[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Rules and Regulations]
[Pages 16683-16686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7098]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Rules
and Regulations
[[Page 16683]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 93
[Docket No. APHIS-2008-0112]
RIN 0579-AD31
Importation of Horses From Contagious Equine Metritis-Affected
Countries
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are amending the regulations regarding the importation of
horses from countries affected with contagious equine metritis (CEM) by
incorporating an additional certification requirement for imported
horses 731 days of age or less and adding new testing protocols for
test mares and imported stallions and mares more than 731 days of age.
We are taking these actions in response to incidents that prompted an
investigation by an expert review panel, which identified specific
weaknesses in the current regulations. This action will provide
additional safeguards against the introduction of CEM through the
importation of affected horses.
DATES: This interim rule is effective March 25, 2011. We will consider
all comments that we receive on or before May 24, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0112 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2008-0112, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0112.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Ellen Buck, Senior Staff
Veterinarian, Equine Imports, National Center for Import and Export,
VS, APHIS, 4700 River Road, Unit 36, Riverdale, MD 20737-1231; (301)
734-8364.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 93 (referred to below as the
regulations) prohibit or restrict the importation of certain animals
into the United States to prevent the introduction of communicable
diseases of livestock. Subpart C--Horses, Sec. Sec. 93.300 through
93.326, pertains to the importation of horses into the United States.
Sections 93.301 and 93.304 of the regulations contain specific
provisions for the importation of horses from regions affected with
contagious equine metritis (CEM), which is a highly contagious venereal
disease of horses and other equines caused by an infection with the
bacterium Taylorella equigenitalis.
The regulations provide that some types of horses may be imported
from CEM-affected regions without restriction. For instance, weanlings
and yearlings are exempt under Sec. 93.301(c)(2)(iii). Other horses
are allowed to be imported from CEM-affected regions provided they meet
certain requirements that include quarantine, testing, and treatment as
provided under Sec. 93.301(d), (e), and (f). Horses that fall under
this category include Spanish Pure Breed horses from Spain; racing
thoroughbreds from Germany, France, Ireland, and the United Kingdom;
stallions and mares over 731 days of age; and horses that are imported
under special provisions for temporary importation for competition or
entertainment purposes.
Approximately 2,500 horses imported from CEM-affected regions
undergo CEM quarantine in the United States each year. Over the past 10
years, despite current requirements for pre-import CEM testing in the
country of origin, more than 28 CEM-positive horses have been
identified during quarantine in the United States.
In 2006, a private veterinarian in the United States detected a T.
equigenitalis infection during a routine breeding soundness exam of an
imported stallion that had been released from CEM quarantine in 2004
after testing negative for CEM. The epidemiological investigation that
followed detected two other infected stallions on the same premises.
This incident jeopardized the CEM-free status of the United States and
had a significant impact on U.S. horse exports. In 2007, in response to
this incident, APHIS' Veterinary Services program initiated a review
and assessment by Federal, State, and industry officials of U.S. equine
import activities to identify any improvements to testing procedures
that may be necessary to better mitigate the risk of a CEM-positive
horse being released into the U.S. equine population.
A second incident indicating a need to strengthen the CEM
regulations occurred in April 2008 when an imported mare undergoing CEM
quarantine demonstrated positive results for CEM on a complement-
fixation (CF) test, which has not been required for imported mares
under the regulations; the required sampling of the clitoral sinuses
and clitoral fossa of the mare had shown negative results for T.
equigenitalis. The attending veterinarian administered the CF test
because she knew about the recommendations that followed from the
review and assessment of the 2006 incident.
In December 2008, a U.S. origin stallion with no history of
residence in a CEM-affected region was undergoing routine testing for
semen export, and cultured positive for CEM. APHIS initiated an
epidemiologic investigation
[[Page 16684]]
to identify other potentially infected horses. Ultimately 23 stallions
and 5 mares were identified as infected. An additional 250 stallions
and 718 mares were identified as exposed to positive horses. All
infected or exposed horses required culturing and treatment at their
owners' expense. The suspected source of the outbreak was a stallion
imported from Denmark in late 2000 whose CEM infection was not detected
on import testing. Because of the outbreak, some countries no longer
recognized the United States as CEM-free and consequently placed
restrictions on U.S. equine exports. The 2006 and 2008 incidents
indicate that the regulations that have been in place are inadequate to
identify all imported horses infected with T. equigenitalis.
Given the incidents noted above, we have determined that the
following regulatory changes are necessary and need to be implemented
immediately in order to prevent the potential introduction and spread
of CEM in the United States.
Exemption for Weanlings and Yearlings
The regulations in Sec. 93.301(c)(2)(iii) have exempted weanlings
or yearlings (defined as not more than 731 days of age) from CEM
quarantine requirements when their age is certified on the import
health certificate required under Sec. 93.314(a). The regulations have
provided for this exemption because horses less than 2 years old have
generally been considered too young to breed and therefore pose only a
minimal risk of entering the United States with a venereal disease such
as CEM. However, this assumption is now in question because APHIS has
identified imported mares 731 days or less of age that were pregnant
and therefore at risk of CEM infection.
While retaining the current certification-of-age requirement, we
are limiting the exemption from CEM-related restrictions to weanlings
and yearlings that have never been bred, and we are requiring that
their breeding status be certified on the import health certificate
required under Sec. 93.314(a). This change to the regulations provides
an additional safeguard against the spread of CEM to the U.S. horse
population.
Imported Stallions
Because stallions do not show clinical signs of CEM after becoming
exposed to the bacterium T. equigenitalis, diagnosis of CEM cannot be
based on clinical signs alone. Furthermore, culture tests do not always
detect T. equigenitalis. The stallion can look normal and test negative
for T. equigenitalis, but still infect the mare to which it is bred
naturally or by artificial insemination. Therefore, the regulations
under Sec. 93.301(e) provide that stallions over 731 days of age from
CEM-affected regions are to be bred to two test mares.
Specifically, the regulations in paragraph (e)(3)(i) have stated
that upon arrival at a CEM facility in an approved State, a set of
specimens must be taken from a stallion's prepuce, urethral sinus, and
fossa glandis, and that after negative culture results have been
obtained, the stallion must be test bred to two test mares. After being
test bred, a stallion that cultured negative prior to being test bred
has not been required to undergo another culture to test for T.
equigenitalis unless a test mare tested positive for CEM, in which case
the stallion would be treated for CEM and the testing process begun
again.
We are amending paragraph (e)(3)(i) of Sec. 93.301 to require a
fourth specimen to be taken from the stallion's distal urethra and to
increase the number of required sets of specimens (a set consists of
one culture swab from each location) from imported stallions from one
set to three sets at each of the four sites, all taken within a 12-day
period with a minimum of 72 hours between each set. At least two of the
three sets of specimens must be collected from the stallion, with
negative results, before the stallion is bred to two test mares. If the
test mares test negative for CEM after breeding, and if all of the
stallion's culture specimens test negative for CEM, then the stallion
will be released from quarantine.
These changes to the regulations will increase the likelihood of
detecting T. equigenitalis in imported stallions, thereby reducing the
risk that imported stallions will be released from quarantine with
undiagnosed CEM infections.
Test Mares
Test mares are mares used to test stallions for CEM. To qualify to
become a test mare, each mare must test negative for CEM as provided
under Sec. 93.301(e)(4). The regulations in Sec. 93.301(e)(3)(i)(B)
have required that the mucosal surfaces of the clitoral sinuses and
clitoral fossa of a test mare must be cultured for T. equigenitalis on
the third, sixth, and ninth days after breeding with an imported
stallion in CEM quarantine. To increase the likelihood of detecting CEM
in test mares, we are amending the regulations to require that either
the distal cervix or endometrium be cultured for CEM in addition to the
clitoral sinuses and clitoral fossa. We are also extending the
allowable timeframe in (e)(4)(ii) to complete all three culture sets
from the current 7-day period to a 12-day period, with specimens
collected anytime between the third and the fourteenth day after
breeding, with a minimum of 72 hours between each set. The additional
time allowed to collect all culture samplings was added at the request
of the veterinarians, because the 7-day timeframe did not allow any
flexibility in scheduling, since samples generally could not be shipped
or processed on weekends. Extending the timeframe from 7 days to 12
days to account for the laboratory's hours of operations will help
decrease testing delays caused by unusable samples.
Furthermore, the regulations in paragraph (e)(3)(i)(B) have
required the blood sample for the required CF test to be drawn from the
test mare on the fifteenth day after breeding. We are amending the
paragraph to require that a test mare's blood be drawn for a CF test on
the twenty-first day after breeding. This amendment aligns our
requirements with the World Organization for Animal Health's (OIE)
Manual of Diagnostic Tests,\1\ which recommends screening mares between
21 and 45 days after breeding.
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\1\ To view the OIE Terrestrial Animal Health Code, go to http://www.oie.int/eng/normes/mcode/en_sommaire.htm.
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Imported Mares
Once an imported mare has arrived at a CEM quarantine facility in
an approved State, the regulations in Sec. 93.301(e)(5)(i) have
required specimens to be collected from the mucosal surfaces of the
clitoral sinuses and clitoral fossa on days 1, 4, and 7 during a 7-day
period with all culture sets received by an approved laboratory within
48 hours of collection. To increase the likelihood of detecting CEM in
these imported mares, we are adding a requirement, as we are doing for
test mares, to collect specimens from either the distal cervix or the
endometrium in nonpregnant mares in addition to the specimens taken
from the mucosal surfaces of the clitoral sinuses and clitoral fossa.
To help avoid test delays and unusable samples due to facility and
laboratory hours of operations, we are extending the timeframe to
complete sampling from the current 7-day period to a 12-day period with
no less than 72 hours between each set.
In addition, we are now requiring that an imported mare be given a
CF test upon arrival at a State's CEM quarantine facility. CF testing
will allow identification of antibodies from any recent exposure to CEM
and provide
[[Page 16685]]
supplementary information concerning the mare's CEM status.
Spanish Pure Breed Horses and Thoroughbred Horses; Horses Temporarily
Imported for Competition or Entertainment Purposes
To reflect the changes discussed above, we are amending paragraph
(d)(1)(ii)(D) in Sec. 93.301 to require that Spanish Pure Breed horses
from Spain and thoroughbred horses over 731 days of age from France,
Germany, Ireland, and the United Kingdom, test negative for CEM based
on the culturing of three sets of specimens. For female horses, the
specimens must be collected from the mucosal surfaces of the clitoral
fossa, distal cervix or endometrium, and the clitoral sinuses; for any
male horses, the specimens must be collected from the surfaces of the
prepuce, the urethral sinus, the distal urethra, and the fossa glandis,
including the diverticulum of the fossa glandis. For both female and
male horses, the sets of specimens must be collected on three separate
occasions within a 12-day period with no less than 72 hours between
each set, and the last of these sets of specimens must be collected
within 30 days prior to the exportation of the horses to the United
States. All specimens must be collected by a licensed veterinarian who
either is, or is acting in the presence of, the veterinarian signing
the required health certificate.
We are making similar changes to paragraph (f)(3) in Sec. 93.301,
which contains special provisions for temporary importation of horses
for competition or entertainment purposes. Specifically, we will
require that such horses be accompanied by a health certificate that
certifies that cultures negative for CEM were obtained from three sets
of specimens. For female horses, the specimens must be collected from
the mucosal surfaces of the clitoral fossa and clitoral sinuses, with
one set of specimens including a specimen from the surfaces of the
distal cervix or endometrium; for male horses, the specimens must be
collected from the surfaces of the prepuce, the urethral sinus, the
distal urethra, and the fossa glandis, including the diverticulum of
the fossa glandis. For both female and male horses, the sets of
specimens must be collected on three separate occasions within a 12-day
period with no less than 72 hours between each set, and the last of
these sets of specimens must be collected within 30 days prior to the
exportation of horses to the United States. All specimens must be
collected by a licensed veterinarian who either is, or is acting in the
presence of, the veterinarian signing the certificate.
These changes, which represent an increase in the number of
specimens that must be collected, are consistent with the changes we
are making for other mares and stallions being imported from CEM-
affected regions to the United States and will provide additional
safeguards against the spread of CEM to the U.S. horse population.
Emergency Action
This rulemaking is necessary on an emergency basis to prevent the
introduction and spread of CEM into the equine population of the United
States. Under these circumstances, the Administrator has determined
that prior notice and opportunity for public comment are contrary to
the public interest and that there is good cause under 5 U.S.C. 553 for
making this rule effective less than 30 days after publication in the
Federal Register.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Executive Order 12866 and Regulatory Flexibility Act
This interim rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
We have prepared an initial regulatory flexibility analysis for
this action. The analysis identifies U.S. importers of mares and
stallions from CEM countries as the small entities most likely to be
affected by this action and considers the costs associated with
complying with new requirements. Based on the information presented in
the analysis, we expect that U.S. importers will experience a slight
increase in quarantine and treatment costs as a result of this action.
The overall impact of the additional costs for the horse industry is
not expected to be significant, given the relatively small number of
horses imported from CEM countries.
We invite comment on our initial regulatory flexibility analysis,
which is posted with this interim rule on the Regulations.gov Web site
(see ADDRESSES above for instructions for accessing Regulations.gov)
and may be obtained from the person listed under FOR FURTHER
INFORMATION CONTACT.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are in conflict with this rule; (2) has no retroactive
effect; and (3) does not require administrative proceedings before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
This interim rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR part 93 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY,
AND CERTAIN ANIMAL, BIRD, AND POULTRY PROUDUCTS; REQUIREMENTS FOR
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS
0
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 93.301 is amended as follows:
0
a. By revising paragraph (c)(2)(iii);
0
b. By revising paragraph (d)(1)(ii)(D);
0
c. In paragraph (e)(1)(iii), by adding the words ``distal urethra,''
after the words ``urethral sinus,'' in the second sentence;
0
d. By revising paragraphs (e)(3)(i) introductory text, (e)(3)(i)(B),
(e)(4)(ii), and (e)(5)(i); and
0
e. By revising paragraphs (f)(3).
The revisions read as follows:
Sec. 93.301 General prohibitions; exceptions.
* * * * *
(c) * * *
(2) * * *
(iii) Weanlings or yearlings that have never been used for
breeding, and whose age and breeding status are certified on the import
health certificate required under Sec. 93.314(a);
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(D) For Spanish Pure Breed horses and thoroughbred horses over 731
days
[[Page 16686]]
of age, cultures negative for CEM were obtained from three sets of
specimens collected within a 12-day period from the mucosal surfaces of
the clitoral fossa, distal cervix or endometrium, and the clitoral
sinuses of any female horses and from the surfaces of the prepuce, the
urethral sinus, the distal urethra, and the fossa glandis, including
the diverticulum of the fossa glandis, of any male horses. For both
male and female horses, the sets of specimens must be taken within a
12-day period with no less than 72 hours between each set, and the last
of these sets of specimens must be collected within 30 days prior to
exportation. All specimens required by this paragraph must be collected
by a licensed veterinarian who either is, or is acting in the presence
of, the veterinarian signing the certificate; and
* * * * *
(e) * * *
(3) * * *
(i) Once the stallion is in the approved State, three sets of
specimens consisting of one culture swab from each location shall be
taken from the prepuce, the urethral sinus, the distal urethra, and the
fossa glandis, including the diverticulum of the fossa glandis, of the
stallion and be cultured for CEM. The sets of specimens must be
collected on three separate occasions within a 12-day period with no
less than 72 hours between each set. No sooner than after the second
set of specimens is collected and cultured for CEM with negative
results, the stallion must be test bred to two test mares that meet the
requirements of paragraph (e)(4) of this section. Upon completion of
the test breeding:
* * * * *
(B) Each mare to which the stallion has been test bred shall be
cultured for CEM from three sets of specimens from the mucosal surfaces
of the clitoral fossa, clitoral sinuses, and from either the distal
cervix or endometrium between the third and fourteenth day after
breeding, with negative results. The sets of specimens must be
collected on three separate occasions within a 12-day period with no
less than 72 hours between each set. A complement fixation test for CEM
must be done with negative results on the twenty-first day after the
breeding.
* * * * *
(4) * * *
(ii) The test mares must be qualified prior to breeding as
apparently free from CEM and may not be used for breeding from the time
specimens are taken to qualify the mares as free from CEM. To qualify,
each mare shall be tested with negative results by a complement
fixation test for CEM, and specimens taken from each mare shall be
cultured negative for CEM. For each culture, sets of specimens shall be
collected on three separate occasions from the mucosal surfaces of the
clitoral fossa, clitoral sinuses, and from either the distal cervix or
endometrium within a 12-day period with no less than 72 hours between
each set.
* * * * *
(5) * * *
(i) Once the mare is in the approved State, a complement fixation
test for CEM must be done, and three sets of specimens shall be
collected from the mucosal surfaces of the clitoral fossa and clitoral
sinuses, with one set of specimens including a specimen from the
surfaces of the distal cervix or endometrium in nonpregnant mares. The
sets of specimens must be collected on three separate occasions within
a 12-day period with no less than 72 hours between each set. An
accredited veterinarian shall collect specimens and shall submit each
set of specimens to the National Veterinary Services Laboratories in
Ames, IA, or to a laboratory approved by the Administrator in
accordance with paragraph (i) of this section to conduct CEM cultures
and tests.
* * * * *
(f) * * *
(3) At the time of importation, each horse must be accompanied by
an import permit in accordance with Sec. 93.304 and a health
certificate issued in accordance with Sec. 93.314. For horses imported
in accordance with paragraph (f)(2) of this section, the health
certificate must also certify that cultures negative for CEM were
obtained from three sets of specimens collected from the mucosal
surfaces of the clitoral fossa and clitoral sinuses, with one set of
specimens including a specimen from the surfaces of the distal cervix
or endometrium, of any female horses and from the surfaces of the
prepuce, the urethral sinus, the distal urethra, and the fossa glandis,
including the diverticulum of the fossa glandis, of any male horses.
For both female and male horses, the sets of specimens must be
collected on three separate occasions within a 12-day period with no
less than 72 hours between each set, and the last of these sets of
specimens must be collected within 30 days prior to exportation. All
specimens required by this paragraph must be collected by a licensed
veterinarian who either is, or is acting in the presence of, the
veterinarian signing the certificate.
* * * * *
Done in Washington, DC, this 21st day of March 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-7098 Filed 3-24-11; 8:45 am]
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