Browse: Departments Dates Agencies
Docket ID: [Docket No. APHIS-2006-0013]
RIN ID: RIN 0579-AC00
SUBJECT CATEGORY: Standards for Permanent, Privately Owned Horse Quarantine Facilities
DOCUMENT 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.
SUMMARY: Horse quarantine facilities, permanent, privately owned; standards,
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 3698636996, 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 0841). Then, on May 6, 1996, we published a notice (61 FR 2018920190, Docket No. 950842) 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. 990121) 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. 990122).
We received 59 comments by the close of the extended comment period. They were from importexport brokers, horse traders, operators of quarantine facilities, and representatives of State governments. The majority of these comments came from importexport 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 lotholding areas; a new
provision that would allow necropsies to be conducted offsite 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.
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 APHISoperated
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.
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 lotholding 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 lotholding area can comprise a stall, a group of stalls, or an entire building, provided that the physical plant and operational requirements relating to a lotholding 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 lotholding 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 lotholding areas, which are discussed later in this document, have been adjusted. In all cases, when addressing issues related to lotholding 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 APHISoperated horse quarantine facilities. For these reasons, we believe that the safeguards against the transmission of disease between lotholding 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.
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, lotholding 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 lotholding 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 lotholding 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.
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.
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.
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
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 207371231. The application letter would have to include:
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 firstcome, firstserved basis.
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
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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 ``firstcome, firstserved'' 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:
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.
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:
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.
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.
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 onehalf 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 onehalf 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.
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 ``allin, allout'' 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 selfclosing 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 lotholding 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 LotHolding Areas.''
We propose to require that the facility be constructed so that any windows or other openings in the quarantine area are doublescreened 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 wearresistant. 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 clothesstorage and clotheschanging 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 lotholding area in a facility in which it is not possible to move to any lotholding area except by first passing through another lotholding area. It would also have required that all persons granted access to the quarantine area shower before entering a lotholding area if previously exposed from access to another lotholding 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 LotHolding 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 refrigeratorfreezer 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.
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 refrigeratorfreezer 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 verminproof 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 lotholding 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 lotholding 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 LotHolding 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 casebycase 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 LotHolding Areas,'' this reproposal would require that the air handling system be adequate to ensure that there is no crosscontamination of air between the separate lotholding 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.
The facility, including the lotholding 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 clotheschanging area. One commenter questioned the necessity of the television monitoring system given that the proposed rule also would have required that a fulltime 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.
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 LotHolding 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 offsite.
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 crosscontamination 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 LotHolding Areas.'' We believe this changed requirement would provide protection against transmission of communicable diseases of horses without placing an undue burden on facility operators.
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
FOR FURTHER INFORMATION CONTACT Dr. Freeda Isaac, Staff Veterinarian, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 207371231; (301) 7348364.
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