[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
                                                    --------------------
    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