[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Proposed Rules]
[Page 74827-74847]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-17]
-----------------------------------------------------------------------
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: Proposed rule; withdrawal and reproposal.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend 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 demand for quarantine services for horses
exceeds the space available at existing facilities. This proposed rule
replaces a previously published proposed rule, which we are withdrawing
as part of this document, that contained substantially different
restrictions on ownership and substantially different requirements for
the physical plant, operating procedures, and compliance date. We
believe that allowing imported horses to be quarantined in permanent,
privately owned quarantine facilities that meet these newly proposed
criteria would facilitate the importation of horses while continuing to
protect against the
[[Page 74828]]
introduction of communicable diseases of horses.
DATES: We will consider all comments that we receive on or before
February 12, 2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2006-0013 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2006-0013, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS-2006-0013.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Freeda Isaac, Staff Veterinarian,
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 into the
United States of specified animals and animal products in order to help
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) of the
U.S. Department of Agriculture (USDA) 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, referred to below as the
regulations) pertain to the importation of horses and include
requirements for privately owned quarantine facilities for horses.
These requirements are for the approval and establishment of temporary
quarantine facilities for the purpose of quarantining imported horses
for a specific event.
In addition to operating Federal animal quarantine facilities and
authorizing the operation of temporary, privately owned quarantine
facilities for horses, APHIS currently authorizes the operation of one
permanent, privately owned quarantine facility for horses, located in
Los Angeles County, CA.
The demand for import quarantine facilities for horses has risen in
recent years as the amount of trade between the United States and other
countries has risen. From 1992 to 2003, the number of horses imported
annually into the United States increased substantially. In some cases,
the demand for quarantine services for horses has exceeded 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 exist for quarantining imported horses, reducing the ability
of importers to profitably bring horses to those States. The demand for
quarantine services for horses cannot always be filled by temporary,
privately owned quarantine facilities because such facilities are
established, approved, and operated by importers on a temporary basis
to handle only horses imported for a unique importation, race, or show.
We have considered the possible need for permanent, privately owned
quarantine facilities for horses in the past. On September 6, 1989, we
published in the Federal Register (54 FR 36986-36996, Docket No. 85-
061) a proposed rule that would have (1) allowed the operation of
permanent, privately owned quarantine facilities for horses; (2) added
new requirements for the approval of temporary, privately owned
quarantine facilities for horses; and (3) required payment from each
privately owned quarantine facility for services provided by APHIS at
the facility. These changes would have been made in 9 CFR part 92;
however, a 1990 final rule reorganized part 92, and the proposed
provisions were no longer consistent with the new format of the part.
Because of this inconsistency and for other reasons, we withdrew the
proposed rule and reopened the issue for public discussion in a notice
of withdrawal and an advance notice of proposed rulemaking published in
the Federal Register on February 26, 1996 (61 FR 7079, Docket No. 95-
084-1). Then, on May 6, 1996, we published a notice (61 FR 20189-20190,
Docket No. 95-084-2) that we were reopening and extending the public
comment period for the advance notice of proposed rulemaking and
holding a public meeting on May 17, 1996, regarding the issue of
permanent, privately owned quarantine facilities for horses.
We received 10 comments during the 2 comment periods and at the
public meeting just described. Some commenters supported the concept of
permanent, privately owned quarantine facilities for horses, and some
commenters were opposed. We considered the comments and decided to
propose regulations that would allow the establishment of permanent,
privately owned horse quarantine facilities that would operate under
the oversight of an APHIS veterinarian.
On July 1, 2002, we published in the Federal Register (67 FR 44097-
44111, Docket No. 99-012-1) a proposal to establish requirements in the
regulations for the approval and operation of such facilities. We
solicited comments concerning our proposal for 60 days ending August
30, 2002. We subsequently extended the deadline for comments until
October 15, 2002, in a document published in the Federal Register on
September 30, 2002 (67 FR 61293, Docket No. 99-012-2).
We received 59 comments by the close of the extended comment
period. They were from import-export brokers, horse traders, operators
of quarantine facilities, and representatives of State governments. The
majority of these comments came from import-export brokers who
supported the proposed rule on the grounds that current shortages in
USDA quarantine space were negatively impacting their businesses.
However, commenters raised issues about proposed ownership
requirements, physical plant requirements, operating procedures,
compliance, and other provisions that led us to rethink aspects of the
proposed rule.
As a consequence, we are withdrawing the July 2002 proposed rule
mentioned above and replacing it with an alternative proposal. This
alternative proposal retains many of the
[[Page 74829]]
provisions of the July 2002 proposed rule, but incorporates numerous
suggestions made by commenters and proposes a few new requirements. The
most significant new provisions and changes in this reproposal are: A
new provision that would require that the operator or any person
responsibly connected with the business of a permanent, privately owned
facility not act as a broker for the sale or importation of horses;
several amended provisions that would change the biosecurity safeguards
relating to disease transmission between lot-holding areas; a new
provision that would allow necropsies to be conducted off-site from the
facility; and a change to prohibit vaccinations from being performed at
the facility.
The full text of the proposed regulations appears in the rule
portion of this document. Our discussion of the proposed provisions
follows. We have incorporated our responses to comments we received
concerning the July 2002 proposed rule into our discussion of the
provisions in this proposed rule.
General Discussion
We intend to maintain the current requirements in the regulations
for the approval of temporary, privately owned quarantine facilities
for horses. We believe that these requirements are sufficient for
facilities that are intended to quarantine horses imported only for a
particular event. Temporary facilities are generally used to quarantine
small numbers of animals in a single group and are in operation for
only a short period of time before all the animals are removed and the
facility is closed.
We continue to believe that permanent, privately owned horse
quarantine facilities, 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. We
are, therefore, proposing to add requirements to the regulations for
the establishment and approval of permanent, privately owned quarantine
facilities for horses.
These proposed requirements are designed to maintain the same level
of biological security standards as other permanent quarantine
facilities operated by APHIS. We believe that the permanent, privately
owned facilities must be designed, equipped, and monitored similarly to
APHIS quarantine facilities in order to provide sufficient protection
against the introduction of disease. Like an APHIS facility, a
permanent, privately owned quarantine facility could be occupied on a
continuing basis by a large number of horses imported from many
different regions. These circumstances dictate that security measures
must be tighter, and disease detection and prevention measures must be
different, at permanent facilities than at temporary ones. While the
requirements for temporary facilities allow for variation in physical
plants, the proposed requirements for permanent facilities would ensure
a greater degree of consistency in the physical plants of those
facilities. Such consistency should help ensure a greater degree of
biological security. The proposed requirements for permanent facilities
would also set out the operational and monitoring procedures necessary
to prevent the spread of disease into, within, and from the facilities
in much more detail than the requirements for temporary facilities.
In response to the July 2002 proposed rule, which also sought to
ensure that permanent, privately owned facilities were similar to APHIS
facilities, one commenter argued that it would be inappropriate to
require a level of biological security similar to that of current APHIS
quarantine facilities because APHIS facilities handle other livestock
such as cattle and goats in addition to handling horses. In this
commenter's view, horses require less stringent biological security
measures than other animals, because the purpose of quarantining horses
is to isolate the horses while blood tests are run and to monitor horse
health, rather than to diagnose communicable diseases of horses. Thus,
the commenter argued, the level of biological security that would be
required under the standards described in the July 2002 proposed rule
was excessive and would not have resulted in an appreciable reduction
of risk.
The purpose of horse quarantine is to observe imported horses for
any sign of communicable animal diseases, not just to determine whether
the horses are affected with any of the diseases for which APHIS
requires imported horses to be tested. The requirements described in
the July 2002 proposed rule were designed to ensure that horses would
be observed for signs of disease in a facility that presented the
smallest possible risk of disease being transmitted into the domestic
horse population, while ensuring that the horses in the facility were
properly cared for, fed, and handled. The proposed requirements were
developed specifically to address the unique problems and risks posed
in quarantining horses. Given the myriad foreign animal diseases that
may be detected only under proper quarantine scrutiny and the
continuing risk that such diseases may be transmitted into the domestic
horse population, we believe that lowering the level of biological
security required by the standards described in the July 2002 proposed
rule would be inconsistent with APHIS' duty to prevent the introduction
of dangerous foreign animal diseases. Therefore, we have made no
changes to the approach of the July 2002 proposed rule in response to
this comment.
The same commenter stated that no evidence exists to justify
biological security measures for permanent facilities that are more
restrictive than the biological security measures already in place at
the one currently operating permanent, privately owned horse quarantine
facility. The commenter noted that no equine disease has ever passed
from imported horses quarantined in the currently operating permanent
facility into the general horse population, and requested that APHIS
conduct a risk assessment to determine exactly what level of biological
security is necessary for horse quarantine facilities.
In guarding against the introduction of foreign animal diseases
into the United States, APHIS, among other things, examines the
possible ways that such diseases could be spread among or from animals
being held in quarantine, and determines what measures are necessary to
guard against such spread. While it is true that the measures in place
at the one currently operating permanent, privately owned facility
serve to a great extent to mitigate the risk of such spread, based on
the nature of diseases affecting horses and our own experience
quarantining horses intended for entry into the United States, we
consider more restrictive measures to be necessary to mitigate the risk
of disease spread from horses entered into any permanent, privately
owned horse quarantined facility.
APHIS based the requirements in the July 2002 proposed rule for
permanent facilities on an evaluation of our experience in mitigating
the risk of disease introduction via imported horses, and modeled the
proposed risk mitigation measures on those in place at APHIS-operated
and -approved quarantine facilities. In those cases where commenters on
the July 2002 proposed rule asserted that certain specific mitigating
measures were not necessary, and the available evidence supported their
claims, we have removed those measures from this new proposal. The fact
that no equine diseases are known to have passed
[[Page 74830]]
through the currently operating permanent, privately owned facility
into the general horse population to date does not in itself address
potential risks.
Changes in Our Approach With Respect to Lot-Holding Areas
We have modified one aspect of our approach to biological security
in response to various comments we received. The July 2002 proposed
rule included numerous biological security requirements intended to
prevent disease transmission between lots of horses held within the
quarantine facility. A lot of horses is 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 during their shipment to the United States. The
lot-holding area, therefore, is that area in a permanent, privately
owned quarantine facility in which a single lot of horses is held at
one time. A lot-holding area can comprise a stall, a group of stalls,
or an entire building, provided that the physical plant and operational
requirements relating to a lot-holding area are met.
The July 2002 proposed rule included proposed safeguards designed
to prevent the transmission of any diseases that might be present in
one lot of horses to another lot of horses held in the same quarantine
facility. These safeguards included: Separate drainage and heating,
ventilation, and air conditioning (HVAC) systems; physical barriers
including lockable doors; and operational safeguards including
showering and changing clothing when moving between lot-holding areas.
While these safeguards would meet the goal of reducing exposure
between lots of horses, they do not in all cases reflect the
construction of the permanent horse quarantine facilities operated by
APHIS or the operational procedures in place at those facilities. We do
not believe it is appropriate to require that permanent, privately
owned quarantine facilities meet biosecurity standards different from
those that have been determined and proven by APHIS to be effective
when employed at our own facilities. Therefore, the proposed
requirements related to lot-holding areas, which are discussed later in
this document, have been adjusted. In all cases, when addressing issues
related to lot-holding areas in this reproposal, we have either
retained the proposed requirements presented in the July 2002 proposed
rule or have provided more options for complying with the requirements
while continuing to prevent the transmission of diseases between lots
of horses and from the quarantine facility to domestic horses.
These changes to the July 2002 proposed rule make the construction
standards and the operating procedures described in this reproposal
consistent with those of the permanent horse quarantine facilities
operated by APHIS. The construction standards and the operating
procedures of these facilities have been reviewed repeatedly by APHIS
veterinarians and disease biologists and found to be adequate to
prevent the transmission of disease between lots of horses. Under both
the July 2002 proposed rule and this reproposal, permanent, privately
owned horse quarantine facilities would operate under continuous APHIS
oversight to ensure that operating procedures are correctly followed to
prevent the spread of disease between lots. In addition, if there was a
disease outbreak in a permanent, privately owned horse quarantine
facility, APHIS would conduct tracebacks for any horses that had been
quarantined in the facility at the time the infected horse was
quarantined there, as is standard procedure at APHIS-operated horse
quarantine facilities. For these reasons, we believe that the
safeguards against the transmission of disease between lot-holding
areas that we would require in this reproposal are adequate to prevent
the spread of disease within and from a permanent, privately owned
quarantine facility.
Definitions
We are proposing to add to Sec. 93.300 definitions for the terms
permanent, privately owned quarantine facility and temporary, privately
owned quarantine facility to make clear the differences between the two
types of facilities. A permanent, privately owned quarantine facility
would be one 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. A temporary, privately owned
quarantine facility would be one that offers quarantine services for a
special event and that is owned and operated by an entity other than
the Federal government. Throughout the rest of this document, use of
the term ``permanent facility'' means a permanent, privately owned
quarantine facility for horses, and use of the term ``temporary
facility'' means a temporary, privately owned quarantine facility for
horses.
We are proposing to revise the definition for operator contained in
Sec. 93.300. Operator is currently defined as ``for the purposes of
Sec. 93.308, any person operating an approved quarantine facility.''
The revised definition of operator would read: ``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.'' We are
proposing this change because we want to emphasize that, although
private entities would own these facilities, they would be subject to
APHIS approval and oversight.
We would also add definitions for the terms lot, lot-holding area,
quarantine area, and nonquarantine area. We would define a lot as a
group of horses that, while held on a conveyance or premises, have had
opportunity for physical contact with other horses in the group or with
their excrement or discharges at any time during their shipment to the
United States. A lot-holding area would be an area in a facility in
which a single lot of horses is held at one time. The quarantine area
of a facility would be the area of a facility that comprises all of the
lot-holding areas in the facility and any other areas that the horses
have access to, including loading docks for receiving and releasing
horses. The quarantine area would also include any areas in the
facility that are used to conduct examinations of horses and take
samples or areas where samples are processed and examined. The
nonquarantine area of a facility would include offices, storage areas,
and other areas that are outside the quarantine area and off limits to
horses, samples taken from horses that have not yet been prepared or
packaged for shipment to laboratories, and any other objects or
substances that have been in the quarantine area during quarantine of
horses.
Nonsubstantive Changes
The requirements for temporary facilities are currently located in
Sec. 93.308(b) and (c). Although we are not proposing to make any
substantive changes to these requirements, we are proposing to make
some nonsubstantive changes to update the language. We are also
proposing to combine paragraphs (b) and (c), so that all of the
requirements pertaining to the establishment and operation of temporary
facilities are located in paragraph (b). (We would make minor editorial
changes to these requirements as well.) We would place the proposed
regulations pertaining to permanent facilities in the newly vacated
Sec. 93.308(c). We would also correct an error in footnote numbering
in the regulations.
[[Page 74831]]
In addition, we are proposing to revise the heading for Sec.
93.309 to indicate more clearly that the section pertains to payment
information for use of all quarantine facilities, including privately
owned temporary and permanent quarantine facilities, and quarantine
facilities owned by APHIS. The section heading currently reads ``Horse
quarantine facilities''; we believe a more helpful heading would be
``Horse quarantine facilities; payment information.'' Therefore, as
proposed, Sec. 93.308(a) would contain general information about
quarantine requirements for imported horses; Sec. 93.308(b) would
contain requirements for temporary facilities; Sec. 93.308(c) would
contain requirements for permanent facilities; and Sec. 93.309 would
contain information about payment for services provided at all
quarantine facilities.
Section 93.303 of the regulations pertains to ports designated for
the importation of horses. Paragraph (e) of that section pertains to
ports used by persons who quarantine horses at temporary facilities.
The paragraph heading in Sec. 93.303(e) currently reads ``Ports and
quarantine facilities provided by the importer for horses,'' and the
text of the paragraph also refers to quarantine facilities provided by
the importer. We are proposing to revise the paragraph heading and text
because, under this proposed rule, the owner of a permanent facility
would be prohibited from acting as a paid agent (broker) for the
importation or subsequent sale of horses. (The July 2002 proposed rule
did not include this proposed restriction on quarantine facility
ownership; the restriction is discussed in more detail below under the
heading ``Approval Requirements.'') The new paragraph heading for Sec.
93.303(e) would read ``Ports for horses to be quarantined at privately
owned quarantine facilities,'' and the text would refer to privately
owned quarantine facilities rather than to facilities provided by the
importer. We would continue to allow brokers to establish temporary,
privately owned quarantine facilities.
Section 93.304 contains permit requirements for horses imported
from certain regions affected by contagious equine metritis. Paragraphs
(a)(1) and (a)(2) contain references to quarantine facilities provided
by importers of horses. Under this proposed rule, all quarantine
facilities provided by importers of horses could only be temporary,
privately owned quarantine facilities. However, we would need to
require a permit for importation of horses from these regions into
permanent, privately owned facilities as well. Therefore, we are
proposing to revise those paragraphs to refer to privately owned
quarantine facilities.
Proposed Requirements for Permanent Facilities
We are proposing to add to the regulations information about how to
apply for approval of a permanent facility and information concerning
denial and withdrawal of approval. Owners of any currently approved
quarantine facilities, whether temporary or permanent, who wish to
convert to, or be recognized as, a permanent facility would need to
meet the proposed requirements for permanent facilities described below
and apply for approval as a permanent facility.
Under this proposed rule, any permanent, privately owned quarantine
facility operating under APHIS authorization at the time these
regulations went into effect would have 1 year to be approved by APHIS;
otherwise, it would have to cease operations as a horse quarantine
facility. Under the July 2002 proposed rule, that approval would have
to have been secured by the effective date of the final rule following
that proposal in order for the facility to continue quarantine
operations. We made this change to the proposed regulations in response
to a comment received regarding the economic analysis of the July 2002
proposed rule; the rationale behind this change is discussed in the
context of the economic analysis in this proposed rule, under the
heading ``Executive Order 12866 and Regulatory Flexibility Act.''
Approval of Permanent Facilities
Application Process
Proposed Sec. 93.308(c)(1)(i) sets out procedures for applying for
approval of a permanent facility. Under the proposed regulations,
interested persons would be required to 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
would have to 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.
The July 2002 proposed rule would not have required the application
letter to include a contingency plan for horses needing emergency
veterinary care. We believe having such a plan is important to the
success of a quarantine facility at preventing the transmission of
diseases of horses, and therefore we have included that requirement in
this reproposal.
If APHIS determines that a submitted application is complete and
merits further consideration, we would require that the person applying
for facility approval enter into a service agreement with APHIS wherein
the applicant agrees to pay the cost of all APHIS services \1\
associated with APHIS' evaluation of the application and facility. This
service agreement would apply only to fees accrued during the
application process. If the facility is approved by APHIS, facility
owners would have to enter into a new compliance agreement in
accordance with Sec. 93.308(c)(2) of the proposed regulations.
---------------------------------------------------------------------------
\1\ APHIS charges for evaluation services at hourly rates listed
in 9 CFR Sec. 130.30.
---------------------------------------------------------------------------
Requests for approval would have to be submitted to APHIS at least
120 days prior to the date of application for local building permits in
order to ensure that APHIS has adequate time to evaluate the plans for
the facility, assess potential environmental effects, and determine
that adequate APHIS personnel are available to staff the facility.
Requests for approval of a proposed facility would be evaluated on
a first-come, first-served basis.
Approval Requirements
Proposed Sec. 93.308(c)(1)(ii) lists the basic criteria that a
permanent facility would have to meet to be approved by APHIS. A
permanent facility would have to meet all the requirements in Sec.
93.308(c). The facility would also have to meet any additional
requirements that may be imposed by the Administrator to ensure that
the quarantine is adequate to determine the horses' health status and
to prevent the transmission of diseases into, within, and from the
facility. These additional requirements would be specified in the
compliance agreement that would be required under proposed Sec.
93.308(c)(2). Finally, we are proposing that, to be approved as a
permanent facility, the Administrator must determine that sufficient
APHIS personnel (including
[[Page 74832]]
veterinarians and animal health technicians) are available to ensure
the biological security of the facility. This determination would 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. Only if
a facility met all of the other proposed requirements and APHIS
personnel were available would APHIS approve the facility and assign
personnel to it. Because the assignment of APHIS personnel would be
handled on a ``first-come, first-served'' basis, the deployment of
APHIS personnel at one permanent facility might result in another
facility not being approved for lack of necessary APHIS personnel. The
Administrator would have sole discretion in determining the number of
APHIS personnel to be assigned to the facility.
One commenter on the July 2002 proposed rule objected to the
requirement that approval be contingent upon the availability of
sufficient APHIS personnel. The commenter doubted that, given perceived
staffing shortages, any APHIS personnel would be available to serve at
these facilities and suggested that this would constitute a barrier to
entry for persons applying to own or operate permanent facilities. The
commenter further asserted that the presence of APHIS personnel at a
permanent facility was unnecessary to ensure the safety of the horses.
While we realize that there may not be enough APHIS personnel
available to serve every permanent, privately owned horse quarantine
facility that persons may wish to operate, we believe that APHIS
personnel must be present at these facilities in order to provide
continuous oversight and other technical services, as needed, to ensure
the biological security of the facility. Therefore, we would only
approve facilities for which sufficient APHIS personnel would be
available to ensure the biological security of the facility.
Proposed Sec. 93.308(c)(1)(iii) would require that the operator of
a permanent, privately owned horse quarantine facility continue to
comply with the requirements of proposed Sec. 93.308(c) and the terms
of the compliance agreement executed in accordance with proposed Sec.
93.308(c)(2) in order to maintain APHIS approval.
Proposed Sec. 93.308(c)(1)(iv) sets out procedures for denying or
withdrawing approval of permanent facilities. This paragraph would also
establish due process procedures regarding a denial or withdrawal of
approval and an opportunity for a hearing when there is a dispute of
material fact regarding the denial or withdrawal and would provide that
the withdrawal of approval for an existing facility will become
effective prior to a final disposition of the matter when the
Administrator determines it necessary to protect animal health or the
public health, interest, or safety. This paragraph would also provide
for approval to be withdrawn automatically by the Administrator when
the owner notifies, in writing, the Veterinarian in Charge for the
State in which the facility is located that the facility is no longer
in operation.
Under the proposed regulations, the approval of a permanent
facility may be denied or withdrawn if:
Any requirement of Sec. 93.308 or the compliance
agreement is not complied with;
The operator fails to pay for APHIS services rendered;
The operator or a person responsibly connected with the
business of the permanent facility acts as a paid agent (broker) for
the importation or subsequent sale of horses;
The operator or a person responsibly connected with the
business of the permanent 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;
The operator or a person responsibly connected with the
business of the permanent facility is or has been convicted of any
crime involving fraud, bribery, or extortion or any other crime
involving a lack of integrity needed for the conduct of operations
affecting the importation of animals; or
The approved permanent facility has not been in use to
quarantine horses for a period of at least 1 year.
The proposed regulations would provide that a person is responsibly
connected with the business of the permanent facility if the 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 an employee in a
managerial or executive capacity for the operation of the permanent
facility.
The July 2002 proposed rule did not include any provisions that
would have prohibited the operator or a person responsibly connected
with the business of the permanent facility from acting as a paid agent
or broker for the importation or subsequent sale of horses. We have
added this prohibition to the reproposal in response to a request from
four of the commenters on the July 2002 proposal. These commenters
asserted that a person holding both these positions would face
conflicts of interest while housing, treating, and caring for horses
imported by other brokers.
We agree that the potential for conflicts of interest is a concern.
It is possible that an owner of a permanent, privately owned horse
quarantine facility who also engaged in the sale and transport of
horses for profit might block a competitor from using the owner's
quarantine space, or cancel the competitor's reservations if the owner
determined that the competitor's imports would affect the profitability
of the owner's brokering business. Similarly, an owner of a permanent,
privately owned horse quarantine facility who also is engaged in the
sale and transport of horses might choose to weaken competitors in the
brokerage business by charging exorbitant fees for quarantine space
that could not be obtained elsewhere, as USDA quarantine facilities are
filled most of the time; the owner would have even greater leverage if
the quarantine facility in question was operating in a geographical
area not served by other facilities.
Compliance Agreement
Proposed Sec. 93.308(c)(2) would require permanent facilities to
operate in accordance with a compliance agreement executed by the owner
and by the APHIS Administrator that must be renewed on an annual basis.
The compliance agreement would provide that the facility is required to
meet all applicable requirements of Sec. 93.308 of the regulations and
that the facility's quarantine operations are subject to the oversight
of APHIS representatives. The compliance agreement would also state
that the operator of the facility agrees to be responsible for all the
costs associated with operating a permanent facility, including:
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 9 CFR part 130.
The compliance agreement would also state that the operator agrees
to bar from the facility any employee or other personnel at the
facility who fail to comply with the proposed regulations
[[Page 74833]]
in Sec. 93.308(c), other regulations in 9 CFR part 93, any terms of
the compliance agreement, or related instructions from APHIS
representatives.
These proposed requirements are identical to those in the July 2002
proposed rule.
Physical Plant Requirements
Proposed Sec. 93.308(c)(3) sets out physical plant requirements.
The proposed requirements for the physical plant of permanent
facilities are designed to ensure that permanent facilities are capable
of preventing the spread of diseases to horses outside the facility. A
permanent facility would have to meet these requirements before horses
were admitted to the facility.
Location
To minimize the risk of disease introduction from imported horses
moving from the port of entry to the permanent facility, proposed Sec.
93.308(c)(3)(i) would require that the facility be located in proximity
to a port authorized under Sec. 93.303(e). While requiring that a
permanent facility be located in proximity to the port, we decided for
several reasons not to require that the port and the facility be
located within a certain distance of one another. Some ports will be in
large metropolitan areas with the nearest concentration of livestock
many miles away. Other ports may be in towns with rural areas and
concentrations of livestock within a very short distance of the port.
Considering the diversity of places in which persons may consider
locating permanent facilities, it would be difficult to stipulate a
maximum distance from the port of entry.
The specific routes for the movement of horses from the port to the
permanent facility would have to be approved by the Administrator. In
evaluating the suitability of a particular site for a permanent
facility, the Administrator would consider whether the site of the
proposed facility or the routes for movement of horses from the port of
entry to the proposed facility would put the animals in a position that
could result in the transmission of communicable diseases.
In the July 2002 proposed rule, we proposed to require that the
facility be located at least one-half mile from any premises holding
livestock or horses. One commenter stated that the other safeguards in
the proposed rule provide adequate biological security to mitigate the
risk that a communicable disease of horses might be transmitted into
the domestic horse population from horses in the quarantine facility.
We agree that the distance requirement would be unnecessary if all
other procedures described in this proposed rule were followed at a
private, permanently owned horse quarantine facility. In addition, just
as the diversity of places in which persons may consider locating
permanent facilities makes it difficult to stipulate a maximum distance
from the port of entry, that diversity also makes it difficult to
stipulate a minimum distance from existing horse populations.
Therefore, we are not including in this reproposal a requirement that a
permanent, privately owned horse quarantine facility must be located at
least one-half mile from any premises holding livestock or horses from
this reproposal, and we have indicated in this reproposal that the
location would simply have to be approved by the Administrator in
advance based on consideration of whether the site would put the horses
in a position that could result in the transmission of communicable
diseases to domestic horses.
Construction
Proposed requirements for facility construction would be contained
in Sec. 93.308(c)(3)(ii). We are proposing to require that the
facility be of sound construction, in good repair, and properly
designed to prevent the escape of horses from quarantine. The facility
would be required to have the capacity to receive and house shipments
of horses as lots on an ``all-in, all-out'' basis, whereby separate
lots could be received and housed without contact with any other lots
being quarantined at the facility.
We would also require that the facility be enclosed by a security
fence of sufficient height and design to prevent unauthorized persons,
horses, and other animals from outside the facility from having contact
with horses quarantined in the facility. One commenter on the July 2002
proposed rule questioned the need for a security fence, stating that
sound horse fencing should be used and that the entrance should be
gated to prevent public access in lieu of a security fence. However,
the fence enclosing the facility is intended to ensure not only that
horses do not escape quarantine but also to prevent the unauthorized
entry of persons, horses, and other animals. Sound horse fencing would
not provide adequate protection against unauthorized entry.
We would also require that all entryways into the nonquarantine
area of the facility be equipped with a secure and lockable door.
Further, while horses are in quarantine, all access to the quarantine
area for horses would have to be from within the building, and each
such entryway to the quarantine area would have to be equipped with a
series of solid self-closing double doors. Emergency exits would be
permitted in the quarantine area, but such exits would have to be
constructed so as to permit their being opened only from the inside of
the facility in order to ensure the security of the horses in
quarantine and the integrity of quarantine operations.
The July 2002 proposed rule included a requirement that entryways
to each lot-holding area be equipped with a solid, lockable door. We
are not including that provision in this reproposal, for the reasons
discussed earlier in this document under the heading ``Changes in Our
Approach With Respect to Lot-Holding Areas.''
We propose to require that the facility 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 would have to be
separated by at least 3 inches (7.62 cm). The screens would have to be
easily removable for cleaning, but otherwise remain locked and secure
at all times in a manner satisfactory to APHIS representatives to
ensure the biological security of the facility.
In response to the July 2002 proposed rule, one commenter
recommended that we amend the proposed specifications for windows or
other openings in the quarantine area to require adequate ventilation.
In this reproposal, we have included the requirement that the window
screens would have to provide ventilation sufficient to ensure the
comfort and health of all horses in the facility. We believe this
language will ensure that windows in permanent facilities provide
sufficient ventilation to prevent horses from becoming uncomfortable or
suffering injury for that reason.
The entire facility, including its stalls and hallways, would have
to have adequate lighting to ensure that horses are moved and kept
safely and that permanent facility employees can safely do their work.
Proposed paragraph Sec. 93.308 (c)(3)(ii)(E) would provide that a
facility must have separate loading docks for receiving and releasing
animals and for general receiving and pickup, unless a single dock used
for both purposes is cleaned and disinfected after each use
[[Page 74834]]
according to the procedures set out in proposed paragraph Sec.
93.308(c)(4)(iv)(F). That paragraph states that if the facility has a
single loading dock, the loading dock would have to be immediately
cleaned and disinfected after each use under the oversight of an APHIS
representative with a disinfectant authorized in 9 CFR part 71 or
otherwise approved by the Administrator. (Disinfectants are currently
approved in 9 CFR part 71 under Sec. Sec. 71.10, 71.11, and 71.12.)
The July 2002 proposed rule would have required that the facility
have two separate loading docks. One would have been part of the
quarantine area and would have been used for receiving and releasing
horses, and one would have been part of the nonquarantine area and
would have been used for general receiving and pickup. One commenter on
the July 2002 proposed rule suggested that separate docks would be
unnecessary; if a single dock were properly cleaned and disinfected
after each use, the facility would achieve adequate protection against
the risk that communicable diseases of horses might be transmitted. We
agree with this comment and have modified the July 2002 proposed rule
as suggested by the commenter. We believe this proposed requirement
would adequately protect against the transmission of communicable
diseases of horses while providing facility owners with greater
flexibility.
We would require that the facility be constructed so that the floor
surfaces with which horses have contact in the facility are nonslip and
wear-resistant. All floor surfaces with which the horses, their
excrement, or discharges have contact would have to provide for
adequate drainage. All floor and wall surfaces with which the horses,
their excrement, or discharges have contact would have to 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 would have
to be able to withstand cleaning and disinfection between shipments of
horses. The cleaning and disinfection of all of these surfaces would
help ensure that disease agents would not be spread from one lot of
horses to another. We would further require that surfaces with which
the horses could have contact must not have any sharp edges that could
cause injury to the horses.
The July 2002 proposed rule would have additionally required floor
surfaces to have drains of at least 8 inches in diameter. One commenter
suggested that it was unnecessary for us to specify the required
diameter for the floor drains, since the proposed rule prescribed that
all floor surfaces must provide for adequate drainage. We agree that it
would be better to allow facility designers flexibility to achieve the
adequate drainage requirement, and we are not including a specific
diameter requirement for the floor drains in these facilities in this
reproposal.
In proposed Sec. 93.308(c)(3)(ii)(G), we would require that the
stalls in which horses are held be large enough to allow each animal to
make normal postural and social adjustments (including turning around
and making way for other humans or horses) with adequate freedom of
movement. Horses that do not have adequate space for movement could be
at risk for poor conditioning due to lack of movement, malnutrition due
to refusal to eat, rapid weight loss, increased stress, depression, or
abnormal behavior patterns. These could increase the likelihood of the
horses exhibiting clinical symptoms of disease or, if disease is
present, transmitting or becoming infected with disease. The stall size
requirement would also allow the stalls to be cleaned more easily by
facilitating access to the stalls for quarantine facility personnel.
To help prevent transmission of disease between horses in permanent
facilities, we would require that the aisleways used by horses within
the quarantine area be wide enough to provide for safe movement of
horses, including allowing horses to turn around in the aisleway, to
prevent horses in facing stalls from coming into contact with horses in
the aisleway, and to adequately ventilate the stalls. Narrow aisleways
can lead to injury to horses and personnel and can allow direct
physical contact between horses, which could facilitate the spread of
disease.
The facility would have to be constructed so that different lots of
horses held at the facility at the same time would be separated by
physical barriers in such a manner that horses in one lot could not
have physical contact with horses in another lot or with the excrement
or discharges of horses in another lot. In addition, we would require
that permanent facilities include stalls capable of isolating any
horses exhibiting signs of illness. This provision would help ensure
that horses infected with or exposed to disease do not spread the
disease or expose other horses in the facility to the disease.
To prevent dissemination of disease via persons at the facility, we
are proposing to require that the facility contain showers for use
before entering and after exiting the quarantine area. A shower would
also be needed at the entrance to the necropsy area if necropsies will
be conducted onsite. (The proposed requirements for the necropsy area
are described in greater detail later in this document.) We would also
require that a clothes-storage and clothes-changing area be provided at
each end of each shower area, and that there 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.
The July 2002 proposed rule would have required that the facility
have showers at the entrance to each lot-holding area in a facility in
which it is not possible to move to any lot-holding area except by
first passing through another lot-holding area. It would also have
required that all persons granted access to the quarantine area shower
before entering a lot-holding area if previously exposed from access to
another lot-holding area. This reproposal removes these proposed
requirements, for the reasons discussed earlier in this document under
the heading ``Changes in Our Approach With Respect to Lot-Holding
Areas.''
Because of the need for APHIS representatives assigned to a
permanent facility to examine horses and draw samples for testing, we
would require that permanent facilities contain adequate space for
these purposes and that the space include equipment to provide for the
safe inspection of horses. In this reproposal, we are also proposing to
require that the space provided to conduct examinations and testing
include a refrigerator-freezer in which to store samples, which would
facilitate conducting disease tests. The facility would have to include
adequate storage space for the necessary equipment and supplies, work
space for preparing and packaging samples for mailing, and storage
space for duplicate samples. We would further require that the facility
include a secure, lockable office space with enough room to contain a
desk, chair, and filing cabinet for APHIS use.
Proposed Sec. 93.308(c)(3)(ii)(L) would require that the facility
either have a necropsy area or designate an alternate facility for
conducting necropsies. A necropsy area would be necessary to perform
post mortem inspection of horses that die in the permanent facility and
to collect samples for laboratory diagnosis. These actions would be
needed to determine whether the death of a horse was associated with a
disease, or if it was caused by other factors, such as colic or
physical injury.
[[Page 74835]]
If the facility has a necropsy area, it would have to 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 would have to 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 would have to be approved by the Administrator
under the procedures for requesting variances in these proposed
regulations for permanent facilities as outlined in Sec. 93.308(c)(6).
This provision would require the operator to submit a request for a
variance from the requirements for the construction of the facility
prior to approval of the facility; because facilities would generally
be required to have a necropsy area onsite, a request to designate an
alternate facility for necropsies would be a request for a variance
from the facility construction requirements.
If a facility did not have either a necropsy area that met the
requirements of proposed Sec. 93.308(c)(3)(ii)(L) or an alternate
facility approved under the variances provision in proposed Sec.
93.308(c)(6), it would not be approved.
The July 2002 proposed rule did not provide for the use of an
alternative facility to perform necropsies. Three commenters asserted
that requiring the construction of a necropsy area onsite at a
permanent facility would be excessively costly, since the necropsy area
would be expected to be used only rarely. Two commenters expressed a
desire to designate an alternate facility at which necropsies and
carcass incineration could be performed if necessary. We agree that, if
carried out with the proper safeguards and notification, an alternate
facility for necropsies could be used, and we have added provisions for
designating an alternate facility, as described above. We believe that
this change to the July 2002 proposed rule will ensure that biological
security is maintained while allowing owners and operators some
flexibility in design and construction of permanent, privately owned
horse quarantine facilities.
These commenters also stated that the construction of a carcass
incinerating facility should not be required; however, neither the July
2002 proposed rule nor this reproposal would require the construction
of a carcass incinerating facility, but instead would require that the
facility have the capability to dispose of carcasses safely and without
spreading disease.
We are also proposing to require that the facility have sufficient
storage space for equipment and supplies used in quarantine operations.
Storage space would have to 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 to be stored at the facility.
We are proposing to require that separate storage space be provided
for each lot-holding area for any reusable equipment and supplies that
are not disinfected after each use in accordance with 9 CFR part 71.
The July 2002 proposed rule included a provision that each lot-holding
area have separate storage space for equipment and supplies; we are not
including this requirement in this reproposal, for the reasons
discussed earlier in this document under the heading ``Changes in Our
Approach With Respect to Lot-Holding Areas.''
We are proposing to require that the facility 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 would
also have to include a work area for the repair of equipment. These
areas are essential to ensure the continuity of quarantine operations.
The facility would have to have permanent restrooms in both the
quarantine and nonquarantine areas of the facility so that persons do
not need to leave or enter the quarantine area simply to use a
restroom. Leaving the quarantine area would necessitate the person
showering prior to entering the nonquarantine area, and then again upon
reentering the quarantine area.
The July 2002 proposed rule included a provision that the facility
have an area within the quarantine area for breaks and meals in order
to eliminate the need for workers to leave the quarantine area for
breaks. One commenter on the July 2002 proposed rule opposed this
requirement, stating that a break area in the quarantine area would not
play any role in providing biological security and should not be
mandatory. We agree with this comment; additionally, we recognize that,
unlike use of the restroom, movement into and out of the quarantined
area for breaks could be planned to some extent. Therefore, we have
removed the break area requirement from this reproposal.
We would also require that the facility 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. We would
prohibit air supplied to the quarantine areas from being recirculated
or reused for other ventilation needs. Further, air handling systems
for quarantine areas would have to be separate from air handling
systems for other operational and administrative areas of the facility
in order to ensure that air from the quarantine areas is not diverted
into nonquarantine areas of the facility.
The July 2002 proposed rule would have specifically required the
facility to have a heating, ventilation, and air conditioning (HVAC)
system. In this reproposal, rather than refer to an HVAC system, we
refer to an ``air handling system.'' This change is intended to
indicate that any air handling system may be used provided that it is
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. In some cases, an HVAC system
may be necessary to fulfill this requirement; the less specific
language, however, provides us with the flexibility to decide that
matter on a case-by-case basis.
The July 2002 proposed rule would have required that each lot-
holding area within the quarantine facility have its own separate HVAC
system. For the reasons discussed earlier in this document under the
heading ``Changes in Our Approach With Respect to Lot-Holding Areas,''
this reproposal would require that the air handling system be adequate
to ensure that there is no cross-contamination of air between the
separate lot-holding areas. This would provide protection against
transmission of communicable diseases of horses without placing an
undue burden on facility operators.
One commenter maintained that if the necropsy room is enclosed, it
should have a separate air handling system to prevent the possible
transmission of disease from carcasses to live horses.
As discussed above, air inside the quarantine area would not be
recirculated, but rather ventilated directly to the outside; thus, any
airborne disease agents would be vented from inside the quarantine
area. Therefore, we believe that requiring a separate air handling
system for the necropsy area would not appreciably enhance the
biological security at quarantine facilities.
[[Page 74836]]
The facility, including the lot-holding areas, would have to be
equipped with a fire alarm voice communication system so that personnel
working in those areas can be readily warned of any potential emergency
and can warn other personnel.
The July 2002 proposed rule would have required that the facility
also have a television monitoring system or other arrangement
sufficient to provide a full view of the quarantine area or areas,
excluding the clothes-changing area. One commenter questioned the
necessity of the television monitoring system given that the proposed
rule also would have required that a full-time security service monitor
the facility or that an electronic alarm system be used to indicate the
entry of unauthorized persons into the facility. The proposed
requirement for a television monitoring system was intended to
facilitate surveillance within the quarantine facility, so that any
persons attempting to gain unauthorized access could be detected. We
believe the commenter is correct in stating that the television
monitoring system would be unnecessary given the other proposed
requirements, and we have not included a requirement for a television
monitoring system in this reproposal.
The facility would also have to have a communication system between
the nonquarantine and quarantine areas of the facility. Such a system
would allow persons working in the quarantine area to communicate with
persons working in the nonquarantine area and vice versa without moving
from one area to the other.
Sanitation
To ensure that proper animal health and biological security
measures are observed, proposed Sec. 93.308(c)(3)(iii) would require
that permanent facilities have the 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.
We would require that any reusable equipment and supplies that are
not disinfected after each use in accordance with 9 CFR part 71 be kept
separately for each lot of horses. The July 2002 proposed rule would
have required that facilities keep separate equipment and supplies for
each lot of horses; we are not including this requirement in this
reproposal for the reasons discussed earlier in this document under the
heading ``Changes in Our Approach With Respect to Lot-Holding Areas.''
Equipment and supplies to be used in the quarantine area would have
to be maintained separately from equipment and supplies used in the
nonquarantine area.
We would require facilities to maintain a supply of potable water
adequate to meet all watering and cleaning needs at the facility. We
would require that water faucets for hoses be located throughout the
facility to ensure that personnel would not need to drag hoses across
areas that have already been cleaned and disinfected. We would also
require that an emergency supply of water for horses in quarantine be
maintained at the facility.
Facilities would also need to maintain a stock of disinfectant
authorized in 9 CFR part 71, or otherwise approved by the
Administrator, sufficient to disinfect the entire facility.
We would also require permanent facilities to have the capability
to dispose of wastes, including manure, urine, and used bedding, by
means of burial, incineration, or public sewer. Facilities would have
to handle other waste material in a manner that minimizes spoilage and
the attraction of pests and would have to dispose of the waste material
by incineration, public sewer, or other preapproved manner that
prevents the spread of disease. Disposal of wastes would have to be
carried out under the oversight of APHIS representatives.
We would further require permanent facilities to 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 from carcasses. This requirement is necessary to prevent the
dissemination of any disease agents that may be present in horse
carcasses.
For incineration to be carried out at the facility, the facility
would have to have incineration equipment that is detached from other
facility structures and is capable of burning animal waste and refuse.
We would require the incineration site to include an area sufficient
for solid waste holding. Incineration could also take place at a local
site away from the facility premises. Furthermore, we would require all
incineration activities to be carried out under the direct oversight of
APHIS representatives, even if conducted off-site.
We would require the facility to have 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 was approved to handle more than one lot of
horses at the same time, the drainage system would have to be adequate
to ensure that there would be no cross-contamination between lot-
holding areas.
The July 2002 proposed rule would have required that each lot-
holding area have a separate drainage system to prevent cross-
contamination. We have modified this requirement in this reproposal for
reasons discussed earlier in this document under the heading ``Changes
in Our Approach With Respect to Lot-Holding Areas.'' We believe this
changed requirement would provide protection against transmission of
communicable diseases of horses without placing an undue burden on
facility operators.
Security
Proposed Sec. 93.308(c)(3)(iv) would require that the facility and
premises be kept locked and secure at all times to ensure the integrity
of quarantine operations. We would also require the facility and
premises to have signs indicating that the facility is a quarantine
area and no visitors are allowed.
The facility and premises would also have to be guarded at all
times by one or more representatives of a bonded security company or,
alternatively, would have to have an electronic security system that
would indicate the entry of unauthorized persons into the facility.
We would require that such an electronic security system be
coordinated either through or with the local police so that the
quarantine facility is monitored whenever APHIS representatives are not
at the facility. We would also require that such an electronic security
system be of the ``silent type'' and must be triggered to ring at the
monitoring site and not at the facility. The electronic security system
would have to be approved by Underwriter's Laboratories. We would also
require that the operator 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 would be required to submit a copy of
those instructions to the Administrator. The operator of the facility
would be required to notify the designated APHIS representative
whenever a breach of security occurs or is suspected of having
occurred. Further, in the event that disease is diagnosed in
quarantined horses, the Administrator could require the operator to
have the facility guarded by a bonded security company in a manner that
the Administrator deems
[[Page 74837]]
necessary to ensure the biological security of the facility.
In response to the July 2002 proposed rule, one commenter stated
that the requirement that a representative of a security company be
present at the facility at all times would not ensure the safety of the
horses inside the barns, and that the requirement should be eliminated
for that reason. The purpose of having a representative of a bonded
security company (or, alternatively, an electronic security system) is
not only to ensure the safety of the horses but also to ensure that no
unauthorized persons enter the facility. Preventing unauthorized
persons from accessing the facility is essential to providing
quarantine security.
We would require that the operator of the facility furnish a
telephone number or numbers to APHIS at which the operator or his or
her agent can be reached at all times while horses are in quarantine.
We would also provide that APHIS may place APHIS seals on any or
all entrances and exits of the facility when determined necessary by
APHIS and take all necessary steps to ensure that such seals are broken
only in the presence of an APHIS representative. In the event that
someone other than an APHIS representative breaks such seals, we would
consider the act a breach in security, and APHIS representatives would
make an immediate accounting of all horses in the facility. If we
determine that a breach in security has occurred, we may extend the
quarantine period for horses as long as necessary to ensure that the
horses are free of communicable diseases.
These proposed security requirements are unchanged from our July
2002 proposal.
Operating Procedures
APHIS Oversight
Proposed requirements regarding APHIS oversight would be contained
in Sec. 93.308(c)(4)(i).
The quarantine of horses at the facility would be subject to
oversight by APHIS representatives, who could include one or more
veterinarians and other professional, technical, and support personnel
who are employed by APHIS and authorized to perform the services
required by the regulations and the compliance agreement. Unlike
temporary facilities, which are inspected on a regular basis by an
APHIS veterinarian, a permanent facility would have at least one APHIS
representative overseeing the care of all horses in quarantine during
normal working hours. Depending on the size of the facility and the
number of horses present, additional APHIS veterinarians and animal
health technicians could be necessary to ensure adequate oversight of
the horses in quarantine. The deployment of APHIS representatives to
oversee and provide other professional, technical, and support services
at a quarantine facility would be determined by the Administrator.
If, for any reason, the operator fails to properly care for, feed,
or handle the quarantined horses as required under the regulations, or
fails to maintain and operate the facility as required under the
regulations, APHIS representatives would furnish such services or make
arrangements for the sale or disposal of quarantined horses at the
quarantine facility owner's expense.
Personnel
Proposed requirements concerning personnel would be contained in
Sec. 93.308(c)(4)(ii).
We would require the operator of the facility to provide adequate
personnel to maintain the facility and care for the horses in
quarantine, including attendants to care for and feed the horses, and
other personnel to maintain, operate, and administer the facility.
We would also require that the operator provide APHIS with a list
of employees and other personnel assigned to work at the facility. The
list would have to include the names, current residential addresses,
and employee identification numbers of employees and other personnel.
We would require that, when the operator wishes to grant access to the
facility to persons who have not previously had access to it, the
operator update the list prior to such persons having access to the
quarantine facility. These requirements are necessary to ensure that
APHIS has knowledge of, and can identify, all persons working at the
facility.
In conjunction with the above requirements, we would require the
operator to 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 proposed Sec. 93.308(c) of
the regulations, 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, including
contact with animals both inside and outside the facility.
Authorized Access
Proposed requirements regarding access would be contained in Sec.
93.308(c)(4)(iii).
We are proposing to grant access to the quarantine facility
premises as well as inside the quarantine facility only to APHIS
representatives and authorized employees and other personnel of the
operator assigned to work at the facility. All other persons would be
prohibited from the premises unless specifically granted access by the
overseeing APHIS representative. Any visitors granted access would be
required to be accompanied at all times by an APHIS representative
while on the premises or in the quarantine area of the facility.
Sanitary Requirements
Under proposed Sec. 93.308(c)(4)(iv), all facility employees and
other personnel, as well as any other person granted access to the
quarantine area, would have to:
Shower when entering and leaving the quarantine area;
Shower when leaving the necropsy area if a necropsy is in
the process of being performed or has just been completed, or if any
portion of the examined animal remains exposed;
Wear clean protective work clothing and footwear upon
entering the quarantine area;
Wear disposable gloves when handling sick horses, and then
wash hands after removing gloves; and
Change protective clothing, footwear, and gloves when they
become soiled or contaminated.
The July 2002 proposed rule would have required that persons
granted access to quarantine areas in a facility shower before entering
a lot-holding area if previously exposed from access to another lot-
holding area. It would also have required that persons granted access
to the quarantine area not have contact with any horses in the facility
other than the lot or lots of horses to which the person would be
assigned or granted access. For reasons discussed earlier in this
document under the heading ``Changes in Our Approach With Respect to
Lot-Holding Areas,'' we are not including these requirements in this
reproposal.
The July 2002 proposed rule would also have required that no person
granted access to the quarantine area have contact with any horses
outside the quarantine facility for at least 7 days after the last
contact with the horses in quarantine. One commenter suggested
retaining the requirement only for visitors to the quarantine area and
shortening the length of time from 7 to 5 days to make the requirement
consistent with that of the Foreign Animal Diagnostic Disease
Laboratory operated by APHIS. This commenter further stated that the
APHIS
[[Page 74838]]
representative at the facility, authorized employees, other personnel
of the operator assigned to work at the facility, and veterinary
practitioners who enter the facility to provide emergency care should
be exempt from this requirement altogether provided the other sanitary
requirements in the proposed rule, such as showering when entering and
exiting the quarantine area and changing clothes when entering and
exiting the quarantine area, are met. Two commenters stated that such a
requirement should be unnecessary for any visitors if the other
sanitary requirements are met.
We agree with the latter commenters that restrictions on contact
with horses outside the quarantine facility should not be necessary for
any visitors to a permanent facility, provided that all visitors
fulfill the sanitary requirements of this proposed rule. We are,
therefore, not including in this reproposal any restrictions on contact
with horses outside the quarantine facility for visitors to the
quarantine facility.
We would require that the operator provide clean, protective
clothing to persons granted access to the quarantine area. The July
2002 proposed rule would have required that the operator provide clean,
protective clothing to be worn when persons provided access to the
quarantine area move from one lot of horses to another lot of horses.
For the reasons discussed earlier in this document under the heading
``Changes In Our Approach With Respect to Lot-Holding Areas,'' we have
revised this proposed requirement to refer to the quarantine area
rather than to lot-holding areas.
The operator or the operator's designated representative would also
be responsible for the handling, washing, and disposal of soiled and
contaminated clothing worn within the quarantine facility in a manner
approved by the overseeing APHIS representative as adequate to preclude
transmission of any animal disease agent from the facility. Work
clothing worn into the quarantine area would be required to be washed
at the end of each workday. Used footwear would either be left in the
clothes changing area or cleaned with hot water (148 [deg]F minimum)
and detergent and disinfected as directed by an APHIS representative.
The July 2002 proposed rule would have required that work clothing
worn into each lot-holding area be collected and kept in a bag until
the clothing is washed at the end of each workday. For reasons
discussed earlier in this document under the heading ``Changes in Our
Approach With Respect to Lot-Holding Areas,'' we have revised this
proposed requirement to refer to the quarantine area rather than to
lot-holding areas.
We would require that all equipment (including tractors) be cleaned
and disinfected prior to being used in a quarantine area of the
facility with a disinfectant authorized in 9 CFR part 71 or otherwise
approved by the Administrator. The equipment would have to remain
dedicated to the facility for the entire quarantine period in order to
prevent the spread of disease agents outside the facility. Any
equipment used with quarantined horses (e.g., halters, floats, feed and
water buckets) would have to 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 to ensure that no cross contamination occurs. Prior to its
use on another lot of horses or its removal from the quarantine
premises, any equipment would have to be cleaned and disinfected to the
satisfaction of an APHIS representative.
The proposed regulations would also require that any vehicle,
before entering or leaving the quarantine area of the facility, be
cleaned and disinfected under the oversight of an APHIS representative
within a time period authorized by the APHIS representative and with a
disinfectant authorized in 9 CFR part 71 of the regulations or
otherwise approved by the Administrator.
We would also require that, if the facility has a single loading
dock instead of two as described earlier in this document, the loading
dock would have to be cleaned and disinfected after each use under the
oversight of an APHIS representative within a time period authorized by
the APHIS representative and with a disinfectant authorized in 9 CFR
part 71 of the regulations or otherwise approved by the Administrator.
Further, we would require the area of the facility in which a lot
of horses has been held to be thoroughly cleaned and disinfected, with
a disinfectant authorized in 9 CFR part 71, under the oversight of an
APHIS representative upon release of the horses before a new lot of
horses is placed in that area of the facility. This requirement is
necessary to ensure that horses entering quarantine are not exposed to
disease agents present in the previous lot of horses.
Handling of the Horses in Quarantine
Under the proposed regulations, horses that are quarantined in
private facilities would have to undergo the appropriate quarantine
specified in Sec. 93.308(a) and would be subject to any other
applicable regulations in title 9 of the Code of Federal Regulations.
For the purposes of quarantine operations, private facilities would
operate no differently than Federal horse quarantine facilities.
Each lot of horses to be quarantined would have to be placed in the
facility on an ``all-in, all-out'' basis. Under this requirement, no
horse could be taken out of the lot while it is in quarantine, except
for diagnostic purposes or as provided in Sec. 93.308(a)(4), and no
horse could be added to the lot while the lot is in quarantine.
The regulations would require that the facility provide sufficient
feed and bedding that is free of vermin and that is not spoiled for the
horses in quarantine. Feed and bedding would have to originate from an
area that is not listed in 9 CFR part 72 as an area quarantined for
splenetic or tick fever.
We would prohibit the breeding of horses and the collection of
germplasm from horses during the quarantine period. The July 2002
proposed rule would have prohibited the breeding of horses or the
collection of germplasm from horses during the quarantine period unless
necessary for a required import testing procedure. Because there are
currently no import testing procedures that require the breeding of
horses or the collection of germplasm from horses, we have removed that
exception from this reproposal.
We propose to require that horses in quarantine be subjected to
such tests and procedures as directed by the overseeing APHIS
representative to determine whether they are free from communicable
diseases of horses.
We would require that any death or suspected illness of horses in
quarantine be reported immediately to the overseeing APHIS
representative so that appropriate measures may be taken to ensure the
health of the other horses in quarantine. The affected horses would
have to be disposed of as the Administrator may direct or, depending on
the nature of the disease, would have to be cared for as directed by
the overseeing APHIS representative.
The regulations would provide that quarantined horses requiring
specialized medical attention or additional post-mortem testing may be
transported off the quarantine site, if authorized by the overseeing
APHIS representative. In such situations, a second quarantine site
would have to be established to house the horses at the facility of
destination (e.g., veterinary teaching hospital), and the overseeing
APHIS representative could extend the quarantine period for that horse
and for
[[Page 74839]]
its lot until the results of any outstanding tests or postmortem
results are received.
Further, if we determine that a horse is infected with or exposed
to a communicable disease of horses, we would require that arrangements
for the final disposition of the infected or exposed horse 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. We would require the horses to be
disposed of under the direct oversight of APHIS representatives. We
would require the operator to have a preapproved contingency plan for
the disposal of all horses housed in the facility prior to issuance of
an import permit. This requirement is essential to ensure that diseased
horses can be disposed of without posing a risk of disseminating
diseases outside the quarantine facility.
In the July 2002 proposed rule, we would have allowed horses in
quarantine to be vaccinated. One commenter recommended that we prohibit
vaccinations entirely in permanent, privately owned horse quarantine
facilities. Vaccinations performed on horses while they are in
quarantine can alter the immune system of the horses and therefore
affect diagnostic serology, potentially producing inaccurate results in
response to the diagnostic tests administered in quarantine. We agree
and have therefore added a new paragraph Sec. 93.308(c)(4)(v)(I) in
this reproposal specifically prohibiting vaccination of horses in these
facilities.
Records
Under proposed Sec. 93.308(c)(4)(vi), it would be the facility
operator's responsibility to maintain current daily records to record
the entry and exit of all persons entering and leaving the quarantine
facility. We would require the operator or the operator's designated
representative to hold the daily records, 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 to make
such records available to APHIS representatives upon request.
Environmental Requirements
Under proposed Sec. 93.308(c)(5), if APHIS determines that a
privately operated quarantine facility does not meet all applicable
local, State, and Federal environmental regulations, APHIS reserves the
right to deny or suspend approval of the facility until appropriate
remedial measures have been applied. This requirement is necessary to
ensure that APHIS-approved facilities meet all applicable waste
disposal and other environmental quality standards.
Variances
Under proposed Sec. 93.308(c)(6), the Administrator may grant
variances to the 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 the regulations, but only if the Administrator determines
that the variance causes no detrimental impact to the overall
biological security of the quarantine operation. The operator of a
permanent facility would have to submit a request for a variance from
the requirements for the construction of a facility to the
Administrator in writing prior to approval of the facility; for a
variance from the requirements for the operation of a facility, the
operator would have to submit a request to the Administrator in writing
at least 30 days in advance of the arrival of horses to the facility.
Any variance would also have to be expressly provided for in the
compliance agreement.
In conjunction with these changes, we would also make editorial
changes to Sec. 93.310 to update the regulations and make them easier
to understand.
We believe that these proposed regulations would ensure that
permanent facilities could operate without posing a risk of foreign
animal disease introduction and allow U.S. horse importers another
option for quarantining imported horses. We welcome public comment on
the proposed regulations.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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.
In accordance with 5 U.S.C. 603, we have performed an initial
regulatory flexibility analysis, which is set out below, regarding the
potential economic costs and benefits of this rule and its potential
economic effects on small entities. Based on the information we have,
there is no basis to conclude that this rule will result in any
significant economic effect on a substantial number of small entities.
However, we do not currently have all of the data necessary for a
comprehensive analysis of the effects of this proposed rule on small
entities. Therefore, we are inviting comments on potential effects.
This proposed rule would allow the establishment and operation,
under APHIS oversight, of permanent, privately owned quarantine
facilities for horses imported into the United States. Currently, the
regulations set standards only for temporary, privately owned
quarantine facilities for horses. Such temporary facilities are used to
quarantine horses imported for a particular event or purpose. APHIS has
also authorized the operation of one permanent, privately owned and
operated animal quarantine facility in Los Angeles County, CA.
Under the Animal Health Protection Act, specifically 7 U.S.C. 8303,
the Secretary 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.
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.
Trade in live horses between the United States and other countries
has increased considerably, both recently and over the past decade.
Even though the United States is a net exporter of live horses, imports
of live horses have increased dramatically. Specifically, from 2001 to
2003, U.S. imports of live horses increased by 54 percent in number
(from 27,236 horses to 41,960 horses). During the 3-year period 2001-
2003, the number of U.S. live horse imports averaged 39,434 annually,
134 percent more than the annual average for the 1991-1993 3-year
period. In 2003, the value of U.S. live horse imports was $259.3
million.
The increased demand for importing horses in the United States has
resulted in an increased demand for import quarantine services. As can
be seen from the data above, horses play an important role in the
international trade of the United States.
Effects on Small Entities
We have identified two types of entities that could be affected by
implementation of this rule: The existing permanent, privately owned
[[Page 74840]]
quarantine facility and horse importers or farmers.
Quarantine Facilities
According to 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 County, CA, is
believed to be a small entity.
If this proposed rule is implemented, the operators of that
quarantine facility may need to upgrade its facilities to be in
compliance with the proposed requirements. If and when the facility is
approved for operation under the proposed regulations, the cost of any
needed renovations to the facility, as well as the costs associated
with being in compliance with the proposed regulations, would likely be
passed on to importers of horses who elect to use the facility to
quarantine imported horses. Such a cost pass-through to the facility's
users is likely to occur, at least in the short run, given the
increased demand for quarantine services in the United States, the
small number of Federal horse quarantine facilities currently in
operation, 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. That only one or two additional
quarantine facilities are expected to open in the next several years
suggests that this action would not have a significant effect on the
facility, even in the long run. Nevertheless, at this time, we are
unable to determine the effect that implementation of this rule would
have on the facility's business volume and revenue.
In response to the July 2002 proposed rule, one commenter objected
to the proposed standards for permanent, privately owned horse
quarantine facilities on the grounds that they would impose significant
additional costs on the existing quarantine facility. The commenter
cited decreasing demand for imported horses as grounds for fear that
these significant additional costs could eventually result in a
reduction of the total quarantine space available for imported horses,
since the existing permanent, privately owned horse quarantine facility
would likely exit the market and prospective owners of permanent horse
quarantine facilities would be discouraged by the regulations from
entering it.
As noted earlier in this document, the demand for import quarantine
facilities for horses has risen in recent years, and in some cases the
demand for quarantine services for horses has exceeded the space
available at existing facilities. Most of the comments we received
cited this increased demand and the resulting shortage of quarantine
services as the reason for supporting our proposed standards for
permanent, privately owned horse quarantine facilities. However, we
cannot allow horses to be quarantined in privately owned facilities
that are not constructed and operated in such a manner as to mitigate
the risk of transmission of foreign animal diseases into the domestic
horse population. We have determined that the standards set out in the
proposed rule would ensure that permanent, privately owned horse
quarantine facilities are constructed and operated properly.
In response to this comment, however, this reproposal provides
additional time for the existing permanent, privately owned horse
quarantine facility to comply with any requirements that may be
established by a final rule. This deadline would be 1 year after the
final rule takes effect. We have also made changes to substantive
provisions in this reproposal that we expect would reduce the
compliance costs associated with this rulemaking.
We continue to lack data of the kind that could be used in an
economic analysis to assess the proposed rule's potential impact on the
existing permanent, privately owned horse quarantine facility. We are
inviting comments on such impacts, particularly estimates of compliance
costs and impacts on revenue. This will allow us to better assess this
proposal's potential impact.
Importers of Horses and Horse Farms
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 of permanent,
privately owned quarantine facilities for horses has the potential to
make the import process easier and more timely while at the same time
protecting against the introduction of communicable diseases of horses,
a clear benefit for importers if the demand for, and worth of, live
horse imports continues to increase. However, as discussed above,
importers may be subject to higher fees and charges from the current
quarantine facility or from new facilities that may open in the future.
Additional quarantine facilities could be expected to benefit
brokers, and they may also have positive economic effects for horse
owners who purchase horses, since increased competition from foreign
imports may serve to depress domestic prices. However, any decline in
domestic horse prices stemming from increased imports would have an
adverse impact on domestic sellers.
Given the available data, it is not possible for us to predict the
proposed rule's economic impact. Nevertheless, any increase in horse
imports, which the rule would 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.\2\ Although the rule's impact on domestic producers is
uncertain, it is expected to provide benefits to consumers (domestic
importers, brokers) that would exceed any potential losses to domestic
producers. The net welfare effect for the United States of increased
horse imports will be positive.
---------------------------------------------------------------------------
\2\ 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 minus
the seller's cost.
---------------------------------------------------------------------------
The additional number of horses that might be imported into the
United States as a result of this proposed rule is not known. However,
because the proposed rule is expected to result in the opening of only
one or two additional quarantine facilities in the next several years,
the expected benefits are likely to be small.
Alternatives Considered
This proposed rule would establish standards for the approval of
permanent, privately owned quarantine facilities for horses.
Alternatives to the proposed rule would be to either leave the
regulations unchanged, or to require a different set of standards than
is proposed. Leaving the regulations unchanged would be unsatisfactory,
because it would perpetuate the current situation, i.e., one which does
not fully address the potential disease risks, and one which does not
facilitate the importation of horses.
APHIS considers the proposed set of standards to be the minimum
necessary to accomplish the rule's objectives. In this regard, we have
made changes to
[[Page 74841]]
substantive provisions in this reproposal that we expect would reduce
the compliance costs associated with this rulemaking. This reproposal
also provides additional time for the existing permanent, privately
owned horse quarantine facility to comply with any requirements that
may be established by a final rule. The deadline would be 1 year after
the final rule takes effect.
Nevertheless, we invite public comment on the proposed rule,
including any comments on the expected impacts for small entities and
on how the proposed rule could be modified to reduce expected costs or
burdens for small entities consistent with its objectives. Any comment
suggesting changes to the proposed standards should be supported by an
explanation of why the changes should be considered.
This proposed rule contains information collection requirements,
which have been submitted for approval to the Office of Management and
Budget (see ``Paperwork Reduction Act'' below).
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comment refers to Docket No. APHIS-
2006-0013. Please send a copy of your comment to: (1) Docket No. APHIS-
2006-0013, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2)
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of
having its full effect if OMB receives it within 30 days of publication
of this proposed rule.
Because recent demand for quarantine services for horses exceeds
the space available at existing facilities, we are proposing to allow
the establishment of permanent, privately owned horse quarantine
facilities if they meet requirements proposed in this document.
Accomplishing this will necessitate the use of several information
collection activities, including an application for facility approval,
a compliance agreement explaining the conditions under which the
facility must be operated, and a certification that the facility meets
all applicable environmental regulations.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 0.78571 hours per response.
Respondents: Owners of approved permanent, privately owned horse
quarantine facilities and applicants for approval.
Estimated annual number of respondents: 3.
Estimated annual number of responses per respondent: 4.666.
Estimated annual number of responses: 14.
Estimated total annual burden on respondents: 11 hours.
Copies of this information collection can be obtained from: Mrs.
Celeste Sickles, APHIS's Information Collection Coordinator, at (301)
734-7477.
E-Government Act 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 proposed rule, please contact Mrs. Celeste
Sickles, APHIS's Information Collection Coordinator, at (301) 734-7477.
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 9 CFR part 93 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
1. The authority citation for part 93 would continue to read as
follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
2-3. Section 93.300 would be 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 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 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.
[[Page 74842]]
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 special event and
that is owned and operated by an entity other than the Federal
Government (also temporary facility).
* * * * *
4. Section 93.303 would be amended as follows:
a. By revising the heading of paragraph (e) to read as set forth
below.
b. In paragraph (e), by removing the words ``provided by the
importer'' and by adding the words ``privately owned'' before the word
``quarantine''.
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]
5. In Sec. 93.304, paragraph (a)(1)(i), the first sentence would
be amended by removing the words ``quarantine facility provided by the
importer'' and adding the words ``privately owned quarantine facility''
in their place.
6. In Sec. 93.304, paragraph (a)(2), the words ``of the
regulations, horses intended for quarantine at a quarantine facility
provided by the importer,'' would be removed, and the words ``or horses
intended for quarantine at a privately owned quarantine facility''
would be added in their place.
7. In Sec. 93.308, in paragraph (a), footnote 14 would be
redesignated as footnote 13, paragraph (b) would be revised and a new
footnote 14 would be added, and paragraph (c), including footnote 15,
would be revised to read as follows:
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 (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 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 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.
(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
[[Page 74843]]
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 and provide continuous oversight over
import quarantine operations and other technical services to ensure the
biological security of the facility, if approved. This 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
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 quarantine 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 convicted of any
crime involving fraud, bribery, or extortion or any other crime
involving a lack of 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 at the
time these regulations become effective must be approved by APHIS to
continue quarantine operations by [Insert date 1 year after effective
date of final rule] 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
[[Page 74844]]
compliance agreement executed by the operator or his or her agent and
the Administrator, and that 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 facility's quarantine operations are subject to the
oversight of APHIS representatives;
(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; and
(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;
(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.
(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, prevent
horses in facing stalls from coming into contact with horses in the
aisleway, and to adequately ventilate 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.
[[Page 74845]]
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 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 the 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 under the
oversight of 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 under the direct oversight of 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.
(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) APHIS oversight.
(A) The quarantine of horses at a privately owned quarantine
facility is
[[Page 74846]]
subject to the oversight of APHIS representatives authorized to perform
the services required by this section and by the compliance agreement.
(B) If, for any reason, the operator fails to properly care for,
feed, or handle the quarantined horses as required in this paragraph
(c), or fails to maintain and operate the facility as provided in this
paragraph (c), APHIS representatives will furnish such services or make
arrangements for the sale or disposal of quarantined horses at the
quarantine facility owner's expense.
(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 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 a manner approved by APHIS as adequate to preclude
transmission of any animal disease agent from the facility. 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 as directed by
an APHIS representative.
(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 and water buckets) 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 to the satisfaction of an APHIS representative.
(E) Any vehicle, before entering or leaving the quarantine area of
the facility, must be cleaned and disinfected under the oversight of an
APHIS representative 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.
(F) If the facility has a single loading dock, the loading dock
must be cleaned and disinfected after each use under the oversight of
an APHIS representative 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.
(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, under the oversight of an APHIS
representative upon release of the horses before a new lot of horses is
placed in that area of the facility.
(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.
(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 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 communicable disease of horses, arrangements for the final
disposition of the infected or exposed horse must be accomplished
within 10 days of the date
[[Page 74847]]
that the importer is notified by the overseeing APHIS representative
that the horse has been refused entry into the United States.
Subsequent disposition of the horse must occur under the direct
oversight of APHIS representatives. The operator must have a
preapproved contingency plan for the disposal of all horses housed in
the facility prior to issuance of the import permit.
(I) Vaccination of horses in quarantine is prohibited.
(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 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.
8. In Sec. 93.309, the section heading would be revised to read as
follows:
Sec. 93.309 Horse quarantine facilities; payment information.
* * * * *
9. Section 93.310 would be 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 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 1st day of December 2006.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E6-21032 Filed 12-12-06; 8:45 am]
BILLING CODE 3410-34-P