[Federal Register Volume 61, Number 195 (Monday, October 7, 1996)]
[Rules and Regulations]
[Pages 52236-52246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25639]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 92
[Docket No. 95-054-2]
Importation of Horses from CEM Countries
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations regarding the importation of
horses from countries affected with contagious equine metritis by
incorporating new testing and treatment protocols for mares and
stallions, providing for the use of accredited veterinarians to monitor
horses temporarily imported into the United States for competition
purposes, incorporating a new testing protocol for thoroughbred horses
in training in their country of origin, and removing the requirements
for endometrial cultures and clitoral sinusectomies in mares. These
changes will update, clarify, and streamline the existing regulations
and will simplify the requirements for importing horses from countries
affected with contagious equine metritis without increasing the risk of
the disease being introduced into or disseminated within the United
States.
EFFECTIVE DATE: November 6, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. Joyce Bowling, Staff Veterinarian,
Import/Export Animals, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231, (301) 734-
6479; or E-mail: jbowling@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 92 (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 and poultry. Subpart C--Horses, Secs. 92.300
through 92.326 of the regulations, pertains to the importation of
horses into the United States. Sections 92.301 and 92.304 of the
regulations contain specific provisions for the importation and post-
entry handling of horses from countries affected with contagious equine
metritis (CEM), a highly contagious bacterial venereal disease.
On June 4, 1996, we published in the Federal Register (61 FR 28073-
28085, Docket No. 95-054-1) a proposal to amend the regulations by:
Reorganizing the CEM regulations to eliminate duplication
and to make their provisions easier to find and use;
Removing the requirements for clitoral sinusectomies and
endometrial cultures in female horses and establishing new protocols
for the collection of specimens for culturing;
Incorporating new testing and treatment protocols for
stallions and test mares;
Incorporating a new testing protocol for thoroughbred
horses in training in their country of origin; and
Providing for the use of accredited veterinarians to
monitor horses from CEM-affected countries that are temporarily in the
United States for competition purposes.
We solicited comments concerning our proposal for 60 days ending
August 5, 1996. We received eight comments by that date. They were from
a horse transporter/customs house broker, a State veterinarian, two
private practice veterinarians, two thoroughbred owners/breeders
associations, a horse industry council, and the director of a CEM
quarantine facility. All of the commenters supported the proposed rule,
although six of them offered suggestions or sought clarification
regarding the changes proposed in the proposed rule. Those comments are
discussed below.
Collection of Specimens
In the proposed rule, we proposed that for all mares over 731 days
of age offered for importation or in quarantine in an approved State,
specimens would be collected from the mucosal surfaces of the urethra,
clitoral sinuses, and cervix. Six of the commenters disagreed with
those proposed collection sites for two main reasons: (1) The
commenters
[[Page 52237]]
pointed out that experience in Europe and the United States has shown
the clitoral fossa, including the clitoral sinuses, to be the site from
which the CEM organism is most likely to be located, and (2) the
commenters all expressed reservations about the collection of specimens
from the cervix of pregnant mares, given the risk of infection or even
abortion that could result from swabbing that site. Based on those
considerations, the commenters suggested that the urethra and cervix be
eliminated as collection sites and that the clitoral fossa be added as
a collection site. We agree with the reasoning and suggestions of the
commenters and have, therefore, changed the collection sites for
samples from female horses in this final rule. Specifically, we have
changed the testing requirements for female thoroughbred horses in
Sec. 92.301(d)(1)(ii)(D), mares over 731 days of age in
Sec. 92.301(e)(1)(iii), and test mares in Secs. 92.301(e)(3)(i)(B),
92.301(e)(4)(ii), and 92.301(e)(5)(i) to require that specimens for
culturing be collected from the clitoral fossa and clitoral sinuses.
Treatment in Country of Origin
We had proposed to remove certain specific treatment instructions
for stallions diagnosed with CEM in their country of origin and replace
them with the requirement that the stallion be treated for CEM in a
manner approved by the national veterinary service of the country of
origin. One commenter was concerned that the treatment protocols used
in a stallion's country of origin may not be as demanding as those that
would be required by the Animal and Plant Health Inspection Service
(APHIS) and thus may not eliminate the CEM organism; rather, the
commenter suggested, the stallions should be treated in a manner
approved in the country of destination, i.e., the United States.
As noted in the proposed rule, the treatments performed in the
country of origin and the dates of the treatments will have to be
recorded on the horse's health certificate, so APHIS will have the
opportunity to consider the treatments used when the stallion is
offered for importation into the United States. Further, we will
continue to require that the stallion be retested no less than 21 days
following the completion of treatment and found free of CEM before it
will be eligible to enter the United States. Because that retesting
requirement will be in place, we believe that allowing the national
veterinary service of the country of origin to use its discretion in
deciding the appropriate treatment for stallions that have been found
to be positive for CEM will not result in an increased risk of CEM-
infected stallions entering the United States. We have not, therefore,
made any changes in response to that comment.
Treatment and Cleaning Protocol
The proposed rule also included a proposed protocol for the
treatment and cleaning of the clitoral sinuses of mares over 731 days
of age imported into an approved State. The protocol involved the
flushing of the clitoral sinuses with a cerumalytic agent, followed by
5 days of cleaning the external genitalia and vaginal vestibule,
including the clitoral fossa, with a solution of not less than 2
percent chlorhexidine in a detergent base and then filling the clitoral
fossa and sinuses, and coating the external genitalia and vaginal
vestibule, with an antibiotic ointment effective against the CEM
organism. Three of the commenters were concerned that the 5 consecutive
days of cleaning and coating would be irritating and even painful to a
mare and would likely result in the mare violently resisting the
treatment, which would pose a risk of injury to both the mare and the
person doing the cleaning and possibly result in the procedure not
being completed properly. Two commenters suggested that if the cleaning
procedure were conducted properly and thoroughly, the period of
treatment could be reduced to 3 or even 2 days.
The researchers who developed the cleaning and treatment procedure
described above concluded that the cleaning and flushing of the
clitoral sinuses should be followed by 5 consecutive days of washing
and application of ointment to ensure that the treatment is effective.
We will, therefore, retain the requirement for 5 days of post-flush
treatment. We acknowledge that a mare undergoing the treatment may well
become anxious or irritated as a result of the repeated handling of the
genitalia and thus require restraint or anesthesia; if that is the
case, the quarantine center personnel would be able to note the change
in the mare's disposition and take whatever precautions they deem
necessary to prevent any harm coming to them and to the mare. If
subsequent research indicates that the procedure should be modified to
reduce the length of treatment or increase its effectiveness, we will
publish a new proposed rule in the Federal Register to modify the
procedure. We have not, however, made any changes to the procedure in
this final rule.
Clitoral Sinusectomy
We had proposed to eliminate the requirement that certain mares
undergo a clitoral sinusectomy because the availability of procedures
for the cleaning and treatment of the clitoral sinuses to eliminate the
CEM organism had rendered clitoral sinusectomies unnecessary. One
commenter did not agree and recommended that the clitoral sinusectomy
be retained for use on mares that had tested positive for CEM, rather
than depending on the cleaning and treatment procedure to eliminate the
CEM organism. The cleaning and treatment procedure, the commenter
suggested, could be retained for use on mares that had tested negative
for CEM.
We have full confidence in the efficacy of the procedures described
in the proposed rule for flushing and cleaning the clitoral sinuses,
cleaning and washing the external genitalia and vaginal vestibule, and
filling the clitoral fossa and sinuses and coating the external
genitalia and vaginal vestibule with an antibiotic ointment effective
against the CEM organism. This procedure has been shown to effectively
eliminate debris that could harbor the CEM organism, which we believe
renders clitoral sinusectomies in all mares, whether they have been
diagnosed with CEM or not, unnecessary. We have, therefore, made no
changes in response to that comment.
High-Risk Mares
Two commenters suggested that mares that had been diagnosed with
and treated for CEM in their country of origin prior to importation
into the United States should be classified as ``high-risk mares.'' The
commenters did not recommend that any additional restrictions be placed
on such mares, but only that APHIS notify the animal health authorities
in the approved State to which a high-risk mare has been consigned when
the mare is released from CEM quarantine.
Under the provisions of the regulations, a mare cannot be imported
into the United States from a CEM country until a set of specimens has
been collected from the mare and cultured negative for CEM. Once the
mare has been imported into the United States and released from Federal
port-of-entry quarantine, specimens must be collected from that mare
three more times over a 7-day period and cultured, all with negative
results. The mare must then undergo the cleaning and treatment
procedure described in the previous paragraphs. Only after the mare has
satisfied all those requirements may it
[[Page 52238]]
be released from quarantine. With these requirements in place, we are
confident that any mare released from quarantine will be free from CEM;
in that case, one mare would not present a higher risk than another. We
do not believe, therefore, that it is necessary to differentiate
between mares that have not been diagnosed with CEM and mares that were
diagnosed with and effectively treated for CEM prior to their
importation into the United States, so we have made no changes to this
rule in response to that comment.
Use of Accredited Veterinarians
Two commenters supported the idea of allowing accredited
veterinarians to conduct the monitoring required for horses imported
for no more than 90 days to compete in specified events, but the
commenters suggested that the accredited veterinarians be required to
undergo some type of additional training to ensure that they are fully
versed in the regulations regarding such temporary importations.
The monitoring required by Sec. 92.301(f)(2)(ii) is to ensure that
the horse is kept on a premises approved by an APHIS representative; is
kept, except when actually competing or being exercised, in a stall
that prevents any contact with other horses; and has no sexual contact
with other horses and does not undergo any genital examinations. As
noted in the proposed rule, an accredited veterinarian must be familiar
with APHIS' animal health programs and regulations in order to be
approved by the Administrator to perform the functions associated with
those programs, and any accredited veterinarian monitoring temporarily
imported horses would be subject to spot checks by an APHIS
representative. Although we do not believe that accredited
veterinarians will need to receive any additional training, as
suggested by the commenter, we believe it would be useful for the APHIS
Veterinarian in Charge in the State where the monitoring would take
place to check with the accredited veterinarian to make sure that he or
she is conversant in the duties and responsibilities associated with
the monitoring of temporarily imported horses. We have, therefore,
modified Sec. 92.301(f)(2)(ii) in this final rule to state that the
Veterinarian in Charge will ensure that the accredited veterinarian is
familiar with the requirements of the regulations with regard to
monitoring temporarily imported horses.
Release from Quarantine
One commenter sought clarification in three areas regarding the
timing or sequence of certain testing and treatment requirements for
stallions and mares in quarantine. First, the commenter asked whether
the release of a stallion from quarantine would be a set number of days
after it entered quarantine or if the release would be contingent upon
the receipt of the results of the complement fixation test conducted 15
days after breeding on the two test mares. The regulations in
Sec. 92.301(e)(3)(iii) state that a stallion may be released from
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. Because the
results of all tests and cultures must be negative before the stallion
can be released from quarantine, the release of a stallion from
quarantine would indeed be contingent upon the receipt of the results
of the complement fixation tests.
The commenter also noted that because many imported stallions have
no previous breeding experience, it often takes several days to train
them to safely breed a mare. Under the provisions described in the
proposed rule, the stallion is test bred to two mares after it has been
cultured negative for CEM, which the commenter speculated could be as
soon as the stallion's first day in quarantine. The commenter
recommended, therefore, that some flexibility should be built into the
regulations to allow the quarantine facility staff sufficient time to
train imported stallions to safely breed the test mares. Because there
is no set time limit in the regulations for the completion of the test
breeding, the flexibility sought by the commenter is, in fact, already
present. The regulations in Sec. 92.301(e)(3)(i) require only that the
test breeding take place after negative results have been obtained from
the stallion's CEM cultures, which is usually at least 2 or 3 days
after the collection of specimens. If an imported stallion requires
training to safely breed a mare, there is nothing in the regulations to
prevent a quarantine facility's staff from taking the time necessary to
conduct that training.
Finally, the commenter asked that we clarify the sequence of the
actions described in the proposed rule under Sec. 92.301(e)(5),
``Testing and treatment requirements for mares.'' The commenter was
uncertain as to whether the washing and packing of the mare's external
genitalia and vaginal vestibule was to be conducted prior to, or
concurrent with, the collection of specimens from the mare on days one,
four, and seven of quarantine. Actually, the washing and packing is to
be after the three sets of specimens have been collected. The required
actions are listed sequentially in Sec. 92.301(e)(5): Collect three
sets of specimens over 7 days, then clean and flush the sinuses, then
wash and pack for 5 consecutive days. The commenter's confusion could
be due to a lack of clarity at the start of Sec. 92.301(e)(5)(ii),
which begins ``Following the collections of specimens * * *'' without
specifying that all three sets of specimens must be collected before
the cleaning and flushing of the clitoral sinuses begins. In order to
eliminate that potential source of confusion, we have modified the
language in Sec. 92.301(e)(5) in this final rule to make it clear that
the collection of specimens is to be completed prior to the cleaning
and flushing.
Another instance where a lack of clarity could lead to confusion is
in Sec. 92.301(d)(3). That paragraph states that thoroughbred horses
found free from CEM and imported under Sec. 92.301(d)(1) may be
released after completing the Federal quarantine required under
Sec. 92.308; the paragraph does not, however, specify the post-entry
requirements for thoroughbred horses over 731 days of age that were
found positive for CEM and subsequently treated and retested for CEM as
provided by Sec. 92.301(d)(2). It was our intent when drafting the
proposed rule that such thoroughbred horses, as is required for all
other horses over 731 days of age that have been found positive for CEM
and subsequently treated and retested for CEM, should be consigned to
an approved State for post-entry testing and treatment. We have,
therefore, modified the language in Sec. 92.301(d)(3) to make it clear
that thoroughbred horses over 731 days of age that have been treated
and retested for CEM in accordance with Sec. 92.301(d)(2) must undergo
post-entry quarantine in an approved State.
In addition to the changes discussed above, we have also made
several nonsubstantive editorial changes for the sake of clarity or
consistency.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule, with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The 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.
[[Page 52239]]
This rule amends the regulations regarding the importation of
horses from countries affected with CEM by incorporating new testing
and treatment protocols for mares and stallions, providing for the use
of accredited veterinarians to monitor horses temporarily imported into
the United States for competition purposes, incorporating a new testing
protocol for thoroughbred horses in training in their country of
origin, and removing the requirements for endometrial cultures and
clitoral sinusectomies in mares. These changes will update, clarify,
and streamline the existing regulations and simplify the requirements
for importing horses from countries affected with CEM without
increasing the risk of the disease being introduced into or
disseminated within the United States.
The United States is a net exporter of horses, exporting
approximately two horses for every one imported, and unit values for
imports and exports slightly favored the United States during fiscal
year (FY) 1994 and FY 1995. The unit value of exports was $3,762 per
head in FY 1994, while the unit import value was $3,336 per head; in FY
1995, these values shifted to $2,742 per head (export) and $2,674 per
head (import).
In FY 1994, U.S. exports of horses totaled 62,064 head valued at
$233.4 million; in FY 1995, the total was 81,487 head valued at $223.4
million. Most of those horses were exported to Canada, Mexico, and
Western Europe (especially the United Kingdom and Ireland). U.S.
imports of horses, on the other hand, are small relative to total
inventory and equal about half of U.S. horse exports. In FY 1994, U.S.
horse imports totaled 17,881 head valued at $59.6 million; in FY 1995,
the total was 43,545 head valued at $116.4 million. Canada and Mexico
were the source of over 90 percent of all U.S. horse imports in those
years. In each year, those imports equaled approximately 1 percent of
the domestic horse inventory (USDA, Economic Research Service,
``Foreign Agricultural Trade of the United States,'' Fiscal Year 1995
Supplement). Small entities maintain almost 95 percent of the domestic
horse inventory.
The new testing and treatment protocols presented in this document
are the only aspects of this rule that are expected to have an economic
impact. In each case, the changes will reduce the time required to
collect samples, conduct tests, and administer treatments, which will
shorten the period that an imported horse will have to spend in
quarantine. Because the importer or owner of an imported horse must
bear the cost of providing care, feeding, and handling of the horse
during the time it is quarantined for CEM testing and treatment in an
approved State, a shorter quarantine period will clearly reduce an
owner's or importer's boarding costs. The current course of testing and
treatment runs, on average, from 4 to 6 weeks; the testing and
treatment protocols in this rule are expected to cut that time frame to
2 to 3 weeks.
We do not expect, however, that these changes will result in an
increase of horse imports into the United States. Those countries that
can already profitably ship horses to the United States and meet the
current requirements of the regulations will not be significantly
affected, and those countries that do not currently meet those
requirements are not expected to meet the new requirements either.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
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 inconsistent 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 rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
Regulatory Reform
This action is part of the President's Regulatory Reform
Initiative, which, among other things, directs agencies to remove
obsolete and unnecessary regulations and to find less burdensome ways
to achieve regulatory goals.
List of Subjects in 9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 92 is amended as follows:
PART 92--IMPORTATION OF CERTAIN ANIMALS AND POULTRY AND CERTAIN
ANIMAL AND POULTRY PRODUCTS; INSPECTION AND OTHER REQUIREMENTS FOR
CERTAIN MEANS OF CONVEYANCE AND SHIPPING CONTAINERS THEREON
1. The authority citation for part 92 continues to read as follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 92.300, the definition of Weanling or yearling is
revised to read as follows:
Sec. 92.300 Definitions.
* * * * *
Weanling or yearling. Any horse, weaned from its dam, that was
foaled not more than 731 days prior to its being offered for entry into
the United States. A horse will not be considered to be a weanling or
yearling if its first permanent incisors have erupted.
Secs. 92.303 and 92.304 [Amended]
3. Sections 92.303 and 92.304 are amended as follows:
a. In Sec. 92.304, footnote 12 and its reference in the section
heading are removed.
b. In Sec. 92.303(e), footnote 11 and its reference are
redesignated as footnote 12.
4. In Sec. 92.301, paragraph (c) is revised and new paragraphs (d)
through (i) are added to read as follows:
Sec. 92.301 General prohibitions; exceptions.
* * * * *
(c) Specific prohibitions regarding contagious equine metritis;
exceptions--(1) Importation prohibited. Except as provided in paragraph
(c)(2) of this section, notwithstanding the other provisions of this
part concerning the importation of horses into the United States, the
importation of all horses from any of the following listed countries
and the importation of all horses that have been in any listed country
within the 12 months immediately preceding their being offered for
entry into the United States is prohibited, either because contagious
equine metritis (CEM) exists in the listed country or because the
listed country trades horses freely with a country in which CEM exists
without testing for CEM: Austria, Belgium, Bosnia and Herzegovina,
Croatia, Czech Republic, Denmark, Finland, France, Germany, Guinea-
Bissau, Ireland, Italy,
[[Page 52240]]
Japan, the Member States of the European Union, The Netherlands,
Norway, Slovakia, Slovenia, Sweden, Switzerland, The Former Yugoslav
Republic of Macedonia, the United Kingdom (England, Northern Ireland,
Scotland, Wales, and the Isle of Man), and the nonrecognized areas of
the former Yugoslavia (Montenegro and Serbia).
Note: Montenegro and Serbia have asserted the formation of a
joint independent State entitled ``The Federal Republic of
Yugoslavia,'' but this entity has not been formally recognized by
the United States.
(2) Exceptions. The provisions of paragraph (c)(1) of this section
shall not apply to the following:
(i) Wild (non-domesticated) species of equidae if captured in the
wild or imported from a zoo or other facility where it would be
unlikely that the animal would come in contact with domesticated horses
used for breeding;
(ii) Geldings;
(iii) Weanlings or yearlings whose age is certified on the import
health certificate required under Sec. 92.314(a);
(iv) Horses imported in accordance with conditions prescribed by
the Administrator as provided in Sec. 92.301(a);
(v) Thoroughbred horses imported for permanent entry from France,
Germany, Ireland, or the United Kingdom if the horses meet the
requirements of paragraph (d) of this section;
(vi) Stallions or mares over 731 days of age imported for permanent
entry if the horses meet the requirements of paragraph (e) of this
section;
(vii) Horses over 731 days of age imported into the United States
for no more than 90 days to compete in specified events if the horses
meet the requirements of paragraph (f) of this section; and
(viii) Horses temporarily exported from the United States or from
another country not known to be affected with CEM to a country listed
in paragraph (c)(1) of this section within the 12 months immediately
preceding their being offered for entry into the United States if the
horses meet the requirements of paragraph (g) of this section.
(d) Thoroughbred horses from France, Germany, Ireland, and the
United Kingdom. (1) Thoroughbred horses may be imported for permanent
entry from France, Germany, Ireland, or the United Kingdom if the
horses meet the following requirements:
(i) Each horse is accompanied at the time of importation by an
import permit in accordance with Sec. 92.304;
(ii) Each horse is accompanied at the time of importation by an
import health certificate issued in accordance with Sec. 92.314(a). In
addition to the information required by Sec. 92.314(a), the
veterinarian signing and issuing the certificate shall certify that:
(A) He or she has examined the daily records of the horse's
activities maintained by the trainer and certified to be current, true,
and factual by the veterinarian in charge of the training or racing
stable;
(B) He or she has examined the records of the horse's activities
maintained by a breed association specifically approved by the
Department 6 and certified by the breed association to be current,
true, and factual for the following information: Identification of the
horse by name, sex, age, breed, and all identifying marks;
identification of all premises where the horse has been since reaching
731 days of age and the dates that the horse was at such premises; and
that none of the premises are breeding premises;
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\6\ The following breed associations and their record systems
have been approved by the Department: Weatherby's Ltd. for the
United Kingdom and Ireland; Haras du Pain for France; and
Direktorium fur Vollblutzucht und Rennen e.v. for Germany.
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(C) He or she has compared the records maintained by the approved
breed association with the records kept by the trainer and has found
the information in those two sets of records to be consistent and
current;
(D) For thoroughbred horses over 731 days of age, cultures negative
for CEM were obtained from sets of specimens collected on 3 separate
occasions within a 7-day period from the mucosal surfaces of the
clitoral fossa and the clitoral sinuses of any female horses and from
the surfaces of the prepuce, the urethral sinus, 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 days 1, 4, and 7 of the 7-day period, and the last of
these sets of specimens must be collected within 30 days of
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) All specimens required by paragraph (d)(1)(ii)(D) of this
section were received within 48 hours of collection by a laboratory
approved to culture for CEM by the national veterinary service of the
country of export and were accompanied by a statement indicating the
date and time of their collection.
(2) If any specimen collected in accordance with paragraph
(d)(1)(ii)(D) of this section is found to be positive for CEM, the
horse must be treated for CEM in a manner approved by the national
veterinary service of the country of export. After the treatment is
completed, at least 21 days must pass before the horse will be eligible
to be tested again in accordance with paragraph (d)(1)(ii)(D) of this
section. All treatments performed, and the dates of the treatments,
must be recorded on the health certificate.
(3) Thoroughbred horses imported under paragraph (d)(1) of this
section may be released upon completion of the Federal quarantine
required under Sec. 92.308. Thoroughbred horses found positive for CEM
that have been treated and retested as provided in paragraph (d)(2) of
this section shall, upon completion of the Federal quarantine required
under Sec. 92.308, be consigned to an approved State listed in
paragraph (h)(6) or (h)(7) of this section, where they shall be
quarantined under State or Federal supervision until the stallions have
met the testing and treatment requirements of paragraph (e)(3) of this
section and the mares have met the testing and treatment requirements
of paragraph (e)(5) of this section.
(e) Stallions and mares over 731 days of age from CEM-affected
countries. (1) Stallions or mares over 731 days of age may be imported
for permanent entry from a country listed in paragraph (c)(1) of this
section if the horses meet the following requirements:
(i) Each horse is accompanied at the time of importation by an
import permit issued in accordance with Sec. 92.304. The import permit
must indicate that, after completion of the Federal quarantine required
in Sec. 92.308, the stallion or mare will be consigned to a State that
the Administrator has approved to receive such horses in accordance
with paragraph (h) of this section;
(ii) The horses are accompanied at the time of importation by an
import health certificate issued in accordance with Sec. 92.314(a);
(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 specimens must be collected from
the prepuce, urethral sinus, and fossa glandis, including the
diverticulum of the fossa glandis; for mares, the specimens must be
collected from the mucosal surfaces of the clitoral fossa and the
clitoral sinuses. All of the specimens collected must be cultured for
CEM with negative results in a laboratory approved to culture for CEM
[[Page 52241]]
by the national veterinary service of the country of origin;
(iv) The horses described on the certificate must not have been
used for natural breeding, for the collection of semen for artificial
insemination in the case of stallions, or for artificial insemination
in the case of mares, from the time the specimens were collected
through the date of export;
(v) All specimens required by paragraph (e)(1)(iii) of this section
must be received within 48 hours of collection by a laboratory approved
to culture for CEM by the national veterinary service of the country of
export and must be accompanied by a statement indicating the date and
time of their collection; and
(vi) If any specimen collected in accordance with paragraph
(e)(1)(iii) of this section is found to be positive for CEM, the
stallion or mare must be treated for CEM in a manner approved by the
national veterinary service of the country of export. After the
treatment is completed, at least 21 days must pass before the horse
will be eligible to be tested again in accordance with paragraph
(e)(1)(ii) of this section. All treatments performed, and the dates of
the treatments, must be recorded on the health certificate.
(2) Post-entry. (i) Stallions and mares imported under paragraph
(e)(1) of this section must complete the Federal quarantine required
under Sec. 92.308. Upon completion of the Federal quarantine, stallions
must be sent to an approved State listed in paragraph (h)(6) of this
section, and mares must be sent to an approved State listed in
paragraph (h)(7) of this section.
(ii) Once in the approved State, the stallions or mares shall be
quarantined under State or Federal supervision until the stallions have
met the testing and treatment requirements of paragraph (e)(3) of this
section and the mares have met the testing and treatment requirements
of paragraph (e)(5) of this section.
(iii) All tests and cultures required by paragraphs (e)(3) through
(e)(5) of this section shall be conducted at the National Veterinary
Services Laboratories, Ames, IA, or at a laboratory approved by the
Administrator in accordance with paragraph (i) of this section to
conduct CEM cultures and tests.
(iv) To be eligible for CEM culture or testing, all specimens
collected in accordance with paragraphs (e)(3) through (e)(5) of this
section must be received by the National Veterinary Services
Laboratories or the approved laboratory within 48 hours of collection
and must be accompanied by a statement indicating the date and time of
their collection.
(3) Testing and treatment requirements for stallions. (i) Once the
stallion is in the approved State, one specimen each shall be taken
from the prepuce, the urethral sinus, 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:
(A) The stallion must be treated for 5 consecutive days by
thoroughly cleaning and washing (scrubbing) its prepuce, penis,
including the fossa glandis, and urethral sinus while the stallion is
in full erection with a solution of not less than 2 percent surgical
scrub chlorhexidine and then thoroughly coating (packing) the
stallion's prepuce, penis, including the fossa glandis, and urethral
sinus with an ointment effective against the CEM organism.7 The
treatment shall be performed by an accredited veterinarian and
monitored by a State or Federal veterinarian.
---------------------------------------------------------------------------
\7\ A list of ointments effective against the CEM organism may
be obtained from the National Center for Import and Export, Import/
Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD
20737-1231.
---------------------------------------------------------------------------
(B) Each mare to which the stallion has been test bred shall be
cultured for CEM from sets of specimens that are collected from the
mucosal surfaces of the clitoral fossa and clitoral sinuses on the
third, sixth, and ninth days after the breeding, with negative results.
A complement fixation test for CEM must be done with negative results
on the fifteenth day after the breeding.
(ii) If any culture or test required by this paragraph is positive
for CEM, the stallion shall be treated as described in paragraph
(e)(3)(i)(A) of this section and retested by being test bred to two
mares no less than 21 days after the last day of treatment.
(iii) 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.
(4) Requirements for test mares. (i) Mares to be used to test
stallions for CEM shall be permanently identified before the mares are
used for such testing with the letter ``T.'' The marking shall be
permanently applied by an inspector, a State inspector, or an
accredited veterinarian who shall use a hot iron, freezemarking, or a
lip tattoo. If a hot iron or freezemarking is used, the marking shall
not be less than 2 inches (5.08 cm) high and shall be applied to the
left shoulder or left side of the neck of the mare. If a lip tattoo is
used, the marking shall not be less than 1 inch (2.54 cm) high and 0.75
inch (1.9 cm) wide and shall be applied to the inside surface of the
upper lip of the test mare.
(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 culture, sets of specimens shall be
collected on the first, fourth, and seventh days of a 7-day period from
the mucosal surfaces of the clitoral fossa and clitoral sinuses.
(iii) A test mare that has been used to test stallions for CEM may
be released from quarantine only if:
(A) The test mare is found negative for CEM on all cultures and
tests required under paragraph (e)(3)(ii) of this section; or
(B) The test mare is subjected to an ovariectomy by an accredited
veterinarian under the direct supervision of a State or Federal
veterinarian; or
(C) The test mare is treated and handled in accordance with
paragraph (e)(5) of this section; or
(D) The test mare is moved directly to slaughter without unloading
en route, is euthanized, or dies.
(5) Testing and treatment requirements for mares. (i) Once the mare
is in the approved State, sets of specimens shall be collected from the
mare on three separate occasions within a 7-day period. On days 1, 4,
and 7, an accredited veterinarian shall collect specimens from the
mucosal surfaces of the clitoral fossa and clitoral sinuses and shall
submit each set of specimens to the National Veterinary Services
Laboratories, Ames, IA, or to a laboratory approved by the
Administrator in accordance with paragraph (i) of this section to
conduct CEM cultures and tests.
(ii) After the three sets of specimens required by paragraph
(e)(5)(i) of this section have been collected, an accredited
veterinarian shall manually remove organic debris from the sinuses of
each mare and then flush the sinuses with a cerumalytic agent.8
---------------------------------------------------------------------------
\8\ Recommended protocols for the flushing of sinuses may be
obtained from the National Center for Import and Export, Import/
Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD
20737-1231.
---------------------------------------------------------------------------
[[Page 52242]]
(iii) For 5 consecutive days after the sinuses have been cleaned,
an accredited veterinarian shall aseptically clean and wash (scrub) the
external genitalia and vaginal vestibule, including the clitoral fossa,
with a solution of not less than 2 percent chlorhexidine in a detergent
base and then fill the clitoral fossa and sinuses, and coat the
external genitalia and vaginal vestibule with an antibiotic ointment
effective against the CEM organism.9
---------------------------------------------------------------------------
\9\ A list of ointments effective against the CEM organism may
be obtained from the National Center for Import and Export, Import/
Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD
20737-1231.
---------------------------------------------------------------------------
(iv) A mare may be released from State quarantine only if all
cultures performed on specimens taken from the mare are negative for
CEM.
(v) If any culture required by this paragraph is positive for CEM,
the mare shall be treated as described in paragraphs (e)(5)(ii) and
(e)(5)(iii) of this section. No less than 21 days after the last day of
treatment, the mare shall be tested again in accordance with paragraph
(e)(5)(i) of this section. If all specimens are negative for CEM, the
mare may be released from quarantine.
(f) Special provisions for temporary importation. Horses over 731
days of age may be imported into the United States for no more than 90
days to compete in specified events if the following conditions are
met:
(1) The horse may remain in the United States for not more than 90
days following the horse's arrival in the United States, except as
provided in paragraph (f)(6) of this section and, while in the United
States, the horse must be moved according to the itinerary and methods
of transport specified in the import permit provided for in Sec. 92.304
of this part;
(2) While the horse is in the United States, the following
conditions must be met:
(i) Except when in transit, the horse must be kept on a premises
that has been approved, orally or in writing, by an APHIS
representative. If the approval is oral, it will be confirmed in
writing by the Administrator as soon as circumstances permit. To
receive approval, the premises:
(A) Must not be a breeding premises; and
(B) Must be or contain a building in which the horse can be kept in
a stall that is separated from other stalls containing horses, either
by an empty stall, by an open area across which horses cannot touch
each other, or by a solid wall that is at least 8 feet (2.4 m) high.
(ii) While at the premises at which the horse competes, the horse
must be monitored by an accredited veterinarian or APHIS representative
to ensure that the provisions of paragraphs (f)(2)(i), (f)(2)(iv), and
(f)(2)(v) of this section are met. If the monitoring is performed by an
accredited veterinarian, the Veterinarian in Charge will ensure that
the accredited veterinarian is familiar with the requirements of this
section and spot checks will be conducted by an APHIS representative to
ensure that the requirements of this section are being met. If an APHIS
representative finds that requirements are not being met, the
Administrator may require that all remaining monitoring for the event
be conducted by APHIS representatives to ensure compliance.
(iii) While in transit, the horse must be moved in either an
aircraft or a sealed van or trailer. If the horse is moved in a sealed
van or trailer, the seal may be broken only by an APHIS representative
at the horse's destination, except in situations where the horse's life
is in danger.
(iv) Except when actually competing or being exercised, the horse
must be kept in a stall that is separated from other stalls containing
horses, either by an empty stall, by an open area across which horses
cannot touch each other, or by a solid wall that is at least 8 feet
(2.4 m) high.
(v) The horse may not be used for breeding purposes (including
artificial insemination), may not have any other sexual contact with
other horses, and may not undergo any genital examinations.
(vi) After the horse is transported anywhere in the United States,
any vehicle in which the horse was transported must be cleaned and
disinfected in the presence of an APHIS representative, according to
the procedures specified in Secs. 71.7 through 71.12 of this chapter,
before any other horse is transported in the vehicle.
(vii) The cleaning and disinfection specified in paragraph
(f)(2)(vi) of this section must be completed before the vehicle is
moved from the place where the horse is unloaded. In those cases where
the facilities or equipment for cleaning and disinfection are
inadequate at the place where the horse is unloaded, the Administrator
may allow the vehicle to be moved to another location for cleaning and
disinfection when the move will not pose a disease risk to other horses
in the United States.
(viii) The owner or importer of the horse must comply with any
other provisions of this part applicable to him or her.
(3) If the owner or importer wishes to change the horse's itinerary
or the methods by which the horse is transported from that which he or
she specified in the application for the import permit, the owner or
importer must make the request for change in writing to the
Administrator. Requests should be sent to the Administrator, c/o
Import-Export Animals Staff, VS, APHIS, 4700 River Road Unit 39,
Riverdale, MD 20737-1231. The change in itinerary or method of
transport may not be made without the written approval of the
Administrator, who may grant the request for change when he or she
determines that granting the request will not endanger other horses in
the United States and that sufficient APHIS personnel are available to
provide the services required by the owner or importer. If more than
one application for an import permit is received, APHIS personnel will
be assigned in the order that the applications that otherwise meet the
requirements of this section are received.
(4) The Administrator may cancel, orally or in writing, the import
permit provided for under Sec. 92.304 of this part whenever the
Administrator finds that the owner or importer of the horse has not
complied with the provisions of paragraphs (f)(1) through (f)(3) of
this section or any conditions imposed under those provisions. If the
cancellation is oral, the Administrator will confirm the cancellation
and the reasons for the cancellation in writing as soon as
circumstances permit. Any person whose import permit is canceled may
appeal the decision in writing to the Administrator within 10 days
after receiving oral or written notification of the cancellation,
whichever is earlier. If the appeal is sent by mail, it must be
postmarked within 10 days after the owner or importer receives oral or
written notification of the cancellation, whichever is earlier. The
appeal must include all of the facts and reasons upon which the person
relies to show that the import permit was wrongfully canceled. The
Administrator will grant or deny the appeal in writing as promptly as
circumstances permit, stating the reason for his or her decision. If
there is a conflict as to any material fact, a hearing will be held to
resolve the conflict. Rules of practice concerning the hearing will be
adopted by the Administrator.
(5) Except in those cases where an appeal is in process, any person
whose import permit is canceled must move the horse identified in the
import permit out of the United States within 10 days after receiving
oral or written
[[Page 52243]]
notification of cancellation, whichever is earlier. The horse is not
permitted to enter competition from the date the owner or importer
receives the notice of cancellation until the horse is moved out of the
United States or until resolution of an appeal in favor of the owner or
importer. Except when being exercised, the horse must be kept, at the
expense of the owner or importer, in a stall on the premises where the
horse is located when the notice of cancellation is received, or, if
the horse is in transit when the notice of cancellation is received, on
the premises where it is next scheduled to compete according to the
import permit. The stall in which the horse is kept must be separated
from other stalls containing horses, either by an empty stall, by an
open area across which horses cannot touch each other, or a by solid
wall that is at least 8 feet (2.4 m) high. In cases where the owners of
the above specified premises do not permit the horse to be kept on
those premises, or when the Administrator determines that keeping the
horse on the above specified premises will pose a disease risk to
horses in the United States, the horse must be kept, at the expense of
the owner or importer, on an alternative premises approved by the
Administrator.
(6) Stallions or mares over 731 days of age that are imported for
no more than 90 days in accordance with paragraphs (f)(1) through
(f)(3) of this section may be eligible to remain in the United States
if the following is completed:
(i) Following completion of the itinerary specified in the import
permit provided for in Sec. 92.304 of this part, the horse's owner or
importer applies for and receives a new import permit that specifies
that the stallion or mare will be moved to an approved State listed in
paragraph (h)(6) or (h)(7) of this section; and
(ii) The stallion or mare is transported in a sealed vehicle that
has been cleaned and disinfected to an approved facility in an approved
State where it is quarantined under State or Federal supervision until
the stallion or mare has met the testing and treatment requirements of
paragraph (e)(3) or (e)(5) of this section.
(7) All costs and charges associated with the supervision and
maintenance of a horse imported under paragraphs (f)(1) through (f)(3)
of this section will be borne by the horse's owner or importer. The
costs associated with the supervision and maintenance of the horse by
an APHIS representative at his or her usual places of duty will be
reimbursed by the horse's owner or importer through user fees payable
under part 130 of this chapter.
(8) In the event that an APHIS representative must be temporarily
detailed from his or her usual place of duty in connection with the
supervision and maintenance of a horse imported under paragraphs (f)(1)
through (f)(3) of this section, the owner or importer of the horse must
execute a trust fund agreement with APHIS to reimburse all expenses
(including travel costs, salary, per diem or subsistence,
administrative expenses, and incidental expenses) incurred by the
Department in connection with the temporary detail. Under the trust
fund agreement, the horse's owner or importer must deposit with APHIS
an amount equal to the estimated cost, as determined by APHIS, for the
APHIS representative to inspect the premises at which the horse will
compete, to conduct the monitoring required by paragraph (f)(2)(ii) of
this section, and to supervise the cleaning and disinfection required
by paragraph (f)(2)(vi) of this section. The estimated costs will be
based on the following factors:
(i) Number of hours needed for an APHIS representative to conduct
the required inspection and monitoring;
(ii) For services provided during regular business hours (8 a.m. to
4:30 p.m., Monday through Saturday, except holidays), the average
salary, per hour, for an APHIS representative;
(iii) For services provided outside regular business hours, the
applicable rate for overtime, night differential, or Sunday or holiday
pay, based on the average salary, per hour, for an APHIS
representative;
(iv) Number of miles from the premises at which the horse competes
to the APHIS office or facility that is monitoring the activities;
(v) Government rate per mile for automobile travel or, if
appropriate, cost of other means of transportation between the premises
at which the horse competes and the APHIS office or facility;
(vi) Number of trips between the premises at which the horse
competes and the APHIS office or facility that APHIS representatives
are required to make in order to conduct the required inspection and
monitoring;
(vii) Number of days the APHIS representative conducting the
inspection and monitoring must be in ``travel status;''
(viii) Applicable government per diem rate; and
(ix) Cost of related administrative support services.
(9) If a trust fund agreement with APHIS has been executed by the
owner or importer of a horse in accordance with paragraph (f)(8) of
this section and APHIS determines, during the horse's stay in the
United States, that the amount deposited will be insufficient to cover
the services APHIS is scheduled to provide during the remainder of the
horse's stay, APHIS will issue to the horse's owner or importer a bill
to restore the deposited amount to a level sufficient to cover the
estimated cost to APHIS for the remainder of the horse's stay in the
United States. The horse's owner or importer must pay the amount billed
within 14 days after receiving the bill. If the bill is not paid within
14 days after its receipt, APHIS will cease to perform the services
provided for in paragraph (f)(2) of this section until the bill is
paid. The Administrator will inform the owner or importer of the
cessation of services orally or in writing. If the notice of cessation
is oral, the Administrator will confirm, in writing, the notice of
cessation and the reason for the cessation of services as soon as
circumstances permit. In such a case, the horse must be kept, at the
expense of the owner or importer and until the bill is paid, in a stall
either on the premises at which the horse is located when the notice of
cessation of services is received, or, if the horse is in transit when
the notice of cessation of services is received, on the premises at
which it is next scheduled to compete according to the import permit.
The stall in which the horse is kept must be separated from other
stalls containing horses either by an empty stall, an open area across
which horses cannot touch each other, or a solid wall that is at least
8 feet (2.4 m) high. In cases where the owners of the above specified
premises do not permit the horse to be kept on those premises, or when
the Administrator determines that keeping the horse on the above
specified premises will pose a disease risk to other horses in the
United States, the horse must be kept, at the expense of the owner or
importer, on an alternative premises approved by the Administrator.
Until the bill is paid, the horse is not permitted to enter
competition. Any amount deposited in excess of the costs to APHIS to
provide the required services will be refunded to the horse's owner or
importer.
(g) Special provisions for the importation of horses that have been
temporarily exported to a CEM-affected country. If a horse has been
temporarily exported for not more than 60 days from the United States
to a CEM-affected country listed in paragraph (c)(1) of this section,
or if a horse has been temporarily exported for not more than 60 days
from another country not
[[Page 52244]]
known to be affected with CEM to a CEM-affected country during the 12
months preceding its exportation to the United States, the horse may be
eligible for return or importation into the United States without
meeting the requirements of paragraphs (d) through (f) of this section
under the following conditions:
(1) The horse must be accompanied by a certificate that meets the
requirements of Sec. 92.314(a) of this part issued by each CEM-affected
country that the horse has visited during the term of its temporary
exportation, and each certificate must contain the following additional
declarations:
(i) That the horse was held separate and apart from all other
horses except for the time it was actually participating in an event or
was being exercised by its trainer;
(ii) That the premises on which the horse was held were not used
for any equine breeding purpose;
(iii) That the horse was not bred to or bred by any animal, nor did
it have any other sexual contact or genital examination while in such
country; and
(iv) That all transport while in such country was carried out in
cleaned and disinfected vehicles in which no other horses were
transported since such cleaning and disinfection;
(2) The horse is accompanied by an import permit issued in
accordance with Sec. 92.304 of this part at the time of exportation;
(3) If the horse was temporarily exported from the United States
and is being returned to the United States, the horse must be
accompanied by a copy of the United States health certificate issued
for its exportation from the United States and endorsed in accordance
with the export regulations in part 91 of this chapter;
(4) The horse must be examined by an inspector at the U.S. port of
entry and found by the inspector to be the identical horse covered by
the documents required by paragraphs (a) through (c) of this section
and found by the inspector to be free of communicable disease and
exposure thereto; and
(5) The horse must be quarantined and tested at the U.S. port of
entry as provided in Sec. 92.308 of this part prior to release.
(h) Approval of States. In order for a State to be approved to
receive stallions or mares over 731 days of age from a CEM-affected
country listed in paragraph (c)(1) of this section that are imported
under paragraph (e) of this section, the State must meet the following
conditions:
(1) The State must enter into a written agreement with the
Administrator, whereby the State agrees to enforce its laws and
regulations to control CEM and to abide by the conditions of approval
established by the regulations in this part.
(2) The State must agree to quarantine all stallions and mares over
731 days of age imported under the provisions of paragraph (e) of this
section until the stallions have been treated in accordance with
paragraph (e)(3) of this section and the mares have been treated in
accordance with paragraph (e)(5) of this section.
(3) The State must agree to quarantine all mares used to test
stallions for CEM until the mares have been released from quarantine in
accordance with paragraph (e)(4) of this section.
(4) The State must have laws or regulations requiring that
stallions over 731 days of age imported under paragraph (e) of this
section be treated in the manner specified in paragraph (e)(3) of this
section, and that mares over 731 days of age imported under paragraph
(e) of this section be treated in the manner specified in paragraph
(e)(5) of this section.
(5) Approval of any State to receive stallions or mares imported
from countries affected with CEM may be suspended by the Administrator
upon his or her determination that any requirements of this section are
not being met. After such action is taken, the animal health
authorities of the approved State will be informed of the reasons for
the action and afforded an opportunity to present their views thereon
before such suspension is finalized; however, such suspension of
approval shall continue in effect unless otherwise ordered by the
Administrator. In those instances where there is a conflict as to the
facts, a hearing shall be held to resolve such conflict.
(6) The following States have been approved to receive stallions
over 731 days of age imported under paragraph (e) of this section:
The State of Alabama
The State of California
The State of Colorado
The State of Florida
The State of Kentucky
The State of Louisiana
The State of Maryland
The State of Montana
The State of New Hampshire
The State of New Jersey
The State of New York
The State of North Carolina
The State of Ohio
The State of South Carolina
The State of Tennessee
The State of Texas
The State of Virginia
The State of Wisconsin
(7) The following States have been approved to receive mares over
731 days of age imported under paragraph (e) of this section:
The State of Alabama
The State of California
The State of Colorado
The State of Kentucky
The State of Louisiana
The State of Maryland
The State of Montana
The State of Hew Hampshire
The State of New Jersey
The State of New York
The State of North Carolina
The State of Ohio
The State of South Carolina
The State of Tennessee
The State of Texas
The State of Virginia
The State of Wisconsin
(i) Approval of laboratories. (1) The Administrator will approve a
laboratory to conduct CEM cultures and tests only after consulting with
the State animal health official in the State in which the laboratory
is located and after determining that the laboratory:
(i) Has technical personnel assigned to conduct the CEM culturing
and testing who possess the following minimum qualifications:
(A) A bachelor's degree in microbiology;
(B) A minimum of 2 years experience working in a bacteriology
laboratory; and
(C) Experience working with the CEM organism, including knowledge
of the specific media requirements, atmospheric requirements, and
procedures for the isolation and identification of the CEM
organism.10
---------------------------------------------------------------------------
\10\ When training regarding CEM culturing and testing is
necessary, it may be obtained at the National Veterinary Services
Laboratories, Ames, IA 50010.
---------------------------------------------------------------------------
(ii) Follows standard test protocols that will reliably and
consistently provide for the isolation and identification of the CEM
organism; 11 and
---------------------------------------------------------------------------
\11\ Standard test protocols recommended by the National
Veterinary Services Laboratories and a list of approved laboratories
can be obtained from the National Veterinary Services Laboratories,
Ames, IA 50010.
---------------------------------------------------------------------------
(iii) Reports all official test results to the State animal health
official and the Veterinarian in Charge.
(2) To retain approval, the laboratory must meet the requirements
prescribed in paragraph (i)(1) of this section, and shall test with the
CEM organism each lot of media it prepares to ensure that the media
will support growth of the laboratory's reference culture. Media that
will not support growth of the reference culture must be discarded.
[[Page 52245]]
(3) The Administrator may deny or withdraw approval of any
laboratory to conduct CEM culturing or testing upon a determination
that the laboratory does not meet the criteria for approval or
maintenance of approval under paragraphs (i)(1) and (i)(2) of this
section.
(i) In the case of a denial of approval, the operator of the
laboratory will be informed of the reasons for denial and, upon
request, will be afforded an opportunity for a hearing with respect to
the merits or validity of the denial in accordance with rules of
practice that will be adopted for the hearing.
(ii) In the case of a withdrawal of approval, before such action is
taken, the operator of the laboratory will be informed of the reasons
for the proposed withdrawal and, upon request, will be afforded an
opportunity for a hearing with respect to the merits or validity of the
proposed withdrawal in accordance with rules of practice that will be
adopted for the hearing. However, the withdrawal will become effective
pending a final determination in the hearing when the Administrator
determines that such action is necessary to protect the public health,
interest, or safety. The withdrawal will be effective upon oral or
written notification, whichever is earlier, to the operator of the
laboratory. In the event of oral notification, written confirmation
will be given as promptly as circumstances allow. The withdrawal will
continue in effect pending completion of the hearing and any judicial
review of the hearing, unless otherwise ordered by the Administrator.
(iii) Approval for a laboratory to conduct CEM culturing or testing
will be automatically withdrawn by the Administrator when the operator
of the approved laboratory notifies the National Veterinary Services
Laboratories, Ames, IA 50010, in writing, that the laboratory no longer
conducts CEM culturing and testing.
(Approved by the Office of Management and Budget under control
number 0579-0040)
5. Section 92.304 is amended as follows:
a. The section heading is revised to read as set forth below.
b. In the introductory text of paragraph (a)(1)(ii), the reference
``Sec. 92.301(c)(2)(viii)'' is removed both times it appears and the
reference ``Sec. 92.301(f)'' added in its place.
c. In paragraph (a)(1)(iii), in the first sentence, the reference
``Sec. 92.301(c)(2)(viii)'' is removed and the reference
``Sec. 92.301(f)'' added in its place.
d. Paragraphs (a)(4) through (a)(12) are removed.
e. Paragraph (b) is revised to read as set forth below.
Sec. 92.304 Import permits for horses from countries affected with CEM
and for horse specimens for diagnostic purposes; reservation fees for
space at quarantine facilities maintained by APHIS.
* * * * *
(b) Permit. (1) When a permit is issued, the original and two
copies will be sent to the importer. It shall be the responsibility of
the importer to forward the original permit and one copy to the shipper
in the country of origin, and it shall also be the responsibility of
the importer to ensure that the shipper presents the copy of the permit
to the carrier and makes the necessary arrangements for the original
permit to accompany the shipment to the specified U.S. port of entry
for presentation to the collector of customs.
(2) Horses and horse test specimens for which a permit is required
under paragraph (a) of this section will be received at the port of
entry specified on the permit within the time prescribed in the permit,
which shall not exceed 14 days from the first day that the permit is
effective.
(3) Horses and horse test specimens for which a permit is required
under paragraph (a) of this section will not be eligible for entry if:
(i) A permit has not been issued for the importation of the horse
or horse test specimen;
(ii) If the horse or horse test specimen is unaccompanied by the
permit issued for its importation;
(iii) If the horse or horse test specimen is shipped from any port
other than the one designated in the permit;
(iv) If the horse or horse test specimen arrives in the United
States at any port other than the one designated in the permit;
(v) If the horse or horse test specimen offered for entry differs
from that described in the permit; or
(vi) If the horse or horse test specimen is not handled as outlined
in the application for the permit and as specified in the permit
issued.
Sec. 92.308 [Amended]
6. In Sec. 92.308(a)(3), footnote 16 and its reference in the text
are redesignated as footnote 14.
7. In Sec. 92.308(c)(1), footnote 17 and its reference in the text
are redesignated as footnote 15.
8. Section 92.314 is revised to read as follows:
Sec. 92.314 Horses, certification, and accompanying equipment.
(a) Horses offered for importation from any part of the world shall
be accompanied by a certificate of a salaried veterinary officer of the
national government of the country of origin, or if exported from
Mexico, shall be accompanied either by such a certificate or by a
certificate issued by a veterinarian accredited by the National
Government of Mexico and endorsed by a full-time salaried veterinary
officer of the National Government of Mexico, thereby representing that
the veterinarian issuing the certificate was authorized to do so,
showing that:
(1) The horses described in the certificate have been in said
country during the 60 days preceding exportation;
(2) That each horse has been inspected on the premises of origin
and found free of evidence of communicable disease and, insofar as can
be determined, exposure thereto during the 60 days preceding
exportation;
(3) That each horse has not been vaccinated with a live or
attenuated or inactivated vaccine during the 14 days preceding
exportation: Provided, however, that in specific cases the
Administrator may authorize horses that have been vaccinated with an
inactivated vaccine to enter the United States when he or she
determines that in such cases and under such conditions as he or she
may prescribe such importation will not endanger the livestock in the
United States, and such horses comply with all other applicable
requirements of this part;
(4) That, insofar as can be determined, no case of African horse
sickness, dourine, glanders, surra, epizootic lymphangitis, ulcerative
lymphangitis, equine piroplasmosis, Venezuelan equine
encephalomyelitis, or equine infectious anemia has occurred on the
premises of origin or on adjoining premises during the 60 days
preceding exportation; and
(5) That, except as provided in Sec. 92.301(g):
(i) The horses have not been in any country listed in
Sec. 92.301(c)(1) as affected with CEM during the 12 months immediately
prior to their importation into the United States;
(ii) The horses have not been on any premises at any time during
which time such premises were found by an official of the veterinary
services of the national government of the country where such premises
are located, to be affected with CEM;
[[Page 52246]]
(iii) The horses have not been bred by or bred to any horses from
an affected premises; and
(iv) The horses have had no other contact with horses that have
been found to be affected with CEM or with horses that were imported
from countries affected with CEM.
(b) If a horse is presented for importation from a country where it
has been for less than 60 days, the horse must be accompanied by a
certificate that meets the requirements of paragraph (a) of this
section that has been issued by a salaried veterinary officer of the
national government of each country in which the horse has been during
the 60 days immediately preceding its shipment to the United States.
The dates during which the horse was in each country during the 60 days
immediately preceding its exportation to the United States shall be
included as a part of the certification.
(c) Following the port-of-entry inspection required by Sec. 92.306
of this part, and before a horse offered for importation from any part
of the world is released from the port of entry, an inspector may
require the horse and its accompanying equipment to be disinfected as a
precautionary measure against the introduction of foot-and-mouth
disease or any other disease dangerous to the livestock of the United
States.
9. Preceding Sec. 92.315, in the undesignated center heading
``CANADA18'', footnote 18 and its reference are redesignated as
footnote 16.
10. Preceding Sec. 92.319, in the undesignated center heading
``COUNTRIES OF CENTRAL AMERICA AND WEST INDIES19'', footnote 19
and its reference are redesignated as footnote 17.
11. Preceding Sec. 92.321, in the undesignated center heading
``MEXICO20'', footnote 20 and its reference are redesignated as
footnote 18.
Sec. 92.324 [Amended]
12. In Sec. 92.324, in the third sentence, footnote 21 and its
reference in the text are redesignated as footnote 19.
Done in Washington, DC, this 2nd day of October 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-25639 Filed 10-04-96; 8:45 am]
BILLING CODE 3410-34-P
