Temporary Suspension of Dogs Entering the United States From High-Risk Rabies Countries, 32041-32049 [2021-12418]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
D That the information security
program contain safeguards that are
based on the volume and sensitivity of
the personal information at risk;
D That testing and monitoring of the
safeguards are conducted regularly but
no less often than once a year; and
D That the information security
program be documented, evaluated, and
adjusted in light of any changes to
business operations or new
technological advancements.
Æ Parts III and IV respectively require
the three respondents (1) to obtain an
initial and then biennial third-party
information security assessments and
(2) to cooperate with the third parties
conducting the assessments.
Æ Part V requires the three
respondents to report to the
Commission any event involving
consumers’ personal information that
constitutes a reportable event to any
U.S. federal, state, or local government
authority.
Æ Part VI mandates that the three
respondents submit an annual
certification regarding their compliance
with the Proposed Order’s data security
requirements.
• Parts VII through XI are reporting
and compliance provisions. Part VII
mandates that all Respondents
acknowledge receipt of the Proposed
Order and, for 20 years, distribute the
Proposed Order to certain employees
and agents and secure acknowledgments
from recipients of the Proposed Order.
Part VIII requires that Respondents
submit compliance reports to the FTC
one year after the order’s issuance and
submit additional reports when certain
events occur. Part IX requires that, for
20 years, Respondents create certain
records and retain them for at least 5
years. Part X provides for the FTC’s
continued compliance monitoring of
Respondents’ activity during the
Proposed Order’s effective dates. Part XI
is a provision ‘‘sunsetting’’ the Proposed
Order after 20 years, with certain
exceptions. Respondents MoviePass,
Inc. and Helios are exempt from
Sections II–X of the Proposed Order
until their bankruptcy cases are closed,
and these bankruptcies led the FTC to
not seek a monetary judgment in this
matter.
The purpose of this analysis is to
facilitate public comment on the
Proposed Order. It is not intended to
constitute an official interpretation of
the complaint or Proposed Order, or to
modify in any way the Proposed Order’s
terms.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
By direction of the Commission.
Joel Christie,
Acting Secretary.
[FR Doc. 2021–12701 Filed 6–15–21; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Temporary Suspension of Dogs
Entering the United States From HighRisk Rabies Countries
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) announces a temporary
suspension in the importation of dogs
from high-risk rabies-enzootic countries
(hereinafter referred to as high-risk
country or countries) into the United
States. Due to the unprecedented global
response to the Coronavirus Disease
2019 (COVID–19) pandemic and limited
availability of public health resources at
the Federal, state, and local level, this
action is necessary to protect the public
health against the reintroduction of
canine rabies virus variant (CRVV) into
the United States and to ensure the
welfare of dogs being imported into the
U.S. This suspension, with limited
exceptions, includes dogs imported
from low-risk or CRVV-free countries if
the dogs have been in any high-risk
countries during the previous six
months.
SUMMARY:
DATES:
This notice is effective July 14,
2021.
For
information regarding this notice
contact: Ashley C. Altenburger, J.D.,
Division of Global Migration and
Quarantine, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS–H16–4, Atlanta, GA 30329 or 404–
498–1600.
For information regarding HHS/CDC
regulations for the importation of dogs,
please contact: Dr. Emily Pieracci,
D.V.M., Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–V–18–2, Atlanta, GA
30329 or 404–498–1600. Either Mrs.
Altenburger or Dr. Pieracci may also be
reached by email at
CDCAnimalImports@cdc.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
32041
I. Background and Authority
Rabies, one of the deadliest zoonotic
diseases, accounts for an estimated
59,000 human deaths globally each
year 1—which equates to one human
death every 9 minutes. Canine rabies
virus variant (CRVV) is responsible for
98% of these deaths.2 The rabies virus
can infect any mammal, and once
clinical signs appear, the disease is
almost always fatal.2 In September 2007,
at the Inaugural World Rabies Day
Symposium, HHS/CDC declared the
United States to be free of CRVV.
However, this rabies virus variant is still
a serious public health threat in the
more than 120 countries where CRVV
remains enzootic. Preventing the entry
of animals infected with CRVV into the
United States is a public health priority.
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 the Secretary’s
judgment are necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the United States and
from one State or possession into any
other State or possession.3 Since at least
1956, Federal quarantine regulations
(currently found at 42 CFR 71.51) have
controlled the entry of dogs into the
United States. See 21 FR 9870, Dec. 12,
1956. One of the principal goals of these
regulations is to prevent the
reintroduction and spread of CRVV 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
regulatory efforts on preventing the
reintroduction of this rabies variant.
Under 42 CFR 71.51, all dogs
admitted into the United States must be
accompanied by a valid rabies
vaccination certificate.4 This
1 WHO
Technical Report Series 1012, 2018; Page
6.
2 Fooks AR, Banyard AC, Horton DL, Johnson N,
McElhinney LM, Jackson AC. Current status of
rabies and prospects for elimination. Lancet
2014;384:1389–99.
3 Although the statute assigns authority to the
Surgeon General, all statutory powers and functions
of the Surgeon General were transferred to the
Secretary of HHS in 1966, 31 FR 8855, 80 Stat. 1610
(June 25, 1966), see also Public Law 96–88, 509(b),
October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C.
3508(b)). The Secretary has retained these
authorities despite the reestablishment of the Office
of the Surgeon General in 1987.
4 https://www.cdc.gov/importation/bringing-ananimal-into-the-united-states/vaccinecertificate.html.
E:\FR\FM\16JNN1.SGM
16JNN1
32042
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
requirement applies unless the dog’s
owner or importer submits satisfactory
evidence that the dog is less than 6
months old and has only been in a
CRVV-free or low-risk country, or has
only been in a CRVV-free or low-risk
country for the 6 months before arrival
if it is older than 6 months.5 CDC
maintains a current, publicly available
list of countries with high risk of
CRVV 6 and provides guidance for dog
entry requirements based on the dog’s
country of import.
Additionally, under 42 CFR 71.51(e),
CDC may exclude dogs coming into the
United States from areas determined to
have high rates of rabies. Under 42 CFR
71.63, CDC may also temporarily
suspend the entry of animals, articles, or
things from designated foreign countries
and places into the United States when
it determines there exists in a foreign
country a communicable disease that
threatens the public health of the United
States and the entry of imports from that
country increases the risk that the
communicable disease may be
introduced. When such a suspension is
issued, CDC designates the period of
time or conditions under which imports
into the United States may be
suspended. CDC bases this temporary
suspension on these legal authorities.
jbell on DSKJLSW7X2PROD with NOTICES
II. Public Health Rationale
The United States was declared
CRVV-free in 2007. Importing dogs from
high-risk CRVV countries involves a
significant public health risk. CDC
requires strict compliance with all its
public health entry requirements.
Although the U.S. Government does not
track the total number of dogs imported
each year, it is estimated that
approximately 1 million dogs are
imported into the U.S. annually, of
which 100,000 dogs are from countries
at high- risk of CRVV.7 This estimate
was based on information provided by
airlines, the Department of Homeland
Security’s Customs and Border
Protection (CBP) staff, and a study
conducted at a U.S.-Mexico land border
crossing.8
5 CDC. Guidance Regarding Agency Interpretation
of ‘‘Rabies-Free’’ as It Relates to the Importation of
Dogs Into the United States. Fed Register
2019;84:724–730. https://www.federalregister.gov/
documents/2019/01/31/2019-00506/guidanceregarding-agency-interpretation-of-rabies-free-as-itrelates-to-the-importation-of-dogs.
6 https://www.cdc.gov/importation/bringing-ananimal-into-the-united-states/rabies-vaccine.html.
7 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
8 McQuiston, J.H., et al., Importation of dogs into
the United States: risks from rabies and other
zoonotic diseases. Zoonoses Public Health, 2008.
55(8–10): p. 421–6.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
CBP does record, by country, the
number of dogs imported with formal
entry under Harmonized Tariff
Schedule (HTS) code 0106199120 and
HTS Description: Other live animals,
other, dogs. The total number of dogs
imported into the United States from all
countries under this HTS category
varied from 25,232 in 2018 to 58,540 in
2020. The number of dogs from highrisk countries under this HTS category
averaged 16,390 and varied from 9,966
to 24,031 over this 3-year period. The
number of dogs reported under this HTS
category does not include dogs imported
as checked baggage, hand-carried in
airplane cabins, or crossing at land
borders without formal entry. Thus, the
number underestimates the true number
of dogs imported into the United States.
The importation of just one dog
infected with CRVV risks reintroduction of the virus into the United
States resulting in a potential public
health risk with consequent monetary
cost and potential loss of human and
animal life.9 10 11 CRVV has been highly
successful at adapting to new host
species, particularly wildlife.12 One
CRVV-infected dog could result in
transmission to humans, domestic pets
or wildlife. The importation in 2019 of
a single dog with rabies cost more than
$400,000 USD for the public health
investigations and rabies port-exposure
prophylaxis (PEP) of exposed
persons.13 14
Since 2015 there have been three
known rabid dogs imported into the
United States. All three dogs were
rescue dogs imported by different rescue
organizations for the purposes of
adoption. These three cases, discussed
below, highlight the immense public
health resources required to investigate,
respond to, and mitigate the public
health threat posed by the importation.
In 2015, a rabid dog was part of a
group of eight dogs and 27 cats
imported from Egypt by a rescue group.
The dog had an unhealed leg fracture
and began showing signs of rabies four
9 Smith J, le Gall F, Stephenson S, et al. People,
pathogens and our planet. The Economics of One
Health 2012;2.
10 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. Morb Mort Wkly 2020; 69 (38):
1374–1377.
11 Jeon S, Cleaton J, Meltzer M, et al. Determining
the post-elimination level of vaccination needed to
prevent re-establishment of dog rabies. PLoS Neg
Trop Dis 2019; 13 (12): e0007869.
12 Velasco-Villa A, Mauldin MR, Shi M, et al. The
history of rabies in the Western Hemisphere.
Antiviral Res. 2017;146:221–232. doi:10.1016/
j.antiviral.2017.03.013.
13 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. Morb Mort Wkly 2020; 69 (38):
1374–1377.
14 https://www.cdc.gov/rabies/medical_care/
index.html.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
days after arrival. Following the rabies
diagnosis, the rescue workers in Egypt
admitted that the dog’s rabies
vaccination certificate had been
intentionally falsified to evade CDC
entry requirements.15 Eighteen persons
were recommended to receive rabies
PEP, seven dogs underwent a six-month
quarantine, and eight additional dogs
housed in the same home as the rabid
dog had to receive rabies booster
vaccinations and undergo a 45-day
monitoring period.
In 2017, a ‘‘flight parent’’ (a person
solicited through social media, often not
affiliated with the rescue organization,
and usually compensated with an
airline ticket) imported four dogs on
behalf of a rescue organization. One of
the dogs appeared agitated at the airport
and bit the flight parent prior to the
flight. The dog also had tooth fractures
from reportedly having been hit by a
car. A U.S. veterinarian examined the
dog one day after its arrival and then
euthanized and tested the dog for rabies.
A post-mortem rabies test showed that
the dog was positive for the virus.
Public health officials recommended
that at least four people receive rabies
PEP, and the remaining three dogs
underwent quarantine periods ranging
from 30 days to 4 months. An
investigation revealed the possibility of
falsified rabies vaccination
documentation presented on entry to
the United States.16
In 2019, twenty-six dogs were
imported into the United States by a
rescue organization. All dogs had rabies
vaccination certificates and serologic
documentation, indicating the
development of rabies antibodies (in
response to immunization), based on
results from an Egyptian governmentaffiliated rabies laboratory. However,
one dog developed signs of rabies three
weeks after arrival and had to be
euthanized. The dog tested positive for
rabies. Forty-four persons received PEP,
and the 25 dogs imported on the same
flight underwent re-vaccination and
quarantines of 4–6 months. An
additional 12 dogs had contact with the
rabid dog and had to be re-vaccinated
and undergo quarantine periods ranging
15 Sinclair JR, Wallace RM, Gruszynski K, et al.
Rabies in a dog imported from Egypt with a falsified
rabies vaccination certificate—Virginia, 2015.
MMWR Morb Mortal Wkly Rep 2015;64:1359–62.
https://doi.org/10.15585/mmwr.mm6449a2.
16 Hercules Y, Bryant NJ, Wallace RM, et al.
Rabies in a dog imported from Egypt—Connecticut,
2017. MMWR Morb Mortal Wkly Rep
2018;67:1388–91. https://doi.org/10.15585/
mmwr.mm6750a3.
E:\FR\FM\16JNN1.SGM
16JNN1
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
from 45 days to 6 months based on their
previous vaccination status.17
HHS/CDC estimates a range of costs
for public health investigations and
subsequent cost of care for people
exposed to rabid dogs to cost between
$215,386 and $508,879 per importation
event as summarized in Section IV.18 19
This cost estimate does not account for
the worst-case outcomes, which include
(1) transmission of rabies to a person
who dies from the disease or (2) ongoing
transmission to other domestic and
wildlife species in the United States. Reestablishment of CRVV into the United
States, while unlikely, could result in
costly efforts over several years to again
eliminate the virus.
A previous campaign to eliminate
domestic dog-coyote rabies virus variant
jointly with gray fox (Texas fox) rabies
virus variant in Texas over the period
from 1995 through 2003 cost $34
million 20 21, or $52 million in 2019 U.S.
dollars. Since January 2020, public
health resources globally have been
diverted to COVID–19 response
activities which may have caused a
lapse in canine rabies vaccination
efforts in high-risk countries. The
increased number of dogs with
inadequate or falsified rabies
vaccination certificates arriving in the
United States 22 may increase the
likelihood of a CRVV-importation event.
An importation of a dog with CRVV
would divert U.S. public health
resources away from ongoing and time
sensitive COVID–19 response activities.
On January 21, 2020, CDC launched
an agency-wide response to the COVID–
19 pandemic, dedicating over 7,200 of
the approximately 10,000 CDC
personnel to support the outbreak
response. CDC’s focus from the
17 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. Morb Mort Wkly 2020; 69 (38):
1374–1377.
18 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. Morb Mort Wkly 2020; 69 (38):
1374–1377.
19 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. Fed
Register 2019;84:724–730. https://
www.federalregister.gov/documents/2019/01/31/
2019-00506/guidance-regarding-agencyinterpretation-of-rabies-free-as-it-relates-to-theimportation-of-dogs.
20 TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies
epizootics in coyotes and gray foxes: 1995–2003.
Journal of the American Veterinary Medicine
Association; 227(5):785–92.
21 R.T. Sterner et al. (2009) Tactics and Economics
of Wildlife Oral Rabies Vaccination, Canada and the
United States. Emerging Infectious Diseases; 15(8),
1176–1184.
22 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog Importation data, 2018–2020.
Accessed: 15 February 2021.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
beginning has been to assist health
departments, frontline healthcare
workers, businesses, communities, and
the public to protect themselves and
save lives. As of March 15, 2021, over
one thousand CDC personnel have
conducted 3,150 deployments to 265
cities across the United States and
abroad, and over three thousand
documents have been developed
providing information and guidance for
government agencies, business and the
public.23 The unprecedented nature of
this public health response has
naturally drawn federal, state, and local
public health resources away from other
important public health efforts,
including preventing the reimportation
of CRVV into the United States.
Historically, approximately 60–70%
of CDC’s dog entry denials (or about 200
cases annually) have been due to
fraudulent paperwork.24 This number is
less than 1 percent of dog importations.
Between January and December 2020,
(during the COVID–19 pandemic), CDC
documented more than 450 instances of
incomplete, inadequate, or fraudulent
rabies vaccination certificates for dogs
arriving from high-risk countries. These
cases resulted in the dogs being denied
entry into the United States and
returned to their countries of origin. The
increase in the number of dogs
inadequately vaccinated against rabies
that importers are attempting to import
into the United States has created a
public health risk of importing CRVV
into the U.S. and public health
management of these dogs is
unsustainable during the current
COVID–19 pandemic.
To be considered complete and
adequate, rabies vaccination certificates
currently must include all the following
information:
• Name and address of owner
• Breed, sex, date of birth (approximate
age if date of birth unknown), color,
markings, and other identifying
information for the dog
• Date of rabies vaccination and vaccine
product information
• Date the vaccination expires
• Name, license number, address, and
signature of veterinarian who
administered the vaccination
Upon the dog’s arrival, federal
officials examine the rabies vaccination
certificates and ensure the description
of the dog listed on the paperwork
matches the dog presented. For a rabies
23 https://www.cdc.gov/coronavirus/2019-ncov/
cdcresponse/by-the-numbers.html.
24 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog Importation data, 2010–2019.
Accessed: 15 February 2021.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
32043
vaccine to be effective, the dog must be
at least 12 weeks (84 days) of age at the
time of administration. A dog’s initial
vaccine must also be administered at
least 4 weeks (28 days) before arrival in
the United States.
CDC has documented instances of
fraudulent paperwork for dogs based on
various factors. These include: Dogs that
were younger than the age indicated on
their rabies vaccination paperwork—
based on dental examination by U.S.
veterinarians; differences between the
breed, sex, color, or microchip number
listed on the rabies vaccine certificate
and the dog presented for entry;
suspicious veterinary stamps and
inconsistent signatures between
different veterinary paperwork;
inconsistent dates of rabies vaccination
between different veterinary documents;
and vaccines administered after
expiration date of the vaccine lot.
Under CDC’s regulatory authority,
dogs arriving from high-risk countries
without appropriate rabies vaccination
certificates are denied entry and
returned to the country of origin on the
next available flight.25 Airlines are
required to house dogs awaiting return
to their country of origin at a facility,
preferably a live animal care facility,
that has an active custodial bond and a
Facilities Information and Resource
Management System (FIRMS) code
issued by U.S. Customs and Border
Protection (CBP), which indicates the
facility can provide accommodation that
meets the US Department of
Agriculture’s Animal Welfare Act
standards. However, there are
insufficient live animal care facilities
with a CBP-issued FIRMS code available
to house dogs that are denied entry.
Currently only one facility exists
nationwide (www.arkjfk.com).
If a live animal facility with a CBPissued FIRMS code is not available, the
airline must, at a minimum, provide
accommodation that meets the U.S.
Department of Agriculture’s Animal
Welfare Act standards.26 Many airlines
choose to leave dogs in cargo
warehouses, which can create an unsafe
environment for the dogs due to the
prolonged periods of time between
flights, inadequate cooling and heating,
unacceptable cleaning and sanitization
of crates, and inability to physically
25 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. Federal Register
Notice; Vol. 84, No. 21. 31 January 2019. Available
at: 2019–00506.pdf (govinfo.gov).
26 U.S. Department of Agriculture. Animal
Welfare Regulations; Part 3, Subpart A:
Transportation Standards. Sections 3.14–3.20. July
2020. Available at: USDA Animal Care: Animal
Welfare Act and Animal Welfare Regulations.
E:\FR\FM\16JNN1.SGM
16JNN1
32044
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
separate the animals from areas of the
warehouse where other equipment,
machinery, and goods are used and
stored.
During 2020, due to the COVID–19
pandemic, there were fewer
international flights worldwide,27 28
resulting in delayed returns for dogs
denied entry. In August 2020, while in
the custody of an airline, a dog died at
Chicago O’Hare International Airport
after CDC denied entry based on
falsified rabies vaccination certificates.
Despite CDC’s request to find
appropriate housing at a local kennel or
veterinary clinic, the airline left the dog,
along with 17 other dogs, in a cargo
warehouse without food and water for
more than 48 hours.29
While airlines are ultimately
responsible for finding appropriate
housing for dogs denied entry, the
decreased number of flights combined
with inadequate numbers of live animal
care facilities with a CBP-issued FIRMS
code for holding animals creates
significant administrative and financial
burden for federal, state, and local
governments. The government may be
required to find individualized
solutions to ensure appropriate
accommodations for prolonged periods
of time for these animals.
While costs associated with housing,
caring for dogs, and returning dogs are
the responsibility of the importer (or
airline if the importer abandons the
dog), some importers and airlines are
reluctant to pay these costs, requiring
the Federal government to find
appropriate interim housing facilities
and veterinary care. The cost for
housing, care, and returning improperly
vaccinated dogs ranges between $1,000–
$4,000 per dog depending on the
location and time required until the
next available return flight. The Federal
government bears these costs when
airlines and importers do not.
During 2020, CDC observed a 52%
increase in dogs that were ineligible for
entry compared to 2018 and 2019.30 The
increasing demand to vaccinate and
quarantine dogs that have been denied
27 https://www.cnbc.com/2020/04/02/
coronavirus-update-american-airlines-cutssummer-international-flights-by-60percent-asdemand-suffers.html.
28 https://news.aa.com/news/news-details/2020/
American-Airlines-Announces-AdditionalSchedule-Changes-in-Response-to-CustomerDemand-Related-to-COVID-19-031420-OPS-DIS-03/
default.aspx.
29 Dog Dies At O’Hare Airport Warehouse, 17
Others Saved After Being Left Without Food Or
Water For 3 Days—CBS Chicago (cbslocal.com).
30 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog Importation data, 2018–2020.
Accessed: 15 February 2021.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
entry presents an increased burden to
federal, state and local public health
agencies already responding to the
COVID pandemic. The increased
inspections, medical care, and
appropriate quarantine of dogs
inadequately vaccinated against rabies
has financially burdened federal and
state public health agencies.
Between May through December
2020, CDC spent more than 3,000
personnel-hours at an estimated cost of
$270,000 to respond to the attempted
importation of unvaccinated or
inadequately vaccinated dogs from highrisk rabies countries during these eight
months. The time spent represented a
substantial increase from previous years
because of (1) the 52% increase in dogs
with inadequate documentation; and (2)
the additional time spent identifying
interim accommodations for the dogs
because of the reduced outbound
international flight schedules due to the
pandemic. These are resources and
personnel-hours diverted from CDC’s
current paramount objective in
mitigating the COVID–19 pandemic and
do not include time from other Federal,
state, and local public health partners.
Pursuant to the terms of this notice,
HHS/CDC is temporarily suspending the
importation of dogs from high-risk
countries. This suspension includes
dogs originating in low-risk or CRVVfree countries that have been in a highrisk country in the previous six months
(not including animals transiting
through high-risk countries). The
suspension will reduce the risk of
importation of CRVV and preserve
public health resources needed for the
COVID–19 response. The suspension
will also allow CDC to work with
Federal and state partners, airlines, and
other stakeholders to consider options
for a more streamlined and efficient dog
importation process that will be safer for
pets. Most importantly, it will ensure
that U.S. public health remains
protected.
This notice creates a narrow set of
exceptions for certain categories of dogs
imported into the United States with
advance written approval from CDC.
The requirement for advanced written
approval will help ensure that the
limited number of dogs imported into
the United State from high-risk
countries have valid documentation of
rabies vaccination upon entry. It will
also mitigate the costs placed upon the
U.S. government, airlines, and importers
associated with reexporting dogs that do
not meet CDC entry requirements.
III. Advance Written Approval
The suspension provisions of this
notice do not apply if advance written
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
approval from CDC has been obtained to
import a dog from a high-risk country
that has been fully immunized against
rabies. This includes a dog that has been
in a high-risk country in the previous 6
months and is being imported from a
low-risk or CRVV-free country. Such
approvals will be granted on a limited
and case-by-case basis and at CDC’s
discretion. CDC’s decision will be
considered final.
The following categories of importers
are eligible to request advance written
approval to import a dog into the United
States:
• U.S. government personnel who are
relocating back to the United States with
Permanent Change of Station (PCS)
orders or Temporary Duty (TDY)
orders.31
• U.S. citizens and lawful residents
relocating to the United States. The
application should include written
documentation from an employer or
other official source stating the reason
for the relocation, such as a letter by an
employer or university stating that the
U.S. citizen or lawful resident is
relocating for reasons of employment or
education.
• Importers who wish to import dogs
for purposes related to science,
education, or exhibition, as these terms
are defined in 42 CFR 71.50, or for a
bona fide law enforcement purpose.
• Owners of service animals, if the
dog is individually trained to do work
or perform tasks for the benefit of an
individual with a disability, including a
physical, sensory, psychiatric,
intellectual, or other mental disability.
In accordance with U.S. Department of
Transportation regulations at 14 CFR
part 382, emotional support animals,
comfort animals, companionship
animals, and service animals in training
are not considered service animals for
the purposes of this Notice.
During this temporary suspension,
importers who meet the eligibility
criteria listed above may make a onetime request to import up to three dogs
as part of a single importation. All dogs
must be six months of age or older at the
time of entry and, as further explained
in this notice, must enter the United
States at a port of entry with a live
animal care facility with a CBP-issued
FIRMS code. Importers of dogs for
science, education, or exhibition, as
these terms are defined in 42 CFR 71.50,
or bona fide law-enforcement purposes
may import more than three dogs.
To request the advance written
approval of the CDC, importers who
31 PCS Order definition https://www.gsa.gov/
policy-regulations/regulations/federal-travelregulation-ftr/i1186607#i1186607.
E:\FR\FM\16JNN1.SGM
16JNN1
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
meet the eligibility criteria listed above
must submit the Application for a
Permit to Import a Dog Inadequately
Immunized Against Rabies, (approved
under OMB Control Number 0920–0134
Foreign Quarantine Regulations (exp.
03/31/2022), or as revised). To request
an application for the permit, an
importer must send an email to the
Director, Division of Global Migration
and Quarantine, at cdcanimalimports@
cdc.gov.
Once an importer receives
instructions and the permit application,
the importer’s request with all
supporting documentation must be
submitted at least 30 business days
before the date on which the dog will
enter the United States. A request
cannot be made at the port of entry
upon the dogs’ arrival into the United
States; dogs that arrive without advance
written approval from the CDC will be
returned to their country of origin on
the next available flight. As required by
the permit application, a request must
present sufficient and reliable evidence
conclusively demonstrating that the dog
to be imported has been fully
immunized against rabies.32 Such
evidence includes:
1. A valid rabies vaccination
certificate that was issued in the United
States by a U.S.-licensed veterinarian.
The certificate must state that the
vaccine was administered on or after the
dog was 12 weeks (84 days) of age and
at least 28 days prior to entry, if it was
the dog’s initial vaccine. OR
2. A valid rabies vaccination
certificate from a non-U.S.-licensed
veterinarian AND serologic evidence of
rabies vaccination from an approved
rabies serology laboratory 33 (serologic
results >0.5IU/mL required)collected in
accordance with the OIE Terrestrial
Manual.34 The certificate must state that
the vaccine was administered on or after
the dog was 12 weeks (84 days) of age
and at least 28 days prior to entry, if it
was the dog’s initial vaccine. The
certificate must be in English or
accompanied by a certified English
translation.
Furthermore, based on the
circumstances, an importer may also be
required to submit the following:
32 The permit is currently under revision (Permit
to Import a Dog Inadequately Immunized Against
Rabies, (OMB Control Number 0920–0134 Foreign
Quarantine Regulations (exp. 03/31/2022)). Despite
the permit application’s current title, inadequately
immunized dogs do not qualify for the exception.
33 Will provide link to CDC website with list of
approved laboratories.
34 OIE Terrestrial Animal Health Code. Chapter
5.11. Available at: Access online: OIE—World
Organisation for Animal Health.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
• Permanent Change of Station (PCS)
orders, or Temporary Duty Orders (TDY)
(U.S. Government personnel);
• Documentation or evidence that the
dog to be imported is a service dog (as
defined in this Notice);
• Employment letter or other
evidence of relocating to the United
States after living abroad; or
• Other justification that meets the
above-listed eligibility criteria along
with supporting documentation.
Dogs arriving from a high-risk country
with a CDC permit must enter the
United States at a port of entry with a
live animal care facility with a CBPissued FIRMS code that can provide
accommodation that meets the U.S
Department of Agriculture’s Animal
Welfare Act standards. Currently, John
F. Kennedy International Airport in
New York City is the only U.S. port of
entry with a live animal care facility
that meets these standards. However, if
any additional ports of entry become
capable of meeting these standards, CDC
will publish the list of ports of entry in
the Federal Register and on the CDC
animal importation website. Animals
imported for bona fide law-enforcement
purposes are not required to enter the
United States at a port of entry with a
live animal care facility with a CBPissued FIRMS code.
CDC additionally requires dogs
arriving from a high-risk country with a
CDC permit be microchipped on or
before the date that they receive their
rabies vaccination. The microchip
number must be listed on the rabies
vaccination certificate. Photographs of
the dog’s teeth are required for age
verification. CDC will respond to an
importer’s request in writing and may
impose additional conditions in
granting the approval. An importer must
present CDC’s written response and
approval upon entry into the United
States. If a request for advance approval
is denied, CDC’s written denial will
constitute final agency action.
Any dog from a high-risk country will
be excluded from entering the United
States and returned to its country of
origin on the next available flight,
regardless of carrier or route, if it arrives
without advance written approval from
the CDC, arrives at a port of entry
without a live animal care facility with
a CBP-issued FIRMS code, or if the
animal presented does not match the
description of the animal listed on the
permit. The importer (or airline carrier
if the importer abandons the animal)
will be financially responsible for all
housing, care, and return costs. In
keeping with current practice, importers
should continue to check with Federal,
state, and local government officials
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
32045
regarding additional requirements of the
final destination prior to entry or reentry into the United States.
IV. Economic Impact of This
Temporary Suspension
Executive Orders 12866: ‘‘Regulatory
Planning and Review’’ and 13563:
‘‘Improving Regulation and Regulatory
Review’’ 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.
Although the temporary suspension of
dogs from countries at high-risk for
CRVV is expected to reduce the number
of dogs imported into the United States,
importers of dogs from high-risk
countries will be able to submit a
request for advanced written permission
at least 30 days prior to planned
importation in the United States. Thus,
some importers will be able to import
up to three dogs from high-risk
countries with CDC-issued permits.
CDC has previously estimated that
between 87,000 and 116,000 dogs are
imported from high-risk countries each
year.35 This estimate is significantly
greater than the numbers recorded by
CBP for formal entry under HTS code
0106199120 and HTS Description: Other
live animals, other, dogs, which
averaged 16,390 and varied from 9,966
to 24,031 over the 3-year period from
2018 through 2020.
The number of dogs reported under
this HTS category do not include handcarried dogs traveling in airplane cabins
or crossing at land borders without
formal entry and, thus, are not inclusive
of all dog imports. To account for the
uncertainty in the number of dogs
imported to the United States from highrisk countries without formal entry,
CDC used the following assumptions in
the analysis of this action: (1) Most
likely estimate: 3 times the average
number of dogs with formal entry from
2018–2020 = 60,696 dogs per year, (2)
Lower bound: 2 times the average
number of dogs with formal entry from
2018–2020 = 32,781, and (3) Upper
bound: 5 times the number of dogs
arriving in the highest year (2019) =
35 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
E:\FR\FM\16JNN1.SGM
16JNN1
32046
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
120,155. These baseline estimates are
used throughout the analysis (Table 1).
CDC assumed that the temporary
suspension would reduce the number of
dogs imported from high-risk countries
by 75% and considered a range of 50%–
90% to calculate lower and upper
bound estimates. This would result in
estimates of 15,124 (range: 3,203–60,040
dogs) dogs imported with CDC-issued
permits per year with the suspension in
place. The temporary suspension would
reduce the estimated numbers of dogs
imported per year by 45,572 (range:
29,758–60,115). CDC also estimated the
numbers of dogs denied entry under the
baseline and with the temporary
suspension in effect. An estimated 500
(range: 300–750) dogs would be denied
entry under the baseline based on data
from 2020 and previous years. The
temporary suspension and CDC permit
process are expected to reduce the
number of dogs denied entry by 90%
(range: 75%–95%) such that only 50
(range: 15–188) dogs would be denied
entry with the temporary suspension.
TABLE 1—ESTIMATED NUMBERS OF DOGS FROM HIGH-RISK COUNTRIES IMPORTED OR DENIED ENTRY UNDER THE
BASELINE AND WITH THE TEMPORARY SUSPENSION
Most likely
estimate
Estimated number of dogs imported from high-risk countries at baseline .................................
Estimated % reduction in number of dogs imported from high-risk countries with temporary
suspension ...............................................................................................................................
Estimated number of dogs imported from high-risk countries with temporary suspension ........
Change in number of dogs imported from high-risk countries ....................................................
Estimated number of dogs denied entry from high risk countries at baseline ...........................
Estimated % reduction in dogs denied entry with temporary suspension ..................................
Estimated number of dogs denied entry with temporary suspension .........................................
Change in numbers of dogs denied entry with temporary suspension ......................................
The estimated costs and benefits (in
2019 U.S. dollars) associated with the
temporary suspension of dogs from
countries at high-risk for CRVV are
summarized in Table 2. CDC estimates
that importers, CDC, and DHS/CBP will
incur about $11.8 million in costs
(range: $2.2–$57.6 million) over the oneyear period anticipated for the
suspension. The large difference
between the lower and upper bound is
due to both uncertainty in the number
of dogs imported from high-risk
countries under the baseline as well as
uncertainty in many of the costs
associated with the suspension.
Most of the costs will be incurred by
importers (most likely estimate of $10.8
million, 91% of the total), who will
have to (1) spend time requesting
advance written permission, (2) pay for
serologic testing unless the imported
dog already has a valid U.S. rabies
vaccination certificate issued by a U.S.licensed veterinarian, (3) re-route travel
to a port of entry with a live animal care
facility with a CBP-issued FIRMS code,
and (4) the potential economic costs of
being unable to import a dog from a
high-risk country (either the inability to
travel with a pet from a high-risk
country or the need to substitute the
importation of a dog from CRVV-free or
low-risk country instead of a dog from
a high-risk country).
The one-year benefits (averted costs)
from the temporary suspension are
estimated to be $2.3 million, range:
$1.0–$5.1 million). Most of the benefits
(most likely estimate of $1.5 million,
Lower bound
Upper bound
60,696
32,781
120,155
75%
15,174
45,522
500
90%
50
450
90%
3,278
29,503
300
95%
15
285
50%
60,078
60,078
750
75%
188
563
64% of total) of the temporary
suspension accrue to CBP due to the
reduction in the number of dogs
imported from high-risk countries
(which require screening), the number
of dogs denied entry, and an estimated
decrease in the amount of time to
review a CDC permit vs. the time
required to review documentation under
the baseline. Importers, CDC, and
airlines also benefit from the averted
costs associated with the reduction in
the number of dogs denied entry with
the suspension relative to baseline. The
net cost of the temporary suspension is
calculated from the annual
costs¥annual benefits resulting in an
estimate of $9.5 million (range: $1.2–
$52.5 million).
TABLE 2—SUMMARY TABLE OF COSTS AND BENEFITS IN 2019 DOLLARS, OVER A 1-YEAR TIME HORIZON
Most likely
estimate
Category
Benefits:
Annual
Annual
Annual
Annual
monetized
monetized
monetized
monetized
benefits
benefits
benefits
benefits
to
to
to
to
Upper bound
importers/owners of dogs from high risk countries ..............
airlines ..................................................................................
DHS/CBP ..............................................................................
HHS/CDC .............................................................................
$579,260
54,000
1,491,418
198,369
$215,765
11,400
678,417
92,153
$1,508,443
168,750
3,055,534
398,948
Total annualized monetized benefits ............................................................................
2,175,209
920,521
4,836,488
Quantified, but unmonetized, benefits ..................................................................................
jbell on DSKJLSW7X2PROD with NOTICES
Lower bound
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
The estimated response costs associated with a
dog imported while infected with canine rabies
virus variant (CRVV) are $315,682, range:
$215,386 to $508,879. The permit requirement
for high risk countries should reduce the risk of
importation of dogs infected with CRVV.
E:\FR\FM\16JNN1.SGM
16JNN1
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
32047
TABLE 2—SUMMARY TABLE OF COSTS AND BENEFITS IN 2019 DOLLARS, OVER A 1-YEAR TIME HORIZON—Continued
Most likely
estimate
Category
Qualitative benefits ...............................................................................................................
Upper bound
Any importation of a dog with CRVV will require
the reallocation of limited public health resources to support a response to mitigate the
risk of transmission of CRVV. This could reduce the effectiveness of COVID–19 response
activities and vaccination programs. In addition, these competing priorities may increase
the risk of unlikely, but very costly outcomes
associated with an importation of a dog with
CRVV such as (1) the potential risk of death in
a person who may be unaware of his/her exposure to a dog with CRVV and (2) the risk of reintroduction of CRVV in the United States.
Costs:
Annualized monetized costs to Importers/owners of dogs from high risk countries ...........
Annual monetized costs to airlines ......................................................................................
Annualized monetized costs to DHS/CBP ...........................................................................
Annual monetized costs to HHS/CDC .................................................................................
$10,752,595
0
192,498
848,142
$1,956,530
0
0
280,952
$54,191,420
0
461,994
2,974,298
Total annualized monetized costs .................................................................................
11,793,199
2,237,473
57,627,615
The primary public health benefit of
the temporary suspension is the reduced
risk that a dog with CRVV will be
imported from a high-risk country.
Based on experience with previous
importations, CDC estimated the cost
per imported dog with CRVV to be
$315,682, range $215,386 to
$508,879.36 37 This cost estimate
includes health department staff time
for the public health response,
payments for post-exposure prophylaxis
for exposed persons, and the costs
associated with quarantining or
euthanizing exposed animals. Any
importation of a dog with CRVV would
also likely divert public health
resources away from COVID–19
response activities.
Using the most likely estimates of the
net cost ($9.5 million) and the most
likely estimate of the potential benefits
of averting the importation of a dog with
CRVV from a high-risk country
($316,000), it is possible to calculate
how many dogs with CRVV would need
to be imported under the baseline for
the benefits to equal costs. The net costs
($9.5 million) divided by the cost per
importation ($316,000) suggests that at
least 30 dogs with CRVV would need to
be imported under the baseline for
benefits to exceed costs. This would
jbell on DSKJLSW7X2PROD with NOTICES
Lower bound
36 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. Morb Mort Wkly 2020; 69 (38):
1374–1377.
37 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. Fed
Register 2019;84:724–730. https://
www.federalregister.gov/documents/2019/01/31/
2019-00506/guidance-regarding-agencyinterpretation-of-rabies-free-as-it-relates-to-theimportation-of-dogs.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
require a huge increase in the number
of dogs imported into the United States
while infected with CRVV, which could
only occur as a result of widespread
failures of rabies control programs in
multiple high-risk countries.
The above estimate of the cost of an
importation of a dog with CRVV does
not account for the worst-case
outcomes, which include (1)
transmission of rabies to a person who
dies from the disease or (2) ongoing
transmission to other domestic and
wildlife species in the United States. Reestablishment of CRVV into the United
States, while unlikely, could result in
costly efforts over several years to again
eliminate the virus.
The cost of re-introduction could be
especially high if CRVV spreads to other
species of U.S. wildlife. Both of these
worst-case outcomes may be more likely
to occur during the COVID–19
pandemic because public health
resources have been diverted to COVID–
19 response activities and vaccination
programs.
Human deaths from rabies continue to
occur in the United States after
exposures to wild animals. However, no
U.S. resident has died after exposure to
an imported dog with CRVV in at least
20 years. CDC uses the value of
statistical life (VSL) to assign a value to
interventions that can result in mortality
risk reductions. For 2019, the estimated
VSL is $10.6 million with a range of
$5.0 to $16.2 million.38 However, CDC
38 HHS/ASPE, 2016. Office of the Assistant
Secretary for Planning and Evaluation, U.S.
Department of Health and Human Services.
Guidelines for Regulatory Impact Analysis. https://
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
is unable to estimate the potential
magnitude of the mortality risk
reduction associated with the temporary
suspension.
Re-establishment of CRVV into the
United States, while unlikely, would
also result in costly efforts over a
number of years to eliminate the virus.
A previous campaign to eliminate
domestic dog-coyote rabies virus variant
jointly with gray fox (Texas fox) rabies
virus variant in Texas over the period
from 1995 through 2003 cost $34
million,39 40 or $52 million in 2019 U.S.
dollars. The costs to contain any
reintroduction would depend on the
time period before the reintroduction
was realized, the wildlife species in
which CRVV was transmitted, and the
geographic area over which
reintroduction occurs. The above
estimate is limited to the cost of rabies
vaccination programs for targeted
wildlife and does not include the costs
to administer post-exposure prophylaxis
to any persons exposed after the
reintroduction has been identified.
Assumptions Used To Estimate Costs
and Benefits
CDC estimated costs and benefits to
importers, CDC, CBP, and airlines under
the baseline and with the temporary
aspe.hhs.gov/system/files/pdf/242926/HHS_
RIAGuidance.pdf. Accessed April 20, 2020.
39 TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies
epizootics in coyotes and gray foxes: 1995–2003.
Journal of the American Veterinary Medicine
Association; 227(5):785–92.
40 R.T. Sterner et al. (2009) Tactics and Economics
of Wildlife Oral Rabies Vaccination, Canada and the
United States. Emerging Infectious Diseases; 15(8),
1176–1184.
E:\FR\FM\16JNN1.SGM
16JNN1
32048
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
suspension in place. All cost estimates
were converted to 2019 U.S. dollars.
The costs to importers with the
temporary suspension were calculated
using the following assumptions:
• The opportunity costs for importer
time were estimated at $36.41 (range:
$25.72–$47.10) per hour based on the
average U.S. wage rate and a
Department of Transportation estimate
specific to international travelers.41 42
• Importers seeking advance written
permission for 15,124 (range: 3,263–
59,890) dogs.
Æ An assumption of 1 hour (range
0.5—2 hours) to submit advance written
approval and fulfill the informational
and testing requirements for a permit.
Æ Estimated costs of $50 (range: $20–
$65) for a rabies titer test at an approved
rabies serology laboratory.43
Æ Assumed cost of $100 (range: $80–
$120) for a veterinarian to draw blood
sample and ship it to an approved rabies
serology laboratory.
Æ Estimated cost of $40 (range: $25–
$50) to implant a microchip.44
Æ An assumption that 40% of
importers will already have a valid
rabies vaccination certificate issued by a
U.S.-licensed veterinarian and will not
need testing from an approved rabies
serology laboratory or microchip.
Æ An assumption that 75% of
importers of dogs from high-risk
countries would need to re-route travel
to a port of entry with a live animal care
facility with a CBP-issued FIRMS code,
which would incur an increased ticket
cost of $200 and 4 additional hours of
travel time.
• Importers who are unable to import
a dog from a high-risk country because
of the temporary suspension (45,572,
range: 29,518–60,265 dogs) would incur
an assumed cost of $100 (range: $50–
$400) per dog because of time spent
away from pets or increased costs of
substitution to import a dog from a
CRVV-free or low-risk country.
41 Bureau of Labor Statistics in the May 2019
National Occupational Employment and Wage
Estimates United States https://www.bls.gov/oes/
current/oes_nat.htm.
42 U.S. Department of Transportation, Office of
Transportation Policy. The Value of Travel Time
Savings: Departmental Guidance for Conducting
Economic Evaluations Revision 2 (2016 Update),
‘‘Table 4 (Revision 2—2016 Update): Recommended
Hourly Values of Travel Time Savings.’’ September
27, 2016. https://www.transportation.gov/sites/
dot.gov/files/docs/2016%20Revised%
20Value%20of%20
Travel%20Time%20Guidance.pdf. Accessed June
4, 2020.
43 United Kingdom Animal and Plant Health
Agency Laboratory Price List TC702. https://
science.vla.gov.uk/Tests/SearchResults.aspx?Site
Name=CDT&PriceListCategoryId=33. Accessed 11/
1/2020.
44 PetSide. How Much Does it Cost to Microchip
a Dog. https://www.petside.com/dog-microchipcost/ Accessed 2/17/2021.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
The costs for CDC were estimated
based on:
• An assumed staff time cost of 20
minutes (range: 15–30 minutes) per
permit issued by a GS–12, step 5
reviewer.
• Oversight of the permit process by
two GS–13, step 5 veterinarians.
• 30 minutes of staff time to revise
training materials for CBP staff.
• CDC staffing costs are estimated
using the GS pay scale for the Atlanta
area and multiplying by 2 to account for
non-wage benefits and overhead.
The costs for CBP included 5 minutes
(range 0–10 minutes) for 25,052 (range:
20,402–30,602) CBP officers (average
level GS–12, step 5) to receive training
on the temporary suspension. CBP
staffing costs are estimated using the GS
pay scale for the Washington, DC area
and multiplying by 2 to account for nonwage benefits and overhead.
CDC assumed that airlines would not
incur new costs for this temporary
suspension because the time required to
review CDC-issued permits prior to
boarding dogs from high-risk countries
should be similar to the amount of time
required to review vaccination
certificates under the current baseline.
There may be some reduction in cargo
fees revenue associated with the
reduction in dogs imported from
countries at high risk for CRVV (range:
29,518–60,265 dogs), but this lost
revenue may be offset by revenues
received to import dogs from CRVV-free
or low-risk countries or revenue
received for cargo other than dogs. CDC
lacks sufficient data to estimate such
costs but expects the net cost to airlines
to be limited.
The expected annual benefits (averted
costs) were estimated for importers,
CDC, CBP, and airlines based on the
reduced numbers of dogs delayed entry
and the reduced time spent by CBP
officers to screen dogs from high-risk
countries.
The estimated benefits (averted costs)
for importers were estimated based on:
• An estimated reduction in time
spent by CBP to review documentation
for dogs from high-risk countries
assuming an estimate of 17 minutes
(range: 13.6–20.4 minutes) per dog to
review documentation under the
baseline 45 to 5 minutes (range: 3–8
minutes) per dog to review permits
during the suspension.
• An estimated 2 hours per dog
denied entry (estimated at 450 fewer
dogs denied entry, range: 285–563) with
the suspension relative to baseline.
45 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
• CDC assumed that 80% of dogs
denied entry would be re-imported to
the United States at a round-trip cost of
$1,200 per dog to the importer.46
• CDC assumed that 20% of dogs
denied entry would be abandoned by
importers at a cost of $100 per dog to
the importer.
The estimated benefits (averted costs)
to CDC were estimated based on:
• An estimated 4 hours of CDC staff
time per dog denied entry at an average
GS-level 13, step 5 at CDC Headquarters
and an average of 30 minutes of CDC
quarantine station staff time per dog
denied entry at an average GS-level 11,
step 5. The actual mix of staff at CDC
Headquarters who need to support
denials of entry would vary from GS–11
through Senior Executive Staff and
varies depending on time spent on
appeals and finding shelter for
abandoned dogs.
The estimated benefits (averted costs)
to CBP were estimated based on:
• An estimated reduction in the
number of dogs imported from high-risk
countries due to the temporary
suspension: 45,572 (range: 29,758–
60,115) relative to baseline.
• Under the baseline, CDC estimated
that each dog imported from a high-risk
country requires 17 minutes (range:
13.6–20.4 minutes) of CBP officer time
to review documents (GS–12, step 5).47
• With the temporary suspension in
place, CDC estimates that the time
required to review CDC-issued permits
would decrease from the above to 5
(range: 3–8) minutes per dog for the
estimated 15,124 (range: 3,263–59,890)
dogs arriving with permits.
• An estimated reduction in the
number of dogs denied entry because of
the temporary suspension: (estimated at
450 fewer dogs denied entry, range:
285–563).
• An estimate of 71 (range: 47–95)
minutes of CBP staff time required per
dog denied entry (GS–12, step 5).48
The estimated benefits (averted costs)
for airlines were estimated based on:
• The reduction in the estimated
numbers of dogs denied entry and
abandoned by importers (100 under the
baseline vs. 10 with the suspension of
entry).
46 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
47 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
48 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
E:\FR\FM\16JNN1.SGM
16JNN1
Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• An assumed cost of $600 per dog
for airlines to fly abandoned dogs back
to their countries of origin.49
The costs associated with an
importation of a dog with CRVV
includes health department staff time
for the public health response,
payments for post-exposure prophylaxis
treatment for exposed persons, and the
costs associated with quarantining or
euthanizing exposed animals. CDC
estimated the response cost per
imported dog with CRVV to be
$315,682, range $215,386 to $508,879
based on the following assumptions:
• An estimate of 800 hours of health
department staff time per importation.50
• The public health response time is
split evenly among veterinarians (code
29–1131, $50.39 per hour),
epidemiologists (19–1041, $37.64 per
hour), registered nurses (29–1141,
$37.24 per hour), licensed practical
nurses (29–2061, $23.32 per hour), and
office and administrative assistants (43–
0000, $19.73 per hour).51 52 These wage
estimates are multiplied by 2 to account
for non-wage benefits and overhead.
• An average of 25 (range: 16–44)
individuals will require post-exposure
prophylaxis because of exposure to the
dog with CRVV.53 54
• The average cost of post-exposure
prophylaxis was estimated to be
$9,290.55
• An estimated 29.6 animals would
need to be quarantined or euthanized
due to exposure to the dog with CRVV.
• Each exposed animal would incur
economic costs of $1,000 for quarantine
or euthanasia.56
49 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
50 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
51 Bureau of Labor Statistics, May 2019 National
Occupational Employment and Wage Estimates.
https://www.bls.gov/oes/current/oes_nat.htm.
52 Bureau of Labor Statistics in the May 2019
National Occupational Employment and Wage
Estimates United States https://www.bls.gov/oes/
current/oes_nat.htm.
53 Rayburn et al. (2020) Rabies in a Dog Imported
from Egypt—Kansas, 2019. MMWR; 69(38): 1374–
1377.
54 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
55 Rayburn et al. (2020) Rabies in a Dog Imported
from Egypt—Kansas, 2019. MMWR; 69(38): 1374–
1377.
56 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. (January
31, 2019) 84 FR 724: 724–730.
VerDate Sep<11>2014
17:27 Jun 15, 2021
Jkt 253001
V. Terms of This Notice
Therefore, pursuant to 42 CFR
71.51(e) and 42 CFR 71.63, and subject
to the terms of this notice, CDC hereby
excludes the entry and suspends the
importation of dogs from high-risk
countries, including dogs from low-risk
and CRVV-free countries if the dogs
have been present in a high-risk country
in the previous six months.
Additionally, under 42 CFR 71.63,
CDC finds that CRVV exists in countries
designated as high-risk countries and
that, if reintroduced into the United
States, CRVV would threaten the public
health of the United States. The
continued entry of dogs from high-risk
countries in the context of the current
limited CDC resources and personnel
diverted to respond to COVID–19
further increases the risk that CRVV
may be introduced, transmitted, or
spread into the United States. CDC has
coordinated in advance with other
federal agencies as necessary to
implement and enforce this notice.
This notice is not a rule within the
meaning of the Administrative
Procedure Act (‘‘APA’’), but rather
notice of an emergency action taken
under the existing authority of 42 CFR
71.51(e) and 42 CFR 71.63. In the event
that this notice qualifies as a rule under
the APA, notice and comment and a
delay in effective date are not required
because there is good cause to dispense
with prior public notice and the
opportunity to comment on this notice.
Considering the public health
emergency caused by the virus
associated with COVID–19, the ongoing
diversion of public health resources and
personnel to respond to the pandemic,
and the risk of reintroduction of CRVV
from dogs being imported from high-risk
countries, it would be impractical and
contrary to the public’s health, and by
extension the public’s interest, to delay
the issuance and effective date of this
notice.
Effective July 14, 2021: Pursuant to
the exception, dogs from high riskcountries must be 6 months of age to be
imported and fully vaccinated against
rabies, and eligible importers may only
import up to 3 dogs upon receipt of
advanced written approval from the
CDC. Importers wishing to import dogs
from high-risk countries should:
1. Submit a request for advanced
written permission (i.e., Application for
a Permit to Import a Dog Inadequately
Immunized Against Rabies, (approved
under OMB Control Number 0920–0134
Foreign Quarantine Regulations (exp.
03/31/2022), or as revised)) at least 30
days prior to planned importation in the
United States.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
32049
2. Submit all documentation listed
above in Section III Advanced Written
Approval.
The request for advance written
permission must include proof of the
dog’s identity including pictures of the
dogs’ teeth, other descriptive details,
proof of rabies vaccination, and
microchip information. Dogs arriving
from high-risk countries must enter the
United States at a port of entry with a
live animal care facility with a CBPissued FIRMS code that can provide
accommodation that meets the U.S
Department of Agriculture’s Animal
Welfare Act standards.
This temporary suspension will
remain in place until the earliest of (1)
the expiration of the Secretary of Health
and Human Services’ declaration that
COVID–19 constitutes a public health
emergency; (2) the CDC Director
rescinds or modifies this suspension
based on specific public health or other
considerations; or (3) 360 days from
publication in the Federal Register.
Dated: June 9, 2021.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2021–12418 Filed 6–14–21; 4:15 pm]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10494 and CMS–
10773]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
SUMMARY:
E:\FR\FM\16JNN1.SGM
16JNN1
]]>Agencies
[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Notices]
[Pages 32041-32049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12418]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Temporary Suspension of Dogs Entering the United States From
High-Risk Rabies Countries
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS) announces a temporary
suspension in the importation of dogs from high-risk rabies-enzootic
countries (hereinafter referred to as high-risk country or countries)
into the United States. Due to the unprecedented global response to the
Coronavirus Disease 2019 (COVID-19) pandemic and limited availability
of public health resources at the Federal, state, and local level, this
action is necessary to protect the public health against the
reintroduction of canine rabies virus variant (CRVV) into the United
States and to ensure the welfare of dogs being imported into the U.S.
This suspension, with limited exceptions, includes dogs imported from
low-risk or CRVV-free countries if the dogs have been in any high-risk
countries during the previous six months.
DATES: This notice is effective July 14, 2021.
FOR FURTHER INFORMATION CONTACT: For information regarding this notice
contact: Ashley C. Altenburger, J.D., Division of Global Migration and
Quarantine, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-H16-4, Atlanta, GA 30329 or 404-498-1600.
For information regarding HHS/CDC regulations for the importation
of dogs, please contact: Dr. Emily Pieracci, D.V.M., Division of Global
Migration and Quarantine, Centers for Disease Control and Prevention,
1600 Clifton Road NE, MS-V-18-2, Atlanta, GA 30329 or 404-498-1600.
Either Mrs. Altenburger or Dr. Pieracci may also be reached by email at
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Authority
Rabies, one of the deadliest zoonotic diseases, accounts for an
estimated 59,000 human deaths globally each year \1\--which equates to
one human death every 9 minutes. Canine rabies virus variant (CRVV) is
responsible for 98% of these deaths.\2\ The rabies virus can infect any
mammal, and once clinical signs appear, the disease is almost always
fatal.\2\ In September 2007, at the Inaugural World Rabies Day
Symposium, HHS/CDC declared the United States to be free of CRVV.
However, this rabies virus variant is still a serious public health
threat in the more than 120 countries where CRVV remains enzootic.
Preventing the entry of animals infected with CRVV into the United
States is a public health priority.
---------------------------------------------------------------------------
\1\ WHO Technical Report Series 1012, 2018; Page 6.
\2\ Fooks AR, Banyard AC, Horton DL, Johnson N, McElhinney LM,
Jackson AC. Current status of rabies and prospects for elimination.
Lancet 2014;384:1389-99.
---------------------------------------------------------------------------
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 the Secretary's judgment are necessary
to prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the United States and from one
State or possession into any other State or possession.\3\ Since at
least 1956, Federal quarantine regulations (currently found at 42 CFR
71.51) have controlled the entry of dogs into the United States. See 21
FR 9870, Dec. 12, 1956. One of the principal goals of these regulations
is to prevent the reintroduction and spread of CRVV 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 regulatory efforts on preventing the reintroduction of this
rabies variant.
---------------------------------------------------------------------------
\3\ Although the statute assigns authority to the Surgeon
General, all statutory powers and functions of the Surgeon General
were transferred to the Secretary of HHS in 1966, 31 FR 8855, 80
Stat. 1610 (June 25, 1966), see also Public Law 96-88, 509(b),
October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)). The
Secretary has retained these authorities despite the reestablishment
of the Office of the Surgeon General in 1987.
---------------------------------------------------------------------------
Under 42 CFR 71.51, all dogs admitted into the United States must
be accompanied by a valid rabies vaccination certificate.\4\ This
[[Page 32042]]
requirement applies unless the dog's owner or importer submits
satisfactory evidence that the dog is less than 6 months old and has
only been in a CRVV-free or low-risk country, or has only been in a
CRVV-free or low-risk country for the 6 months before arrival if it is
older than 6 months.\5\ CDC maintains a current, publicly available
list of countries with high risk of CRVV \6\ and provides guidance for
dog entry requirements based on the dog's country of import.
---------------------------------------------------------------------------
\4\ https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html.
\5\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. Fed Register 2019;84:724-730. https://www.federalregister.gov/documents/2019/01/31/2019-00506/guidance-regarding-agency-interpretation-of-rabies-free-as-it-relates-to-the-importation-of-dogs.
\6\ https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/rabies-vaccine.html.
---------------------------------------------------------------------------
Additionally, under 42 CFR 71.51(e), CDC may exclude dogs coming
into the United States from areas determined to have high rates of
rabies. Under 42 CFR 71.63, CDC may also temporarily suspend the entry
of animals, articles, or things from designated foreign countries and
places into the United States when it determines there exists in a
foreign country a communicable disease that threatens the public health
of the United States and the entry of imports from that country
increases the risk that the communicable disease may be introduced.
When such a suspension is issued, CDC designates the period of time or
conditions under which imports into the United States may be suspended.
CDC bases this temporary suspension on these legal authorities.
II. Public Health Rationale
The United States was declared CRVV-free in 2007. Importing dogs
from high-risk CRVV countries involves a significant public health
risk. CDC requires strict compliance with all its public health entry
requirements. Although the U.S. Government does not track the total
number of dogs imported each year, it is estimated that approximately 1
million dogs are imported into the U.S. annually, of which 100,000 dogs
are from countries at high- risk of CRVV.\7\ This estimate was based on
information provided by airlines, the Department of Homeland Security's
Customs and Border Protection (CBP) staff, and a study conducted at a
U.S.-Mexico land border crossing.\8\
---------------------------------------------------------------------------
\7\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
\8\ McQuiston, J.H., et al., Importation of dogs into the United
States: risks from rabies and other zoonotic diseases. Zoonoses
Public Health, 2008. 55(8-10): p. 421-6.
---------------------------------------------------------------------------
CBP does record, by country, the number of dogs imported with
formal entry under Harmonized Tariff Schedule (HTS) code 0106199120 and
HTS Description: Other live animals, other, dogs. The total number of
dogs imported into the United States from all countries under this HTS
category varied from 25,232 in 2018 to 58,540 in 2020. The number of
dogs from high-risk countries under this HTS category averaged 16,390
and varied from 9,966 to 24,031 over this 3-year period. The number of
dogs reported under this HTS category does not include dogs imported as
checked baggage, hand-carried in airplane cabins, or crossing at land
borders without formal entry. Thus, the number underestimates the true
number of dogs imported into the United States.
The importation of just one dog infected with CRVV risks re-
introduction of the virus into the United States resulting in a
potential public health risk with consequent monetary cost and
potential loss of human and animal life.9 10 11 CRVV has
been highly successful at adapting to new host species, particularly
wildlife.\12\ One CRVV-infected dog could result in transmission to
humans, domestic pets or wildlife. The importation in 2019 of a single
dog with rabies cost more than $400,000 USD for the public health
investigations and rabies port-exposure prophylaxis (PEP) of exposed
persons.13 14
---------------------------------------------------------------------------
\9\ Smith J, le Gall F, Stephenson S, et al. People, pathogens
and our planet. The Economics of One Health 2012;2.
\10\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. Morb Mort Wkly 2020; 69 (38): 1374-1377.
\11\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
\12\ Velasco-Villa A, Mauldin MR, Shi M, et al. The history of
rabies in the Western Hemisphere. Antiviral Res. 2017;146:221-232.
doi:10.1016/j.antiviral.2017.03.013.
\13\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. Morb Mort Wkly 2020; 69 (38): 1374-1377.
\14\ https://www.cdc.gov/rabies/medical_care/.
---------------------------------------------------------------------------
Since 2015 there have been three known rabid dogs imported into the
United States. All three dogs were rescue dogs imported by different
rescue organizations for the purposes of adoption. These three cases,
discussed below, highlight the immense public health resources required
to investigate, respond to, and mitigate the public health threat posed
by the importation.
In 2015, a rabid dog was part of a group of eight dogs and 27 cats
imported from Egypt by a rescue group. The dog had an unhealed leg
fracture and began showing signs of rabies four days after arrival.
Following the rabies diagnosis, the rescue workers in Egypt admitted
that the dog's rabies vaccination certificate had been intentionally
falsified to evade CDC entry requirements.\15\ Eighteen persons were
recommended to receive rabies PEP, seven dogs underwent a six-month
quarantine, and eight additional dogs housed in the same home as the
rabid dog had to receive rabies booster vaccinations and undergo a 45-
day monitoring period.
---------------------------------------------------------------------------
\15\ Sinclair JR, Wallace RM, Gruszynski K, et al. Rabies in a
dog imported from Egypt with a falsified rabies vaccination
certificate--Virginia, 2015. MMWR Morb Mortal Wkly Rep 2015;64:1359-
62. https://doi.org/10.15585/mmwr.mm6449a2.
---------------------------------------------------------------------------
In 2017, a ``flight parent'' (a person solicited through social
media, often not affiliated with the rescue organization, and usually
compensated with an airline ticket) imported four dogs on behalf of a
rescue organization. One of the dogs appeared agitated at the airport
and bit the flight parent prior to the flight. The dog also had tooth
fractures from reportedly having been hit by a car. A U.S. veterinarian
examined the dog one day after its arrival and then euthanized and
tested the dog for rabies. A post-mortem rabies test showed that the
dog was positive for the virus. Public health officials recommended
that at least four people receive rabies PEP, and the remaining three
dogs underwent quarantine periods ranging from 30 days to 4 months. An
investigation revealed the possibility of falsified rabies vaccination
documentation presented on entry to the United States.\16\
---------------------------------------------------------------------------
\16\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a dog
imported from Egypt--Connecticut, 2017. MMWR Morb Mortal Wkly Rep
2018;67:1388-91. https://doi.org/10.15585/mmwr.mm6750a3.
---------------------------------------------------------------------------
In 2019, twenty-six dogs were imported into the United States by a
rescue organization. All dogs had rabies vaccination certificates and
serologic documentation, indicating the development of rabies
antibodies (in response to immunization), based on results from an
Egyptian government-affiliated rabies laboratory. However, one dog
developed signs of rabies three weeks after arrival and had to be
euthanized. The dog tested positive for rabies. Forty-four persons
received PEP, and the 25 dogs imported on the same flight underwent re-
vaccination and quarantines of 4-6 months. An additional 12 dogs had
contact with the rabid dog and had to be re-vaccinated and undergo
quarantine periods ranging
[[Page 32043]]
from 45 days to 6 months based on their previous vaccination
status.\17\
---------------------------------------------------------------------------
\17\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. Morb Mort Wkly 2020; 69 (38): 1374-1377.
---------------------------------------------------------------------------
HHS/CDC estimates a range of costs for public health investigations
and subsequent cost of care for people exposed to rabid dogs to cost
between $215,386 and $508,879 per importation event as summarized in
Section IV.18 19 This cost estimate does not account for the
worst-case outcomes, which include (1) transmission of rabies to a
person who dies from the disease or (2) ongoing transmission to other
domestic and wildlife species in the United States. Re-establishment of
CRVV into the United States, while unlikely, could result in costly
efforts over several years to again eliminate the virus.
---------------------------------------------------------------------------
\18\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. Morb Mort Wkly 2020; 69 (38): 1374-1377.
\19\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. Fed Register 2019;84:724-730. https://www.federalregister.gov/documents/2019/01/31/2019-00506/guidance-regarding-agency-interpretation-of-rabies-free-as-it-relates-to-the-importation-of-dogs.
---------------------------------------------------------------------------
A previous campaign to eliminate domestic dog-coyote rabies virus
variant jointly with gray fox (Texas fox) rabies virus variant in Texas
over the period from 1995 through 2003 cost $34 million
20 21, or $52 million in 2019 U.S. dollars. Since January
2020, public health resources globally have been diverted to COVID-19
response activities which may have caused a lapse in canine rabies
vaccination efforts in high-risk countries. The increased number of
dogs with inadequate or falsified rabies vaccination certificates
arriving in the United States \22\ may increase the likelihood of a
CRVV-importation event. An importation of a dog with CRVV would divert
U.S. public health resources away from ongoing and time sensitive
COVID-19 response activities.
---------------------------------------------------------------------------
\20\ TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies epizootics in coyotes and
gray foxes: 1995-2003. Journal of the American Veterinary Medicine
Association; 227(5):785-92.
\21\ R.T. Sterner et al. (2009) Tactics and Economics of
Wildlife Oral Rabies Vaccination, Canada and the United States.
Emerging Infectious Diseases; 15(8), 1176-1184.
\22\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog Importation
data, 2018-2020. Accessed: 15 February 2021.
---------------------------------------------------------------------------
On January 21, 2020, CDC launched an agency-wide response to the
COVID-19 pandemic, dedicating over 7,200 of the approximately 10,000
CDC personnel to support the outbreak response. CDC's focus from the
beginning has been to assist health departments, frontline healthcare
workers, businesses, communities, and the public to protect themselves
and save lives. As of March 15, 2021, over one thousand CDC personnel
have conducted 3,150 deployments to 265 cities across the United States
and abroad, and over three thousand documents have been developed
providing information and guidance for government agencies, business
and the public.\23\ The unprecedented nature of this public health
response has naturally drawn federal, state, and local public health
resources away from other important public health efforts, including
preventing the reimportation of CRVV into the United States.
---------------------------------------------------------------------------
\23\ https://www.cdc.gov/coronavirus/2019-ncov/cdcresponse/by-the-numbers.html.
---------------------------------------------------------------------------
Historically, approximately 60-70% of CDC's dog entry denials (or
about 200 cases annually) have been due to fraudulent paperwork.\24\
This number is less than 1 percent of dog importations. Between January
and December 2020, (during the COVID-19 pandemic), CDC documented more
than 450 instances of incomplete, inadequate, or fraudulent rabies
vaccination certificates for dogs arriving from high-risk countries.
These cases resulted in the dogs being denied entry into the United
States and returned to their countries of origin. The increase in the
number of dogs inadequately vaccinated against rabies that importers
are attempting to import into the United States has created a public
health risk of importing CRVV into the U.S. and public health
management of these dogs is unsustainable during the current COVID-19
pandemic.
---------------------------------------------------------------------------
\24\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog Importation
data, 2010-2019. Accessed: 15 February 2021.
To be considered complete and adequate, rabies vaccination
---------------------------------------------------------------------------
certificates currently must include all the following information:
Name and address of owner
Breed, sex, date of birth (approximate age if date of birth
unknown), color, markings, and other identifying information for the
dog
Date of rabies vaccination and vaccine product information
Date the vaccination expires
Name, license number, address, and signature of veterinarian
who administered the vaccination
Upon the dog's arrival, federal officials examine the rabies
vaccination certificates and ensure the description of the dog listed
on the paperwork matches the dog presented. For a rabies vaccine to be
effective, the dog must be at least 12 weeks (84 days) of age at the
time of administration. A dog's initial vaccine must also be
administered at least 4 weeks (28 days) before arrival in the United
States.
CDC has documented instances of fraudulent paperwork for dogs based
on various factors. These include: Dogs that were younger than the age
indicated on their rabies vaccination paperwork--based on dental
examination by U.S. veterinarians; differences between the breed, sex,
color, or microchip number listed on the rabies vaccine certificate and
the dog presented for entry; suspicious veterinary stamps and
inconsistent signatures between different veterinary paperwork;
inconsistent dates of rabies vaccination between different veterinary
documents; and vaccines administered after expiration date of the
vaccine lot.
Under CDC's regulatory authority, dogs arriving from high-risk
countries without appropriate rabies vaccination certificates are
denied entry and returned to the country of origin on the next
available flight.\25\ Airlines are required to house dogs awaiting
return to their country of origin at a facility, preferably a live
animal care facility, that has an active custodial bond and a
Facilities Information and Resource Management System (FIRMS) code
issued by U.S. Customs and Border Protection (CBP), which indicates the
facility can provide accommodation that meets the US Department of
Agriculture's Animal Welfare Act standards. However, there are
insufficient live animal care facilities with a CBP-issued FIRMS code
available to house dogs that are denied entry. Currently only one
facility exists nationwide (www.arkjfk.com).
---------------------------------------------------------------------------
\25\ 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. Federal Register
Notice; Vol. 84, No. 21. 31 January 2019. Available at: 2019-
00506.pdf (govinfo.gov).
---------------------------------------------------------------------------
If a live animal facility with a CBP-issued FIRMS code is not
available, the airline must, at a minimum, provide accommodation that
meets the U.S. Department of Agriculture's Animal Welfare Act
standards.\26\ Many airlines choose to leave dogs in cargo warehouses,
which can create an unsafe environment for the dogs due to the
prolonged periods of time between flights, inadequate cooling and
heating, unacceptable cleaning and sanitization of crates, and
inability to physically
[[Page 32044]]
separate the animals from areas of the warehouse where other equipment,
machinery, and goods are used and stored.
---------------------------------------------------------------------------
\26\ U.S. Department of Agriculture. Animal Welfare Regulations;
Part 3, Subpart A: Transportation Standards. Sections 3.14-3.20.
July 2020. Available at: USDA Animal Care: Animal Welfare Act and
Animal Welfare Regulations.
---------------------------------------------------------------------------
During 2020, due to the COVID-19 pandemic, there were fewer
international flights worldwide,27 28 resulting in delayed
returns for dogs denied entry. In August 2020, while in the custody of
an airline, a dog died at Chicago O'Hare International Airport after
CDC denied entry based on falsified rabies vaccination certificates.
Despite CDC's request to find appropriate housing at a local kennel or
veterinary clinic, the airline left the dog, along with 17 other dogs,
in a cargo warehouse without food and water for more than 48 hours.\29\
---------------------------------------------------------------------------
\27\ https://www.cnbc.com/2020/04/02/coronavirus-update-american-airlines-cuts-summer-international-flights-by-60percent-as-demand-suffers.html.
\28\ https://news.aa.com/news/news-details/2020/American-Airlines-Announces-Additional-Schedule-Changes-in-Response-to-Customer-Demand-Related-to-COVID-19-031420-OPS-DIS-03/default.aspx.
\29\ Dog Dies At O'Hare Airport Warehouse, 17 Others Saved After
Being Left Without Food Or Water For 3 Days--CBS Chicago
(cbslocal.com).
---------------------------------------------------------------------------
While airlines are ultimately responsible for finding appropriate
housing for dogs denied entry, the decreased number of flights combined
with inadequate numbers of live animal care facilities with a CBP-
issued FIRMS code for holding animals creates significant
administrative and financial burden for federal, state, and local
governments. The government may be required to find individualized
solutions to ensure appropriate accommodations for prolonged periods of
time for these animals.
While costs associated with housing, caring for dogs, and returning
dogs are the responsibility of the importer (or airline if the importer
abandons the dog), some importers and airlines are reluctant to pay
these costs, requiring the Federal government to find appropriate
interim housing facilities and veterinary care. The cost for housing,
care, and returning improperly vaccinated dogs ranges between $1,000-
$4,000 per dog depending on the location and time required until the
next available return flight. The Federal government bears these costs
when airlines and importers do not.
During 2020, CDC observed a 52% increase in dogs that were
ineligible for entry compared to 2018 and 2019.\30\ The increasing
demand to vaccinate and quarantine dogs that have been denied entry
presents an increased burden to federal, state and local public health
agencies already responding to the COVID pandemic. The increased
inspections, medical care, and appropriate quarantine of dogs
inadequately vaccinated against rabies has financially burdened federal
and state public health agencies.
---------------------------------------------------------------------------
\30\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog Importation
data, 2018-2020. Accessed: 15 February 2021.
---------------------------------------------------------------------------
Between May through December 2020, CDC spent more than 3,000
personnel-hours at an estimated cost of $270,000 to respond to the
attempted importation of unvaccinated or inadequately vaccinated dogs
from high-risk rabies countries during these eight months. The time
spent represented a substantial increase from previous years because of
(1) the 52% increase in dogs with inadequate documentation; and (2) the
additional time spent identifying interim accommodations for the dogs
because of the reduced outbound international flight schedules due to
the pandemic. These are resources and personnel-hours diverted from
CDC's current paramount objective in mitigating the COVID-19 pandemic
and do not include time from other Federal, state, and local public
health partners.
Pursuant to the terms of this notice, HHS/CDC is temporarily
suspending the importation of dogs from high-risk countries. This
suspension includes dogs originating in low-risk or CRVV-free countries
that have been in a high-risk country in the previous six months (not
including animals transiting through high-risk countries). The
suspension will reduce the risk of importation of CRVV and preserve
public health resources needed for the COVID-19 response. The
suspension will also allow CDC to work with Federal and state partners,
airlines, and other stakeholders to consider options for a more
streamlined and efficient dog importation process that will be safer
for pets. Most importantly, it will ensure that U.S. public health
remains protected.
This notice creates a narrow set of exceptions for certain
categories of dogs imported into the United States with advance written
approval from CDC. The requirement for advanced written approval will
help ensure that the limited number of dogs imported into the United
State from high-risk countries have valid documentation of rabies
vaccination upon entry. It will also mitigate the costs placed upon the
U.S. government, airlines, and importers associated with reexporting
dogs that do not meet CDC entry requirements.
III. Advance Written Approval
The suspension provisions of this notice do not apply if advance
written approval from CDC has been obtained to import a dog from a
high-risk country that has been fully immunized against rabies. This
includes a dog that has been in a high-risk country in the previous 6
months and is being imported from a low-risk or CRVV-free country. Such
approvals will be granted on a limited and case-by-case basis and at
CDC's discretion. CDC's decision will be considered final.
The following categories of importers are eligible to request
advance written approval to import a dog into the United States:
U.S. government personnel who are relocating back to the
United States with Permanent Change of Station (PCS) orders or
Temporary Duty (TDY) orders.\31\
---------------------------------------------------------------------------
\31\ PCS Order definition https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr/i1186607#i1186607.
---------------------------------------------------------------------------
U.S. citizens and lawful residents relocating to the
United States. The application should include written documentation
from an employer or other official source stating the reason for the
relocation, such as a letter by an employer or university stating that
the U.S. citizen or lawful resident is relocating for reasons of
employment or education.
Importers who wish to import dogs for purposes related to
science, education, or exhibition, as these terms are defined in 42 CFR
71.50, or for a bona fide law enforcement purpose.
Owners of service animals, if the dog is individually
trained to do work or perform tasks for the benefit of an individual
with a disability, including a physical, sensory, psychiatric,
intellectual, or other mental disability. In accordance with U.S.
Department of Transportation regulations at 14 CFR part 382, emotional
support animals, comfort animals, companionship animals, and service
animals in training are not considered service animals for the purposes
of this Notice.
During this temporary suspension, importers who meet the
eligibility criteria listed above may make a one-time request to import
up to three dogs as part of a single importation. All dogs must be six
months of age or older at the time of entry and, as further explained
in this notice, must enter the United States at a port of entry with a
live animal care facility with a CBP-issued FIRMS code. Importers of
dogs for science, education, or exhibition, as these terms are defined
in 42 CFR 71.50, or bona fide law-enforcement purposes may import more
than three dogs.
To request the advance written approval of the CDC, importers who
[[Page 32045]]
meet the eligibility criteria listed above must submit the Application
for a Permit to Import a Dog Inadequately Immunized Against Rabies,
(approved under OMB Control Number 0920-0134 Foreign Quarantine
Regulations (exp. 03/31/2022), or as revised). To request an
application for the permit, an importer must send an email to the
Director, Division of Global Migration and Quarantine, at
[email protected]
Once an importer receives instructions and the permit application,
the importer's request with all supporting documentation must be
submitted at least 30 business days before the date on which the dog
will enter the United States. A request cannot be made at the port of
entry upon the dogs' arrival into the United States; dogs that arrive
without advance written approval from the CDC will be returned to their
country of origin on the next available flight. As required by the
permit application, a request must present sufficient and reliable
evidence conclusively demonstrating that the dog to be imported has
been fully immunized against rabies.\32\ Such evidence includes:
---------------------------------------------------------------------------
\32\ The permit is currently under revision (Permit to Import a
Dog Inadequately Immunized Against Rabies, (OMB Control Number 0920-
0134 Foreign Quarantine Regulations (exp. 03/31/2022)). Despite the
permit application's current title, inadequately immunized dogs do
not qualify for the exception.
---------------------------------------------------------------------------
1. A valid rabies vaccination certificate that was issued in the
United States by a U.S.-licensed veterinarian. The certificate must
state that the vaccine was administered on or after the dog was 12
weeks (84 days) of age and at least 28 days prior to entry, if it was
the dog's initial vaccine. OR
2. A valid rabies vaccination certificate from a non-U.S.-licensed
veterinarian AND serologic evidence of rabies vaccination from an
approved rabies serology laboratory \33\ (serologic results >0.5IU/mL
required)collected in accordance with the OIE Terrestrial Manual.\34\
The certificate must state that the vaccine was administered on or
after the dog was 12 weeks (84 days) of age and at least 28 days prior
to entry, if it was the dog's initial vaccine. The certificate must be
in English or accompanied by a certified English translation.
---------------------------------------------------------------------------
\33\ Will provide link to CDC website with list of approved
laboratories.
\34\ OIE Terrestrial Animal Health Code. Chapter 5.11. Available
at: Access online: OIE--World Organisation for Animal Health.
---------------------------------------------------------------------------
Furthermore, based on the circumstances, an importer may also be
required to submit the following:
Permanent Change of Station (PCS) orders, or Temporary
Duty Orders (TDY) (U.S. Government personnel);
Documentation or evidence that the dog to be imported is a
service dog (as defined in this Notice);
Employment letter or other evidence of relocating to the
United States after living abroad; or
Other justification that meets the above-listed
eligibility criteria along with supporting documentation.
Dogs arriving from a high-risk country with a CDC permit must enter
the United States at a port of entry with a live animal care facility
with a CBP-issued FIRMS code that can provide accommodation that meets
the U.S Department of Agriculture's Animal Welfare Act standards.
Currently, John F. Kennedy International Airport in New York City is
the only U.S. port of entry with a live animal care facility that meets
these standards. However, if any additional ports of entry become
capable of meeting these standards, CDC will publish the list of ports
of entry in the Federal Register and on the CDC animal importation
website. Animals imported for bona fide law-enforcement purposes are
not required to enter the United States at a port of entry with a live
animal care facility with a CBP-issued FIRMS code.
CDC additionally requires dogs arriving from a high-risk country
with a CDC permit be microchipped on or before the date that they
receive their rabies vaccination. The microchip number must be listed
on the rabies vaccination certificate. Photographs of the dog's teeth
are required for age verification. CDC will respond to an importer's
request in writing and may impose additional conditions in granting the
approval. An importer must present CDC's written response and approval
upon entry into the United States. If a request for advance approval is
denied, CDC's written denial will constitute final agency action.
Any dog from a high-risk country will be excluded from entering the
United States and returned to its country of origin on the next
available flight, regardless of carrier or route, if it arrives without
advance written approval from the CDC, arrives at a port of entry
without a live animal care facility with a CBP-issued FIRMS code, or if
the animal presented does not match the description of the animal
listed on the permit. The importer (or airline carrier if the importer
abandons the animal) will be financially responsible for all housing,
care, and return costs. In keeping with current practice, importers
should continue to check with Federal, state, and local government
officials regarding additional requirements of the final destination
prior to entry or re-entry into the United States.
IV. Economic Impact of This Temporary Suspension
Executive Orders 12866: ``Regulatory Planning and Review'' and
13563: ``Improving Regulation and Regulatory Review'' 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.
Although the temporary suspension of dogs from countries at high-
risk for CRVV is expected to reduce the number of dogs imported into
the United States, importers of dogs from high-risk countries will be
able to submit a request for advanced written permission at least 30
days prior to planned importation in the United States. Thus, some
importers will be able to import up to three dogs from high-risk
countries with CDC-issued permits.
CDC has previously estimated that between 87,000 and 116,000 dogs
are imported from high-risk countries each year.\35\ This estimate is
significantly greater than the numbers recorded by CBP for formal entry
under HTS code 0106199120 and HTS Description: Other live animals,
other, dogs, which averaged 16,390 and varied from 9,966 to 24,031 over
the 3-year period from 2018 through 2020.
---------------------------------------------------------------------------
\35\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
The number of dogs reported under this HTS category do not include
hand-carried dogs traveling in airplane cabins or crossing at land
borders without formal entry and, thus, are not inclusive of all dog
imports. To account for the uncertainty in the number of dogs imported
to the United States from high-risk countries without formal entry, CDC
used the following assumptions in the analysis of this action: (1) Most
likely estimate: 3 times the average number of dogs with formal entry
from 2018-2020 = 60,696 dogs per year, (2) Lower bound: 2 times the
average number of dogs with formal entry from 2018-2020 = 32,781, and
(3) Upper bound: 5 times the number of dogs arriving in the highest
year (2019) =
[[Page 32046]]
120,155. These baseline estimates are used throughout the analysis
(Table 1).
CDC assumed that the temporary suspension would reduce the number
of dogs imported from high-risk countries by 75% and considered a range
of 50%-90% to calculate lower and upper bound estimates. This would
result in estimates of 15,124 (range: 3,203-60,040 dogs) dogs imported
with CDC-issued permits per year with the suspension in place. The
temporary suspension would reduce the estimated numbers of dogs
imported per year by 45,572 (range: 29,758-60,115). CDC also estimated
the numbers of dogs denied entry under the baseline and with the
temporary suspension in effect. An estimated 500 (range: 300-750) dogs
would be denied entry under the baseline based on data from 2020 and
previous years. The temporary suspension and CDC permit process are
expected to reduce the number of dogs denied entry by 90% (range: 75%-
95%) such that only 50 (range: 15-188) dogs would be denied entry with
the temporary suspension.
Table 1--Estimated Numbers of Dogs From High-Risk Countries Imported or Denied Entry Under the Baseline and With
the Temporary Suspension
----------------------------------------------------------------------------------------------------------------
Most likely
estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Estimated number of dogs imported from high-risk countries at 60,696 32,781 120,155
baseline.......................................................
Estimated % reduction in number of dogs imported from high-risk 75% 90% 50%
countries with temporary suspension............................
Estimated number of dogs imported from high-risk countries with 15,174 3,278 60,078
temporary suspension...........................................
Change in number of dogs imported from high-risk countries...... 45,522 29,503 60,078
Estimated number of dogs denied entry from high risk countries 500 300 750
at baseline....................................................
Estimated % reduction in dogs denied entry with temporary 90% 95% 75%
suspension.....................................................
Estimated number of dogs denied entry with temporary suspension. 50 15 188
Change in numbers of dogs denied entry with temporary suspension 450 285 563
----------------------------------------------------------------------------------------------------------------
The estimated costs and benefits (in 2019 U.S. dollars) associated
with the temporary suspension of dogs from countries at high-risk for
CRVV are summarized in Table 2. CDC estimates that importers, CDC, and
DHS/CBP will incur about $11.8 million in costs (range: $2.2-$57.6
million) over the one-year period anticipated for the suspension. The
large difference between the lower and upper bound is due to both
uncertainty in the number of dogs imported from high-risk countries
under the baseline as well as uncertainty in many of the costs
associated with the suspension.
Most of the costs will be incurred by importers (most likely
estimate of $10.8 million, 91% of the total), who will have to (1)
spend time requesting advance written permission, (2) pay for serologic
testing unless the imported dog already has a valid U.S. rabies
vaccination certificate issued by a U.S.-licensed veterinarian, (3) re-
route travel to a port of entry with a live animal care facility with a
CBP-issued FIRMS code, and (4) the potential economic costs of being
unable to import a dog from a high-risk country (either the inability
to travel with a pet from a high-risk country or the need to substitute
the importation of a dog from CRVV-free or low-risk country instead of
a dog from a high-risk country).
The one-year benefits (averted costs) from the temporary suspension
are estimated to be $2.3 million, range: $1.0-$5.1 million). Most of
the benefits (most likely estimate of $1.5 million, 64% of total) of
the temporary suspension accrue to CBP due to the reduction in the
number of dogs imported from high-risk countries (which require
screening), the number of dogs denied entry, and an estimated decrease
in the amount of time to review a CDC permit vs. the time required to
review documentation under the baseline. Importers, CDC, and airlines
also benefit from the averted costs associated with the reduction in
the number of dogs denied entry with the suspension relative to
baseline. The net cost of the temporary suspension is calculated from
the annual costs-annual benefits resulting in an estimate of $9.5
million (range: $1.2-$52.5 million).
Table 2--Summary Table of Costs and Benefits in 2019 Dollars, Over a 1-Year Time Horizon
----------------------------------------------------------------------------------------------------------------
Most likely
Category estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Benefits:
Annual monetized benefits to importers/owners of dogs from $579,260 $215,765 $1,508,443
high risk countries........................................
Annual monetized benefits to airlines....................... 54,000 11,400 168,750
Annual monetized benefits to DHS/CBP........................ 1,491,418 678,417 3,055,534
Annual monetized benefits to HHS/CDC........................ 198,369 92,153 398,948
-----------------------------------------------
Total annualized monetized benefits..................... 2,175,209 920,521 4,836,488
-----------------------------------------------
Quantified, but unmonetized, benefits....................... The estimated response costs associated with a
dog imported while infected with canine rabies
virus variant (CRVV) are $315,682, range:
$215,386 to $508,879. The permit requirement
for high risk countries should reduce the risk
of importation of dogs infected with CRVV.
[[Page 32047]]
Qualitative benefits........................................ Any importation of a dog with CRVV will
require the reallocation of limited public
health resources to support a response to
mitigate the risk of transmission of CRVV.
This could reduce the effectiveness of COVID-
19 response activities and vaccination
programs. In addition, these competing
priorities may increase the risk of unlikely,
but very costly outcomes associated with an
importation of a dog with CRVV such as (1) the
potential risk of death in a person who may be
unaware of his/her exposure to a dog with CRVV
and (2) the risk of re-introduction of CRVV in
the United States.
-----------------------------------------------
Costs:
Annualized monetized costs to Importers/owners of dogs from $10,752,595 $1,956,530 $54,191,420
high risk countries........................................
Annual monetized costs to airlines.......................... 0 0 0
Annualized monetized costs to DHS/CBP....................... 192,498 0 461,994
Annual monetized costs to HHS/CDC........................... 848,142 280,952 2,974,298
-----------------------------------------------
Total annualized monetized costs........................ 11,793,199 2,237,473 57,627,615
----------------------------------------------------------------------------------------------------------------
The primary public health benefit of the temporary suspension is
the reduced risk that a dog with CRVV will be imported from a high-risk
country. Based on experience with previous importations, CDC estimated
the cost per imported dog with CRVV to be $315,682, range $215,386 to
$508,879.36 37 This cost estimate includes health department
staff time for the public health response, payments for post-exposure
prophylaxis for exposed persons, and the costs associated with
quarantining or euthanizing exposed animals. Any importation of a dog
with CRVV would also likely divert public health resources away from
COVID-19 response activities.
---------------------------------------------------------------------------
\36\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. Morb Mort Wkly 2020; 69 (38): 1374-1377.
\37\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. Fed Register 2019;84:724-730. https://www.federalregister.gov/documents/2019/01/31/2019-00506/guidance-regarding-agency-interpretation-of-rabies-free-as-it-relates-to-the-importation-of-dogs.
---------------------------------------------------------------------------
Using the most likely estimates of the net cost ($9.5 million) and
the most likely estimate of the potential benefits of averting the
importation of a dog with CRVV from a high-risk country ($316,000), it
is possible to calculate how many dogs with CRVV would need to be
imported under the baseline for the benefits to equal costs. The net
costs ($9.5 million) divided by the cost per importation ($316,000)
suggests that at least 30 dogs with CRVV would need to be imported
under the baseline for benefits to exceed costs. This would require a
huge increase in the number of dogs imported into the United States
while infected with CRVV, which could only occur as a result of
widespread failures of rabies control programs in multiple high-risk
countries.
The above estimate of the cost of an importation of a dog with CRVV
does not account for the worst-case outcomes, which include (1)
transmission of rabies to a person who dies from the disease or (2)
ongoing transmission to other domestic and wildlife species in the
United States. Re-establishment of CRVV into the United States, while
unlikely, could result in costly efforts over several years to again
eliminate the virus.
The cost of re-introduction could be especially high if CRVV
spreads to other species of U.S. wildlife. Both of these worst-case
outcomes may be more likely to occur during the COVID-19 pandemic
because public health resources have been diverted to COVID-19 response
activities and vaccination programs.
Human deaths from rabies continue to occur in the United States
after exposures to wild animals. However, no U.S. resident has died
after exposure to an imported dog with CRVV in at least 20 years. CDC
uses the value of statistical life (VSL) to assign a value to
interventions that can result in mortality risk reductions. For 2019,
the estimated VSL is $10.6 million with a range of $5.0 to $16.2
million.\38\ However, CDC is unable to estimate the potential magnitude
of the mortality risk reduction associated with the temporary
suspension.
---------------------------------------------------------------------------
\38\ HHS/ASPE, 2016. Office of the Assistant Secretary for
Planning and Evaluation, U.S. Department of Health and Human
Services. Guidelines for Regulatory Impact Analysis. https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf. Accessed
April 20, 2020.
---------------------------------------------------------------------------
Re-establishment of CRVV into the United States, while unlikely,
would also result in costly efforts over a number of years to eliminate
the virus. A previous campaign to eliminate domestic dog-coyote rabies
virus variant jointly with gray fox (Texas fox) rabies virus variant in
Texas over the period from 1995 through 2003 cost $34
million,39 40 or $52 million in 2019 U.S. dollars. The costs
to contain any reintroduction would depend on the time period before
the reintroduction was realized, the wildlife species in which CRVV was
transmitted, and the geographic area over which reintroduction occurs.
The above estimate is limited to the cost of rabies vaccination
programs for targeted wildlife and does not include the costs to
administer post-exposure prophylaxis to any persons exposed after the
reintroduction has been identified.
---------------------------------------------------------------------------
\39\ TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies epizootics in coyotes and
gray foxes: 1995-2003. Journal of the American Veterinary Medicine
Association; 227(5):785-92.
\40\ R.T. Sterner et al. (2009) Tactics and Economics of
Wildlife Oral Rabies Vaccination, Canada and the United States.
Emerging Infectious Diseases; 15(8), 1176-1184.
---------------------------------------------------------------------------
Assumptions Used To Estimate Costs and Benefits
CDC estimated costs and benefits to importers, CDC, CBP, and
airlines under the baseline and with the temporary
[[Page 32048]]
suspension in place. All cost estimates were converted to 2019 U.S.
dollars. The costs to importers with the temporary suspension were
calculated using the following assumptions:
The opportunity costs for importer time were estimated at
$36.41 (range: $25.72-$47.10) per hour based on the average U.S. wage
rate and a Department of Transportation estimate specific to
international travelers.41 42
---------------------------------------------------------------------------
\41\ Bureau of Labor Statistics in the May 2019 National
Occupational Employment and Wage Estimates United States https://www.bls.gov/oes/current/oes_nat.htm.
\42\ U.S. Department of Transportation, Office of Transportation
Policy. The Value of Travel Time Savings: Departmental Guidance for
Conducting Economic Evaluations Revision 2 (2016 Update), ``Table 4
(Revision 2--2016 Update): Recommended Hourly Values of Travel Time
Savings.'' September 27, 2016. https://www.transportation.gov/sites/dot.gov/files/docs/2016%20Revised%20Value%20of%20Travel%20Time%20Guidance.pdf. Accessed
June 4, 2020.
---------------------------------------------------------------------------
Importers seeking advance written permission for 15,124
(range: 3,263-59,890) dogs.
[cir] An assumption of 1 hour (range 0.5--2 hours) to submit
advance written approval and fulfill the informational and testing
requirements for a permit.
[cir] Estimated costs of $50 (range: $20-$65) for a rabies titer
test at an approved rabies serology laboratory.\43\
---------------------------------------------------------------------------
\43\ United Kingdom Animal and Plant Health Agency Laboratory
Price List TC702. https://science.vla.gov.uk/Tests/SearchResults.aspx?SiteName=CDT&PriceListCategoryId=33. Accessed 11/
1/2020.
---------------------------------------------------------------------------
[cir] Assumed cost of $100 (range: $80-$120) for a veterinarian to
draw blood sample and ship it to an approved rabies serology
laboratory.
[cir] Estimated cost of $40 (range: $25-$50) to implant a
microchip.\44\
---------------------------------------------------------------------------
\44\ PetSide. How Much Does it Cost to Microchip a Dog. https://www.petside.com/dog-microchip-cost/ Accessed 2/17/2021.
---------------------------------------------------------------------------
[cir] An assumption that 40% of importers will already have a valid
rabies vaccination certificate issued by a U.S.-licensed veterinarian
and will not need testing from an approved rabies serology laboratory
or microchip.
[cir] An assumption that 75% of importers of dogs from high-risk
countries would need to re-route travel to a port of entry with a live
animal care facility with a CBP-issued FIRMS code, which would incur an
increased ticket cost of $200 and 4 additional hours of travel time.
Importers who are unable to import a dog from a high-risk
country because of the temporary suspension (45,572, range: 29,518-
60,265 dogs) would incur an assumed cost of $100 (range: $50-$400) per
dog because of time spent away from pets or increased costs of
substitution to import a dog from a CRVV-free or low-risk country.
The costs for CDC were estimated based on:
An assumed staff time cost of 20 minutes (range: 15-30
minutes) per permit issued by a GS-12, step 5 reviewer.
Oversight of the permit process by two GS-13, step 5
veterinarians.
30 minutes of staff time to revise training materials for
CBP staff.
CDC staffing costs are estimated using the GS pay scale
for the Atlanta area and multiplying by 2 to account for non-wage
benefits and overhead.
The costs for CBP included 5 minutes (range 0-10 minutes) for
25,052 (range: 20,402-30,602) CBP officers (average level GS-12, step
5) to receive training on the temporary suspension. CBP staffing costs
are estimated using the GS pay scale for the Washington, DC area and
multiplying by 2 to account for non-wage benefits and overhead.
CDC assumed that airlines would not incur new costs for this
temporary suspension because the time required to review CDC-issued
permits prior to boarding dogs from high-risk countries should be
similar to the amount of time required to review vaccination
certificates under the current baseline. There may be some reduction in
cargo fees revenue associated with the reduction in dogs imported from
countries at high risk for CRVV (range: 29,518-60,265 dogs), but this
lost revenue may be offset by revenues received to import dogs from
CRVV-free or low-risk countries or revenue received for cargo other
than dogs. CDC lacks sufficient data to estimate such costs but expects
the net cost to airlines to be limited.
The expected annual benefits (averted costs) were estimated for
importers, CDC, CBP, and airlines based on the reduced numbers of dogs
delayed entry and the reduced time spent by CBP officers to screen dogs
from high-risk countries.
The estimated benefits (averted costs) for importers were estimated
based on:
An estimated reduction in time spent by CBP to review
documentation for dogs from high-risk countries assuming an estimate of
17 minutes (range: 13.6-20.4 minutes) per dog to review documentation
under the baseline \45\ to 5 minutes (range: 3-8 minutes) per dog to
review permits during the suspension.
---------------------------------------------------------------------------
\45\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
An estimated 2 hours per dog denied entry (estimated at
450 fewer dogs denied entry, range: 285-563) with the suspension
relative to baseline.
CDC assumed that 80% of dogs denied entry would be re-
imported to the United States at a round-trip cost of $1,200 per dog to
the importer.\46\
---------------------------------------------------------------------------
\46\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
CDC assumed that 20% of dogs denied entry would be
abandoned by importers at a cost of $100 per dog to the importer.
The estimated benefits (averted costs) to CDC were estimated based
on:
An estimated 4 hours of CDC staff time per dog denied
entry at an average GS-level 13, step 5 at CDC Headquarters and an
average of 30 minutes of CDC quarantine station staff time per dog
denied entry at an average GS-level 11, step 5. The actual mix of staff
at CDC Headquarters who need to support denials of entry would vary
from GS-11 through Senior Executive Staff and varies depending on time
spent on appeals and finding shelter for abandoned dogs.
The estimated benefits (averted costs) to CBP were estimated based
on:
An estimated reduction in the number of dogs imported from
high-risk countries due to the temporary suspension: 45,572 (range:
29,758-60,115) relative to baseline.
Under the baseline, CDC estimated that each dog imported
from a high-risk country requires 17 minutes (range: 13.6-20.4 minutes)
of CBP officer time to review documents (GS-12, step 5).\47\
---------------------------------------------------------------------------
\47\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
With the temporary suspension in place, CDC estimates that
the time required to review CDC-issued permits would decrease from the
above to 5 (range: 3-8) minutes per dog for the estimated 15,124
(range: 3,263-59,890) dogs arriving with permits.
An estimated reduction in the number of dogs denied entry
because of the temporary suspension: (estimated at 450 fewer dogs
denied entry, range: 285-563).
An estimate of 71 (range: 47-95) minutes of CBP staff time
required per dog denied entry (GS-12, step 5).\48\
---------------------------------------------------------------------------
\48\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
The estimated benefits (averted costs) for airlines were estimated
based on:
The reduction in the estimated numbers of dogs denied
entry and abandoned by importers (100 under the baseline vs. 10 with
the suspension of entry).
[[Page 32049]]
An assumed cost of $600 per dog for airlines to fly
abandoned dogs back to their countries of origin.\49\
---------------------------------------------------------------------------
\49\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
The costs associated with an importation of a dog with CRVV
includes health department staff time for the public health response,
payments for post-exposure prophylaxis treatment for exposed persons,
and the costs associated with quarantining or euthanizing exposed
animals. CDC estimated the response cost per imported dog with CRVV to
be $315,682, range $215,386 to $508,879 based on the following
assumptions:
An estimate of 800 hours of health department staff time
per importation.\50\
---------------------------------------------------------------------------
\50\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
The public health response time is split evenly among
veterinarians (code 29-1131, $50.39 per hour), epidemiologists (19-
1041, $37.64 per hour), registered nurses (29-1141, $37.24 per hour),
licensed practical nurses (29-2061, $23.32 per hour), and office and
administrative assistants (43-0000, $19.73 per hour).51 52
These wage estimates are multiplied by 2 to account for non-wage
benefits and overhead.
---------------------------------------------------------------------------
\51\ Bureau of Labor Statistics, May 2019 National Occupational
Employment and Wage Estimates. https://www.bls.gov/oes/current/oes_nat.htm.
\52\ Bureau of Labor Statistics in the May 2019 National
Occupational Employment and Wage Estimates United States https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
An average of 25 (range: 16-44) individuals will require
post-exposure prophylaxis because of exposure to the dog with
CRVV.53 54
---------------------------------------------------------------------------
\53\ Rayburn et al. (2020) Rabies in a Dog Imported from Egypt--
Kansas, 2019. MMWR; 69(38): 1374-1377.
\54\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
The average cost of post-exposure prophylaxis was
estimated to be $9,290.\55\
---------------------------------------------------------------------------
\55\ Rayburn et al. (2020) Rabies in a Dog Imported from Egypt--
Kansas, 2019. MMWR; 69(38): 1374-1377.
---------------------------------------------------------------------------
An estimated 29.6 animals would need to be quarantined or
euthanized due to exposure to the dog with CRVV.
Each exposed animal would incur economic costs of $1,000
for quarantine or euthanasia.\56\
---------------------------------------------------------------------------
\56\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. (January 31, 2019) 84 FR 724: 724-730.
---------------------------------------------------------------------------
V. Terms of This Notice
Therefore, pursuant to 42 CFR 71.51(e) and 42 CFR 71.63, and
subject to the terms of this notice, CDC hereby excludes the entry and
suspends the importation of dogs from high-risk countries, including
dogs from low-risk and CRVV-free countries if the dogs have been
present in a high-risk country in the previous six months.
Additionally, under 42 CFR 71.63, CDC finds that CRVV exists in
countries designated as high-risk countries and that, if reintroduced
into the United States, CRVV would threaten the public health of the
United States. The continued entry of dogs from high-risk countries in
the context of the current limited CDC resources and personnel diverted
to respond to COVID-19 further increases the risk that CRVV may be
introduced, transmitted, or spread into the United States. CDC has
coordinated in advance with other federal agencies as necessary to
implement and enforce this notice.
This notice is not a rule within the meaning of the Administrative
Procedure Act (``APA''), but rather notice of an emergency action taken
under the existing authority of 42 CFR 71.51(e) and 42 CFR 71.63. In
the event that this notice qualifies as a rule under the APA, notice
and comment and a delay in effective date are not required because
there is good cause to dispense with prior public notice and the
opportunity to comment on this notice. Considering the public health
emergency caused by the virus associated with COVID-19, the ongoing
diversion of public health resources and personnel to respond to the
pandemic, and the risk of reintroduction of CRVV from dogs being
imported from high-risk countries, it would be impractical and contrary
to the public's health, and by extension the public's interest, to
delay the issuance and effective date of this notice.
Effective July 14, 2021: Pursuant to the exception, dogs from high
risk-countries must be 6 months of age to be imported and fully
vaccinated against rabies, and eligible importers may only import up to
3 dogs upon receipt of advanced written approval from the CDC.
Importers wishing to import dogs from high-risk countries should:
1. Submit a request for advanced written permission (i.e.,
Application for a Permit to Import a Dog Inadequately Immunized Against
Rabies, (approved under OMB Control Number 0920-0134 Foreign Quarantine
Regulations (exp. 03/31/2022), or as revised)) at least 30 days prior
to planned importation in the United States.
2. Submit all documentation listed above in Section III Advanced
Written Approval.
The request for advance written permission must include proof of
the dog's identity including pictures of the dogs' teeth, other
descriptive details, proof of rabies vaccination, and microchip
information. Dogs arriving from high-risk countries must enter the
United States at a port of entry with a live animal care facility with
a CBP-issued FIRMS code that can provide accommodation that meets the
U.S Department of Agriculture's Animal Welfare Act standards.
This temporary suspension will remain in place until the earliest
of (1) the expiration of the Secretary of Health and Human Services'
declaration that COVID-19 constitutes a public health emergency; (2)
the CDC Director rescinds or modifies this suspension based on specific
public health or other considerations; or (3) 360 days from publication
in the Federal Register.
Dated: June 9, 2021.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-12418 Filed 6-14-21; 4:15 pm]
BILLING CODE 4163-18-P
