Guidance Regarding Agency Interpretation of “Rabies-Free” as It Relates to the Importation of Dogs Into the United States, 724-730 [2019-00506]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 724-730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00506]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

[[Page 725]]

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.\1\ 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/.
---------------------------------------------------------------------------

    \1\ World Organisation for Animal Health. Ch 1.4 Animal Health 
Surveillance. In: Terrestrial Animal Health Code 27th ed; 2018. 
Available from: https://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_surveillance_general.htm. 
Accessed August 31, 2018.
---------------------------------------------------------------------------

    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/

[[Page 726]]

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) \2\ 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.
---------------------------------------------------------------------------

    \2\ https://www.cdc.gov/importation/pdf/Unimmunized-Dog-Permit-Application.pdf. Accessed August 31, 2018.
---------------------------------------------------------------------------

    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.\3\
---------------------------------------------------------------------------

    \3\ Ma, X., et al. (2018). ``Rabies surveillance in the United 
States during 2016.'' JAVMA 252(8): 945-957.
---------------------------------------------------------------------------

    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.\4\ 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,\5\ \6\ \7\ \8\ \9\ which would be 
considered high-risk under this new guidance.
---------------------------------------------------------------------------

    \4\ Hampson, K., et al. (2015). ``Estimating the Global Burden 
of Endemic Canine Rabies.'' PLoS Negl Trop Dis 9(4): e0003709.
    \5\ Castrodale, L., et al. (2008). ``Rabies in a Puppy Imported 
from India to the USA, March 2007.'' Zoonoses Public Health 55: 427-
430.
    \6\ Mangieri, N., et al. (2008). ``Rabies in a dog imported from 
Iraq--New Jersey, June 2008.'' MMWR 57(39): 1076-1078.
    \7\ Manning, S., et al. (2008). ``Human Rabies Prevention--
United States, 2008 Recommendations of the Advisory Committee on 
Immunization Practices.'' MMWR 57(RR03): 1-26.
    \8\ Sinclair, J. R., et al. (2014). ``Dogs Entering the United 
States from Rabies-Endemic Countries, 2011-2012.'' Zoonoses Public 
Health 62: 393-400.
    \9\ Sinclair, J. R., et al. (2015). ``Rabies in a Dog Imported 
from Egypt with a Falsified Rabies Vaccination Certificate--
Virginia, 2015.'' MMWR 64(49): 1359-1362.
---------------------------------------------------------------------------

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

[[Page 727]]

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.
    [cir] 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.
    [cir] 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.
    [cir] 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).
    [cir] 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.

         Table 1--Estimated Average Annual Numbers of Dog Imports by Country and by Immunization Status
----------------------------------------------------------------------------------------------------------------
                                                                                    Lower bound     Upper bound
                Baseline estimate of dog imports                   Best estimate        \b\             \c\
----------------------------------------------------------------------------------------------------------------
Airports \a\....................................................         700,000         560,000         840,000
From rabies-free countries......................................         161,000         128,800         193,200
From CRVV-free countries........................................         235,900         188,720         283,080
    Dogs with rabies vaccination certificates...................         234,750         187,800         281,700
    Dogs with unimmunized dog permits...........................             920             736           1,104
    Dogs with DCAs..............................................              62              50              74
    Dogs denied entry...........................................             168             134             202
From CRVV low-risk countries under new guidance.................         196,000         128,800         277,200
    Dogs with rabies vaccination certificates...................         195,910         128,728         277,092
    Dogs with DCAs..............................................              48              38              58
    Dogs denied entry...........................................              42              34              50
From CRVV high-risk countries...................................         107,100         113,680          86,520
    Dogs with rabies vaccination certificates...................         106,634         113,307          85,961
    Dogs with DCAs..............................................              12              10              14
    Dogs denied entry...........................................             454             363             545
Land borders....................................................         364,796         324,036         405,555
Canada-US land borders..........................................         122,000          97,600         146,400
    Dogs with rabies vaccination certificates...................         120,344          96,275         144,413
        Dogs from Canada, other CRVV-free or low-risk countries.         119,141          94,350         143,691
        Dogs from high-risk countries...........................           1,203           1,926             722
    Dogs with unimmunized dog permits...........................           1,572           1,258           1,886
    Dogs with DCAs..............................................              84              67             101
    Dogs denied entry...........................................               0               0               0
Mexico-US land borders..........................................         242,796         226,436         259,155
    Dogs with rabies vaccination certificates...................         241,500         225,400         257,600
    Dogs with DCAs..............................................           1,184             947           1,420
    Dogs denied entry...........................................             112              90             134
                                                                 -----------------------------------------------
        Total...................................................       1,064,796         884,036       1,245,555
----------------------------------------------------------------------------------------------------------------
\a\ DHS/CBP field staff provided estimates of the proportions of dogs from (1) rabies-free countries (23%) (2)
  CRVV-free countries (34%), (3) CRVV low-risk countries under the new guidance, including Mexico and Israel
  (28%), and (4) CRVV high-risk countries (15%, these countries are considered high-risk under both the previous
  and new guidance).
\b\ For the lower bound estimate, it was assumed that a larger proportion of dogs arrive from high-risk
  countries, which would result in less benefits (reduced costs) from the clarification in guidance. For the
  lower bound the following proportions are used: (3) CRVV low-risk countries under the new guidance, including
  Mexico and Israel (23%), (4) CRVV high-risk countries (20%).
\c\ For the upper bound estimate, it was assumed that a larger proportion of dogs arrive from countries that
  will be considered low-risk in the new guidance, which would result in more benefits (reduced costs) from the
  clarification in guidance. For the upper bound the following proportions are used: (3) CRVV low-risk countries
  under the new guidance, including Mexico and Israel (33%), (4) high-risk countries (10%).


[[Page 728]]

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).

                                             Table 2--Summary Table
                                 [In $2017 dollars, over a 10-year time horizon]
----------------------------------------------------------------------------------------------------------------
                                          Most likely     Lower bound     Upper bound
               Category                    estimate        estimate        estimate          Source citation
----------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized monetized benefit to         $1,478,057        $469,678      $2,300,409  RIA (Appendix Section
     importers/owners (3% discount                                                       3).
     rate) \a\.
    Annualized monetized benefit to             22,680           4,536          61,236  RIA (Appendix Section 3,
     airlines (3% discount rate).                                                        Table A9).
    Annualized monetized benefit to          4,007,188       1,849,245       7,441,556  RIA (Appendix Section
     DHS/CBP.                                                                            4).
    Annualized monetized benefit to            391,982         115,893         829,398  RIA (Appendix Section
     HHS/CDC.                                                                            5).
    Annualized monetized benefit to            218,511         116,633         349,479  RIA (Appendix Section
     Sates and local PHDs.                                                               6).
                                       -------------------------------------------------------------------------
        Total annualized monetized           6,118,418       2,555,984      10,982,077  RIA.
         benefits (3% discount rate).
----------------------------------------------------------------------------------------------------------------
Annualized quantified, but              The estimated response costs estimate           RIA (Appendix Sections 7
 unmonetized, benefits.                 associated with a dog imported while infected    and 8).
                                        with CRVV are $213,833, range $171,066 to
                                        $256,599. If the additional time spent
                                        screening dogs from high-risk countries leads
                                        to a reduced risk of the importation of a dog
                                        with CRVV, future response costs may decrease.
----------------------------------------------------------------------------------------------------------------
Costs:
    Annualized monetized costs to             $375,450        $121,172        $479,487  RIA (Appendix Section 3,
     Importers/owners (3% discount                                                       Tables A7b and A8b).
     rate) \b\.
    Annualized monetized costs to DHS/          79,154          49,278         295,666  RIA (Appendix Section 4,
     CBP (3% discount rate) \c\.                                                         Table A15).
                                       -------------------------------------------------------------------------
        Total annualized monetized             454,604         170,449         775,053  RIA.
         costs (3% discount rate).
----------------------------------------------------------------------------------------------------------------

[[Page 729]]

 
Annual quantified, but unmonetized,     The estimated response costs estimate           RIA (Appendix Section
 costs.                                 associated with a dog imported while infected    7).
                                        with CRVV are $213,833, range $171,066 to
                                        $256,599. If eliminating the rabies vaccine
                                        certificate requirement for dogs from CRVV-
                                        free or low-risk countries leads to an
                                        increased risk of the importation of a dog
                                        with CRVV, future response costs may increase.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified costs)......  State and local governments may have to         NA.
                                        increase efforts to educate their populations
                                        about dog vaccination requirements in the
                                        absence of the HHS/CDC requirement for rabies
                                        vaccination certificates for dogs to enter
                                        from CRVV-free or low-risk countries under the
                                        previous guidance.
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ Importers/owners who bring dogs from CRVV-free or low-risk countries.
\b\ Importers/owners who bring dogs from high-risk countries.
\c\ Costs for DHS/CBP training is one-time costs during the first year of implementation.

    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).

                                      Table 3--Present Value Summary Table
                   [In $ million 2017 dollars, over a 10-year time horizon, 3% discount rate]
----------------------------------------------------------------------------------------------------------------
                                                                    Most likely
                                                                     estimate       Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
Present value of cost savings:
    Importers/owners \a\........................................           $12.6            $4.0           $19.6
    Airlines....................................................             0.2            0.04             0.5
    DHS/CBP.....................................................            34.2            15.8            63.5
    HHS/CDC.....................................................             3.3             1.0             7.1
    States and local health departments.........................             1.9             1.0             3.0
                                                                 -----------------------------------------------
        Total (A)...............................................            52.2            21.8            93.7
Present value of costs:
    Importers/owners \b\........................................             3.2             1.0             4.1
    DHS/CBP \c\.................................................             0.7             0.4             2.5
                                                                 -----------------------------------------------
        Total (B)...............................................             3.9             1.5             6.6
Present value of net cost savings:
    Total (A) - (B).............................................            48.3            20.3            87.1
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ Importers/owners who bring dogs from CRVV-free or low-risk countries.
\b\ Importers/owners who bring dogs from high-risk countries.
\c\ Costs for DHS/CBP training is a one-time cost during the first year of implementation.

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

[[Page 730]]

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.\10\ 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.
---------------------------------------------------------------------------

    \10\ Ma, X., et al. (2018). ``Rabies surveillance in the United 
States during 2016.'' JAVMA 252(8): 945-957.
---------------------------------------------------------------------------

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.

    Dated: January 28, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-00506 Filed 1-30-19; 8:45 am]
 BILLING CODE 4163-18-P