[Federal Register Volume 74, Number 126 (Thursday, July 2, 2009)]
[Rules and Regulations]
[Pages 31582-31601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15509]



[[Page 31582]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 93

[Docket No. APHIS-2006-0013]
RIN 0579-AC00


Standards for Permanent, Privately Owned Horse Quarantine 
Facilities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations pertaining to the importation 
of horses to establish standards for the approval of permanent, 
privately owned quarantine facilities for horses. We are taking this 
action because regional and seasonal demand for quarantine services for 
horses often exceeds the space available at existing facilities. 
Allowing imported horses to be quarantined in permanent, privately 
owned quarantine facilities that meet the criteria established in this 
rule will facilitate the importation of horses while continuing to 
protect against the introduction of communicable diseases of horses.

DATES: Effective Date: August 3, 2009.

FOR FURTHER INFORMATION CONTACT: Dr. Ellen Buck, Staff Veterinary 
Medical Officer, Equine Imports, National Center for Import and Export, 
VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 
734-8364.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 93 govern the importation of 
specified animals and animal products in order to prevent the 
introduction of various animal diseases into the United States. The 
regulations in part 93 require that some of these animals be 
quarantined upon arrival in the United States as a condition of entry. 
The Animal and Plant Health Inspection Service (APHIS) operates animal 
quarantine facilities and authorizes the use of privately owned 
quarantine facilities for certain animal importations. The regulations 
in subpart C of part 93 (9 CFR 93.300 through 93.326) pertain to the 
importation of horses and include requirements for privately owned 
quarantine facilities for horses. Prior to this final rule, these 
requirements applied solely to the approval and establishment of 
temporary quarantine facilities for the purpose of quarantining 
imported horses for a specific event. However, APHIS did authorize the 
operation of one permanent, privately owned quarantine facility for 
horses, located in Los Angeles County, CA.
    On December 13, 2006, we published in the Federal Register (71 FR 
74827-74847; Docket No. APHIS-2006-0013) a proposal\1\ to amend the 
regulations by establishing standards for the approval of permanent, 
privately owned horse quarantine facilities. We stated that such 
facilities, if constructed and operated using the proper safeguards, 
would provide an effective and efficient means of bringing horses into 
the United States without compromising our ability to protect against 
the introduction of communicable diseases of horses. In that proposal, 
we also withdrew an earlier proposal, published in the Federal Register 
on July 1, 2002 (67 FR 44097-44111, Docket No. 99-012-1), which would 
have established differing requirements in the regulations for the 
approval and operation of such permanent facilities.
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    \1\ To view the proposal and the comments we received, go to 
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

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facility to be approved, the Administrator must determine that 
sufficient APHIS personnel are available to serve as representatives at 
the facility and to provide continuous oversight over import quarantine 
operations and other technical services related to biological security 
of the facility. In this final rule, that paragraph now states that, if 
a facility is approved, APHIS representatives will be present at all 
import quarantine operations to monitor them and will be present to 
provide technical services to ensure the biological security of the 
facility. It also specifies that these technical services include 
overseeing the disposition of an infected or exposed horse at the 
facility, in accordance with paragraph (c)(4)(v)(H). Import quarantine 
operations include, but are not limited to, visual inspection of the 
animal on arrival, identification of the animal with its accompanying 
import certificate, serological testing, and monitoring of routine 
diagnostic tests.
     In the proposed rule, paragraph (c)(2)(ii)(B) stated that 
the compliance agreement that the operator of a privately owned 
facility or the operator's agent and the Administrator must execute 
must provide that the facility's quarantine operations are subject to 
the oversight of APHIS representatives. In this final rule, as part of 
the agreement, the operator now must agree to have APHIS 
representatives present at all import quarantine operations at the 
facility in order to monitor the import quarantine operations.
     In the proposed rule, paragraph (c)(4)(i)(A) stated that, 
as part of the operating procedures at the facility, the quarantine of 
horses at the facility are subject to the oversight of APHIS 
representatives authorized to perform the services required by the rule 
and by the compliance agreement. In this final rule, that paragraph now 
specifies that APHIS representatives will be physically present at and 
monitor all import quarantine operations at the facility.
     In the proposed rule, paragraph (c)(4)(v)(H) stated that 
should a horse be determined to be infected with or exposed to a 
communicable disease of horses, the final disposition of the horse must 
occur under the direct oversight of APHIS representatives. In this 
final rule, that paragraph now states that APHIS representatives must 
be physically present at and directly monitor the disposition of the 
horse.
     In the proposed rule, we referred throughout 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