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[Federal Register: July 2, 2009 (Volume 74, Number 126)]
[Rules and Regulations]
[Page 31582-31601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy09-3]
[[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
http://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
[[Page 31588]]
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 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 Sec. 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 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
[[Page 31591]]
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 Sec. 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 Sec. 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 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 non-
compliance 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) Sec. 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.
In proposed paragraph (c)(4)(v)(H) of Sec. 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
[[Page 31592]]
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\
---------------------------------------------------------------------------
\3\ Source: The American Horse Council. Found at http://
www.horsecouncil.org/statistics.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
Table 1--U.S. Equine Imports From Countries for Which Quarantine Is Required, 2003-2007, Number of Head
----------------------------------------------------------------------------------------------------------------
Country 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
The Netherlands................. 2,176 2,810 3,035 2,920 2,600
Germany......................... 1,424 1,285 1,345 1,630 1,517
Argentina....................... 683 771 869 741 786
United Kingdom.................. 587 630 640 614 529
Other countries................. 2,270 2,036 1,956 1,746 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 31593]]
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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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
[[Page 31594]]
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 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 per-farm revenue for all U.S. equine farms in 2002 was $7,158,
an indication that these farms are by and large small entities.
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 APHIS-operated horse quarantine facilities, the fact
that there are no other permanent, privately owned quarantine
facilities operating at this time, and the fact that
[[Page 31595]]
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 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 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.
0
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
0
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 93.300 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:
Sec. 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
[[Page 31596]]
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 lot-holding 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).
* * * * *
0
3. Section 93.303 is amended as follows:
0
a. By revising the heading of paragraph (e) to read as set forth below.
0
b. In paragraph (e), by removing the words ``provided by the importer''
and by adding the words ``privately owned'' before the word
``quarantine''.
Sec. 93.303 Ports designated for the importation of horses.
* * * * *
(e) Ports for horses to be quarantined at privately owned
quarantine facilities. * * *
* * * * *
Sec. 93.304 [Amended]
0
4. Section 93.304 is amended as follows:
0
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.
0
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.
0
5. Section 93.308 is amended as follows:
0
a. In paragraph (a)(3), by redesignating footnote 14 as footnote 13.
0
b. By revising paragraphs (b) and (c) to read as set forth below.
0
c. By adding an OMB citation at the end of the section to read as set
forth below.
Sec. 93.308 Quarantine requirements.
* * * * *
(b) Temporary, privately owned quarantine facilities. Horses
presented for entry into the United States as provided in Sec.
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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(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.
[[Page 31597]]
(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 Sec.
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 Sec. 130.30 of
this chapter. This service agreement 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, first-served
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 Sec. 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 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(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
[[Page 31598]]
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 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 Sec. 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 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
[[Page 31599]]
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
refrigerator-freezer 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 operations. Storage
space must include separate, secure storage for pesticides and for
medical and other biological supplies, as well as a separate vermin-
proof storage area for feed and bedding, if feed and bedding are stored
at the facility. If the facility has multiple lot-holding 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.
(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.
[[Page 31600]]
(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 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.
(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 [deg]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
[[Page 31601]]
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.
(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 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)
0
6. In Sec. 93.309, the section heading is revised to read as follows:
Sec. 93.309 Horse quarantine facilities; payment information.
* * * * *
0
7. Section 93.310 is revised to read as follows:
Sec. 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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/ Thursday, July 02, 2009
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