[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Proposed Rules]
[Pages 28073-28085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13897]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 /
Proposed Rules
[[Page 28073]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 92
[Docket No. 95-054-1]
Importation of Horses From CEM Countries
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations regarding the
importation of horses from countries affected with contagious equine
metritis to incorporate new testing and treatment protocols for mares
and stallions, provide for the use of accredited veterinarians to
monitor horses temporarily imported into the United States for
competition purposes, incorporate a new testing protocol for
thoroughbred horses in training in their country of origin, and remove
the requirements for endometrial cultures and clitoral sinusectomies in
mares. These proposed changes are intended to update, clarify, and
streamline the existing regulations. The proposed changes would
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.
DATES: Consideration will be given only to comments received on or
before August 5, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-054-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 95-054-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room.
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.
Currently, the regulations in Sec. 92.301(c)(1) identify countries
where CEM exists and countries that trade horses freely with countries
where CEM exists without testing for CEM and prohibit, with certain
exceptions, the importation of horses into the United States from those
countries (hereafter referred to as CEM-affected countries). The
specific conditions under which certain horses may be imported into the
United States from CEM-affected countries are set forth in
Sec. 92.301(c)(2). The regulations in Sec. 92.304 (a)(4) through
(a)(12) provide for the approval of States to receive stallions and
mares from CEM-affected countries, list the States that have received
such approval from the Administrator of the Animal and Plant Health
Inspection Service (APHIS), and provide for the approval of
laboratories to conduct CEM cultures and tests.
We have determined that our CEM regulations can be changed to make
horse importations easier without increasing the risk of introducing
CEM into the United States. Therefore, we are proposing 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.
These proposed changes, along with several more minor proposed
changes, are discussed in greater detail below.
Reorganization of Provisions
We are proposing to reorganize Sec. 92.301(c) and Sec. 92.304
(a)(4) through (a)(12) to eliminate duplication and make the provisions
directly related to CEM easier to find and use. The proposed new
structure would be as follows:
The prohibition on the importation of horses from CEM-affected
countries and the list of countries affected with CEM would remain in
Sec. 92.301(c)(1). The exceptions to that prohibition would remain in
Sec. 92.301(c)(2), but only as categories of horses that may be
imported into the United States from countries affected with CEM under
certain conditions; we are proposing to set out the specific conditions
applicable to importation of horses from each category in new
paragraphs Sec. 92.301 (d), (e), (f), and (g). In this way, rather than
having the categories and conditions spread across many pages of
regulatory text as is currently the case, the reader would be presented
with a single list of all the categories of eligible horses, and then
directed to a specific paragraph to find the conditions that apply to
the importation of a particular category of horses.
The conditions that apply to the importation of horses in one of
the categories that would be listed in Sec. 92.301(c)(2) are brief and
require little elaboration. Specifically, current Sec. 92.301(c)(2)(ii)
provides for the importation of geldings, weanlings, or yearlings whose
age is certified on the import health certificate prescribed in
[[Page 28074]]
Sec. 92.314. In short, the category defines the conditions, so there is
no need to list the conditions in a separate paragraph. We are
proposing, however, to make geldings a separate category, distinct from
weanlings and yearlings, because the age certification required for
weanlings and yearlings is not necessary for geldings.
With regard to weanlings and yearlings, we are also proposing to
amend the definition in Sec. 92.300 of the term weanling or yearling,
which is currently defined as ``any horse, weaned from its dam, which
was foaled not more than 731 days prior to its offer for entry into the
United States.'' There have been instances in which an individual
certified that a horse being offered for entry was younger than 731
days of age, but the horse, upon examination by APHIS, was found to
have erupted first permanent incisors. Those teeth are not expected to
erupt until a horse has reached 2\1/2\ years of age, and subsequent
investigation disclosed that the horse was indeed older than 731 days
of age and had been fraudulently certified. We are, therefore,
proposing to include the eruption of the first permanent incisors in
the definition of weanling or yearling as a benchmark; specifically, a
sentence would be added to the definition to make it clear that if a
horse's first permanent incisors have erupted, the horse will not be
considered to be a weanling or yearling.
We are also proposing to add a new category of exceptions in
Sec. 92.301(c)(2) for wild (non-domesticated) species of equidae, such
as zebras and wild asses. These animals would be allowed to be imported
without additional restrictions for CEM if the animal had been captured
in the wild or was to be imported from a zoo or other facility where it
would be unlikely that the animal would have had contact with
domesticated horses used for breeding. That lack of contact minimizes
the risk of such an animal contracting CEM and spreading the disease to
horses in the United States. The wild or non-domesticated equine would
still have to meet the inspection and certification requirements of
Sec. 92.314 with regard to CEM and other diseases, as well as all the
applicable permit, port-of-entry inspection, and other applicable
requirements of the regulations, so the general health and movement
issues associated with its importation would continue to be addressed.
The specific provisions for importing horses in the remaining
categories would be moved to four proposed new paragraphs:
Thoroughbred horses imported for permanent entry from
France, Germany, Ireland, or the United Kingdom (current
Sec. 92.301(c)(2)(iii)) would become new Sec. 92.301(d);
Stallions and mares over 731 days of age imported for
permanent entry (current Sec. 92.301(c)(2) (iv) through (vii)) would
become new Sec. 92.301(e). The post-entry testing and treatment
requirements for those stallions and mares (current Sec. 92.304 (a)(4)
to (a)(5) and (a)(7) to (a)(8), respectively) would also be
incorporated into new Sec. 92.301(e);
Horses over 731 days of age imported for no more than 90
days to compete in specified events (current Sec. 92.301(c)(2) (viii)
through (x)) would become new Sec. 92.301(f); and
Horses that have been temporarily exported from the United
States or another country not known to be affected with CEM to a
country affected with CEM (current Sec. 92.301(c)(2)(xi)) would become
new Sec. 92.301(g).
We are also proposing to establish two more new paragraphs in
Sec. 92.301 into which we would move the remaining CEM-specific
provisions of Sec. 92.304. First, we are proposing to move the
provisions of paragraphs Sec. 92.304 (a)(4) through (a)(9) to proposed
new paragraph Sec. 92.301(h). Those paragraphs provide for the approval
of States to accept stallions and mares from CEM-affected countries and
list the States that have received such approval. Second, the
provisions of Sec. 92.304 (a)(10) through (a)(12), which pertain to the
approval of laboratories to conduct CEM cultures and tests, would
become new Sec. 92.301(i).
We are also proposing to make nonsubstantive organizational changes
to Secs. 92.304(b) and 92.314 to improve their readability. Current
Sec. 92.304(b) consists of four sentences, the last of which contains
six clauses, that can logically be divided into three subordinate
paragraphs. Similarly, current Sec. 92.314 consists of three sentences
of regulatory text, the first of which takes up over a half a page in
the Code of Federal Regulations and contains numerous clauses and two
provisos. To make those portions of the regulations easier to read and
use, we are proposing to amend Sec. 92.304(b) by organizing its
regulatory text into paragraphs (b)(1) through (b)(3) and to amend
Sec. 92.314 by organizing its regulatory text into paragraphs (a)
through (c).
As part of our proposed reorganization of the regulations, we would
also make several nonsubstantive editorial changes to improve the
clarity of the regulations.
Elimination of Duplication
There are places in the current regulations where provisions found
in one section are unnecessarily duplicated in another. Specifically,
the regulations pertaining to the importation of thoroughbred horses
(Sec. 92.301(c)(2)(iii)), stallions over 731 days of age
(Sec. 92.301(c)(2)(iv)), mares over 731 days of age (Sec. 92.301(c)(2)
(v), (vi), and (vii)), and horses that have been temporarily exported
to a CEM-affected country from the United States or another country not
known to be affected with CEM (Sec. 92.301(c)(2)(xi)) all require a
horse offered for importation to be accompanied by a certificate that
confirms certain facts regarding the horse's health.
The certificate referred to in those paragraphs is the same
certificate required by Sec. 92.314 for all horses offered for
importation, and Sec. 92.314 clearly describes the information that the
certificate must contain and who may sign the certificate. Two of the
criteria found in Sec. 92.314--the description of who may sign the
certificate and a requirement that the certificate confirm that each
horse has been found free of evidence of communicable disease--are
repeated in those paragraphs of Sec. 92.301(c)(2) cited in the
preceding paragraph. Because those signature and confirmation criteria
are clearly described in Sec. 92.314, we do not believe that it is
necessary to repeat them in other sections of the regulations.
Therefore, proposed new Sec. 92.301 (d), (e), and (g), which would
contain the requirements for the importation of thoroughbred horses,
stallions and mares over 731 days of age, and horses temporarily
exported to a CEM-affected country, would simply state that the horses
must be accompanied by a certificate issued in accordance with
Sec. 92.314.
We are proposing to eliminate duplication in several other places
in the regulations by combining, where appropriate, separate provisions
for mares and stallions. We believe that combining separate provisions
is possible in those parts of the regulations dealing with the
collection of specimens because the requirements as to when and by whom
the specimens are to be collected are the same for both stallions and
mares; it is only the sites from which the specimens are to be
collected that differ. Therefore, in proposed new Sec. 92.301 (d), (e),
and (h), we would combine those provisions that are common to both male
and female horses, while keeping separate those provisions that must
necessarily be gender-specific.
[[Page 28075]]
Similarly, where there are now three different sets of provisions
for importing female horses over 731 days of age for permanent entry
(Sec. 92.301 (c)(2)(v), (c)(2)(vi), and (c)(2)(vii)), proposed new
Sec. 92.301(e) would contain a single set of provisions. The proposed
consolidation of those three sets of provisions would be made possible,
in large part, by other proposed changes, discussed below, that would
remove the clitoral sinusectomy requirement and standardize testing
protocols.
Use of Nitrofurazone
The regulations require, as a pre-import treatment for certain
stallions and a post-entry treatment for certain stallions and mares,
that a nitrofurazone ointment be used to coat or pack the animals'
genitalia as a means of killing the CEM organism. However, many
countries now prohibit the use of nitrofurazone on horses due to
concerns about its residues in horsemeat, so we are proposing to amend
those portions of the regulations that specifically require the use of
nitrofurazone.
Under the regulations in current Sec. 92.301(c)(2)(iv)(E), if a
specimen taken from a stallion prior to export to the United States is
found positive for CEM, the stallion's prepuce, urethral sinus, and
fossa glandis must be scrubbed with a solution of chlorhexidine and
then packed with an ointment of nitrofurazone for 5 consecutive days in
order to kill the CEM organism. We are proposing to remove those
specific instructions for scrubbing and packing 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.
We would require that the treatments performed and the dates of the
treatments be recorded on the horse's health certificate, so APHIS
would have the opportunity to consider the treatments used when the
stallion is offered for importation into the United States. We would
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
could enter the United States. Because the requirement for retesting
would 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 would not result in an increased risk of CEM-infected stallions
entering the United States.
As part of these proposed changes, we are also proposing to amend
Sec. 92.301(c)(2)(iv)(B) by removing footnote 7, which is referenced at
the end of the paragraph. Footnote 7 states: ``Except for stallions
that test positive for CEM, treatment in the country of origin is
optional.'' We are proposing to remove that footnote because we believe
that the regulatory text of proposed new Sec. 92.301(e) clearly
describes the testing and treatment requirements for stallions and
spells out which stallions must be treated to be eligible for
importation into the United States. Subsequent footnotes in the
regulations that refer the reader to ``footnote 7 to subpart C'' would
also be removed.
Once the stallion has been imported into the United States and has
been sent to an approved State for quarantine, the regulations in
current Sec. 92.304(a)(5)(iii)(A) require, among other things, that the
prepuce, penis, and urethral sinus of the stallion be scrubbed with a
solution of chlorhexidine and packed with an ointment of nitrofurazone
for 5 consecutive days. Similarly, the regulations in
Sec. 92.304(a)(8)(iii)(B) regarding the treatment and handling of
imported mares in quarantine in approved States require that the mare's
external genitalia, vaginal vestibule, and, if present, clitoral
sinuses, must be scrubbed with a solution of chlorhexidine and then
coated with an ointment of not less than 0.2 percent nitrofurazone; the
clitoral fossa and, if present, the clitoral sinuses, must also be
packed with an ointment of not less than 0.2 percent nitrofurazone. We
are proposing to modify those requirements by removing the reference to
nitrofurazone and requiring only that an ointment effective against the
CEM organism be used. Because the availability of such ointments can
vary over time and from place to place, and because the treatments must
be performed by an accredited veterinarian and monitored by a State or
Federal veterinarian, we do not believe it is necessary to maintain a
list of specific ointments in the regulations. Rather, the accredited
veterinarian, State veterinarian, and Federal veterinarian, or any
other interested person, could obtain a list of ointments recognized as
being effective against the CEM organism from APHIS. A footnote to that
effect would be added to the regulations regarding the post-entry
treatment and handling of stallions and mares.
Clitoral Sinusectomy
We are proposing to eliminate the requirement that certain mares
undergo a clitoral sinusectomy. Currently, clitoral sinusectomies are
required for female horses over 731 days of age imported for permanent
entry (Sec. 92.301 (c)(2)(v)(C), (c)(2)(v)(G), and (c)(2)(vi)(G)),
certain mares over 731 days of age that had originally been imported
for no more than 90 days and that are moved to an approved State for
permanent entry (Sec. 92.301(c)(2)(x)), and mares that were not
required to undergo a clitoral sinusectomy as a condition of
importation but that have been cultured for CEM with positive results
in an approved State prior to release from State quarantine
(Sec. 92.304(a)(8)(iii)(E)).
We believe that the clitoral sinusectomy requirement can be
eliminated completely because the procedure is no longer necessary to
ensure that imported mares do not introduce CEM into the United States.
A new procedure has been developed that allows veterinarians to clean
and treat the clitoral sinuses to eliminate the CEM organism, thus
rendering clitoral sinusectomies unnecessary. Therefore, the clitoral
sinusectomy requirement and any provisions related to that requirement
would be removed from the regulations. Proposed new Sec. 92.301(e)(5),
which contains the testing and treatment requirements for mares, would
spell out the proposed new cleaning and treatment procedure. In that
procedure, an accredited veterinarian would manually remove organic
debris from the clitoral sinuses of a mare, then flush the sinuses with
a cerumalytic agent. For 5 consecutive days after the cleaning, the
accredited veterinarian would aseptically clean and wash the mare's
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. This procedure has been shown to effectively
eliminate debris that could harbor the CEM organism and can be carried
out without the use of the restraints, anesthesia, or tranquilizers
needed for the clitoral sinusectomy surgery, which would clearly be to
the mare's benefit.
Endometrial Cultures
We are proposing to remove the requirement for the collection and
culturing of endometrial specimens from mares. Currently, the
regulations require that endometrial specimens be collected during
estrus from female thoroughbred horses (Sec. 92.301(c)(2)(iii)(B)),
female horses over 731 days of age (Sec. 92.301 (c)(2)(v)(F) and
(c)(2)(vi)(D)), test mares used for testing stallions in an approved
State (Sec. 92.304 (a)(5)(iii)(B)(2) and (a)(5)(iii)(C)(2)), pregnant
mares over 731 days of age (Sec. 92.304(a)(8)(iii)(C)(1)),
[[Page 28076]]
nonpregnant mares over 731 days of age (Sec. 92.304(a)(8)(iii)(C)(2)),
and mares over 731 days of age that have been found to be positive for
CEM (Sec. 92.304 (a)(8)(iii)(D) and (a)(8)(iii)(E)). We believe that
the required collection and culturing of endometrial specimens can be
eliminated completely because over the last 10 to 12 years we have
cultured over 900 pregnant mares offered for importation and have never
found a positive endometrial culture in specimens collected from mares
that were negative on cultures of the clitoral sinuses. Because we
would continue to require the collection of specimens from the clitoral
sinuses, and because additional specimens would be drawn from the
urethra and cervix, we believe that the requirement for endometrial
cultures could be removed without increasing the risk of CEM being
introduced into or disseminated within the United States.
As part of this proposed change, we are also proposing to remove
the requirement for testing the foals of mares that had been pregnant
at the time they were received in quarantine in an approved State. The
regulations in Sec. 92.304(a)(8)(iii)(C)(1) require that 7 days after
the mare foals, three endometrial specimens be collected from the mare
and another specimen be collected from the vaginal vestibule or prepuce
of her foal, depending on its sex. We believe that the accuracy of the
cultures of specimens collected from the clitoral sinuses, which we
cited in the previous paragraph as rendering endometrial cultures
unnecessary, also makes it unnecessary to test foals. If cultures of
specimens collected from a pregnant mare indicated she was free from
CEM infection, there would be no cause to test her foal, since the foal
could only contract the disease from its dam during birth. This
proposed change would also mean that a pregnant mare would no longer
have to remain under quarantine in the approved State until 7 days
after foaling, since endometrial cultures from the mare and cultures
from the foal would no longer be required.
Collecting Specimens From Mares Over 731 Days of Age
The current regulations contain three different pre-import test
protocols for mares over 731 days of age; a protocol for testing
pregnant mares and, later, their foals, in quarantine in an approved
State after importation; and yet another protocol for testing
nonpregnant mares in quarantine in an approved State. Those protocols
differ in terms of their timing and sites from which specimens are to
be collected for culturing because some mares require endometrial
cultures while others do not, and some mares must undergo a clitoral
sinusectomy, some do not, and others would have already undergone the
surgery before a particular test. With the requirements for endometrial
cultures and clitoral sinusectomies removed as proposed above, we
believe that we can simplify matters by standardizing the sites from
which specimens would be collected from mares and the timing of those
collections when multiple sets of specimens are needed for culturing.
We are proposing 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 surface of the urethra, the mucosal
surface of the clitoral sinuses, and the mucosal surface of the cervix.
Using the mucosal surfaces of the urethra, clitoral sinuses, and cervix
as sites for the collection of specimens for culturing is in keeping
with current codes of practice for the diagnosis of CEM and would allow
us to accurately assess the CEM status of mares over 731 days of age
that are offered for importation or that are quarantined in an approved
State.
The regulations currently require that three sets of specimens be
collected from mares over 731 days of age in quarantine in an approved
State; those specimens are to be drawn at intervals of no less than 7
days. We are proposing to decrease the time over which specimens are to
be drawn by requiring that all three sets of specimens be collected
over a single 7-day period, with the collections taking place on the
first, fourth, and seventh days. When collecting multiple sets of
specimens from a horse for culturing, it is prudent to collect sets of
specimens on different days in order to increase the likelihood that
any infection will be detected. However, we believe the current 7-day
minimum interval between collections is unnecessarily long; the
proposed 7-day collection period would simplify and shorten the testing
process for mares while continuing to provide for a sufficient amount
of time between the collection of sets of specimens.
Testing and Treatment for Stallions Over 731 days of Age
Once a stallion over 731 days of age has been imported into the
United States and has been sent to quarantine in an approved State, the
regulations currently require that a set of specimens be collected from
the stallion and cultured for CEM, after which the stallion's genitalia
are to be washed with a surgical scrub and packed with an antibiotic
ointment for 5 consecutive days; 7 days after the fifth day of cleaning
and packing, the stallion must be test bred to two qualified test
mares. In order to increase the likelihood that testing will detect the
presence of CEM, we are proposing to reverse the order of the latter
two items, i.e., we would require that the test breeding take place
before the cleaning and packing. If the stallion was infected with CEM,
the two test mares would most likely contract the disease as a result
of the test breeding, so there would be, in effect, three chances to
detect the disease--one through the tests conducted on the stallion and
two through the tests conducted on each test mare. The cleaning and
packing, when conducted first, may reduce the chance that an infected
stallion would transmit the disease to the test mares by reducing the
presence of the CEM organism to a low level.
Test Mares
The current regulations require that a test mare must qualify as
apparently free from CEM. To qualify, the mare must be tested with
negative results by a complement fixation test for CEM, and specimens
taken from the mare must be cultured negative for CEM. Currently, one
set of specimens must be drawn from the endometrium, clitoral sinuses,
and clitoral fossa; then, no less than 7 days later, another set of
specimens must be drawn from the cervix, clitoral sinuses, and clitoral
fossa. As previously explained, we are proposing to remove the
requirement for the collection and culturing of endometrial specimens
from imported mares. We are proposing to remove that requirement for
test mares, for the same reasons. We are also proposing that test mares
would have specimens collected from the mucosal surface of the urethra,
clitoral sinuses, and cervix, as proposed for all mares over 731 days
of age offered for importation. This would be in keeping with current
codes of practice for the diagnosis of CEM and would allow us to
accurately assess the CEM status of test mares. We are also proposing
that three sets of specimens be collected, and that all sets of
specimens be collected within a 7-day period, on days 1, 4, and 7. This
would be consistent with proposed CEM tests for mares offered for
importation.
After being test bred by the stallion, the regulations currently
require that specimens be collected from the test mares on the second,
fourth, and seventh days after breeding and cultured for CEM;
endometrial specimens must be collected and cultured during the next
estrus; and two blood serum samples must be drawn
[[Page 28077]]
from the test mares 15 to 40 days after breeding and tested for CEM
using the complement fixation test. As discussed above, we have
proposed to remove the requirement for endometrial cultures, so that
step would be eliminated. We are proposing to further amend those
requirements by shifting the collection of specimens to the third,
sixth, and ninth days after breeding, which means that any CEM
infection would have an additional day to manifest itself in the test
mares, followed by a full 2 days between the collection of each
additional set of samples. By delaying and slightly lengthening the
period over which specimens are collected from bred test mares, we
would increase the likelihood that the presence of CEM infection will
be detected in the test mares. We are also proposing to reduce the
number of required complement fixation tests to a single test conducted
15 days after breeding. We believe that the second complement fixation
test is unnecessary because the multiple cultures conducted on the
specimens drawn during the 9 days after breeding would provide, in
nearly all cases, an accurate indication of the test mare's CEM status;
a single complement fixation test would be adequate to confirm the
findings of the culturing.
New Testing Protocol for Thoroughbred Horses
We are proposing to simplify the pre-export testing protocols for
thoroughbred horses from France, Germany, Ireland, and the United
Kingdom. Under the current regulations, three sets of specimens must be
collected and cultured from thoroughbred horses at intervals of no less
than 7 days, with the final collection and culturing being completed
within 30 days of export. We are proposing to shorten the time frame
for collections and culturing from over 2 weeks to 1, with specimens
being collected on the first, fourth, and seventh days of the 7-day
period. We would, however, retain the requirement that the last set of
specimens must be collected and cultured within 30 days of export. As
noted above with regard to test mares and mares over 731 days of age
quarantined in an approved State, we believe the current 7-day interval
between collections is unnecessarily long; the proposed 2-day interval
simplifies and shortens the pre-export testing process for thoroughbred
horses while continuing to provide for a sufficient amount of time
between the collection of sets of specimens.
We are also proposing to modify the collection sites for specimens
drawn from female thoroughbred horses to make those sites consistent
with the proposed changes regarding collection sites for test mares and
mares over 731 days of age and to reflect the proposed discontinuation
of the collection and culturing of endometrial specimens. As was
proposed for the other two categories of female horses, and for the
same reasons, the collection sites for specimens from female
thoroughbred horses would be the mucosal surfaces of the urethra,
clitoral sinuses, and cervix.
The regulations regarding the importation of thoroughbred horses
currently contain no specific provisions for the treatment and
retesting of thoroughbred horses that test positive for CEM during pre-
export testing. We are proposing to add provisions that would allow the
thoroughbred horse to be treated for CEM in a manner approved by the
national veterinary service of the country of origin. We would require
that the treatments performed and the dates of the treatments be
recorded on the horse's health certificate, so APHIS would have the
opportunity to consider the treatments used when the thoroughbred horse
is offered for importation into the United States. We would require
that the retesting of the thoroughbred horse take place no less than 21
days following the completion of treatment. The horse would have to be
found free of CEM on the retest before it could enter the United
States. These proposed provisions for retesting thoroughbred horses are
consistent with the retest provisions for stallions and mares over 731
days of age and would serve the same purpose. Because the thoroughbred
horses would not be allowed entry into the United States until they had
been found free of CEM, we believe that allowing thoroughbred horses
that have tested positive for CEM to be treated and retested would not
result in an increased risk of CEM-infected horses entering the United
States.
We are also proposing to make two minor changes in the regulations
regarding the importation of thoroughbred horses. First, we are
proposing to remove two references to the ``Federal Republic of
Germany'' and replace them with references simply to ``Germany,''
because the reunification of East Germany and West Germany has removed
the need to differentiate between the two. Second, footnote 6 in
current Sec. 92.301(c)(2)(iii)(A), which lists specifically approved
recordkeeping associations in those countries from which thoroughbred
horses may be imported, contains an out-of-date reference to such
associations in Australia. We are proposing to remove that reference
because Australia is no longer on the list of CEM-affected countries in
Sec. 92.301(c)(1).
Use of Accredited Veterinarians
The regulations in Sec. 92.301(c)(2)(viii)(B)(2) require that
horses imported for no more than 90 days to compete in specified events
must be monitored by an APHIS representative--i.e., an APHIS
veterinarian or other authorized APHIS employee--while the horse is on
the premises at which it is competing. The regulations pertaining to
import permits in Sec. 92.304(a)(1)(iii) state that the approval of a
permit application to temporarily import a horse is contingent upon
APHIS' determination that a sufficient number of APHIS personnel are
available to provide the required services. In order to increase the
number of qualified veterinarians available to perform the required
activities and decrease the costs associated with the temporary
importation of horses for competition, we are proposing to allow the
required monitoring to be conducted by an accredited veterinarian. An
accredited veterinarian is, by definition, already familiar with APHIS'
animal health programs and regulations and is approved by the
Administrator to perform the functions associated with those programs,
so we believe that accredited veterinarians would be fully capable of
monitoring temporarily imported horses at the premises on which they
are competing. We would, however, provide for an APHIS representative
to conduct spot checks to ensure compliance with the regulations. If
the APHIS representative found that the requirements of the regulations
were not being met, APHIS would have the option of requiring that all
remaining monitoring for a particular event be conducted by APHIS
representatives. The proposed spot checks and the option for APHIS to
take over monitoring duties would act as additional safeguards against
the spread of disease and would help to ensure compliance with the
regulations.
Other Proposed Changes
The regulations in Sec. 92.301(c)(2)(viii)(G) currently require the
owner or importer of a temporarily imported horse to enter into a trust
fund agreement with APHIS to ensure that he or she pays all costs
associated with APHIS' supervision and maintenance of the horse during
the time it is in the United States. When the required supervision and
maintenance services can be provided by an APHIS representative
operating out of his or her usual place of duty, however,
[[Page 28078]]
APHIS' costs can be recovered through user fees payable under 9 CFR
part 130, so it would not be necessary for the owner or importer to
enter into a trust fund agreement. There are still cases, though, in
which a trust fund agreement would be necessary, such as when an APHIS
representative is not available to provide the necessary services in a
given area, or there is an insufficient number of APHIS representatives
to meet the needs of a large event, and an APHIS representative must be
temporarily detailed from his or her usual place of duty to the site of
a particular event. Therefore, we are proposing to amend the
regulations to differentiate between those cases where user fees would
be sufficient to recover APHIS' costs and those cases where the owner
or importer of a horse would have to enter into a trust fund agreement
with APHIS.
Miscellaneous Changes
Several of the proposed changes discussed above would result in
footnotes being added, deleted, or moved; therefore, we are proposing
to redesignate the footnotes that follow those that would be affected
by the proposed changes to maintain numerical order.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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.
This proposed rule would amend the regulations regarding the
importation of horses from countries affected with contagious equine
metritis to incorporate new testing and treatment protocols for mares
and stallions, provide for the use of accredited veterinarians to
monitor horses temporarily imported into the United States for
competition purposes, incorporate a new testing protocol for
thoroughbred horses in training in their country of origin, and remove
the requirements for endometrial cultures and clitoral sinusectomies in
mares. These proposed changes are intended to update, clarify, and
streamline the existing regulations. The proposed changes would
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.
The United States is a net exporter of horses, exporting three to
four horses for every one imported, and unit values for imports and
exports favored the United States until 1994. The unit value of exports
was $3,197 per head in 1993, while the unit import value was $2,944 per
head; in 1994, these values shifted to $2,458 per head (export) and
$4,032 per head (import).
In 1993, U.S. exports of horses totaled 64,478 head valued at
$206.1 million; in 1994, the total was 85,299 head valued at $209.7
million. Most of those horses were exported to Canada, Mexico, Western
Europe (especially the United Kingdom and Ireland), the Middle East, or
Asia. U.S. imports of horses, on the other hand, are small relative to
total inventory and U.S. horse exports. In 1993, U.S. horse imports
totaled 20,715 head valued at $61 million; in 1994, the total was
23,186 head valued at $93.5 million. Canada and Mexico were the source
of almost 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,'' January/February 1995).
Small entities maintain almost 95 percent of the domestic horse
inventory.
The proposed new testing and treatment protocols presented in this
document are the only aspects of this proposed rule that are expected
to have an economic impact. In each case, the proposed changes would
reduce the time required to collect samples, conduct tests, and
administer treatments, which would shorten the period that an imported
horse would 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 would
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 proposed in this document are
expected to cut that time frame to 2 to 3 weeks.
We do not expect, however, that the proposed 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 would not be significantly
affected, and those countries that do not currently meet those
requirements are not expected to meet the proposed new requirements
either.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
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 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 92 would be 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 would continue 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 would be
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.
[[Page 28079]]
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 would be amended as follows:
a. In Sec. 92.304, footnote 12 and its reference in the section
heading would be removed.
b. In Sec. 92.303(e), footnote 11 and its reference in the text
would be redesignated as footnote 12.
4. In Sec. 92.301, paragraph (c) would be revised and new
paragraphs (d) through (i) would be 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, 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 as a State 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;
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(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 surface of the
urethra, the mucosal surface of the clitoral sinuses, and the mucosal
surface of the cervix 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 must complete the Federal quarantine required under
Sec. 92.308. Upon completion of the Federal quarantine, the horses may
be released.
(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:
[[Page 28080]]
(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 surface of the urethra, the mucosal surface
of the clitoral sinuses, and the mucosal surface of the cervix. 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 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 each of
the mucosal surfaces of the cervix, urethra, 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 urethra, clitoral sinuses, and cervix.
(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;
(B) The test mare is subjected to an ovariectomy by an accredited
veterinarian under the direct supervision of a State or Federal
veterinarian;
[[Page 28081]]
(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
each mare on three separate occasions within a 7-day period. On days 1,
4, and 7, an accredited veterinarian shall collect a specimen from the
mucosal surfaces of the urethra, clitoral sinuses, and cervix, and
shall submit each specimen or set of specimens to 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.
(ii) Following the collection of specimens in accordance with
paragraph (e)(5)(i) of the section, 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.
---------------------------------------------------------------------------
(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, 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
[[Page 28082]]
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 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 by 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 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 hours, 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,
[[Page 28083]]
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 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 or horse 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
[[Page 28084]]
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 protocol prescribed by the National
Veterinary Services Laboratories; 11 and
---------------------------------------------------------------------------
\11\ Standard test protocols prescribed 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.
(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 would be amended as follows:
a. The section heading would be 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)'' would be 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)'' would be removed and the reference
``Sec. 92.301(f)'' added in its place.
d. Paragraphs (a)(4) through (a)(12) would be removed.
e. Paragraph (b) would be 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.
(a) * * *
(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
would be redesignated as footnote 14.
7. In Sec. 92.308(c)(1), footnote 17 and its reference in the text
would be redesignated as footnote 15.
8. Section 92.314 would be 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,
[[Page 28085]]
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;
(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.
Sec. 92.315 [Amended]
9. In Sec. 92.315, in the undesignated center heading ``CANADA
18'', footnote 18 and its reference in the center heading would be
redesignated as footnote 16.
Sec. 92.319 [Amended]
10. In Sec. 92.319, in the undesignated center heading ``COUNTRIES
OF CENTRAL AMERICA AND WEST INDIES 19'', footnote 19 and its
reference in the center heading would be redesignated as footnote 17.
Sec. 92.321 [Amended]
11. In Sec. 92.321, in the undesignated center heading
``MEXICO\20\'', footnote 20 and its reference in the center heading
would be redesignated as footnote 18.
Sec. 92.324 [Amended]
12. In Sec. 92.324, in the second sentence, footnote 21 and its
reference in the text would be redesignated as footnote 19.
Done in Washington, DC, this 30th day of May 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-13897 Filed 6-03-96; 8:45 am]
BILLING CODE 3410-34-P
