31582 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

1To view the proposal and the comments we 

received, go to http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2006-0013. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 93 

[Docket No. APHIS–2006–0013] 

RIN 0579–AC00 

Standards for Permanent, Privately 

Owned Horse Quarantine Facilities 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

regulations pertaining to the 

importation of horses to establish 

standards for the approval of 

permanent, privately owned quarantine 

facilities for horses. We are taking this 

action because regional and seasonal 

demand for quarantine services for 

horses often exceeds the space available 

at existing facilities. Allowing imported 

horses to be quarantined in permanent, 

privately owned quarantine facilities 

that meet the criteria established in this 

rule will facilitate the importation of 

horses while continuing to protect 

against the introduction of 

communicable diseases of horses. 

DATES: Effective Date: August 3, 2009. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Ellen Buck, Staff Veterinary Medical 

Officer, Equine Imports, National Center 

for Import and Export, VS, APHIS, 4700 

River Road Unit 39, Riverdale, MD 

20737–1231; (301) 734–8364. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 9 CFR part 93 

govern the importation of specified 

animals and animal products in order to 

prevent the introduction of various 

animal diseases into the United States. 

The regulations in part 93 require that 

some of these animals be quarantined 

upon arrival in the United States as a 

condition of entry. The Animal and 

Plant Health Inspection Service (APHIS) 

operates animal quarantine facilities 

and authorizes the use of privately 

owned quarantine facilities for certain 

animal importations. The regulations in 

subpart C of part 93 (9 CFR 93.300 

through 93.326) pertain to the 

importation of horses and include 

requirements for privately owned 

quarantine facilities for horses. Prior to 

this final rule, these requirements 

applied solely to the approval and 

establishment of temporary quarantine 

facilities for the purpose of quarantining 

imported horses for a specific event. 

However, APHIS did authorize the 

operation of one permanent, privately 

owned quarantine facility for horses, 

located in Los Angeles County, CA. 

On December 13, 2006, we published 

in the Federal Register (71 FR 74827– 

74847; Docket No. APHIS–2006–0013) a 

proposal1 to amend the regulations by 

establishing standards for the approval 

of permanent, privately owned horse 

quarantine facilities. We stated that 

such facilities, if constructed and 

operated using the proper safeguards, 

would provide an effective and efficient 

means of bringing horses into the 

United States without compromising 

our ability to protect against the 

introduction of communicable diseases 

of horses. In that proposal, we also 

withdrew an earlier proposal, published 

in the Federal Register on July 1, 2002 

(67 FR 44097–44111, Docket No. 99– 

012–1), which would have established 

differing requirements in the regulations 

for the approval and operation of such 

permanent facilities. 

We solicited comments concerning 

our proposal for 60 days ending 

February 12, 2007. We received 15 

comments by that date. They were from 

horse owners, breeders, members of 

Congress, State agricultural agencies, 

equine industry groups, the operators of 

a quarantine facility, and several private 

citizens. They are discussed in the 

sections below, by topic. 

General Comments on the 2006 

Proposed Rule 

One commenter suggested that 

establishing standards for privately 

owned horse quarantine facilities was 

unnecessary. Citing the absence of any 

diseased horses that have passed 

through the one currently operating 

permanent, privately owned quarantine 

facility into the domestic horse 

population, the commenter stated that 

this facility has demonstrated adequate 

biological security measures to prevent 

the introduction of communicable 

diseases of horses into the United 

States. The commenter suggested that 

the biosecurity requirements of the 

proposed rule were disproportionate to 

the actual disease risk associated with 

quarantining horses at the facility. 

Although the biosecurity measures in 

place at that particular facility may 

serve to mitigate the risk of disease 

spread from that site, we still consider 

the biosecurity requirements described 

in our proposal to be necessary. This is 

because APHIS based the requirements 

on our experience in mitigating the risk 

of disease introduction via imported 

horses. We modeled the proposed risk 

mitigation measures on those in place at 

APHIS-operated and -approved 

facilities, after assessing them for 

adequacy and general applicability. We 

determined such an approach to be 

necessary in order to create national 

standards for such facilities. 

The fact that no equine diseases are 

known to have passed through the one 

privately owned facility currently in 

operation into the domestic horse 

population does not in itself address the 

potential disease risks that other 

quarantine facilities elsewhere in the 

United States could encounter. 

Two commenters suggested that 

private ownership of permanent horse 

quarantine facilities presents an 

unavoidable and irresolvable conflict of 

interest, inasmuch as we allow a private 

entity to operate a Federally regulated 

facility. One of these commenters 

recommended that APHIS withdraw the 

proposed rule, and assume management 

of all horse quarantine facilities. If that 

is not feasible, the commenter suggested 

exclusive oversight of the facilities 

should be delegated to public agencies, 

including universities, agricultural 

colleges, and other institutions under 

contract or cooperative agreement with 

APHIS. 

We do not consider private ownership 

of an equine quarantine facility to 

present an irresolvable conflict of 

interest, provided that the facility 

operates under adequate Federal 

oversight. We consider the degree of 

APHIS oversight of private facilities 

required by this rule to be sufficient to 

mitigate this potential conflict of 

interest. 

A more extensive discussion of 

APHIS oversight of permanent, privately 

owned equine quarantine facilities is 

found below, in the section titled 

‘‘Changes and Clarifications with Regard 

to APHIS Oversight.’’ 

Several commenters questioned 

APHIS’ intent in establishing standards 

for privately owned quarantine 

facilities. One suggested that APHIS will 

use the rule to expedite the slaughter of 

horses, while another stated that the 

rule constitutes collusion with the 

parimutuel horseracing industry to 

facilitate gambling. Accordingly, both 

commenters suggested we withdraw the 

rule. 

As explained in the proposed rule, 

our reasons for developing standards for 

permanent, privately owned equine 

quarantine facilities were the increased 

demand for import quarantine facilities 

that has arisen in the last 20 years, the 

geographic distribution of the currently 

operating horse quarantine facilities, 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31583 

which can make it difficult or costly to 

import horses to some areas, and the 

inability, because of the nature of their 

construction and operation, of 

temporary, privately owned quarantine 

facilities to fill the continual demand for 

import quarantine services. 

One commenter stated that the 

proposed rule lacked sufficient 

safeguards to protect the health of the 

domestic horse population. The 

commenter pointed out that the rule 

does not establish a ‘‘follow-up’’ system 

for horses once they are released from 

quarantine and does not address 

diseases of horses endemic to the 

United States. 

The purpose of horse quarantine 

facilities is to observe imported horses 

for any sign of communicable equine 

diseases, in order to prevent the 

introduction or further dissemination of 

those diseases within the United States. 

In this regard, it is worth noting that no 

permanent equine quarantine facility, 

whether privately or Federally operated, 

currently has a ‘‘follow-up’’ system such 

as that suggested by the commenter. 

Instead, APHIS conducts tracebacks 

during animal disease events to 

determine the premises of origin of the 

outbreak, and also administers various 

domestic surveillance, control and 

eradication programs for equine 

diseases. Among these programs are our 

surveillance and vaccination efforts to 

prevent the spread of West Nile equine 

encephalomyelitis and our surveillance 

and control program for contagious 

equine metritis (CEM). 

The aim of the proposed rule was to 

create standards and protocols for 

permanent, privately owned quarantine 

facilities in order to prevent such 

diseases from being transmitted through 

these facilities and into the domestic 

horse population. Thus, establishing 

ongoing surveillance of horses of foreign 

origin and addressing diseases of horses 

endemic to the United States both fall 

outside of the scope of this rulemaking. 

One commenter asked whether an 

approved facility, if vacant, could be 

used to house and quarantine domestic 

horses in transit from a disaster area, 

provided that the horses are subject to 

the same quarantine operations as 

horses imported into the United States. 

Establishing rules for such an 

alternate use of permanent horse 

quarantine facilities falls outside of the 

scope of this rulemaking. However, in 

the event of an animal disease outbreak 

or a natural disaster, APHIS may consult 

with the operators of a quarantine 

facility in order to facilitate emergency 

operations, including emergency 

housing and quarantines. 

Finally, one commenter asked 

whether we intend to gradually phase 

out existing APHIS-operated and 

-approved quarantine facilities as a 

result of the rule, while another 

suggested that we build another APHISoperated facility on the west coast. 

We will maintain the APHIS-operated 

facilities that presently exist. However, 

we have no current plans to build 

additional facilities. 

Changes and Clarifications With 

Regard to APHIS Oversight 

In the proposed rule, we stated that 

permanent, privately owned horse 

quarantine facilities would be subject to 

oversight by APHIS representatives, 

would operate under continuous APHIS 

oversight, and would have at least one 

APHIS representative overseeing the 

care of all horses in quarantine. We also 

proposed that quarantine operations, the 

disposal of wastes, and cleaning and 

disinfection procedures at the facility 

would occur under the oversight of 

APHIS representatives, and further 

specified that incineration activities, 

whether onsite or offsite, would occur 

under direct APHIS oversight. We stated 

that APHIS would furnish services 

related to maintenance of the facility 

and daily care of horses under 

quarantine if the operator of the facility 

failed to do so as provided in the 

proposed rule, but did not provide 

further criteria by which we would 

evaluate facilities in this regard. Finally, 

we proposed that the handling, 

washing, and disposal of soiled and 

contaminated clothing at the facility 

would have to occur in a manner 

approved by APHIS. 

Many commenters expressed concern 

regarding these proposed provisions. 

One considered continual oversight 

unnecessary. Others stated that we 

should reevaluate the need for ongoing 

and direct APHIS oversight of cleaning 

and disinfection procedures and 

incineration activities. 

Several commenters asserted that we 

failed to adequately define ‘‘oversight.’’ 

As a result, these commenters were 

uncertain whether APHIS oversight 

consisted of direct and continual 

supervision only of quarantine 

operations, of quarantine operations and 

other related procedures, or of all 

operations within the quarantine 

facility. If we intended APHIS oversight 

to be only of quarantine operations, the 

commenters stated, it was unclear 

whether we intended quarantine 

operations to take place during normal 

working hours or continually 

throughout the day. If we intended 

oversight to cover other procedures, the 

commenters were uncertain to what 

degree APHIS representatives would 

oversee them and when they would 

occur. Finally, several commenters 

asked how much APHIS oversight 

would cost. 

We regard APHIS oversight of the 

facility to be necessary in order for us 

to carry out our responsibility under the 

Animal Health Protection Act (7 U.S.C. 

8301 et seq., AHPA) to ensure that 

imported horses released from a 

quarantine facility are free of 

communicable equine diseases. 

However, we have revisited the 

proposed rule in light of the 

commenters’ concerns and appreciate 

the opportunity to clarify the nature of 

APHIS oversight. In our proposal, we 

used the term ‘‘APHIS oversight’’ in two 

different ways. In certain instances, it 

meant the responsibilities and duties 

that require APHIS to assume ultimate 

accountability for the biological security 

of the facility and the welfare of horses 

onsite, without usually being physically 

present at the facility. If we determine 

that either biosecurity or animal welfare 

is being jeopardized at the facility, this 

oversight may require us to be 

physically present at the facility to 

provide services to safeguard either 

biosecurity or welfare of the horses. 

Additionally, APHIS may withdraw 

approval of the facility. However, 

APHIS often exercises this type of 

oversight by developing care plans and 

compliance agreements with entities, 

and by conducting subsequent spot 

audits in order to ensure that the terms 

of these plans and agreements are 

followed. 

In other instances within the 

proposed rule, ‘‘APHIS oversight’’ 

meant those occasions when APHIS 

representatives must be physically 

present at the facility to carry out a 

particular function. Those occasions 

will vary somewhat from facility to 

facility, and may even vary within the 

facility from importation to importation. 

Nonetheless, we have determined that 

APHIS representatives must be present 

at a facility to monitor import 

quarantine operations whenever they 

occur, and to provide other technical 

services related to biological security. 

Technical services include, but are not 

limited to, those measures necessary to 

prevent or limit the spread of disease 

within the facility if a horse in 

quarantine has been determined to be 

affected with an equine disease. 

To clarify this distinction, we have 

modified several paragraphs in § 93.308 

from our proposal to make the occasions 

that will necessitate our physical 

presence at the facility more explicit: 

• In the proposed rule, paragraph 

(c)(1)(ii)(C) stated that, in order for a 

31584 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

2Best 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. 

facility to be approved, the 

Administrator must determine that 

sufficient APHIS personnel are available 

to serve as representatives at the facility 

and to provide continuous oversight 

over import quarantine operations and 

other technical services related to 

biological security of the facility. In this 

final rule, that paragraph now states 

that, if a facility is approved, APHIS 

representatives will be present at all 

import quarantine operations to monitor 

them and will be present to provide 

technical services to ensure the 

biological security of the facility. It also 

specifies that these technical services 

include overseeing the disposition of an 

infected or exposed horse at the facility, 

in accordance with paragraph 

(c)(4)(v)(H). Import quarantine 

operations include, but are not limited 

to, visual inspection of the animal on 

arrival, identification of the animal with 

its accompanying import certificate, 

serological testing, and monitoring of 

routine diagnostic tests. 

• In the proposed rule, paragraph 

(c)(2)(ii)(B) stated that the compliance 

agreement that the operator of a 

privately owned facility or the 

operator’s agent and the Administrator 

must execute must provide that the 

facility’s quarantine operations are 

subject to the oversight of APHIS 

representatives. In this final rule, as part 

of the agreement, the operator now must 

agree to have APHIS representatives 

present at all import quarantine 

operations at the facility in order to 

monitor the import quarantine 

operations. 

• In the proposed rule, paragraph 

(c)(4)(i)(A) stated that, as part of the 

operating procedures at the facility, the 

quarantine of horses at the facility are 

subject to the oversight of APHIS 

representatives authorized to perform 

the services required by the rule and by 

the compliance agreement. In this final 

rule, that paragraph now specifies that 

APHIS representatives will be 

physically present at and monitor all 

import quarantine operations at the 

facility. 

• In the proposed rule, paragraph 

(c)(4)(v)(H) stated that should a horse be 

determined to be infected with or 

exposed to a communicable disease of 

horses, the final disposition of the horse 

must occur under the direct oversight of 

APHIS representatives. In this final rule, 

that paragraph now states that APHIS 

representatives must be physically 

present at and directly monitor the 

disposition of the horse. 

• In the proposed rule, we referred 

throughout § 93.308 to ‘‘quarantine 

operations.’’ In this final rule, to better 

delineate those procedures for which 

APHIS representatives will maintain a 

physical presence at quarantine 

facilities, we have changed every such 

reference to ‘‘import quarantine 

operations.’’ 

As part of the reevaluation that led to 

these clarifications, we also examined 

whether the maintenance of the facility, 

the daily care of horses under 

quarantine, the disposal of wastes, 

cleaning and disinfection procedures, 

incineration activities, and the 

handling, washing, and disposal of 

soiled and contaminated clothing at the 

facility could be performed without 

APHIS personnel being physically 

present on each occasion. We have 

determined that these activities and 

procedures need APHIS oversight, but 

that it is not necessary for APHIS 

representatives to maintain physical 

presence at them and direct or continual 

monitoring of them, unless we have 

reason to believe that these activities are 

being neglected or carried out in a 

manner that compromises either the 

biological security of the facility or the 

welfare of horses onsite. 

In order for APHIS to allow these 

practices to be conducted without our 

physical presence, however, we have 

determined that we must possess 

adequate knowledge of the standard 

practices that the operator of the facility 

will employ regarding these activities 

prior to APHIS’ initial approval of the 

facility. We have also determined that 

we must possess some mechanism 

whereby we can evaluate the operator’s 

adherence to these practices once the 

site is operational and, if necessary, take 

remedial measures to address any 

failure to comply with these standards. 

As a result of this determination, in 

§ 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 § 93.308 of this final rule. 

Accordingly, proposed paragraph 

(c)(4)(i)(B) of § 93.308, which pertained 

to the maintenance of the facility and 

the daily care of animals in quarantine, 

has been modified to reflect these 

changes to the compliance agreement. In 

this final rule, the paragraph provides 

that, if, as the result of a spot audit, or 

for any other reason, APHIS determines 

that the operator has failed to properly 

care for, feed, or handle quarantined 

horses as required by this final rule or 

in accordance with the terms of the 

compliance agreement, or has failed to 

maintain and operate the facility as 

provided in the rule or in accordance 

with the terms of the compliance 

agreement, APHIS representatives will 

furnish such services, will make 

arrangements for the sale or disposal of 

quarantined horses at the quarantine 

facility owner’s expense, or will begin 

the process for withdrawal of approval 

of the quarantine facility. In the 

proposed rule, this paragraph did not 

mention either spot audits or the 

compliance agreement, and did not state 

that nonadherence to the provisions of 

the rule could result in withdrawal of 

approval. 

In this final rule, the following 

paragraphs have been modified to 

specify that the procedures detailed in 

the paragraphs must be carried out in 

accordance with the term of the 

compliance agreement, and to state that 

the procedures are therefore subject to 

spot audits: 

• Paragraph (c)(3)(iii)(F), which 

pertains to the disposal of wastes at the 

facility; 

• Paragraph (c)(3)(iii)(H), which 

pertains to incineration activities; 

• Proposed (c)(3)(iv)(F), which 

pertains to the disposal of wastes at the 

facility; 

• Paragraph (c)(4)(iv)(C), which 

pertains to the handling, washing, and 

disposal of soiled and contaminated 

clothing worn within the quarantine 

facility; 

• Paragraph (c)(4)(iv)(D), which 

pertains to cleaning and disinfection 

procedures for equipment used in the 

quarantine area; 

• Paragraph (c)(4)(iv)(E), which 

pertains to cleaning and disinfection 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31585 

procedures for vehicles entering and 

exiting the quarantine area; and 

• Paragraph (c)(4)(iv)(G), which 

pertains to cleaning and disinfection 

procedures for lot-holding areas. 

If, at any time, an APHIS 

representative discovers that employees 

or other authorized personnel are not 

following the terms of the compliance 

agreement, he or she may issue 

additional instructions regarding the 

measures that these individuals must 

take while import quarantine operations 

are being conducted at the facility 

(paragraph (c)(4)(ii)(C) of § 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 § 93.308). 

Finally, in this final rule, both 

paragraphs (c)(1)(iv)(C)(1) and 

(c)(4)(i)(B) of § 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 § 93.308(c)(1)(ii)(C) 

stated that part of APHIS’ initial 

evaluation of an application for 

approval of a facility would be a 

determination of whether sufficient 

APHIS personnel are available to serve 

as APHIS representatives at the facility, 

in order to provide continuous oversight 

of import quarantine operations and 

other technical services pertaining to 

biological security. 

Several commenters expressed 

concern regarding this paragraph. One 

commenter stated that APHIS does not 

currently have sufficient personnel at 

existing APHIS-operated quarantine 

facilities, and thus cannot assume 

oversight of privately owned facilities. 

Another stated that recent outbreaks of 

equine herpes virus (EHV–1) at an 

APHIS-operated quarantine facility 

suggest that the biological security risks 

associated with horse quarantine 

facilities have increased and necessitate 

that more personnel be assigned to the 

facility than APHIS can provide. A third 

commenter stated that it is unlikely that 

APHIS personnel will be available to 

continually staff the facilities, and we 

should therefore consider providing 

funding opportunities through 

cooperative agreements for State animal 

health officials to provide health 

inspection services at the facilities. A 

fourth commenter suggested that, in the 

event of a lack of adequate personnel, 

APHIS should delegate supervision of 

certain quarantine operations, such as 

the collection of blood samples, to 

private practitioners. 

Those commenters who stated that 

APHIS does not have sufficient 

personnel to serve as representatives at 

or to provide continual oversight of a 

quarantine facility appear to have based 

their evaluation, in large part, on an 

expansive understanding of ‘‘APHIS 

oversight.’’ We consider the 

clarifications and amendments we have 

made to the proposed rule regarding the 

nature of this oversight to be sufficient 

to address this aspect of the 

commenters’ concerns. 

In addition, by making a 

determination that APHIS must have 

sufficient personnel to serve as 

representatives to a facility one of the 

conditions for the Administrator’s 

initial approval of the facility, we are 

afforded the opportunity to evaluate 

both the extent to which such approval 

could have a detrimental impact on 

existing import quarantine operations at 

APHIS-operated facilities, and the 

likelihood that a future outbreak of a 

foreign animal disease would cause us 

to have insufficient personnel to oversee 

import quarantine operations and assure 

biosecurity at any facility, whether 

privately operated or maintained by 

APHIS. If the Administrator determines 

that approval of a privately operated 

facility would jeopardize import 

quarantine operations or biosecurity at 

an existing quarantine facility, he or she 

will not grant such approval. 

We consider APHIS oversight of 

import quarantine operations and other 

related services conducted at a facility 

to be necessary for us to carry out our 

responsibility under the AHPA to 

prevent the introduction of a foreign 

communicable disease of horses into the 

domestic equine population. We do not 

consider it appropriate to delegate this 

responsibility to private practitioners or 

State animal health officials. However, 

this rule does not amend or supplant the 

existing regulations in 9 CFR part 93 

that pertain to the various operations 

that accredited veterinarians and State 

animal health officials may conduct in 

order to provide care for imported 

horses or in order to prevent the spread 

of communicable equine diseases. 

We address the commenter’s concerns 

regarding the biological security of 

equine quarantine facilities in light of 

the 2006 outbreak of EHV–1 in the 

section below titled ‘‘Comments on 

Construction Requirements.’’ 

Comment Regarding the Role of State 

Departments of Agriculture 

One commenter asked whether APHIS 

oversight involves parallel supervision 

of the quarantine facility by State 

departments of agriculture, State 

veterinarians, and State animal health 

agencies. If it does not, the commenter 

suggested the final rule authorize such 

entities to be consulted and have some 

authority in the approval of the facility, 

in any decision regarding the location of 

the facility, in approval of contingency 

plans for emergency medical care of 

quarantined horses and possible 

disposal of all horses housed at the 

facility, in the granting of variances 

from the terms of the rule, and in the 

decisionmaking process for denying or 

withdrawing approval of the facility. 

As we mentioned above, it is APHIS’ 

responsibility under the AHPA to 

prevent the introduction of foreign 

communicable diseases of horses into 

the domestic equine population. As part 

of this duty, it is necessary for us to 

make the ultimate determination in 

those areas described by the commenter. 

Therefore, we do not consider it 

possible to delegate responsibility to or 

share responsibility with State animal 

health authorities for these 

determinations in the manner requested 

by the commenter. 

However, our responsibility does not 

preclude APHIS from asking State 

authorities to provide guidance 

regarding the approval of a proposed 

facility. Indeed, on many occasions, we 

may have to solicit such input in order 

to determine whether a proposed 

facility meets local and State 

environmental regulations. Such a 

determination is required in paragraph 

(c)(5) of § 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 

31586 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

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 § 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 § 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 § 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 § 93.308 and 

that the facility’s quarantine operations 

would be subject to the oversight of 

APHIS representatives. The compliance 

agreement also stated that the operator 

of the facility would be responsible for: 

• The cost of the facility; 

• All costs associated with the 

facility’s maintenance and operation; 

• All costs associated with the hiring 

of employees and other personnel to 

attend to the horses as well as to 

maintain and operate the facility; 

• All costs associated with the care of 

quarantined horses, such as feed, 

bedding, medicines, inspections, 

testing, laboratory procedures, and 

necropsy examinations; and 

• All APHIS charges for the services 

of APHIS representatives in accordance 

with § 93.308 and 9 CFR part 130. 

The compliance agreement would 

further provide that the operator would 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31587 

agree to bar from the facility any 

employee or other personnel at the 

facility who fails to comply with the 

standards governing permanent, 

privately owned quarantine facilities, 

found in paragraph (c) of § 93.308, with 

other provisions of 9 CFR part 93, with 

any terms of the compliance agreement, 

or with any related instructions from 

APHIS representatives. 

Two commenters expressed concern 

regarding the section of the compliance 

agreement in which the operator agrees 

to pay all charges for services rendered 

by APHIS representatives assigned to 

the facility. One of the commenters 

stated that this stipulation is at odds 

with the procedures in place at the one 

permanent, privately owned quarantine 

facility currently in operation, and is 

inconsistent with the practices of 

APHIS-operated quarantine facilities. 

The commenter stated that at such 

facilities the importer of record or the 

shipping agent is responsible for all fees 

for APHIS services. 

The fees that APHIS assesses on 

importers and shipping agents at the 

quarantine facilities that we operate are 

for services rendered directly on behalf 

of the importer or shipping agent, such 

as meeting the importer or agent at the 

port of entry in order to facilitate 

transportation of the animal to the 

quarantine facility, or drawing blood for 

routine serological tests once import 

quarantine operations have been 

completed. 

In contrast, the services that APHIS 

employees will provide at privately 

owned equine quarantine facilities will 

be directly related to conducting import 

quarantine operations and maintaining 

biosecurity for all horses at the facility, 

and are thus properly rendered on 

behalf of the operator of the facility, 

rather than on behalf of a specific 

importer or agent. Therefore, it is 

reasonable that the operator of the 

facility should agree to pay all charges 

for such services. This provision is 

consistent with the standards currently 

in place for temporary, privately owned 

quarantine facilities, which require the 

operator of the facility to bear all 

maintenance and operation costs. 

Finally, it is important to note that 

this rule does not prohibit the operator 

of a privately owned equine quarantine 

facility from passing on the costs of 

APHIS’ services to the importer of 

record or the shipping agent. 

Another commenter asked if pricing 

structures for the services rendered at 

the privately owned facilities will 

correspond to those already in place for 

APHIS-operated quarantine facilities. 

As we mentioned in the proposed 

rule, APHIS will charge for its services 

according to 9 CFR part 130. We will 

not regulate the amount that the 

operators of a facility may charge for 

services that they themselves provide. 

Comments Regarding Location 

Requirements 

In § 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 § 93.303 of the 

regulations, and that the site and the 

specific routes for the movement of 

horses from the port to the site must be 

approved by the Administrator based on 

consideration of whether the site or 

routes would put the horses in a 

position that could result in the 

transmission of communicable diseases 

to domestic horses. In both our 

December 2006 proposal and our July 

2002 proposal, we decided not to 

specify a maximum distance that a 

facility could be located from a port of 

entry. In each proposal, we cited the 

diversity of locations of possible ports of 

entry as a reason for not setting such a 

distance: Some may be located in large 

metropolitan areas, with the nearest 

concentration of livestock many miles 

away, while others may be in towns 

with rural areas and high concentrations 

of livestock within a very short distance 

of the port. 

Two commenters asked that APHIS 

add provisions to specify a maximum 

distance that a quarantine facility can be 

from a port of entry. One of these 

commenters stated that, if a quarantine 

facility were located many miles from a 

port of entry, a horse refused entry at 

one of the quarantine facilities would 

have to be transported a great distance 

before being exported from the United 

States. In the commenter’s estimation, 

transporting a diseased horse for such a 

period of time, even under the most 

stringent biological security measures, 

would pose a substantial risk of disease 

spread through third-party vectors, such 

as flies and gnats. 

We do not consider it possible to set 

a maximum distance that a quarantine 

facility can be located from a port of 

entry. In light of the diversity of places 

in which persons may consider locating 

a permanent facility, and the possibly 

substantive variations among different 

ports of entry, setting specific distances 

may result in regulations that are too 

stringent for some facilities, and too lax 

for others. 

In a similar matter, in our July 2002 

proposal, we proposed to require that 

the facility be located at least one-half 

mile from premises holding livestock or 

horses. In response to a commenter who 

suggested that other requirements in our 

proposal established adequate 

biosecurity to render such a requirement 

unnecessary, we reevaluated the need 

for this requirement, and removed it 

from our December 2006 proposal. 

Instead, we specified that the site would 

have to be approved by the 

Administrator as described above. The 

Administrator will take into 

consideration the proximity of the 

quarantine facility to the nearest port of 

entry, and the disease risks posed by 

transit of an infected horse from the port 

to the facility, in making his or her 

determination whether to approve the 

construction of the facility. 

A commenter on the December 2006 

proposal suggested that mandating a 

minimum distance that a facility can be 

constructed from the surrounding horse 

population greatly reduces the 

likelihood of disease spread to that 

population and the possibility of a 

subsequent equine disease outbreak in 

the vicinity of the facility, and such a 

requirement ought to be included in the 

final rule. 

We have evaluated the biosecurity 

requirements we described in the 

proposed rule, and determined that they 

are adequate to mitigate the possibility 

of disease spread. Therefore, if all other 

procedures described in this rule are 

followed at a private, permanently 

owned quarantine facility, a distance 

requirement is unnecessary. 

We note, however, that we are 

requiring that each application for 

approval of a quarantine facility must 

specify the location and street address 

of the facility. This requirement affords 

the Administrator the opportunity to 

assess the specific risks posed by that 

location, in accordance with paragraph 

(c)(3)(i) of § 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 § 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 § 93.308, proposed paragraph 

(c)(3)(ii) set forth construction 

requirements for permanent, privately 

31588 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

owned horse quarantine facilities. The 

proposed basic standards for the facility 

addressed perimeter fencing, entrances 

and exits, windows, lighting, loading 

docks, surfaces, horse stalls, aisleways, 

isolation stalls, showers, APHIS space, 

necropsy areas, storage space, 

restrooms, ventilation, climate control, 

fire alarms, and communications 

systems. 

Our July 2002 proposed rule included 

several specific construction 

requirements for lot-holding areas. 

These areas, which we defined as ‘‘areas 

within a permanent, privately owned 

quarantine facility in which lots of 

horses are held,’’ would have had 

separate drainage and heating, 

ventilation, air conditioning systems, 

and physical barriers. Our December 

2006 proposed rule retained the 

provisions regarding lot-holding areas, 

but provided more options for operators 

to provide biological security within 

these areas, such as cleaning and 

disinfection after each use of an area. 

One commenter suggested that APHIS 

remove those additional options for 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 EHV–1 mutation in a lot of 

horses at a permanent, APHIS-operated 

quarantine facility as evidence of the 

significant disease risks that may arise 

at a quarantine facility, and suggested 

that the revisions to lot-holding areas set 

forth in our December 2006 proposal 

did not take these risks into adequate 

account. The commenter therefore 

suggested that APHIS reevaluate the 

construction standards proposed for 

these areas in light of the outbreak. 

We are making no change in response 

to this comment. The construction 

standards in the December 2006 

proposal called for physical barriers to 

be erected to separate different lots of 

horses at the facility, so that horses in 

one lot cannot have physical contact 

with horses in another lot, their 

excrement, or their discharges. In 

addition, the sanitary standards in the 

2006 proposal stated that each 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 lot-holding 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 EHV–1 outbreak limited the 

spread of the disease to one lot of 

horses—neither lots in adjacent holding 

areas nor subsequent lots at the 

quarantine facility tested positive for the 

virus. 

Finally, if a disease of horses, whether 

foreign or endemic to the United States, 

spreads within a particular lot of horses, 

the horses in that lot are subject to the 

provisions of paragraph (c)(4)(v)(H) of 

§ 93.308, which sets forth requirements 

regarding the final disposition of horses 

infected with or exposed to a 

communicable disease of horses. 

Another commenter stated that the 

construction requirements presented in 

the December 2006 proposed rule were 

not sufficiently delineated. The 

commenter asserted that, instead of 

creating objective and unilaterally 

binding specifications, APHIS had made 

standards primarily dependent on the 

judgment of APHIS representatives who 

inspect and approve the facility. In the 

commenter’s opinion, this could result 

in wide deviations regarding the 

biological security of various facilities, 

and would necessarily make it difficult 

for a third party to determine the criteria 

by which the representative has 

evaluated a facility. The commenter 

suggested that, at a minimum, the final 

rule provide more detailed criteria for 

the construction of drainage and heating 

systems, ventilation, air conditioning 

systems, physical barriers, and material 

used in the construction of floors and 

walls within the quarantined area. 

We are making no change in response 

to this comment. Our June 2002 

proposed rule contained more specific 

construction criteria for lot-holding 

areas, floor drains, physical barriers, 

showering areas, areas for breaks and 

meals, and heating and ventilation units 

within the facility. In response to those 

proposed requirements, several 

commenters pointed out that some of 

these requirements were more 

restrictive than the design of various 

APHIS-operated facilities. Other 

commenters suggested that we generally 

amend the construction requirements to 

allow operators as many design 

variations as possible. Accordingly, in 

drafting our December 2006 proposal, 

we reevaluated the construction 

requirements that we proposed in 2002 

and determined that, on certain 

occasions, the requirements of our 2002 

proposal were indeed inconsistent with 

those at APHIS-approved facilities. On 

other occasions, we determined that the 

requirements could be adjusted to allow 

operators more options to provide 

adequate biological security at the 

facility. This led us to modify the 

construction requirements mentioned 

by the commenter. 

The APHIS approval process will 

ensure that all permanent, privately 

owned facilities are constructed in a 

manner adequate to prevent the 

transmission of disease between lotholding areas, thus preventing any wide 

deviations with regard to biosecurity. In 

addition, we note that, under paragraph 

(c)(1)(ii)(B) of § 93.308, the 

Administrator may impose additional 

construction requirements within the 

terms of the compliance agreement, 

beyond those specified in the rule, if he 

or she determines these requirements to 

be necessary to prevent the transmission 

of diseases into, within, or from the 

facility. 

Several commenters suggested that 

the construction standards be modified 

to allow or require exercise equipment 

or ‘‘turn-out’’ pens for horses in 

quarantine. Such accommodations, the 

commenters stated, would allow horses 

under quarantine to maintain muscle 

tone and general overall health. 

Allowing a horse under quarantine to 

be separated from its lot and released for 

exercise to an area of the facility outside 

the lot-holding area, whether indoor or 

outdoor, presents an unacceptable risk 

of disease spread. We note, in this 

regard, that horses that are required 

under the regulations to be quarantined 

for extended periods of time after their 

importation often have been imported 

from regions where a communicable 

equine disease is known to exist, or 

from regions that engage in trade with 

such regions and do not require testing 

or vaccination for that disease. 

We recognize, however, that it may be 

possible to place exercise equipment in 

the stalls or in other parts of the lotholding areas, depending on the size or 

construction of such areas. Therefore, 

we have modified proposed paragraph 

(c)(3)(i)(G) of § 93.308, which stated that 

the stalls in which horses are kept 

would have to be large enough to allow 

each animal to make normal postural 

and social adjustments with adequate 

freedom of movement, to further state 

that exercise equipment for horses may 

be kept in the stalls, provided that there 

will still be sufficient space within the 

stall for the horses to move freely once 

the equipment is installed. 

Moreover, the regulations in this final 

rule allow exercise equipment to be kept 

in the lot-holding areas themselves. Any 

such equipment would, however, be 

subject to the cleaning and disinfection 

procedures required for lot-holding 

areas. To clarify this provision, we have 

modified proposed paragraph 

(c)(4)(iv)(D), which contained cleaning 

and disinfection requirements for 

equipment used within the quarantine 

area of the facility, to specify that these 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31589 

requirements also pertain to exercise 

equipment located within the 

quarantine area. 

Comment Regarding Requirements for 

Isolation Stalls 

In § 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 § 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 § 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 

§ 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 

§ 93.308, we set forth personnel 

requirements for permanent, privately 

owned quarantine facilities. Among 

other provisions, these proposed that: 

• The operator of the facility would 

have to provide APHIS with a 

continually updated list of all personnel 

who have access to the facility; and 

• The operator of the facility would 

have to provide APHIS with signed 

statements from every employee and 

any other personnel hired by the 

operator and working at the facility in 

which the person agrees to comply with 

all regulations governing permanent, 

privately owned horse quarantine 

facilities, other applicable provisions of 

9 CFR part 93, all terms of the 

compliance agreement, and any related 

instructions from APHIS representatives 

pertaining to quarantine operations. 

One commenter stated that both the 

list of personnel and the signed 

compliance statements appear to be 

unnecessary, if APHIS representatives 

will be physically present at all times to 

oversee the facility. 

As discussed earlier, APHIS will 

ordinarily only maintain a physical 

presence at and direct supervision of 

import quarantine operations and 

certain technical services related to the 

biological security of the facility. 

Therefore, in order to ensure the general 

biological security of the facility, it is 

important that APHIS representatives 

have a continually updated list of all 

personnel with access to the facility, 

one that takes into consideration 

employee turnover at the facility itself 

and at any company with access to the 

facility. It is also important that all 

personnel agree to adhere to the 

biological security measures set forth 

within the rule and the compliance 

agreement. 

That said, we do recognize that the 

proposed rule could be construed to 

suggest that, although APHIS personnel 

will be physically present at the facility, 

compliance agreements and signed 

statements from personnel must be 

submitted to APHIS employees at an 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 

veterinarian-in-charge office. 

Comments Regarding Showering 

Requirements 

In § 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 

31590 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

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 risk-mitigation 

measures. 

The same commenter stated that 

showering requirements, in themselves, 

do not adequately address the risk of the 

spread of communicable diseases of 

horses, since they do not preclude the 

movement of waste material from a 

quarantined area. 

The rule provides multiple safeguards 

to prevent the movement of waste 

material from the quarantine area. In 

§ 93.308, paragraphs (c)(4)(iv)(A)(3) 

through (5) require that personnel at the 

facility who enter or leave the 

quarantine area must wear protective 

work clothing and footwear upon 

entering the area and must change this 

clothing if it becomes soiled or 

contaminated. Paragraph (c)(4)(iv)(C) 

stipulates that the operator of the 

facility must handle, wash, or dispose of 

this soiled and contaminated clothing in 

accordance with the terms of the 

compliance agreement, and thus in a 

manner approved by the Administrator 

as consistent with the best practices of 

biological security. Paragraphs 

(c)(4)(iv)(D), (E), (F), and (G) establish 

cleaning and disinfection protocols for 

equipment and vehicles used within the 

facility, loading docks, and lot-holding 

areas. Thus, our proposed showering 

requirements were simply one of several 

sanitary practices that the facility would 

have to employ to address, among other 

things, the risk associated with the 

movement of waste material from the 

quarantine area. 

Finally, the commenter asserted that 

the sanitary requirements of the 

proposed rule do not prevent grooms, 

owners, and other personnel who have 

traveled with a diseased horse from its 

country of origin from moving freely 

throughout the United States once they 

have disembarked. The commenter 

suggested that, if such individuals 

became exposed to a communicable 

equine disease, they could spread the 

disease throughout the United States. 

APHIS personnel and employees of 

the Department of Homeland Security’s 

Bureau of Customs and Border 

Protection may inspect individuals, 

their clothing, and their articles at ports 

of entry in order to prevent the 

introduction of a communicable equine 

disease into the domestic equine 

population. 

Comments Regarding Requirements for 

the Handling of Horses Under 

Quarantine 

In § 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 § 93.308, and no horse may be 

added to the lot while the lot is in 

quarantine. 

One commenter objected to the ‘‘all 

in, all out’’ requirement. The commenter 

stated that this requirement is not the 

practice of the one permanent, privately 

owned horse quarantine facility 

currently in operation, and is not 

consistent with the practices employed 

at APHIS-operated quarantine facilities. 

At the privately operated facility, the 

commenter stated, a horse under 

quarantine may be removed from its lot 

if the importer provides evidence that 

the horse has originated from a separate 

premise of origin than other horses in 

the lot. 

It presents a grave risk to the 

biological security of a facility to allow 

horses onsite to be separated from their 

lot before import quarantine operations 

are conducted or while they are still 

ongoing for any reason other than 

diagnostic purposes or disposition of a 

diseased horse. For this reason, we only 

allow horses to be separated from their 

lot at an APHIS-operated facility for the 

purposes of diagnosis or disposition. 

Therefore, the provisions of the 

proposed rule were indeed modeled on 

APHIS’ practices at our facilities. 

However, in reviewing our proposal, 

we have determined that, once import 

quarantine operations are completed, 

these risks are attenuated, and horses 

still at the facility may be separated 

from their lot without a significant risk 

of disease spread. Accordingly, we have 

modified proposed paragraph 

(c)(4)(v)(B) to specify that, once import 

quarantine operations have been 

completed on a lot, but while the lot is 

still at the facility, a horse may be 

removed from that lot. 

Proposed paragraph (c)(4)(v)(C) stated 

that the facility must provide sufficient 

feed and bedding for horses in 

quarantine, and that the feed and 

bedding must be free of vermin and not 

spoiled, and cannot originate from an 

area that we have designated as an area 

quarantined for splenetic or tick fever. 

One commenter agreed that feed and 

bedding should not originate from an 

area quarantined for splenetic or tick 

fever, but suggested that we should also 

prohibit facilities from being 

constructed in those areas. 

We are making no change in response 

to this comment. The initial application 

for approval of a facility must provide 

the location of the proposed facility. 

This is necessary, in part, for the 

Administrator to adequately evaluate 

the disease risks endemic to the area in 

which the facility would be located, and 

the biological security measures that the 

facility would need to adhere to in order 

to adequately respond to these disease 

risks. Approval of the facility is 

contingent on such evaluations. 

Proposed paragraph (c)(4)(v)(D) would 

have prohibited the breeding of horses 

or collection of germplasm from horses 

during the quarantine period, and stated 

that horses in quarantine would be 

subject to tests and procedures as 

directed by an APHIS representative to 

determine whether they are free from 

communicable diseases of horses. 

Two commenters suggested that we 

remove our prohibition on the 

collection of germplasm during the 

quarantine period. One stated that such 

collection is often necessary during 

quarantine operations to aid in the 

differential diagnosis and proper 

treatment of a horse under quarantine. 

Another pointed out that the July 2002 

proposed rule had provided for the 

collection of germplasm during 

quarantine operations, if it was 

necessary for a required import testing 

procedure. This commenter suggested 

that our reason for removing this 

exception from the December 2006 

proposed rule, that no such testing 

procedures are currently required, does 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31591 

not take into account mandatory testing 

requirements for CEM. 

The first commenter provided no 

examples of diseases for which 

germplasm collection is necessary for 

differential diagnosis or treatment, nor 

did the commenter explain under what 

circumstances the efficacy of quarantine 

operations depends on germplasm 

collection. 

We note that germplasm collection is 

not part of APHIS’ required import 

testing procedures for CEM. In 

§ 93.301(e)(3) of the regulations, as part 

of these testing procedures, APHIS does 

require the collecting of specimens from 

the surface of the prepuce, urethral 

sinus, and fossa glandis of stallions 

while the horses are in full erection. 

However, the specimens collected are 

not germplasm, but a bacterial culture 

from the areas. 

There are, therefore, no foreign 

communicable diseases of horses for 

which APHIS considers germplasm 

collection necessary for differential 

diagnosis or proper treatment. 

Proposed paragraph (c)(4)(v)(I) of 

§ 93.308 would have prohibited the 

vaccination of horses in quarantine. 

Several commenters suggested that 

APHIS remove this prohibition. They 

agreed with APHIS that vaccinating a 

horse before serological exams are 

conducted may alter a horse’s immune 

system, affect diagnostic serology, and 

potentially produce inaccurate results. 

However, they suggested that after the 

results of these serological exams have 

been obtained and confirmed, but before 

horses have been released from the 

facility, we should allow the animals to 

be vaccinated, especially for equine 

diseases endemic to the area of the 

United States in which the facility is 

located. 

We agree with these commenters, and 

have therefore modified in this rule 

proposed paragraph (c)(4)(v)(I) to 

provide that, once import quarantine 

operations have been completed on a lot 

at the facility, but while the lot is still 

held at the facility, horses in that lot 

may be vaccinated. 

Miscellaneous 

In our proposal, we proposed to 

define a ‘‘temporary, privately owned 

quarantine facility’’ as ‘‘a facility that 

offers quarantine services for a special 

event and that is owned and operated by 

an entity other than the Federal 

government (also temporary facility).’’ 

In reviewing our proposal, we have 

decided that it may be difficult, in some 

instances, to determine what constitutes 

a special event, and that our intent in 

proposing such a definition was to 

differentiate such temporary facilities 

from permanent facilities by stating that 

the services offered by such facilities are 

not continuous. We have therefore 

changed ‘‘special’’ to ‘‘specific.’’ 

In proposed paragraph (c)(4)(ii)(C), we 

stated that, as part of APHIS’ oversight 

of a privately owned equine quarantine 

facility, the operator of the facility must 

provide APHIS with signed statements 

from each employee and any other 

personnel hired by the operator and 

working at the facility in which the 

person agrees to comply with related 

instructions from APHIS representatives 

pertaining to quarantine operations, 

including contact with animals both 

inside or outside the facility, that are 

issued while the facility is operational. 

Moreover, in proposed paragraph 

(c)(2)(ii)(D), we stated that, in each 

compliance agreement executed by the 

operator of a quarantine facility or his 

or her agent and the Administrator, 

there must be a provision that the 

operator agrees to bar from the facility 

any employee or other personnel who 

fails to comply with these related 

instructions. Finally, in proposed 

paragraph (c)(2)(ii), we stated that the 

compliance agreement would be 

renewed yearly. 

In reviewing our proposal, we have 

determined that these provisions could 

result in a scenario where the 

compliance agreement did not reflect 

related additional instructions issued by 

APHIS representatives while the facility 

is operational, or where these related 

instructions had provided an 

amendment to, interpretation of, or 

redaction of the compliance agreement. 

Moreover, depending on the date of 

issuance of these instructions, it could 

be several months before the 

compliance agreement was updated 

during the renewal process to reflect 

these changes. In such a scenario, the 

operator of the facility could be 

compelled to bar employees or 

personnel from the facility for noncompliance with instructions issued by 

APHIS representatives while the facility 

was operational without knowledge of 

the exact provisions of these 

instructions. 

Therefore, we have added an 

additional provision to the requirements 

for each compliance agreement: The 

operator of the facility will allow APHIS 

to amend the compliance agreement at 

any time after approval of the facility in 

order to incorporate related instructions 

issued by APHIS representatives while 

the facility is operational. This 

provision is paragraph (c)(2)(ii)(G) 

§ 93.308 in this final rule. APHIS will 

contact the operator or his or her agent 

each time the compliance agreement 

needs to be so amended. 

In proposed paragraph (c)(4)(v)(H) of 

§ 93.308, we stated that, if a horse were 

determined to be infected with or 

exposed to a communicable disease of 

horses, arrangements for the final 

disposition of the horse would have to 

be accomplished within 10 days of the 

date the importer is notified by an 

APHIS representative that the horse has 

been refused entry into the United 

States. 

In reviewing our proposal, we have 

determined that this paragraph could be 

interpreted as stating that infection with 

or exposure to any communicable 

disease of horses will result in a horse 

in quarantine being euthanized or 

refused entry to the United States. This 

is not the case. Only infection with or 

exposure to a Federally regulated 

disease of horses will result in such 

disposition. We have therefore amended 

the paragraph by removing the word 

‘‘communicable’’ and adding ‘‘Federally 

regulated’’ in its place. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been reviewed under 

Executive Order 12866. The rule has 

been determined to be significant for the 

purposes of Executive Order 12866 and, 

therefore, has been reviewed by the 

Office of Management and Budget. 

We have prepared an economic 

analysis for this final rule, which is set 

out below. It includes a final regulatory 

flexibility analysis, in accordance with 

5 U.S.C. 604, regarding the probable 

economic impact of this rule on small 

entities and a cost-benefit analysis, in 

accordance with Executive Order 12866. 

Under the AHPA, specifically 7 U.S.C. 

8303, the Secretary of Agriculture is 

authorized to promulgate regulations 

requiring that any animal imported or 

entered into the United States be raised 

or handled under post-importation 

quarantine conditions by or under the 

supervision of the Secretary for the 

purpose of determining whether the 

animal is or may be affected by any pest 

or disease of livestock. 

This rule establishes standards for the 

approval of permanent, privately owned 

quarantine facilities for horses. We are 

taking this action because regional and 

seasonal demand for quarantine services 

for horses often exceeds the space 

available at existing facilities. Such 

privately owned facilities, if constructed 

and operated using the proper 

safeguards, will provide an effective and 

efficient means of bringing horses into 

31592 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

3Source: The American Horse Council. Found at 

http://www.horsecouncil.org/statistics. 

4This does not include horses from Mexico. 

Under the regulations in 9 CFR part 93, these horses 

are subject to quarantine but may be quarantined 

either at one of the permanent equine quarantine 

facilities in the United States or at a facility located 

at a border port in Mexico. 

5 In accordance with 9 CFR part 130, services 

performed outside an APHIS employee’s normal 

tour of duty, Monday through Saturday, cost $100/ 

hour, and, on Sunday and holidays, $112/hour. 

the United States without compromising 

our ability to protect against the 

introduction of communicable diseases 

of horses. 

Costs and Benefits Associated With 

This Rule 

The horse industry in the United 

States contributes $39 billion annually 

to the U.S. gross domestic product via 

direct spending, and it supports 1.4 

million full-time equivalent jobs. The 

horse industry pays approximately $1.9 

billion in taxes annually to all levels of 

government. Approximately 1.96 

million people own the estimated 9.2 

million horses in the United States.3

In the last 20 years, as the level of 

trade between the equine industry in the 

United States and that in other countries 

has risen, the number of horses 

imported into the United States and 

subject to quarantine has likewise 

increased. This, in turn, has led to an 

increased demand for the resources 

provided by import quarantine facilities. 

In some cases, the demand for 

quarantine services for horses has 

exceeded the space available at existing 

Federal facilities. 

From 2003 through 2007, the annual 

average number of equines imported 

into the United States originating in 

countries for which quarantine is 

required at the port of entry was about 

7,500 (see table 1).4 This represents an 

increase of more than 225 percent over 

the annual average for 1990 through 

1994, which was about 2,300 horses per 

year. 

TABLE 1—U.S. EQUINE IMPORTS FROM COUNTRIES FOR WHICH QUARANTINE IS REQUIRED, 2003–2007, NUMBER OF

HEAD

Country 2003 2004 2005 2006 2007 

The Netherlands .................................................................. 2,176 2,810 3,035 2,920 2,600 

Germany .............................................................................. 1,424 1,285 1,345 1,630 1,517 

Argentina .............................................................................. 683 771 869 741 786 

United Kingdom ................................................................... 587 630 640 614 529 

Other countries .................................................................... 2,270 2,036 1,956 1,746 1,691 

The establishment of standards for the 

approval and operation of permanent, 

privately owned quarantine facilities for 

horses has the potential to make the 

import process easier and timelier while 

simultaneously protecting against the 

introduction of communicable diseases 

of horses. This will provide a clear 

benefit to importers when demand for 

quarantine services surpasses the 

number of spaces available at APHIS’ 

Federal facilities. In addition, the 

geographic distribution of the currently 

operating horse quarantine facilities can 

make it difficult or costly to import 

horses to some areas; in some 

geographically isolated locations, such 

as Hawaii and Puerto Rico, no facilities 

for quarantining imported horses exist, 

reducing the ability of importers to 

profitably bring horses into those areas. 

Because of their nature and size, 

temporary facilities are not always able 

to meet these demands. The 

construction of additional permanent, 

privately owned equine quarantine 

facilities could remove or attenuate 

some of those difficulties and thus 

facilitate imports to those areas. 

The implementation of this rule will 

likely require upgrades at the one 

permanent, privately owned equine 

quarantine facility in operation. In 

addition, when a facility is approved for 

operation under these regulations, it 

will incur the cost of any needed 

renovations to the facility as well as the 

costs associated with being in 

compliance with the regulations. We 

expect one or two such facilities to be 

approved and open in the years 

immediately following implementation 

of this rule. 

The rule sets forth requirements for 

the physical structure of permanent, 

privately owned horse quarantine 

facilities. These include basic standards 

for the facility for perimeter fencing, 

entrances and exits, windows, lighting, 

loading docks, surfaces, horse stalls, 

aisleways, isolation stalls, showers, 

APHIS space, necropsy areas, storage 

space, restrooms, ventilation, climate 

control, fire alarms, and communication 

systems. The rule also sets forth the type 

of services that APHIS employees will 

provide at a privately owned equine 

quarantine facility. These services 

include overseeing the conduct of 

import quarantine operations and 

maintaining biosecurity at the facility. 

Necessary upgrades to the physical 

structure of the permanent, privately 

owned horse quarantine facility 

currently in operation, as well as 

additional APHIS supervision of 

operations at that facility, will likely 

result in an increase in costs for the 

facility. Similar costs are likely to be 

borne by future privately owned equine 

quarantine facilities. The fees that 

APHIS assesses related to import 

quarantine operations and maintaining 

biosecurity at a private facility will be 

charged to the operator of the facility. 

Fees for services rendered directly on 

behalf of the importer or shipping agent, 

such as meeting the importer or agent at 

the port of entry in order to facilitate 

transportation of the animal to the 

quarantine facility, or drawing blood for 

routine serological tests once import 

quarantine operations have been 

completed, are charged directly to the 

importer or agent. These distinctions in 

fee assessments will continue. 

It has been estimated that, on average, 

this rule will add 2 to 3 hours per 

workday for additional APHIS 

supervision at the one current 

permanent, privately owned quarantine 

facility. Based on this estimate, the 

facility could expect to be billed for 

between 520 and 780 additional hours 

of APHIS supervision annually as a 

result of the rule. At the normal rate of 

$84/hour, this will be an annual cost of 

between $43,680 and $65,520.5 We 

expect that some additional onsite 

supervision will be needed during an 

initial evaluation phase for other aspects 

of import quarantine operations, which 

will be reduced to spot checks over 

time. As such, the cost associated with 

APHIS onsite supervision will be higher 

initially, and then decline. 

The new requirements may also alter 

the type of horses that move through the 

one current permanent, privately owned 

horse quarantine facility. The 

importation of horses intended for 

resale at low margins may decline if the 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31593 

6Consumer surplus is the difference between the 

amount a consumer is willing to pay for a good and 

the amount actually paid. Producer surplus is the 

amount a seller is paid for the good less the seller’s 

cost. 

cost of quarantine at the facility 

increases. These horses constitute a 

large portion of the current imports at 

this quarantine facility. Any reduction 

of this type of import through the 

facility as a result of increased 

quarantine fees will negatively affect 

revenues at the facility to the extent 

they are not replaced by other classes of 

imported horses. 

However, a significant portion of the 

horses imported annually into the 

United States must go through 

quarantine, and this rule will not alter 

those requirements. Imports of horses 

from countries requiring quarantine 

have increased more than 225 percent 

since 1990, but there are still only three 

permanent quarantine facilities 

operating in the United States: Two 

Federal facilities, and one private one. 

Moreover, as we mentioned above, 

demand for quarantine services for 

horses often exceeds the space available 

at the existing Federal facilities. The 

cost of providing quarantine services at 

the private facility should be similar to 

providing the same services at a Federal 

facility. In addition, this facility is the 

only permanent horse quarantine 

facility located on the west coast, 

making it an appealing alternative to 

quarantine in a Federal facility for horse 

imports arriving in the Western United 

States. 

Additional costs incurred at the 

private facility because of this rule can 

most likely be passed on to importers 

who elect to use the facility to 

quarantine imported horses, at least in 

the short run, given the limited space at 

Federal horse quarantine facilities and 

the fact that there are no other 

permanent, privately owned quarantine 

facilities operating at this time. Over the 

long term, the impact of the rule on the 

facility is less certain, given the 

possibility of additional—and 

potentially competing—quarantine 

facilities opening in the future. The 

effect of implementation of this rule on 

the facility’s business volume and 

revenue is uncertain. However, the fact 

that only one or two additional 

permanent, privately owned quarantine 

facilities are expected to open in the 

next several years suggests that these 

effects will be limited, even in the long 

run. 

It is not possible to predict the 

number of additional horses that might 

be imported into the United States as a 

result of this rule. Nevertheless, any 

increase in horse imports that the rule 

may facilitate should yield net benefits. 

This is because trade of a commodity 

generally increases social welfare. To 

the extent that consumer choice is 

broadened and the increased supply of 

the imported commodity leads to a price 

decline, gains in consumer surplus will 

outweigh losses in domestic producer 

surplus.6 Although the rule’s impact on 

domestic producers is uncertain, it is 

expected to provide benefits to 

consumers (domestic importers, 

brokers) that will exceed any potential 

losses to domestic producers. The net 

welfare effect for the United States of 

increased horse imports will be positive. 

However, because the rule is expected 

to result in only one or two additional 

permanent, privately owned quarantine 

facilities over the next several years, the 

expected benefits are likely to be small. 

Final Regulatory Flexibility Analysis 

The Regulatory Flexibility Act 

requires agencies to evaluate the 

potential effects of their proposed and 

final rules on small business, small 

organizations, and small governmental 

jurisdictions. Section 604 of the Act 

requires agencies to prepare and make 

available to the public a final regulatory 

flexibility analysis (FRFA) describing 

any changes made to the rule as a result 

of comments received and the steps the 

agency has taken to minimize any 

significant economic impacts on small 

entities. Section 604(a) of the Act 

specifies the content of a FRFA. In this 

section, we address these FRFA 

requirements. 

Objectives and Need for the Rule 

Demand for quarantine services for 

horses often exceeds the space available 

at existing Federal facilities. In addition, 

the geographic distribution of the 

currently operating horse quarantine 

facilities can make it difficult or costly 

to import horses to some areas; in some 

geographically isolated locations, such 

as Hawaii and Puerto Rico, no facilities 

for quarantining imported horses exist, 

reducing the ability of importers to 

profitably bring horses into those States. 

Finally, temporary, privately owned 

quarantine facilities cannot always meet 

the demand for quarantine services, 

because such facilities are established, 

approved, and operated by importers on 

a temporary basis to handle horses 

imported for a unique importation, race, 

or show. 

This final rule will establish 

standards for the approval of 

permanent, privately owned horse 

quarantine facilities. Such facilities, if 

constructed and operated using the 

proper safeguards, will provide an 

effective and efficient means of bringing 

horses into the United States without 

compromising our ability to protect 

against the introduction of 

communicable diseases of horses. 

Summary of Significant Issues Raised 

by Commenters 

In our proposal, we invited comments 

about expected impacts of the rule on 

small entities. We particularly asked for 

estimates of compliance costs and 

impacts on revenue for the one 

permanent, privately owned equine 

quarantine facility currently in 

operation. 

One commenter suggested that 

APHIS’ basis for rulemaking, that 

nationwide demand for such permanent 

quarantine facilities currently outpaces 

supply, is erroneous. The commenter 

cited the decreasing number of horses 

quarantined between 2004 and 2006 at 

the one permanent, privately owned 

horse quarantine facility currently in 

operation: In 2004, this facility 

quarantined approximately 2,500 

horses, whereas in 2006 the facility 

quarantined 2,238 horses. 

Since we issued the proposed rule, 

the number of horses imported yearly 

into the United States and subject to 

quarantine has decreased slightly. 

However, from 2003 through 2007, the 

annual average number of equines 

imported into the United States that 

originated from countries for which 

post-importation quarantine is required 

was nearly 7,500. This represents an 

increase of more than 225 percent from 

the annual average for 1990 through 

1994, which was about 2,300 horses per 

year. Moreover, in our proposal, we did 

not cite yearly importation trends as our 

sole basis for proposing standards for 

privately owned equine quarantine 

facilities. Rather, we also cited the 

limited space at our existing Federal 

facilities, a demand for quarantine 

services that often exceeds the spaces 

available, and the inability of 

temporary, privately owned equine 

quarantine facilities to fill the continual 

demand for quarantine services. 

As several commenters on our 

proposal pointed out, even with the 

recent decrease in the number of horses 

imported yearly into the United States, 

seasonal and regional demand for 

quarantine services still often surpasses 

the number of spaces available at our 

Federal facilities. Moreover, because of 

their nature and size, temporary 

facilities are not always able to meet this 

demand. Therefore, we have determined 

that the need for permanent, privately 

owned equine quarantine facilities still 

remains. 

Several commenters suggested that 

the proposed rule could be construed to 

31594 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

mean that APHIS representatives must 

be present to supervise and staff the 

facility at all hours, or that the facility 

can only operate while APHIS 

representatives are physically present to 

supervise its operations. Either 

interpretation, these commenters stated, 

would have a direct, substantive, and 

detrimental economic impact on all 

permanent, privately owned equine 

quarantine facilities, in general, and the 

one such facility currently in operation, 

in particular. One of the commenters 

stated that APHIS oversight would cost 

this facility approximately $360,000 

annually. 

The amount submitted by the 

commenter could be construed to 

suggest that the facility does not 

currently pay for APHIS’ services. This 

is not the case; in fact, the facility has 

always paid for APHIS’ oversight of 

import quarantine operations. 

It is true that this rule will add an 

additional annual cost to the facility, 

beyond those costs already assumed for 

our services. However, as we mentioned 

earlier, we expect the additional annual 

cost to be no greater than $65,520. 

Finally, we have clarified the nature 

of APHIS oversight to make more 

explicit those occasions when we will 

be present at the facility and charge for 

our monitoring of certain activities. In 

light of these clarifications, we find the 

estimate submitted by the commenter, 

irrespective of current costs, to be high. 

One commenter suggested that 

meeting certain of the proposed 

construction requirements would 

reduce the overall capacity of the one 

currently operating permanent, 

privately owned facility, would reduce 

its flexibility in providing quarantine 

services, and could eliminate the 

facility’s ability to quarantine 

ruminants. 

We received no information from the 

commenter regarding the potential cost 

of the upgrades necessary to bring this 

facility into compliance with the 

construction requirements of the 

proposed rule, or the amount of revenue 

the facility would stand to lose because 

of adherence to these requirements. In 

the absence of itemized expenditures, 

an estimate of lost yearly revenue, or an 

estimated total cost, it is difficult to 

assess the impact of these requirements 

on the facility. 

Moreover, we consider the 

construction requirements that we are 

finalizing in this rule to be necessary in 

order to promote the biological security 

of any permanent, privately owned 

equine quarantine facility. In addition, 

as we mentioned above in the section 

titled ‘‘Comments Regarding 

Construction Requirements,’’ we have 

made most of these requirements 

performance-based in order to provide 

facilities with a degree of flexibility in 

meeting them. 

The same commenter stated that the 

operator of the one permanent, privately 

owned quarantine facility currently in 

operation also acts as a broker. The 

commenter pointed out that, under the 

provisions of the rule, the operator 

would no longer be able to act as a 

broker, and cited this among the reasons 

why the rule, if finalized, would have 

an adverse economic impact on that 

operator. 

We received no information from the 

commenter regarding the revenue that 

the operator currently generates as a 

broker, or estimated losses that the 

operator expected to incur by no longer 

acting as a broker. Without such 

information, we cannot assess the 

economic impact that these provisions 

will have on the operator. 

We proposed to require that each 

facility would have to have a supply of 

potable water adequate to meet all 

watering and cleaning needs. 

A commenter stated that, in order to 

comply with this standard, the one 

permanent, privately owned equine 

quarantine facility in operation would 

have to install automatic water bowls 

for all horses in quarantine. 

The commenter suggests one means 

by which that facility could meet this 

requirement. There are, however, other 

means by which the facility could 

secure a supply of potable water that 

would not require the installation of 

such bowls or any other modifications 

to existing structures at the facility. 

Description and Estimate of Small 

Entities 

We have identified two types of small 

entities that could be affected by the 

implementation of this rule: The 

existing permanent, privately owned 

quarantine facility and horse importers 

and owners. 

According to the Small Business 

Administration (SBA) criteria, a horse 

quarantine facility is considered a small 

entity if it has annual revenues of $6 

million or less. The existing permanent, 

privately owned quarantine facility that 

operates in Los Angeles is believed to be 

a small entity. According to SBA 

criteria, a farm that keeps horses for 

breeding and has annual revenues of 

$750,000 or less is considered a small 

entity. According to the most recent 

Census of Agriculture data, average perfarm revenue for all U.S. equine farms 

in 2002 was $7,158, an indication that 

these farms are by and large small 

entities. 

The establishment of standards for the 

approval and operation of permanent, 

privately owned quarantine facilities for 

horses has the potential to make the 

import process easier and timelier while 

simultaneously protecting against the 

introduction of communicable diseases 

of horses. This will provide a clear 

benefit to importers when seasonal or 

regional demand for quarantine 

facilities surpasses the number of spaces 

available at our Federal facilities. In 

addition, the geographic distribution of 

equine quarantine facilities, which 

currently makes it difficult or costly to 

import horses to some areas, may 

change with the construction of more 

quarantine facilities throughout the 

United States. 

On the other hand, importers may be 

subject to higher fees and charges at the 

current permanent, privately owned 

equine quarantine facility. This is 

because the implementation of this rule 

will likely require upgrades at that 

facility. Moreover, if another quarantine 

facility is approved for operation under 

these regulations (e.g., if a ruminant 

quarantine facility seeks approval to 

begin to quarantine imported horses), it 

will incur the cost of any renovations 

needed to establish adherence to the 

construction requirements, as well as 

the costs associated with maintaining 

compliance with the regulations. 

This rule sets forth requirements for 

the physical structure of permanent, 

privately owned equine quarantine 

facilities. The rule also sets forth the 

type of services that APHIS employees 

will provide at a privately owned 

equine quarantine facility: Overseeing 

the conduct of import quarantine 

operations and maintaining biosecurity 

at the facility. Necessary upgrades to the 

physical structure of the currently 

operating privately owned horse 

quarantine facility and additional 

APHIS supervision of operations at that 

facility will likely result in an increase 

in costs at the facility. The fees that 

APHIS assesses related to import 

quarantine operations and maintaining 

biosecurity at a private facility will be 

charged to the operator of the facility. 

Similar costs are likely to be borne by 

any other privately owned horse 

quarantine facilities that begin 

operations in the future. 

Additional costs incurred at the 

private facility will most likely be 

passed on to importers of horses who 

elect to use the facility to quarantine 

imported horses, at least in the short 

run, given the limited space at APHISoperated horse quarantine facilities, the 

fact that there are no other permanent, 

privately owned quarantine facilities 

operating at this time, and the fact that 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31595 

quarantines are mandatory for 

significant classes of imported horses. If 

the low-margin horse imports that pass 

through the permanent, privately owned 

quarantine facility decline because of 

increased quarantine fees, and those 

imports are not replaced by other 

classes of imported horses, however, 

revenues at the facility could be 

negatively affected. Over the long term, 

the possibility of additional—and, 

potentially, competing—quarantine 

facilities opening in the future creates 

more uncertainty regarding the effects of 

this rule on the facility. The effect of the 

rule on the facility’s business volume 

and revenue is uncertain. However, it is 

likely that, following implementation of 

this rule, only one or two additional 

permanent, privately owned quarantine 

facilities will open in the next several 

years. This suggests that these effects 

will be limited, even in the long run. 

It is not possible to predict the 

number of additional horses that might 

be imported into the United States as a 

result of this rule. Nevertheless, any 

increase in horse imports that the rule 

may facilitate should yield net benefits. 

This is because trade of a commodity 

generally increases social welfare. To 

the extent that consumer choice is 

broadened and the increased supply of 

the imported commodity leads to a price 

decline, gains in consumer surplus will 

outweigh losses in domestic producer 

surplus. Although the rule’s impact on 

domestic producers is uncertain, it is 

expected to provide benefits to 

consumers (domestic importers, 

brokers) that will exceed any potential 

losses to domestic producers. The net 

welfare effect for the United States of 

increased horse imports will be positive. 

However, because the rule will likely 

result in only one or two additional 

permanent, privately owned quarantine 

facilities over the next several years, the 

expected benefits are likely to be small. 

Description and Estimate of 

Compliance Requirements 

This rule establishes various 

information collection and 

recordkeeping requirements for the 

operators of permanent, privately 

owned equine quarantine facilities. A 

description of the requirements 

associated with the rule was presented 

in the proposal under the heading 

‘‘Paperwork Reduction Act.’’ 

Alternatives Considered 

This rule establishes standards for the 

approval of permanent, privately owned 

quarantine facilities for horses. 

Alternatives to the rule would have 

been to either leave the regulations 

unchanged, or to require a different set 

of standards than those being 

implemented in this rule. Leaving the 

regulations unchanged would be 

unsatisfactory, because it would 

perpetuate the current situation, i.e., 

one which does not facilitate the 

importation of horses or address the 

disease risks associated with such 

importation in as timely and quick a 

manner as possible. 

APHIS considers the set of standards 

implemented by this rule to be the 

minimum necessary to accomplish the 

rule’s objectives. In this regard, we have 

made substantive changes to several of 

the provisions of our proposal that we 

expect to reduce the compliance costs 

associated with this rulemaking. In 

particular, we have decided that several 

of a permanent, privately owned equine 

quarantine facility’s operating 

procedures—the routine cleaning and 

maintenance of the facility, the daily 

care of animals in quarantine, the 

disposal of wastes at the facility, the 

cleaning and disinfection procedures 

employed by the facility, the handling, 

washing, and disposal of soiled and 

contaminated clothing worn within the 

facility, and the incineration of dead 

horses, whether onsite or offsite—will 

not ordinarily need APHIS’ direct 

supervision or physical presence. 

Description of Steps Taken To 

Minimize Significant Economic Impacts 

on Small Entities 

In our proposal, we solicited 

comments regarding how the rule could 

be modified to reduce expected impacts 

on small entities. While no commenters 

cited this request in providing their 

responses, as we mentioned above, 

several commenters asked us to clarify 

the nature of APHIS oversight required 

by the proposal, and to reevaluate the 

need for ongoing and direct APHIS 

oversight of several operations at the 

facility: Cleaning and disinfection 

procedures and incineration activities. 

In response to these comments, we have 

decided that these operations, as well as 

maintenance of the facility, the daily 

care of horses under quarantine, the 

disposal of wastes at the facility, and the 

handling, washing, and disposal of 

soiled and contaminated clothing at the 

facility, will not ordinarily require our 

direct presence and/or continual 

oversight. We expect that this change 

from the terms of the proposal will 

lessen the economic impact of this rule 

on small entities. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 301 et 

seq.), the information collection or 

recordkeeping requirements included in 

this rule have been approved by the 

Office of Management and Budget 

(OMB) under OMB control number 

0579–0313. 

E-Government Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

List of Subjects in 9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 

■ Accordingly, we are amending 9 CFR 

part 93 as follows: 

PART 93—IMPORTATION OF CERTAIN 

ANIMALS, BIRDS, FISH, AND 

POULTRY, AND CERTAIN ANIMAL, 

BIRD, AND POULTRY PRODUCTS; 

REQUIREMENTS FOR MEANS OF 

CONVEYANCE AND SHIPPING 

CONTAINERS 

■ 1. The authority citation for part 93 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

■ 2. Section 93.300 is amended by 

revising the definition for Operator and 

by adding, in alphabetical order, new 

definitions of Lot, Lot-holding area, 

Nonquarantine area, Permanent, 

privately owned quarantine facility, 

Quarantine area, and Temporary, 

privately owned quarantine facility to 

read as follows: 

§ 93.300 Definitions. 

* * * * * 

Lot. A group of horses that, while held 

on a premises or conveyance, have had 

opportunity for physical contact with 

other horses in the group or with their 

excrement or discharges at any time 

31596 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

14The name and the address of the Veterinarian 

in Charge in any State is available from APHIS, 

Veterinary Services, National Center for Import and 

Export, 4700 River Road Unit 39, Riverdale, MD 

20737–1231. 

during their shipment to the United 

States. 

Lot-holding area. That area in a 

permanent, privately owned quarantine 

facility in which a single lot of horses 

is held at one time. 

Nonquarantine area. That area in a 

permanent, privately owned quarantine 

facility that includes offices, storage 

areas, and other areas outside the 

quarantine area, and that is off limits to 

horses, samples taken from horses, and 

any other objects or substances that 

have been in the quarantine area during 

the quarantine of horses. 

Operator. A person other than the 

Federal Government who owns or 

manages and has responsibility for the 

services provided by a temporary, 

privately owned quarantine facility or a 

permanent, privately owned quarantine 

facility. 

Permanent, privately owned 

quarantine facility. A facility that offers 

quarantine services for horses to the 

general public on a continuing basis and 

that is owned and operated by an entity 

other than the Federal Government (also 

permanent facility). 

* * * * * 

Quarantine area. That area in a 

permanent, privately owned quarantine 

facility that comprises all of the lotholding areas in the facility, and any 

other areas in the facility that horses 

have access to, including loading docks 

for receiving and releasing horses, and 

any areas used to conduct examinations 

of horses and take samples and where 

samples are processed or examined. 

* * * * * 

Temporary, privately owned 

quarantine facility. A facility that offers 

quarantine services for horses imported 

for a specific event and that is owned 

and operated by an entity other than the 

Federal Government (also temporary 

facility). 

* * * * * 

■ 3. Section 93.303 is amended as 

follows: 

■ a. By revising the heading of 

paragraph (e) to read as set forth below. 

■ b. In paragraph (e), by removing the 

words ‘‘provided by the importer’’ and 

by adding the words ‘‘privately owned’’ 

before the word ‘‘quarantine’’. 

§ 93.303 Ports designated for the 

importation of horses. 

* * * * * 

(e) Ports for horses to be quarantined 

at privately owned quarantine facilities. 

* * * 

* * * * * 

§ 93.304 [Amended] 

■ 4. Section 93.304 is amended as 

follows: 

■ a. In paragraph (a)(1)(i), first sentence, 

by removing the words ‘‘quarantine 

facility provided by the importer’’ and 

adding the words ‘‘privately owned 

quarantine facility’’ in their place. 

■ b. In paragraph (a)(2), by removing the 

words ‘‘of the regulations, horses 

intended for quarantine at a quarantine 

facility provided by the importer’’, and 

by adding the words ‘‘or horses 

intended for quarantine at a privately 

owned quarantine facility’’ in their 

place. 

■ 5. Section 93.308 is amended as 

follows: 

■ a. In paragraph (a)(3), by redesignating 

footnote 14 as footnote 13. 

■ b. By revising paragraphs (b) and (c) 

to read as set forth below. 

■ c. By adding an OMB citation at the 

end of the section to read as set forth 

below. 

§ 93.308 Quarantine requirements. 

* * * * * 

(b) Temporary, privately owned 

quarantine facilities. Horses presented 

for entry into the United States as 

provided in § 93.303(e) may be 

quarantined in temporary, privately 

owned quarantine facilities that meet 

the requirements of paragraphs (b)(1) 

and (b)(2) of this section and that have 

been approved by the Administrator for 

a specific importation. 

(1) Approval. Requests for approval 

and plans for proposed temporary 

facilities must be submitted no less than 

15 days before the proposed date of 

entry of horses into the facility to 

APHIS, Veterinary Services, National 

Center for Import and Export, 4700 

River Road Unit 39, Riverdale, MD 

20737–1231. Before facility approval 

can be granted, a veterinary medical 

officer of APHIS must inspect the 

facility to determine whether it 

complies with the standards set forth in 

this section: Provided, however, that 

approval of any temporary facility and 

use of such facility will be contingent 

upon a determination made by the 

Administrator that adequate personnel 

are available to provide required 

services at the facility. Approval of any 

facility may be refused and approval of 

any quarantine facility may be 

withdrawn at any time by the 

Administrator, upon his or her 

determination that any requirements of 

this section are not being met. Before 

such action is taken, the operator of the 

facility will be informed of the reasons 

for the proposed action by the 

Administrator and afforded an 

opportunity to present his or her views. 

If there is a conflict as to any material 

fact, a hearing will be held to resolve the 

conflict. The cost of the facility and all 

maintenance and operational costs of 

the facility will be borne by the 

operator. 

(2) Standards and handling 

procedures. The facility must be 

maintained and operated in accordance 

with the following standards: 

(i) Inspection. Inspection and 

quarantine services must be arranged by 

the operator or his or her agent with the 

APHIS Veterinarian in Charge for the 

State in which the approved facility is 

located 14 no less than 7 days before the 

proposed date of entry of the horses into 

the quarantine facility. 

(ii) Physical plant requirements. 

(A) The facility must be located and 

constructed to prevent horses from 

having physical contact with animals 

outside the facility. 

(B) The facility must be constructed 

only with materials that can withstand 

repeated cleaning and disinfection. 

Disinfectants authorized in 9 CFR part 

71 must be used. All walls, floors, and 

ceilings must be constructed of solid 

material that is impervious to moisture. 

Doors, windows, and other openings of 

the facility must be provided with 

double screens that will prevent insects 

from entering the facility. 

(iii) Sanitation and security. 

(A) The operator of the facility must 

arrange for a supply of water adequate 

to clean and disinfect the facility. 

(B) All feed and bedding must 

originate from an area not under 

quarantine because of splenetic or tick 

fever (see part 72 of this chapter) and 

must be stored within the facility. 

(C) Upon the death of any horse, the 

operator must arrange for the disposal of 

the horse’s carcass by incineration. 

Disposal of all other waste removed 

from the facility during the time the 

horses are in quarantine or from horses 

that are refused entry into the United 

States must be either by incineration or 

in a public sewer system that meets all 

applicable environmental quality 

control standards. Following 

completion of the quarantine period and 

the release of the horses into the United 

States, all waste may be removed from 

the quarantine facility without further 

restriction. 

(D) The facility must be maintained 

and operated in accordance with any 

additional requirements the 

Administrator deems appropriate to 

prevent the dissemination of any 

communicable disease. 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31597 

15The name and address of the Veterinarian in 

Charge in any State is available from APHIS, 

Veterinary Services, National Center for Import and 

Export, 4700 River Road Unit 39, Riverdale, MD 

20737–1231. 

(E) The facility must comply with all 

applicable local, State, and Federal 

requirements for environmental quality. 

(iv) Personnel. 

(A) Access to the facility will be 

granted only to persons working at the 

facility or to persons specifically 

granted such access by an APHIS 

representative. 

(B) The operator must provide 

attendants for the care and feeding of 

horses while in the quarantine facility. 

(C) Persons working in the quarantine 

facility may not come in contact with 

any horses outside the quarantine 

facility during the quarantine period for 

any horses in the facility. 

(v) Handling of horses in quarantine. 

Horses offered for importation into the 

United States that are quarantined in an 

approved temporary facility must be 

handled in accordance with paragraph 

(a) of this section while in quarantine. 

(c) Permanent, privately owned 

quarantine facilities. Horses presented 

for entry into the United States as 

provided in § 93.303(e) may be 

quarantined in permanent, privately 

owned quarantine facilities approved by 

the Administrator as meeting the 

requirements of paragraphs (c)(1) 

through (c)(6) of this section. 

(1) APHIS approval. 

(i) Approval procedures. Persons 

seeking APHIS approval of a permanent, 

privately owned quarantine facility 

must write to the Administrator, c/o 

National Center for Import and Export, 

Veterinary Services, APHIS, 4700 River 

Road Unit 39, Riverdale, MD 20737– 

1231. The application letter must 

include the full name and mailing 

address of the applicant; the location 

and street address of the facility for 

which approval is sought; blueprints of 

the facility; a description of the 

financial resources available for 

construction, operation, and 

maintenance of the facility; the 

anticipated source or origin of horses to 

be quarantined, as well as the expected 

size and frequency of shipments; a 

contingency plan for horses needing 

emergency veterinary care; and a 

contingency plan for the disposal of all 

the horses capable of being housed in 

the facility. 

(A) If APHIS determines that an 

application is complete and merits 

further consideration, the person 

applying for facility approval must enter 

into a service agreement with APHIS 

wherein the applicant agrees to pay the 

cost of all APHIS services associated 

with APHIS’ evaluation of the 

application and facility. APHIS charges 

for the evaluation of the application and 

facility at hourly rates listed in § 130.30 

of this chapter. This service agreement 

applies only to fees accrued during the 

application process. If the facility is 

approved by APHIS, facility owners 

must enter into a compliance agreement 

in accordance with paragraph (c)(2) of 

this section. 

(B) Requests for approval must be 

submitted to APHIS at least 120 days 

prior to the date of application for local 

building permits. Requests for approval 

will be evaluated on a first-come, firstserved basis. 

(ii) Criteria for approval. Before a 

facility may operate as a permanent, 

privately owned quarantine facility for 

horses, it must be approved by APHIS. 

To be approved: 

(A) The facility must meet all of the 

requirements of this section; 

(B) The facility must meet any 

additional requirements that may be 

imposed by the Administrator in each 

specific case, as specified in the 

compliance agreement required under 

paragraph (c)(2) of this section, to 

ensure that the quarantine of horses in 

the facility will be adequate to 

determine their health status, as well as 

to prevent the transmission of diseases 

into, within, and from the facility; and 

(C) The Administrator must determine 

that sufficient personnel, including one 

or more APHIS veterinarians and other 

professional, technical, and support 

personnel, are available to serve as 

APHIS representatives at the facility. If 

the facility is approved, APHIS 

representatives will be present at all 

import quarantine operations in order to 

monitor them and will be present in 

order to provide other technical services 

to ensure the biological security of the 

facility, including, but not limited to, 

those specified in paragraph (c)(4)(v)(H) 

of § 93.308. The Administrator’s 

determination will be based on the 

expected size and frequency of 

shipments to the facility, as described in 

the application for approval of a 

permanent facility, as well as any other 

pertinent information in the application. 

APHIS will assign personnel to facilities 

requesting approval in the order that the 

facilities are approved. The 

Administrator has sole discretion on the 

number of APHIS personnel to be 

assigned to the facility. 

(iii) Maintaining approval. To 

maintain APHIS approval, the operator 

must continue to comply with all the 

requirements of paragraph (c) of this 

section and the terms of the compliance 

agreement executed in accordance with 

paragraph (c)(2) of this section. 

(iv) Denial or withdrawal of approval. 

Approval for a proposed permanent, 

privately owned quarantine facility may 

be denied or approval for a facility 

already in operation may be withdrawn 

at any time by the Administrator for any 

of the reasons provided in paragraph 

(c)(1)(iv)(C) of this section. 

(A) Before facility approval is denied 

or withdrawn, the operator of the 

facility will be informed of the reasons 

for the proposed action by the 

Administrator and afforded an 

opportunity to present his or her views. 

If there is a conflict as to any material 

fact, APHIS will afford the operator, 

upon request, the opportunity for a 

hearing with respect to the merits or 

validity of such action. 

(B) The Administrator may withdraw 

approval of an existing facility prior to 

a final determination in the hearing if 

the Administrator determines that such 

action is necessary to protect animal 

health or the public health, interest, or 

safety. Such withdrawal will be 

effective upon oral or written 

notification, whichever is earlier, to the 

operator of the facility. In the event of 

oral notification, APHIS will promptly 

give written confirmation to the 

operator of the facility. This withdrawal 

will continue in effect pending the 

completion of the hearing and any 

judicial review, unless otherwise 

ordered by the Administrator. In 

addition to withdrawal of approval for 

the reasons provided in paragraph 

(c)(1)(iv)(C) of this section, the 

Administrator will also automatically 

withdraw approval when the operator of 

any approved facility notifies the APHIS 

Veterinarian in Charge for the State in 

which the facility is located, in writing, 

that the facility is no longer in 

operation.15

(C) The Administrator may deny or 

withdraw approval of a permanent, 

privately owned facility if: 

(1) Any requirement of this section or 

the compliance agreement is not 

complied with; or 

(2) The operator fails to remit any 

charges for APHIS services rendered; or 

(3) The operator or a person 

responsibly connected with the business 

of the quarantine facility acts as a paid 

agent (broker) for the importation or 

subsequent sale of horses; or 

(4) The operator or a person 

responsibly connected with the business 

of the quarantine facility is or has been 

found by a court of competent 

jurisdiction to have violated any law or 

regulation pertaining to the importation 

or quarantine of any animal; or 

(5) The operator or a person 

responsibly connected with the business 

of the quarantine facility is or has been 

31598 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

convicted of any crime involving fraud, 

bribery, or extortion or any other crime 

involving a lack of the integrity needed 

for the conduct of operations affecting 

the importation of animals; or 

(6) The approved quarantine facility 

has not been in use to quarantine horses 

for a period of at least 1 year. 

(D) For the purposes of this section, 

a person is deemed to be responsibly 

connected with the business of the 

quarantine facility if such person has an 

ownership, mortgage, or lease interest in 

the facility’s physical plant, or if such 

person is a partner, officer, director, 

holder, or owner of 10 percent or more 

of its voting stock, or is an employee in 

a managerial or executive capacity. 

(v) Approval for existing facilities. 

Any permanent, privately owned 

quarantine facility operating under 

APHIS authorization on August 3, 2009 

must be approved by APHIS to continue 

quarantine operations by August 3, 2010 

or else must cease horse quarantine 

operations. 

(2) Compliance agreement. 

(i) All permanent, privately owned 

quarantine facilities for horses must 

operate in accordance with a 

compliance agreement executed by the 

operator or his or her agent and the 

Administrator, which must be renewed 

on an annual basis. 

(ii) The compliance agreement must 

provide that: 

(A) The facility must meet all 

applicable requirements of this section; 

(B) The operator agrees to have APHIS 

representatives present at all import 

quarantine operations at the facility in 

order to monitor the import quarantine 

operations; 

(C) The operator agrees to be 

responsible for the cost of the facility; 

all costs associated with its maintenance 

and operation; all costs associated with 

the hiring of employees and other 

personnel to attend to the horses as well 

as to maintain and operate the facility; 

all costs associated with the care of 

quarantined horses, such as feed, 

bedding, medicines, inspections, 

testing, laboratory procedures, and 

necropsy examinations; and all APHIS 

charges for the services of APHIS 

representatives in accordance with this 

section and part 130 of this chapter; 

(D) The operator agrees to bar from 

the facility any employee or other 

personnel at the facility who fails to 

comply with paragraph (c) of this 

section or other provisions of this part, 

any terms of the compliance agreement, 

or related instructions from APHIS 

representatives; 

(E) The operator agrees to 

demonstrate, to the satisfaction of the 

Administrator, that the routine cleaning 

and maintenance of the facility, the 

daily care of animals in quarantine, the 

disposal of wastes at the facility, the 

cleaning and disinfection procedures 

employed by the facility, the handling, 

washing, and disposal of soiled and 

contaminated clothing worn within the 

facility, and the disposal of dead horses, 

whether onsite or offsite, adhere to the 

best practices of biological security and 

animal care; 

(F) The operator agrees to random 

spot audits by APHIS representatives to 

determine whether employees and other 

personnel are complying with these 

practices; and 

(G) The operator of the facility allows 

the Administrator to amend the 

compliance agreement at any time after 

approval of the facility in order to 

incorporate related instructions issued 

by APHIS representatives while the 

facility is operational 

(3) Physical plant requirements. The 

facility must meet the following 

requirements as determined by an 

APHIS inspection prior to admitting 

horses into the facility: 

(i) Location. The quarantine facility 

must be located in proximity to a port 

authorized under § 93.303(e). The site 

and the specific routes for the 

movement of horses from the port to the 

site must be approved by the 

Administrator based on consideration of 

whether the site or routes would put the 

horses in a position that could result in 

the transmission of communicable 

diseases to domestic horses. 

(ii) Construction. The facility must be 

of sound construction, in good repair, 

and properly designed to prevent the 

escape of quarantined horses. It must 

have adequate capacity to receive and 

house shipments of horses as lots on an 

‘‘all in, all out’’ basis, whereby separate 

lots of horses can be received and 

housed without contact with any other 

lots being quarantined at the facility. 

The facility must include the following: 

(A) Perimeter fencing. The facility 

must be surrounded by a security fence 

of sufficient height and design to 

prevent the entry of unauthorized 

people and animals from outside the 

facility and to prevent the escape of the 

horses in quarantine. 

(B) Entrances and exits. All entryways 

into the nonquarantine area of the 

facility must be equipped with a secure 

and lockable door. While horses are in 

quarantine, all access to the quarantine 

area for horses must be from within the 

building, and each such entryway to the 

quarantine area must be equipped with 

a series of solid self-closing double 

doors. Emergency exits to the outside 

are permitted in the quarantine area. 

Such emergency exits must be 

constructed so as to permit their being 

opened from the inside of the facility 

only. 

(C) Windows and other openings. The 

facility must be constructed so that any 

windows or other openings in the 

quarantine area are double-screened 

with screening of sufficient gauge and 

mesh to prevent the entry or exit of 

insects and other vectors of diseases of 

horses and to provide ventilation 

sufficient to ensure the comfort and 

safety of all horses in the facility. The 

interior and exterior screens must be 

separated by at least 3 inches (7.62 cm). 

All screening of windows or other 

openings must be easily removable for 

cleaning, but must otherwise remain 

locked and secure at all times in a 

manner satisfactory to APHIS 

representatives in order to ensure the 

biological security of the facility. 

(D) Lighting. The entire facility, 

including its stalls and hallways, must 

have adequate lighting. 

(E) Loading docks. The facility must 

have separate docks for animal receiving 

and releasing and for general receiving 

and pickup, unless a single dock used 

for both purposes is cleaned and 

disinfected after each use in accordance 

with paragraph (c)(4)(iv)(F) of this 

section. 

(F) Surfaces. The facility must be 

constructed so that the floor surfaces 

with which horses have contact are 

nonslip and wear-resistant. All floor 

surfaces with which the horses, their 

excrement, or discharges have contact 

must provide for adequate drainage. All 

floor and wall surfaces with which the 

horses, their excrement, or discharges 

have contact must be impervious to 

moisture and be able to withstand 

frequent cleaning and disinfection 

without deterioration. Ceilings and wall 

surfaces with which the horses, their 

excrement, or discharges do not have 

contact must be able to withstand 

cleaning and disinfection between 

shipments of horses. All floor and wall 

surfaces must be free of sharp edges that 

could cause injury to horses. 

(G) Horse stalls. The stalls in which 

horses are kept must be large enough to 

allow each animal to make normal 

postural and social adjustments with 

adequate freedom of movement. 

Exercise equipment for horses may be 

kept in the stalls, provided that there 

will still be sufficient space within the 

stalls for the horses to move freely once 

the equipment is installed. 

(H) Aisleways. The aisleways through 

which horses are moved to and from 

stalls must be wide enough to provide 

for safe movement of horses, including 

allowing horses to turn around in the 

aisleway, preventing horses in facing 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31599 

stalls from coming into contact with 

horses in the aisleway, and adequately 

ventilating the stalls. 

(I) Means of isolation. Physical 

barriers must separate different lots of 

horses in the facility so that horses in 

one lot cannot have physical contact 

with horses in another lot or with their 

excrement or discharges. Stalls must be 

available that are capable of isolating 

any horses exhibiting signs of illness. 

(J) Showers. A shower must be located 

at each entrance to the quarantine area. 

If the facility has a necropsy area, a 

shower must be located at the entrance 

to the necropsy area. A clothes-storage 

and clothes-changing area must be 

provided with each shower area. There 

must also be one or more receptacles 

near each shower so that clothing that 

has been worn into the quarantine area 

can be deposited in a receptacle prior to 

entering the shower. 

(K) APHIS space. The facility must 

have adequate space for APHIS 

representatives to conduct examinations 

and testing of the horses in quarantine, 

prepare and package samples for 

mailing, and store the necessary 

equipment and supplies for duplicate 

samples. The space provided to conduct 

examinations and testing must include 

a refrigerator-freezer in which to store 

samples. The examination space must 

include equipment to provide for the 

safe inspection of horses. The facility 

must also include a secure, lockable 

office for APHIS use with enough room 

for a desk, chair, and filing cabinet. 

(L) Necropsy area. The facility must 

either include an area for conducting 

necropsies onsite or must have 

designated an alternate facility at which 

a suitable necropsy area is available. If 

the facility has a necropsy area, it must 

be of sufficient size to perform 

necropsies on horses and be equipped 

with adequate lighting, hot and cold 

running water, a drain, a cabinet for 

storing instruments, a refrigeratorfreezer for storing specimens, and an 

autoclave to sterilize veterinary 

equipment. If the facility does not have 

such an area, it must specify an 

alternate facility at which a suitable 

necropsy area is available, a route from 

the quarantine facility to the alternate 

facility’s necropsy area, and the 

safeguards that will be in place to 

ensure that communicable diseases of 

horses are not spread during transit. 

This alternate facility and transport 

methodology must be approved by the 

Administrator under the procedures for 

requesting variances outlined in 

paragraph (c)(6) of this section. 

(M) Storage. The facility must have 

sufficient storage space for equipment 

and supplies used in import quarantine 

operations. Storage space must include 

separate, secure storage for pesticides 

and for medical and other biological 

supplies, as well as a separate verminproof storage area for feed and bedding, 

if feed and bedding are stored at the 

facility. If the facility has multiple lotholding areas, then separate storage 

space for any reusable supplies and 

equipment that are not disinfected after 

each use in accordance with part 71 of 

this chapter must be provided for each 

lot-holding area. 

(N) Additional space needs. The 

facility must have an area for washing 

and drying clothes, linens, and towels 

and an area for cleaning and 

disinfecting equipment used in the 

facility. The facility must also include a 

work area for the repair of equipment. 

(O) Restrooms. The facility must have 

permanent restrooms in both the 

quarantine and nonquarantine areas of 

the facility. 

(P) Ventilation and climate control. 

The facility must be constructed with an 

air handling system capable of 

controlling and maintaining the ambient 

temperature, air quality, humidity, and 

odor at levels that are not injurious or 

harmful to the health of horses in 

quarantine. Air supplied to the 

quarantine area must not be recirculated 

or reused for other ventilation needs. 

Air handling systems for lot-holding 

areas must be separate from air handling 

systems for other operational and 

administrative areas of the facility. In 

addition, if the facility is equipped to 

handle more than one lot of horses at a 

time, the air handling system must be 

adequate to ensure that there is no 

cross-contamination of air between 

separate lot-holding areas. 

(Q) Fire protection. The facility, 

including the lot-holding areas, must 

have a fire alarm voice communication 

system. 

(R) Communication system. The 

facility must have a communication 

system between the nonquarantine and 

quarantine areas of the facility. 

(iii) Sanitation. To ensure that proper 

animal health and biological security 

measures are observed, the facility must 

have the following: 

(A) Equipment and supplies necessary 

to maintain the facility in clean and 

sanitary condition, including pest 

control equipment and supplies and 

cleaning and disinfecting equipment 

with adequate capacity to disinfect the 

facility and equipment. 

(B) Any reusable equipment and 

supplies that are not disinfected after 

each use in accordance with part 71 of 

this chapter maintained separately for 

each lot of horses. 

(C) Equipment and supplies used in 

the quarantine area maintained 

separately from equipment and supplies 

used in the nonquarantine area. 

(D) A supply of potable water 

adequate to meet all watering and 

cleaning needs, with water faucets for 

hoses located throughout the facility. 

An emergency supply of water for 

horses in quarantine must also be 

maintained. 

(E) A stock of disinfectant authorized 

in part 71 of this chapter or otherwise 

approved by the Administrator that is 

sufficient to disinfect the entire facility. 

(F) The capability to dispose of 

wastes, including manure, urine, and 

used bedding, by means of burial, 

incineration, or public sewer. Other 

waste material must be handled in such 

a manner that minimizes spoilage and 

the attraction of pests and must be 

disposed of by incineration, public 

sewer, or other preapproved manner 

that prevents the spread of disease. 

Disposal of wastes must be carried out 

in accordance with the terms of the 

compliance agreement, and is subject to 

spot audits by APHIS representatives. 

(G) The capability to dispose of horse 

carcasses in a manner approved by the 

Administrator and under conditions 

that minimize the risk of disease spread 

from carcasses. 

(H) For incineration to be carried out 

at the facility, the facility must have 

incineration equipment that is detached 

from other facility structures and is 

capable of burning animal waste and 

refuse. The incineration site must also 

include an area sufficient for solid waste 

holding. Incineration may also take 

place at a local site away from the 

facility premises. All incineration 

activities, whether onsite or offsite, 

must be carried out in accordance with 

the terms of the compliance agreement, 

and are subject to spot audits by APHIS 

representatives. 

(I) The capability to control surface 

drainage and effluent into, within, and 

from the facility in a manner that 

prevents the spread of disease into, 

within, or from the facility. If the facility 

is approved to handle more than one lot 

of horses at the same time, the drainage 

system must be adequate to ensure that 

there is no cross-contamination between 

lot-holding areas. 

(iv) Security. Facilities must provide 

the following security measures: 

(A) The facility and premises must be 

kept locked and secure at all times 

while horses are in quarantine. 

(B) The facility and premises must 

have signs indicating that the facility is 

a quarantine area and no visitors are 

allowed. 

31600 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 

(C) The facility and premises must be 

guarded at all times by one or more 

representatives of a bonded security 

company, or, alternatively, the facility 

must have an electronic security system 

that indicates the entry of unauthorized 

persons into the facility. Electronic 

security systems must be coordinated 

through or with the local police so that 

monitoring of the quarantine facility is 

maintained whenever APHIS 

representatives are not at the facility. 

The electronic security system must be 

of the ‘‘silent type’’ and must be 

triggered to ring at the monitoring site 

and not at the facility. The electronic 

security system must be approved by 

Underwriter’s Laboratories. The 

operator must provide written 

instructions to the monitoring agency 

stating that the police and a 

representative of APHIS designated by 

APHIS must be notified by the 

monitoring agency if the alarm is 

triggered. The operator must also submit 

a copy of those instructions to the 

Administrator. The operator must notify 

the designated APHIS representative 

whenever a breach of security occurs or 

is suspected of having occurred. In the 

event that disease is diagnosed in 

quarantined horses, the Administrator 

may require the operator to have the 

facility guarded by a bonded security 

company in a manner that the 

Administrator deems necessary to 

ensure the biological security of the 

facility. 

(D) The operator must furnish a 

telephone number or numbers to APHIS 

at which the operator or his or her agent 

can be reached at all times. 

(E) APHIS is authorized to place 

APHIS seals on any or all entrances and 

exits of the facility when determined 

necessary by APHIS and to take all 

necessary steps to ensure that such seals 

are broken only in the presence of an 

APHIS representative. If someone other 

than an APHIS representative breaks 

such seals, APHIS will consider the act 

a breach in security and APHIS 

representatives will make an immediate 

accounting of all horses in the facility. 

If a breach in security occurs, APHIS 

may extend the quarantine period as 

long as necessary to determine that the 

horses are free of communicable 

diseases. 

(4) Operating procedures. The 

following procedures must be observed 

at the facility at all times: 

(i) Oversight by APHIS 

representatives. 

(A) Import quarantine operations at a 

privately owned quarantine facility may 

only be conducted with the physical 

presence of and monitoring by APHIS 

representatives. APHIS representatives 

are also authorized to perform the 

services required by this section and by 

the compliance agreement. 

(B) If, as the result of a spot audit, or 

for any other reason, APHIS determines 

that the operator has failed to properly 

care for, feed, or handle quarantined 

horses as required in this paragraph (c) 

or in accordance with the terms of the 

compliance agreement, or has failed to 

maintain and operate the facility as 

provided in this paragraph (c) or in 

accordance with the terms of the 

compliance agreement, APHIS 

representatives will furnish such 

services, will make arrangements for the 

sale or disposal of quarantined horses at 

the quarantine facility owner’s expense, 

or will begin the process for withdrawal 

of approval of the quarantine facility 

specified in paragraph (c)(1)(iv) of this 

section. 

(ii) Personnel. 

(A) The operator must provide 

adequate personnel to maintain the 

facility and care for the horses in 

quarantine, including attendants to care 

for and feed horses, and other personnel 

as needed to maintain, operate, and 

administer the facility. 

(B) The operator must provide APHIS 

with an up-to-date list of all personnel 

who have access to the facility. The list 

must include the names, current 

residential addresses, and employee 

identification numbers of each person. 

When the operator wishes to grant 

access to the facility to persons who 

have not previously had access to it, the 

operator must update the list prior to 

such persons having access to the 

quarantine facility. 

(C) The operator must provide APHIS 

with signed statements from each 

employee and any other personnel hired 

by the operator and working at the 

facility in which the person agrees to 

comply with paragraph (c) of this 

section and applicable provisions of this 

part, all terms of the compliance 

agreement, and any related instructions 

from APHIS representatives pertaining 

to import quarantine operations, 

including contact with animals both 

inside and outside the facility. 

(iii) Authorized access. Access to the 

facility premises as well as inside the 

quarantine area will be granted only to 

APHIS representatives, authorized 

employees, and other personnel of the 

operator assigned to work at the facility. 

All other persons are prohibited from 

the premises unless specifically granted 

access by an APHIS representative. Any 

visitors granted access must be 

accompanied at all times by an APHIS 

representative while on the premises or 

in the quarantine area of the facility. 

(iv) Sanitary requirements. 

(A) All persons granted access to the 

quarantine area must: 

(1) Shower when entering and leaving 

the quarantine area; 

(2) Shower when leaving the necropsy 

area if a necropsy is in the process of 

being performed or has just been 

completed, or if all or portions of the 

examined animal remain exposed; 

(3) Wear clean protective work 

clothing and footwear upon entering the 

quarantine area; 

(4) Wear disposable gloves when 

handling sick horses and then wash 

hands after removing gloves; and 

(5) Change protective clothing, 

footwear, and gloves when they become 

soiled or contaminated. 

(B) The operator is responsible for 

providing a sufficient supply of clothing 

and footwear to ensure that all persons 

provided access to the quarantine area 

at the facility have clean, protective 

clothing, and footwear when they enter 

the quarantine area. 

(C) The operator is responsible for the 

handling, washing, and disposal of 

soiled and contaminated clothing worn 

within the quarantine facility in 

accordance with the terms of the 

compliance agreement. At the end of 

each workday, work clothing worn into 

the quarantine area must be collected 

and kept in a bag until the clothing is 

washed. Used footwear must either be 

left in the clothes-changing area or 

cleaned with hot water (148 °F 

minimum) and detergent and 

disinfected in accordance with the 

terms of the compliance agreement. 

APHIS representatives may conduct 

spot audits of all handling, cleaning, 

and/or disposal of used clothing or used 

footwear. 

(D) All equipment (including tractors) 

must be cleaned and disinfected prior to 

being used in the quarantine area of the 

facility with a disinfectant authorized in 

part 71 of this chapter or otherwise 

approved by the Administrator. The 

equipment must remain dedicated to the 

facility for the entire quarantine period. 

Any equipment used with quarantined 

horses (e.g., halters, floats, feed, water 

buckets, and exercise equipment) must 

remain dedicated to that particular lot of 

quarantined horses for the duration of 

the quarantine period or be cleaned and 

disinfected before coming in contact 

with horses from another lot. Prior to its 

removal from the quarantine premises, 

any equipment must be cleaned and 

disinfected in accordance with the 

terms of the compliance agreement. 

APHIS representatives may conduct 

spot audits of all cleaning and 

disinfection of equipment. 

(E) Any vehicle, before entering or 

leaving the quarantine area of the 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Rules and Regulations 31601 

facility, must be cleaned and disinfected 

in accordance with the terms of the 

compliance agreement within a time 

period authorized by the APHIS 

representative and with a disinfectant 

authorized in part 71 of this chapter or 

otherwise approved by the 

Administrator. APHIS representatives 

may conduct spot audits of all cleaning 

and disinfection of vehicles. 

(F) If the facility has a single loading 

dock, the loading dock must be cleaned 

and disinfected after each use in 

accordance with the terms of the 

compliance agreement within a time 

period authorized by the APHIS 

representative and with a disinfectant 

authorized in part 71 of this chapter or 

otherwise approved by the 

Administrator. APHIS representatives 

may conduct spot audits of all cleaning 

and disinfection of the loading dock. 

(G) That area of the facility in which 

a lot of horses has been held or has had 

access to must be thoroughly cleaned 

and disinfected, with a disinfectant 

authorized in part 71 of this chapter or 

otherwise approved by the 

Administrator, in accordance with the 

terms of the compliance agreement, 

upon release of the horses before a new 

lot of horses is placed in that area of the 

facility. APHIS representatives may 

conduct spot audits of all cleaning and 

disinfection of lot-holding areas. 

(v) Handling of the horses in 

quarantine. 

(A) All horses must be handled in 

accordance with paragraph (a) of this 

section. 

(B) Each lot of horses to be 

quarantined must be placed in the 

facility on an ‘‘all-in, all out’’ basis. No 

horse may be taken out of the lot while 

it is in quarantine, except for diagnostic 

purposes or as provided in paragraph 

(a)(4) of this section, and no horse may 

be added to the lot while the lot is in 

quarantine. Once import quarantine 

operations have been completed on a 

lot, but while the lot is still at the 

facility, a horse may be removed from 

that lot. 

(C) The facility must provide 

sufficient feed and bedding for the 

horses in quarantine, and it must be free 

of vermin and not spoiled. Feed and 

bedding must originate from an area that 

is not listed in part 72 of this chapter 

as an area quarantined for splenetic or 

tick fever. 

(D) Breeding of horses or collection of 

germplasm from horses is prohibited 

during the quarantine period. 

(E) Horses in quarantine will be 

subjected to such tests and procedures 

as directed by an APHIS representative 

to determine whether they are free from 

communicable diseases of horses. 

(F) Any death or suspected illness of 

horses in quarantine must be reported 

immediately to APHIS. The affected 

horses must be disposed of as the 

Administrator may direct, or depending 

on the nature of the disease, must be 

cared for as directed by APHIS to 

prevent the spread of the disease. 

(G) Quarantined horses requiring 

specialized medical attention or 

additional postmortem testing may be 

transported off the quarantine site, if 

authorized by APHIS. A second 

quarantine site must be established to 

house the horses at the facility of 

destination (e.g., veterinary teaching 

hospital). In such cases, APHIS may 

extend the quarantine period for that 

horse and for its lot until the results of 

any outstanding tests or postmortem 

results are received. 

(H) Should a horse be determined to 

be infected with or exposed to a 

Federally regulated disease of horses, 

arrangements for the final disposition of 

the infected or exposed horse must be 

accomplished within 10 days of the date 

that the importer is notified by the 

overseeing APHIS representative that 

the horse has been refused entry into the 

United States. APHIS representatives 

must be physically present at and 

directly monitor the subsequent 

disposition of the horse. The operator 

must have a preapproved contingency 

plan for the disposal of all horses 

housed at the facility prior to issuance 

of the import permit. 

(I) Vaccination of horses in quarantine 

is prohibited. However, once import 

quarantine operations have been 

completed on a lot, but while the lot is 

still at the facility, horses in that lot may 

be vaccinated. 

(vi) Records. 

(A) The facility operator must 

maintain a current daily record to 

record the entry and exit of all persons 

entering and leaving the quarantine 

facility. 

(B) The operator must maintain the 

daily record, along with any records 

kept by APHIS and deposited with the 

operator, for at least 2 years following 

the date of release of the horses from 

quarantine and must make such records 

available to APHIS representatives upon 

request. 

(5) Environmental quality. If APHIS 

determines that a privately operated 

quarantine facility does not meet 

applicable local, State, or Federal 

environmental regulations, APHIS may 

deny or suspend approval of the facility 

until appropriate remedial measures 

have been applied. 

(6) Variances. The Administrator may 

grant variances to existing requirements 

relating to location, construction, and 

other design features of the physical 

facility, as well as to sanitation, 

security, operating procedures, 

recordkeeping, and other provisions of 

paragraph (c) of this section, but only if 

the Administrator determines that the 

variance causes no detrimental impact 

to the overall biological security of the 

import quarantine operations. The 

operator must submit a request for a 

variance from the requirements for the 

construction of the facility in paragraph 

(c)(3) of this section to the 

Administrator in writing prior to the 

construction of the facility. The operator 

must submit a request for a variance 

from the operational requirements in 

paragraph (c)(4) of this section to the 

Administrator in writing at least 30 days 

in advance of the arrival of horses to the 

facility. Any variance must also be 

expressly provided for in the 

compliance agreement. 

(Approved by the Office of Management 

and Budget under control number 0579– 

0313) 

■ 6. In § 93.309, the section heading is 

revised to read as follows: 

§ 93.309 Horse quarantine facilities; 

payment information. 

* * * * * 

■ 7. Section 93.310 is revised to read as 

follows: 

§ 93.310 Quarantine stations, visiting 

restricted; sales prohibited. 

Visitors are not permitted in the 

quarantine enclosure during any time 

that the horses are in quarantine unless 

an APHIS representative specifically 

grants access under such conditions and 

restrictions as may be imposed by 

APHIS. An importer (or his or her agent 

or accredited veterinarian) may be 

admitted to the lot-holding area(s) 

containing his or her quarantined horses 

at such intervals as may be deemed 

necessary, and under such conditions 

and restrictions as may be imposed, by 

an APHIS representative. On the last 

day of the quarantine period, owners, 

officers or registry societies, and others 

having official business or whose 

services may be necessary in the 

removal of the horses may be admitted 

upon written permission from an APHIS 

representative. No exhibition or sale 

shall be allowed within the quarantine 

grounds. 

Done in Washington, DC, this 26th day of 

June 2009. 

Cindy Smith, 

Acting Deputy Under Secretary for Marketing 

and Regulatory Programs. 

[FR Doc. E9–15509 Filed 7–1–09; 8:45 am] 

BILLING CODE 3410–34–P