[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Rules and Regulations]
[Pages 9577-9581]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03024]


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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: Final rule.

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SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that amended 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. 
This document revises certain CEM-testing requirements for imported 
stallions and mares, and for test mares, that were amended in the 
interim rule. The interim rule was necessary to provide additional 
safeguards against the introduction of CEM through the importation of 
affected horses.

DATES: Effective Date: March 13, 2013.

FOR FURTHER INFORMATION CONTACT: Dr. Ellen Buck, Senior Staff 
Veterinarian, Equine Imports, National Center for Import and Export, 
VS, APHIS, 4700

[[Page 9578]]

River Road Unit 36, Riverdale, MD 20737-1231; (301) 851-3361.

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 infection or 
contamination with the bacterium Taylorella equigenitalis.
    In an interim rule \1\ effective and published in the Federal 
Register on March 25, 2011 (76 FR 16683-16686, Docket No. APHIS-2008-
0112), we amended the regulations in Sec.  93.301 regarding the 
importation of horses from countries affected with 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.
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    \1\ To view the interim rule, the two documents delaying 
enforcement, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0112.
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    We solicited comments concerning the interim rule for 60 days 
ending May 24, 2011. In response to implementation concerns raised by 
commenters, we published a document in the Federal Register on May 31, 
2011 (76 FR 31220-31221, Docket No. APHIS-2008-0112), in which we 
announced that we were delaying enforcement of the interim rule until 
July 25, 2011, in order to provide CEM testing facilities time to make 
necessary adjustments to their operating procedures for the rule to be 
successfully implemented. In a subsequent document published in the 
Federal Register on August 23, 2011 (76 FR 52547-52548, Docket No. 
APHIS-2008-0112), we announced that the delay of enforcement would 
continue until the publication of a final rule, and reopened the 
comment period until September 7, 2011.
    We received a total of 18 comments by that date. They were from 
private citizens, foreign governments and commission, State departments 
of agriculture, a State veterinary agency, and U.S. horse 
organizations. Seventeen of the commenters agreed that additional 
safeguarding measures were warranted to protect the U.S. horse 
industry; however, those commenters did not agree with certain aspects 
of the changes made in the interim rule. The comments are discussed by 
topic below.

Imported Mares

    The March 2011 interim rule contained a new requirement that mares 
over 731 days of age imported from a CEM-affected region be given a 
complement fixation (CF) test at the post-arrival CEM quarantine 
facility. A few commenters suggested that we allow the blood to be 
taken and the CF test to be completed at the port of entry rather than 
at the post-arrival quarantine facility in order to reduce the post-
arrival quarantine period.
    While we understand the commenters' concern regarding import delays 
and convenience, we believe that since the CF test on imported mares is 
a component of the CEM testing program, the blood sample must be taken 
and the test completed at a CEM quarantine facility. CEM testing, 
including CF testing, is a separate function from import quarantine 
testing, requirements for which are contained in 9 CFR 93.308. Ports 
are not equipped or staffed to provide CEM testing services that are 
available at designated CEM quarantine facilities.
    In any case, we believe the commenters' concern is unwarranted. 
Collecting and submitting a blood sample at CEM quarantine facilities 
will not add any time to the CEM quarantine, since CF test results 
would be available before the mare has finished the culture and 
treatment phase of CEM testing.
    One commenter stated that we needed to clarify the procedure for 
imported mares that test positive for CEM. The commenter asked whether 
the positive mare would be returned to the country of origin or treated 
at the quarantine facility.
    Imported mares that test positive for CEM are not returned to their 
country of origin. Rather, as provided under Sec.  93.301(e)(5), 
imported mares that test positive for CEM are treated and retested.
    One commenter stated that it was important to identify pregnant and 
nonpregnant mares due to the difference in testing requirements for 
each. The commenter asked whether there was a declaration required to 
identify pregnant and nonpregnant mares and, if so, whether the 
declaration is confirmed by an accredited veterinarian.
    Mares over 731 days of age are accompanied at the time of 
importation by an import health certificate, but the health certificate 
does not include the breeding status of the mare. Our expectation, 
however, is that the owner, importer, or agent will tell the 
veterinarian in the United States or the exporting country the breeding 
status of the mare and that the veterinarian will test accordingly. We 
recommend that accredited veterinarians performing CEM testing at the 
post-entry quarantine facility examine mares by rectal palpation or 
ultrasound to determine the breeding status as part of their standard 
operating procedures.

Imported Stallions

    Previously, Sec.  93.301(e)(3)(i) required stallions to be cultured 
for CEM and test bred to two test mares after negative results from the 
cultures are obtained. The March 2011 interim rule amended that 
requirement to require that, prior to test breeding, three sets of 
cultures be collected from imported stallions rather than one set. The 
interim rule allowed test breeding to take place only after the first 
two sets of cultures had yielded negative results.
    Some commenters questioned the necessity of collecting more than 
one set of pre-breeding cultures from imported stallions. One commenter 
recommended taking post-breeding cultures.
    We are making a change to the final rule based on these comments 
and the 2007 CEM Program Review, which determined that test breeding is 
a more sensitive test for CEM than pre-breeding cultures. This final 
rule amends paragraph (e)(3)(i) of Sec.  93.301 to require that one set 
of cultures be collected from the stallion prior to breeding with 
negative results, consistent with our previous regulations. A stallion 
may be released from State quarantine only if all cultures and tests of 
specimens from the mares used for test breeding are negative for CEM 
and all cultures performed on specimens taken from the stallion are 
negative for CEM. If any culture or test is positive for CEM, the 
stallion would be treated for CEM as described in Sec.  
93.301(e)(3)(i)(A) and retested by being test bred to two mares no less 
than 21 days after the last day of treatment. Given the interim rule's 
enhancements to the testing process for test mares, we believe that 
requiring one set of cultures to be taken from imported stallions will 
be sufficient to prevent the introduction of CEM.
    One commenter stated that we needed to clarify whether stallions 
must be treated for CEM at quarantine facilities regardless of test 
results.
    As stated in Sec.  93.301(e)(3)(i), upon completion of the test 
breeding, stallions must be treated for 5 consecutive days in 
accordance with

[[Page 9579]]

paragraph (e)(3)(i)(A) of Sec.  93.301, regardless of their test 
status. If a test mare cultured for CEM shows positive results, then 
the stallion is treated again and retested. A stallion may be released 
from State quarantine only if all cultures and tests collected from 
test mares are negative for CEM and all cultures and tests collected 
from the stallion are negative for CEM.

Test Mares

    The March 2011 interim rule required three sets of cultures to be 
taken from the distal cervix or endometrial of test mares. One 
commenter questioned whether three sets of distal cervix or endometrial 
cultures from test mares would be an effective method for detecting CEM 
because of the potential of overgrowth and contamination of the second 
and third set of cultures. This would result in repeat cultures which 
would increase the cost and time of the post-arrival quarantine 
process. The commenter suggested that cultures from the distal cervix 
or endometrial be collected on the third set of cultures only.
    We agree with the commenter and are making a change to the interim 
rule as a result. Specifically, we are no longer requiring that 
cultures from the distal cervix or endometrium be included with all 
three sets of cultures collected from the test mares. Instead, 
paragraphs (e)(3)(i)(B) and (e)(4)(ii) of Sec.  93.301 now require that 
only the third set of cultures include a swab from the distal cervix or 
endometrium. In addition, we are amending paragraph (d)(1)(ii)(D), 
which contains similar requirement for the importation of Spanish Pure 
Breed horses and thoroughbred horses over 731 days, to require that 
only the third set of cultures from imported mares include a swab from 
the distal cervix or endometrium.
    The interim rule required CF testing to be completed for test mares 
on the twenty-first day after breeding. One commenter asked what date 
range would be acceptable if the blood test for the CF testing could 
not be done exactly on day 21. The commenter stated that the date range 
for the completion of the CF test needs to be spelled out due to 
weekends, scheduling, and operation status of the laboratories.
    We agree with this comment. If a test mare becomes CEM positive 
after breeding, the CF test titer begins to rise at day 15 post 
breeding, and would be expected to continue rising between days 21 and 
28. Therefore, we are amending paragraph (e)(3)(i)(B) of Sec.  93.301 
to state that a CF test for CEM must be done with negative results 
between the twenty-first and twenty-eighth day after the breeding. This 
change will provide additional flexibility in test scheduling, without 
compromising the ability to detect infection.

Exemptions; Geldings and Horses 731 Days of Age or Younger

    The regulations in paragraph (c)(2) of Sec.  93.301 exempts 
recently castrated stallions (geldings) from CEM-related importation 
requirements. Several commenters suggested that geldings be tested and 
treated for CEM, as recommended by the 2007 CEM Program Review. A 
concern was expressed that recently castrated stallions could maintain 
stallion-like behavior and attempt and achieve intromission with mares 
in estrus, thereby creating a risk for CEM transmission.
    Geldings will not be used for breeding purposes, which is where the 
risk of CEM transmission is greatest. We do not believe that the 
possibility of incidental contact between a gelding and an in-season 
mare warrants the additional time and expense associated with CEM 
testing and treatment for geldings.
    The regulations also exempt weanlings or yearlings whose age is 
certified on the import health certificate. One commenter suggested 
that newborn colts from CEM-infected mares should be tested and treated 
for CEM. In addition, the commenter suggested that all weanlings and 
yearlings be tested and treated for CEM as there is evidence that non-
venereal transmission is possible.
    We acknowledge that it is possible for a foal to be born with CEM 
if the dam was infected; however, the risk of non-venereal transmission 
of CEM is low and does not justify testing and treating imported 
weanlings and yearlings that have not been bred.
    One commenter stated that some cryptorchid stallions look like 
geldings and, therefore, all geldings should be tested to ensure no 
stallions that might be misidentified are admitted into the United 
States.
    Each horse is accompanied at the time of importation by an import 
permit issued in accordance with Sec.  93.304. We acknowledge that it 
is possible for a stallion to be misidentified; however, the risk is 
low and does not justify testing and treating every male horse that is 
imported into the United States.
    One commenter asked how we regulate imported mares 731 days of age 
or younger that are determined to be pregnant.
    If an imported mare 731 days of age or younger is pregnant upon 
arrival to the port of entry, the mare will be tested and treated in 
accordance with Sec.  93.301(e).
    One commenter asked why competition horses are tested if they are 
not used for breeding.
    As stated in Sec.  93.301(f), horses temporarily imported into the 
United States for competition or entertainment purposes are not subject 
to CEM testing upon entry. Stallions and mares imported for permanent 
entry into the United States must be tested for CEM even if importers 
plan to use those horses solely for competition at the time of import 
because the horses may be used for breeding after competition.
    One commenter asked that we clarify the required testing protocols 
for each category of horse imported into the United States. 
Specifically, the commenter wanted clarification whether horses 
temporarily imported for competition are exempt from post-arrival 
quarantine, while horses temporarily imported for entertainment 
purposes are now subject to the post-arrival quarantine.
    Horses imported into the United States temporarily under Sec.  
93.301(f) for either competition or entertainment purposes are not 
required to be tested for CEM in the United States. Horses entering 
temporarily for entertainment purposes must be tested in the country of 
origin. Horses entering temporarily for competition for periods of 90 
days or less do not need to be tested in the country of origin. Mares 
and stallions imported permanently must be tested in the United States 
and in the country of origin.

Miscellaneous

    A few commenters suggested that we address the recommendations 
presented in the 2007 CEM Program Review regarding oversight, asking 
that we establish minimum standards for quarantine facilities, testing 
protocols, and recordkeeping. The commenters suggested that we conduct 
regular training of testing officials and make unscheduled visits to 
animal import centers, quarantine facilities, and labs to review each 
facility's compliance with the regulations.
    We cooperate with State officials to ensure compliance and 
accountability at each facility. At present, we are drafting a policy 
document that provides minimum standards of operation for each stage of 
the post-arrival quarantine process. We have conducted training courses 
for testing officials and laboratory personnel, and will conduct 
training in the future as resources become available. Therefore, it is 
not necessary to amend the regulations by adding minimum standards for

[[Page 9580]]

quarantine facilities, testing protocols, and recordkeeping.
    One commenter asked if there was a system in place to ensure that 
horses imported under temporary status for competition exit the country 
after the completion of their competition and that they are not used 
for breeding purposes during their stay.
    As stated in Sec.  93.301(f), any horse temporarily imported would 
be monitored by the Animal and Plant Health Inspection Service (APHIS) 
to ensure that the horse is moved according to the itinerary and 
methods of transport specified by the import permit. The regulations 
clearly state that a horse imported temporarily for competition or 
entertainment must not be used for breeding. If an owner or importer 
subsequently seeks permission to keep the horse in the United States, 
the horse would be transported to a State quarantine facility to 
undergo the post-arrival quarantine testing and treatment procedures.
    A commenter inquired about the CEM testing and treatment 
requirements for horses being exported. The commenter stated that 
requiring exporters to test and treat horses prior to exportation, 
particularly if that horse has never tested positive for CEM, is an 
unnecessary burden on exporters and results in a loss of sales.
    Export testing requirements are determined by the destination 
country, not by APHIS. Thus, exporters must test and treat horses prior 
to exportation as required by the destination country.
    One commenter stated that APHIS' list of CEM-affected countries in 
Sec.  93.301 is different from the list established by Canadian 
officials.
    APHIS considers a country CEM-affected when CEM has been reported 
in that country or where free movement of horses from CEM-affected 
regions is allowed. APHIS will add additional countries to the list of 
CEM-affected regions when evidence is available that the organism is 
present in those countries, or when a country reports the disease to 
the World Organization for Animal Health. Canada uses a different 
approach for determining countries from which imported horses must be 
tested for CEM, and Canada's list includes countries that have not 
reported CEM.
    One commenter recommended that we require horses with a history of 
residing in a CEM-affected country for more than 30 days to be tested 
for CEM, even if they have resided in a CEM-free country for 12 or more 
months prior to exportation.
    Our current regulations only require CEM testing if a horse has 
resided in a CEM-affected region during the 12 months prior to 
importation. We acknowledge that there may be some benefit to testing 
horses that have resided in a CEM-affected region at any time prior to 
importation, especially if the horse has not been adequately tested and 
found free of CEM after importation into a CEM-free region. We are 
considering a future action to amend the regulations accordingly.
    One commenter recommended that we provide detailed pictures of the 
sites required to be cultured for CEM testing since the nomenclature 
for these test sites differs between countries.
    We recognize that each country has its own system of identifying 
the required culture sites. We cannot include color pictures within the 
regulations, which are essential for accurately identifying the culture 
sites. However, we provide that information in policy documents and on 
our Web site.\2\
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    \2\ For more information, go to http://www.aphis.usda.gov/import_export/animals/live_animals.shtml.
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    Paragraph (e)(1)(iii) of Sec.  93.301 provides the testing 
requirements for horses prior to exportation from their country of 
origin. We neglected to amend this paragraph in the interim rule by 
adding the additional culture sites for stallions and mares that the 
interim rule required for horses tested in domestic CEM quarantine. 
Therefore, we are amending Sec.  93.301(e)(1)(iii) by adding the distal 
urethra as a culture site for stallions and the distal cervix or the 
endometrium as a culture site for mares imported into the United 
States. The addition of the culture sites will make the regulations 
consistent with the changes made in the interim rule.
    Therefore, for the reasons given in the interim rule and in this 
document, we are adopting the interim rule as a final rule, with the 
changes discussed in this document.
    This final rule also affirms the information contained in the 
interim rule concerning Executive Order 12866 and the Regulatory 
Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork 
Reduction Act.
    Further, this action 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.

Regulatory Flexibility Act

    This final rule follows an interim rule that amended the 
regulations regarding the importation of horses from countries affected 
with 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.
    In accordance with 5 U.S.C. 604, we have performed a final 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this rule on small entities. Copies of the full 
analysis are available on the Regulations.gov Web site (see footnote 1 
in this document for a link to Regulations.gov) or by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
    The final regulatory flexibility analysis examines expected impacts 
for U.S. small entities of amending the regulations under which 
stallions and mares are imported from CEM-affected countries. For an 
importer of a mare from a CEM-affected country, we expect the 
additional costs will range from $80 to $255. For an importer of a 
stallion from a CEM-affected country, we expect the additional costs 
will range from $620 to $830.
    Currently, CEM testing costs vary by State and within State, 
averaging about $1,760 for mares and $5,070 for stallions. 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 (less than 2 percent of imports). The additional 
costs are also not large when compared to expected benefits in terms of 
reduced risk of a CEM outbreak in the United States.

List of Subjects in 9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

    Accordingly, the interim rule amending 9 CFR part 93 that was 
published at 76 FR 16683-16686 on March 25, 2011, is adopted as a final 
rule with the following changes:

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, 
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; 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 the first sentence of paragraph (d)(1)(ii)(D); and

[[Page 9581]]

0
b. By revising paragraphs (e)(1)(iii), (e)(3)(i) introductory text, 
(e)(3)(i)(B), and (e)(4)(ii).
    The revisions read as follows:


Sec.  93.301  General prohibitions; exceptions.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (D) For Spanish Pure Breed horses and thoroughbred horses over 731 
days 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 and the 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. * 
* *
* * * * *
    (e) * * *
    (1) * * *
    (iii) A set of specimens must be collected from each horse within 
30 days prior to the date of export by a licensed veterinarian who 
either is, or is acting in the presence of, the veterinarian signing 
the certificate. For stallions, the set of specimens consists 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; for mares, the specimens must be 
collected from the mucosal surfaces of the clitoral fossa, clitoral 
sinuses, and the distal cervix or endometrium in nonpregnant mares. All 
of the specimens collected must be cultured for CEM with negative 
results in a laboratory approved to culture for CEM by the national 
veterinary service of the region of origin;
* * * * *
    (3) * * *
    (i) Once the stallion is in the approved State, one specimen each 
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. After negative 
results have been obtained, 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 and clitoral sinuses, with one set of specimens 
including a specimen 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 between the twenty-first and twenty-eighth 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. Sets of specimens shall be collected on 
three separate occasions from the mucosal surfaces of the clitoral 
fossa and the clitoral sinuses, with one set of specimens including a 
specimen from either the distal cervix or endometrium, within a 12-day 
period with no less than 72 hours between each set.
* * * * *

    Done in Washington, DC, this 6th day of February 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-03024 Filed 2-8-13; 8:45 am]
BILLING CODE 3410-34-P