[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]
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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.
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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 [email protected].
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/index.html.
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\1\ World Organisation for Animal Health. Ch 1.4 Animal Health
Surveillance. In: Terrestrial Animal Health Code 27th ed; 2018.
Available from: http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_surveillance_general.htm.
Accessed August 31, 2018.
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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.
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\2\ https://www.cdc.gov/importation/pdf/Unimmunized-Dog-Permit-Application.pdf. Accessed August 31, 2018.
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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\
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\3\ Ma, X., et al. (2018). ``Rabies surveillance in the United
States during 2016.'' JAVMA 252(8): 945-957.
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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.
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\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.
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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
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Lower bound Upper bound
Baseline estimate of dog imports Best estimate \b\ \c\
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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
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Total................................................... 1,064,796 884,036 1,245,555
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\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]
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Most likely Lower bound Upper bound
Category estimate estimate estimate Source citation
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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).
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Total annualized monetized 6,118,418 2,555,984 10,982,077 RIA.
benefits (3% discount rate).
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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.
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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).
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Total annualized monetized 454,604 170,449 775,053 RIA.
costs (3% discount rate).
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[[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.
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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.
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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
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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
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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
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Total (B)............................................... 3.9 1.5 6.6
Present value of net cost savings:
Total (A) - (B)............................................. 48.3 20.3 87.1
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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.
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\10\ Ma, X., et al. (2018). ``Rabies surveillance in the United
States during 2016.'' JAVMA 252(8): 945-957.
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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