Guidance Regarding Agency Interpretation of “Rabies-Free” as It Relates to the Importation of Dogs Into the United States

AGENCY:

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

ACTION:

Notice of agency guidance.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this guidance for dog owners and importers who seek to admit a dog without a valid rabies vaccination certificate into the United States. Under current regulations, all dogs admitted into the United States must be accompanied by a valid rabies vaccination certificate unless the dog's owner or importer submits satisfactory evidence that the dog has only been in a rabies-free country if it is less than 6 months old or has only been in a rabies-free country for the 6 months before arrival if it is older than 6 months. Through this guidance, CDC is clarifying that it interprets “rabies-free” for the purposes of dog importation to mean “canine rabies virus variant (CRVV)-free.” For all other public health purposes, CDC will continue to apply the general definition of “rabies free,” which includes and reflects the rabies status of all terrestrial animals and not just dogs. This guidance further describes the considerations taken into account by experts in determining whether a country qualifies as CRVV-free. This notice also informs dog owners and importers on where to locate up-to-date information on a country's CRVV status to facilitate a dog's entry or re-entry into the United States.

DATES:

This guidance will be implemented on January 31, 2019.

FOR FURTHER INFORMATION CONTACT:

For information regarding this notice contact: Ashley A. Altenburger, J.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-H16-4, Atlanta, GA 30329.

For information regarding CDC operations related to this notice contact: Kendra Stauffer, D.V.M., Division of Global Migration and Quarantine, Centers for Disease Control and- Prevention, 1600 Clifton Road NE, MS-V-18-2, Atlanta, GA 30329. Either person may also be reached by telephone 404-498-1600 or email CDCAnimalImports@cdc.gov.

SUPPLEMENTARY INFORMATION:

I. Background and Current Operations

Under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), the Secretary of Health and Human Services may make and enforce such regulations as in his or her 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. Since 1956, Federal quarantine regulations (currently found at 42 CFR 71.51) have controlled the entry of dogs into the United States (21 FR 9870). One of the principal goals of these regulations is to prevent the introduction and spread of rabies into the United States. While the United States continues to have bat rabies lyssavirus (rabies viruses that are enzootic to bat populations) and multiple terrestrial variants of rabies circulating in wildlife species (e.g. fox, raccoon, skunk), it has been free of CRVV since 2007 and now focuses its efforts on preventing the reintroduction of the CRVV rabies variant.

In accordance with 42 CFR 71.51(c)(1)(i), CDC maintains a current, publicly available list of rabies-free countries to assist dog owners and importers in understanding its dog importation requirements. Under this provision, CDC also has the authority to deny entry to an inadequately immunized dog from a country that is not listed as “rabies free” or if the dog was not born in (or spent at least the last 6 months before arrival in) a country that is considered “rabies-free.” Under such circumstances, the dog's owner or importer assumes the costs of returning the dog to its country of origin unless the owner or importer is eligible to receive a dog confinement agreement (79 FR 39403).

Prior to today's clarification, owners or importers of dogs from countries with a low (or zero) prevalence of CRVV but which report some incidences of terrestrial or other rabies virus variants were required to provide proof of rabies vaccination for entry into the United States because such countries were not considered “rabies-free.” 42 CFR 71.51 defines “valid rabies vaccination certificate” for purposes of demonstrating when a dog is considered adequately immunized. Thus, as discussed in more detail in Section IV, dog owners and importers wishing to import dogs from CRVV-free or low-risk countries were potentially subject to relatively high costs and burdens related to presenting a valid rabies vaccination certificate at ports of entry compared to the extremely low risk of importing a dog with CRVV from these CRVV-free or low-risk countries. Furthermore, because having low or zero prevalence of CRVV was not sufficient for a country to be considered “rabies-free,” rabies prevention efforts at U.S. borders were weakened as attention, in part, was diverted away from dogs coming from countries that pose a more significant risk of re-introducing CRVV into the United States. These policies also created public confusion concerning when an unvaccinated dog could be legally imported into the United States, as reflected by the number of public inquiries and appeals from denials of permission to import a dog. Thus, CDC has reassessed and clarified its policy to better focus on the risk of importing CRVV into the United States. Today's clarification seeks to address these issues. We have worked closely with our partners at the federal, state, and local levels to secure support and ensure a seamless transition.

II. New CRVV Risk Categories

Upon the publication of this guidance, CDC will shift enforcement of its United States dog importation regulations from the risk of dogs importing rabies of any variant to the risk of dogs importing CRVV into the United States. This clarification allows federal authorities to better focus their resources on preventing the reintroduction of CRVV from countries that pose the greatest risk. Specifically, CDC now identifies countries as CRVV-free, CRVV low-risk, or CRVV high-risk. For purposes of dog importation, these terms are defined as follows:

• CRVV-free means that CDC has assessed the country as not having CRVV present, based on internationally accepted standards.
• Low-risk means the country is at low risk for CRVV transmission based on the following considerations: The virus is limited to a localized area, surveillance and dog vaccination programs are adequate, and the virus is in a controlled status with the country heading toward eventual CRVV-free status.
• High-risk means the country is at high risk for CRVV transmission as demonstrated by the presence and geographic distribution of the virus and by low quality of or low confidence in the country's surveillance systems and its dog vaccination programs.

Owners and importers importing a dog from CRVV-free or low-risk countries will not need a rabies vaccination certificate for the dog to be admitted into the United States, although they will still be subject to the requirements set forth in 42 CFR 71.51(c)(1). Owners and importers importing a dog from a high-risk country will be required to have a valid rabies vaccination certificate.

We note that today's guidance is limited to the definition of “rabies-free” as it relates to the importation of CRVV by dogs. This guidance does not nor will not affect CDC's interpretation or application of the term “rabies free” for other public health purposes, which will continue to include and reflect the rabies status of all terrestrial animals and not just dogs.

III. Provisions of This Notice

Upon the publication of this guidance, under 42 CFR 71.51, CDC will add or remove countries from its list of rabies-free countries based on the country's risk of importing CRVV into the United States. CDC rabies subject matter experts have reviewed (and continue to review) publicly available country data to estimate the risk posed of reintroducing CRVV into the United States. Data considered in this decision include peer-reviewed publications, publicly available government reports, data and recommendations from international agencies such as the World Health Organization and the World Organization for Animal Health, as well as information provided from global rabies experts. CDC subject matter experts also consider the quality of rabies surveillance systems in the country, the prevalence of reported cases of rabies in humans and animals, characterization of rabies virus genomes, and efforts towards control of the disease in dogs (i.e., dog vaccination coverage, population management, and enforcement of legal codes to curb rabies transmission in dogs). CDC intends to review relevant data on a yearly basis, revise prior risk classifications when new information becomes available, and publish its list of country rabies classifications, including CRVV-free countries, on its website at https://www.cdc.gov/rabies/resources/index.html.

In keeping with current practice, if a dog that is not adequately immunized against rabies arrives at a U.S. port of entry from a country that CDC considers a high-risk for CRVV transmission (See https://www.cdc.gov/importation/ bringing-an-animal-into-the-united-states/rabies-vaccine.html ), the dog will be returned to its country of origin immediately under standard operating procedures at U.S. ports of entry. CDC also will not issue a dog confinement agreement under 42 CFR 71.51(c)(2) and 79 FR 39403 (July 10, 2014) for dogs imported from high-risk CRVV countries. Regardless of vaccination status or country from which imported, CDC may require confinement of dogs that do not appear to be healthy and allow the owner an opportunity to arrange for a public health assessment by a local veterinarian at the owner's expense (42 CFR 71.51(b)(1),(2)). If unhealthy dogs are not adequately immunized against rabies, the dogs will be: (a) Returned to their country of origin once healthy enough for travel, (b) euthanized and tested for rabies, or (c) admitted if there is not a public health threat and the dogs, upon entry, were adequately immunized against rabies. In keeping with current practice, importers should continue to check with state and local government officials regarding requirements of the final destination prior to entry or re-entry into the United States; this new federal policy is not intended to invalidate or supersede such requirements. The policy and program operations described above will be implemented on January 31, 2019.

IV. Economic Impact of Policy Clarification

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs.

The proposed clarification to HHS/CDC guidance described in the preamble is not a regulatory change, but is expected to affect costs for dog importers/owners, airlines, Department of Homeland Security/Customs and Border Protection (DHS/CBP), Department of Health and Human Services/Centers for Disease Control and Prevention (HHS/CDC), and state and local public health departments (PHDs). As noted above, owners and importers importing a dog will still be subject to the requirements set forth in 42 CFR 71.51. However, owners and importers importing dogs from CRVV-free or low-risk countries will no longer need a valid rabies vaccination certificate for the dogs to be admitted into the United States because in this new guidance CDC is revising how it interprets rabies-free for purposes of applying 42 CFR 71.51(c)(1)(i). In the economic analysis, HHS/CDC compares the costs set forth in this notice (“new guidance”) to the costs under the guidance in effect immediately before publication of this notice (“previous guidance”). Owners and importers importing dogs from high-risk countries will still be required to have a valid rabies vaccination certificate for the dogs to enter the United States. This clarification in guidance will reduce the burden to import dogs into the United States from CRVV-free and low-risk countries, and it is anticipated that the costs to import dogs and inspect dogs at ports of entry (POEs) will be reduced. In addition, HHS/CDC expects that considerably fewer Permits to Import a Dog Inadequately Immunized against Rabies (OMB No. 0920-0134) will be sought and issued and that the costs of confinement, as required by the permits, will be reduced. These benefits (reduced costs) are estimated relative to the baseline in which the HHS/CDC guidance is not clarified.

The new guidance may slightly increase the probability that a dog infected with CRVV would be imported into the United States from a CRVV-free or low-risk country and that an imported dog could expose U.S. persons or animals and trigger a public health response with associated costs. However, HHS/CDC believes that there is a very small risk of importation of a rabies-infected dog from a country that is either CRVV-free or classified as low-risk under the new guidance. CRVV-free countries do not have CRVV circulating by definition. Mexico is considered a low-risk country and has only reported 11 dogs with CRVV during 2015 and 2016, the two most recent years with available data. Only three dogs with CRVV were identified in Mexico in the most recent year, 2016.

In addition, HHS/CDC believes that the potentially increased risk of rabies importation from a CRVV-free or low-risk country may be offset by the ability of DHS/CBP officers and HHS/CDC staff to better focus efforts on reducing the risk of rabies-infected dogs being imported from CRRV high-risk countries. Among dogs from high-risk countries, the CRVV incidence rate may approach 2 dogs per 1,000 per year in countries with low rabies vaccination coverage. During the past 15 years, six CRVV-infected dogs were imported into the United States. All of these imports were from countries where CRVV, at the time, was widely circulating, which would be considered high-risk under this new guidance.

Baseline Under the Previous Guidance

When dogs enter the United States from terrestrial rabies virus-free countries or with proof of immunization, such dogs are not routinely tracked in any data systems. With limited data available on dog importations, estimating both the baseline and the change relative to the baseline is difficult. HHS/CDC estimates that about 1.06 million dogs (Table 1) enter the United States each year including 700,000 arriving at airports and 360,000 arriving at land border POEs with Canada and Mexico. In total, 795,492 imported dogs (75% of all imported dogs) are estimated to arrive from CRRV-free or low-risk countries. The remaining 269,303 dogs are from high-risk countries (108,303) or from terrestrial rabies virus-free countries (161,000). Dogs from terrestrial rabies virus-free countries would not require valid rabies vaccination certificates under either the previous or new guidance. For additional details, refer to Section 2 of the supplemental appendix.

Under the previous guidance (baseline), each dog would be screened at U.S. ports of entry. DHS/CBP field officers at U.S. POEs would review rabies immunization documents, review permits for unimmunized dogs, issue dog confinement agreements for dogs allowed to enter the United States without documentation of vaccination or permits, and may deny entry for dogs from CRVV-free, low-risk or high-risk countries. Specifically, HHS/CDC estimated that, each year:

• 791,301 dogs (99.5% of the total from CRVV-free or low-risk countries) enter the United States with rabies immunization certificates.

○ For each dog, DHS/CBP field officers have reported that either 1 or 2 officers spend about 8 minutes to screen each dog of which 3-4 minutes per dog are spent reviewing the rabies immunization certificate and verifying documentation with other agency/official when needed. For more detail on the baseline cost calculations refer to Tables A7a-b, A8a-b, A13, and A14 of the supplemental appendix.

• 2,492 dogs enter the United States with HHS/CDC-issued permits for dogs from CRVV-free or low-risk countries.

○ For each permit, importers were estimated to spend 15-60 minutes to apply and HHS/CDC staff to spend about an hour for review and follow up. 1-2 DHS/CBP officers were estimated to spend 11 minutes per dog of which about 6 minutes are spent to review each permit at POEs. For more detail on the baseline cost calculations refer to Appendix Tables A7a-b, A8a-b, A13, A14, A16 and A17 of the supplemental appendix.

○ After entering the United States, importers were also assumed to spend time confining dogs and state or local health departments were assumed to spend time to contact importers to monitor confinement requirements. For more detail on the baseline cost calculations refer to Tables A11 and A20 of the supplemental appendix.

• 1,378 dogs from CRVV-free and low-risk countries enter the U.S. with DHS/CBP-issued dog confinement agreements (DCAs).

○ 1-2 DHS/CBP officers were estimated to spend 26 minutes per dog of which 20 minutes are spent to issue DCAs at POEs inclusive of time to call HHS/CDC officers for technical support. Importers would also spend time to confine dogs and state/local health departments would follow up and monitor. For more detail on the baseline cost calculations refer to Appendix Tables A7a-b, A8a-b, A13, and A14 of the supplemental appendix.

• 322 dogs from CRVV-free and low-risk countries were denied entry at POEs because of lack of rabies immunization under the previous guidance. In addition to importers and DHS/CBP, the costs associated with denial of entry may also be incurred by airlines to transport dogs back to their country of origin. For more detail on the baseline cost calculations refer to Tables A9, A10, A13, and A14 of the supplemental appendix.

Estimated Costs and Benefits (Reduced Costs) Associated With Clarification in Guidance

Under the new guidance, each dog would be screened at U.S. ports of entry. However, DHS/CBP field officers at U.S. POEs will no longer need to review rabies immunization documents, review permits for unimmunized dogs, issue dog confinement agreements for dogs allowed to enter the United States without rabies vaccination certificates or permits or deny entry for dogs from CRVV-free or low-risk countries (due to lack of valid rabies vaccination certificate) unless these dogs had traveled from a high-risk country to the CRVV-free or low-risk country within the previous six months.

The range of estimated annualized benefits (reduced costs) associated with the clarification in guidance are about $2.6 million to $11.0 million, most likely estimate $6.1 million (Table 2). The largest potential benefits (reduced costs) accrue to federal agencies (DHS/CBP and HHS/CDC), which would spend less time reviewing permit requests and reviewing immunization documents or permits at ports of entry ($2.0 million to $8.3 million) per year. For more information on the model used to estimate costs and benefits (reduced costs) for DHS/CBP and HHS/CDC, refer to Sections 4 and 5 of the supplemental appendix. Importers/owners from CRVV-free or low-risk countries would spend less time applying for a Permit to Import a Dog Inadequately Immunized against Rabies (OMB No. 0920-0134), providing documentation at POEs, and confining dogs. As a result, they would save an estimated $470,000 to $2.3 million per year. For more information on the model used to estimate costs and benefits (reduced costs) for importer/owners, refer to Section 3 of the supplemental appendix. Potential state and local governments' benefits (reduced costs) will depend on the amount of effort spent enforcing dog confinement agreements after importation from CRVV-free countries or countries under the previous guidance that now will be classified as low-risk under the new guidance. With limited data on enforcement, state and local governments are estimated to save between $120,000 and $350,000 annually in reduced costs of monitoring confinement of unimmunized dogs. For more information on the model used to estimate benefits (reduced costs) for state and local health departments, refer to Section 6 of the supplemental appendix. Airlines would also have some benefits (reduced costs) associated with transporting dogs denied entry and abandoned by importers/owners or their agents. Refer to Table A9 in Section 3 of the supplemental appendix for additional details.

The estimated costs associated with this clarification in guidance result from a one-time increase in DHS/CBP training costs during the first year of implementation ($700,000, range: $430,000 to $2.6 million). When annualized over a 10 year period with a 3% discount rate, this would correspond to $80,000 (range: $49,000 to $300,000). More information is available in Appendix Table A15 of the supplemental appendix. Importers/owners, who bring dogs from high-risk countries, were estimated to spend more time at airport and land border POEs (3-10 minutes per dog for importers and 3-17 minutes per dog for CBP staff) because CBP staff reported that they would spend more time on dogs from high-risk countries. This additional time was estimated to correspond to an opportunity cost of $120,000 to $480,000 per year (Tables A7b and A8b of the supplemental appendix).

Over a 10-year time horizon, the total benefits (reduced costs) associated with this clarification in guidance depend on the discount rate selected (3%) to value future benefits (reduced costs). The 10-year time horizon was chosen because countries may become CRVV-free or revert to being high-risk over time. Because limited data exist to estimate the number of dogs imported to the United States at present, HHS/CDC did not attempt to project future dog imports, but instead applied estimates of imported dogs in 2017 to future years. If the number of imported dogs would instead increase in future years, the benefits (reduced costs) from this clarification in guidance would be underestimated.

The most likely estimate of the present value of the 10-year benefits (reduced costs) is $52.2 million at a 3% discount rate (Table 3). The lower bound estimate is $21.8 million and the upper bound estimate is $93.7 million. In comparison, the 10-year costs are estimated at $3.9 million, range $1.5 million to $6.6 million. The 10-year net benefits (i.e., benefits − costs) are estimated at $48.3 million, range ($20.3 million to $87.1 million).

Comparison of Costs and Benefits

As discussed above, HHS/CDC believes the risk of an importation of a dog with CRVV from a country defined as low-risk under the new guidance is extremely low. As noted previously, during the past 15 years, six CRVV-infected dogs were imported into the United States and all of these imports were from high-risk countries. HHS/CDC notes that if dogs travel from a high-risk country to a CRVV-free or low-risk country within six months of U.S. entry, the dogs would still have to present a certificate of rabies vaccination at entry. State and local governments would face the greatest costs to mount responses in the event of an importation of a dog with CRVV. In addition, individuals or their insurance companies may face costs associated with post-exposure prophylaxis if they are exposed to the imported dog.

A threshold analysis was performed to compare the potential annualized costs and benefits of the clarification to the guidance to the potential cost of an importation of a dog with CRVV. To perform the threshold analysis, HHS/CDC compared the most likely estimate, lower bound, and upper bound of the annual net benefits (reduced costs) of the new guidance to the potential costs of an importation and calculated the annual risk of importation necessary for costs to equal benefits (reduced costs).

HHS/CDC rabies subject matter experts estimate that the public health response would require about 800 hours per event for investigation, providing post-exposure prophylaxis to about 16 people exposed to the infected dog after importation, and addressing 30 animal exposures per importation. The net benefits (reduced costs) estimate can be compared to the estimated response costs associated with a dog imported while infected with CRVV ($213,833, range $171,066 to $256,599). See Section 7 of the supplemental appendix for additional details on this cost estimate. This response cost does not include the small risk that a person could die after becoming infected with the rabies virus in the absence of receiving post-exposure prophylaxis. Although U.S. residents have died after exposure to rabid dogs in other countries, no such deaths have resulted from exposures to U.S. dogs since CRVV was eliminated in the United States in 2007. The probability of such a death cannot be quantified, but is expected to be very low under either scenario.

Expected net benefits (reduced costs) would exceed the potential costs associated with the importation of a dog with CRVV if fewer than 26 dogs per year with CRVV are imported from countries classified as CRVV-free or low-risk under the new guidance using the most likely estimates. In the worst case scenario, the lower bound estimate of annualized benefits (reduced costs, $2.6 million) minus the upper bound estimate of annualized costs ($780,000) results in an annualized net benefit of about $1.8 million. This worst case annualized net benefit can be compared to the upper bound cost estimate associated with the importation of a dog with CRVV ($256,599 per event) to estimate a worst case scenario threshold (6.9 dogs per year).

This threshold analysis can be compared to surveillance data from Mexico, a country that is considered low-risk. Mexico only identified 11 dogs over the previous 2 years in which surveillance data were available. Thus, even if all of the dogs found with CRVV in Mexico over the past two years had been imported to the United States, the response costs would have fallen under the threshold result. Even in the worst case scenario, it is extremely unlikely that costs will exceed benefits as a result of this clarification in guidance. As noted above, HHS/CDC also believes that any increased risk of importation from a CRVV-free or low-risk country may be offset by allowing DHS/CBP officers to spend more time evaluating dogs entering the United States from high-risk countries. DHS/CBP officers reported that they expected to increase the amount of time spent on dogs from high-risk countries by 3-17 minutes per dog under the new guidance. By refocusing screening effort at U.S. POEs from dogs from CRVV-free or low-risk countries to dogs from high-risk countries, the overall risk of importation of a dog with CRVV may be reduced.

Possible Additional Activities by State or Local Governments

As noted throughout this FRN, importers should continue to check with state and local government officials regarding requirements of the final destination prior to entry or re-entry into the United States; this new federal policy is not intended to invalidate or supersede such requirements. State and local governments may also have to increase efforts to educate their populations about their dog vaccination requirements in the absence of the HHS/CDC requirement for proof of rabies vaccination for dogs to enter from CRVV-free or low-risk countries under the previous guidance. However, HHS/CDC was not able to estimate any costs associated with these efforts.

V. Paperwork Reduction Act

This clarification does not institute a new collection of information. The collection of information, has been previously approved by the Office of Management and Budget (OMB) in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) and assigned the following OMB control number: Foreign Quarantine: OMB Control No. 0920-0134, expiration date 5/31/2019.