Standards for Permanent, Privately Owned Horse Quarantine Facilities, 31582-31601 [E9-15509]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Part 93
[Docket No. APHIS–2006–0013]
RIN 0579–AC00
Standards for Permanent, Privately
Owned Horse Quarantine Facilities
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
SUMMARY: We are amending the
regulations pertaining to the
importation of horses to establish
standards for the approval of
permanent, privately owned quarantine
facilities for horses. We are taking this
action because regional and seasonal
demand for quarantine services for
horses often exceeds the space available
at existing facilities. Allowing imported
horses to be quarantined in permanent,
privately owned quarantine facilities
that meet the criteria established in this
rule will facilitate the importation of
horses while continuing to protect
against the introduction of
communicable diseases of horses.
DATES: Effective Date: August 3, 2009.
FOR FURTHER INFORMATION CONTACT: Dr.
Ellen Buck, Staff Veterinary Medical
Officer, Equine Imports, National Center
for Import and Export, VS, APHIS, 4700
River Road Unit 39, Riverdale, MD
20737–1231; (301) 734–8364.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 93
govern the importation of specified
animals and animal products in order to
prevent the introduction of various
animal diseases into the United States.
The regulations in part 93 require that
some of these animals be quarantined
upon arrival in the United States as a
condition of entry. The Animal and
Plant Health Inspection Service (APHIS)
operates animal quarantine facilities
and authorizes the use of privately
owned quarantine facilities for certain
animal importations. The regulations in
subpart C of part 93 (9 CFR 93.300
through 93.326) pertain to the
importation of horses and include
requirements for privately owned
quarantine facilities for horses. Prior to
this final rule, these requirements
applied solely to the approval and
establishment of temporary quarantine
facilities for the purpose of quarantining
imported horses for a specific event.
However, APHIS did authorize the
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operation of one permanent, privately
owned quarantine facility for horses,
located in Los Angeles County, CA.
On December 13, 2006, we published
in the Federal Register (71 FR 74827–
74847; Docket No. APHIS–2006–0013) a
proposal1 to amend the regulations by
establishing standards for the approval
of permanent, privately owned horse
quarantine facilities. We stated that
such facilities, if constructed and
operated using the proper safeguards,
would provide an effective and efficient
means of bringing horses into the
United States without compromising
our ability to protect against the
introduction of communicable diseases
of horses. In that proposal, we also
withdrew an earlier proposal, published
in the Federal Register on July 1, 2002
(67 FR 44097–44111, Docket No. 99–
012–1), which would have established
differing requirements in the regulations
for the approval and operation of such
permanent facilities.
We solicited comments concerning
our proposal for 60 days ending
February 12, 2007. We received 15
comments by that date. They were from
horse owners, breeders, members of
Congress, State agricultural agencies,
equine industry groups, the operators of
a quarantine facility, and several private
citizens. They are discussed in the
sections below, by topic.
General Comments on the 2006
Proposed Rule
One commenter suggested that
establishing standards for privately
owned horse quarantine facilities was
unnecessary. Citing the absence of any
diseased horses that have passed
through the one currently operating
permanent, privately owned quarantine
facility into the domestic horse
population, the commenter stated that
this facility has demonstrated adequate
biological security measures to prevent
the introduction of communicable
diseases of horses into the United
States. The commenter suggested that
the biosecurity requirements of the
proposed rule were disproportionate to
the actual disease risk associated with
quarantining horses at the facility.
Although the biosecurity measures in
place at that particular facility may
serve to mitigate the risk of disease
spread from that site, we still consider
the biosecurity requirements described
in our proposal to be necessary. This is
because APHIS based the requirements
on our experience in mitigating the risk
1 To view the proposal and the comments we
received, go to https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS-2006-0013.
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of disease introduction via imported
horses. We modeled the proposed risk
mitigation measures on those in place at
APHIS-operated and -approved
facilities, after assessing them for
adequacy and general applicability. We
determined such an approach to be
necessary in order to create national
standards for such facilities.
The fact that no equine diseases are
known to have passed through the one
privately owned facility currently in
operation into the domestic horse
population does not in itself address the
potential disease risks that other
quarantine facilities elsewhere in the
United States could encounter.
Two commenters suggested that
private ownership of permanent horse
quarantine facilities presents an
unavoidable and irresolvable conflict of
interest, inasmuch as we allow a private
entity to operate a Federally regulated
facility. One of these commenters
recommended that APHIS withdraw the
proposed rule, and assume management
of all horse quarantine facilities. If that
is not feasible, the commenter suggested
exclusive oversight of the facilities
should be delegated to public agencies,
including universities, agricultural
colleges, and other institutions under
contract or cooperative agreement with
APHIS.
We do not consider private ownership
of an equine quarantine facility to
present an irresolvable conflict of
interest, provided that the facility
operates under adequate Federal
oversight. We consider the degree of
APHIS oversight of private facilities
required by this rule to be sufficient to
mitigate this potential conflict of
interest.
A more extensive discussion of
APHIS oversight of permanent, privately
owned equine quarantine facilities is
found below, in the section titled
‘‘Changes and Clarifications with Regard
to APHIS Oversight.’’
Several commenters questioned
APHIS’ intent in establishing standards
for privately owned quarantine
facilities. One suggested that APHIS will
use the rule to expedite the slaughter of
horses, while another stated that the
rule constitutes collusion with the
parimutuel horseracing industry to
facilitate gambling. Accordingly, both
commenters suggested we withdraw the
rule.
As explained in the proposed rule,
our reasons for developing standards for
permanent, privately owned equine
quarantine facilities were the increased
demand for import quarantine facilities
that has arisen in the last 20 years, the
geographic distribution of the currently
operating horse quarantine facilities,
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which can make it difficult or costly to
import horses to some areas, and the
inability, because of the nature of their
construction and operation, of
temporary, privately owned quarantine
facilities to fill the continual demand for
import quarantine services.
One commenter stated that the
proposed rule lacked sufficient
safeguards to protect the health of the
domestic horse population. The
commenter pointed out that the rule
does not establish a ‘‘follow-up’’ system
for horses once they are released from
quarantine and does not address
diseases of horses endemic to the
United States.
The purpose of horse quarantine
facilities is to observe imported horses
for any sign of communicable equine
diseases, in order to prevent the
introduction or further dissemination of
those diseases within the United States.
In this regard, it is worth noting that no
permanent equine quarantine facility,
whether privately or Federally operated,
currently has a ‘‘follow-up’’ system such
as that suggested by the commenter.
Instead, APHIS conducts tracebacks
during animal disease events to
determine the premises of origin of the
outbreak, and also administers various
domestic surveillance, control and
eradication programs for equine
diseases. Among these programs are our
surveillance and vaccination efforts to
prevent the spread of West Nile equine
encephalomyelitis and our surveillance
and control program for contagious
equine metritis (CEM).
The aim of the proposed rule was to
create standards and protocols for
permanent, privately owned quarantine
facilities in order to prevent such
diseases from being transmitted through
these facilities and into the domestic
horse population. Thus, establishing
ongoing surveillance of horses of foreign
origin and addressing diseases of horses
endemic to the United States both fall
outside of the scope of this rulemaking.
One commenter asked whether an
approved facility, if vacant, could be
used to house and quarantine domestic
horses in transit from a disaster area,
provided that the horses are subject to
the same quarantine operations as
horses imported into the United States.
Establishing rules for such an
alternate use of permanent horse
quarantine facilities falls outside of the
scope of this rulemaking. However, in
the event of an animal disease outbreak
or a natural disaster, APHIS may consult
with the operators of a quarantine
facility in order to facilitate emergency
operations, including emergency
housing and quarantines.
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Finally, one commenter asked
whether we intend to gradually phase
out existing APHIS-operated and
-approved quarantine facilities as a
result of the rule, while another
suggested that we build another APHISoperated facility on the west coast.
We will maintain the APHIS-operated
facilities that presently exist. However,
we have no current plans to build
additional facilities.
Changes and Clarifications With
Regard to APHIS Oversight
In the proposed rule, we stated that
permanent, privately owned horse
quarantine facilities would be subject to
oversight by APHIS representatives,
would operate under continuous APHIS
oversight, and would have at least one
APHIS representative overseeing the
care of all horses in quarantine. We also
proposed that quarantine operations, the
disposal of wastes, and cleaning and
disinfection procedures at the facility
would occur under the oversight of
APHIS representatives, and further
specified that incineration activities,
whether onsite or offsite, would occur
under direct APHIS oversight. We stated
that APHIS would furnish services
related to maintenance of the facility
and daily care of horses under
quarantine if the operator of the facility
failed to do so as provided in the
proposed rule, but did not provide
further criteria by which we would
evaluate facilities in this regard. Finally,
we proposed that the handling,
washing, and disposal of soiled and
contaminated clothing at the facility
would have to occur in a manner
approved by APHIS.
Many commenters expressed concern
regarding these proposed provisions.
One considered continual oversight
unnecessary. Others stated that we
should reevaluate the need for ongoing
and direct APHIS oversight of cleaning
and disinfection procedures and
incineration activities.
Several commenters asserted that we
failed to adequately define ‘‘oversight.’’
As a result, these commenters were
uncertain whether APHIS oversight
consisted of direct and continual
supervision only of quarantine
operations, of quarantine operations and
other related procedures, or of all
operations within the quarantine
facility. If we intended APHIS oversight
to be only of quarantine operations, the
commenters stated, it was unclear
whether we intended quarantine
operations to take place during normal
working hours or continually
throughout the day. If we intended
oversight to cover other procedures, the
commenters were uncertain to what
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degree APHIS representatives would
oversee them and when they would
occur. Finally, several commenters
asked how much APHIS oversight
would cost.
We regard APHIS oversight of the
facility to be necessary in order for us
to carry out our responsibility under the
Animal Health Protection Act (7 U.S.C.
8301 et seq., AHPA) to ensure that
imported horses released from a
quarantine facility are free of
communicable equine diseases.
However, we have revisited the
proposed rule in light of the
commenters’ concerns and appreciate
the opportunity to clarify the nature of
APHIS oversight. In our proposal, we
used the term ‘‘APHIS oversight’’ in two
different ways. In certain instances, it
meant the responsibilities and duties
that require APHIS to assume ultimate
accountability for the biological security
of the facility and the welfare of horses
onsite, without usually being physically
present at the facility. If we determine
that either biosecurity or animal welfare
is being jeopardized at the facility, this
oversight may require us to be
physically present at the facility to
provide services to safeguard either
biosecurity or welfare of the horses.
Additionally, APHIS may withdraw
approval of the facility. However,
APHIS often exercises this type of
oversight by developing care plans and
compliance agreements with entities,
and by conducting subsequent spot
audits in order to ensure that the terms
of these plans and agreements are
followed.
In other instances within the
proposed rule, ‘‘APHIS oversight’’
meant those occasions when APHIS
representatives must be physically
present at the facility to carry out a
particular function. Those occasions
will vary somewhat from facility to
facility, and may even vary within the
facility from importation to importation.
Nonetheless, we have determined that
APHIS representatives must be present
at a facility to monitor import
quarantine operations whenever they
occur, and to provide other technical
services related to biological security.
Technical services include, but are not
limited to, those measures necessary to
prevent or limit the spread of disease
within the facility if a horse in
quarantine has been determined to be
affected with an equine disease.
To clarify this distinction, we have
modified several paragraphs in § 93.308
from our proposal to make the occasions
that will necessitate our physical
presence at the facility more explicit:
• In the proposed rule, paragraph
(c)(1)(ii)(C) stated that, in order for a
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facility to be approved, the
Administrator must determine that
sufficient APHIS personnel are available
to serve as representatives at the facility
and to provide continuous oversight
over import quarantine operations and
other technical services related to
biological security of the facility. In this
final rule, that paragraph now states
that, if a facility is approved, APHIS
representatives will be present at all
import quarantine operations to monitor
them and will be present to provide
technical services to ensure the
biological security of the facility. It also
specifies that these technical services
include overseeing the disposition of an
infected or exposed horse at the facility,
in accordance with paragraph
(c)(4)(v)(H). Import quarantine
operations include, but are not limited
to, visual inspection of the animal on
arrival, identification of the animal with
its accompanying import certificate,
serological testing, and monitoring of
routine diagnostic tests.
• In the proposed rule, paragraph
(c)(2)(ii)(B) stated that the compliance
agreement that the operator of a
privately owned facility or the
operator’s agent and the Administrator
must execute must provide that the
facility’s quarantine operations are
subject to the oversight of APHIS
representatives. In this final rule, as part
of the agreement, the operator now must
agree to have APHIS representatives
present at all import quarantine
operations at the facility in order to
monitor the import quarantine
operations.
• In the proposed rule, paragraph
(c)(4)(i)(A) stated that, as part of the
operating procedures at the facility, the
quarantine of horses at the facility are
subject to the oversight of APHIS
representatives authorized to perform
the services required by the rule and by
the compliance agreement. In this final
rule, that paragraph now specifies that
APHIS representatives will be
physically present at and monitor all
import quarantine operations at the
facility.
• In the proposed rule, paragraph
(c)(4)(v)(H) stated that should a horse be
determined to be infected with or
exposed to a communicable disease of
horses, the final disposition of the horse
must occur under the direct oversight of
APHIS representatives. In this final rule,
that paragraph now states that APHIS
representatives must be physically
present at and directly monitor the
disposition of the horse.
• In the proposed rule, we referred
throughout § 93.308 to ‘‘quarantine
operations.’’ In this final rule, to better
delineate those procedures for which
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APHIS representatives will maintain a
physical presence at quarantine
facilities, we have changed every such
reference to ‘‘import quarantine
operations.’’
As part of the reevaluation that led to
these clarifications, we also examined
whether the maintenance of the facility,
the daily care of horses under
quarantine, the disposal of wastes,
cleaning and disinfection procedures,
incineration activities, and the
handling, washing, and disposal of
soiled and contaminated clothing at the
facility could be performed without
APHIS personnel being physically
present on each occasion. We have
determined that these activities and
procedures need APHIS oversight, but
that it is not necessary for APHIS
representatives to maintain physical
presence at them and direct or continual
monitoring of them, unless we have
reason to believe that these activities are
being neglected or carried out in a
manner that compromises either the
biological security of the facility or the
welfare of horses onsite.
In order for APHIS to allow these
practices to be conducted without our
physical presence, however, we have
determined that we must possess
adequate knowledge of the standard
practices that the operator of the facility
will employ regarding these activities
prior to APHIS’ initial approval of the
facility. We have also determined that
we must possess some mechanism
whereby we can evaluate the operator’s
adherence to these practices once the
site is operational and, if necessary, take
remedial measures to address any
failure to comply with these standards.
As a result of this determination, in
§ 93.308, we have modified proposed
paragraph (c)(2)(ii), which sets forth
requirements for the compliance
agreement that an operator of a facility
or his or her agent must execute prior
to APHIS approval of the facility, to
specify that each compliance agreement
must provide that the operator agrees to
demonstrate, to the satisfaction of the
Administrator, that the routine cleaning
and maintenance of the facility, the
daily care of animals in quarantine, the
disposal of wastes at the facility, the
cleaning and disinfection procedures
employed by the facility, the handling,
washing, and disposal of soiled and
contaminated clothing worn within the
facility, and the disposal of dead horses,
whether onsite or offsite, adhere to the
best practices of biological security and
animal care; and provide that the
operator agrees to random spot audits by
APHIS representatives to determine
whether employees and other personnel
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are complying with these practices.2
These two requirements are found in
subparagraphs (E) and (F) of paragraph
(c)(2)(ii) in § 93.308 of this final rule.
Accordingly, proposed paragraph
(c)(4)(i)(B) of § 93.308, which pertained
to the maintenance of the facility and
the daily care of animals in quarantine,
has been modified to reflect these
changes to the compliance agreement. In
this final rule, the paragraph provides
that, if, as the result of a spot audit, or
for any other reason, APHIS determines
that the operator has failed to properly
care for, feed, or handle quarantined
horses as required by this final rule or
in accordance with the terms of the
compliance agreement, or has failed to
maintain and operate the facility as
provided in the rule or in accordance
with the terms of the compliance
agreement, APHIS representatives will
furnish such services, will make
arrangements for the sale or disposal of
quarantined horses at the quarantine
facility owner’s expense, or will begin
the process for withdrawal of approval
of the quarantine facility. In the
proposed rule, this paragraph did not
mention either spot audits or the
compliance agreement, and did not state
that nonadherence to the provisions of
the rule could result in withdrawal of
approval.
In this final rule, the following
paragraphs have been modified to
specify that the procedures detailed in
the paragraphs must be carried out in
accordance with the term of the
compliance agreement, and to state that
the procedures are therefore subject to
spot audits:
• Paragraph (c)(3)(iii)(F), which
pertains to the disposal of wastes at the
facility;
• Paragraph (c)(3)(iii)(H), which
pertains to incineration activities;
• Proposed (c)(3)(iv)(F), which
pertains to the disposal of wastes at the
facility;
• Paragraph (c)(4)(iv)(C), which
pertains to the handling, washing, and
disposal of soiled and contaminated
clothing worn within the quarantine
facility;
• Paragraph (c)(4)(iv)(D), which
pertains to cleaning and disinfection
procedures for equipment used in the
quarantine area;
• Paragraph (c)(4)(iv)(E), which
pertains to cleaning and disinfection
2 Best practices for biological security and animal
care are those employed at our Federally
maintained quarantine facilities or otherwise
specified within operational memoranda issued by
APHIS’ Veterinary Services division. APHIS will
facilitate the operator’s access to these best
practices prior to the execution of the compliance
agreement.
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procedures for vehicles entering and
exiting the quarantine area; and
• Paragraph (c)(4)(iv)(G), which
pertains to cleaning and disinfection
procedures for lot-holding areas.
If, at any time, an APHIS
representative discovers that employees
or other authorized personnel are not
following the terms of the compliance
agreement, he or she may issue
additional instructions regarding the
measures that these individuals must
take while import quarantine operations
are being conducted at the facility
(paragraph (c)(4)(ii)(C) of § 93.308). If
employees do not follow these
additional instructions, APHIS
representatives may require the operator
to bar these personnel from the facility
(paragraph (c)(2)(ii)(D) of § 93.308).
Finally, in this final rule, both
paragraphs (c)(1)(iv)(C)(1) and
(c)(4)(i)(B) of § 93.308 provide that
nonadherence to the terms of this rule
or the compliance agreement by the
operator or his or her employees may
result in withdrawal of approval of the
quarantine facility.
In response to the commenters’
questions regarding when APHIS would
exercise oversight of the facility, APHIS
representatives will ordinarily render
their services during their normal tour
of duty as APHIS employees. An APHIS
employee’s tour of duty may vary, but
always excludes Sundays and holidays.
If circumstances require an APHIS
employee to be present at the facility
outside of his or her tour of duty, we
will charge an overtime rate for those
services. This rate is found in 9 CFR
130.30(b).
Similarly, in response to the
commenters’ questions regarding the
cost associated with APHIS oversight, in
the proposed rule, we stated that we
will charge for APHIS’ inspection of a
facility at the hourly rates listed in 9
CFR 130.30. We also stated that the
operator of the facility would be charged
for the services APHIS representatives
provide in accordance with 9 CFR part
130.
In a related matter, as we mentioned
above, proposed § 93.308(c)(1)(ii)(C)
stated that part of APHIS’ initial
evaluation of an application for
approval of a facility would be a
determination of whether sufficient
APHIS personnel are available to serve
as APHIS representatives at the facility,
in order to provide continuous oversight
of import quarantine operations and
other technical services pertaining to
biological security.
Several commenters expressed
concern regarding this paragraph. One
commenter stated that APHIS does not
currently have sufficient personnel at
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existing APHIS-operated quarantine
facilities, and thus cannot assume
oversight of privately owned facilities.
Another stated that recent outbreaks of
equine herpes virus (EHV–1) at an
APHIS-operated quarantine facility
suggest that the biological security risks
associated with horse quarantine
facilities have increased and necessitate
that more personnel be assigned to the
facility than APHIS can provide. A third
commenter stated that it is unlikely that
APHIS personnel will be available to
continually staff the facilities, and we
should therefore consider providing
funding opportunities through
cooperative agreements for State animal
health officials to provide health
inspection services at the facilities. A
fourth commenter suggested that, in the
event of a lack of adequate personnel,
APHIS should delegate supervision of
certain quarantine operations, such as
the collection of blood samples, to
private practitioners.
Those commenters who stated that
APHIS does not have sufficient
personnel to serve as representatives at
or to provide continual oversight of a
quarantine facility appear to have based
their evaluation, in large part, on an
expansive understanding of ‘‘APHIS
oversight.’’ We consider the
clarifications and amendments we have
made to the proposed rule regarding the
nature of this oversight to be sufficient
to address this aspect of the
commenters’ concerns.
In addition, by making a
determination that APHIS must have
sufficient personnel to serve as
representatives to a facility one of the
conditions for the Administrator’s
initial approval of the facility, we are
afforded the opportunity to evaluate
both the extent to which such approval
could have a detrimental impact on
existing import quarantine operations at
APHIS-operated facilities, and the
likelihood that a future outbreak of a
foreign animal disease would cause us
to have insufficient personnel to oversee
import quarantine operations and assure
biosecurity at any facility, whether
privately operated or maintained by
APHIS. If the Administrator determines
that approval of a privately operated
facility would jeopardize import
quarantine operations or biosecurity at
an existing quarantine facility, he or she
will not grant such approval.
We consider APHIS oversight of
import quarantine operations and other
related services conducted at a facility
to be necessary for us to carry out our
responsibility under the AHPA to
prevent the introduction of a foreign
communicable disease of horses into the
domestic equine population. We do not
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consider it appropriate to delegate this
responsibility to private practitioners or
State animal health officials. However,
this rule does not amend or supplant the
existing regulations in 9 CFR part 93
that pertain to the various operations
that accredited veterinarians and State
animal health officials may conduct in
order to provide care for imported
horses or in order to prevent the spread
of communicable equine diseases.
We address the commenter’s concerns
regarding the biological security of
equine quarantine facilities in light of
the 2006 outbreak of EHV–1 in the
section below titled ‘‘Comments on
Construction Requirements.’’
Comment Regarding the Role of State
Departments of Agriculture
One commenter asked whether APHIS
oversight involves parallel supervision
of the quarantine facility by State
departments of agriculture, State
veterinarians, and State animal health
agencies. If it does not, the commenter
suggested the final rule authorize such
entities to be consulted and have some
authority in the approval of the facility,
in any decision regarding the location of
the facility, in approval of contingency
plans for emergency medical care of
quarantined horses and possible
disposal of all horses housed at the
facility, in the granting of variances
from the terms of the rule, and in the
decisionmaking process for denying or
withdrawing approval of the facility.
As we mentioned above, it is APHIS’
responsibility under the AHPA to
prevent the introduction of foreign
communicable diseases of horses into
the domestic equine population. As part
of this duty, it is necessary for us to
make the ultimate determination in
those areas described by the commenter.
Therefore, we do not consider it
possible to delegate responsibility to or
share responsibility with State animal
health authorities for these
determinations in the manner requested
by the commenter.
However, our responsibility does not
preclude APHIS from asking State
authorities to provide guidance
regarding the approval of a proposed
facility. Indeed, on many occasions, we
may have to solicit such input in order
to determine whether a proposed
facility meets local and State
environmental regulations. Such a
determination is required in paragraph
(c)(5) of § 93.308.
In addition, APHIS has recently
undertaken an initiative to facilitate
greater communication with State
agricultural agencies, and to establish
greater collaboration among Federal and
State officials in the development of
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effective strategies to respond to animal
disease events and emergency situations
at the State and local levels. We will
implement this rule in a manner that is
consistent with that initiative,
especially in matters pertaining to the
biosecurity of the facility and the health
of livestock in the area of the facility.
Comment Regarding Temporary,
Privately Owned Quarantine Facilities
In our proposal, we proposed to
amend paragraphs (b) and (c) of § 93.308
by combining the two paragraphs,
which contained requirements for
temporary, privately owned horse
quarantine facilities, into a single
paragraph (b), and by making several
nonsubstantive changes to the text of
these paragraphs.
One commenter asked whether these
changes established new regulations for
such temporary facilities. In the
commenter’s estimation, it would prove
impracticable to have temporary
facilities adhere to the same standards
as permanent facilities.
We are maintaining the existing
provisions for temporary, privately
owned quarantine facilities. This rule
establishes standards solely for
permanent facilities.
Comments Regarding Denial or
Withdrawal of APHIS Approval
In § 93.308, proposed paragraph
(c)(1)(iv) set forth a protocol for denying
or withdrawing approval of a
permanent, privately owned horse
quarantine facility, and reasons for
APHIS to deny or withdraw such
approval. Among other reasons, we
stated that, if the operator or a person
responsibly connected with the business
of the quarantine facility acts as a paid
agent (broker) for the importation or
subsequent sale of a horse, APHIS could
deny or withdraw approval of a
privately owned horse quarantine
facility.
We deemed a person to be responsibly
connected with the business of the
quarantine facility if that person has an
ownership, mortgage, or lease interest in
the facility’s physical plant, or if that
person is a partner, officer, director,
holder, or owner of 10 percent or more
of its voting stock, or is an employee in
a managerial or executive capacity. We
included these provisions in our
December 2006 proposal in response to
comments that we received regarding
our July 2002 proposal. The commenters
on the earlier proposal suggested that an
operator who also acted as a broker
would face conflicts of interest while
housing, treating, and caring for horses
imported by other brokers.
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We received two comments regarding
these provisions. Both commenters
considered the measure to be overly
restrictive, and suggested that a person
engaged in both operation of the facility
and import brokerage would not
necessarily encounter a substantive and
irresoluble conflict of interest. One of
these commenters asserted that the one
permanent, privately owned horse
quarantine facility currently in
operation has functioned as an import
broker almost since its establishment,
without incident or complaint. In lieu of
these provisions, the commenters
suggested that APHIS forbid operators
from discriminating against any
importer or agent, under penalty of fines
or withdrawal of approval.
We are making no changes to the
proposed rule in response to these
comments. If an operator acts as a
broker, this may not necessarily lead to
conscious discrimination against the
horses of other brokers, or in favor of
one’s own horses. However, it does
predispose the operator to act in a
manner that serves, or at least preserves,
his or her economic interest in the
horses under quarantine, and creates an
incentive for the operator to
discriminate in favor of his or her own
horses, those of a family member, or
those belonging to an individual who
has a business relationship with the
operator. Prohibiting operators from
acting as brokers is necessary to prevent
these conflicts.
Another commenter suggested that
APHIS could largely resolve this
conflict of interest and make this
provision unnecessary by privatizing all
existing Federal horse quarantine
facilities. The commenter did not
explicitly state why such privatization
would attenuate this conflict of interest,
but appeared to suggest that this action
would provide an opportunity for other
brokers to assume ownership of these
Federal facilities.
Such privatization would not remove
the conflict of interest, since it would
still allow operators to act as brokers.
The same commenter suggested that,
if we do not pursue privatization, these
provisions are insufficient. The
commenter pointed out that the one
currently operating permanent,
privately owned horse quarantine
facility not only engages in import
brokerage, but also functions as a
retailer in the shipping industry. The
commenter suggested that operators
who act as shippers may encounter
similar conflicts to those who act as
brokers. Therefore, the commenter
asked that, if we do not pursue
privatization, we should consider
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prohibiting operators not only from
brokerage, but also from retail shipping.
Operators do not possess as
immediate and substantive an economic
interest in the horses they ship as they
do in those horses for which they act as
brokers. If an operator assumes
brokerage of a horse, the economic
interest that the operator gains in the
horse necessarily creates incentives for
the individual to use his or her position
as an operator in order to preserve and,
if possible, increase the value of the
horse, or conversely, to use that position
to create competitive disadvantages for
other brokers utilizing his or her facility.
If an operator becomes the shipping
agent for a horse, but does not function
as the horse’s broker, the economic
interest that the operator has lies not in
the horse itself, but in conveyance of the
animal to or from the quarantine
facility. This sort of interest creates only
tangential or incidental incentives for
the individual to use his or her position
as an operator to maintain or increase
the value of the animal to be shipped.
For this reason, we do not consider the
potential conflicts associated with retail
shipping equivalent to those associated
with brokerage, and are therefore not
including shipping of horses as a reason
to deny or withdraw approval of a
permanent, privately owned quarantine
facility in this final rule.
Comments Regarding the Compliance
Agreement for Permanent Facilities
In § 93.308, proposed paragraph (c)(2)
stated that the operator of the facility or
his or her agent would have to execute
a compliance agreement with the
Administrator. In the proposal, we
specified that the compliance agreement
would have to provide that the facility
would have to meet all applicable
requirements of proposed § 93.308 and
that the facility’s quarantine operations
would be subject to the oversight of
APHIS representatives. The compliance
agreement also stated that the operator
of the facility would be responsible for:
• The cost of the facility;
• All costs associated with the
facility’s maintenance and operation;
• All costs associated with the hiring
of employees and other personnel to
attend to the horses as well as to
maintain and operate the facility;
• All costs associated with the care of
quarantined horses, such as feed,
bedding, medicines, inspections,
testing, laboratory procedures, and
necropsy examinations; and
• All APHIS charges for the services
of APHIS representatives in accordance
with § 93.308 and 9 CFR part 130.
The compliance agreement would
further provide that the operator would
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agree to bar from the facility any
employee or other personnel at the
facility who fails to comply with the
standards governing permanent,
privately owned quarantine facilities,
found in paragraph (c) of § 93.308, with
other provisions of 9 CFR part 93, with
any terms of the compliance agreement,
or with any related instructions from
APHIS representatives.
Two commenters expressed concern
regarding the section of the compliance
agreement in which the operator agrees
to pay all charges for services rendered
by APHIS representatives assigned to
the facility. One of the commenters
stated that this stipulation is at odds
with the procedures in place at the one
permanent, privately owned quarantine
facility currently in operation, and is
inconsistent with the practices of
APHIS-operated quarantine facilities.
The commenter stated that at such
facilities the importer of record or the
shipping agent is responsible for all fees
for APHIS services.
The fees that APHIS assesses on
importers and shipping agents at the
quarantine facilities that we operate are
for services rendered directly on behalf
of the importer or shipping agent, such
as meeting the importer or agent at the
port of entry in order to facilitate
transportation of the animal to the
quarantine facility, or drawing blood for
routine serological tests once import
quarantine operations have been
completed.
In contrast, the services that APHIS
employees will provide at privately
owned equine quarantine facilities will
be directly related to conducting import
quarantine operations and maintaining
biosecurity for all horses at the facility,
and are thus properly rendered on
behalf of the operator of the facility,
rather than on behalf of a specific
importer or agent. Therefore, it is
reasonable that the operator of the
facility should agree to pay all charges
for such services. This provision is
consistent with the standards currently
in place for temporary, privately owned
quarantine facilities, which require the
operator of the facility to bear all
maintenance and operation costs.
Finally, it is important to note that
this rule does not prohibit the operator
of a privately owned equine quarantine
facility from passing on the costs of
APHIS’ services to the importer of
record or the shipping agent.
Another commenter asked if pricing
structures for the services rendered at
the privately owned facilities will
correspond to those already in place for
APHIS-operated quarantine facilities.
As we mentioned in the proposed
rule, APHIS will charge for its services
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according to 9 CFR part 130. We will
not regulate the amount that the
operators of a facility may charge for
services that they themselves provide.
Comments Regarding Location
Requirements
In § 93.308, proposed paragraph
(c)(3)(i) set forth location requirements
for permanent, privately owned
quarantine facilities. These required that
the quarantine facility must be located
in proximity to a port authorized under
paragraph (e) of § 93.303 of the
regulations, and that the site and the
specific routes for the movement of
horses from the port to the site must be
approved by the Administrator based on
consideration of whether the site or
routes would put the horses in a
position that could result in the
transmission of communicable diseases
to domestic horses. In both our
December 2006 proposal and our July
2002 proposal, we decided not to
specify a maximum distance that a
facility could be located from a port of
entry. In each proposal, we cited the
diversity of locations of possible ports of
entry as a reason for not setting such a
distance: Some may be located in large
metropolitan areas, with the nearest
concentration of livestock many miles
away, while others may be in towns
with rural areas and high concentrations
of livestock within a very short distance
of the port.
Two commenters asked that APHIS
add provisions to specify a maximum
distance that a quarantine facility can be
from a port of entry. One of these
commenters stated that, if a quarantine
facility were located many miles from a
port of entry, a horse refused entry at
one of the quarantine facilities would
have to be transported a great distance
before being exported from the United
States. In the commenter’s estimation,
transporting a diseased horse for such a
period of time, even under the most
stringent biological security measures,
would pose a substantial risk of disease
spread through third-party vectors, such
as flies and gnats.
We do not consider it possible to set
a maximum distance that a quarantine
facility can be located from a port of
entry. In light of the diversity of places
in which persons may consider locating
a permanent facility, and the possibly
substantive variations among different
ports of entry, setting specific distances
may result in regulations that are too
stringent for some facilities, and too lax
for others.
In a similar matter, in our July 2002
proposal, we proposed to require that
the facility be located at least one-half
mile from premises holding livestock or
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horses. In response to a commenter who
suggested that other requirements in our
proposal established adequate
biosecurity to render such a requirement
unnecessary, we reevaluated the need
for this requirement, and removed it
from our December 2006 proposal.
Instead, we specified that the site would
have to be approved by the
Administrator as described above. The
Administrator will take into
consideration the proximity of the
quarantine facility to the nearest port of
entry, and the disease risks posed by
transit of an infected horse from the port
to the facility, in making his or her
determination whether to approve the
construction of the facility.
A commenter on the December 2006
proposal suggested that mandating a
minimum distance that a facility can be
constructed from the surrounding horse
population greatly reduces the
likelihood of disease spread to that
population and the possibility of a
subsequent equine disease outbreak in
the vicinity of the facility, and such a
requirement ought to be included in the
final rule.
We have evaluated the biosecurity
requirements we described in the
proposed rule, and determined that they
are adequate to mitigate the possibility
of disease spread. Therefore, if all other
procedures described in this rule are
followed at a private, permanently
owned quarantine facility, a distance
requirement is unnecessary.
We note, however, that we are
requiring that each application for
approval of a quarantine facility must
specify the location and street address
of the facility. This requirement affords
the Administrator the opportunity to
assess the specific risks posed by that
location, in accordance with paragraph
(c)(3)(i) of § 93.308, and to specify
additional biological security measures,
beyond those specified in the rule, that
the facility must adopt in order to
address these risks and prevent disease
spread. As specified in paragraph
(c)(1)(ii)(B) of § 93.308, the
Administrator may impose such
additional requirements within the
terms of the compliance agreement.
If the Administrator decides that the
disease risks associated with a
particular location are insurmountable,
even with the imposition of such
additional biosecurity requirements, he
or she will not approve the location of
the facility.
Comments Regarding Construction
Requirements
In § 93.308, proposed paragraph
(c)(3)(ii) set forth construction
requirements for permanent, privately
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owned horse quarantine facilities. The
proposed basic standards for the facility
addressed perimeter fencing, entrances
and exits, windows, lighting, loading
docks, surfaces, horse stalls, aisleways,
isolation stalls, showers, APHIS space,
necropsy areas, storage space,
restrooms, ventilation, climate control,
fire alarms, and communications
systems.
Our July 2002 proposed rule included
several specific construction
requirements for lot-holding areas.
These areas, which we defined as ‘‘areas
within a permanent, privately owned
quarantine facility in which lots of
horses are held,’’ would have had
separate drainage and heating,
ventilation, air conditioning systems,
and physical barriers. Our December
2006 proposed rule retained the
provisions regarding lot-holding areas,
but provided more options for operators
to provide biological security within
these areas, such as cleaning and
disinfection after each use of an area.
One commenter suggested that APHIS
remove those additional options for lotholding areas and return to the more
stringent requirements presented in the
July 2002 proposed rule. The
commenter cited the 2006 outbreak of a
neurotropic EHV–1 mutation in a lot of
horses at a permanent, APHIS-operated
quarantine facility as evidence of the
significant disease risks that may arise
at a quarantine facility, and suggested
that the revisions to lot-holding areas set
forth in our December 2006 proposal
did not take these risks into adequate
account. The commenter therefore
suggested that APHIS reevaluate the
construction standards proposed for
these areas in light of the outbreak.
We are making no change in response
to this comment. The construction
standards in the December 2006
proposal called for physical barriers to
be erected to separate different lots of
horses at the facility, so that horses in
one lot cannot have physical contact
with horses in another lot, their
excrement, or their discharges. In
addition, the sanitary standards in the
2006 proposal stated that each lotholding area of the facility would have
to be thoroughly cleaned with a
disinfectant upon release of a lot of
horses before a new lot of horses can
enter the lot-holding area. APHIS has
determined that these safeguards, which
are comparable to those at APHISoperated facilities, effectively limit the
spread of communicable diseases of
horses between lots of horses at a
facility. We note, in this regard, that the
biological security measures in place at
the quarantine facility that was the site
of the EHV–1 outbreak limited the
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spread of the disease to one lot of
horses—neither lots in adjacent holding
areas nor subsequent lots at the
quarantine facility tested positive for the
virus.
Finally, if a disease of horses, whether
foreign or endemic to the United States,
spreads within a particular lot of horses,
the horses in that lot are subject to the
provisions of paragraph (c)(4)(v)(H) of
§ 93.308, which sets forth requirements
regarding the final disposition of horses
infected with or exposed to a
communicable disease of horses.
Another commenter stated that the
construction requirements presented in
the December 2006 proposed rule were
not sufficiently delineated. The
commenter asserted that, instead of
creating objective and unilaterally
binding specifications, APHIS had made
standards primarily dependent on the
judgment of APHIS representatives who
inspect and approve the facility. In the
commenter’s opinion, this could result
in wide deviations regarding the
biological security of various facilities,
and would necessarily make it difficult
for a third party to determine the criteria
by which the representative has
evaluated a facility. The commenter
suggested that, at a minimum, the final
rule provide more detailed criteria for
the construction of drainage and heating
systems, ventilation, air conditioning
systems, physical barriers, and material
used in the construction of floors and
walls within the quarantined area.
We are making no change in response
to this comment. Our June 2002
proposed rule contained more specific
construction criteria for lot-holding
areas, floor drains, physical barriers,
showering areas, areas for breaks and
meals, and heating and ventilation units
within the facility. In response to those
proposed requirements, several
commenters pointed out that some of
these requirements were more
restrictive than the design of various
APHIS-operated facilities. Other
commenters suggested that we generally
amend the construction requirements to
allow operators as many design
variations as possible. Accordingly, in
drafting our December 2006 proposal,
we reevaluated the construction
requirements that we proposed in 2002
and determined that, on certain
occasions, the requirements of our 2002
proposal were indeed inconsistent with
those at APHIS-approved facilities. On
other occasions, we determined that the
requirements could be adjusted to allow
operators more options to provide
adequate biological security at the
facility. This led us to modify the
construction requirements mentioned
by the commenter.
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The APHIS approval process will
ensure that all permanent, privately
owned facilities are constructed in a
manner adequate to prevent the
transmission of disease between lotholding areas, thus preventing any wide
deviations with regard to biosecurity. In
addition, we note that, under paragraph
(c)(1)(ii)(B) of § 93.308, the
Administrator may impose additional
construction requirements within the
terms of the compliance agreement,
beyond those specified in the rule, if he
or she determines these requirements to
be necessary to prevent the transmission
of diseases into, within, or from the
facility.
Several commenters suggested that
the construction standards be modified
to allow or require exercise equipment
or ‘‘turn-out’’ pens for horses in
quarantine. Such accommodations, the
commenters stated, would allow horses
under quarantine to maintain muscle
tone and general overall health.
Allowing a horse under quarantine to
be separated from its lot and released for
exercise to an area of the facility outside
the lot-holding area, whether indoor or
outdoor, presents an unacceptable risk
of disease spread. We note, in this
regard, that horses that are required
under the regulations to be quarantined
for extended periods of time after their
importation often have been imported
from regions where a communicable
equine disease is known to exist, or
from regions that engage in trade with
such regions and do not require testing
or vaccination for that disease.
We recognize, however, that it may be
possible to place exercise equipment in
the stalls or in other parts of the lotholding areas, depending on the size or
construction of such areas. Therefore,
we have modified proposed paragraph
(c)(3)(i)(G) of § 93.308, which stated that
the stalls in which horses are kept
would have to be large enough to allow
each animal to make normal postural
and social adjustments with adequate
freedom of movement, to further state
that exercise equipment for horses may
be kept in the stalls, provided that there
will still be sufficient space within the
stall for the horses to move freely once
the equipment is installed.
Moreover, the regulations in this final
rule allow exercise equipment to be kept
in the lot-holding areas themselves. Any
such equipment would, however, be
subject to the cleaning and disinfection
procedures required for lot-holding
areas. To clarify this provision, we have
modified proposed paragraph
(c)(4)(iv)(D), which contained cleaning
and disinfection requirements for
equipment used within the quarantine
area of the facility, to specify that these
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requirements also pertain to exercise
equipment located within the
quarantine area.
Comment Regarding Requirements for
Isolation Stalls
In § 93.308, proposed paragraph
(c)(3)(ii)(I) addressed requirements for
the means of isolation within
permanent, privately owned facilities.
We stated that the facility must have
physical barriers to separate different
lots of horses at the facility, so that
horses in one lot cannot have physical
contact with horses in another lot, or
their excrement or discharges. We also
stated that the facility must have stalls
capable of isolating any horses
exhibiting signs of illness.
One commenter pointed out that we
did not specify a location for these
stalls. As a result, the commenter was
uncertain whether APHIS intended
stalls to be constructed in a separate
building or merely in such a manner
that the horse does not have direct
contact with other horses in its lot.
An isolation stall may be constructed
in a separate building or within the
quarantine area, provided that, in the
estimation of the Administrator, the
stall is able to physically isolate the
horse from other horses at the facility.
Comment Regarding Requirements for
Necropsy Areas and Carcass Removal
In § 93.308, proposed paragraph
(c)(3)(ii)(L) set forth construction
requirements for necropsy areas used by
permanent, privately owned quarantine
facilities. These required that all
facilities must either have an area for
conducting necropsies onsite, or must
have designated an alternate facility,
approved by the Administrator, at
which a suitable necropsy area is
available. In proposed paragraph
(c)(3)(iii)(G) of § 93.308, which set forth
sanitation requirements for permanent,
privately owned quarantine facilities,
we stated that each facility must have
the capability to dispose of horse
carcasses in a manner approved by the
Administrator and under conditions
that minimize the risk of disease spread.
One commenter stated that the carcass
disposal requirements appear to be
based on the quarantine facility’s use of
an onsite necropsy area. If the
quarantine facility utilizes an alternate
facility for necropsies, however, the
commenter suggested that these
disposal requirements no longer apply,
since the sanitary disposal of the carcass
after necropsy would become the
responsibility of this other facility.
We are making no change in response
to this comment. When a horse dies at
a permanent, privately owned facility,
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the operator assumes ultimate
responsibility for the disposal of its
carcass in a manner acceptable to the
Administrator, and under direct
oversight of APHIS, whether the
necropsy is conducted onsite or at
another facility. The location of the
necropsy, then, has no bearing on the
disposal requirements.
Comment Regarding Security
Requirements
In proposed paragraph (c)(3)(iv) of
§ 93.308, we set forth security
requirements for permanent, privately
owned facilities. We proposed that the
facility and premises be kept locked and
secure at all times. We also proposed to
require that the facility and premises
must have signs indicating that the
facility is a quarantine area and no
visitors are allowed.
Further, we proposed to require that
the facility and premises either be
guarded at all times by representatives
of a bonded security company or,
alternatively, have an electronic security
system that indicates the entry of
unauthorized persons into the facility.
Finally, we proposed to require that
the operator of the facility notify the
designated APHIS representative
whenever a breach of security occurs or
is suspected of having occurred.
Further, if a disease is diagnosed in
quarantined horses, we stated that the
Administrator may require the operator
to have the facility guarded by a bonded
security company in a manner that the
Administrator deems necessary to
ensure the biological security of the
facility.
One commenter stated that these
provisions appear to prohibit any
individual, including authorized
personnel, from entering the facility,
except in the presence of an APHIS
representative. During all other times, it
appeared to the commenter as if the
facility would have to be locked and the
entrances to it guarded, protected by
alarm, barred, or sealed.
Paragraph (c)(4)(iii) grants authorized
employees and other personnel assigned
to work at the facility access to the
facility premises as well as the
quarantine area, even in the absence of
an APHIS representative. This provision
addresses the commenter’s concerns.
Comment Regarding Personnel
Requirements
In proposed paragraph (c)(4)(ii) of
§ 93.308, we set forth personnel
requirements for permanent, privately
owned quarantine facilities. Among
other provisions, these proposed that:
• The operator of the facility would
have to provide APHIS with a
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continually updated list of all personnel
who have access to the facility; and
• The operator of the facility would
have to provide APHIS with signed
statements from every employee and
any other personnel hired by the
operator and working at the facility in
which the person agrees to comply with
all regulations governing permanent,
privately owned horse quarantine
facilities, other applicable provisions of
9 CFR part 93, all terms of the
compliance agreement, and any related
instructions from APHIS representatives
pertaining to quarantine operations.
One commenter stated that both the
list of personnel and the signed
compliance statements appear to be
unnecessary, if APHIS representatives
will be physically present at all times to
oversee the facility.
As discussed earlier, APHIS will
ordinarily only maintain a physical
presence at and direct supervision of
import quarantine operations and
certain technical services related to the
biological security of the facility.
Therefore, in order to ensure the general
biological security of the facility, it is
important that APHIS representatives
have a continually updated list of all
personnel with access to the facility,
one that takes into consideration
employee turnover at the facility itself
and at any company with access to the
facility. It is also important that all
personnel agree to adhere to the
biological security measures set forth
within the rule and the compliance
agreement.
That said, we do recognize that the
proposed rule could be construed to
suggest that, although APHIS personnel
will be physically present at the facility,
compliance agreements and signed
statements from personnel must be
submitted to APHIS employees at an offsite location, rather than to the
personnel assigned to the facility, for
review. This is not the case. The
operator may submit such records to
APHIS personnel assigned to the
facility. The records will then be
forwarded to the appropriate area
veterinarian-in-charge office.
Comments Regarding Showering
Requirements
In § 93.308, proposed paragraph
(c)(4)(iv) set forth sanitation
requirements for permanent, privately
owned facilities. Proposed
(c)(4)(iv)(A)(1) and (2) included
provisions requiring that all persons
granted access to the quarantine area
shower when entering and leaving that
area, and that all persons shower when
leaving the necropsy area if a necropsy
is in the process of being performed or
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has just been completed, and portions of
the animal remain exposed.
One commenter stated that these
provisions were not the practice of the
one permanent, privately owned horse
quarantine facility currently in
operation. The commenter suggested
that the facility’s standards, which
require personnel to wash their overalls
and shower before leaving work, would
provide a less burdensome alternative to
the provisions of our proposal.
‘‘Shower in/shower out’’ is
considered a cornerstone of biosecurity,
and is recognized and recommended by
government, academia, and industry to
prevent the spread of disease agents into
or from live animal facilities.
Accordingly, APHIS has determined
that showering reduces the risk of
disease spread from quarantine or
necropsy areas, and may, in certain
instances, remove a pathway for the
transmission of a communicable disease
of horses. Therefore, these provisions
represent the practices of APHISoperated facilities. They have thus been
evaluated for efficacy and general
applicability. Conversely, the
commenter provided no data suggesting
that the practices of the one permanent,
privately owned horse quarantine
facility currently in operation are
equally effective risk-mitigation
measures.
The same commenter stated that
showering requirements, in themselves,
do not adequately address the risk of the
spread of communicable diseases of
horses, since they do not preclude the
movement of waste material from a
quarantined area.
The rule provides multiple safeguards
to prevent the movement of waste
material from the quarantine area. In
§ 93.308, paragraphs (c)(4)(iv)(A)(3)
through (5) require that personnel at the
facility who enter or leave the
quarantine area must wear protective
work clothing and footwear upon
entering the area and must change this
clothing if it becomes soiled or
contaminated. Paragraph (c)(4)(iv)(C)
stipulates that the operator of the
facility must handle, wash, or dispose of
this soiled and contaminated clothing in
accordance with the terms of the
compliance agreement, and thus in a
manner approved by the Administrator
as consistent with the best practices of
biological security. Paragraphs
(c)(4)(iv)(D), (E), (F), and (G) establish
cleaning and disinfection protocols for
equipment and vehicles used within the
facility, loading docks, and lot-holding
areas. Thus, our proposed showering
requirements were simply one of several
sanitary practices that the facility would
have to employ to address, among other
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things, the risk associated with the
movement of waste material from the
quarantine area.
Finally, the commenter asserted that
the sanitary requirements of the
proposed rule do not prevent grooms,
owners, and other personnel who have
traveled with a diseased horse from its
country of origin from moving freely
throughout the United States once they
have disembarked. The commenter
suggested that, if such individuals
became exposed to a communicable
equine disease, they could spread the
disease throughout the United States.
APHIS personnel and employees of
the Department of Homeland Security’s
Bureau of Customs and Border
Protection may inspect individuals,
their clothing, and their articles at ports
of entry in order to prevent the
introduction of a communicable equine
disease into the domestic equine
population.
Comments Regarding Requirements for
the Handling of Horses Under
Quarantine
In § 93.308, proposed paragraph
(c)(4)(v) set forth requirements for the
handling of horses in quarantine at a
permanent, privately operated facility.
Proposed paragraph (c)(4)(v)(B) stated
that each lot of horses to be quarantined
must be placed in the facility on an ‘‘all
in, all out’’ basis, so that no horse may
be taken out of the lot while it is in
quarantine, except for diagnostic
purposes or as provided in paragraph
(a)(4) of § 93.308, and no horse may be
added to the lot while the lot is in
quarantine.
One commenter objected to the ‘‘all
in, all out’’ requirement. The commenter
stated that this requirement is not the
practice of the one permanent, privately
owned horse quarantine facility
currently in operation, and is not
consistent with the practices employed
at APHIS-operated quarantine facilities.
At the privately operated facility, the
commenter stated, a horse under
quarantine may be removed from its lot
if the importer provides evidence that
the horse has originated from a separate
premise of origin than other horses in
the lot.
It presents a grave risk to the
biological security of a facility to allow
horses onsite to be separated from their
lot before import quarantine operations
are conducted or while they are still
ongoing for any reason other than
diagnostic purposes or disposition of a
diseased horse. For this reason, we only
allow horses to be separated from their
lot at an APHIS-operated facility for the
purposes of diagnosis or disposition.
Therefore, the provisions of the
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proposed rule were indeed modeled on
APHIS’ practices at our facilities.
However, in reviewing our proposal,
we have determined that, once import
quarantine operations are completed,
these risks are attenuated, and horses
still at the facility may be separated
from their lot without a significant risk
of disease spread. Accordingly, we have
modified proposed paragraph
(c)(4)(v)(B) to specify that, once import
quarantine operations have been
completed on a lot, but while the lot is
still at the facility, a horse may be
removed from that lot.
Proposed paragraph (c)(4)(v)(C) stated
that the facility must provide sufficient
feed and bedding for horses in
quarantine, and that the feed and
bedding must be free of vermin and not
spoiled, and cannot originate from an
area that we have designated as an area
quarantined for splenetic or tick fever.
One commenter agreed that feed and
bedding should not originate from an
area quarantined for splenetic or tick
fever, but suggested that we should also
prohibit facilities from being
constructed in those areas.
We are making no change in response
to this comment. The initial application
for approval of a facility must provide
the location of the proposed facility.
This is necessary, in part, for the
Administrator to adequately evaluate
the disease risks endemic to the area in
which the facility would be located, and
the biological security measures that the
facility would need to adhere to in order
to adequately respond to these disease
risks. Approval of the facility is
contingent on such evaluations.
Proposed paragraph (c)(4)(v)(D) would
have prohibited the breeding of horses
or collection of germplasm from horses
during the quarantine period, and stated
that horses in quarantine would be
subject to tests and procedures as
directed by an APHIS representative to
determine whether they are free from
communicable diseases of horses.
Two commenters suggested that we
remove our prohibition on the
collection of germplasm during the
quarantine period. One stated that such
collection is often necessary during
quarantine operations to aid in the
differential diagnosis and proper
treatment of a horse under quarantine.
Another pointed out that the July 2002
proposed rule had provided for the
collection of germplasm during
quarantine operations, if it was
necessary for a required import testing
procedure. This commenter suggested
that our reason for removing this
exception from the December 2006
proposed rule, that no such testing
procedures are currently required, does
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not take into account mandatory testing
requirements for CEM.
The first commenter provided no
examples of diseases for which
germplasm collection is necessary for
differential diagnosis or treatment, nor
did the commenter explain under what
circumstances the efficacy of quarantine
operations depends on germplasm
collection.
We note that germplasm collection is
not part of APHIS’ required import
testing procedures for CEM. In
§ 93.301(e)(3) of the regulations, as part
of these testing procedures, APHIS does
require the collecting of specimens from
the surface of the prepuce, urethral
sinus, and fossa glandis of stallions
while the horses are in full erection.
However, the specimens collected are
not germplasm, but a bacterial culture
from the areas.
There are, therefore, no foreign
communicable diseases of horses for
which APHIS considers germplasm
collection necessary for differential
diagnosis or proper treatment.
Proposed paragraph (c)(4)(v)(I) of
§ 93.308 would have prohibited the
vaccination of horses in quarantine.
Several commenters suggested that
APHIS remove this prohibition. They
agreed with APHIS that vaccinating a
horse before serological exams are
conducted may alter a horse’s immune
system, affect diagnostic serology, and
potentially produce inaccurate results.
However, they suggested that after the
results of these serological exams have
been obtained and confirmed, but before
horses have been released from the
facility, we should allow the animals to
be vaccinated, especially for equine
diseases endemic to the area of the
United States in which the facility is
located.
We agree with these commenters, and
have therefore modified in this rule
proposed paragraph (c)(4)(v)(I) to
provide that, once import quarantine
operations have been completed on a lot
at the facility, but while the lot is still
held at the facility, horses in that lot
may be vaccinated.
Miscellaneous
In our proposal, we proposed to
define a ‘‘temporary, privately owned
quarantine facility’’ as ‘‘a facility that
offers quarantine services for a special
event and that is owned and operated by
an entity other than the Federal
government (also temporary facility).’’
In reviewing our proposal, we have
decided that it may be difficult, in some
instances, to determine what constitutes
a special event, and that our intent in
proposing such a definition was to
differentiate such temporary facilities
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from permanent facilities by stating that
the services offered by such facilities are
not continuous. We have therefore
changed ‘‘special’’ to ‘‘specific.’’
In proposed paragraph (c)(4)(ii)(C), we
stated that, as part of APHIS’ oversight
of a privately owned equine quarantine
facility, the operator of the facility must
provide APHIS with signed statements
from each employee and any other
personnel hired by the operator and
working at the facility in which the
person agrees to comply with related
instructions from APHIS representatives
pertaining to quarantine operations,
including contact with animals both
inside or outside the facility, that are
issued while the facility is operational.
Moreover, in proposed paragraph
(c)(2)(ii)(D), we stated that, in each
compliance agreement executed by the
operator of a quarantine facility or his
or her agent and the Administrator,
there must be a provision that the
operator agrees to bar from the facility
any employee or other personnel who
fails to comply with these related
instructions. Finally, in proposed
paragraph (c)(2)(ii), we stated that the
compliance agreement would be
renewed yearly.
In reviewing our proposal, we have
determined that these provisions could
result in a scenario where the
compliance agreement did not reflect
related additional instructions issued by
APHIS representatives while the facility
is operational, or where these related
instructions had provided an
amendment to, interpretation of, or
redaction of the compliance agreement.
Moreover, depending on the date of
issuance of these instructions, it could
be several months before the
compliance agreement was updated
during the renewal process to reflect
these changes. In such a scenario, the
operator of the facility could be
compelled to bar employees or
personnel from the facility for noncompliance with instructions issued by
APHIS representatives while the facility
was operational without knowledge of
the exact provisions of these
instructions.
Therefore, we have added an
additional provision to the requirements
for each compliance agreement: The
operator of the facility will allow APHIS
to amend the compliance agreement at
any time after approval of the facility in
order to incorporate related instructions
issued by APHIS representatives while
the facility is operational. This
provision is paragraph (c)(2)(ii)(G)
§ 93.308 in this final rule. APHIS will
contact the operator or his or her agent
each time the compliance agreement
needs to be so amended.
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31591
In proposed paragraph (c)(4)(v)(H) of
§ 93.308, we stated that, if a horse were
determined to be infected with or
exposed to a communicable disease of
horses, arrangements for the final
disposition of the horse would have to
be accomplished within 10 days of the
date the importer is notified by an
APHIS representative that the horse has
been refused entry into the United
States.
In reviewing our proposal, we have
determined that this paragraph could be
interpreted as stating that infection with
or exposure to any communicable
disease of horses will result in a horse
in quarantine being euthanized or
refused entry to the United States. This
is not the case. Only infection with or
exposure to a Federally regulated
disease of horses will result in such
disposition. We have therefore amended
the paragraph by removing the word
‘‘communicable’’ and adding ‘‘Federally
regulated’’ in its place.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule 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 significant for the
purposes of Executive Order 12866 and,
therefore, has been reviewed by the
Office of Management and Budget.
We have prepared an economic
analysis for this final rule, which is set
out below. It includes a final regulatory
flexibility analysis, in accordance with
5 U.S.C. 604, regarding the probable
economic impact of this rule on small
entities and a cost-benefit analysis, in
accordance with Executive Order 12866.
Under the AHPA, specifically 7 U.S.C.
8303, the Secretary of Agriculture is
authorized to promulgate regulations
requiring that any animal imported or
entered into the United States be raised
or handled under post-importation
quarantine conditions by or under the
supervision of the Secretary for the
purpose of determining whether the
animal is or may be affected by any pest
or disease of livestock.
This rule establishes standards for the
approval of permanent, privately owned
quarantine facilities for horses. We are
taking this action because regional and
seasonal demand for quarantine services
for horses often exceeds the space
available at existing facilities. Such
privately owned facilities, if constructed
and operated using the proper
safeguards, will provide an effective and
efficient means of bringing horses into
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the United States without compromising
our ability to protect against the
introduction of communicable diseases
of horses.
Costs and Benefits Associated With
This Rule
The horse industry in the United
States contributes $39 billion annually
to the U.S. gross domestic product via
direct spending, and it supports 1.4
million full-time equivalent jobs. The
horse industry pays approximately $1.9
billion in taxes annually to all levels of
government. Approximately 1.96
million people own the estimated 9.2
million horses in the United States.3
In the last 20 years, as the level of
trade between the equine industry in the
United States and that in other countries
has risen, the number of horses
imported into the United States and
subject to quarantine has likewise
increased. This, in turn, has led to an
increased demand for the resources
provided by import quarantine facilities.
In some cases, the demand for
quarantine services for horses has
exceeded the space available at existing
Federal facilities.
From 2003 through 2007, the annual
average number of equines imported
into the United States originating in
countries for which quarantine is
required at the port of entry was about
7,500 (see table 1).4 This represents an
increase of more than 225 percent over
the annual average for 1990 through
1994, which was about 2,300 horses per
year.
TABLE 1—U.S. EQUINE IMPORTS FROM COUNTRIES FOR WHICH QUARANTINE IS REQUIRED, 2003–2007, NUMBER OF
HEAD
Country
2003
The Netherlands ..................................................................
Germany ..............................................................................
Argentina ..............................................................................
United Kingdom ...................................................................
Other countries ....................................................................
2004
2,176
1,424
683
587
2,270
2005
2,810
1,285
771
630
2,036
3,035
1,345
869
640
1,956
2006
2,920
1,630
741
614
1,746
2007
2,600
1,517
786
529
1,691
The establishment of standards for the
approval and operation of permanent,
privately owned quarantine facilities for
horses has the potential to make the
import process easier and timelier while
simultaneously protecting against the
introduction of communicable diseases
of horses. This will provide a clear
benefit to importers when demand for
quarantine services surpasses the
number of spaces available at APHIS’
Federal facilities. In addition, the
geographic distribution of the currently
operating horse quarantine facilities can
make it difficult or costly to import
horses to some areas; in some
geographically isolated locations, such
as Hawaii and Puerto Rico, no facilities
for quarantining imported horses exist,
reducing the ability of importers to
profitably bring horses into those areas.
Because of their nature and size,
temporary facilities are not always able
to meet these demands. The
construction of additional permanent,
privately owned equine quarantine
facilities could remove or attenuate
some of those difficulties and thus
facilitate imports to those areas.
The implementation of this rule will
likely require upgrades at the one
permanent, privately owned equine
quarantine facility in operation. In
addition, when a facility is approved for
operation under these regulations, it
will incur the cost of any needed
renovations to the facility as well as the
costs associated with being in
compliance with the regulations. We
expect one or two such facilities to be
approved and open in the years
immediately following implementation
of this rule.
The rule sets forth requirements for
the physical structure of permanent,
privately owned horse quarantine
facilities. These include basic standards
for the facility for perimeter fencing,
entrances and exits, windows, lighting,
loading docks, surfaces, horse stalls,
aisleways, isolation stalls, showers,
APHIS space, necropsy areas, storage
space, restrooms, ventilation, climate
control, fire alarms, and communication
systems. The rule also sets forth the type
of services that APHIS employees will
provide at a privately owned equine
quarantine facility. These services
include overseeing the conduct of
import quarantine operations and
maintaining biosecurity at the facility.
Necessary upgrades to the physical
structure of the permanent, privately
owned horse quarantine facility
currently in operation, as well as
additional APHIS supervision of
operations at that facility, will likely
result in an increase in costs for the
facility. Similar costs are likely to be
borne by future privately owned equine
quarantine facilities. The fees that
APHIS assesses related to import
quarantine operations and maintaining
biosecurity at a private facility will be
charged to the operator of the facility.
Fees for services rendered directly on
behalf of the importer or shipping agent,
such as meeting the importer or agent at
the port of entry in order to facilitate
transportation of the animal to the
quarantine facility, or drawing blood for
routine serological tests once import
quarantine operations have been
completed, are charged directly to the
importer or agent. These distinctions in
fee assessments will continue.
It has been estimated that, on average,
this rule will add 2 to 3 hours per
workday for additional APHIS
supervision at the one current
permanent, privately owned quarantine
facility. Based on this estimate, the
facility could expect to be billed for
between 520 and 780 additional hours
of APHIS supervision annually as a
result of the rule. At the normal rate of
$84/hour, this will be an annual cost of
between $43,680 and $65,520.5 We
expect that some additional onsite
supervision will be needed during an
initial evaluation phase for other aspects
of import quarantine operations, which
will be reduced to spot checks over
time. As such, the cost associated with
APHIS onsite supervision will be higher
initially, and then decline.
The new requirements may also alter
the type of horses that move through the
one current permanent, privately owned
horse quarantine facility. The
importation of horses intended for
resale at low margins may decline if the
3 Source: The American Horse Council. Found at
https://www.horsecouncil.org/statistics.
4 This does not include horses from Mexico.
Under the regulations in 9 CFR part 93, these horses
are subject to quarantine but may be quarantined
either at one of the permanent equine quarantine
facilities in the United States or at a facility located
at a border port in Mexico.
5 In accordance with 9 CFR part 130, services
performed outside an APHIS employee’s normal
tour of duty, Monday through Saturday, cost $100/
hour, and, on Sunday and holidays, $112/hour.
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cost of quarantine at the facility
increases. These horses constitute a
large portion of the current imports at
this quarantine facility. Any reduction
of this type of import through the
facility as a result of increased
quarantine fees will negatively affect
revenues at the facility to the extent
they are not replaced by other classes of
imported horses.
However, a significant portion of the
horses imported annually into the
United States must go through
quarantine, and this rule will not alter
those requirements. Imports of horses
from countries requiring quarantine
have increased more than 225 percent
since 1990, but there are still only three
permanent quarantine facilities
operating in the United States: Two
Federal facilities, and one private one.
Moreover, as we mentioned above,
demand for quarantine services for
horses often exceeds the space available
at the existing Federal facilities. The
cost of providing quarantine services at
the private facility should be similar to
providing the same services at a Federal
facility. In addition, this facility is the
only permanent horse quarantine
facility located on the west coast,
making it an appealing alternative to
quarantine in a Federal facility for horse
imports arriving in the Western United
States.
Additional costs incurred at the
private facility because of this rule can
most likely be passed on to importers
who elect to use the facility to
quarantine imported horses, at least in
the short run, given the limited space at
Federal horse quarantine facilities and
the fact that there are no other
permanent, privately owned quarantine
facilities operating at this time. Over the
long term, the impact of the rule on the
facility is less certain, given the
possibility of additional—and
potentially competing—quarantine
facilities opening in the future. The
effect of implementation of this rule on
the facility’s business volume and
revenue is uncertain. However, the fact
that only one or two additional
permanent, privately owned quarantine
facilities are expected to open in the
next several years suggests that these
effects will be limited, even in the long
run.
It is not possible to predict the
number of additional horses that might
be imported into the United States as a
result of this rule. Nevertheless, any
increase in horse imports that the rule
may facilitate should yield net benefits.
This is because trade of a commodity
generally increases social welfare. To
the extent that consumer choice is
broadened and the increased supply of
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the imported commodity leads to a price
decline, gains in consumer surplus will
outweigh losses in domestic producer
surplus.6 Although the rule’s impact on
domestic producers is uncertain, it is
expected to provide benefits to
consumers (domestic importers,
brokers) that will exceed any potential
losses to domestic producers. The net
welfare effect for the United States of
increased horse imports will be positive.
However, because the rule is expected
to result in only one or two additional
permanent, privately owned quarantine
facilities over the next several years, the
expected benefits are likely to be small.
Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act
requires agencies to evaluate the
potential effects of their proposed and
final rules on small business, small
organizations, and small governmental
jurisdictions. Section 604 of the Act
requires agencies to prepare and make
available to the public a final regulatory
flexibility analysis (FRFA) describing
any changes made to the rule as a result
of comments received and the steps the
agency has taken to minimize any
significant economic impacts on small
entities. Section 604(a) of the Act
specifies the content of a FRFA. In this
section, we address these FRFA
requirements.
Objectives and Need for the Rule
Demand for quarantine services for
horses often exceeds the space available
at existing Federal facilities. In addition,
the geographic distribution of the
currently operating horse quarantine
facilities can make it difficult or costly
to import horses to some areas; in some
geographically isolated locations, such
as Hawaii and Puerto Rico, no facilities
for quarantining imported horses exist,
reducing the ability of importers to
profitably bring horses into those States.
Finally, temporary, privately owned
quarantine facilities cannot always meet
the demand for quarantine services,
because such facilities are established,
approved, and operated by importers on
a temporary basis to handle horses
imported for a unique importation, race,
or show.
This final rule will establish
standards for the approval of
permanent, privately owned horse
quarantine facilities. Such facilities, if
constructed and operated using the
proper safeguards, will provide an
effective and efficient means of bringing
6 Consumer surplus is the difference between the
amount a consumer is willing to pay for a good and
the amount actually paid. Producer surplus is the
amount a seller is paid for the good less the seller’s
cost.
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31593
horses into the United States without
compromising our ability to protect
against the introduction of
communicable diseases of horses.
Summary of Significant Issues Raised
by Commenters
In our proposal, we invited comments
about expected impacts of the rule on
small entities. We particularly asked for
estimates of compliance costs and
impacts on revenue for the one
permanent, privately owned equine
quarantine facility currently in
operation.
One commenter suggested that
APHIS’ basis for rulemaking, that
nationwide demand for such permanent
quarantine facilities currently outpaces
supply, is erroneous. The commenter
cited the decreasing number of horses
quarantined between 2004 and 2006 at
the one permanent, privately owned
horse quarantine facility currently in
operation: In 2004, this facility
quarantined approximately 2,500
horses, whereas in 2006 the facility
quarantined 2,238 horses.
Since we issued the proposed rule,
the number of horses imported yearly
into the United States and subject to
quarantine has decreased slightly.
However, from 2003 through 2007, the
annual average number of equines
imported into the United States that
originated from countries for which
post-importation quarantine is required
was nearly 7,500. This represents an
increase of more than 225 percent from
the annual average for 1990 through
1994, which was about 2,300 horses per
year. Moreover, in our proposal, we did
not cite yearly importation trends as our
sole basis for proposing standards for
privately owned equine quarantine
facilities. Rather, we also cited the
limited space at our existing Federal
facilities, a demand for quarantine
services that often exceeds the spaces
available, and the inability of
temporary, privately owned equine
quarantine facilities to fill the continual
demand for quarantine services.
As several commenters on our
proposal pointed out, even with the
recent decrease in the number of horses
imported yearly into the United States,
seasonal and regional demand for
quarantine services still often surpasses
the number of spaces available at our
Federal facilities. Moreover, because of
their nature and size, temporary
facilities are not always able to meet this
demand. Therefore, we have determined
that the need for permanent, privately
owned equine quarantine facilities still
remains.
Several commenters suggested that
the proposed rule could be construed to
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mean that APHIS representatives must
be present to supervise and staff the
facility at all hours, or that the facility
can only operate while APHIS
representatives are physically present to
supervise its operations. Either
interpretation, these commenters stated,
would have a direct, substantive, and
detrimental economic impact on all
permanent, privately owned equine
quarantine facilities, in general, and the
one such facility currently in operation,
in particular. One of the commenters
stated that APHIS oversight would cost
this facility approximately $360,000
annually.
The amount submitted by the
commenter could be construed to
suggest that the facility does not
currently pay for APHIS’ services. This
is not the case; in fact, the facility has
always paid for APHIS’ oversight of
import quarantine operations.
It is true that this rule will add an
additional annual cost to the facility,
beyond those costs already assumed for
our services. However, as we mentioned
earlier, we expect the additional annual
cost to be no greater than $65,520.
Finally, we have clarified the nature
of APHIS oversight to make more
explicit those occasions when we will
be present at the facility and charge for
our monitoring of certain activities. In
light of these clarifications, we find the
estimate submitted by the commenter,
irrespective of current costs, to be high.
One commenter suggested that
meeting certain of the proposed
construction requirements would
reduce the overall capacity of the one
currently operating permanent,
privately owned facility, would reduce
its flexibility in providing quarantine
services, and could eliminate the
facility’s ability to quarantine
ruminants.
We received no information from the
commenter regarding the potential cost
of the upgrades necessary to bring this
facility into compliance with the
construction requirements of the
proposed rule, or the amount of revenue
the facility would stand to lose because
of adherence to these requirements. In
the absence of itemized expenditures,
an estimate of lost yearly revenue, or an
estimated total cost, it is difficult to
assess the impact of these requirements
on the facility.
Moreover, we consider the
construction requirements that we are
finalizing in this rule to be necessary in
order to promote the biological security
of any permanent, privately owned
equine quarantine facility. In addition,
as we mentioned above in the section
titled ‘‘Comments Regarding
Construction Requirements,’’ we have
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made most of these requirements
performance-based in order to provide
facilities with a degree of flexibility in
meeting them.
The same commenter stated that the
operator of the one permanent, privately
owned quarantine facility currently in
operation also acts as a broker. The
commenter pointed out that, under the
provisions of the rule, the operator
would no longer be able to act as a
broker, and cited this among the reasons
why the rule, if finalized, would have
an adverse economic impact on that
operator.
We received no information from the
commenter regarding the revenue that
the operator currently generates as a
broker, or estimated losses that the
operator expected to incur by no longer
acting as a broker. Without such
information, we cannot assess the
economic impact that these provisions
will have on the operator.
We proposed to require that each
facility would have to have a supply of
potable water adequate to meet all
watering and cleaning needs.
A commenter stated that, in order to
comply with this standard, the one
permanent, privately owned equine
quarantine facility in operation would
have to install automatic water bowls
for all horses in quarantine.
The commenter suggests one means
by which that facility could meet this
requirement. There are, however, other
means by which the facility could
secure a supply of potable water that
would not require the installation of
such bowls or any other modifications
to existing structures at the facility.
Description and Estimate of Small
Entities
We have identified two types of small
entities that could be affected by the
implementation of this rule: The
existing permanent, privately owned
quarantine facility and horse importers
and owners.
According to the Small Business
Administration (SBA) criteria, a horse
quarantine facility is considered a small
entity if it has annual revenues of $6
million or less. The existing permanent,
privately owned quarantine facility that
operates in Los Angeles is believed to be
a small entity. According to SBA
criteria, a farm that keeps horses for
breeding and has annual revenues of
$750,000 or less is considered a small
entity. According to the most recent
Census of Agriculture data, average perfarm revenue for all U.S. equine farms
in 2002 was $7,158, an indication that
these farms are by and large small
entities.
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The establishment of standards for the
approval and operation of permanent,
privately owned quarantine facilities for
horses has the potential to make the
import process easier and timelier while
simultaneously protecting against the
introduction of communicable diseases
of horses. This will provide a clear
benefit to importers when seasonal or
regional demand for quarantine
facilities surpasses the number of spaces
available at our Federal facilities. In
addition, the geographic distribution of
equine quarantine facilities, which
currently makes it difficult or costly to
import horses to some areas, may
change with the construction of more
quarantine facilities throughout the
United States.
On the other hand, importers may be
subject to higher fees and charges at the
current permanent, privately owned
equine quarantine facility. This is
because the implementation of this rule
will likely require upgrades at that
facility. Moreover, if another quarantine
facility is approved for operation under
these regulations (e.g., if a ruminant
quarantine facility seeks approval to
begin to quarantine imported horses), it
will incur the cost of any renovations
needed to establish adherence to the
construction requirements, as well as
the costs associated with maintaining
compliance with the regulations.
This rule sets forth requirements for
the physical structure of permanent,
privately owned equine quarantine
facilities. The rule also sets forth the
type of services that APHIS employees
will provide at a privately owned
equine quarantine facility: Overseeing
the conduct of import quarantine
operations and maintaining biosecurity
at the facility. Necessary upgrades to the
physical structure of the currently
operating privately owned horse
quarantine facility and additional
APHIS supervision of operations at that
facility will likely result in an increase
in costs at the facility. The fees that
APHIS assesses related to import
quarantine operations and maintaining
biosecurity at a private facility will be
charged to the operator of the facility.
Similar costs are likely to be borne by
any other privately owned horse
quarantine facilities that begin
operations in the future.
Additional costs incurred at the
private facility will most likely be
passed on to importers of horses who
elect to use the facility to quarantine
imported horses, at least in the short
run, given the limited space at APHISoperated horse quarantine facilities, the
fact that there are no other permanent,
privately owned quarantine facilities
operating at this time, and the fact that
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quarantines are mandatory for
significant classes of imported horses. If
the low-margin horse imports that pass
through the permanent, privately owned
quarantine facility decline because of
increased quarantine fees, and those
imports are not replaced by other
classes of imported horses, however,
revenues at the facility could be
negatively affected. Over the long term,
the possibility of additional—and,
potentially, competing—quarantine
facilities opening in the future creates
more uncertainty regarding the effects of
this rule on the facility. The effect of the
rule on the facility’s business volume
and revenue is uncertain. However, it is
likely that, following implementation of
this rule, only one or two additional
permanent, privately owned quarantine
facilities will open in the next several
years. This suggests that these effects
will be limited, even in the long run.
It is not possible to predict the
number of additional horses that might
be imported into the United States as a
result of this rule. Nevertheless, any
increase in horse imports that the rule
may facilitate should yield net benefits.
This is because trade of a commodity
generally increases social welfare. To
the extent that consumer choice is
broadened and the increased supply of
the imported commodity leads to a price
decline, gains in consumer surplus will
outweigh losses in domestic producer
surplus. Although the rule’s impact on
domestic producers is uncertain, it is
expected to provide benefits to
consumers (domestic importers,
brokers) that will exceed any potential
losses to domestic producers. The net
welfare effect for the United States of
increased horse imports will be positive.
However, because the rule will likely
result in only one or two additional
permanent, privately owned quarantine
facilities over the next several years, the
expected benefits are likely to be small.
Description and Estimate of
Compliance Requirements
This rule establishes various
information collection and
recordkeeping requirements for the
operators of permanent, privately
owned equine quarantine facilities. A
description of the requirements
associated with the rule was presented
in the proposal under the heading
‘‘Paperwork Reduction Act.’’
Alternatives Considered
This rule establishes standards for the
approval of permanent, privately owned
quarantine facilities for horses.
Alternatives to the rule would have
been to either leave the regulations
unchanged, or to require a different set
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of standards than those being
implemented in this rule. Leaving the
regulations unchanged would be
unsatisfactory, because it would
perpetuate the current situation, i.e.,
one which does not facilitate the
importation of horses or address the
disease risks associated with such
importation in as timely and quick a
manner as possible.
APHIS considers the set of standards
implemented by this rule to be the
minimum necessary to accomplish the
rule’s objectives. In this regard, we have
made substantive changes to several of
the provisions of our proposal that we
expect to reduce the compliance costs
associated with this rulemaking. In
particular, we have decided that several
of a permanent, privately owned equine
quarantine facility’s operating
procedures—the routine cleaning and
maintenance of the facility, the daily
care of animals in quarantine, the
disposal of wastes at the facility, the
cleaning and disinfection procedures
employed by the facility, the handling,
washing, and disposal of soiled and
contaminated clothing worn within the
facility, and the incineration of dead
horses, whether onsite or offsite—will
not ordinarily need APHIS’ direct
supervision or physical presence.
Description of Steps Taken To
Minimize Significant Economic Impacts
on Small Entities
In our proposal, we solicited
comments regarding how the rule could
be modified to reduce expected impacts
on small entities. While no commenters
cited this request in providing their
responses, as we mentioned above,
several commenters asked us to clarify
the nature of APHIS oversight required
by the proposal, and to reevaluate the
need for ongoing and direct APHIS
oversight of several operations at the
facility: Cleaning and disinfection
procedures and incineration activities.
In response to these comments, we have
decided that these operations, as well as
maintenance of the facility, the daily
care of horses under quarantine, the
disposal of wastes at the facility, and the
handling, washing, and disposal of
soiled and contaminated clothing at the
facility, will not ordinarily require our
direct presence and/or continual
oversight. We expect that this change
from the terms of the proposal will
lessen the economic impact of this rule
on small entities.
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
all State and local laws and regulations
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31595
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
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 301 et
seq.), the information collection or
recordkeeping requirements included in
this rule have been approved by the
Office of Management and Budget
(OMB) under OMB control number
0579–0313.
E-Government Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this rule, please contact Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 851–2908.
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock,
Poultry and poultry products,
Quarantine, Reporting and
recordkeeping requirements.
■ Accordingly, we are amending 9 CFR
part 93 as follows:
PART 93—IMPORTATION OF CERTAIN
ANIMALS, BIRDS, FISH, AND
POULTRY, AND CERTAIN ANIMAL,
BIRD, AND POULTRY PRODUCTS;
REQUIREMENTS FOR MEANS OF
CONVEYANCE AND SHIPPING
CONTAINERS
1. The authority citation for part 93
continues to read as follows:
■
Authority: 7 U.S.C. 1622 and 8301–8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.4.
2. Section 93.300 is amended by
revising the definition for Operator and
by adding, in alphabetical order, new
definitions of Lot, Lot-holding area,
Nonquarantine area, Permanent,
privately owned quarantine facility,
Quarantine area, and Temporary,
privately owned quarantine facility to
read as follows:
■
§ 93.300
Definitions.
*
*
*
*
*
Lot. A group of horses that, while held
on a premises or conveyance, have had
opportunity for physical contact with
other horses in the group or with their
excrement or discharges at any time
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during their shipment to the United
States.
Lot-holding area. That area in a
permanent, privately owned quarantine
facility in which a single lot of horses
is held at one time.
Nonquarantine area. That area in a
permanent, privately owned quarantine
facility that includes offices, storage
areas, and other areas outside the
quarantine area, and that is off limits to
horses, samples taken from horses, and
any other objects or substances that
have been in the quarantine area during
the quarantine of horses.
Operator. A person other than the
Federal Government who owns or
manages and has responsibility for the
services provided by a temporary,
privately owned quarantine facility or a
permanent, privately owned quarantine
facility.
Permanent, privately owned
quarantine facility. A facility that offers
quarantine services for horses to the
general public on a continuing basis and
that is owned and operated by an entity
other than the Federal Government (also
permanent facility).
*
*
*
*
*
Quarantine area. That area in a
permanent, privately owned quarantine
facility that comprises all of the lotholding areas in the facility, and any
other areas in the facility that horses
have access to, including loading docks
for receiving and releasing horses, and
any areas used to conduct examinations
of horses and take samples and where
samples are processed or examined.
*
*
*
*
*
Temporary, privately owned
quarantine facility. A facility that offers
quarantine services for horses imported
for a specific event and that is owned
and operated by an entity other than the
Federal Government (also temporary
facility).
*
*
*
*
*
■ 3. Section 93.303 is amended as
follows:
■ a. By revising the heading of
paragraph (e) to read as set forth below.
■ b. In paragraph (e), by removing the
words ‘‘provided by the importer’’ and
by adding the words ‘‘privately owned’’
before the word ‘‘quarantine’’.
§ 93.303 Ports designated for the
importation of horses.
*
*
*
*
*
(e) Ports for horses to be quarantined
at privately owned quarantine facilities.
* * *
*
*
*
*
*
§ 93.304
[Amended]
4. Section 93.304 is amended as
follows:
■
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13:31 Jul 01, 2009
Jkt 217001
a. In paragraph (a)(1)(i), first sentence,
by removing the words ‘‘quarantine
facility provided by the importer’’ and
adding the words ‘‘privately owned
quarantine facility’’ in their place.
■ b. In paragraph (a)(2), by removing the
words ‘‘of the regulations, horses
intended for quarantine at a quarantine
facility provided by the importer’’, and
by adding the words ‘‘or horses
intended for quarantine at a privately
owned quarantine facility’’ in their
place.
■ 5. Section 93.308 is amended as
follows:
■ a. In paragraph (a)(3), by redesignating
footnote 14 as footnote 13.
■ b. By revising paragraphs (b) and (c)
to read as set forth below.
■ c. By adding an OMB citation at the
end of the section to read as set forth
below.
■
§ 93.308
Quarantine requirements.
*
*
*
*
*
(b) Temporary, privately owned
quarantine facilities. Horses presented
for entry into the United States as
provided in § 93.303(e) may be
quarantined in temporary, privately
owned quarantine facilities that meet
the requirements of paragraphs (b)(1)
and (b)(2) of this section and that have
been approved by the Administrator for
a specific importation.
(1) Approval. Requests for approval
and plans for proposed temporary
facilities must be submitted no less than
15 days before the proposed date of
entry of horses into the facility to
APHIS, Veterinary Services, National
Center for Import and Export, 4700
River Road Unit 39, Riverdale, MD
20737–1231. Before facility approval
can be granted, a veterinary medical
officer of APHIS must inspect the
facility to determine whether it
complies with the standards set forth in
this section: Provided, however, that
approval of any temporary facility and
use of such facility will be contingent
upon a determination made by the
Administrator that adequate personnel
are available to provide required
services at the facility. Approval of any
facility may be refused and approval of
any quarantine facility may be
withdrawn at any time by the
Administrator, upon his or her
determination that any requirements of
this section are not being met. Before
such action is taken, the operator of the
facility will be informed of the reasons
for the proposed action by the
Administrator and afforded an
opportunity to present his or her views.
If there is a conflict as to any material
fact, a hearing will be held to resolve the
conflict. The cost of the facility and all
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maintenance and operational costs of
the facility will be borne by the
operator.
(2) Standards and handling
procedures. The facility must be
maintained and operated in accordance
with the following standards:
(i) Inspection. Inspection and
quarantine services must be arranged by
the operator or his or her agent with the
APHIS Veterinarian in Charge for the
State in which the approved facility is
located 14 no less than 7 days before the
proposed date of entry of the horses into
the quarantine facility.
(ii) Physical plant requirements.
(A) The facility must be located and
constructed to prevent horses from
having physical contact with animals
outside the facility.
(B) The facility must be constructed
only with materials that can withstand
repeated cleaning and disinfection.
Disinfectants authorized in 9 CFR part
71 must be used. All walls, floors, and
ceilings must be constructed of solid
material that is impervious to moisture.
Doors, windows, and other openings of
the facility must be provided with
double screens that will prevent insects
from entering the facility.
(iii) Sanitation and security.
(A) The operator of the facility must
arrange for a supply of water adequate
to clean and disinfect the facility.
(B) All feed and bedding must
originate from an area not under
quarantine because of splenetic or tick
fever (see part 72 of this chapter) and
must be stored within the facility.
(C) Upon the death of any horse, the
operator must arrange for the disposal of
the horse’s carcass by incineration.
Disposal of all other waste removed
from the facility during the time the
horses are in quarantine or from horses
that are refused entry into the United
States must be either by incineration or
in a public sewer system that meets all
applicable environmental quality
control standards. Following
completion of the quarantine period and
the release of the horses into the United
States, all waste may be removed from
the quarantine facility without further
restriction.
(D) The facility must be maintained
and operated in accordance with any
additional requirements the
Administrator deems appropriate to
prevent the dissemination of any
communicable disease.
14 The name and the address of the Veterinarian
in Charge in any State is available from APHIS,
Veterinary Services, National Center for Import and
Export, 4700 River Road Unit 39, Riverdale, MD
20737–1231.
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(E) The facility must comply with all
applicable local, State, and Federal
requirements for environmental quality.
(iv) Personnel.
(A) Access to the facility will be
granted only to persons working at the
facility or to persons specifically
granted such access by an APHIS
representative.
(B) The operator must provide
attendants for the care and feeding of
horses while in the quarantine facility.
(C) Persons working in the quarantine
facility may not come in contact with
any horses outside the quarantine
facility during the quarantine period for
any horses in the facility.
(v) Handling of horses in quarantine.
Horses offered for importation into the
United States that are quarantined in an
approved temporary facility must be
handled in accordance with paragraph
(a) of this section while in quarantine.
(c) Permanent, privately owned
quarantine facilities. Horses presented
for entry into the United States as
provided in § 93.303(e) may be
quarantined in permanent, privately
owned quarantine facilities approved by
the Administrator as meeting the
requirements of paragraphs (c)(1)
through (c)(6) of this section.
(1) APHIS approval.
(i) Approval procedures. Persons
seeking APHIS approval of a permanent,
privately owned quarantine facility
must write to the Administrator, c/o
National Center for Import and Export,
Veterinary Services, APHIS, 4700 River
Road Unit 39, Riverdale, MD 20737–
1231. The application letter must
include the full name and mailing
address of the applicant; the location
and street address of the facility for
which approval is sought; blueprints of
the facility; a description of the
financial resources available for
construction, operation, and
maintenance of the facility; the
anticipated source or origin of horses to
be quarantined, as well as the expected
size and frequency of shipments; a
contingency plan for horses needing
emergency veterinary care; and a
contingency plan for the disposal of all
the horses capable of being housed in
the facility.
(A) If APHIS determines that an
application is complete and merits
further consideration, the person
applying for facility approval must enter
into a service agreement with APHIS
wherein the applicant agrees to pay the
cost of all APHIS services associated
with APHIS’ evaluation of the
application and facility. APHIS charges
for the evaluation of the application and
facility at hourly rates listed in § 130.30
of this chapter. This service agreement
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13:31 Jul 01, 2009
Jkt 217001
applies only to fees accrued during the
application process. If the facility is
approved by APHIS, facility owners
must enter into a compliance agreement
in accordance with paragraph (c)(2) of
this section.
(B) Requests for approval must be
submitted to APHIS at least 120 days
prior to the date of application for local
building permits. Requests for approval
will be evaluated on a first-come, firstserved basis.
(ii) Criteria for approval. Before a
facility may operate as a permanent,
privately owned quarantine facility for
horses, it must be approved by APHIS.
To be approved:
(A) The facility must meet all of the
requirements of this section;
(B) The facility must meet any
additional requirements that may be
imposed by the Administrator in each
specific case, as specified in the
compliance agreement required under
paragraph (c)(2) of this section, to
ensure that the quarantine of horses in
the facility will be adequate to
determine their health status, as well as
to prevent the transmission of diseases
into, within, and from the facility; and
(C) The Administrator must determine
that sufficient personnel, including one
or more APHIS veterinarians and other
professional, technical, and support
personnel, are available to serve as
APHIS representatives at the facility. If
the facility is approved, APHIS
representatives will be present at all
import quarantine operations in order to
monitor them and will be present in
order to provide other technical services
to ensure the biological security of the
facility, including, but not limited to,
those specified in paragraph (c)(4)(v)(H)
of § 93.308. The Administrator’s
determination will be based on the
expected size and frequency of
shipments to the facility, as described in
the application for approval of a
permanent facility, as well as any other
pertinent information in the application.
APHIS will assign personnel to facilities
requesting approval in the order that the
facilities are approved. The
Administrator has sole discretion on the
number of APHIS personnel to be
assigned to the facility.
(iii) Maintaining approval. To
maintain APHIS approval, the operator
must continue to comply with all the
requirements of paragraph (c) of this
section and the terms of the compliance
agreement executed in accordance with
paragraph (c)(2) of this section.
(iv) Denial or withdrawal of approval.
Approval for a proposed permanent,
privately owned quarantine facility may
be denied or approval for a facility
already in operation may be withdrawn
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31597
at any time by the Administrator for any
of the reasons provided in paragraph
(c)(1)(iv)(C) of this section.
(A) Before facility approval is denied
or withdrawn, the operator of the
facility will be informed of the reasons
for the proposed action by the
Administrator and afforded an
opportunity to present his or her views.
If there is a conflict as to any material
fact, APHIS will afford the operator,
upon request, the opportunity for a
hearing with respect to the merits or
validity of such action.
(B) The Administrator may withdraw
approval of an existing facility prior to
a final determination in the hearing if
the Administrator determines that such
action is necessary to protect animal
health or the public health, interest, or
safety. Such withdrawal will be
effective upon oral or written
notification, whichever is earlier, to the
operator of the facility. In the event of
oral notification, APHIS will promptly
give written confirmation to the
operator of the facility. This withdrawal
will continue in effect pending the
completion of the hearing and any
judicial review, unless otherwise
ordered by the Administrator. In
addition to withdrawal of approval for
the reasons provided in paragraph
(c)(1)(iv)(C) of this section, the
Administrator will also automatically
withdraw approval when the operator of
any approved facility notifies the APHIS
Veterinarian in Charge for the State in
which the facility is located, in writing,
that the facility is no longer in
operation.15
(C) The Administrator may deny or
withdraw approval of a permanent,
privately owned facility if:
(1) Any requirement of this section or
the compliance agreement is not
complied with; or
(2) The operator fails to remit any
charges for APHIS services rendered; or
(3) The operator or a person
responsibly connected with the business
of the quarantine facility acts as a paid
agent (broker) for the importation or
subsequent sale of horses; or
(4) The operator or a person
responsibly connected with the business
of the quarantine facility is or has been
found by a court of competent
jurisdiction to have violated any law or
regulation pertaining to the importation
or quarantine of any animal; or
(5) The operator or a person
responsibly connected with the business
of the quarantine facility is or has been
15 The name and address of the Veterinarian in
Charge in any State is available from APHIS,
Veterinary Services, National Center for Import and
Export, 4700 River Road Unit 39, Riverdale, MD
20737–1231.
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convicted of any crime involving fraud,
bribery, or extortion or any other crime
involving a lack of the integrity needed
for the conduct of operations affecting
the importation of animals; or
(6) The approved quarantine facility
has not been in use to quarantine horses
for a period of at least 1 year.
(D) For the purposes of this section,
a person is deemed to be responsibly
connected with the business of the
quarantine facility if such person has an
ownership, mortgage, or lease interest in
the facility’s physical plant, or if such
person is a partner, officer, director,
holder, or owner of 10 percent or more
of its voting stock, or is an employee in
a managerial or executive capacity.
(v) Approval for existing facilities.
Any permanent, privately owned
quarantine facility operating under
APHIS authorization on August 3, 2009
must be approved by APHIS to continue
quarantine operations by August 3, 2010
or else must cease horse quarantine
operations.
(2) Compliance agreement.
(i) All permanent, privately owned
quarantine facilities for horses must
operate in accordance with a
compliance agreement executed by the
operator or his or her agent and the
Administrator, which must be renewed
on an annual basis.
(ii) The compliance agreement must
provide that:
(A) The facility must meet all
applicable requirements of this section;
(B) The operator agrees to have APHIS
representatives present at all import
quarantine operations at the facility in
order to monitor the import quarantine
operations;
(C) The operator agrees to be
responsible for the cost of the facility;
all costs associated with its maintenance
and operation; all costs associated with
the hiring of employees and other
personnel to attend to the horses as well
as to maintain and operate the facility;
all costs associated with the care of
quarantined horses, such as feed,
bedding, medicines, inspections,
testing, laboratory procedures, and
necropsy examinations; and all APHIS
charges for the services of APHIS
representatives in accordance with this
section and part 130 of this chapter;
(D) The operator agrees to bar from
the facility any employee or other
personnel at the facility who fails to
comply with paragraph (c) of this
section or other provisions of this part,
any terms of the compliance agreement,
or related instructions from APHIS
representatives;
(E) The operator agrees to
demonstrate, to the satisfaction of the
Administrator, that the routine cleaning
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and maintenance of the facility, the
daily care of animals in quarantine, the
disposal of wastes at the facility, the
cleaning and disinfection procedures
employed by the facility, the handling,
washing, and disposal of soiled and
contaminated clothing worn within the
facility, and the disposal of dead horses,
whether onsite or offsite, adhere to the
best practices of biological security and
animal care;
(F) The operator agrees to random
spot audits by APHIS representatives to
determine whether employees and other
personnel are complying with these
practices; and
(G) The operator of the facility allows
the Administrator to amend the
compliance agreement at any time after
approval of the facility in order to
incorporate related instructions issued
by APHIS representatives while the
facility is operational
(3) Physical plant requirements. The
facility must meet the following
requirements as determined by an
APHIS inspection prior to admitting
horses into the facility:
(i) Location. The quarantine facility
must be located in proximity to a port
authorized under § 93.303(e). The site
and the specific routes for the
movement of horses from the port to the
site must be approved by the
Administrator based on consideration of
whether the site or routes would put the
horses in a position that could result in
the transmission of communicable
diseases to domestic horses.
(ii) Construction. The facility must be
of sound construction, in good repair,
and properly designed to prevent the
escape of quarantined horses. It must
have adequate capacity to receive and
house shipments of horses as lots on an
‘‘all in, all out’’ basis, whereby separate
lots of horses can be received and
housed without contact with any other
lots being quarantined at the facility.
The facility must include the following:
(A) Perimeter fencing. The facility
must be surrounded by a security fence
of sufficient height and design to
prevent the entry of unauthorized
people and animals from outside the
facility and to prevent the escape of the
horses in quarantine.
(B) Entrances and exits. All entryways
into the nonquarantine area of the
facility must be equipped with a secure
and lockable door. While horses are in
quarantine, all access to the quarantine
area for horses must be from within the
building, and each such entryway to the
quarantine area must be equipped with
a series of solid self-closing double
doors. Emergency exits to the outside
are permitted in the quarantine area.
Such emergency exits must be
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constructed so as to permit their being
opened from the inside of the facility
only.
(C) Windows and other openings. The
facility must be constructed so that any
windows or other openings in the
quarantine area are double-screened
with screening of sufficient gauge and
mesh to prevent the entry or exit of
insects and other vectors of diseases of
horses and to provide ventilation
sufficient to ensure the comfort and
safety of all horses in the facility. The
interior and exterior screens must be
separated by at least 3 inches (7.62 cm).
All screening of windows or other
openings must be easily removable for
cleaning, but must otherwise remain
locked and secure at all times in a
manner satisfactory to APHIS
representatives in order to ensure the
biological security of the facility.
(D) Lighting. The entire facility,
including its stalls and hallways, must
have adequate lighting.
(E) Loading docks. The facility must
have separate docks for animal receiving
and releasing and for general receiving
and pickup, unless a single dock used
for both purposes is cleaned and
disinfected after each use in accordance
with paragraph (c)(4)(iv)(F) of this
section.
(F) Surfaces. The facility must be
constructed so that the floor surfaces
with which horses have contact are
nonslip and wear-resistant. All floor
surfaces with which the horses, their
excrement, or discharges have contact
must provide for adequate drainage. All
floor and wall surfaces with which the
horses, their excrement, or discharges
have contact must be impervious to
moisture and be able to withstand
frequent cleaning and disinfection
without deterioration. Ceilings and wall
surfaces with which the horses, their
excrement, or discharges do not have
contact must be able to withstand
cleaning and disinfection between
shipments of horses. All floor and wall
surfaces must be free of sharp edges that
could cause injury to horses.
(G) Horse stalls. The stalls in which
horses are kept must be large enough to
allow each animal to make normal
postural and social adjustments with
adequate freedom of movement.
Exercise equipment for horses may be
kept in the stalls, provided that there
will still be sufficient space within the
stalls for the horses to move freely once
the equipment is installed.
(H) Aisleways. The aisleways through
which horses are moved to and from
stalls must be wide enough to provide
for safe movement of horses, including
allowing horses to turn around in the
aisleway, preventing horses in facing
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stalls from coming into contact with
horses in the aisleway, and adequately
ventilating the stalls.
(I) Means of isolation. Physical
barriers must separate different lots of
horses in the facility so that horses in
one lot cannot have physical contact
with horses in another lot or with their
excrement or discharges. Stalls must be
available that are capable of isolating
any horses exhibiting signs of illness.
(J) Showers. A shower must be located
at each entrance to the quarantine area.
If the facility has a necropsy area, a
shower must be located at the entrance
to the necropsy area. A clothes-storage
and clothes-changing area must be
provided with each shower area. There
must also be one or more receptacles
near each shower so that clothing that
has been worn into the quarantine area
can be deposited in a receptacle prior to
entering the shower.
(K) APHIS space. The facility must
have adequate space for APHIS
representatives to conduct examinations
and testing of the horses in quarantine,
prepare and package samples for
mailing, and store the necessary
equipment and supplies for duplicate
samples. The space provided to conduct
examinations and testing must include
a refrigerator-freezer in which to store
samples. The examination space must
include equipment to provide for the
safe inspection of horses. The facility
must also include a secure, lockable
office for APHIS use with enough room
for a desk, chair, and filing cabinet.
(L) Necropsy area. The facility must
either include an area for conducting
necropsies onsite or must have
designated an alternate facility at which
a suitable necropsy area is available. If
the facility has a necropsy area, it must
be of sufficient size to perform
necropsies on horses and be equipped
with adequate lighting, hot and cold
running water, a drain, a cabinet for
storing instruments, a refrigeratorfreezer for storing specimens, and an
autoclave to sterilize veterinary
equipment. If the facility does not have
such an area, it must specify an
alternate facility at which a suitable
necropsy area is available, a route from
the quarantine facility to the alternate
facility’s necropsy area, and the
safeguards that will be in place to
ensure that communicable diseases of
horses are not spread during transit.
This alternate facility and transport
methodology must be approved by the
Administrator under the procedures for
requesting variances outlined in
paragraph (c)(6) of this section.
(M) Storage. The facility must have
sufficient storage space for equipment
and supplies used in import quarantine
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operations. Storage space must include
separate, secure storage for pesticides
and for medical and other biological
supplies, as well as a separate verminproof storage area for feed and bedding,
if feed and bedding are stored at the
facility. If the facility has multiple lotholding areas, then separate storage
space for any reusable supplies and
equipment that are not disinfected after
each use in accordance with part 71 of
this chapter must be provided for each
lot-holding area.
(N) Additional space needs. The
facility must have an area for washing
and drying clothes, linens, and towels
and an area for cleaning and
disinfecting equipment used in the
facility. The facility must also include a
work area for the repair of equipment.
(O) Restrooms. The facility must have
permanent restrooms in both the
quarantine and nonquarantine areas of
the facility.
(P) Ventilation and climate control.
The facility must be constructed with an
air handling system capable of
controlling and maintaining the ambient
temperature, air quality, humidity, and
odor at levels that are not injurious or
harmful to the health of horses in
quarantine. Air supplied to the
quarantine area must not be recirculated
or reused for other ventilation needs.
Air handling systems for lot-holding
areas must be separate from air handling
systems for other operational and
administrative areas of the facility. In
addition, if the facility is equipped to
handle more than one lot of horses at a
time, the air handling system must be
adequate to ensure that there is no
cross-contamination of air between
separate lot-holding areas.
(Q) Fire protection. The facility,
including the lot-holding areas, must
have a fire alarm voice communication
system.
(R) Communication system. The
facility must have a communication
system between the nonquarantine and
quarantine areas of the facility.
(iii) Sanitation. To ensure that proper
animal health and biological security
measures are observed, the facility must
have the following:
(A) Equipment and supplies necessary
to maintain the facility in clean and
sanitary condition, including pest
control equipment and supplies and
cleaning and disinfecting equipment
with adequate capacity to disinfect the
facility and equipment.
(B) Any reusable equipment and
supplies that are not disinfected after
each use in accordance with part 71 of
this chapter maintained separately for
each lot of horses.
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(C) Equipment and supplies used in
the quarantine area maintained
separately from equipment and supplies
used in the nonquarantine area.
(D) A supply of potable water
adequate to meet all watering and
cleaning needs, with water faucets for
hoses located throughout the facility.
An emergency supply of water for
horses in quarantine must also be
maintained.
(E) A stock of disinfectant authorized
in part 71 of this chapter or otherwise
approved by the Administrator that is
sufficient to disinfect the entire facility.
(F) The capability to dispose of
wastes, including manure, urine, and
used bedding, by means of burial,
incineration, or public sewer. Other
waste material must be handled in such
a manner that minimizes spoilage and
the attraction of pests and must be
disposed of by incineration, public
sewer, or other preapproved manner
that prevents the spread of disease.
Disposal of wastes must be carried out
in accordance with the terms of the
compliance agreement, and is subject to
spot audits by APHIS representatives.
(G) The capability to dispose of horse
carcasses in a manner approved by the
Administrator and under conditions
that minimize the risk of disease spread
from carcasses.
(H) For incineration to be carried out
at the facility, the facility must have
incineration equipment that is detached
from other facility structures and is
capable of burning animal waste and
refuse. The incineration site must also
include an area sufficient for solid waste
holding. Incineration may also take
place at a local site away from the
facility premises. All incineration
activities, whether onsite or offsite,
must be carried out in accordance with
the terms of the compliance agreement,
and are subject to spot audits by APHIS
representatives.
(I) The capability to control surface
drainage and effluent into, within, and
from the facility in a manner that
prevents the spread of disease into,
within, or from the facility. If the facility
is approved to handle more than one lot
of horses at the same time, the drainage
system must be adequate to ensure that
there is no cross-contamination between
lot-holding areas.
(iv) Security. Facilities must provide
the following security measures:
(A) The facility and premises must be
kept locked and secure at all times
while horses are in quarantine.
(B) The facility and premises must
have signs indicating that the facility is
a quarantine area and no visitors are
allowed.
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(C) The facility and premises must be
guarded at all times by one or more
representatives of a bonded security
company, or, alternatively, the facility
must have an electronic security system
that indicates the entry of unauthorized
persons into the facility. Electronic
security systems must be coordinated
through or with the local police so that
monitoring of the quarantine facility is
maintained whenever APHIS
representatives are not at the facility.
The electronic security system must be
of the ‘‘silent type’’ and must be
triggered to ring at the monitoring site
and not at the facility. The electronic
security system must be approved by
Underwriter’s Laboratories. The
operator must provide written
instructions to the monitoring agency
stating that the police and a
representative of APHIS designated by
APHIS must be notified by the
monitoring agency if the alarm is
triggered. The operator must also submit
a copy of those instructions to the
Administrator. The operator must notify
the designated APHIS representative
whenever a breach of security occurs or
is suspected of having occurred. In the
event that disease is diagnosed in
quarantined horses, the Administrator
may require the operator to have the
facility guarded by a bonded security
company in a manner that the
Administrator deems necessary to
ensure the biological security of the
facility.
(D) The operator must furnish a
telephone number or numbers to APHIS
at which the operator or his or her agent
can be reached at all times.
(E) APHIS is authorized to place
APHIS seals on any or all entrances and
exits of the facility when determined
necessary by APHIS and to take all
necessary steps to ensure that such seals
are broken only in the presence of an
APHIS representative. If someone other
than an APHIS representative breaks
such seals, APHIS will consider the act
a breach in security and APHIS
representatives will make an immediate
accounting of all horses in the facility.
If a breach in security occurs, APHIS
may extend the quarantine period as
long as necessary to determine that the
horses are free of communicable
diseases.
(4) Operating procedures. The
following procedures must be observed
at the facility at all times:
(i) Oversight by APHIS
representatives.
(A) Import quarantine operations at a
privately owned quarantine facility may
only be conducted with the physical
presence of and monitoring by APHIS
representatives. APHIS representatives
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13:31 Jul 01, 2009
Jkt 217001
are also authorized to perform the
services required by this section and by
the compliance agreement.
(B) If, as the result of a spot audit, or
for any other reason, APHIS determines
that the operator has failed to properly
care for, feed, or handle quarantined
horses as required in this paragraph (c)
or in accordance with the terms of the
compliance agreement, or has failed to
maintain and operate the facility as
provided in this paragraph (c) or in
accordance with the terms of the
compliance agreement, APHIS
representatives will furnish such
services, will make arrangements for the
sale or disposal of quarantined horses at
the quarantine facility owner’s expense,
or will begin the process for withdrawal
of approval of the quarantine facility
specified in paragraph (c)(1)(iv) of this
section.
(ii) Personnel.
(A) The operator must provide
adequate personnel to maintain the
facility and care for the horses in
quarantine, including attendants to care
for and feed horses, and other personnel
as needed to maintain, operate, and
administer the facility.
(B) The operator must provide APHIS
with an up-to-date list of all personnel
who have access to the facility. The list
must include the names, current
residential addresses, and employee
identification numbers of each person.
When the operator wishes to grant
access to the facility to persons who
have not previously had access to it, the
operator must update the list prior to
such persons having access to the
quarantine facility.
(C) The operator must provide APHIS
with signed statements from each
employee and any other personnel hired
by the operator and working at the
facility in which the person agrees to
comply with paragraph (c) of this
section and applicable provisions of this
part, all terms of the compliance
agreement, and any related instructions
from APHIS representatives pertaining
to import quarantine operations,
including contact with animals both
inside and outside the facility.
(iii) Authorized access. Access to the
facility premises as well as inside the
quarantine area will be granted only to
APHIS representatives, authorized
employees, and other personnel of the
operator assigned to work at the facility.
All other persons are prohibited from
the premises unless specifically granted
access by an APHIS representative. Any
visitors granted access must be
accompanied at all times by an APHIS
representative while on the premises or
in the quarantine area of the facility.
(iv) Sanitary requirements.
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(A) All persons granted access to the
quarantine area must:
(1) Shower when entering and leaving
the quarantine area;
(2) Shower when leaving the necropsy
area if a necropsy is in the process of
being performed or has just been
completed, or if all or portions of the
examined animal remain exposed;
(3) Wear clean protective work
clothing and footwear upon entering the
quarantine area;
(4) Wear disposable gloves when
handling sick horses and then wash
hands after removing gloves; and
(5) Change protective clothing,
footwear, and gloves when they become
soiled or contaminated.
(B) The operator is responsible for
providing a sufficient supply of clothing
and footwear to ensure that all persons
provided access to the quarantine area
at the facility have clean, protective
clothing, and footwear when they enter
the quarantine area.
(C) The operator is responsible for the
handling, washing, and disposal of
soiled and contaminated clothing worn
within the quarantine facility in
accordance with the terms of the
compliance agreement. At the end of
each workday, work clothing worn into
the quarantine area must be collected
and kept in a bag until the clothing is
washed. Used footwear must either be
left in the clothes-changing area or
cleaned with hot water (148 °F
minimum) and detergent and
disinfected in accordance with the
terms of the compliance agreement.
APHIS representatives may conduct
spot audits of all handling, cleaning,
and/or disposal of used clothing or used
footwear.
(D) All equipment (including tractors)
must be cleaned and disinfected prior to
being used in the quarantine area of the
facility with a disinfectant authorized in
part 71 of this chapter or otherwise
approved by the Administrator. The
equipment must remain dedicated to the
facility for the entire quarantine period.
Any equipment used with quarantined
horses (e.g., halters, floats, feed, water
buckets, and exercise equipment) must
remain dedicated to that particular lot of
quarantined horses for the duration of
the quarantine period or be cleaned and
disinfected before coming in contact
with horses from another lot. Prior to its
removal from the quarantine premises,
any equipment must be cleaned and
disinfected in accordance with the
terms of the compliance agreement.
APHIS representatives may conduct
spot audits of all cleaning and
disinfection of equipment.
(E) Any vehicle, before entering or
leaving the quarantine area of the
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facility, must be cleaned and disinfected
in accordance with the terms of the
compliance agreement within a time
period authorized by the APHIS
representative and with a disinfectant
authorized in part 71 of this chapter or
otherwise approved by the
Administrator. APHIS representatives
may conduct spot audits of all cleaning
and disinfection of vehicles.
(F) If the facility has a single loading
dock, the loading dock must be cleaned
and disinfected after each use in
accordance with the terms of the
compliance agreement within a time
period authorized by the APHIS
representative and with a disinfectant
authorized in part 71 of this chapter or
otherwise approved by the
Administrator. APHIS representatives
may conduct spot audits of all cleaning
and disinfection of the loading dock.
(G) That area of the facility in which
a lot of horses has been held or has had
access to must be thoroughly cleaned
and disinfected, with a disinfectant
authorized in part 71 of this chapter or
otherwise approved by the
Administrator, in accordance with the
terms of the compliance agreement,
upon release of the horses before a new
lot of horses is placed in that area of the
facility. APHIS representatives may
conduct spot audits of all cleaning and
disinfection of lot-holding areas.
(v) Handling of the horses in
quarantine.
(A) All horses must be handled in
accordance with paragraph (a) of this
section.
(B) Each lot of horses to be
quarantined must be placed in the
facility on an ‘‘all-in, all out’’ basis. No
horse may be taken out of the lot while
it is in quarantine, except for diagnostic
purposes or as provided in paragraph
(a)(4) of this section, and no horse may
be added to the lot while the lot is in
quarantine. Once import quarantine
operations have been completed on a
lot, but while the lot is still at the
facility, a horse may be removed from
that lot.
(C) The facility must provide
sufficient feed and bedding for the
horses in quarantine, and it must be free
of vermin and not spoiled. Feed and
bedding must originate from an area that
is not listed in part 72 of this chapter
as an area quarantined for splenetic or
tick fever.
(D) Breeding of horses or collection of
germplasm from horses is prohibited
during the quarantine period.
(E) Horses in quarantine will be
subjected to such tests and procedures
as directed by an APHIS representative
to determine whether they are free from
communicable diseases of horses.
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13:31 Jul 01, 2009
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(F) Any death or suspected illness of
horses in quarantine must be reported
immediately to APHIS. The affected
horses must be disposed of as the
Administrator may direct, or depending
on the nature of the disease, must be
cared for as directed by APHIS to
prevent the spread of the disease.
(G) Quarantined horses requiring
specialized medical attention or
additional postmortem testing may be
transported off the quarantine site, if
authorized by APHIS. A second
quarantine site must be established to
house the horses at the facility of
destination (e.g., veterinary teaching
hospital). In such cases, APHIS may
extend the quarantine period for that
horse and for its lot until the results of
any outstanding tests or postmortem
results are received.
(H) Should a horse be determined to
be infected with or exposed to a
Federally regulated disease of horses,
arrangements for the final disposition of
the infected or exposed horse must be
accomplished within 10 days of the date
that the importer is notified by the
overseeing APHIS representative that
the horse has been refused entry into the
United States. APHIS representatives
must be physically present at and
directly monitor the subsequent
disposition of the horse. The operator
must have a preapproved contingency
plan for the disposal of all horses
housed at the facility prior to issuance
of the import permit.
(I) Vaccination of horses in quarantine
is prohibited. However, once import
quarantine operations have been
completed on a lot, but while the lot is
still at the facility, horses in that lot may
be vaccinated.
(vi) Records.
(A) The facility operator must
maintain a current daily record to
record the entry and exit of all persons
entering and leaving the quarantine
facility.
(B) The operator must maintain the
daily record, along with any records
kept by APHIS and deposited with the
operator, for at least 2 years following
the date of release of the horses from
quarantine and must make such records
available to APHIS representatives upon
request.
(5) Environmental quality. If APHIS
determines that a privately operated
quarantine facility does not meet
applicable local, State, or Federal
environmental regulations, APHIS may
deny or suspend approval of the facility
until appropriate remedial measures
have been applied.
(6) Variances. The Administrator may
grant variances to existing requirements
relating to location, construction, and
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31601
other design features of the physical
facility, as well as to sanitation,
security, operating procedures,
recordkeeping, and other provisions of
paragraph (c) of this section, but only if
the Administrator determines that the
variance causes no detrimental impact
to the overall biological security of the
import quarantine operations. The
operator must submit a request for a
variance from the requirements for the
construction of the facility in paragraph
(c)(3) of this section to the
Administrator in writing prior to the
construction of the facility. The operator
must submit a request for a variance
from the operational requirements in
paragraph (c)(4) of this section to the
Administrator in writing at least 30 days
in advance of the arrival of horses to the
facility. Any variance must also be
expressly provided for in the
compliance agreement.
(Approved by the Office of Management
and Budget under control number 0579–
0313)
■ 6. In § 93.309, the section heading is
revised to read as follows:
§ 93.309 Horse quarantine facilities;
payment information.
*
*
*
*
*
7. Section 93.310 is revised to read as
follows:
■
§ 93.310 Quarantine stations, visiting
restricted; sales prohibited.
Visitors are not permitted in the
quarantine enclosure during any time
that the horses are in quarantine unless
an APHIS representative specifically
grants access under such conditions and
restrictions as may be imposed by
APHIS. An importer (or his or her agent
or accredited veterinarian) may be
admitted to the lot-holding area(s)
containing his or her quarantined horses
at such intervals as may be deemed
necessary, and under such conditions
and restrictions as may be imposed, by
an APHIS representative. On the last
day of the quarantine period, owners,
officers or registry societies, and others
having official business or whose
services may be necessary in the
removal of the horses may be admitted
upon written permission from an APHIS
representative. No exhibition or sale
shall be allowed within the quarantine
grounds.
Done in Washington, DC, this 26th day of
June 2009.
Cindy Smith,
Acting Deputy Under Secretary for Marketing
and Regulatory Programs.
[FR Doc. E9–15509 Filed 7–1–09; 8:45 am]
BILLING CODE 3410–34–P
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Agencies
[Federal Register Volume 74, Number 126 (Thursday, July 2, 2009)]
[Rules and Regulations]
[Pages 31582-31601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15509]
[[Page 31582]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 93
[Docket No. APHIS-2006-0013]
RIN 0579-AC00
Standards for Permanent, Privately Owned Horse Quarantine
Facilities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations pertaining to the importation
of horses to establish standards for the approval of permanent,
privately owned quarantine facilities for horses. We are taking this
action because regional and seasonal demand for quarantine services for
horses often exceeds the space available at existing facilities.
Allowing imported horses to be quarantined in permanent, privately
owned quarantine facilities that meet the criteria established in this
rule will facilitate the importation of horses while continuing to
protect against the introduction of communicable diseases of horses.
DATES: Effective Date: August 3, 2009.
FOR FURTHER INFORMATION CONTACT: Dr. Ellen Buck, Staff Veterinary
Medical Officer, Equine Imports, National Center for Import and Export,
VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301)
734-8364.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 93 govern the importation of
specified animals and animal products in order to prevent the
introduction of various animal diseases into the United States. The
regulations in part 93 require that some of these animals be
quarantined upon arrival in the United States as a condition of entry.
The Animal and Plant Health Inspection Service (APHIS) operates animal
quarantine facilities and authorizes the use of privately owned
quarantine facilities for certain animal importations. The regulations
in subpart C of part 93 (9 CFR 93.300 through 93.326) pertain to the
importation of horses and include requirements for privately owned
quarantine facilities for horses. Prior to this final rule, these
requirements applied solely to the approval and establishment of
temporary quarantine facilities for the purpose of quarantining
imported horses for a specific event. However, APHIS did authorize the
operation of one permanent, privately owned quarantine facility for
horses, located in Los Angeles County, CA.
On December 13, 2006, we published in the Federal Register (71 FR
74827-74847; Docket No. APHIS-2006-0013) a proposal\1\ to amend the
regulations by establishing standards for the approval of permanent,
privately owned horse quarantine facilities. We stated that such
facilities, if constructed and operated using the proper safeguards,
would provide an effective and efficient means of bringing horses into
the United States without compromising our ability to protect against
the introduction of communicable diseases of horses. In that proposal,
we also withdrew an earlier proposal, published in the Federal Register
on July 1, 2002 (67 FR 44097-44111, Docket No. 99-012-1), which would
have established differing requirements in the regulations for the
approval and operation of such permanent facilities.
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\1\ To view the proposal and the comments we received, go to
https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0013.
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We solicited comments concerning our proposal for 60 days ending
February 12, 2007. We received 15 comments by that date. They were from
horse owners, breeders, members of Congress, State agricultural
agencies, equine industry groups, the operators of a quarantine
facility, and several private citizens. They are discussed in the
sections below, by topic.
General Comments on the 2006 Proposed Rule
One commenter suggested that establishing standards for privately
owned horse quarantine facilities was unnecessary. Citing the absence
of any diseased horses that have passed through the one currently
operating permanent, privately owned quarantine facility into the
domestic horse population, the commenter stated that this facility has
demonstrated adequate biological security measures to prevent the
introduction of communicable diseases of horses into the United States.
The commenter suggested that the biosecurity requirements of the
proposed rule were disproportionate to the actual disease risk
associated with quarantining horses at the facility.
Although the biosecurity measures in place at that particular
facility may serve to mitigate the risk of disease spread from that
site, we still consider the biosecurity requirements described in our
proposal to be necessary. This is because APHIS based the requirements
on our experience in mitigating the risk of disease introduction via
imported horses. We modeled the proposed risk mitigation measures on
those in place at APHIS-operated and -approved facilities, after
assessing them for adequacy and general applicability. We determined
such an approach to be necessary in order to create national standards
for such facilities.
The fact that no equine diseases are known to have passed through
the one privately owned facility currently in operation into the
domestic horse population does not in itself address the potential
disease risks that other quarantine facilities elsewhere in the United
States could encounter.
Two commenters suggested that private ownership of permanent horse
quarantine facilities presents an unavoidable and irresolvable conflict
of interest, inasmuch as we allow a private entity to operate a
Federally regulated facility. One of these commenters recommended that
APHIS withdraw the proposed rule, and assume management of all horse
quarantine facilities. If that is not feasible, the commenter suggested
exclusive oversight of the facilities should be delegated to public
agencies, including universities, agricultural colleges, and other
institutions under contract or cooperative agreement with APHIS.
We do not consider private ownership of an equine quarantine
facility to present an irresolvable conflict of interest, provided that
the facility operates under adequate Federal oversight. We consider the
degree of APHIS oversight of private facilities required by this rule
to be sufficient to mitigate this potential conflict of interest.
A more extensive discussion of APHIS oversight of permanent,
privately owned equine quarantine facilities is found below, in the
section titled ``Changes and Clarifications with Regard to APHIS
Oversight.''
Several commenters questioned APHIS' intent in establishing
standards for privately owned quarantine facilities. One suggested that
APHIS will use the rule to expedite the slaughter of horses, while
another stated that the rule constitutes collusion with the parimutuel
horseracing industry to facilitate gambling. Accordingly, both
commenters suggested we withdraw the rule.
As explained in the proposed rule, our reasons for developing
standards for permanent, privately owned equine quarantine facilities
were the increased demand for import quarantine facilities that has
arisen in the last 20 years, the geographic distribution of the
currently operating horse quarantine facilities,
[[Page 31583]]
which can make it difficult or costly to import horses to some areas,
and the inability, because of the nature of their construction and
operation, of temporary, privately owned quarantine facilities to fill
the continual demand for import quarantine services.
One commenter stated that the proposed rule lacked sufficient
safeguards to protect the health of the domestic horse population. The
commenter pointed out that the rule does not establish a ``follow-up''
system for horses once they are released from quarantine and does not
address diseases of horses endemic to the United States.
The purpose of horse quarantine facilities is to observe imported
horses for any sign of communicable equine diseases, in order to
prevent the introduction or further dissemination of those diseases
within the United States. In this regard, it is worth noting that no
permanent equine quarantine facility, whether privately or Federally
operated, currently has a ``follow-up'' system such as that suggested
by the commenter. Instead, APHIS conducts tracebacks during animal
disease events to determine the premises of origin of the outbreak, and
also administers various domestic surveillance, control and eradication
programs for equine diseases. Among these programs are our surveillance
and vaccination efforts to prevent the spread of West Nile equine
encephalomyelitis and our surveillance and control program for
contagious equine metritis (CEM).
The aim of the proposed rule was to create standards and protocols
for permanent, privately owned quarantine facilities in order to
prevent such diseases from being transmitted through these facilities
and into the domestic horse population. Thus, establishing ongoing
surveillance of horses of foreign origin and addressing diseases of
horses endemic to the United States both fall outside of the scope of
this rulemaking.
One commenter asked whether an approved facility, if vacant, could
be used to house and quarantine domestic horses in transit from a
disaster area, provided that the horses are subject to the same
quarantine operations as horses imported into the United States.
Establishing rules for such an alternate use of permanent horse
quarantine facilities falls outside of the scope of this rulemaking.
However, in the event of an animal disease outbreak or a natural
disaster, APHIS may consult with the operators of a quarantine facility
in order to facilitate emergency operations, including emergency
housing and quarantines.
Finally, one commenter asked whether we intend to gradually phase
out existing APHIS-operated and -approved quarantine facilities as a
result of the rule, while another suggested that we build another
APHIS-operated facility on the west coast.
We will maintain the APHIS-operated facilities that presently
exist. However, we have no current plans to build additional
facilities.
Changes and Clarifications With Regard to APHIS Oversight
In the proposed rule, we stated that permanent, privately owned
horse quarantine facilities would be subject to oversight by APHIS
representatives, would operate under continuous APHIS oversight, and
would have at least one APHIS representative overseeing the care of all
horses in quarantine. We also proposed that quarantine operations, the
disposal of wastes, and cleaning and disinfection procedures at the
facility would occur under the oversight of APHIS representatives, and
further specified that incineration activities, whether onsite or
offsite, would occur under direct APHIS oversight. We stated that APHIS
would furnish services related to maintenance of the facility and daily
care of horses under quarantine if the operator of the facility failed
to do so as provided in the proposed rule, but did not provide further
criteria by which we would evaluate facilities in this regard. Finally,
we proposed that the handling, washing, and disposal of soiled and
contaminated clothing at the facility would have to occur in a manner
approved by APHIS.
Many commenters expressed concern regarding these proposed
provisions. One considered continual oversight unnecessary. Others
stated that we should reevaluate the need for ongoing and direct APHIS
oversight of cleaning and disinfection procedures and incineration
activities.
Several commenters asserted that we failed to adequately define
``oversight.'' As a result, these commenters were uncertain whether
APHIS oversight consisted of direct and continual supervision only of
quarantine operations, of quarantine operations and other related
procedures, or of all operations within the quarantine facility. If we
intended APHIS oversight to be only of quarantine operations, the
commenters stated, it was unclear whether we intended quarantine
operations to take place during normal working hours or continually
throughout the day. If we intended oversight to cover other procedures,
the commenters were uncertain to what degree APHIS representatives
would oversee them and when they would occur. Finally, several
commenters asked how much APHIS oversight would cost.
We regard APHIS oversight of the facility to be necessary in order
for us to carry out our responsibility under the Animal Health
Protection Act (7 U.S.C. 8301 et seq., AHPA) to ensure that imported
horses released from a quarantine facility are free of communicable
equine diseases.
However, we have revisited the proposed rule in light of the
commenters' concerns and appreciate the opportunity to clarify the
nature of APHIS oversight. In our proposal, we used the term ``APHIS
oversight'' in two different ways. In certain instances, it meant the
responsibilities and duties that require APHIS to assume ultimate
accountability for the biological security of the facility and the
welfare of horses onsite, without usually being physically present at
the facility. If we determine that either biosecurity or animal welfare
is being jeopardized at the facility, this oversight may require us to
be physically present at the facility to provide services to safeguard
either biosecurity or welfare of the horses. Additionally, APHIS may
withdraw approval of the facility. However, APHIS often exercises this
type of oversight by developing care plans and compliance agreements
with entities, and by conducting subsequent spot audits in order to
ensure that the terms of these plans and agreements are followed.
In other instances within the proposed rule, ``APHIS oversight''
meant those occasions when APHIS representatives must be physically
present at the facility to carry out a particular function. Those
occasions will vary somewhat from facility to facility, and may even
vary within the facility from importation to importation. Nonetheless,
we have determined that APHIS representatives must be present at a
facility to monitor import quarantine operations whenever they occur,
and to provide other technical services related to biological security.
Technical services include, but are not limited to, those measures
necessary to prevent or limit the spread of disease within the facility
if a horse in quarantine has been determined to be affected with an
equine disease.
To clarify this distinction, we have modified several paragraphs in
Sec. 93.308 from our proposal to make the occasions that will
necessitate our physical presence at the facility more explicit:
In the proposed rule, paragraph (c)(1)(ii)(C) stated that,
in order for a
[[Page 31584]]
facility to be approved, the Administrator must determine that
sufficient APHIS personnel are available to serve as representatives at
the facility and to provide continuous oversight over import quarantine
operations and other technical services related to biological security
of the facility. In this final rule, that paragraph now states that, if
a facility is approved, APHIS representatives will be present at all
import quarantine operations to monitor them and will be present to
provide technical services to ensure the biological security of the
facility. It also specifies that these technical services include
overseeing the disposition of an infected or exposed horse at the
facility, in accordance with paragraph (c)(4)(v)(H). Import quarantine
operations include, but are not limited to, visual inspection of the
animal on arrival, identification of the animal with its accompanying
import certificate, serological testing, and monitoring of routine
diagnostic tests.
In the proposed rule, paragraph (c)(2)(ii)(B) stated that
the compliance agreement that the operator of a privately owned
facility or the operator's agent and the Administrator must execute
must provide that the facility's quarantine operations are subject to
the oversight of APHIS representatives. In this final rule, as part of
the agreement, the operator now must agree to have APHIS
representatives present at all import quarantine operations at the
facility in order to monitor the import quarantine operations.
In the proposed rule, paragraph (c)(4)(i)(A) stated that,
as part of the operating procedures at the facility, the quarantine of
horses at the facility are subject to the oversight of APHIS
representatives authorized to perform the services required by the rule
and by the compliance agreement. In this final rule, that paragraph now
specifies that APHIS representatives will be physically present at and
monitor all import quarantine operations at the facility.
In the proposed rule, paragraph (c)(4)(v)(H) stated that
should a horse be determined to be infected with or exposed to a
communicable disease of horses, the final disposition of the horse must
occur under the direct oversight of APHIS representatives. In this
final rule, that paragraph now states that APHIS representatives must
be physically present at and directly monitor the disposition of the
horse.
In the proposed rule, we referred throughout Sec. 93.308
to ``quarantine operations.'' In this final rule, to better delineate
those procedures for which APHIS representatives will maintain a
physical presence at quarantine facilities, we have changed every such
reference to ``import quarantine operations.''
As part of the reevaluation that led to these clarifications, we
also examined whether the maintenance of the facility, the daily care
of horses under quarantine, the disposal of wastes, cleaning and
disinfection procedures, incineration activities, and the handling,
washing, and disposal of soiled and contaminated clothing at the
facility could be performed without APHIS personnel being physically
present on each occasion. We have determined that these activities and
procedures need APHIS oversight, but that it is not necessary for APHIS
representatives to maintain physical presence at them and direct or
continual monitoring of them, unless we have reason to believe that
these activities are being neglected or carried out in a manner that
compromises either the biological security of the facility or the
welfare of horses onsite.
In order for APHIS to allow these practices to be conducted without
our physical presence, however, we have determined that we must possess
adequate knowledge of the standard practices that the operator of the
facility will employ regarding these activities prior to APHIS' initial
approval of the facility. We have also determined that we must possess
some mechanism whereby we can evaluate the operator's adherence to
these practices once the site is operational and, if necessary, take
remedial measures to address any failure to comply with these
standards.
As a result of this determination, in Sec. 93.308, we have
modified proposed paragraph (c)(2)(ii), which sets forth requirements
for the compliance agreement that an operator of a facility or his or
her agent must execute prior to APHIS approval of the facility, to
specify that each compliance agreement must provide that the operator
agrees to demonstrate, to the satisfaction of the Administrator, that
the routine cleaning and maintenance of the facility, the daily care of
animals in quarantine, the disposal of wastes at the facility, the
cleaning and disinfection procedures employed by the facility, the
handling, washing, and disposal of soiled and contaminated clothing
worn within the facility, and the disposal of dead horses, whether
onsite or offsite, adhere to the best practices of biological security
and animal care; and provide that the operator agrees to random spot
audits by APHIS representatives to determine whether employees and
other personnel are complying with these practices.\2\ These two
requirements are found in subparagraphs (E) and (F) of paragraph
(c)(2)(ii) in Sec. 93.308 of this final rule.
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\2\ Best practices for biological security and animal care are
those employed at our Federally maintained quarantine facilities or
otherwise specified within operational memoranda issued by APHIS'
Veterinary Services division. APHIS will facilitate the operator's
access to these best practices prior to the execution of the
compliance agreement.
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Accordingly, proposed paragraph (c)(4)(i)(B) of Sec. 93.308, which
pertained to the maintenance of the facility and the daily care of
animals in quarantine, has been modified to reflect these changes to
the compliance agreement. In this final rule, the paragraph provides
that, if, as the result of a spot audit, or for any other reason, APHIS
determines that the operator has failed to properly care for, feed, or
handle quarantined horses as required by this final rule or in
accordance with the terms of the compliance agreement, or has failed to
maintain and operate the facility as provided in the rule or in
accordance with the terms of the compliance agreement, APHIS
representatives will furnish such services, will make arrangements for
the sale or disposal of quarantined horses at the quarantine facility
owner's expense, or will begin the process for withdrawal of approval
of the quarantine facility. In the proposed rule, this paragraph did
not mention either spot audits or the compliance agreement, and did not
state that nonadherence to the provisions of the rule could result in
withdrawal of approval.
In this final rule, the following paragraphs have been modified to
specify that the procedures detailed in the paragraphs must be carried
out in accordance with the term of the compliance agreement, and to
state that the procedures are therefore subject to spot audits:
Paragraph (c)(3)(iii)(F), which pertains to the disposal
of wastes at the facility;
Paragraph (c)(3)(iii)(H), which pertains to incineration
activities;
Proposed (c)(3)(iv)(F), which pertains to the disposal of
wastes at the facility;
Paragraph (c)(4)(iv)(C), which pertains to the handling,
washing, and disposal of soiled and contaminated clothing worn within
the quarantine facility;
Paragraph (c)(4)(iv)(D), which pertains to cleaning and
disinfection procedures for equipment used in the quarantine area;
Paragraph (c)(4)(iv)(E), which pertains to cleaning and
disinfection
[[Page 31585]]
procedures for vehicles entering and exiting the quarantine area; and
Paragraph (c)(4)(iv)(G), which pertains to cleaning and
disinfection procedures for lot-holding areas.
If, at any time, an APHIS representative discovers that employees
or other authorized personnel are not following the terms of the
compliance agreement, he or she may issue additional instructions
regarding the measures that these individuals must take while import
quarantine operations are being conducted at the facility (paragraph
(c)(4)(ii)(C) of Sec. 93.308). If employees do not follow these
additional instructions, APHIS representatives may require the operator
to bar these personnel from the facility (paragraph (c)(2)(ii)(D) of
Sec. 93.308). Finally, in this final rule, both paragraphs
(c)(1)(iv)(C)(1) and (c)(4)(i)(B) of Sec. 93.308 provide that
nonadherence to the terms of this rule or the compliance agreement by
the operator or his or her employees may result in withdrawal of
approval of the quarantine facility.
In response to the commenters' questions regarding when APHIS would
exercise oversight of the facility, APHIS representatives will
ordinarily render their services during their normal tour of duty as
APHIS employees. An APHIS employee's tour of duty may vary, but always
excludes Sundays and holidays. If circumstances require an APHIS
employee to be present at the facility outside of his or her tour of
duty, we will charge an overtime rate for those services. This rate is
found in 9 CFR 130.30(b).
Similarly, in response to the commenters' questions regarding the
cost associated with APHIS oversight, in the proposed rule, we stated
that we will charge for APHIS' inspection of a facility at the hourly
rates listed in 9 CFR 130.30. We also stated that the operator of the
facility would be charged for the services APHIS representatives
provide in accordance with 9 CFR part 130.
In a related matter, as we mentioned above, proposed Sec.
93.308(c)(1)(ii)(C) stated that part of APHIS' initial evaluation of an
application for approval of a facility would be a determination of
whether sufficient APHIS personnel are available to serve as APHIS
representatives at the facility, in order to provide continuous
oversight of import quarantine operations and other technical services
pertaining to biological security.
Several commenters expressed concern regarding this paragraph. One
commenter stated that APHIS does not currently have sufficient
personnel at existing APHIS-operated quarantine facilities, and thus
cannot assume oversight of privately owned facilities. Another stated
that recent outbreaks of equine herpes virus (EHV-1) at an APHIS-
operated quarantine facility suggest that the biological security risks
associated with horse quarantine facilities have increased and
necessitate that more personnel be assigned to the facility than APHIS
can provide. A third commenter stated that it is unlikely that APHIS
personnel will be available to continually staff the facilities, and we
should therefore consider providing funding opportunities through
cooperative agreements for State animal health officials to provide
health inspection services at the facilities. A fourth commenter
suggested that, in the event of a lack of adequate personnel, APHIS
should delegate supervision of certain quarantine operations, such as
the collection of blood samples, to private practitioners.
Those commenters who stated that APHIS does not have sufficient
personnel to serve as representatives at or to provide continual
oversight of a quarantine facility appear to have based their
evaluation, in large part, on an expansive understanding of ``APHIS
oversight.'' We consider the clarifications and amendments we have made
to the proposed rule regarding the nature of this oversight to be
sufficient to address this aspect of the commenters' concerns.
In addition, by making a determination that APHIS must have
sufficient personnel to serve as representatives to a facility one of
the conditions for the Administrator's initial approval of the
facility, we are afforded the opportunity to evaluate both the extent
to which such approval could have a detrimental impact on existing
import quarantine operations at APHIS-operated facilities, and the
likelihood that a future outbreak of a foreign animal disease would
cause us to have insufficient personnel to oversee import quarantine
operations and assure biosecurity at any facility, whether privately
operated or maintained by APHIS. If the Administrator determines that
approval of a privately operated facility would jeopardize import
quarantine operations or biosecurity at an existing quarantine
facility, he or she will not grant such approval.
We consider APHIS oversight of import quarantine operations and
other related services conducted at a facility to be necessary for us
to carry out our responsibility under the AHPA to prevent the
introduction of a foreign communicable disease of horses into the
domestic equine population. We do not consider it appropriate to
delegate this responsibility to private practitioners or State animal
health officials. However, this rule does not amend or supplant the
existing regulations in 9 CFR part 93 that pertain to the various
operations that accredited veterinarians and State animal health
officials may conduct in order to provide care for imported horses or
in order to prevent the spread of communicable equine diseases.
We address the commenter's concerns regarding the biological
security of equine quarantine facilities in light of the 2006 outbreak
of EHV-1 in the section below titled ``Comments on Construction
Requirements.''
Comment Regarding the Role of State Departments of Agriculture
One commenter asked whether APHIS oversight involves parallel
supervision of the quarantine facility by State departments of
agriculture, State veterinarians, and State animal health agencies. If
it does not, the commenter suggested the final rule authorize such
entities to be consulted and have some authority in the approval of the
facility, in any decision regarding the location of the facility, in
approval of contingency plans for emergency medical care of quarantined
horses and possible disposal of all horses housed at the facility, in
the granting of variances from the terms of the rule, and in the
decisionmaking process for denying or withdrawing approval of the
facility.
As we mentioned above, it is APHIS' responsibility under the AHPA
to prevent the introduction of foreign communicable diseases of horses
into the domestic equine population. As part of this duty, it is
necessary for us to make the ultimate determination in those areas
described by the commenter. Therefore, we do not consider it possible
to delegate responsibility to or share responsibility with State animal
health authorities for these determinations in the manner requested by
the commenter.
However, our responsibility does not preclude APHIS from asking
State authorities to provide guidance regarding the approval of a
proposed facility. Indeed, on many occasions, we may have to solicit
such input in order to determine whether a proposed facility meets
local and State environmental regulations. Such a determination is
required in paragraph (c)(5) of Sec. 93.308.
In addition, APHIS has recently undertaken an initiative to
facilitate greater communication with State agricultural agencies, and
to establish greater collaboration among Federal and State officials in
the development of
[[Page 31586]]
effective strategies to respond to animal disease events and emergency
situations at the State and local levels. We will implement this rule
in a manner that is consistent with that initiative, especially in
matters pertaining to the biosecurity of the facility and the health of
livestock in the area of the facility.
Comment Regarding Temporary, Privately Owned Quarantine Facilities
In our proposal, we proposed to amend paragraphs (b) and (c) of
Sec. 93.308 by combining the two paragraphs, which contained
requirements for temporary, privately owned horse quarantine
facilities, into a single paragraph (b), and by making several
nonsubstantive changes to the text of these paragraphs.
One commenter asked whether these changes established new
regulations for such temporary facilities. In the commenter's
estimation, it would prove impracticable to have temporary facilities
adhere to the same standards as permanent facilities.
We are maintaining the existing provisions for temporary, privately
owned quarantine facilities. This rule establishes standards solely for
permanent facilities.
Comments Regarding Denial or Withdrawal of APHIS Approval
In Sec. 93.308, proposed paragraph (c)(1)(iv) set forth a protocol
for denying or withdrawing approval of a permanent, privately owned
horse quarantine facility, and reasons for APHIS to deny or withdraw
such approval. Among other reasons, we stated that, if the operator or
a person responsibly connected with the business of the quarantine
facility acts as a paid agent (broker) for the importation or
subsequent sale of a horse, APHIS could deny or withdraw approval of a
privately owned horse quarantine facility.
We deemed a person to be responsibly connected with the business of
the quarantine facility if that person has an ownership, mortgage, or
lease interest in the facility's physical plant, or if that person is a
partner, officer, director, holder, or owner of 10 percent or more of
its voting stock, or is an employee in a managerial or executive
capacity. We included these provisions in our December 2006 proposal in
response to comments that we received regarding our July 2002 proposal.
The commenters on the earlier proposal suggested that an operator who
also acted as a broker would face conflicts of interest while housing,
treating, and caring for horses imported by other brokers.
We received two comments regarding these provisions. Both
commenters considered the measure to be overly restrictive, and
suggested that a person engaged in both operation of the facility and
import brokerage would not necessarily encounter a substantive and
irresoluble conflict of interest. One of these commenters asserted that
the one permanent, privately owned horse quarantine facility currently
in operation has functioned as an import broker almost since its
establishment, without incident or complaint. In lieu of these
provisions, the commenters suggested that APHIS forbid operators from
discriminating against any importer or agent, under penalty of fines or
withdrawal of approval.
We are making no changes to the proposed rule in response to these
comments. If an operator acts as a broker, this may not necessarily
lead to conscious discrimination against the horses of other brokers,
or in favor of one's own horses. However, it does predispose the
operator to act in a manner that serves, or at least preserves, his or
her economic interest in the horses under quarantine, and creates an
incentive for the operator to discriminate in favor of his or her own
horses, those of a family member, or those belonging to an individual
who has a business relationship with the operator. Prohibiting
operators from acting as brokers is necessary to prevent these
conflicts.
Another commenter suggested that APHIS could largely resolve this
conflict of interest and make this provision unnecessary by privatizing
all existing Federal horse quarantine facilities. The commenter did not
explicitly state why such privatization would attenuate this conflict
of interest, but appeared to suggest that this action would provide an
opportunity for other brokers to assume ownership of these Federal
facilities.
Such privatization would not remove the conflict of interest, since
it would still allow operators to act as brokers.
The same commenter suggested that, if we do not pursue
privatization, these provisions are insufficient. The commenter pointed
out that the one currently operating permanent, privately owned horse
quarantine facility not only engages in import brokerage, but also
functions as a retailer in the shipping industry. The commenter
suggested that operators who act as shippers may encounter similar
conflicts to those who act as brokers. Therefore, the commenter asked
that, if we do not pursue privatization, we should consider prohibiting
operators not only from brokerage, but also from retail shipping.
Operators do not possess as immediate and substantive an economic
interest in the horses they ship as they do in those horses for which
they act as brokers. If an operator assumes brokerage of a horse, the
economic interest that the operator gains in the horse necessarily
creates incentives for the individual to use his or her position as an
operator in order to preserve and, if possible, increase the value of
the horse, or conversely, to use that position to create competitive
disadvantages for other brokers utilizing his or her facility. If an
operator becomes the shipping agent for a horse, but does not function
as the horse's broker, the economic interest that the operator has lies
not in the horse itself, but in conveyance of the animal to or from the
quarantine facility. This sort of interest creates only tangential or
incidental incentives for the individual to use his or her position as
an operator to maintain or increase the value of the animal to be
shipped. For this reason, we do not consider the potential conflicts
associated with retail shipping equivalent to those associated with
brokerage, and are therefore not including shipping of horses as a
reason to deny or withdraw approval of a permanent, privately owned
quarantine facility in this final rule.
Comments Regarding the Compliance Agreement for Permanent Facilities
In Sec. 93.308, proposed paragraph (c)(2) stated that the operator
of the facility or his or her agent would have to execute a compliance
agreement with the Administrator. In the proposal, we specified that
the compliance agreement would have to provide that the facility would
have to meet all applicable requirements of proposed Sec. 93.308 and
that the facility's quarantine operations would be subject to the
oversight of APHIS representatives. The compliance agreement also
stated that the operator of the facility would be responsible for:
The cost of the facility;
All costs associated with the facility's maintenance and
operation;
All costs associated with the hiring of employees and
other personnel to attend to the horses as well as to maintain and
operate the facility;
All costs associated with the care of quarantined horses,
such as feed, bedding, medicines, inspections, testing, laboratory
procedures, and necropsy examinations; and
All APHIS charges for the services of APHIS
representatives in accordance with Sec. 93.308 and 9 CFR part 130.
The compliance agreement would further provide that the operator
would
[[Page 31587]]
agree to bar from the facility any employee or other personnel at the
facility who fails to comply with the standards governing permanent,
privately owned quarantine facilities, found in paragraph (c) of Sec.
93.308, with other provisions of 9 CFR part 93, with any terms of the
compliance agreement, or with any related instructions from APHIS
representatives.
Two commenters expressed concern regarding the section of the
compliance agreement in which the operator agrees to pay all charges
for services rendered by APHIS representatives assigned to the
facility. One of the commenters stated that this stipulation is at odds
with the procedures in place at the one permanent, privately owned
quarantine facility currently in operation, and is inconsistent with
the practices of APHIS-operated quarantine facilities. The commenter
stated that at such facilities the importer of record or the shipping
agent is responsible for all fees for APHIS services.
The fees that APHIS assesses on importers and shipping agents at
the quarantine facilities that we operate are for services rendered
directly on behalf of the importer or shipping agent, such as meeting
the importer or agent at the port of entry in order to facilitate
transportation of the animal to the quarantine facility, or drawing
blood for routine serological tests once import quarantine operations
have been completed.
In contrast, the services that APHIS employees will provide at
privately owned equine quarantine facilities will be directly related
to conducting import quarantine operations and maintaining biosecurity
for all horses at the facility, and are thus properly rendered on
behalf of the operator of the facility, rather than on behalf of a
specific importer or agent. Therefore, it is reasonable that the
operator of the facility should agree to pay all charges for such
services. This provision is consistent with the standards currently in
place for temporary, privately owned quarantine facilities, which
require the operator of the facility to bear all maintenance and
operation costs.
Finally, it is important to note that this rule does not prohibit
the operator of a privately owned equine quarantine facility from
passing on the costs of APHIS' services to the importer of record or
the shipping agent.
Another commenter asked if pricing structures for the services
rendered at the privately owned facilities will correspond to those
already in place for APHIS-operated quarantine facilities.
As we mentioned in the proposed rule, APHIS will charge for its
services according to 9 CFR part 130. We will not regulate the amount
that the operators of a facility may charge for services that they
themselves provide.
Comments Regarding Location Requirements
In Sec. 93.308, proposed paragraph (c)(3)(i) set forth location
requirements for permanent, privately owned quarantine facilities.
These required that the quarantine facility must be located in
proximity to a port authorized under paragraph (e) of Sec. 93.303 of
the regulations, and that the site and the specific routes for the
movement of horses from the port to the site must be approved by the
Administrator based on consideration of whether the site or routes
would put the horses in a position that could result in the
transmission of communicable diseases to domestic horses. In both our
December 2006 proposal and our July 2002 proposal, we decided not to
specify a maximum distance that a facility could be located from a port
of entry. In each proposal, we cited the diversity of locations of
possible ports of entry as a reason for not setting such a distance:
Some may be located in large metropolitan areas, with the nearest
concentration of livestock many miles away, while others may be in
towns with rural areas and high concentrations of livestock within a
very short distance of the port.
Two commenters asked that APHIS add provisions to specify a maximum
distance that a quarantine facility can be from a port of entry. One of
these commenters stated that, if a quarantine facility were located
many miles from a port of entry, a horse refused entry at one of the
quarantine facilities would have to be transported a great distance
before being exported from the United States. In the commenter's
estimation, transporting a diseased horse for such a period of time,
even under the most stringent biological security measures, would pose
a substantial risk of disease spread through third-party vectors, such
as flies and gnats.
We do not consider it possible to set a maximum distance that a
quarantine facility can be located from a port of entry. In light of
the diversity of places in which persons may consider locating a
permanent facility, and the possibly substantive variations among
different ports of entry, setting specific distances may result in
regulations that are too stringent for some facilities, and too lax for
others.
In a similar matter, in our July 2002 proposal, we proposed to
require that the facility be located at least one-half mile from
premises holding livestock or horses. In response to a commenter who
suggested that other requirements in our proposal established adequate
biosecurity to render such a requirement unnecessary, we reevaluated
the need for this requirement, and removed it from our December 2006
proposal. Instead, we specified that the site would have to be approved
by the Administrator as described above. The Administrator will take
into consideration the proximity of the quarantine facility to the
nearest port of entry, and the disease risks posed by transit of an
infected horse from the port to the facility, in making his or her
determination whether to approve the construction of the facility.
A commenter on the December 2006 proposal suggested that mandating
a minimum distance that a facility can be constructed from the
surrounding horse population greatly reduces the likelihood of disease
spread to that population and the possibility of a subsequent equine
disease outbreak in the vicinity of the facility, and such a
requirement ought to be included in the final rule.
We have evaluated the biosecurity requirements we described in the
proposed rule, and determined that they are adequate to mitigate the
possibility of disease spread. Therefore, if all other procedures
described in this rule are followed at a private, permanently owned
quarantine facility, a distance requirement is unnecessary.
We note, however, that we are requiring that each application for
approval of a quarantine facility must specify the location and street
address of the facility. This requirement affords the Administrator the
opportunity to assess the specific risks posed by that location, in
accordance with paragraph (c)(3)(i) of Sec. 93.308, and to specify
additional biological security measures, beyond those specified in the
rule, that the facility must adopt in order to address these risks and
prevent disease spread. As specified in paragraph (c)(1)(ii)(B) of
Sec. 93.308, the Administrator may impose such additional requirements
within the terms of the compliance agreement.
If the Administrator decides that the disease risks associated with
a particular location are insurmountable, even with the imposition of
such additional biosecurity requirements, he or she will not approve
the location of the facility.
Comments Regarding Construction Requirements
In Sec. 93.308, proposed paragraph (c)(3)(ii) set forth
construction requirements for permanent, privately
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owned horse quarantine facilities. The proposed basic standards for the
facility addressed perimeter fencing, entrances and exits, windows,
lighting, loading docks, surfaces, horse stalls, aisleways, isolation
stalls, showers, APHIS space, necropsy areas, storage space, restrooms,
ventilation, climate control, fire alarms, and communications systems.
Our July 2002 proposed rule included several specific construction
requirements for lot-holding areas. These areas, which we defined as
``areas within a permanent, privately owned quarantine facility in
which lots of horses are held,'' would have had separate drainage and
heating, ventilation, air conditioning systems, and physical barriers.
Our December 2006 proposed rule retained the provisions regarding lot-
holding areas, but provided more options for operators to provide
biological security within these areas, such as cleaning and
disinfection after each use of an area.
One commenter suggested that APHIS remove those additional options
for lot-holding areas and return to the more stringent requirements
presented in the July 2002 proposed rule. The commenter cited the 2006
outbreak of a neurotropic EHV-1 mutation in a lot of horses at a
permanent, APHIS-operated quarantine facility as evidence of the
significant disease risks that may arise at a quarantine facility, and
suggested that the revisions to lot-holding areas set forth in our
December 2006 proposal did not take these risks into adequate account.
The commenter therefore suggested that APHIS reevaluate the
construction standards proposed for these areas in light of the
outbreak.
We are making no change in response to this comment. The
construction standards in the December 2006 proposal called for
physical barriers to be erected to separate different lots of horses at
the facility, so that horses in one lot cannot have physical contact
with horses in another lot, their excrement, or their discharges. In
addition, the sanitary standards in the 2006 proposal stated that each
lot-holding area of the facility would have to be thoroughly cleaned
with a disinfectant upon release of a lot of horses before a new lot of
horses can enter the lot-holding area. APHIS has determined that these
safeguards, which are comparable to those at APHIS-operated facilities,
effectively limit the spread of communicable diseases of horses between
lots of horses at a facility. We note, in this regard, that the
biological security measures in place at the quarantine facility that
was the site of the EHV-1 outbreak limited the spread of the disease to
one lot of horses--neither lots in adjacent holding areas nor
subsequent lots at the quarantine facility tested positive for the
virus.
Finally, if a disease of horses, whether foreign or endemic to the
United States, spreads within a particular lot of horses, the horses in
that lot are subject to the provisions of paragraph (c)(4)(v)(H) of
Sec. 93.308, which sets forth requirements regarding the final
disposition of horses infected with or exposed to a communicable
disease of horses.
Another commenter stated that the construction requirements
presented in the December 2006 proposed rule were not sufficiently
delineated. The commenter asserted that, instead of creating objective
and unilaterally binding specifications, APHIS had made standards
primarily dependent on the judgment of APHIS representatives who
inspect and approve the facility. In the commenter's opinion, this
could result in wide deviations regarding the biological security of
various facilities, and would necessarily make it difficult for a third
party to determine the criteria by which the representative has
evaluated a facility. The commenter suggested that, at a minimum, the
final rule provide more detailed criteria for the construction of
drainage and heating systems, ventilation, air conditioning systems,
physical barriers, and material used in the construction of floors and
walls within the quarantined area.
We are making no change in response to this comment. Our June 2002
proposed rule contained more specific construction criteria for lot-
holding areas, floor drains, physical barriers, showering areas, areas
for breaks and meals, and heating and ventilation units within the
facility. In response to those proposed requirements, several
commenters pointed out that some of these requirements were more
restrictive than the design of various APHIS-operated facilities. Other
commenters suggested that we generally amend the construction
requirements to allow operators as many design variations as possible.
Accordingly, in drafting our December 2006 proposal, we reevaluated the
construction requirements that we proposed in 2002 and determined that,
on certain occasions, the requirements of our 2002 proposal were indeed
inconsistent with those at APHIS-approved facilities. On other
occasions, we determined that the requirements could be adjusted to
allow operators more options to provide adequate biological security at
the facility. This led us to modify the construction requirements
mentioned by the commenter.
The APHIS approval process will ensure that all permanent,
privately owned facilities are constructed in a manner adequate to
prevent the transmission of disease between lot-holding areas, thus
preventing any wide deviations with regard to biosecurity. In addition,
we note that, under paragraph (c)(1)(ii)(B) of Sec. 93.308, the
Administrator may impose additional construction requirements within
the terms of the compliance agreement, beyond those specified in the
rule, if he or she determines these requirements to be necessary to
prevent the transmission of diseases into, within, or from the
facility.
Several commenters suggested that the construction standards be
modified to allow or require exercise equipment or ``turn-out'' pens
for horses in quarantine. Such accommodations, the commenters stated,
would allow horses under quarantine to maintain muscle tone and general
overall health.
Allowing a horse under quarantine to be separated from its lot and
released for exercise to an area of the facility outside the lot-
holding area, whether indoor or outdoor, presents an unacceptable risk
of disease spread. We note, in this regard, that horses that are
required under the regulations to be quarantined for extended periods
of time after their importation often have been imported from regions
where a communicable equine disease is known to exist, or from regions
that engage in trade with such regions and do not require testing or
vaccination for that disease.
We recognize, however, that it may be possible to place exercise
equipment in the stalls or in other parts of the lot-holding areas,
depending on the size or construction of such areas. Therefore, we have
modified proposed paragraph (c)(3)(i)(G) of Sec. 93.308, which stated
that the stalls in which horses are kept would have to be large enough
to allow each animal to make normal postural and social adjustments
with adequate freedom of movement, to further state that exercise
equipment for horses may be kept in the stalls, provided that there
will still be sufficient space within the stall for the horses to move
freely once the equipment is installed.
Moreover, the regulations in this final rule allow exercise
equipment to be kept in the lot-holding areas themselves. Any such
equipment would, however, be subject to the cleaning and disinfection
procedures required for lot-holding areas. To clarify this provision,
we have modified proposed paragraph (c)(4)(iv)(D), which contained
cleaning and disinfection requirements for equipment used within the
quarantine area of the facility, to specify that these
[[Page 31589]]
requirements also pertain to exercise equipment located within the
quarantine area.
Comment Regarding Requirements for Isolation Stalls
In Sec. 93.308, proposed paragraph (c)(3)(ii)(I) addressed
requirements for the means of isolation within permanent, privately
owned facilities. We stated that the facility must have physical
barriers to separate different lots of horses at the facility, so that
horses in one lot cannot have physical contact with horses in another
lot, or their excrement or discharges. We also stated that the facility
must have stalls capable of isolating any horses exhibiting signs of
illness.
One commenter pointed out that we did not specify a location for
these stalls. As a result, the commenter was uncertain whether APHIS
intended stalls to be constructed in a separate building or merely in
such a manner that the horse does not have direct contact with other
horses in its lot.
An isolation stall may be constructed in a separate building or
within the quarantine area, provided that, in the estimation of the
Administrator, the stall is able to physically isolate the horse from
other horses at the facility.
Comment Regarding Requirements for Necropsy Areas and Carcass Removal
In Sec. 93.308, proposed paragraph (c)(3)(ii)(L) set forth
construction requirements for necropsy areas used by permanent,
privately owned quarantine facilities. These required that all
facilities must either have an area for conducting necropsies onsite,
or must have designated an alternate facility, approved by the
Administrator, at which a suitable necropsy area is available. In
proposed paragraph (c)(3)(iii)(G) of Sec. 93.308, which set forth
sanitation requirements for permanent, privately owned quarantine
facilities, we stated that each facility must have the capability to
dispose of horse carcasses in a manner approved by the Administrator
and under conditions that minimize the risk of disease spread.
One commenter stated that the carcass disposal requirements appear
to be based on the quarantine facility's use of an onsite necropsy
area. If the quarantine facility utilizes an alternate facility for
necropsies, however, the commenter suggested that these disposal
requirements no longer apply, since the sanitary disposal of the
carcass after necropsy would become the responsibility of this other
facility.
We are making no change in response to this comment. When a horse
dies at a permanent, privately owned facility, the operator assumes
ultimate responsibility for the disposal of its carcass in a manner
acceptable to the Administrator, and under direct oversight of APHIS,
whether the necropsy is conducted onsite or at another facility. The
location of the necropsy, then, has no bearing on the disposal
requirements.
Comment Regarding Security Requirements
In proposed paragraph (c)(3)(iv) of Sec. 93.308, we set forth
security requirements for permanent, privately owned facilities. We
proposed that the facility and premises be kept locked and secure at
all times. We also proposed to require that the facility and premises
must have signs indicating that the facility is a quarantine area and
no visitors are allowed.
Further, we proposed to require that the facility and premises
either be guarded at all times by representatives of a bonded security
company or, alternatively, have an electronic security system that
indicates the entry of unauthorized persons into the facility.
Finally, we proposed to require that the operator of the facility
notify the designated APHIS representative whenever a breach of
security occurs or is suspected of having occurred. Further, if a
disease is diagnosed in quarantined horses, we stated that the
Administrator may require the operator to have the facility guarded by
a bonded security company in a manner that the Administrator deems
necessary to ensure the biological security of the facility.
One commenter stated that these provisions appear to prohibit any
individual, including authorized personnel, from entering the facility,
except in the presence of an APHIS representative. During all other
times, it appeared to the commenter as if the facility would have to be
locked and the entrances to it guarded, protected by alarm, barred, or
sealed.
Paragraph (c)(4)(iii) grants authorized employees and other
personnel assigned to work at the facility access to the facility
premises as well as the quarantine area, even in the absence of an
APHIS representative. This provision addresses the commenter's
concerns.
Comment Regarding Personnel Requirements
In proposed paragraph (c)(4)(ii) of Sec. 93.308, we set forth
personnel requirements for permanent, privately owned quarantine
facilities. Among other provisions, these proposed that:
The operator of the facility would have to provide APHIS
with a continually updated list of all personnel who have access to the
facility; and
The operator of the facility would have to provide APHIS
with signed statements from every employee and any other personnel
hired by the operator and working at the facility in which the person
agrees to comply with all regulations governing permanent, privately
owned horse quarantine facilities, other applicable provisions of 9 CFR
part 93, all terms of the compliance agreement, and any related
instructions from APHIS representatives pertaining to quarantine
operations.
One commenter stated that both the list of personnel and the signed
compliance statements appear to be unnecessary, if APHIS
representatives will be physically present at all times to oversee the
facility.
As discussed earlier, APHIS will ordinarily only maintain a
physical presence at and direct supervision of import quarantine
operations and certain technical services related to the biological
security of the facility. Therefore, in order to ensure the general
biological security of the facility, it is important that APHIS
representatives have a continually updated list of all personnel with
access to the facility, one that takes into consideration employee
turnover at the facility itself and at any company with access to the
facility. It is also important that all personnel agree to adhere to
the biological security measures set forth within the rule and the
compliance agreement.
That said, we do recognize that the proposed rule could be
construed to suggest that, although APHIS personnel will be physically
present at the facility, compliance agreements and signed statements
from personnel must be submitted to APHIS employees at an off-site
location, rather than to the personnel assigned to the facility, for
review. This is not the case. The operator may submit such records to
APHIS personnel assigned to the facility. The records will then be
forwarded to the appropriate area veterinarian-in-charge office.
Comments Regarding Showering Requirements
In Sec. 93.308, proposed paragraph (c)(4)(iv) set forth sanitation
requirements for permanent, privately owned facilities. Proposed
(c)(4)(iv)(A)(1) and (2) included provisions requiring that all persons
granted access to the quarantine area shower when entering and leaving
that area, and that all persons shower when leaving the necropsy area
if a necropsy is in the process of being performed or
[[Page 31590]]
has just been completed, and portions of the animal remain exposed.
One commenter stated that these provisions were not the practice of
the one permanent, privately owned horse quarantine facility currently
in operation. The commenter suggested that the facility's standards,
which require personnel to wash their overalls and shower before
leaving work, would provide a less burdensome alternative to the
provisions of our proposal.
``Shower in/shower out'' is considered a cornerstone of
biosecurity, and is recognized and recommended by government, academia,
and industry to prevent the spread of disease agents into or from live
animal facilities. Accordingly, APHIS has determined that showering
reduces the risk of disease spread from quarantine or necropsy areas,
and may, in certain instances, remove a pathway for the transmission of
a communicable disease of horses. Therefore, these provisions represent
the practices of APHIS-operated facilities. They have thus been
evaluated for efficacy and general applicability. Conversely, the
commenter provided no data suggesting that the practices of the one
permanent, privately owned horse quarantine facility currently in
operation are equally effective risk-mitigation measures.
The same commenter stated that showering requirements, in
themselves, do not adequately address the risk of the spread of
communicable diseases of horses, since they do not preclude the
movement of waste material from a quarantined area.
The rule provides multiple safeguards to prevent the movement of
waste material from the quarantine area. In Sec. 93.308, paragraphs
(c)(4)(iv)(A)(3) through (5) require that personnel at the facility who
enter or leave the quarantine area must wear protective work clothing
and footwear upon entering the area and must change this clothing if it
becomes soiled or contaminated. Paragraph (c)(4)(iv)(C) stipulates that
the operator of the facility must handle, wash, or dispose of this
soiled and contaminated clothing in accordance with the terms of the
compliance agreement, and thus in a manner approved by the
Administrator as consistent with the best practices of biological
security. Paragraphs (c)(4)(iv)(D), (E), (F), and (G) establish
cleaning and disinfection protocols for equipment and vehicles used
within the facility, loading docks, and lot-holding areas. Thus, our
proposed showering requirements were simply one of several sanitary
practices that the facility would have to employ to address, among
other things, the risk associated with the movement of waste material
from the quarantine area.
Finally, the commenter asserted that the sanitary requirements of
the proposed rule do not prevent grooms, owners, and other personnel
who have traveled with a diseased horse from its country of origin from
moving freely throughout the United States once they have disembarked.
The commenter suggested that, if such individuals became exposed to a
communicable equine disease, they could spread the disease throughout
the United States.
APHIS personnel and employees of the Department of Homeland
Security's Bureau of Customs and Border Protection may inspect
individuals, their clothing, and their articles at ports of entry in
order to prevent the introduction of a communicable equine disease into
the domestic equine population.
Comments Regarding Requirements for the Handling of Horses Under
Quarantine
In Sec. 93.308, proposed paragraph (c)(4)(v) set forth
requirements for the handling of horses in quarantine at a permanent,
privately opera