unhealthy dogs. Federal action allows risks to be addressed and mitigated prior to dogs' arrival in the United States. The rule is expected to affect the following categories of interested parties and implementing partners:

• Importers of dogs from countries that are DMRVV-free or at low risk for DMRVV;
• Importers of dogs from countries that are at high risk of DMRVV;
• Airlines and other carriers;
• CBP;
• CDC;
• USDA; and
• State and local public health and animal health departments.

As discussed above, the rule incorporates different requirements depending on whether dogs are imported from DMRVV high-risk countries compared to countries that are DMRVV-free or DMRVV low-risk. Requirements for dogs from DMRVV high-risk countries are further differentiated depending on whether imported dogs have received their rabies vaccines in the United States or in another country. Foreign-vaccinated dogs imported from DMRVV high-risk countries would have to arrive at one of currently six airports with a CDC-registered Animal Care Facility. Importers of foreign-vaccinated dogs from DMRVV high-risk countries would make reservations prior to arrival with a CDC-registered ACF for a veterinary examination and revaccination. As part of the entry requirements, importers would either agree to a 28-day post-arrival quarantine period for the dog or prior to arrival submit samples of the dog's blood to a CDC-approved laboratory for serologic testing at a time interval specified in CDC technical instructions to demonstrate immunity to rabies virus. CDC assumes that most importers would choose serologic testing in lieu of the quarantine period. All importers of dogs from DMRVV high-risk countries need a Certification of Foreign Rabies Vaccination and Microchip form or Certification of U.S.-issued Rabies Vaccination form, which require certification by an Official Government Veterinarian in the country of origin or a USDA Official Veterinarian, respectively. However, dogs imported from DMRVV-free or DMRVV low-risk countries and importers of U.S.-vaccinated dogs from DMRVV high-risk countries do not require examination at CDC-registered Animal Care Facilities and are eligible to arrive at any U.S. port.

In lieu of the Certification of Foreign Rabies Vaccination and Microchip form or Certification of U.S.-issued Rabies Vaccination form, importers may provide documentation that the dogs have been only in DMRVV-free or DMRVV low-risk countries during the six months prior to arriving in the United States ( i.e., to demonstrate the dog had not been in a high-risk country). This documentation must be certified by an official government veterinarian, but many importers must already obtain a foreign export certificate from a DMRVV-free or DMRVV low-risk country that has been certified by an official government veterinarian in that country prior to importing dogs into the United States. In addition, importers who make multiple trips to and from the United States ( e.g., across land borders) may use the Certification of U.S.-issued Rabies Vaccination form for U.S.-vaccinated dogs, which will remain valid for three years after a dog receives a three-year rabies vaccine in the United States. Thus, the additional costs will only be incurred for a subset of dogs imported from DMRVV-free or low-risk countries.

All dog imports arriving on aircraft conveyances, regardless of whether they arrive from countries that are DMRVV-free or at low- or high-risk for DMRVV, are subject to a six-month minimum age requirement. In addition, all dogs, other than those in transit, need to be implanted with microchips for identification purposes. All dogs, regardless of country of origin, must be listed on a bill of lading or CDC-approved alternative by the airline, if entering the U.S. via air. All importers of dogs arriving at an air, land, or seaport must submit a CDC Dog Import Form to CDC via a CDC-approved system prior to the dog's departure from the foreign country. The form must be presented to the airline or other carrier prior to boarding and to Federal officials upon arrival in the United States.

The annualized and present value estimates of monetized costs and benefits over the 10-year period from 2024 through 2033 using three percent and seven percent discount rates are summarized in Tables 2 and 3. The annualized, monetized costs (2020 USD) of the provisions in the final rule are estimated to be $59 million (range: $13 to $207 million) using a three percent discount rate, and the results were almost unchanged using a seven percent discount rate. Most monetized costs are expected to be incurred by importers (87 percent for the most likely estimate). The estimated monetized costs are expected to be less for importers of dogs from DMRVV-free or DMRVV low-risk countries compared to importers of dogs from DMRVV high-risk countries. The provisions estimated to result in the greatest increase in costs for importers of dogs imported from DMRVV-free or low-risk countries were associated with the additional costs associated with the documentation requirements to show that the dogs have not been in a DMRVV high-risk country, minimum age, and with the microchip requirements, and completing the new CDC Dog Import Form.

The provisions estimated to result in the greatest increase in costs for importers of dogs from DMRVV high-risk countries were associated with the requirements regarding use of a CDC-registered Animal Care Facility for foreign-vaccinated dogs from DMRVV high-risk countries in section 71.51(k). Other costs included: (1) laboratory testing, (2) an expected reduction in the number of dogs imported from DMRVV high-risk countries, (3) the need for some travelers to reroute travel to an airport with a CDC quarantine station (also known as a CDC port health station) and CDC-registered Animal Care Facility, and (4) the costs with providing a CDC Import Certification of Rabies Vaccination and Microchip Record form or Certification of U.S.-issued Rabies Vaccination form (certified by an Official Government Veterinarian or USDA Official Veterinarian, respectively). Most of these requirements are specific to foreign-vaccinated dogs from DMRVV high-risk countries.

Airlines are expected to incur the greatest costs among carriers and their costs are estimated to comprise about 7.0 percent of the estimated annualized, monetized costs, with most of their costs associated with ensuring that all transported dogs comply with the bill of lading or CDC-approved alternative requirements of the final rule and a reduction in the number of dogs transported. HHS/CDC was unable to estimate costs from other types of carriers of dogs arriving by land or sea. Specifically, CDC does not have any data on how the six-month age requirement may impact surface transportation conveyances importing dogs from Canada or Mexico (although CDC notes that importation of dogs less than six months of age for resale is already prohibited by USDA regulations). CDC is estimated to incur about 3.3 percent of the annualized, monetized costs (most likely estimate) associated with the provisions of this final rule. Most CDC costs would be associated with the oversight of animal care facilities and laboratory proficiency testing programs for dogs imported from high-risk countries. CBP is expected to incur about 3.0 percent of the annualized costs (most likely estimate) associated with the provisions of this final rule. Most CBP costs would result from the additional time spent on reviewing documentation for importers of dogs from DMRVV-free or low-risk countries and for training personnel to enforce the requirements. USDA is expected to receive payments commensurate with its cost to provide Certification of U.S.-issued Rabies Vaccination forms for U.S.-vaccinated dogs traveling internationally.

The annualized monetized benefits of the provisions in the final rule are estimated to be about $1.8 million (range: $0.75 to $3.6 million) using a three percent or seven percent discount rate, with most of the benefits accruing to importers (47 percent of the most likely estimates) and to CBP (30 percent of the most likely estimates). Some of the benefits estimated for both importers and CBP would result from reduced time spent on screening dogs from high-risk countries at U.S. ports. The amount of time required per dog at U.S. ports would be reduced because it is assumed that the CDC standardized vaccination forms would be easier to review compared to non-standardized documentation for dogs arriving from DMRVV high-risk countries. The provisions in this final rule are also estimated to reduce the number of dogs denied entry or arriving ill or dead, with benefits estimates for importers, airlines, CBP, and CDC.

The wide range between the lower-bound and upper-bound cost and benefit estimates demonstrates that there is considerable uncertainty in these results. More details on the input parameters and assumptions used to generate these estimates may be found in the Appendix under the Supplemental Materials tab of the docket. At present, the number of dogs imported into the United States is neither accurately nor completely tracked by any data system, and the uncertainty in the cost and benefit estimates reflect uncertainty in both the total number of dogs imported and the number of dogs imported from DMRVV high-risk countries, as well as the cost of the new requirements included in the final rule. The net annualized, monetized costs (total cost estimate—total benefit estimate) are estimated to be about $57 million per year (range: $12 to $203 million) using a three percent discount rate.

Since the estimated costs for foreign-vaccinated dogs from DMRVV high-risk countries are much higher than costs for other dog imports, importers may choose to import dogs from DMRVV-free or low-risk countries instead of from DMRVV high-risk countries. In addition, individuals who travel from the United States to DMRVV high-risk countries with their pet dogs for long-term visits may take the additional step to have their dogs revaccinated with a three-year rabies vaccine prior to departure ( e.g., many deployed Federal employees may obtain the Certification of U.S.-issued Rabies Vaccination, which would allow up to three years for return to the United States). These changes should result in lower overall costs than the above estimates for the final rule in which HHS/CDC assumed individuals would be unable to change the countries from which dogs are imported into the United States.

The present value of the estimated monetized cost over a 10-year period for the provisions in the final rule is estimated to be $502 million (range: $111 to $1,750 million) using a three percent discount or $416 million (range: $91 to $1,450 million) using a seven percent discount rate. The present value of monetized benefits over a 10-year period of the provisions in the final rule is estimated at $15 million (range: $6.4 to $30 million) using a three percent discount rate or $13 million (range: $5.2 to $25 million) using a seven percent discount rate. The net annualized monetized cost (total costs−total benefits) is estimated at $486 million (range: $104 to $1,720 million) using a three percent discount rate and $403 million per year (range: $86 to $1,430 million) using a seven percent discount rate.

As discussed in the response to public comments section of the preamble above, the estimated monetized cost estimate has increased considerably relative to the estimates included in the NPRM. The primary reasons for the increase in cost include:

• The fees charged by CDC-registered ACF have increased relative to CDC's preliminary estimates.
• Some U.S. ports require that dogs that need follow-up care at CDC-registered ACF arrive as cargo. This requirement was not anticipated by CDC and will increase costs for importers of foreign-vaccinated dogs from DMRVV high-risk countries who otherwise would have chosen to transport their dogs as hand-carried or checked baggage. The fee charged for cargo shipments are highly variable. The future costs associated with this rule will depend on U.S. port policies that are subject to change. The average cost for the follow up visit at CDC-registered ACF is estimated to be $900 (range: $500 to $1,300 per dog). The average costs associated with shipping dogs as cargo is estimated to be $2,000 (range: $1,500 to $2,500) compared to an average of $300 (range: $200 to $400) for dogs shipped as hand-carried or checked baggage. Under the regulatory baseline, HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped as cargo. With the final rule, HHS/CDC assumes that 60%, range: 60% to 70% of dogs going to ACF will be shipped as cargo.

• The costs associated with the requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries have increased because HHS/CDC added more examples of the types of proof required. Each type of document requires certification by a USDA or foreign official government veterinarian. Examples include: (a) a valid foreign export certificate from a DMRVV-free or DMRVV low-risk country that has been certified by an official government veterinarian in that country; (b) a USDA export certificate if the certificate is issued to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c) a validCertification of Foreign Rabies Vaccination and Microchip form if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid Certification of U.S.-Issued Rabies Vaccination form. These documents are often required for individuals to travel internationally with their pets but are not required for travel to Canada or Mexico. These documents may be used as long as they specify travel to or from the country from which a dog is imported. Individuals who frequently travel to and from Canada and Mexico (or any other country) can obtain a valid Certification of U.S.-Issued Rabies Vaccination form, which will remain valid for multiple trips for up to three years corresponding to the duration of protection for dog rabies vaccines.
• The cost estimate for foreign-vaccinated dogs from DMRVV high-risk countries to re-route travel destinations to arrive at authorized U.S. ports with ACF was increased.
• CDC increased the estimated costs associated with shipping blood samples to CDC-approved laboratories for serological testing based on a number of comments from individuals suggesting their shipping costs were higher.
• CDC changed the requirement for importing dogs from DMRVV-free or low-risk countries such that no dogs less than six months may be imported at land borders. This will increase costs for individuals who wish to travel with their young dogs to or from Canada and Mexico.
• CDC increased the estimated costs to airlines by 100% for dogs imported from DMRVV-free or low-risk countries and by 50% for dogs imported from DMRVV high-risk countries to account for a number of commenters who suggested that costs to airlines should be higher than the estimates included in the NPRM analysis.

Some of the cost estimates for the final rule have also decreased due to changes made between the NPRM and the final rule. These include:

• The costs to importers of U.S.-vaccinated dogs from DMRVV high-risk countries were reduced because the final rule will not require that such dogs arrive at U.S. ports with CDC quarantine stations (also known as CDC port health stations).
• The costs for serological testing for foreign-vaccinated dogs from DMRVV high-risk countries were reduced because CDC plans to implement a policy that only one serological test will be required during the lifetime of such dogs as long as they remain current with their rabies vaccinations.

The most significant increase in estimated costs is for importers of foreign-vaccinated dogs from high-risk countries, because the expected fees charged by CDC-registered ACF have increased and because some U.S. ports or ACF now require dogs who need to visit to CDC-registered ACF to be shipped as cargo. HHS/CDC did not anticipate that some U.S. ports would require that dogs going to ACF be shipped as cargo in analyzing costs for the NPRM. Other U.S. ports do not require dogs going to ACF to be shipped as cargo. U.S. port-specific policies may change in the future, which, in conjunction with the uncertainty around the number of dogs imported, significantly complicates the project of future costs for the requirements in the final rule. As of March 2024, one U.S. port requires dogs going to ACF to be shipped as cargo, one U.S. port recommends dogs be shipped as cargo to avoid clearance delays and four U.S. ports do not have requirements or recommendations for shipping dogs as cargo. In total six U.S. ports have CDC-registered ACF.

The next key change, which will increase the costs for importers of dogs from DMRVV-free or low-risk countries. In response to public comment, HHS/CDC further defined the required documentation needed for importers to prove that a dog has been only in DMRVV low-risk or DMRVV-free countries. For the NPRM, HHS/CDC had assumed that veterinary records from DMRVV-free or low-risk countries would be sufficient. However, after observing a number of importers using fraudulent documentation to circumvent requirements for DMRVV high-risk countries by moving dogs to DMRVV-free or low-risk countries prior to entering the United States. As a result, HHS/CDC is requiring at least one record certified by an official veterinarian in 42 CFR 71.51(u). A second change is that HHS/CDC is eliminating the exemption for importers of dogs from DMRVV-free or low-risk countries to import three or fewer dogs less than six months of age at land borders. Both of these changes will increase costs to importers of dogs from DMRVV-free or low-risk countries and these changes are reflected in the higher-cost estimates.

The United States was declared DMRVV-free in 2007. Importing dogs from DMRVV high-risk countries involves a significant public health risk. The provisions of this final rule would better align U.S. dog importation requirements with those of other countries that have been declared DMRVV-free. Further, the serologic testing requirements are consistent with standards in the WOAH Terrestrial Manual for dogs imported from DMRVV high-risk countries to DMRVV-free countries. One DMRVV-infected dog may cause transmission to humans, domestic pets, livestock, or wildlife. The social cost of the consequences associated with the importation of a DMRVV-infected dog was estimated to be $270,000 (range: $210,000 to $510,000) to conduct public health investigations and administer rabies PEP to exposed persons.

Historically, CDC has denied entry to approximately 200 dogs annually due to fraudulent, incomplete, or inaccurate paperwork. 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. The diversion of public health resources globally to COVID-19 response activities contributed to a lapse in dog rabies vaccination efforts and a related increase in the prevalence of dogs infected with DMRVV in some high-risk countries. The combination of an increasing number of dogs imported without adequate documentation of rabies vaccination, in addition to the potential increase in the prevalence of DMRVV in high-risk countries, 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.

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

The primary public health benefit of this final rule is the reduced risk that a dog infected with DMRVV will be imported from a DMRVV high-risk country. Using the most likely estimates of the net monetized cost estimate ($57.0 million) and the most likely estimate of the potential benefit of averting the social cost of the consequences associated with an importation of one dog with DMRVV from a high-risk country ($270,000), it is possible to calculate the change in the number of imported dogs infected with DMRVV with the provisions of the final rule relative to the baseline such that the benefit would equal cost. The most likely estimate of the net cost ($57.0 million) divided by the most likely estimate of the social cost of the consequences associated with an importation of a dog infected with DMRVV ($270,000) suggests that the provisions of the final rule relative to baseline would have to avert the importation of 211 dogs infected with DMRVV for the benefit to exceed the cost. This would require an increase in the number of dogs imported into the United States while infected with DMRVV, which could only occur because of widespread failures of rabies control programs in multiple countries. However, this analysis does not consider the potential for fatal rabies cases in people or the risk of reintroduction of DMRVV in the United States, as analyzed below.

The above estimate of the cost of an importation of a dog with DMRVV does not account for the worst-case outcomes, which include (1) transmission of rabies to a person who dies from the disease, or (2) ongoing transmission to other domestic and wildlife species in the United States. The cost of reintroduction could be especially high if DMRVV spreads to other species of U.S. wildlife. Re-establishment of DMRVV in the United States could result in costly efforts over several years to eliminate the virus again. Both worst-case outcomes may be more likely to occur after the COVID-19 pandemic because public health resources were diverted to COVID-19 response activities and disruptions in rabies control programs in high-risk countries. Disruptions to rabies control programs in DMRVV high-risk countries may contribute to elevated risks even as the COVID-19 pandemic wanes. Human deaths from rabies continue to occur in the United States after exposure to wild animals; however, no U.S. resident has died after exposure to an imported dog with DMRVV in over 20 years. CDC uses the value of statistical life (VSL) to assign a value to interventions that can result in mortality risk reductions. For fatal cases, HHS recommends the use of the value of statistical life to estimate the potential benefits of averted deaths, an estimate of $11.6 million in 2020 USD and a range of $5.5 to $17.7 million. However, CDC is unable to estimate the potential magnitude of the mortality risk reduction associated with the final rule. Based on the central VSL, the provisions of the final rule would need to avert 4.9 or more human deaths per year, on average, for the benefits to exceed costs.

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, or $56 million in 2023 USD. The costs to contain any reintroduction would depend on the time-period before the reintroduction was realized, the wildlife species in which DMRVV was transmitted, and the geographic area over which reintroduction occurs. The above estimate is limited to the cost of rabies vaccination programs for targeted wildlife and does not include the costs to administer PEP to any persons exposed after the reintroduction has been identified. Human deaths from DMRVV could increase following the reintroduction of DMRVV to the United States as the risk of exposure would increase.

At the same time, hesitancy towards vaccinating dogs may be increasing in the United States. In a recent survey, about half of survey respondents reported skepticism toward dog vaccination; however, 84% of these survey respondents reported that their dogs were up to date with required vaccinations. If this skepticism leads to reduced coverage rates for U.S. dog rabies vaccination, the United States would become more vulnerable to the reintroduction of DMRVV. In the worst-case scenario, a large-scale reintroduction of DMRVV could result in much greater costs than were reported for the elimination of the fox variant discussed previously.

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

The provisions of the final rule would also ensure that dogs that are denied admission or arrive ill will be housed appropriately and receive the care needed to protect their health and safety. This will reduce the likelihood that dogs may be left in unsafe conditions in cargo warehouses for extended periods of time with the potential to expose workers who are not trained to handle live animals safely.

Under the current baseline, the number of dogs imported into the United States is neither accurately nor completely tracked. The more comprehensive data collection in this final rule through the CDC Dog Import Form will benefit public health investigations and enable better and more timely contact tracing of all animals exposed to an imported dog with DMRVV. The current lack of data also inhibits the Federal government's ability to target interventions for dogs imported from specific countries. The collection of data from the CDC Dog Import Form as required in this final rule may also benefit other agencies such as USDA/Animal and Plant Health Inspection Service (APHIS) that may want to regulate dog imports based on the risk of introduction of diseases that may affect U.S. livestock. For example, in 2021, APHIS regulated importers of dogs for resale based on whether the dogs were imported from countries where African swine fever exists. 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. The requirement in the final rule to report all dogs to CDC via a CDC-approved system would reduce the risk of importation of infected dogs from countries with ongoing disease outbreaks that may affect livestock.

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

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 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. 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 using data from U.S. Fish and Wildlife Service who regulate and track mink importations, it was determined additional regulatory action to prohibit live mink importations was unnecessary due to public health prevention measures taken by mink importers and the low numbers of imported mink. In comparison, CDC would not have the same data available to conduct a risk assessment for dog imports in the event of a future dog-mediated communicable disease outbreak because dog imports are neither accurately nor completely tracked in any government data system in the absence of the CDC Dog Import Form requirement included in this final rule. This would limit HHS/CDC's ability to accurately quantify the risks presented from specific countries because the United States does not have data on the number of dogs imported from each country.

The reporting of dog import volumes by country in an approved CDC import submission data system provides an opportunity to target interventions for dogs imported from specific countries. Such reporting as now required in 42 CFR 71.51(h) would allow CDC or other Federal agencies to more easily implement preventive measures to mitigate the risk of introductions of new zoonotic diseases or foreign animal diseases targeted to specific countries of concern. The import submission data requirement may also help CDC and other Federal agencies, as well as State and local health departments, retrospectively inspect shipments from specific countries. This would reduce the costs of future interventions; however, CDC is not able to quantify future savings.

The provisions of the final rule are expected to reduce the risk of dogs arriving ill. If an animal arrives in the United States and appears ill or is dead, a public health investigation is required to ensure the ill or dead animal does not present a public health threat. The overall health of an animal can play a significant role in whether it can maintain core body functions ( i.e., body temperature regulation and glucose levels) during prolonged flights. Stressed, malnourished, and young animals are more likely to become ill and can transmit communicable diseases that can affect humans; 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.

The required veterinarian examinations of foreign-vaccinated dogs from DMRVV high-risk countries should lead to the earlier detection of other exotic pathogens. A recent study from the United Kingdom performed additional screening for Babesia canis, Ehrlichia canis, Hepatozoon canis, Leishmania infantum, Brucella canis, and Dirofilaria immitis among 133 recently imported rescue dogs. They identified one or more of these pathogens in 24% (32/133) of the fully tested dogs. Although the authors found no significant association between infected dogs and presenting clinical signs, this study helps demonstrate how the mandatory veterinarian examination of foreign-vaccinated dogs from DMRVV high-risk countries may lead to early detection of other diseases prior to spreading into the U.S. dog population.

In addition to the unmonetized benefits described above, there may be additional unmonetized costs. CDC plans to monitor countries with high risk of DMRVV and may suspend entry of dogs from countries with repeated instances of falsified or fraudulent dog vaccine credentials or invalid rabies vaccination documents (defined as DMRVV-restricted countries in this final rule). The lost value of imports from DMRVV-restricted countries would impact some U.S. businesses and dog purchasers. However, the duration of any suspensions for these countries is highly uncertain and may be ended in the event of improvement of those countries' export controls.

HHS/CDC will have the authority to issue orders to revoke a carrier's permission to transport live dogs and cats if a carrier has endangered the public's health; however, CDC does not have plans to suspend any carriers at this time.

CDC lacks data on the cost to airlines of ensuring that a representative be on-site at the U.S. airport and available to coordinate the entry/clearance of dogs with Federal government officials. The representative must remain on site until all live imported dogs have either been cleared for entry or arrangements have been made to transport the dogs to a facility (either a CDC-registered ACF or other veterinary facility approved by CDC) pending admissibility determination. CDC believes this will only incur additional costs on occasion since airline staff are typically available on-site.

Analysis of the Costs and Benefits of the Alternatives

The summary costs and benefits of the lower and higher-cost alternatives are presented assuming that either all of the lower-cost alternatives or all of the higher-cost alternatives are selected. The annualized monetized costs and benefits are calculated relative to the same regulatory baseline used to evaluate the impacts of the final rule. The alternatives are presented above in Table 1. More detail on the impacts of each section is presented in the appendix in the supplemental materials tab of this docket. Some of the key assumptions for the lower-cost alternative include:

• If the age limit were reduced from six months to four months for dogs arriving by air, the estimated reduction in the number of dogs arriving by air would decrease by two percent relative to the regulatory baseline. This is less than the five percent reduction assumed for the six-month age requirement included in the final rule. Also, there would be no reduction in dogs arriving at land borders if there were no age limit for dog imports arriving by land (or sea).
• If dogs were allowed to have either a microchip or tattoo (instead of allowing only microchips), the cost of implementation is assumed to be reduced by 25%. Since dog tattoos usually cost more than microchips, the benefit is mostly due to some importers preferring the tattoo to the microchip. Thus, the additional cost of the tattoo would have to be offset by the utility to dog owners from owners who strongly prefer to have the option of choosing either a tattoo or microchip. The reduction of cost is tied to the increase in options available to dog importers, especially for importers who strongly prefer not to have microchips implanted. This is an approximation since HHS/CDC is unable to measure the disutility for dog owners who are strongly opposed to microchip implantation.

• If only importers of dogs from DMRVV high risk countries are required to provide advance data submission to CDC and airlines only need to provide a bill of lading or CDC-approved alternative for such dogs, the costs for airlines and importers of dogs imported from DMRVV-free or low-risk countries would decrease accordingly (i.e., these costs would only be incurred for importing dogs from DMRVV high-risk countries).
• If importers of U.S.-vaccinated dogs from DMRVV high-risk countries no longer need to have the formCertification of U.S.-issued Rabies Vaccination endorsed by a USDA Official veterinarian, importer costs would decrease. CDC assumed that the vaccinating veterinarians would be willing to fill out the appropriate form at no additional cost.
• If importers of foreign-vaccinated dogs from DMRVV high-risk countries were allowed to have their dogs examined and revaccinated by any licensed U.S. veterinarian instead of visiting a CDC-registered ACF, the cost to these importers would decrease considerably. This alternative process would not require dogs to be transported as cargo (as required for dogs transported to CDC-registered ACF at some U.S. ports). Also, the average fees charged by U.S.-licensed veterinarians (assumed to be $100 to $200 per dog versus $500 to $1,300 per dog at CDC-registered ACF) would be lower. Owners could transport their own dogs to a U.S.-licensed veterinarian. In addition, other U.S.-licensed veterinarians would not have to comply with CDC requirements that are specific to CDC-registered ACF. The change in costs also incorporate the costs to ship dogs as cargo, as described above, which are much higher than for dogs that may be transported as hand-carried or checked baggage.
• If CDC accepted serological test results from any laboratory as opposed to only CDC-approved laboratories, the costs to importers of foreign-vaccinated dogs from DMRVV high-risk countries would be reduced. CDC assumed that blood sample shipping costs would be reduced by 50% and the costs for serological testing would be reduced by 25%. This is because importers could choose from more potential laboratories and may choose laboratories with lower fees since these laboratories would not have to adhere to the requirements for CDC approval.
• If CDC allowed foreign-vaccinated dogs imported from DMRVV high-risk countries to arrive at any U.S. port instead of only U.S. ports with CDC-registered ACF, CDC assumed a much lower percentage of importers would have to change their travel plans (20% instead of 60%). These importers would no longer incur additional ticket costs and travel time costs. This change would probably only affect costs in conjunction with another lower-cost alternative that would allow foreign-vaccinated dogs from DMRVV high-risk countries to be evaluated by any licensed U.S. veterinarian rather than at a CDC-registered ACF). In the absence of a simultaneous change to that requirement, there would be little benefit to arriving at a U.S. port without a CDC-registered ACF for this lower-cost alternative.

The total annualized monetized costs associated with the set of lower-cost alternative are summarized in Table 4. The costs to importers and to airlines would decrease considerably relative to the requirements included in the final rule ($16.7 million versus $51.0 million for annualized monetized importer costs and $1.2 million versus $4.1 million for annualized monetized airline costs, 3% discount rate). The total annualized monetized costs for these alternatives are $22 million (range: $7.0 to $60 million, 3% discount rate). The annualized monetized benefits also decrease for these lower-cost alternatives ($1.3 million, range: $0.54 to $2.6 million).

However, this set of lower-cost alternatives would likely not have a significant impact on reducing the risk of dogs being imported with DMRVV compared to the regulatory baseline. The requirements in the final rule would more effectively reduce this risk. If the age requirements were reduced, importers may be more likely to attempt to circumvent CDC rules to move dogs from DMRVV high-risk to DMRVV-free or low-risk countries prior to importation into the United States. It is difficult to age dogs under six months, and CDC has documented cases of fraud involving the movement of dogs under six months of age from DMRVV high-risk countries to DMRVV-free and DMRVV low-risk countries to avoid rabies vaccination requirements. By requiring all dogs to be at least six months of age, CDC can better confirm that the dog presented matches the documentation presented, particularly the age listed for the dog, and that it is old enough to be adequately vaccinated for rabies.

In addition, transporting dogs under six months of age under conditions with unstable and fluctuating air temperatures, such as those present in the cargo area of a plane, may subject these young animals to adverse events (illness or death) because young animals cannot regulate their body temperature as efficiently as adult animals. International travel often results in prolonged time between feeding and watering of animals leading to potential adverse events (illness and death) in young animals due to physiologic stressors associated with or exacerbated by low blood glucose levels, low oxygen environments (such as the cargo area of a plane), dehydration, and the stress of travel. This could result in more ill and dead dogs arriving on flights (reducing the benefits estimated for the final rule). CDC would lack data on the total number of dogs imported into the United States and would have less data to conduct public health investigations in the event that a sick dog is imported from DMRVV-free or low-risk country. In the absence of official certification of the Certification of U.S.-issued Rabies Vaccination form, CDC believes it would be much easier for importers of dogs from DMRVV high-risk countries to present fraudulent documentation of U.S. rabies vaccination. It would be more difficult for CDC to verify the identity of dogs arriving with tattoos instead of microchips (increasing the risk of fraudulently imported dogs).

Follow-up examination and revaccination of dogs by any U.S.-licensed veterinarian would be less costly in comparison to services provided by CDC-registered ACF; however, this would increase the public health risk associated with foreign-vaccinated dogs from DMRVV high-risk countries. CDC would have limited capacity to follow up with importers to ensure that the dogs had been appropriately examined and revaccinated in a timely manner. Prior to the examination, the dog could come into contact with additional people and potentially other pets or wildlife. Finally, staff at CDC-registered ACF will operate according to CDC regulations and guidance to minimize the risk of disease transmission to humans and other animals.

CDC would have very limited oversight of the laboratories conducting serological tests. Importers would also find it easier to obtain fraudulent serological tests from laboratories that are not approved by CDC or may get inaccurate test results from unapproved laboratories. If CDC allowed foreign-vaccinated dogs to arrive at any U.S. port with a CDC quarantine station (also known as a CDC port health station), the government ( i.e., CBP and CDC) would not be able to ensure that the dogs had been cleared by a CDC-registered ACF prior to admitting the dogs into the United States. In summary, the lower-cost alternatives would result in significantly less costs for importers and airlines but would also significantly limit the ability of CDC to prevent the importation of inadequately vaccinated dogs from DMRVV high-risk countries. CDC has observed that many importers have tried to circumvent CDC requirements for dog importation and the provisions in this final rule are chosen to mitigate these risks. The lower-cost alternatives would lead to a significantly increased risk that dogs infected with DMRVV would be imported. However, CDC is unable to quantify the magnitude of this risk directly.

Some of the key assumptions that increase costs for the higher-cost alternative include:

• If the age limit were increased from six months to seven months for imported dogs, the estimated reduction in the number of imported dogs would be six percent instead of five percent as estimated for the final rule.
• If dogs were required to have both a microchip and a tattoo (instead of requiring only microchips), the cost of implementation is assumed to be increased by 125% because dog tattoos tend to cost more than microchips (i.e., the cost for this requirement would 2.25 times the cost of the microchip only.)
• If all importers of dogs had to use the CBP formal entry process for imported dogs, it would require more time to register for (20 minutes on average) and file an entry (15 minutes on average) with the CBP data systems relative to the estimated time required to submit entry data to CDC (seven minutes on average). This would also increase costs for CBP to review the formal entry documentation.
• If all dog importers had to obtain either theCertification of U.S.-issued Rabies Vaccination or Certification of Foreign Rabies Vaccination and Microchip form endorsed by an USDA Official Veterinarian or Official Government Veterinarian, the costs to importers of dogs from DMRVV-free or low-risk countries would increase because they currently do not need to obtain these documents (with an assumed cost of $35 per document on average).
• If importers of U.S.-vaccinated dogs from DMRVV high-risk countries were required to visit a CDC-registered ACF, their costs would increase commensurate with estimates for foreign-vaccinated dogs. CDC also assumed that five percent fewer U.S.-vaccinated dogs would be imported from DMRVV high-risk countries due to the additional cost associated with this requirement.
• If CDC required a 90-day waiting period from the time a dog blood sample was drawn to perform a serological titer test (instead of 30 days as required in CDC technical instructions), there would be additional costs to some importers who would be unable to plan further in advance. These costs could range from staying in the country for an extra 60 days to no cost if importers could arrange to have the blood sample taken earlier relative to when they plan to enter the United States. CDC assumed that it would cost an extra $200 on average, although this cost would vary considerably according to importer circumstances.
• If CDC required all dogs imported from DMRVV high-risk countries (including U.S.-vaccinated dogs) to arrive at U.S. ports with CDC-registered ACF instead of limiting this requirement to foreign-vaccinated dogs, the costs to importers of U.S.-vaccinated dogs would increase commensurately and 60% of all imported dogs from DMRVV high-risk countries would have to re-route their travel plans to a U.S. port with a CDC-registered ACF instead of their preferred U.S. port.

The total annualized monetized costs associated with the higher-cost alternative are summarized in Table 5. The costs to importers would increase considerably relative to the requirements included in the final rule ($108 million versus $51.0 million for annualized monetized importer costs). The total costs for these alternatives are $122 million (range: $31 to $320 million, 3% discount rate). The annualized monetized benefits this set of higher-cost alternatives is $1.3 million (range: $0.51 to $3.0 million).

CDC did not select any of these higher-cost alternatives because most of these alternatives do not address the highest-risk category of imported dogs, i.e., foreign-vaccinated dogs from DMRVV high-risk countries. As a result, the public health benefits associated with these higher-cost alternatives would not decrease the risk to the public health sufficiently to balance the costs of these alternatives. CDC has not observed any DMRVV infections among U.S.-vaccinated dogs imported from DMRVV high-risk countries or among dogs imported from DMRVV-free or low-risk countries. In addition, CDC can obtain the data it needs from the lower-cost CDC import data submission system and does not require a tattoo in addition to a microchip to confirm the identity of imported dogs. Because of the limited public health benefit and excessive costs, HHS/CDC believes the requirements in the final rule address the risks associated with imported dogs infected with DMRVV or other exotic pathogens more cost effectively than the alternatives.

Impact of the Final Rule on Dog Import Volumes

CDC did not receive any additional data to update its estimates of the number of imported dogs and used the same set of estimates presented in the NPRM analysis. In total, CDC estimates that under the current regulatory baseline, about 800,000 imported dogs would arrive in the United States each year and that about 500 dogs from DMRVV high-risk countries would be denied admission (Table 6). The number denied entry is based on CDC data from 2020 and the first six months of 2021 prior to the suspension of dog imports from DMRVV high-risk countries. This approach may overestimate the number of dogs denied entry in the future if the COVID-19 pandemic was associated with a significant increase in dogs denied admission due to pandemic-associated factors. Since dog rabies vaccine certificates are not currently required for dogs from DMRVV-free or DMRVV low-risk countries, CDC did not assume any dogs from these countries would be denied admission under the baseline.

The provisions of the final rule that are expected to reduce the number of dog imports include: (1) age restrictions on air travel for all dogs under six months of age, including dogs from both DMRVV high-risk and DMRVV low-risk or DMRVV-free countries; and (2) the additional costs of fulfilling the requirements for follow-up and revaccination at CDC-registered Animal Care Facilities for foreign-vaccinated dogs from DMRVV high-risk countries. At the same time, HHS/CDC believes that the number of dogs denied admission and returned to their countries of origin would decrease with the provisions included in the final rule because the standardized forms, requirements for carriers to confirm required documentation, and the requirement for foreign-vaccinated dogs from DMRVV-high-risk countries to have reservations at and arrive at U.S. ports with CDC-registered ACF should reduce the number of dogs denied entry.

The estimated impact of the final rule on the number of dog imports is summarized in Table 7a. HHS/CDC lacks data on what fraction of dogs arriving by air or land are less than six months old under the baseline. In the absence of this information, HHS/CDC assumes five percent (range: three to eight percent) of imported dogs currently are less than six months of age and would not be eligible to be imported into the United States under the final rule. HHS/CDC notes that these provisions should primarily impact individuals traveling with their personal pets because the importation of dogs for resale or adoption (including transfer of ownership) that are less than six months of age is already prohibited by USDA regulations (7 CFR 2148). Another provision of the final rule requires importers of dogs from DMRVV-free or low-risk countries to submit verified documentation that the animal has been in a DMRVV low-risk or DMRVV-free country for the six months prior to importation into the United States. CDC does not anticipate denying admission to dogs that may arrive from DMRVV-free or low-risk countries without such documentation when the final rule goes into effect, but there may be delays at U.S. ports while HHS/CDC confirms dogs from DMRVV-free or low-risk countries have not been in a DMRVV high-risk country within the last six months.

HHS/CDC assumes that the additional costs associated with importing dogs from DMRVV high-risk countries with foreign-issued rabies vaccination documentation would reduce the number of imports by about 20 percent (range: 10 to 30 percent) with the final rule. In addition, CDC believes the number of dogs from DMRVV high-risk countries that are denied entry will decrease with the provisions of the final rule because CDC will be able to require the use of standardized forms to confirm rabies vaccination and CDC-registered ACF follow-up requirements should be clear to importers. The number of dogs denied entry after arriving by air in calendar year 2022 was 96. Based in part on the number of dogs denied entry during HHS/CDC's temporary suspension and assuming that number would continue to decrease with a final rule in place, HHS/CDC estimates that about 50 dogs per year from DMRVV high-risk countries would be denied entry under the final rule. Overall, the final rule is expected to have a small impact on the total number of dogs imported (from about 799,000 [range: 652,000 to 946,000] at baseline to 755,000 [range: 630,000 to 872,000] with the provisions of the final rule in effect).

The estimated numbers of imported dogs arriving in the United States with lower-cost alternatives and the higher-cost alternatives are summarized in Tables 7b and 7c. With the set of lower-cost alternatives, the reduction in the number of imported dogs relative to baseline is relatively small (most likely estimate: 790,000 [range: 648,000 to 926,000] with lower-cost alternatives compared to a most likely estimate of 799,000 for the regulatory baseline). The costs associated with the potential requirements to import foreign-vaccinated dogs from DMRVV high-risk countries would be less than with the final rule. In addition, the age restrictions for all imported dogs would be mitigated for the lower-cost alternatives versus the final rule. As a result, the total number of dogs would be greater with the lower-cost alternatives than with the final rule requirements. With the set of higher-cost alternatives, the reduction in the number of imported dogs relative to baseline is greater (most likely estimate: 747,000 [range: 623,000 to 868,000] with higher-cost alternatives compared to a most likely estimate of 799,000 for the regulatory baseline). With the potential higher-cost alternatives, there would be an additional reduction in the estimated number of U.S.-vaccinated dogs from DMRVV high-risk countries because many of the requirements in the final rule that are limited to foreign-vaccinated dogs would also apply to U.S.-vaccinated dogs. In addition, all imported dogs would have to be seven months of age instead of six months of age, which also result in fewer imported dogs from DMRVV-free or low-risk countries compared to the requirements in the final rule.

HHS/CDC has not attempted to project future changes to the volume of dogs imported annually because of insufficient data. HHS/CDC believes that introducing another factor to project future volumes is not prudent. While HHS/CDC observed an increase in the number of dogs arriving with fraudulent paperwork prior to implementing the temporary suspension, this may not correspond to changes in the total number of dogs imported, of which only a small fraction arrives with fraudulent paperwork.

The most likely estimates of the annual monetized costs and benefits for each interested party or implementing partner with the final rule relative to the regulatory baseline are summarized in Table 8a over a 10-year period from 2024 through 2033 using the estimated values presented in Sections B2 through B9 of the Appendix found in the Supplemental Materials tab of the docket. The most likely estimate of monetized costs across interested parties is $79 million in the first year and $56 million in subsequent years for the final rule relative to the regulatory baseline. The most likely estimate of monetized benefits across interested parties is estimated to be $1.8 million each year.

The annual costs and benefits for importers are split into importers of dogs from DMRVV-free or DMRVV low-risk countries versus importers of dogs from DMRVV high-risk countries. However, it is likely that some importers of dogs from DMRVV high-risk countries may also be importers of dogs from DMRVV-free or low-risk countries. In addition, the provisions of the final rule may result in some importers switching from importing dogs from DMRVV high-risk countries to dogs from DMRVV-free or low-risk countries.

As a percentage of total costs, importers were estimated to incur 85 to 87 percent of the total costs (most likely estimates), with a higher fraction of total costs incurred in the subsequent years after the first year of implementation. Total costs are approximately 3.2 to 3.3 times greater for dogs imported from DMRVV high-risk countries compared to dogs from DMRVV-free or low-risk countries. In addition, it is important to note that more than 10 times as many dogs are estimated to be imported from DMRVV-free or low-risk countries. Thus, the cost per dog for importers of dogs from DMRVV high-risk countries is significantly greater than for importers of dogs from DMRVV-free or low-risk countries. This is especially true for foreign-vaccinated dogs from DMRVV high-risk countries.

The costs to airlines are expected to comprise 6.7 to 7.0 percent of total costs. Among Federal government agency costs for the provisions included in the final rule, CBP's additional costs (2.9 to 3.4 percent of the total) are expected to be less than CDC's additional costs (3.0 to 5.2 percent of the total).

The greatest fractions of the most likely estimates of the monetized benefits associated with the provisions in the final rule would accrue to importers of dogs from DMRVV high-risk countries (45 percent) and to CBP (30 percent). For both groups, the costs of screening dogs at U.S. ports would be reduced for two reasons. First, documentation of rabies vaccination for U.S.-vaccinated dogs from DMRVV high-risk countries would be standardized to reduce the amount time required for screening. Second, fewer dogs would be screened at U.S. ports, reducing time spent on screening. This would result in cost savings for both groups at U.S. ports, although costs for importers to obtain the standardized forms and to forgo importing some dogs would increase (as documented in the cost estimates). Additional benefits are estimated to accrue to importers of dogs from DMRVV high-risk countries, airlines, CBP, and CDC from a reduction in the number of dogs denied entry and returned to their countries of origin.

The most likely estimates of the annual monetized costs and benefits for each interested party or implementing partner for the lower-cost alternatives relative to the regulatory baseline are summarized in Table 8b over a 10-year period using the estimated values presented in the Appendix found in the Supplemental Materials tab of the docket. For the lower-cost alternatives, the most likely estimates of monetized costs across interested parties are $31 million in the first year and $21 million in subsequent years. These estimates are substantially lower than the costs for the final rule as summarized in Table 8a. The most likely estimate of monetized benefits across interested parties is estimated to be $1.3 million each year.

As a percentage of total costs, importers are estimated to incur 72 to 77 percent of the total costs (most likely estimates), with a higher fraction of total costs incurred in the subsequent years after the first year of implementation. Importer costs are similar for dogs imported from DMRVV high-risk countries and dogs from DMRVV-free or low-risk countries for the lower-cost alternatives. The costs to airlines are expected to comprise 5.1 to 5.8 percent of total costs. Among Federal government agency costs for the provisions included in the final rule, CBP's additional costs (9.4 percent of the total) are expected to be less than CDC's additional costs (13.0 percent of the total) in the first year and slightly greater (8.9 percent of the total versus 8.1 percent of the total) in subsequent years.

The most likely estimates of the annual monetized costs and benefits for each interested party or implementing partner for the higher-cost alternatives relative to the regulatory baseline are summarized in Table 8c over a 10-year period using the estimated values presented in the Appendix found in the Supplemental Materials tab of the docket. The most likely estimates of monetized costs across interested parties are $164 million in the first year and $117 million in subsequent years. The most likely estimate of monetized benefits across interested parties is estimated to be $1.3 million each year. These estimates are substantially higher than the costs summarized in Table 8a.

As a percentage of total costs, importers are estimated to incur 88 percent of the total costs (most likely estimates). Importer costs are approximately 3.0 to 3.3 times greater for dogs imported from DMRVV high-risk countries compared to dogs from DMRVV-free or low-risk countries. The costs to airlines are expected to comprise 3.3 to 3.4 percent of total costs. Among Federal government agency costs for the provisions included in the final rule, CBP's additional costs (6.7 percent of the total) are expected to be more than CDC's additional costs (1.4 to 2.5 percent of the total).

B. Regulatory Flexibility Act

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

USDA prohibits the importation of dogs under six-months of age for commercial purposes, which includes any transfer of ownership; therefore, importing dogs under six months of age is already prohibited. Thus, HHS/CDC did not consider this as a change to the regulatory baseline. Additionally, HHS/CDC believes that the six-month age requirement for importation helps protect the health and safety of all dog breeds. Since dogs under six months of age are sexually immature and cannot be used for breeding, delaying their importation may not negatively impact their use as breeding animals. Additionally, waiting until a dog is six months of age to import the dog will help ensure the safety and welfare of the dog during international travel when they are subjected to the stresses of international travel ( e.g., long travel times, temperature fluctuations, oxygen or altitude changes, and food/water deprivation). Any time a dog becomes ill or dies during international travel, regardless of country of import, Federal and State government agencies must conduct public health investigations to ensure the animal is not infected with a zoonotic disease that could be transmitted to people (or did not die from a zoonotic disease). These investigations take a tremendous amount of resources. HHS/CDC believes that the six-month age requirement for importation helps protect the health and safety of all dogs and will result in a reduced burden on Federal and State government agencies.

Based on these analyses, CDC believes that the only small entities for which this rule would have significant impacts would be those that specialize in importing dogs from DMRVV high-risk countries. The provisions of this rule would probably not have a significant economic impact on small airlines and probably would not have a significant impact on small entities that import dogs from DMRVV-free or DMRVV low-risk countries. The requirement most likely to impact small airlines is § 71.51(dd), which requires airlines to provide bills of lading for all imported dogs. However, there is a waiver process for airlines to have an alternative process while preparing to provide bills of lading. CDC notes that the importation of dogs less than six months of age for resale or adoption in the United States is already prohibited by USDA regulations (7 CFR 2148). Thus, the minimum age requirements in this rule should not impact entities that sell or resell imported dogs but may impact entities that import very young dogs for commercial purposes other than resale assuming no transfer of ownership.

As part of the economic impact analysis, CDC calculated the marginal cost associated with the rule per dog imported from DMRVV-free or DMRVV low-risk countries ($23, range: $7.74 to $48 per imported dog). The marginal cost associated with the requirements in the final rule per dog imported from DMRVV high-risk countries was further subdivided between foreign-vaccinated dogs (vaccinated outside the United States) ($1,910, range: $910 to $3,800) compared to U.S.-vaccinated dogs ($41, range: $15 to $73). These estimates cover the first year of implementation after a final rule is published. Marginal costs in the second year and later are estimated to be about 25 percent less per dog compared to the first year of implementation.

As discussed in the response to public comments section of the preamble above, the estimated monetized cost estimate has increased considerably relative to the estimates included in the NPRM. The primary reasons for the increase in cost include:

• The fees charged by CDC-registered ACF have increased relative to CDC's preliminary estimates.
• Some U.S. ports require that dogs that need follow-up care at CDC-registered ACF arrive as cargo. This requirement was not anticipated by CDC and will increase costs for importers of foreign-vaccinated dogs from DMRVV high-risk countries who otherwise would have chosen to transport their dogs as hand-carried or checked baggage. The fee charged for cargo shipments are highly variable. The future costs associated with this rule will depend on U.S. port policies that are subject to change. The average cost for the follow up visit at CDC-registered ACF is estimated to be $900 (range: $500 to $1,300 per dog). The average costs associated with shipping dogs as cargo is estimated to be $2,000 (range: $1,500 to $2,500) compared to an average of $300 (range: $200 to $400) for dogs shipped as hand-carried or checked baggage. Under the regulatory baseline, HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped as cargo. With the final rule, HHS/CDC assumes that 60%, range: 60% to 70% of dogs going to ACF will be shipped as cargo.

• The cost estimate for foreign-vaccinated dogs from DMRVV high-risk countries to re-route travel destinations to arrive at authorized U.S. ports with ACF was increased.
• The costs associated with the requirement for proof that a dog has been only in DMRVV low-risk or DMRVV-free countries have increased because HHS/CDC added more examples of the types of proof required. Each type of document requires certification by a USDA or foreign official government veterinarian. Examples include: (a) a valid foreign export certificate from a DMRVV-free or DMRVV low-risk country that has been certified by an official government veterinarian in that country; (b) a USDA export certificate if the certificate is issued to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c) a validCertification of Foreign Rabies Vaccination and Microchip form if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid Certification of U.S.-Issued Rabies Vaccination form. These documents are often required for individuals to travel internationally with their pets but are not required for travel to Canada or Mexico. These documents may be used as long as they specify travel to or from the country from which a dog is imported. Individuals who frequently travel to and from Canada and Mexico (or any other country) can obtain a valid Certification of U.S.-Issued Rabies Vaccination form, which will remain valid for multiple trips for up to three years corresponding to the duration of protection for dog rabies vaccines.
• CDC increased the estimated costs associated with shipping blood samples to CDC-approved laboratories for serological testing based on a number of comments from individuals suggesting their shipping costs were higher.
• CDC changed the requirement for importing dogs from DMRVV-free or low-risk countries such that no dogs less than six months may be imported at land borders. This will increase costs for individuals who wish to travel with their young dogs to or from Canada and Mexico.
• CDC increased the estimated costs to airlines by 100% for dogs imported from DMRVV-free or low-risk countries and by 50% for dogs imported from DMRVV high-risk countries to account for a number of commenters who suggested that costs to airlines should be higher than the estimates included in the NPRM analysis.

Some of the cost estimates for the final rule have also decreased due to changes made between the NPRM and the final rule. These include:

• The costs to importers of U.S.-vaccinated dogs from DMRVV high-risk countries were reduced because the final rule will not require that such dogs arrive at U.S. ports with CDC quarantine stations (also known as CDC port health stations).
• The costs for serological testing for foreign-vaccinated dogs from DMRVV high-risk countries were reduced because CDC plans to implement a policy that only one serological test will be required during the lifetime of such dogs as long as they remain current with their rabies vaccinations.

The most significant increase in estimated costs is for importers of foreign-vaccinated dogs from high-risk countries, because the expected fees charged by CDC-registered ACF have increased and because some U.S. ports or ACF now require dogs who need to visit to CDC-registered ACF to be shipped as cargo. HHS/CDC did not anticipate that some U.S. ports would require that dogs going to ACF be shipped as cargo in analyzing costs for the NPRM. Other U.S. ports do not require dogs going to ACF to be shipped as cargo. U.S. port-specific policies may change in the future, which, in conjunction with the uncertainty around the number of dogs imported, significantly complicates the project of future costs for the requirements in the final rule. As of March 2024, one U.S. port requires dogs going to ACF to be shipped as cargo, one U.S. port recommends dogs be shipped as cargo to avoid clearance delays and four U.S. ports do not have requirements or recommendations for shipping dogs as cargo. In total six U.S. ports have CDC-registered ACF.

The next key change, which will increase the costs for importers of dogs from DMRVV-free or low-risk countries. In response to public comment, HHS/CDC further defined the required documentation needed for importers to prove that a dog has been only in DMRVV low-risk or DMRVV-free countries. For the NPRM, HHS/CDC had assumed that veterinary records from DMRVV-free or low-risk countries would be sufficient. However, after observing a number of importers using fraudulent documentation to circumvent requirements for DMRVV high-risk countries by moving dogs to DMRVV-free or low-risk countries prior to entering the United States. As a result, HHS/CDC is requiring at least one record certified by an official veterinarian in § 71.51(u). A second change is that HHS/CDC is eliminating the exemption for importers of dogs from DMRVV-free or low-risk countries to import three or fewer dogs less than six months of age at land borders. Both of these changes will increase costs to importers of dogs from DMRVV-free or low-risk countries and these changes are reflected in the higher-cost estimates. More information regarding these cost estimates is available in the Appendix found in the Supplemental Materials tab in the docket.

The estimates summarized below are subject to a great degree of uncertainty. CDC does not know how many dogs any small individual entity currently imports or the average number of imported dogs across entities. However, based on the relative estimates of annual revenues by type of entity and subdivided by the number of employees, CDC calculated how many dogs each entity could import before this final rule would have a significant economic impact on their businesses.

Small Entities That Import Dogs for Commercial Purposes

The estimated revenues of small businesses likely to import and resell dogs are summarized in Table 9. Since there are no specific codes in the North American Industry Classification System (NAICS) specific to dog importers, CDC used the codes 115210, 423820, 424990, 485991, 812910, and 813312 to estimate the revenue of the small businesses that may import and resell dogs. The businesses affected by the final rule would be a fraction of the firms summarized in Table 9, as CDC does not know how many dog importers are in these categories. Small business status was determined based on either firms' revenue or the numbers of employees, according to the Small Business Association's (SBA) table of small business size standards. 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), CDC estimated the revenue based on the assumption that each firm's payroll expense would be approximately 15 to 30 percent.

CDC assumes that the costs associated with the provisions of the final rule would be significant if the additional costs would exceed two percent of the estimated revenue shown in Table 9 by category. Unless a small entity only specializes in importing dogs for resale or adoption, the costs associated with dog importation would only constitute a portion of each firm's operational costs. Other operational costs by an entity should be unaffected by the provisions included in this final rule. CDC is unaware of the proportion of dog import costs relative to all the other activities for each type of entity. Thus, CDC is not able to directly estimate the impact of the final rule as a fraction of total revenue. Instead, CDC calculates a threshold for each category representing the number of imported dogs at which the cost of the provisions in the final rule to importers would begin to exceed two percent of the revenue of firms in each category. To calculate the number of dogs at which point the costs associated with the final rule would be likely to exceed two percent of revenue for each category of the firm, the category-specific revenue per firm in Table 9 (most likely estimate, lower bound, and upper bound) were multiplied by 2 percent and then divided by the marginal cost per foreign-vaccinated dog from high-risk countries ($1,910, range: $910 to $3,800 per dog). This was repeated for U.S.-vaccinated dogs from DMRVV high-risk countries ($41, range: $15 to $73) and dogs from DMRVV-free or DMRVV low-risk countries ($23, range: $7.70 to $48).

The estimated thresholds for the number of Imported dogs per firm for each small business category are summarized in Tables 10a and 10b. For example, if a wildlife organization (NAICS code 813312) with fewer than five employees imports more than 3.9 foreign-vaccinated dogs (most likely final rule cost estimate and midpoint revenue estimate) from high-risk countries, the costs associated with the final rule would be expected to exceed two percent of revenue. For U.S.-vaccinated dogs, the threshold would increase from about four dog imports to 182 dog imports using the most likely cost estimate and midpoint revenue estimate. This NAICS category may include dog rescue organizations that are likely to work with dogs imported from DMRVV high-risk countries, most or all of which would be foreign vaccinated. Because the marginal cost estimate per dog imported from DMRVV-free or DMRVV low-risk countries is much less than per dog imported from DMRVV high-risk countries, the threshold numbers of dogs that may be imported from DMRVV-free or DMRVV low-risk countries are much greater than for DMRVV high-risk countries.

The values shown in Tables 10a and 10b are estimated by assuming that all dogs imported by each firm are either from DMRVV-free or DMRVV low-risk countries or, alternatively, from DMRVV high-risk countries. Some firms may import dogs from both types of countries, in which case, the threshold values would be in between the two sets of estimates. The difference in costs may also cause some entities to shift from importing dogs from DMRVV high-risk countries to dogs imported from DMRVV-free or DMRVV low-risk countries. In this case, for a business with NAICS code of 813312, the estimated threshold number of dogs would increase from four imported foreign-vaccinated dogs from DMRVV high-risk countries to 327 dogs imported from DMRVV-free or DMRVV low-risk countries (both thresholds calculated using most likely final rule cost estimate and midpoint revenue estimate).

The marginal cost per dog imported for the final rule relative to the reported commercial values of imported dogs are estimated using data from CBP for dogs imported under Harmonized Tariff Schedule code 0106.19.91.20, Other live animals, Other, Other, Dogs is shown in Table 11. The estimated ratio of the marginal cost of final rule requirements relative to the reported value of the commercially imported dogs from DMRVV-free or DMRVV low-risk countries is 2.9 percent (range: 1.0 percent to 6.1 percent). Based on this ratio, the expected marginal increase in cost per dog imported should not change much for dogs imported from DMRVV-free or low-risk countries.

However, for the foreign-vaccinated dogs imported from DMRVV high-risk countries, the estimated ratio is 536 percent (range: 256 percent to 1059 percent). This ratio is much larger both because the marginal cost per dog imported for the final rule is much greater and because the reported commercial value of dogs imported from DMRVV high-risk countries is lower compared to dogs imported from DMRVV-free or low-risk countries. Since CBP's commercial values of imported dogs only provide a comparison of the estimated marginal cost of the final rule to reported commercial value, these ratios cannot be directly compared to the revenue estimates by firm since the costs associated with dog imports would only be a portion of each firm's operational cost. However, it does provide an estimate of the potential increase in cost per dog imported from either DMRVV-free or low-risk countries or from DMRVV high-risk countries for the final rule. For this analysis, CDC assumes that most of the dogs imported from DMRVV high-risk countries for commercial purposes would have been vaccinated outside the United States.

U.S. Airlines

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

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

The threshold numbers of dogs that may be transported by each airline such that the costs associated with the provisions of this final rule to airlines would be less than two percent of annual revenue are estimated using the same methodology as for the dog importers above. The annualized marginal cost per dog transported by airlines is estimated to be about $12.81 per dog (range: $7.12 to $20.42 per dog) for the requirements in the final rule. This is calculated based on the annualized costs to airlines divided by the number of dogs transported. However, costs are estimated to be higher in the first year of implementation and some airlines may be disproportionately affected if their customers are proportionally more likely to reduce the number of dogs transported to the United States. The estimated number of dogs is calculated by multiplying the revenue per airline in Table 12 by two percent and then dividing by the marginal airline cost per dog imported in the final rule. As shown in Table 13, the estimated numbers of dogs that each airline could transport were significantly greater than the number of international passengers reported in 2019 and, in most cases, greater than the total estimated number of dogs estimated to be imported into the United States each year.

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

C. Paperwork Reduction Act of 1995

HHS/CDC has determined that this rule includes information collections and recordkeeping requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). A description of these provisions is given below, with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. Comments are invited on the following subjects:

• Whether the collection of information is necessary for the proper performance of the functions of CDC, including whether the information will have practical utility.
• The accuracy of CDC's estimate of the burden of the collection of information.
• Ways to enhance the quality, utility, and clarity of the information to be collected.
• Ways to minimize the burden of the collection of information on respondents, including by using information technology.

Under the PRA, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. In the NPRM, HHS/CDC published a 60-day notice in the Federal Register concerning the collection of information related to proposed updates to 42 CR 71.50 and 71.51. HHS/CDC addressed all comments above in Section VI. To comply with this requirement, OMB is publishing a notice of a revised data collection in conjunction with this final rule.

Data Collection

Importation Regulations (42 CFR 71 Subpart F) OMB Control No. 0920-1383, Exp. 1/31/2026)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This information collection is a Revision to OMB Control No. 0920-1383 related to the importation of animals, animal products, and human remains. Section 361 of the PHS Act (42 U.S.C. 264) authorizes the Secretary of HHS to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. The existing regulations governing foreign quarantine activities (42 CFR 71) authorize quarantine officers (also known as port health officers) and other U.S. government personnel to inspect and undertake necessary control measures with respect to conveyances, persons, shipments of animals, articles, and other items to protect the public's health.

CDC regulations govern the importation of animals and animal products capable of causing human disease. Animals that are regulated by CDC include dogs, cats, turtles, nonhuman primates (NHPs), civets (and other animals in Family Viverridae), African rodents, and bats. CDC controls the importation of these animals to ensure that these animals, or animal products, imported into the United States meet requirements of CDC regulations. CDC does this through a permitting process for certain animals.

HHS/CDC is adding or amending the following information collection instruments:

• CDC is adding a form titledCertification of Foreign Rabies Vaccination and Microchip form. This form will capture the rabies vaccination and microchip information for foreign-vaccinated dogs and it must be completed by an authorized veterinarian and certified by a government official from the exporting country. CDC is including certification by an exporting country to prevent fraud and falsification of documentation.
• CDC is adding a new form titledCertification of U.S.-issued Rabies Vaccination. This is a standardized form to capture rabies vaccination information for U.S-vaccinated dogs. It must be completed by a USDA-accredited veterinarian and endorsed by USDA during the exportation process to prevent fraud and falsification of documentation. CDC is creating this standardized form to assist importers in ensuring they provide all required information and to prevent fraud and falsification of documentation.
• CDC is adding the new form titledCertification of Dog Arriving from DMRVV-free or DMRVV low-risk Country form. The form can be used to demonstrate that a dog has not been in a DMRVV high-risk country within the last six months if accompanied by veterinary records or proof of payment for veterinary services establishing that veterinary services were performed in a DMRVV-free or DMRVV low-risk country at least six months before traveling to the United States. This form must be completed by an Authorized Veterinarian and must be certified by an Official Government Veterinarian in the exporting country. This is one option among multiple options that importers of dogs from DMRVV-free or DMRVV low-risk countries can use to certify that their dog has not been in a DMRVV high-risk country within the last six months. Since this is one of multiple options, CDC is estimating that only a small percentage of importers of dogs from these countries will use this form. Additional options for these importers are outlined in technical instructions.
• CDC will continue using theApplication for Special Exemption for a Permitted Dog Import until the expiration of the temporary suspension on July 31, 2024. Applicants complete this form to apply for a CDC Dog Import Permit. CDC has been issuing CDC Dog Import Permits to importers of foreign-vaccinated personal pet dogs with a valid rabies vaccine and serologic titer results during the temporary suspension. CDC will discontinue issuing permits to that category of importer once this final rule goes into effect on August 1, 2024. Starting August 1, 2024, CDC will instead use this form to issue permits to importers of dogs from DMRVV-restricted countries. Since CDC is not adding any countries to the DMRVV-restricted country in concurrence with the publication of this rule, CDC does not anticipate using this form in 2024.
• CDC is adding a new form—CDC Dog Import Form —which will collect information similar to what is currently approved to be collected on the Application for Special Exemption for a Permitted Dog Import form. The CDC Dog Import Form is an online form that all importers must complete for each dog imported. It collects contact information for the importer and details about the dog being imported. CDC has added this form to gather data on the number of annual importations of dogs as well as where they originate. This information will assist CDC in its public health investigations related to imported dogs with communicable diseases.
• CDC is adding four new forms related to CDC-registered animal care facilities. Per this final rule, CDC-registered animal care facilities are facilities that are registered with CDC for the revaccination, examination, and quarantine (if applicable) of foreign-vaccinated dogs from DMRVV high-risk countries. In order to register with CDC, representatives of the facility need to complete and sign the following documents to attest to their understanding of the requirements and recommendations for CDC-registered Animal Care Facilities.

○ Application to Operate as a CDC-registered Animal Care Facility

○ Technical Instructions for CDC-Registered Animal Care Facilities (ACF)

○ Standard Operating Procedures for SAFE TraQ data use by CDC-registered Animal Care Facilities Participating in Public Health Evaluations of Imported Animals

○ Rules of Behavior Agreement for Access to Centers for Disease Control and Prevention (CDC) Division of Global Migration Health (DGMH) System for Animal Facility Electronic Tracking of Quarantine (SAFE TraQ)

• CDC will make available to air carriers two new forms to assist in the implementation of our requirements for dogs arriving into the United States. Both forms are optional and may be filled out by the air carriers to help them ensure dogs flown on their flights meet entry requirements. One form is for dogs flown as checked baggage or carried-on and the other form is for dogs flown as cargo.
• CDC may collect information from air carriers that are unable to complete a bill of lading for all dogs arriving into the United States on their flights. In order to transport dogs, these air carriers must request a waiver from CDC by submitting the information outlined in the document titledTechnical Instructions for Air Carriers that are Unbale to Create Air Waybills.

In addition to the forms listed above related to the importation of dogs, CDC is also revising the following forms related to the importation of nonhuman primates (NHP). These are existing forms currently approved under this information collection. All edits are minor and non-substantive.

CDC Notification of Proposed Nonhuman Primate (NHP) Importation to the United States

Application for Registration as an Importer of Nonhuman Primates

Registration Form for NHP Importation (Part 2—Full Quarantine Standard Operating Procedures)

Registration Form for NHP Importation (Part 2—Lab-to-Lab Standard Operating Procedures

Registration Form for NHP Importation (Part 2—Zoo-to-Zoo Standard Operating Procedures)

The burden table below has been updated to reflect updated burden hours for the new and amended forms.

D. National Environmental Policy Act (NEPA)

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

E. Executive Order 12988: Civil Justice Reform

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

F. Executive Order 13132: Federalism

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

G. Plain Language Act of 2010

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

List of Subjects in 42 CFR Part 71

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

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

PART 71—FOREIGN QUARANTINE

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

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

2. Amend § 71.50 by:

a. In paragraph (b); adding in alphabetical order definitions for “Authorized veterinarian”, “Cat”, “Dog”, “Histopathy”, and “In-transit shipment” ;

b. Adding in alphabetical order definitions for “Microchip”, “Necropsy”, and “Official government veterinarian;” and

c. Adding paragraph (c).

The revision and additions read as follows:

3. Amend § 71.51 by:

a. In paragraph (a), adding in alphabetical order the definition for “Animal”,

b. Removing the definition for “Cat”;

c. Adding in alphabetical order definitions for “Certification of foreign rabies vaccination and microchip”, “CDC dog import form”, “CDC dog import permit”, “CDC-registered animal care facility”, “Certification of dog arriving from DMRVV-free or DMRVV low-risk country”, “Certification of U.S.-issued rabies vaccination”, and “Conditional release”,

d. Revising the definition of “Confinement”;

e. Removing the definition for “Dog”;

f. Adding in alphabetical order definitions for “DMRVV”, “DMRVV-free country”, “DMRVV high-risk country”, “DMRVV low-risk country”, and “DMRVV-restricted country”, “Flight parent”, “Importer”, “SAFE TraQ”, “Serologic testing”, “USDA-accredited veterinarian”, and “USDA official veterinarian”;

g. Removing the definition for “Valid rabies vaccination certificate”;

h. Removing paragraphs (b) through (g);

i. Adding new paragraphs (b) through (g); and

j. Adding paragraphs (h) through (ff).

The revision and additions read as follows: