As part of the reevaluation that led to these clarifications, we also examined whether the maintenance of the facility, the daily care of horses under quarantine, the disposal of wastes, cleaning and disinfection procedures, incineration activities, and the handling, washing, and disposal of soiled and contaminated clothing at the facility could be performed without APHIS personnel being physically present on each occasion. We have determined that these activities and procedures need APHIS oversight, but that it is not necessary for APHIS representatives to maintain physical presence at them and direct or continual monitoring of them, unless we have reason to believe that these activities are being neglected or carried out in a manner that compromises either the biological security of the facility or the welfare of horses onsite.

In order for APHIS to allow these practices to be conducted without our physical presence, however, we have determined that we must possess adequate knowledge of the standard practices that the operator of the facility will employ regarding these activities prior to APHIS' initial approval of the facility. We have also determined that we must possess some mechanism whereby we can evaluate the operator's adherence to these practices once the site is operational and, if necessary, take remedial measures to address any failure to comply with these standards.

As a result of this determination, in Sec. 93.308, we have modified proposed paragraph (c)(2)(ii), which sets forth requirements for the compliance agreement that an operator of a facility or his or her agent must execute prior to APHIS approval of the facility, to specify that each compliance agreement must provide that the operator agrees to demonstrate, to the satisfaction of the Administrator, that the routine cleaning and maintenance of the facility, the daily care of animals in quarantine, the disposal of wastes at the facility, the cleaning and disinfection procedures employed by the facility, the handling, washing, and disposal of soiled and contaminated clothing worn within the facility, and the disposal of dead horses, whether onsite or offsite, adhere to the best practices of biological security and animal care; and provide that the operator agrees to random spot audits by APHIS representatives to determine whether employees and other personnel are complying with these practices.\2\ These two requirements are found in subparagraphs (E) and (F) of paragraph (c)(2)(ii) in Sec. 93.308 of this final rule.
\2\ Best practices for biological security and animal care are those employed at our Federally maintained quarantine facilities or otherwise specified within operational memoranda issued by APHIS' Veterinary Services division. APHIS will facilitate the operator's access to these best practices prior to the execution of the compliance agreement.

Accordingly, proposed paragraph (c)(4)(i)(B) of Sec. 93.308, which pertained to the maintenance of the facility and the daily care of animals in quarantine, has been modified to reflect these changes to the compliance agreement. In this final rule, the paragraph provides that, if, as the result of a spot audit, or for any other reason, APHIS determines that the operator has failed to properly care for, feed, or handle quarantined horses as required by this final rule or in accordance with the terms of the compliance agreement, or has failed to maintain and operate the facility as provided in the rule or in accordance with the terms of the compliance agreement, APHIS representatives will furnish such services, will make arrangements for the sale or disposal of quarantined horses at the quarantine facility owner's expense, or will begin the process for withdrawal of approval of the quarantine facility. In the proposed rule, this paragraph did not mention either spot audits or the compliance agreement, and did not state that nonadherence to the provisions of the rule could result in withdrawal of approval.

In this final rule, the following paragraphs have been modified to specify that the procedures detailed in the paragraphs must be carried out in accordance with the term of the compliance agreement, and to state that the procedures are therefore subject to spot audits:

If, at any time, an APHIS representative discovers that employees or other authorized personnel are not following the terms of the compliance agreement, he or she may issue additional instructions regarding the measures that these individuals must take while import quarantine operations are being conducted at the facility (paragraph (c)(4)(ii)(C) of Sec. 93.308). If employees do not follow these additional instructions, APHIS representatives may require the operator to bar these personnel from the facility (paragraph (c)(2)(ii)(D) of Sec. 93.308). Finally, in this final rule, both paragraphs (c)(1)(iv)(C)(1) and (c)(4)(i)(B) of Sec. 93.308 provide that nonadherence to the terms of this rule or the compliance agreement by the operator or his or her employees may result in withdrawal of approval of the quarantine facility.

In response to the commenters' questions regarding when APHIS would exercise oversight of the facility, APHIS representatives will ordinarily render their services during their normal tour of duty as APHIS employees. An APHIS employee's tour of duty may vary, but always excludes Sundays and holidays. If circumstances require an APHIS employee to be present at the facility outside of his or her tour of duty, we will charge an overtime rate for those services. This rate is found in 9 CFR 130.30(b).

Similarly, in response to the commenters' questions regarding the cost associated with APHIS oversight, in the proposed rule, we stated that we will charge for APHIS' inspection of a facility at the hourly rates listed in 9 CFR 130.30. We also stated that the operator of the facility would be charged for the services APHIS representatives provide in accordance with 9 CFR part 130.

In a related matter, as we mentioned above, proposed Sec. 93.308(c)(1)(ii)(C) stated that part of APHIS' initial evaluation of an application for approval of a facility would be a determination of whether sufficient APHIS personnel are available to serve as APHIS representatives at the facility, in order to provide continuous oversight of import quarantine operations and other technical services pertaining to biological security.

Several commenters expressed concern regarding this paragraph. One commenter stated that APHIS does not currently have sufficient personnel at existing APHISoperated quarantine facilities, and thus cannot assume oversight of privately owned facilities. Another stated that recent outbreaks of equine herpes virus (EHV1) at an APHIS operated quarantine facility suggest that the biological security risks associated with horse quarantine facilities have increased and necessitate that more personnel be assigned to the facility than APHIS can provide. A third commenter stated that it is unlikely that APHIS personnel will be available to continually staff the facilities, and we should therefore consider providing funding opportunities through cooperative agreements for State animal health officials to provide health inspection services at the facilities. A fourth commenter suggested that, in the event of a lack of adequate personnel, APHIS should delegate supervision of certain quarantine operations, such as the collection of blood samples, to private practitioners.

Those commenters who stated that APHIS does not have sufficient personnel to serve as representatives at or to provide continual oversight of a quarantine facility appear to have based their evaluation, in large part, on an expansive understanding of ``APHIS oversight.'' We consider the clarifications and amendments we have made to the proposed rule regarding the nature of this oversight to be sufficient to address this aspect of the commenters' concerns.

In addition, by making a determination that APHIS must have sufficient personnel to serve as representatives to a facility one of the conditions for the Administrator's initial approval of the facility, we are afforded the opportunity to evaluate both the extent to which such approval could have a detrimental impact on existing import quarantine operations at APHISoperated facilities, and the likelihood that a future outbreak of a foreign animal disease would cause us to have insufficient personnel to oversee import quarantine operations and assure biosecurity at any facility, whether privately operated or maintained by APHIS. If the Administrator determines that approval of a privately operated facility would jeopardize import quarantine operations or biosecurity at an existing quarantine facility, he or she will not grant such approval.

We consider APHIS oversight of import quarantine operations and other related services conducted at a facility to be necessary for us to carry out our responsibility under the AHPA to prevent the introduction of a foreign communicable disease of horses into the domestic equine population. We do not consider it appropriate to delegate this responsibility to private practitioners or State animal health officials. However, this rule does not amend or supplant the existing regulations in 9 CFR part 93 that pertain to the various operations that accredited veterinarians and State animal health officials may conduct in order to provide care for imported horses or in order to prevent the spread of communicable equine diseases.

We address the commenter's concerns regarding the biological security of equine quarantine facilities in light of the 2006 outbreak of EHV1 in the section below titled ``Comments on Construction Requirements.''
Comment Regarding the Role of State Departments of Agriculture

One commenter asked whether APHIS oversight involves parallel supervision of the quarantine facility by State departments of agriculture, State veterinarians, and State animal health agencies. If it does not, the commenter suggested the final rule authorize such entities to be consulted and have some authority in the approval of the facility, in any decision regarding the location of the facility, in approval of contingency plans for emergency medical care of quarantined horses and possible disposal of all horses housed at the facility, in the granting of variances from the terms of the rule, and in the decisionmaking process for denying or withdrawing approval of the facility.

As we mentioned above, it is APHIS' responsibility under the AHPA to prevent the introduction of foreign communicable diseases of horses into the domestic equine population. As part of this duty, it is necessary for us to make the ultimate determination in those areas described by the commenter. Therefore, we do not consider it possible to delegate responsibility to or share responsibility with State animal health authorities for these determinations in the manner requested by the commenter.

However, our responsibility does not preclude APHIS from asking State authorities to provide guidance regarding the approval of a proposed facility. Indeed, on many occasions, we may have to solicit such input in order to determine whether a proposed facility meets local and State environmental regulations. Such a determination is required in paragraph (c)(5) of Sec. 93.308.

In addition, APHIS has recently undertaken an initiative to facilitate greater communication with State agricultural agencies, and to establish greater collaboration among Federal and State officials in the development of
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effective strategies to respond to animal disease events and emergency situations at the State and local levels. We will implement this rule in a manner that is consistent with that initiative, especially in matters pertaining to the biosecurity of the facility and the health of livestock in the area of the facility.
Comment Regarding Temporary, Privately Owned Quarantine Facilities

In our proposal, we proposed to amend paragraphs (b) and (c) of Sec. 93.308 by combining the two paragraphs, which contained requirements for temporary, privately owned horse quarantine facilities, into a single paragraph (b), and by making several nonsubstantive changes to the text of these paragraphs.

One commenter asked whether these changes established new regulations for such temporary facilities. In the commenter's estimation, it would prove impracticable to have temporary facilities adhere to the same standards as permanent facilities.

We are maintaining the existing provisions for temporary, privately owned quarantine facilities. This rule establishes standards solely for permanent facilities.

Comments Regarding Denial or Withdrawal of APHIS Approval

In Sec. 93.308, proposed paragraph (c)(1)(iv) set forth a protocol for denying or withdrawing approval of a permanent, privately owned horse quarantine facility, and reasons for APHIS to deny or withdraw such approval. Among other reasons, we stated that, if the operator or a person responsibly connected with the business of the quarantine facility acts as a paid agent (broker) for the importation or subsequent sale of a horse, APHIS could deny or withdraw approval of a privately owned horse quarantine facility.

We deemed a person to be responsibly connected with the business of the quarantine facility if that person has an ownership, mortgage, or lease interest in the facility's physical plant, or if that person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or is an employee in a managerial or executive capacity. We included these provisions in our December 2006 proposal in response to comments that we received regarding our July 2002 proposal. The commenters on the earlier proposal suggested that an operator who also acted as a broker would face conflicts of interest while housing, treating, and caring for horses imported by other brokers.

We received two comments regarding these provisions. Both commenters considered the measure to be overly restrictive, and suggested that a person engaged in both operation of the facility and import brokerage would not necessarily encounter a substantive and irresoluble conflict of interest. One of these commenters asserted that the one permanent, privately owned horse quarantine facility currently in operation has functioned as an import broker almost since its establishment, without incident or complaint. In lieu of these provisions, the commenters suggested that APHIS forbid operators from discriminating against any importer or agent, under penalty of fines or withdrawal of approval.

We are making no changes to the proposed rule in response to these comments. If an operator acts as a broker, this may not necessarily lead to conscious discrimination against the horses of other brokers, or in favor of one's own horses. However, it does predispose the operator to act in a manner that serves, or at least preserves, his or her economic interest in the horses under quarantine, and creates an incentive for the operator to discriminate in favor of his or her own horses, those of a family member, or those belonging to an individual who has a business relationship with the operator. Prohibiting operators from acting as brokers is necessary to prevent these conflicts.

Another commenter suggested that APHIS could largely resolve this conflict of interest and make this provision unnecessary by privatizing all existing Federal horse quarantine facilities. The commenter did not explicitly state why such privatization would attenuate this conflict of interest, but appeared to suggest that this action would provide an opportunity for other brokers to assume ownership of these Federal facilities.

Such privatization would not remove the conflict of interest, since it would still allow operators to act as brokers.

The same commenter suggested that, if we do not pursue privatization, these provisions are insufficient. The commenter pointed out that the one currently operating permanent, privately owned horse quarantine facility not only engages in import brokerage, but also functions as a retailer in the shipping industry. The commenter suggested that operators who act as shippers may encounter similar conflicts to those who act as brokers. Therefore, the commenter asked that, if we do not pursue privatization, we should consider prohibiting operators not only from brokerage, but also from retail shipping.

Operators do not possess as immediate and substantive an economic interest in the horses they ship as they do in those horses for which they act as brokers. If an operator assumes brokerage of a horse, the economic interest that the operator gains in the horse necessarily creates incentives for the individual to use his or her position as an operator in order to preserve and, if possible, increase the value of the horse, or conversely, to use that position to create competitive disadvantages for other brokers utilizing his or her facility. If an operator becomes the shipping agent for a horse, but does not function as the horse's broker, the economic interest that the operator has lies not in the horse itself, but in conveyance of the animal to or from the quarantine facility. This sort of interest creates only tangential or incidental incentives for the individual to use his or her position as an operator to maintain or increase the value of the animal to be shipped. For this reason, we do not consider the potential conflicts associated with retail shipping equivalent to those associated with brokerage, and are therefore not including shipping of horses as a reason to deny or withdraw approval of a permanent, privately owned quarantine facility in this final rule.
Comments Regarding the Compliance Agreement for Permanent Facilities

In Sec. 93.308, proposed paragraph (c)(2) stated that the operator of the facility or his or her agent would have to execute a compliance agreement with the Administrator. In the proposal, we specified that the compliance agreement would have to provide that the facility would have to meet all applicable requirements of proposed Sec. 93.308 and that the facility's quarantine operations would be subject to the oversight of APHIS representatives. The compliance agreement also stated that the operator of the facility would be responsible for:

The compliance agreement would further provide that the operator would
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agree to bar from the facility any employee or other personnel at the facility who fails to comply with the standards governing permanent, privately owned quarantine facilities, found in paragraph (c) of Sec. 93.308, with other provisions of 9 CFR part 93, with any terms of the compliance agreement, or with any related instructions from APHIS representatives.

Two commenters expressed concern regarding the section of the compliance agreement in which the operator agrees to pay all charges for services rendered by APHIS representatives assigned to the facility. One of the commenters stated that this stipulation is at odds with the procedures in place at the one permanent, privately owned quarantine facility currently in operation, and is inconsistent with the practices of APHISoperated quarantine facilities. The commenter stated that at such facilities the importer of record or the shipping agent is responsible for all fees for APHIS services.

The fees that APHIS assesses on importers and shipping agents at the quarantine facilities that we operate are for services rendered directly on behalf of the importer or shipping agent, such as meeting the importer or agent at the port of entry in order to facilitate transportation of the animal to the quarantine facility, or drawing blood for routine serological tests once import quarantine operations have been completed.

In contrast, the services that APHIS employees will provide at privately owned equine quarantine facilities will be directly related to conducting import quarantine operations and maintaining biosecurity for all horses at the facility, and are thus properly rendered on behalf of the operator of the facility, rather than on behalf of a specific importer or agent. Therefore, it is reasonable that the operator of the facility should agree to pay all charges for such services. This provision is consistent with the standards currently in place for temporary, privately owned quarantine facilities, which require the operator of the facility to bear all maintenance and operation costs.

Finally, it is important to note that this rule does not prohibit the operator of a privately owned equine quarantine facility from passing on the costs of APHIS' services to the importer of record or the shipping agent.

Another commenter asked if pricing structures for the services rendered at the privately owned facilities will correspond to those already in place for APHISoperated quarantine facilities.

As we mentioned in the proposed rule, APHIS will charge for its services according to 9 CFR part 130. We will not regulate the amount that the operators of a facility may charge for services that they themselves provide.

Comments Regarding Location Requirements

In Sec. 93.308, proposed paragraph (c)(3)(i) set forth location requirements for permanent, privately owned quarantine facilities. These required that the quarantine facility must be located in proximity to a port authorized under paragraph (e) of Sec. 93.303 of the regulations, and that the site and the specific routes for the movement of horses from the port to the site must be approved by the Administrator based on consideration of whether the site or routes would put the horses in a position that could result in the transmission of communicable diseases to domestic horses. In both our December 2006 proposal and our July 2002 proposal, we decided not to specify a maximum distance that a facility could be located from a port of entry. In each proposal, we cited the diversity of locations of possible ports of entry as a reason for not setting such a distance: Some may be located in large metropolitan areas, with the nearest concentration of livestock many miles away, while others may be in towns with rural areas and high concentrations of livestock within a very short distance of the port.

Two commenters asked that APHIS add provisions to specify a maximum distance that a quarantine facility can be from a port of entry. One of these commenters stated that, if a quarantine facility were located many miles from a port of entry, a horse refused entry at one of the quarantine facilities would have to be transported a great distance before being exported from the United States. In the commenter's estimation, transporting a diseased horse for such a period of time, even under the most stringent biological security measures, would pose a substantial risk of disease spread through thirdparty vectors, such as flies and gnats.

We do not consider it possible to set a maximum distance that a quarantine facility can be located from a port of entry. In light of the diversity of places in which persons may consider locating a permanent facility, and the possibly substantive variations among different ports of entry, setting specific distances may result in regulations that are too stringent for some facilities, and too lax for others.

In a similar matter, in our July 2002 proposal, we proposed to require that the facility be located at least onehalf mile from premises holding livestock or horses. In response to a commenter who suggested that other requirements in our proposal established adequate biosecurity to render such a requirement unnecessary, we reevaluated the need for this requirement, and removed it from our December 2006 proposal. Instead, we specified that the site would have to be approved by the Administrator as described above. The Administrator will take into consideration the proximity of the quarantine facility to the nearest port of entry, and the disease risks posed by transit of an infected horse from the port to the facility, in making his or her determination whether to approve the construction of the facility.

A commenter on the December 2006 proposal suggested that mandating a minimum distance that a facility can be constructed from the surrounding horse population greatly reduces the likelihood of disease spread to that population and the possibility of a subsequent equine disease outbreak in the vicinity of the facility, and such a requirement ought to be included in the final rule.

We have evaluated the biosecurity requirements we described in the proposed rule, and determined that they are adequate to mitigate the possibility of disease spread. Therefore, if all other procedures described in this rule are followed at a private, permanently owned quarantine facility, a distance requirement is unnecessary.

We note, however, that we are requiring that each application for approval of a quarantine facility must specify the location and street address of the facility. This requirement affords the Administrator the opportunity to assess the specific risks posed by that location, in accordance with paragraph (c)(3)(i) of Sec. 93.308, and to specify additional biological security measures, beyond those specified in the rule, that the facility must adopt in order to address these risks and prevent disease spread. As specified in paragraph (c)(1)(ii)(B) of Sec. 93.308, the Administrator may impose such additional requirements within the terms of the compliance agreement.

If the Administrator decides that the disease risks associated with a particular location are insurmountable, even with the imposition of such additional biosecurity requirements, he or she will not approve the location of the facility.

Comments Regarding Construction Requirements

In Sec. 93.308, proposed paragraph (c)(3)(ii) set forth construction requirements for permanent, privately
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owned horse quarantine facilities. The proposed basic standards for the facility addressed perimeter fencing, entrances and exits, windows, lighting, loading docks, surfaces, horse stalls, aisleways, isolation stalls, showers, APHIS space, necropsy areas, storage space, restrooms, ventilation, climate control, fire alarms, and communications systems.

Our July 2002 proposed rule included several specific construction requirements for lotholding areas. These areas, which we defined as ``areas within a permanent, privately owned quarantine facility in which lots of horses are held,'' would have had separate drainage and heating, ventilation, air conditioning systems, and physical barriers. Our December 2006 proposed rule retained the provisions regarding lot holding areas, but provided more options for operators to provide biological security within these areas, such as cleaning and disinfection after each use of an area.

One commenter suggested that APHIS remove those additional options for lotholding areas and return to the more stringent requirements presented in the July 2002 proposed rule. The commenter cited the 2006 outbreak of a neurotropic EHV1 mutation in a lot of horses at a permanent, APHISoperated quarantine facility as evidence of the significant disease risks that may arise at a quarantine facility, and suggested that the revisions to lotholding areas set forth in our December 2006 proposal did not take these risks into adequate account. The commenter therefore suggested that APHIS reevaluate the construction standards proposed for these areas in light of the outbreak.

We are making no change in response to this comment. The construction standards in the December 2006 proposal called for physical barriers to be erected to separate different lots of horses at the facility, so that horses in one lot cannot have physical contact with horses in another lot, their excrement, or their discharges. In addition, the sanitary standards in the 2006 proposal stated that each lotholding area of the facility would have to be thoroughly cleaned with a disinfectant upon release of a lot of horses before a new lot of horses can enter the lotholding area. APHIS has determined that these safeguards, which are comparable to those at APHISoperated facilities, effectively limit the spread of communicable diseases of horses between lots of horses at a facility. We note, in this regard, that the biological security measures in place at the quarantine facility that was the site of the EHV1 outbreak limited the spread of the disease to one lot of horsesneither lots in adjacent holding areas nor subsequent lots at the quarantine facility tested positive for the virus.

Finally, if a disease of horses, whether foreign or endemic to the United States, spreads within a particular lot of horses, the horses in that lot are subject to the provisions of paragraph (c)(4)(v)(H) of Sec. 93.308, which sets forth requirements regarding the final disposition of horses infected with or exposed to a communicable disease of horses.

Another commenter stated that the construction requirements presented in the December 2006 proposed rule were not sufficiently delineated. The commenter asserted that, instead of creating objective and unilaterally binding specifications, APHIS had made standards primarily dependent on the judgment of APHIS representatives who inspect and approve the facility. In the commenter's opinion, this could result in wide deviations regarding the biological security of various facilities, and would necessarily make it difficult for a third party to determine the criteria by which the representative has evaluated a facility. The commenter suggested that, at a minimum, the final rule provide more detailed criteria for the construction of drainage and heating systems, ventilation, air conditioning systems, physical barriers, and material used in the construction of floors and walls within the quarantined area.

We are making no change in response to this comment. Our June 2002 proposed rule contained more specific construction criteria for lot holding areas, floor drains, physical barriers, showering areas, areas for breaks and meals, and heating and ventilation units within the facility. In response to those proposed requirements, several commenters pointed out that some of these requirements were more restrictive than the design of various APHISoperated facilities. Other commenters suggested that we generally amend the construction requirements to allow operators as many design variations as possible. Accordingly, in drafting our December 2006 proposal, we reevaluated the construction requirements that we proposed in 2002 and determined that, on certain occasions, the requirements of our 2002 proposal were indeed inconsistent with those at APHISapproved facilities. On other occasions, we determined that the requirements could be adjusted to allow operators more options to provide adequate biological security at the facility. This led us to modify the construction requirements mentioned by the commenter.

The APHIS approval process will ensure that all permanent, privately owned facilities are constructed in a manner adequate to prevent the transmission of disease between lotholding areas, thus preventing any wide deviations with regard to biosecurity. In addition, we note that, under paragraph (c)(1)(ii)(B) of Sec. 93.308, the Administrator may impose additional construction requirements within the terms of the compliance agreement, beyond those specified in the rule, if he or she determines these requirements to be necessary to prevent the transmission of diseases into, within, or from the facility.

Several commenters suggested that the construction standards be modified to allow or require exercise equipment or ``turnout'' pens for horses in quarantine. Such accommodations, the commenters stated, would allow horses under quarantine to maintain muscle tone and general overall health.

Allowing a horse under quarantine to be separated from its lot and released for exercise to an area of the facility outside the lot holding area, whether indoor or outdoor, presents an unacceptable risk of disease spread. We note, in this regard, that horses that are required under the regulations to be quarantined for extended periods of time after their importation often have been imported from regions where a communicable equine disease is known to exist, or from regions that engage in trade with such regions and do not require testing or vaccination for that disease.

We recognize, however, that it may be possible to place exercise equipment in the stalls or in other parts of the lotholding areas, depending on the size or construction of such areas. Therefore, we have modified proposed paragraph (c)(3)(i)(G) of Sec. 93.308, which stated that the stalls in which horses are kept would have to be large enough to allow each animal to make normal postural and social adjustments with adequate freedom of movement, to further state that exercise equipment for horses may be kept in the stalls, provided that there will still be sufficient space within the stall for the horses to move freely once the equipment is installed.

Moreover, the regulations in this final rule allow exercise equipment to be kept in the lotholding areas themselves. Any such equipment would, however, be subject to the cleaning and disinfection procedures required for lotholding areas. To clarify this provision, we have modified proposed paragraph (c)(4)(iv)(D), which contained cleaning and disinfection requirements for equipment used within the quarantine area of the facility, to specify that these
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requirements also pertain to exercise equipment located within the quarantine area.

Comment Regarding Requirements for Isolation Stalls

In Sec. 93.308, proposed paragraph (c)(3)(ii)(I) addressed requirements for the means of isolation within permanent, privately owned facilities. We stated that the facility must have physical barriers to separate different lots of horses at the facility, so that horses in one lot cannot have physical contact with horses in another lot, or their excrement or discharges. We also stated that the facility must have stalls capable of isolating any horses exhibiting signs of illness.

One commenter pointed out that we did not specify a location for these stalls. As a result, the commenter was uncertain whether APHIS intended stalls to be constructed in a separate building or merely in such a manner that the horse does not have direct contact with other horses in its lot.

An isolation stall may be constructed in a separate building or within the quarantine area, provided that, in the estimation of the Administrator, the stall is able to physically isolate the horse from other horses at the facility.
Comment Regarding Requirements for Necropsy Areas and Carcass Removal

In Sec. 93.308, proposed paragraph (c)(3)(ii)(L) set forth construction requirements for necropsy areas used by permanent, privately owned quarantine facilities. These required that all facilities must either have an area for conducting necropsies onsite, or must have designated an alternate facility, approved by the Administrator, at which a suitable necropsy area is available. In proposed paragraph (c)(3)(iii)(G) of Sec. 93.308, which set forth sanitation requirements for permanent, privately owned quarantine facilities, we stated that each facility must have the capability to dispose of horse carcasses in a manner approved by the Administrator and under conditions that minimize the risk of disease spread.

One commenter stated that the carcass disposal requirements appear to be based on the quarantine facility's use of an onsite necropsy area. If the quarantine facility utilizes an alternate facility for necropsies, however, the commenter suggested that these disposal requirements no longer apply, since the sanitary disposal of the carcass after necropsy would become the responsibility of this other facility.

We are making no change in response to this comment. When a horse dies at a permanent, privately owned facility, the operator assumes ultimate responsibility for the disposal of its carcass in a manner acceptable to the Administrator, and under direct oversight of APHIS, whether the necropsy is conducted onsite or at another facility. The location of the necropsy, then, has no bearing on the disposal requirements.

Comment Regarding Security Requirements

In proposed paragraph (c)(3)(iv) of Sec. 93.308, we set forth security requirements for permanent, privately owned facilities. We proposed that the facility and premises be kept locked and secure at all times. We also proposed to require that the facility and premises must have signs indicating that the facility is a quarantine area and no visitors are allowed.

Further, we proposed to require that the facility and premises either be guarded at all times by representatives of a bonded security company or, alternatively, have an electronic security system that indicates the entry of unauthorized persons into the facility.

Finally, we proposed to require that the operator of the facility notify the designated APHIS representative whenever a breach of security occurs or is suspected of having occurred. Further, if a disease is diagnosed in quarantined horses, we stated that the Administrator may require the operator to have the facility guarded by a bonded security company in a manner that the Administrator deems necessary to ensure the biological security of the facility.

One commenter stated that these provisions appear to prohibit any individual, including authorized personnel, from entering the facility, except in the presence of an APHIS representative. During all other times, it appeared to the commenter as if the facility would have to be locked and the entrances to it guarded, protected by alarm, barred, or sealed.

Paragraph (c)(4)(iii) grants authorized employees and other personnel assigned to work at the facility access to the facility premises as well as the quarantine area, even in the absence of an APHIS representative. This provision addresses the commenter's concerns.

Comment Regarding Personnel Requirements

In proposed paragraph (c)(4)(ii) of Sec. 93.308, we set forth personnel requirements for permanent, privately owned quarantine facilities. Among other provisions, these proposed that:

One commenter stated that both the list of personnel and the signed compliance statements appear to be unnecessary, if APHIS
representatives will be physically present at all times to oversee the facility.

As discussed earlier, APHIS will ordinarily only maintain a physical presence at and direct supervision of import quarantine operations and certain technical services related to the biological security of the facility. Therefore, in order to ensure the general biological security of the facility, it is important that APHIS representatives have a continually updated list of all personnel with access to the facility, one that takes into consideration employee turnover at the facility itself and at any company with access to the facility. It is also important that all personnel agree to adhere to the biological security measures set forth within the rule and the compliance agreement.

That said, we do recognize that the proposed rule could be construed to suggest that, although APHIS personnel will be physically present at the facility, compliance agreements and signed statements from personnel must be submitted to APHIS employees at an offsite location, rather than to the personnel assigned to the facility, for review. This is not the case. The operator may submit such records to APHIS personnel assigned to the facility. The records will then be forwarded to the appropriate area veterinarianincharge office. Comments Regarding Showering Requirements

In Sec. 93.308, proposed paragraph (c)(4)(iv) set forth sanitation requirements for permanent, privately owned facilities. Proposed (c)(4)(iv)(A)(1) and (2) included provisions requiring that all persons granted access to the quarantine area shower when entering and leaving that area, and that all persons shower when leaving the necropsy area if a necropsy is in the process of being performed or
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has just been completed, and portions of the animal remain exposed.

One commenter stated that these provisions were not the practice of the one permanent, privately owned horse quarantine facility currently in operation. The commenter suggested that the facility's standards, which require personnel to wash their overalls and shower before leaving work, would provide a less burdensome alternative to the provisions of our proposal.
``Shower in/shower out'' is considered a cornerstone of biosecurity, and is recognized and recommended by government, academia, and industry to prevent the spread of disease agents into or from live animal facilities. Accordingly, APHIS has determined that showering reduces the risk of disease spread from quarantine or necropsy areas, and may, in certain instances, remove a pathway for the transmission of a communicable disease of horses. Therefore, these provisions represent the practices of APHISoperated facilities. They have thus been evaluated for efficacy and general applicability. Conversely, the commenter provided no data suggesting that the practices of the one permanent, privately owned horse quarantine facility currently in operation are equally effective riskmitigation measures.

The same commenter stated that showering requirements, in themselves, do not adequately address the risk of the spread of communicable diseases of horses, since they do not preclude the movement of waste material from a quarantined area.

The rule provides multiple safeguards to prevent the movement of waste material from the quarantine area. In Sec. 93.308, paragraphs (c)(4)(iv)(A)(3) through (5) require that personnel at the facility who enter or leave the quarantine area must wear protective work clothing and footwear upon entering the area and must change this clothing if it becomes soiled or contaminated. Paragraph (c)(4)(iv)(C) stipulates that the operator of the facility must handle, wash, or dispose of this soiled and contaminated clothing in accordance with the terms of the compliance agreement, and thus in a manner approved by the Administrator as consistent with the best practices of biological security. Paragraphs (c)(4)(iv)(D), (E), (F), and (G) establish cleaning and disinfection protocols for equipment and vehicles used within the facility, loading docks, and lotholding areas. Thus, our proposed showering requirements were simply one of several sanitary practices that the facility would have to employ to address, among other things, the risk associated with the movement of waste material from the quarantine area.

Finally, the commenter asserted that the sanitary requirements of the proposed rule do not prevent grooms, owners, and other personnel who have traveled with a diseased horse from its country of origin from moving freely throughout the United States once they have disembarked. The commenter suggested that, if such individuals became exposed to a communicable equine disease, they could spread the disease throughout the United States.

APHIS personnel and employees of the Department of Homeland Security's Bureau of Customs and Border Protection may inspect individuals, their clothing, and their articles at ports of entry in order to prevent the introduction of a communicable equine disease into the domestic equine population.
Comments Regarding Requirements for the Handling of Horses Under Quarantine

In Sec. 93.308, proposed paragraph (c)(4)(v) set forth requirements for the handling of horses in quarantine at a permanent, privately operated facility. Proposed paragraph (c)(4)(v)(B) stated that each lot of horses to be quarantined must be placed in the facility on an ``all in, all out'' basis, so that no horse may be taken out of the lot while it is in quarantine, except for diagnostic purposes or as provided in paragraph (a)(4) of Sec. 93.308, and no horse may be added to the lot while the lot is in quarantine.

One commenter objected to the ``all in, all out'' requirement. The commenter stated that this requirement is not the practice of the one permanent, privately owned horse quarantine facility currently in operation, and is not consistent with the practices employed at APHIS operated quarantine facilities. At the privately operated facility, the commenter stated, a horse under quarantine may be removed from its lot if the importer provides evidence that the horse has originated from a separate premise of origin than other horses in the lot.

It presents a grave risk to the biological security of a facility to allow horses onsite to be separated from their lot before import quarantine operations are conducted or while they are still ongoing for any reason other than diagnostic purposes or disposition of a diseased horse. For this reason, we only allow horses to be separated from their lot at an APHISoperated facility for the purposes of diagnosis or disposition. Therefore, the provisions of the proposed rule were indeed modeled on APHIS' practices at our facilities.

However, in reviewing our proposal, we have determined that, once import quarantine operations are completed, these risks are attenuated, and horses still at the facility may be separated from their lot without a significant risk of disease spread. Accordingly, we have modified proposed paragraph (c)(4)(v)(B) to specify that, once import quarantine operations have been completed on a lot, but while the lot is still at the facility, a horse may be removed from that lot.

Proposed paragraph (c)(4)(v)(C) stated that the facility must provide sufficient feed and bedding for horses in quarantine, and tha

FOR FURTHER INFORMATION CONTACT

Dr. Ellen Buck, Staff Veterinary Medical Officer, Equine Imports, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 207371231; (301) 7348364.