Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal-Importation Regulations, 41676-41679 [E7-14623]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 146 (Tuesday, July 31, 2007)]
[Proposed Rules]
[Pages 41676-41679]
From the Federal Register Online via the Government Printing 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 https://www.regulations.gov or via e-mail to 
animalimportcomments@cdc.gov. Electronic comments may be viewed at 
https://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 https://
www.regulations.gov. CDC has also posted the ANPRM and related 
materials to its Web site at https://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

[[Page 41677]]

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

[[Page 41678]]

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

[[Page 41679]]

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): https://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. https://edocket.access.gpo.gov/2003/03-27557.htm
    b. https://www.cdc.gov/ncidod/monkeypox/animals.htm
    c. https://www.cdc.gov/flu/avian/outbreaks/embargo.htm
    d. https://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]
BILLING CODE 4163-18-P