[Federal Register Volume 79, Number 132 (Thursday, July 10, 2014)]
[Notices]
[Pages 39403-39406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16130]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Issuance and Enforcement Guidance for Dog Confinement Agreements
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of Agency Guidance.
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[[Page 39404]]
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) is publishing this
issuance and enforcement guidance for dog confinement agreements under
42 CFR 71.51. Under 42 CFR 71.51(c)(2), the CDC Director may authorize
admission into the United States of a dog that has not been vaccinated
for rabies or that is inadequately immunized if the owner agrees to
subsequently vaccinate and properly confine the dog. This guidance
describes the factors that HHS/CDC will consider in determining whether
it will issue a dog confinement agreement allowing entry of a dog that
has not been adequately immunized against rabies, or whether the dog(s)
will be denied entry. The notice also describes the steps that an
importer may take if his/her imported dog is denied entry.
DATES: This guidance is effective on August 11, 2014.
FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., Division of
Global Migration and Quarantine, Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS-E03, Atlanta, GA 30329;
Telephone, 404-498-1600.
SUPPLEMENTARY INFORMATION:
I. Background
Rabies is caused by a virus that is fatal in humans and animals. In
September 2007, at the Inaugural World Rabies Day Symposium, HHS/CDC
declared the United States to be free of the canine variant of the
rabies virus. However, this rabies virus variant remains a serious
public health threat in many other countries where laboratory and
epidemiologic surveillance for canine variant rabies virus is not as
strong as in the United States. Many other countries also do not
maintain a robust rabies vaccination program for dogs. Preventing the
entry of animals infected with the canine variant of rabies into the
United States is a public health priority. Globally, canine variant
rabies viruses are responsible for 98% of the estimated 55,000 human
rabies deaths worldwide each year (WHO, 2004 [Page 116]).
II. Authority and Operations
Under section 361 of the Public Health Service Act (PHS Act) (42
U.S.C. 264), the Secretary of Health and Human Services, has the
authority to make and enforce such regulations as in his or her
judgment are necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries into the States
or possessions of the United States and from one State or possession
into any other State or possession. For purposes of carrying out and
enforcing such regulations, the Secretary may authorize a variety of
public health measures, including inspection, fumigation, disinfection,
sanitation, pest extermination, destruction of animals or articles
found to be sources of dangerous infection to human beings, and other
measures.
Regulations that implement Federal public health authority with
respect to the importation of certain animals are currently published
in 42 CFR part 71. The Secretary has delegated to the Director of the
CDC the authority for implementing these regulations. Authority for
carrying out most of these functions has been delegated to HHS/CDC's
Division of Global Migration and Quarantine (DGMQ). To carry out its
mission of protecting public health, CDC/DGMQ implements its
regulations through already established and extensive partnerships with
local, national, and international health authorities. DGMQ maintains
quarantine stations at major U.S. ports of entry that fulfill a primary
purpose in reducing the risk of introduction of communicable diseases
into the United States.
Since 1956, Federal quarantine regulations have controlled the
entry of dogs into the United States. See 21 FR 9870, Dec. 12, 1956.
Currently, HHS/CDC regulates imports of dogs into the United States
under regulations found at 42 CFR 71.51. Among the principal concerns
for regulating the import of dogs is to prevent introduction and spread
of rabies.
Upon arrival to the United States, dogs are subject to inspection
and may be denied entry if they show signs of infection with a
communicable disease or if they have not been adequately immunized
against rabies. If a dog appears to be ill, further examination by a
licensed veterinarian, at the owner's expense, may be required before
the dog is admitted into the United States. Currently, licensed rabies
vaccines have not been shown to be effective when administered to dogs
aged less than 3 months. Additionally, full immune response to the
vaccine in dogs that have never been previously vaccinated does not
occur until approximately 30 days after vaccination. Therefore, under
HHS/CDC's current regulations, puppies may not be vaccinated against
rabies earlier than 3 months of age and previously unvaccinated dogs
are only considered adequately immunized 30 days post-vaccination.
Adult dogs that have previously been adequately immunized against
rabies, but whose rabies vaccination certificates have expired, are
considered adequately immunized immediately following administration of
a booster vaccination.
III. Confinement Agreements
Under Sec. 71.51, HHS/CDC currently requires each imported dog to
be accompanied by a valid rabies vaccination certificate indicating
that the animal has been vaccinated against rabies prior to entry into
the United States. The exceptions to this requirement are for dogs from
rabies-free countries and dogs imported for scientific research
purposes when rabies vaccination would interfere with the purpose of
the research. This provision defines a valid rabies vaccination
certificate as a certificate which was issued for a dog not less than 3
months of age at the time of vaccination and which:
(1) Identifies a dog on the basis of breed, sex, age, color,
markings, and other identifying information.
(2) Specifies a date of rabies vaccination at least 30 days before
the date of arrival of the dog at a U.S. port.
(3) Specifies a date of expiration which is after the date of
arrival of the dog at a U.S. port. If no date of expiration is
specified, then the date of vaccination shall be no more than 12 months
before the date of arrival at a U.S. port.
(4) Bears the signature of a licensed veterinarian.
However, subsection 71.51(c)(2) indicates that ``the [CDC] Director
may authorize admission'' of dogs that have not been adequately
immunized against rabies provided that the dogs are confined under
conditions that restrict their contact with humans and other animals
until they have been immunized. Generally, the use of the term
``shall'' in a regulation indicates a regulatory requirement, while the
use of the term ``may'' indicates that the agency has discretion
regarding the manner in which it chooses to enforce this particular
aspect of its regulations. Through this notice, and as discussed in
more detail below, HHS/CDC is informing the public of the manner in
which it applies its discretion in the issuance and enforcement of
confinement agreements.
HHS/CDC reviews rabies vaccination certificates to determine
whether they may be expired, invalid or suspect e.g. dog appears
younger than is stated or does not match the breed, sex, color, or
markings described) in its assessment of whether a dog is ``adequately
immunized.'' Following physical inspection of the dog and
documentation, if HHS/CDC determines
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that a dog has not been adequately immunized, HHS/CDC may enter into a
confinement agreement with the importer.
Section 71.51 defines Confinement as the ``restriction of a dog or
cat to a building or other enclosure at a U.S. port, en route to
destination and at destination, in isolation from other animals and
from persons except for contact necessary for its care or, if the dog
is allowed out of the enclosure, muzzling and keeping it on a leash.''
HHS/CDC Form 75.37 ``Notice to Owners and Importers of Dogs'' explains
the confinement requirements and serves as a binding ``confinement
agreement'' with the importer. This form is approved under OMB
0920-0134 Foreign Quarantine Regulations (expiration 07/31/15). Under
42 CFR 71.51(c)(3), HHS/CDC shares the confinement agreement with the
state agency ``having jurisdiction at the point of destination . . . to
facilitate surveillance and other appropriate action.'' Confinement
agreements are intended to ensure that travelers seeking to enter the
United States with their personal pet dogs have an alternative to their
dogs being denied entry to the United States if they were not
adequately immunized against rabies.
The intent of the confinement agreements between HHS/CDC and the
importer is to ensure that inadequately immunized dogs will be confined
in such a way as to minimize the risk of exposing persons and other
animals especially dogs to rabies until the dogs are considered
adequately immunized against rabies. HHS/CDC considers confinement
agreements to constitute an exception to the general rule that, unless
coming from a rabies-free country or intended for use in scientific
research where rabies vaccination would interfere with that research,
all imported dogs must be properly vaccinated against rabies. HHS/CDC
issued two dog confinement agreements to individuals in 2006 and 10
agreements in 2007. This number has continued to multiply and as of
June 27, 2014, 853 confinement agreements have been issued in 2014 (See
Table 1 below).
Table 1
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Dog confinement
Year agreements issued
by HHS/CDC
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2006............................................... 2
2007............................................... 10
2008............................................... 41
2009............................................... 179
2010............................................... 412
2011............................................... 1814
2012............................................... 2131
2013............................................... 1733
2014 *............................................. 853
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Total.......................................... 7175
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* As of June 27, 2014.
HHS/CDC along with state and local agencies with jurisdiction has
discovered that, in some circumstances, the terms of confinement
agreements are not carried out by the importer. State and local public
health agencies who have jurisdiction to enforce confinement agreements
have reported to HHS/CDC that some importers have either knowingly or
unknowingly provided inaccurate information on the agreement regarding
confinement location. In other circumstances, upon follow up on the
confinement of the dogs, state and local authorities have reported that
the dogs were not properly confined per the terms of the confinement
agreement (i.e., the dog was not kept in isolation from other animals
and from persons except for contact necessary for its care or, if the
dog was allowed out of the enclosure, was not muzzled and kept on a
leash).
With the substantial increase in recent years in the number of
confinement agreements being requested by importers of dogs,
supervision of confinement agreements to identify and address
violations as described above has become administratively burdensome.
The investigations conducted have revealed that in many cases where
importers have violated their confinement agreements, these confinement
agreements were issued to persons who import dogs for commercial
purposes or for reasons other than as personal pets, which is contrary
to the intent of the confinement agreement provisions.
When state and local public health authorities follow up on the
confinement agreement notifications and determine that the importer is
in violation of the agreement, these authorities inform HHS/CDC. In
2009, HHS/CDC began issuing warning letters to known violators of dog
confinement agreements. Warning letters inform importers that they have
violated the legally binding confinement agreement, remind them of
their obligations under federal law, and warn them that further
violations might result in referral of the matter to the United States
Attorney for criminal prosecution. During fiscal year 2013, over 20 dog
importers, including those who import more than 1-2 shipments of dogs
per year into the United States, received warning letters from HHS/CDC
for failure to comply with the confinement agreement.
IV. Provisions of This Notice
Because of the risk that inadequately immunized dogs pose to public
health, HHS/CDC is issuing this guidance describing how it will use its
discretion in issuing confinement agreements to dog importers. In
determining whether a confinement agreement will be issued, HHS/CDC
will take several factors into account to ensure that the terms of the
confinement agreement will not be violated or that an inadequately
immunized dog does not pose a threat to public health. Non-issuance of
a confinement agreement will usually result in denial of entry of the
dog(s). ``Denial of entry'' usually entails the immediate return of the
dog(s) to the country of origin at the importer's expense. The care of
the dog(s) until their final disposition is also at the importer's
expense.
Among other important factors which may pose a risk to public
health, below are circumstances that HHS/CDC will consider in
determining whether it will issue a dog confinement agreement:
(1) The number of dogs presented for import must be consistent with
the purposes of the dog confinement agreement;
(2) The frequency of dog imports must be consistent with the
purposes of the dog confinement agreement;
(3) History of non-compliance with HHS/CDC-issued confinement
agreements;
(4) Prevalence of rabies in country of origin (country where the
dog has lived during the 6 months prior to arrival, or since birth if
the dog is less than 6 months of age); and
(5) Other risk factors as determined by the CDC Director. HHS/CDC
will evaluate each import based on the totality of the circumstances.
If an importer is denied the opportunity to receive a confinement
agreement, the denial will be issued in writing. The letter of denial
received will include reasons for denial as well as detailed
instructions on whom to contact for questions, including name, address,
and telephone number, as well as how to submit an appeal. Persons who
wish to contest HHS/CDC's determination will have five business days
after receiving the letter of denial. The importer must submit the
appeal in writing to the CDC Director, stating the reasons for the
appeal and showing that there is a genuine and substantial issue of
fact in dispute. HHS/CDC will issue a written response, which shall
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constitute final agency action. The appeal will be reviewed and decided
upon by an HHS/CDC senior management official who will be senior to the
employee who issued the initial letter of denial.
Since animals denied entry to the United States will be re-exported
immediately under standard operating procedures at U.S. ports of entry,
any successful appeal of a denial of entry after the dog(s) has already
been re-exported would only permit the importer to reimport the dog(s)
into the United States under the requirements of the confinement
agreement. The appeal would not entitle the importer to recover any
costs related to the re-export and reimport of the dog(s). The policy
and program operations described above will become effective on August
11, 2014.
Dated: July 7, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2014-16130 Filed 7-9-14; 8:45 am]
BILLING CODE 4163-18-P