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[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Rules and Regulations]
[Pages 16683-16686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7098]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
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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.
---------------------------------------------------------------------------

    \1\ To view the OIE Terrestrial Animal Health Code, go to http://www.oie.int/eng/normes/mcode/en_sommaire.htm.
---------------------------------------------------------------------------

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]
BILLING CODE 3410-34-P
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