[Federal Register Volume 72, Number 146 (Tuesday, July 31, 2007)]
[Proposed Rules]
[Pages 41676-41679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14623]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 71
RIN 0920-AA03
Foreign Quarantine Regulations, Proposed Revision of HHS/CDC
Animal-Importation Regulations
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the U.S. Department of Health and Human Services (HHS) is issuing this
Advance Notice of Proposed Rulemaking (ANPRM) to begin the process of
revising the regulations that cover the importation of dogs and cats
(42 CFR 71.51), including by extending these regulations to cover
domesticated ferrets. This ANPRM will also address the importation of
African rodents (42 CFR 71.56) into the United States. HHS/CDC is also
considering the need for additional regulations to prevent the
introduction of zoonotic diseases into the United States.
The input received from stakeholders and other interested parties
via the ANPRM process will lead to a Notice of Proposed Rulemaking
(NPRM), with the aim of improving HHS's ability to prevent importation
of communicable diseases into the United States. The scope of this
ANPRM does not include the non-human primate regulations (42 CFR
71.53).
DATES: To be assured consideration, written comments must be received
on or before October 1, 2007.
ADDRESSES: You may submit written comments to the following address:
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, Division of Global Migration and Quarantine,
ATTN: Animal Importation Regulations, 1600 Clifton Road, N.E., (E03),
Atlanta, GA 30333. Comments will be available for public inspection
Monday through Friday, except for legal holidays, from 9 a.m. until 5
p.m. at 1600 Clifton Road, NE., Atlanta, GA 30333. Please call ahead to
1-866-694-4867 and ask for a representative in the Division of Global
Migration and Quarantine to schedule your visit.
You may also submit written comments electronically via the
Internet at http://www.regulations.gov or via e-mail to
[email protected]. Electronic comments may be viewed at
http://wwwn.cdc.gov/publiccomments/. CDC's general policy for comments
and other submissions from members of the public is to make these
submissions available for public viewing on the Internet as they are
received and without change, including any personal identifiers or
contact information.
You can download an electronic version of the ANPRM at http://www.regulations.gov. CDC has also posted the ANPRM and related
materials to its Web site at http://www.cdc.gov/ncidod/dq.
FOR FURTHER INFORMATION CONTACT: Dr. Robert Mullan, (404) 639-4537.
SUPPLEMENTARY INFORMATION: Zoonoses are diseases that are transmissible
from animals to people. The prevention of zoonoses in humans poses
special challenges, and requires consideration of the role of animals
in disease transmission. For example, domesticated animals such as dogs
and cats can carry rabies, and wild exotic animals can carry a variety
of known and emerging zoonotic pathogens. Under Section 361 of the
Public Health Service Act (42 U.S.C. 264), HHS/CDC is responsible for
regulations to prevent the introduction, transmission, and spread of
communicable diseases from foreign countries into the United States,
and from one U.S. State or possession into another. HHS/CDC recently
published a Notice of Proposed Rulemaking to revise its foreign and
interstate quarantine regulations in 42 CFR, Parts 70 and 71. Under its
statutory authority, HHS/CDC may regulate the importation of animals
into the United States that pose a health risk to humans. The Food and
Drug Administration (FDA) within HHS also has regulatory authority
under the Public Health Service Act to make and enforce regulations to
prevent the introduction, transmission, or spread of communicable
diseases. Within the U.S. Department of Agriculture (USDA), the Animal
and Plant Health Inspection Service (APHIS) has the authority to
regulate the importation of animals; its focus is primarily on animal-
welfare issues and diseases of veterinary and agricultural importance.
In addition, the Office of Law Enforcement within the U.S. Fish and
Wildlife Service (FWS) of the U.S. Department of the Interior (DOI)
regulates the entry of some shipments of animals to ensure compliance
with U.S. laws and international agreements that protect endangered
species.
HHS/CDC currently regulates the importation of dogs and cats into
the United States to prevent the entry of zoonotic diseases through 42
CFR 71.51. Dogs and cats are subject to inspection at ports of entry
for evidence of infectious diseases transmissible to humans. If a dog
or cat appears to be ill, inspectors may require further examination by
a licensed veterinarian.
In addition, HHS/CDC provides additional restrictions on the
importation of dogs to prevent the entry of rabies. Rabies is a virus
that causes a fatal disease in humans and animals, especially dogs. In
the United States, widespread mandatory vaccination of dogs has
eliminated canine strains of rabies, and dramatically reduced the
number of human cases in this country. However, canine strains of
rabies remain a serious health threat in many other countries, and
preventing the entry of animals infected with this strain of rabies
into the United States is an important public-health priority. HHS/CDC
currently regulates the importation of dogs into the United States by
requiring rabies vaccination and the confinement of most dogs for up to
30 days after vaccination, principally to prevent the importation of
rabies. Recently, HHS/CDC has received reports of large-volume
shipments of puppies intended for immediate re-sale. These animals
often appear younger than the age on their accompanying documents, and
their vaccination status is questionable. Although a veterinary
examination can assess many common zoonotic diseases of dogs, current
regulations do not require dogs to be accompanied by a standard
international health certificate signed by a licensed veterinary
authority in the country of origin or means of unique identification
for these animals. In addition, current regulations do not require
rabies vaccination for cats, which are highly susceptible to canine
strains of rabies virus, and can also transmit the infection to humans.
Furthermore, current regulations do not require rabies vaccination or
inspection for ferrets, which are domesticated pet
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carnivores that are also highly susceptible to canine strains of
rabies. Thus, the current regulations might not be sufficient to
prevent the entry of canine strains of rabies into the United States.
Zoonotic pathogens are important not only because of the known
illnesses they cause, which can move to new parts of the world, but
also because of new human diseases that can arise from animal sources.
In 2003, an outbreak of Severe Acute Respiratory Syndrome (SARS) in
humans spread worldwide, and the initial transmission to humans was
linked to civet cats sold for food in marketplaces in China. The
emergence of SARS in humans following exposure to wild animals is an
example of how a previously unrecognized zoonotic disease can quickly
cause unexpected illness in human populations.
HHS/CDC believes many animals imported into the United States for
the commercial pet trade represent a risk to human health. In 2003, an
outbreak of monkeypox occurred in the United States, and involved 37
confirmed human cases. HHS/CDC ultimately traced back the outbreak of
monkeypox, through infected prairie dogs, to the importation of African
rodents. However, our investigators could not identify many potentially
infected animals associated with this outbreak, because no accurate
records were available to trace their movements. This outbreak
eventually led to publication of 42 CFR 71.56, which prohibited the
importation of all African rodents into the United States, except as
approved by the Director of HHS/CDC for scientific, exhibition, or
educational purposes. This outbreak illustrates the possibility of
animals as sources of human infections, and the special risk associated
with keeping wild animals as pets.
The importation of wild animals poses a health risk because most
shipments involve a high volume of animals, most of which are wild-
caught and not captive-raised. Many shipments also include different
species co-mingled or kept in close proximity in confined spaces,
conditions ideal for the transmission of disease. For most species,
there is no screening for the presence of infectious diseases prior to
shipment, and no holding or testing is required on entry into the
United States, which creates an opportunity for the widespread exposure
of humans to pathogens these animals could be harboring. High mortality
rates among some animals, such as rodents, are common, and current U.S.
statutes and regulations do not require importers to have diagnostic
necropsies performed to determine whether the mortality is from a
pathogen that could have an adverse effect on public health. Some
imported animals are also known reservoirs or vectors of communicable
diseases of public-health significance.
HHS/CDC has taken actions to prevent the introduction,
transmission, and spread of specific communicable diseases into the
United States, including monkeypox, SARS, and avian influenza. 42 CFR
71.56 prohibits the importation of African rodents, except as approved
by the Director of HHS/CDC for scientific, exhibition, or educational
purposes. HHS/CDC has issued an order to ban the importation of civets,
because of concerns over the importation of SARS-coronavirus. HHS/CDC
has also issued orders to ban the importation of birds and bird
products from specific countries with highly pathogenic avian influenza
H5N1; these orders mirror similar regulatory actions taken by USDA/
APHIS to prevent the importation of birds with avian influenza H5N1.
These actions might not be sufficient to fully prevent the introduction
of zoonotic diseases into the United States, because they are limited
to specific species and regions.
HHS/CDC believes a number of approaches could further limit the
transmission of zoonotic diseases. Potential solutions to this problem
include screening animals with reliable laboratory tests, treating the
animals empirically for known diseases, or quarantining the animals
upon entry into the United States for the duration of an incubation
period or duration of transmissibility. Many of those solutions,
however, are currently not feasible or practical to employ on the large
volume of imported animals. In addition, the control measures cannot
prevent new or emerging pathogens or infections for which no laboratory
tests or no empiric treatments exist, when practical experiences
regarding a species' susceptibility are lacking, when incubation
periods are unknown, or when the infections are subclinical. In these
instances, import restrictions of a wider range of species than
currently regulated could be the only effective means of preventing the
introduction of exotic infections into this country.
On May 18, 2006, HHS/CDC hosted a public meeting on the subject of
infectious-disease threats associated with the importation and trade of
exotic animals. Stakeholders submitted a variety of positions and views
to the public meeting. Of the 22 statements received for consideration,
seven indicated a measure of support for increased restrictions on the
importation and sale of exotic species, while 15 expressed support for
alternatives to regulatory or legal restrictions, or opposition to
possible restrictions. HHS/CDC posted a summary of this meeting in the
Federal Register of August 7, 2006 (71 FR 44,698).
Advance Notice of Proposed Rulemaking for Animal Importations
Before considering whether to engage in rulemaking, HHS/CDC is
seeking input and background information from stakeholders, including
pet owners, veterinarians, animal breeders and importers, retailers and
distributors, U.S. State agricultural and public-health veterinarians,
medical epidemiologists, infectious-disease internists, animal-welfare
and conservation groups, research facilities, zoological societies,
animal transporters, and other Federal, State, and local agencies on
various issues relating to the potential application of revisions to
the current rules. This process will allow HHS/CDC to consider the
scope of any proposed changes.
HHS/CDC is requesting comments from stakeholders on the issues and
questions below, pertaining to regulations on the importation into the
United States of dogs, cats, and ferrets, as well as other animals. We
request input on the economic, regulatory, management, social, health,
and political impact any changes would have on the various stakeholder
groups. We also request stakeholder groups to provide data to
substantiate their claims of any positive or negative impact of any
changes in the regulation. In addition, HHS/CDC solicits any additional
comments from interested parties that could meaningfully inform the
process of adjusting the current regulations.
Dog, Cat, and Ferret Regulations
Should HHS/CDC extend the regulations that currently cover dogs and
cats to also cover domesticated ferrets?
Should HHS/CDC establish a minimum age for the importation of dogs,
cats, and ferrets into the United States? If so, at what age and why?
Should the minimum age differ for cats, dogs, and ferrets? Should HHS/
CDC establish a requirement for the estimation of age by a licensed
veterinarian?
Should rabies vaccination be a requirement for entry into the
United States for all dogs, cats, and ferrets? What documentation would
suffice as proof of vaccination? Should HHS/CDC require serologic
evidence of immunity? What timeframe of vaccination would be
appropriate? Should dogs, cats, and
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ferrets imported for research purposes be considered exempt from rabies
vaccination requirements if vaccination would interfere with the
intended research?
Should HHS/CDC require each dog, cat, and ferret to have a valid
international health certificate signed by a veterinary authority in
the country of origin as a condition for entry into the United States?
Are there particular international health certificates that should be
used as a model? Would such a requirement be financially feasible for
the importer? What diseases should a health examination and issuance of
a health certificate cover? What are the perceived benefits or
shortcomings of health certificates with respect to accurately
reflecting a dog, cat, or ferret's true health status? How can these
certificates be made difficult to falsify? Are there other methods that
can demonstrate the health of the animal?
Would a requirement for all dogs, cats, and ferrets imported into
the United States to have a unique identifier, such as a tattoo or
microchip, as endorsed by the American Veterinary Medical Association,
reduce the likelihood of fraudulent vaccination claims and health
certificates? Would identifiers unique to each animal assist officials
in locating and tracking dogs, cats, and ferrets during public-health
investigations? How might the uniqueness of identifiers be assured if
they are administered in other countries? What are some possible
difficulties associated with requiring a unique identifier for each
dog, cat, or ferret? Who would read the identifier? Should a database
of identifiers for imported dogs, cats, and ferrets be maintained, and
if so, who would maintain it? What is the impact of the cost of
identification measures? Are there alternative identification methods?
To facilitate the implementation of these regulations, should HHS/
CDC restrict the importation of dogs, cats, and ferrets to only those
ports of entry staffed by HHS/CDC personnel? These quarantine stations
are located in Atlanta, GA; Miami, FL; Chicago, IL; New York City, NY;
Honolulu, HI; San Francisco, CA; Los Angeles, CA; Seattle, WA; Newark,
NJ; Washington, DC; Dallas, TX; El Paso, TX; Houston, TX; Anchorage,
AK; Boston, MA; Detroit, MI; Minneapolis, MN; San Diego, CA;
Philadelphia, PA; and San Juan, PR. What impact would limiting the
importation of dogs, cats, and ferrets to certain ports potentially
have on pet owners and the pet industry?
Many countries allow dogs, cats, and ferrets with appropriate
documentation and vaccination history to accompany travelers. Is there
a need for possible exemptions to importation requirements for dogs,
cats, and ferrets that are traveling with their owners abroad and
returning to the United States? Is there a need for other types of
exemptions for dogs, cats, and ferrets?
Should HHS/CDC consider additional requirements that might reduce
the risk of importing communicable diseases from dogs, cats, and
ferrets into the United States, and make the implementation of these
regulations more feasible and effective at ports of entry?
For firms and other entities potentially affected by the options
discussed in the ANPRM, what types of negative (or positive) impacts
could occur? What types of businesses and other entities would the
options affect? What provisions would have the greatest impact? How
would the revenues and costs of affected businesses change under the
various approaches discussed in the ANPRM? For example, what percent of
revenues are these options likely to affect in the short, medium, and
long term (e.g., one year, 10 years, and 30 years)? How could HHS/CDC
reduce or avoid the impact on small entities, and how would any changes
to reduce impact on small entities affect the potential effectiveness
of the rules?
Other Animal Regulations (Including African Rodents Currently Regulated
Under 42 CFR 71.56)
HHS/CDC's current approach to controlling zoonotic disease threats
has been to issue emergency orders or rules prohibiting importation of
implicated animals. These actions are usually taken after an outbreak
occurs, rather than to proactively prevent outbreaks from known high-
risk animals. Given that this approach might not be sufficient to
prevent fully the introduction of many zoonotic diseases, should HHS/
CDC establish a regulation that maintains a list of species or
categories of high-risk animals for which importation is restricted
(e.g. either prohibited from entry, or subject to certain entry and
permitting requirements)? If so, how would the types of animals
included on such a list be determined? Should these regulations be
based on broad taxonomic groupings (e.g., all rodents), or should they
list individual species? Should HHS/CDC consider issuing these
restrictions on a limited geographical basis (i.e., certain countries
or regions), or more broadly?
If HHS/CDC were to prohibit certain subsets of animals from entry,
how would personnel at ports of entry accurately identify animals,
considering that many species of concern are difficult to identify or
distinguish from each other?
Should the revised rules focus on restricting the importation of
diseases not already present in the United States, or should they also
cover enzootic diseases that may pose a health risk (ex.
salmonellosis)? What data sources should HHS/CDC use to determine a
prioritized list of covered diseases?
Should HHS/CDC require shipments of restricted animals to enter a
port staffed with HHS/CDC personnel? These quarantine stations appear
in the above section on the regulations that cover dogs, cats, and
ferrets. What impact would limiting the importation of restricted
animals to certain ports potentially have on pet owners, the pet
industry, and the scientific research community?
What impact will changing these regulations to include other
species of animals have on the U.S. market for rearing these animals
domestically? What impact will changing the regulations have on the
illegal trade of restricted animal species?
Should HHS/CDC subject restricted animals to a quarantine period to
cover the risks of diseases that have established incubation periods,
as well as to allow assessment of the animals' general health status?
Should there be quarantine exemptions for laboratory animals certified
as being free of pathogens of concern? If a quarantine period is
permitted, should animals that become ill or die during quarantine be
required to have diagnostic tests or necropsies conducted to rule out
communicable diseases of human health concern? Should such a
requirement be mandatory, or should diagnostic tests or necropsies be
ordered at the discretion of HHS/CDC? Who should bear the costs of the
required diagnostic tests or necropsies?
How might changes to these regulations affect current practices
regarding the tracking and handling of animals? What are ways to
improve record-keeping for these animals to allow more rapid tracking
during public-health investigations?
For firms and other entities potentially affected by the options
discussed in the ANPRM, what types of negative (or positive) impacts
could occur? What types of businesses and other entities would the
options affect? What provisions would have the greatest impact? How
would their revenues and costs change under the various approaches
discussed in the ANPRM? For example, what percent of revenues are these
options likely to affect in the short, medium, and long
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term (e.g., one year, 10 years, and 30 years)? Please provide
suggestions about how HHS/CDC could reduce or avoid the impact on small
entities, and how those changes would affect the potential
effectiveness of the rules.
References
1. Regulations on the importation of dogs and cats (42 CFR
71.51): http://a257.g.akamaitech.net/7/257/2422/05dec20031700/edocket.access.gpo.gov/cfr_2003/octqtr/42cfr71.51.htm.
2. Other animal-importation regulations (42 CFR 71.56) and
orders:
a. http://edocket.access.gpo.gov/2003/03-27557.htm
b. http://www.cdc.gov/ncidod/monkeypox/animals.htm
c. http://www.cdc.gov/flu/avian/outbreaks/embargo.htm
d. http://www.cdc.gov/ncidod/sars/civetembargo.htm
Dated: April 16, 2007.
Michael Leavitt,
Secretary.
Editorial Note: This document was received at the Office of the
Federal Register on July 25, 2007.
[FR Doc. E7-14623 Filed 7-30-07; 8:45 am]
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