Source: https://www.federalregister.gov/documents/2003/08/28/03-21857/standards-for-privately-owned-quarantine-facilities-for-ruminants
Timestamp: 2017-09-20 07:52:47
Document Index: 490789870

Matched Legal Cases: ['art 93', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', 'art 130', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', 'art 71', '§\u200971', '§\u200971', '§\u200993', '§\u200993', 'art 71', '§\u200971', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', 'art 93', '§\u200993', '§\u200993', 'art 71', '§\u200971', '§\u200993', 'art 102', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u200993', 'art 93', '§\u200993', 'art 93', '§\u200993', 'art.\n4', '§\u200993', '§\u200993', '§\u200993', '§\u200993', '§\u2009130', '§\u200993']

We will consider all comments that we receive on or before October 27, 2003.
68 FR 51716
51716-51734 (19 pages)
Docket No. 00-022-1
Privately Owned Quarantine Facilities
APHIS Approval of Facilities
Additional Construction Requirements for Medium Security Facilities
Handling of Quarantined Ruminants
https://www.federalregister.gov/d/03-21857 https://www.federalregister.gov/d/03-21857
We are proposing to amend the regulations for the importation of ruminants into the United States to establish standards for privately owned quarantine facilities. The regulations authorize the establishment of privately operated quarantine facilities for ruminants, which are subject to approval and oversight by the Animal and Plant Health Inspection Service. However, the regulations do not provide specific standards for the approval, operation, and oversight of such facilities, with the exception of privately operated quarantine facilities for sheep or goats. Based on recent interest in establishing such facilities for cattle, we are proposing standards for privately owned quarantine facilities covering all ruminants to ensure public participation in their development and to ensure that any facilities that may be approved for this purpose operate in a manner that protects the health of the U.S. livestock population.
You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 00-022-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-022-1. If you use e-mail, address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 00-022-1” on the subject line.
The regulations at subpart D of part 93 (9 CFR 93.400 through 93.435, and referred to below as the regulations) pertain to the importation of ruminants. Ruminants include all animals that chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas, and giraffes. Section 93.411 requires that ruminants imported into the United States be quarantined upon arrival for at least 30 days, with certain exceptions. Ruminants from Canada and Mexico are not subject to this quarantine requirement.
In § 93.412, paragraph (a) authorizes the establishment of privately operated quarantine facilities, subject to APHIS approval and oversight. Paragraph (a) provides, in part, that the “quarantine facility must be suitable for the quarantine of such ruminants and must be approved by the Administrator prior to the issuance of any import permit.” This paragraph also provides that APHIS will “supervise the quarantine” at such facilities.
Section 93.434 of the regulations contains standards for approval, operation, and APHIS oversight of privately operated quarantine facilities Start Printed Page 51717for sheep or goats. The standards covering quarantine facilities for sheep or goats were first implemented in 1988 (53 FR 21794-21809, Docket No. 88-057, published June 10, 1988), based on considerable interest at that time in importing large numbers of sheep into the United States from New Zealand. Since then, privately operated quarantine facilities have been used from time to time for the importation of sheep and goats into the United States.
APHIS has recently received requests from livestock importers who wish to import cattle into the United States through private quarantine facilities. Because there are no approved privately operated quarantine facilities for cattle in operation at the present time, imported cattle subject to quarantine must enter the United States through facilities maintained by APHIS.
Given the interest in establishing private quarantine facilities for cattle, we are proposing specific standards for the approval, operation, and APHIS oversight of such facilities. The requirements contained in this proposed rule are designed to ensure that the health of the U.S. livestock population is not jeopardized by the release of unhealthy animals or communicable disease agents from quarantine facilities. We would refer to these facilities as “privately owned” instead of “privately operated” to underscore that these facilities are privately owned, operated, and financed, but subject to APHIS approval and oversight.
For purposes of consistency, we are proposing that these standards apply not only to privately owned quarantine facilities for imported cattle, but also to privately owned facilities that wish to handle other imported ruminants. Therefore, we would remove from our regulations the existing standards applicable to privately operated quarantine facilities for sheep or goats.
In this time of shrinking Federal resources, we believe that it is appropriate to allow the establishment of privately owned quarantine facilities for ruminants so long as inspection and other activities related to the quarantine are subject to APHIS oversight and direction. We further believe that these facilities, if carefully regulated and monitored by APHIS, would provide an effective and efficient means of bringing ruminants into the United States without compromising our ability to protect against the introduction of communicable animal diseases. The full text of the proposed regulations appears in the rule portion of this document. Our discussion of the proposed provisions follows.
We are proposing to add to § 93.400 definitions for the terms area veterinarian in charge (AVIC), Federal veterinarian, lot, lot-holding area, nonquarantine area, Office International des Epizooties (OIE), operator, privately owned medium security quarantine facility (medium security facility), privately owned minimum security quarantine facility (minimum security facility), quarantine area, State veterinarian, and temporary inspection facility. We also would make several minor technical changes to the definitions of immediate slaughter and recognized slaughtering establishment.
The area veterinarian in charge (AVIC) would refer to the veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in a particular State.
A Federal veterinarian would be defined as a veterinarian employed and authorized by the Federal Government to perform the tasks required by the regulations.
The term lot would be defined as a group of ruminants that, while held on a conveyance or premises, has opportunity for physical contact with each other or with each other's excrement or discharges at any time between arrival at the quarantine facility and 60 days prior to export to the United States. A lot-holding area would describe that area in a privately owned medium or minimum security quarantine facility in which a single lot of ruminants is held at one time.
The nonquarantine area would refer to that area of a privately owned medium or minimum security quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to ruminants, samples taken from ruminants, and any other objects or substances that have been in the quarantine area during the quarantine of ruminants.
The Office International des Epizooties (OIE) would refer to the international organization recognized by the World Trade Organization for setting animal health standards, reporting global animal situations and disease status, and presenting guidelines and recommendations on sanitary measures related to animal health.
We would define an operator as a person other than the Federal Government who owns or operates, subject to APHIS' approval and oversight, a privately owned medium or minimum security quarantine facility.
A privately owned medium security quarantine facility (medium security facility) would refer to a facility that:
Is owned, operated, and financed by a person other than the Federal Government;
Is subject to the strict oversight of APHIS representatives;
Is constructed, operated, and maintained in accordance with the requirements for medium security facilities in § 93.412(d); and
Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services must include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
A privately owned minimum security quarantine facility (minimum security facility) would refer to a facility that:
Is constructed, operated, and maintained in accordance with the requirements for minimum security facilities in § 93.412(d);
Is used for the quarantine of ruminants that pose no significant risk, as determined by the Administrator, of introducing or transmitting to the U.S. livestock population any livestock disease that is biologically transmissible by vectors; and
Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services must include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
The term quarantine area would refer to that area of a privately owned medium or minimum security quarantine facility that comprises all of the lot-holding areas in the facility and any other areas in the facility that ruminants have access to, including loading docks for receiving and releasing ruminants. The quarantine area also would include any areas in the facility that are used to conduct examinations of ruminants and take samples, as well as areas where samples are processed or examined.
A State veterinarian would be defined as a veterinarian employed and authorized by a State or political Start Printed Page 51718subdivision of a State to perform the tasks required by the regulations.
The term temporary inspection facility would refer to a facility owned, operated, and financed by a person other than the Federal Government that is located within 1 mile of the port of entry and used for the inspection of ruminants imported into the United States in accordance with § 93.408.
We are also proposing to make several minor technical changes to the footnotes that accompany the existing definitions of immediate slaughter and recognized slaughtering establishment by providing additional information on how to find the names and addresses of the area veterinarian in charge in any State. We also would make a minor change to the definition of immediate slaughter for stylistic purposes.
Section 93.403, paragraph (g), of the regulations provides that sheep to be quarantined at privately operated facilities may be entered into the United States at any air and ocean port designated for the importation of ruminants under § 93.403(a), as well as any other international port or airport so designated by the U.S. Customs Service (now the Bureau of Customs and Border Protection, U.S. Department of Homeland Security). This provision appears in the regulations to ensure that sheep are imported into the United States only at those ports at which appropriate Federal personnel are available to provide necessary services.
We are proposing to amend § 93.403(g), including the paragraph heading, so that it applies to all ruminants, not just sheep, and so that it refers to “privately owned quarantine facilities” instead of “privately operated quarantine facilities,” for consistency with the use of the term “privately owned quarantine facilities” in the proposed standards to appear in § 93.412(d). These changes would clarify near what ports operators could potentially build a privately owned quarantine facility for imported ruminants.
We would make several more technical changes to § 93.403(g). First, for purposes of clarity, we would amend the phrase “may be entered” in § 93.403(g) by substituting the word “imported” in place of “entered.” “Imported” means moved into the United States, whereas “entered” can mean released into the commerce of the United States, which does not occur until release from quarantine. We would change the reference to “U.S. Customs Service” to appear as “Bureau of Customs and Border Protection.” We also would remove the cross references to § 93.433 and § 93.434 that appear in § 93.403(g). Section 93.433 is currently reserved and contains no regulatory text. Section 93.434 provides the standards for the approval of privately operated quarantine facilities for sheep or goats. As mentioned previously, in proposing to establish quarantine standards applicable to ruminants, we would remove from our regulations the existing standards applicable to privately operated quarantine facilities for sheep or goats.
Section 93.404 contains permit requirements for the importation of ruminants and ruminant test specimens for diagnostic purposes from certain regions. Paragraph (a)(1) specifies the information to be included in the application to APHIS for an import permit.
In order that we receive sufficient notice of the importer's intention to utilize the services of a privately owned quarantine facility, we would amend § 93.404(a)(1) to require that the permit application specify the name and address of the quarantine facility in cases where the ruminants are to be quarantined at a privately owned quarantine facility.
Paragraph (a) of § 93.412 authorizes the establishment of privately operated quarantine facilities, subject to APHIS approval and oversight. We are proposing to amend § 93.412(a), including the paragraph heading, by removing references to the word “operated” as it is used in the terms “privately operated quarantine facility” or “privately operated quarantine facilities” and substituting the word “owned” in each instance. We also would amend § 93.412(a) by substituting the word “operator” in place of “importer or his or her agent,” and substituting the words “APHIS representative'or “overseeing APHIS representative” in place of “inspector assigned to supervise,” for purposes of consistency with the new provisions in proposed § 93.412(d). We also would make other minor technical changes, either to be consistent with proposed § 93.412(d), or for stylistic purposes.
Paragraph (c) of § 93.412 provides that amounts collected from the importer, or his or her agent, for quarantine services furnished by APHIS shall be deposited so as to be available to defray such services as they are rendered. We would amend § 93.412(c) and add a reference to “operator” alongside the current reference to importer, and also make a minor stylistic change. As a result, this provision would apply to operators of privately owned quarantine facilities under § 93.412(a) and importers of ruminants who utilize the services of APHIS quarantine facilities under § 93.412(b).
We are proposing to add a new paragraph (d) to § 93.412 that would set forth the standards for the establishment, operation, and maintenance of privately owned medium and minimum security quarantine facilities for ruminants imported into the United States. The risk of the spread of disease into, within, and from these facilities dictates that security, disease detection, and other prevention measures meet certain standards to ensure the biological security of approved facilities.
We are proposing standards for two types of quarantine facilities: Privately owned medium security quarantine facilities (medium security facilities) and privately owned minimum security quarantine facilities (minimum security facilities). Medium security facilities would need to be built to hold ruminants in an indoor, vector-proof environment that protects the animals against the spread of livestock diseases that are biologically transmitted by vectors.
A minimum security facility would allow for the outdoor holding of ruminants in quarantine. Unlike a medium security facility, the quarantine area of a minimum security facility would not have to be constructed to provide a vector-proof environment against livestock diseases that are transmissible by vectors. However, a minimum security facility could only accept imported animals that the Administrator determines pose no significant risk of harboring livestock diseases that are transmissible by vectors. The Administrator would make this determination on a case-by-case basis, taking into account such factors as the prevalence of diseases transmissible by vectors in the exporting country, and whether any steps have been taken in the exporting country to mitigate the disease risk (i.e., holding the animals in a vector free zone over a prescribed time period prior to shipment).
Importers wishing to utilize the services of a privately owned quarantine facility would be required to state their intention on their application for a permit to import the ruminants. (See discussion under the heading “Import Permits.”) We would determine whether the animals are eligible for importation Start Printed Page 51719and the required level of quarantine security based on review of the application, as well as existing animal import regulations and any protocols that we have with the exporting country. For example, we view certain OIE list A diseases, such as rinderpest and foot-and-mouth disease, to be so serious that § 93.404(a)(2) prohibits the importation of domestic ruminants from regions where those diseases are known to exist. The presence of certain other infectious diseases in the exporting region, such as diseases of the respiratory complex or vesicular diseases such as vesicular stomatitis, could necessitate that the imported ruminants be quarantined in a medium security facility in the absence of mitigating factors such as testing. The Administrator would have the discretion to order testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary. The Administrator also would have the discretion to decide what type of quarantine facility (medium or minimum security facility) to use for a particular importation of ruminants, based on the ruminant species and the health conditions in the region or regions from which the ruminants would be exported.
We are proposing that medium and minimum security facilities receive and hold imported ruminants as a “lot” on an “all-in, all-out” basis. The standards we are proposing would allow for medium security facilities to accommodate more than one lot of ruminants at a time, provided certain requirements are met. The option of holding multiple lots of ruminants simultaneously would not be available for minimum security facilities. We would limit minimum security facilities to one lot for purposes of biosecurity since there would be little, if any, separation between lots of animals. Also, because of the potentially larger number of animals that can be accommodated as a single lot at a minimum security facility, it would not be prudent to put such a large number of animals at risk by allowing another lot of imported ruminants to use the facility at the same time.
Proposed § 93.412(d) would be organized by subparagraphs addressing the following: (1) APHIS approval of facilities; (2) compliance agreement; (3) physical plant requirements; (4) operating procedures; (5) environmental quality; (6) other laws; and (7) variances.
We would provide information in § 93.412(d)(1) on how to obtain APHIS approval to operate a medium or minimum security facility, as well as the basis for denying or withdrawing such approval. As explained earlier, obtaining our approval to operate a medium or minimum security facility, as discussed in this proposed rule, would be separate from the import permit application process for specific animal shipments, which is covered in § 93.404 and elsewhere in the regulations.
Under proposed § 93.412(d)(1)(i), interested persons would be required to make written application to the Administrator, c/o National Center for Import and Export, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231. The application would need to include:
Copies of all approved State permits for construction and operation of the facility (but not local building permits), as well as copies of all approved Federal, State, and local environmental permits;
The anticipated source(s) and origin(s) of ruminants to be quarantined, as well as the expected size and frequency of shipments; and
A contingency plan for the possible destruction and disposal of all ruminants capable of being held in the facility.
The written application for facility approval would have to be submitted to APHIS at least 120 days prior to the date of application for local building permits in order to ensure that APHIS has adequate time to evaluate the plans for the facility, assess potential environmental effects, and determine that sufficient APHIS personnel are available to staff the facility.
If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval would have to agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in 9 CFR 130.30. If the facility is approved by APHIS, the operator would then enter into a compliance agreement, which is explained in more detail under the heading “Compliance Agreement,” under § 93.412(d).
Proposed § 93.412(d)(1)(ii) would set out the criteria for APHIS approval. Before granting approval, we would have to find, based on our own environmental assessment, as well as any required Federal, State, and local environmental permits or evaluations issued by Federal, State, or local authorities, that the operation of the facility would not have significant environmental effects. The operator would have to secure the required permits or evaluations and provide copies to APHIS before we would consider granting approval to build and operate the facility. The facility would also have to comply with all requirements in § 93.412(d). Approval would be subject to the facility meeting any additional conditions that the Administrator believes are necessary to ensure that adequate safeguards are in place to monitor the health status of the ruminants in quarantine and prevent the transmission of livestock diseases into, within, or from the facility. These additional conditions would be set forth in a compliance agreement required under § 93.412(d)(2). The compliance agreement provides us with further assurances that the privately owned quarantine facility would be operated in accordance with the regulations. Finally, the Administrator would have to determine whether sufficient APHIS personnel (including one or more APHIS veterinarians and other animal health technicians) are available to provide continuous oversight and other technical services to ensure the biological security of the facility. In assigning APHIS personnel to a facility, long-term personnel plans and arrangements would need to be made, including the possible hiring of personnel or the transfer of existing personnel. The operator of the facility, not APHIS, would be responsible for hiring other attendants and workers for the care and handling of ruminants and for the maintenance, operation, and administration of the facility.
If a facility meets all of these requirements, APHIS would approve the facility and assign personnel to it. The assignment of APHIS personnel would be handled on a first-come, first-served basis; therefore, the deployment of APHIS personnel at one facility could result in another facility not being staffed due to the lack of necessary Start Printed Page 51720APHIS personnel. The Administrator would have sole discretion in determining the number of APHIS personnel to be assigned to a facility.
Proposed § 93.412(d)(1)(iii) would provide that the operator of a medium or minimum security facility, after receiving our approval, would have to continue to comply with all requirements of § 93.412(d), as well as the terms of the compliance agreement, in order for the facility to maintain its approved status.
Proposed § 93.412(d)(1)(iv) would cover the process for APHIS denying an initial application or withdrawing the approval of a medium or minimum security facility already in operation. Before we would deny or withdraw approval, we would first inform the operator, and include the reasons for our action. We would provide an opportunity for a hearing if there is a conflict as to any material fact regarding our action. The withdrawal of approval of an existing facility would become effective pending a final determination in the proceeding if the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal would take effect upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, we would also provide written confirmation to the operator as promptly as circumstances allow. The withdrawal of approval of a facility would continue in effect pending the completion of the proceeding and any judicial review, unless otherwise ordered by the Administrator.
Under proposed § 93.412(d)(1)(iv), we could deny an initial application or withdraw the approval of an existing facility for failure to comply with the requirements provided in § 93.412(d), or with the terms of the compliance agreement, or for failure to comply with any other requirement under the Animal Health Protection Act (7 U.S.C. 8301-8317) or the regulations thereunder. We would also withdraw approval if the operator notifies us that the facility has ceased operations, or, if the facility has not been used to quarantine ruminants for a period of at least 1 year. The operator's failure to remit outstanding charges for APHIS services at the facility would also be grounds for withdrawing approval. Finally, we could deny approval of an initial application, or withdraw the approval of an existing facility, if the operator or a person responsibly connected with the business of the facility is or has been convicted of a crime under any law regarding the importation or quarantine of any animal, or any crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity needed for the conduct of operations affecting the importation of animals. A person is considered to be responsibly connected with the business of the 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 an employee in a managerial or executive capacity.
We are proposing that all medium and minimum security facilities operate in accordance with a compliance agreement required under § 93.412(d)(2). We would require that the compliance agreement be executed by the operator or other designated representative of the facility and by the Administrator before the facility could commence operations. The compliance agreement would signify the operator's commitment to follow our regulations, as well as underscore the operator's financial responsibilities with respect to building and operating a privately owned quarantine facility.
Under the compliance agreement, the operator would be bound by § 93.412(d) and subject to the strict oversight of APHIS representatives. The operator would agree to be responsible for the cost of building the facility, as well as any costs associated with its maintenance and operation. These costs would include all expenses associated with the hiring of personnel to attend to the ruminants and maintain and operate the facility; all expenses associated with the care of quarantined ruminants, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; all costs associated with the death or destruction and disposition of quarantined ruminants; and all charges for the services of APHIS representatives at the facility, in accordance with § 93.412 of the regulations and 9 CFR part 130.
The compliance agreement would provide that the operator obtained, prior to execution of the agreement, a financial instrument (insurance or surety bond) approved by APHIS that financially guarantees the operator's ability to cover all costs and other financial liabilities and obligations of the facility. This includes financial liability coverage in the event of a worst case scenario in which all quarantined ruminants would have to be destroyed and disposed of because of an animal health emergency, as determined by the Administrator.
The compliance agreement would also provide that, prior to commencing quarantine operations, the operator would deposit with the Administrator a certified check or U.S. money order to cover the estimated costs, as determined by the Administrator, of APHIS professional, technical, and support services at the facility over the duration of the quarantine. The compliance agreement would also provide that if the actual costs incurred by APHIS exceed the deposited amount, the operator would be liable for those additional costs, based on APHIS official accounting records. We would require the compliance agreement to specify that payment for our services received in connection with each lot of ruminants in quarantine must be made prior to the release of the ruminants. The operator would also be responsible for any other costs incurred by us with respect to the quarantine following the release of the ruminants, based on official records, within 14 days of receipt of the bill showing the balance due. Any unobligated funds deposited with us would be returned to the operator after the release of the lot of ruminants from the quarantine facility and termination or expiration of the compliance agreement, or, if requested, credited to the operator's account and applied towards payment of APHIS services at a future date. We would require that, prior to the entry of each subsequent lot of ruminants into the medium or minimum security facility, the operator execute a new compliance agreement with APHIS, as well as deposit a certified check or U.S. money order to cover our estimated costs over the duration of the quarantine for that lot of ruminants.
Proposed § 93.412(d)(3) would set forth the standards for the physical plant at medium and minimum security facilities. These physical plant standards address issues related to location, construction, sanitation, and security. Any requirements that are applicable to only one type of facility would be clearly noted in the regulations. We would inspect a facility to ensure that these standards are met before imported ruminants could be admitted to the facility.
Proposed § 93.412(d)(3)(i) would require that imported ruminants arrive at a port designated for the importation of ruminants under § 93.403(g) (discussed earlier under “Ports of Entry”). Proposed § 93.412(d)(3)(i) also would require that a medium or Start Printed Page 51721minimum security facility be located at a site approved by the Administrator and that the specific routes for the movement of ruminants from the port to the medium or minimum security facility be approved in advance by the Administrator. Approval would be based on a consideration of whether the site or routes would put animals in a position that could result in their transmitting communicable livestock diseases.
We have decided for several reasons not to require that the port and the medium or minimum security facility be located within a certain distance of one another. Some ports will be in large metropolitan areas where the nearest concentrations of livestock are many miles away, while other ports may be in towns with rural areas where concentrations of livestock are within very short distances of the port. Considering the diversity of places in which persons may consider locating quarantine facilities, it would be difficult to stipulate a maximum distance from the port. Doing so could prove unjustified and burdensome for the importer in some circumstances or, in other circumstances, allow construction of a quarantine facility in a location that could prove inadequate in ensuring against the spread of disease into or from the quarantine facility.
For medium security facilities only, the facility would have to be situated at least one-half mile from any premises holding livestock in order to prevent the possible transmission of diseases from ruminants in the facility to livestock outside the facility and vice versa. Our experience in operating indoor quarantine facilities for imported animals indicates that a distance of one-half mile is adequate to prevent the transmission of livestock diseases into and from a medium security facility. In the case of a minimum security facility (outdoor facility), the Administrator would establish the required minimum distance between the facility and other premises holding livestock on a case-by-case basis, taking into account such factors as possible diseases of concern and whether or not the facility is to be located in an agricultural region in proximity to other susceptible animals.
All imported ruminants, upon arrival at the port of entry, are subject to inspection in accordance with § 93.408 of the regulations. If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator would have to make arrangements for the imported ruminants to be held in a temporary inspection facility, which is within 1 mile of the port and approved by the Administrator, to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to the animals' movement to the quarantine facility. We would require that this inspection take place within 1 mile of the port so that in the event the ruminants are found to be infected with or exposed to a disease that precludes their entry, the lot of ruminants could be expeditiously re-exported, if necessary.
The temporary inspection facility would have to provide adequate space for Federal or State veterinarians to conduct examinations and testing of the imported ruminants. The examination space of the temporary inspection facility would have to be equipped with appropriate animal restraining devices for the safe inspection of ruminants. The temporary inspection facility also could hold no more than one lot of animals at the same time.
In seeking APHIS approval of the temporary inspection facility, the operator would have to provide APHIS with the following information: The location and street address, as well as blueprints or a description of the temporary inspection facility; a description of the financial resources available for its construction (if applicable), operation, and maintenance; copies of all approved State permits for construction and operation of the temporary inspection facility, as well as copies of all approved Federal, State, and local environmental permits; and the anticipated source(s) or origin(s), lot size, and frequency of shipments of imported ruminants to be handled at the facility. Following APHIS approval of the temporary inspection facility, the operator would also provide APHIS with a copy of the local building permit, when obtained.
If the ruminants, upon inspection at the temporary inspection facility, are determined to be infected with or exposed to a disease that precludes their entry into the United States, the ruminants would be refused entry. Ruminants refused entry would remain the responsibility of the operator, but subject to further handling or disposition as directed by the Administrator in accordance with § 93.408.
APHIS' approval to build and operate a medium or minimum security quarantine facility outside the 1-mile boundary of a designated port would be contingent upon APHIS' approval of a temporary inspection facility within 1 mile of the port of entry, as well as approval of the routes for the movement of ruminants from the port to the medium or minimum security facility.
The operator or the operator's designated representative would have the opportunity to confirm with us that the location requirements for the facility would be satisfactory before moving ahead with any firm decisions about the site of the facility.
Proposed § 93.412(d)(3)(ii) would provide the basic construction and design standards for medium and minimum security facilities. We would require that each facility be of sound construction, good repair, and designed to prevent the escape of quarantined ruminants. The facility would have to provide adequate capacity to receive and hold ruminants as a “lot” on an “all-in, all-out” basis.
We are proposing that medium and minimum security facilities must provide separate docks for animal receiving and releasing and for general receiving and pickup of supplies and materials such as feed, bedding, disinfectants, pesticides, and equipment. Alternatively, a single dock may be used for both purposes if the dock is cleaned and disinfected after each use with a disinfectant that is either authorized in 9 CFR part 71, § 71.10(a)(5), or is otherwise approved by the Administrator. Paragraph (a)(5) of § 71.10 authorizes, for general use purposes, disinfectants that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq.) with tuberculocidal claims.
We are proposing that medium and minimum security facilities must be surrounded by double-security perimeter fencing separated by at least 30 feet and of sufficient height and design to prevent the entry of unauthorized persons and animals from outside the facility and to prevent the escape of ruminants in quarantine. The fence's height and design should take into consideration the species of wildlife in the surrounding area, as well as the impact of snowfall and other climatic changes. Double-security fencing would further ensure against possible contact between quarantined ruminants and animals outside the facility.
Medium and minimum security facilities would have to provide pens, chutes, and other animal restraining devices, as appropriate, for inspection and identification of each animal, as well as for segregation, treatment, or both, of any ruminant exhibiting signs of illness. We also are proposing that the lot-holding areas in medium and minimum security facilities be of sufficient size to prevent overcrowding. Start Printed Page 51722A medium security facility could hold more than one lot of ruminants at the same time so long as the lots are separated by physical barriers so that ruminants in one lot would not have physical contact with ruminants in another lot, or with their excrement or discharges. A minimum security facility could not hold more than one lot of animals at the same time. These measures would help prevent ruminants infected with or exposed to a disease from spreading it to other ruminants in the facility.
Because of the need for APHIS representatives to examine ruminants and draw samples for testing, we would require that medium and minimum security facilities provide adequate space for such purposes, and that the space include appropriate animal restraining devices for the safe inspection of ruminants. The facility would have to provide sufficient storage space for necessary examination equipment and supplies, work space for preparing and packaging samples for mailing, and storage space for duplicate samples. The facility also would have to provide a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.
Medium and minimum security facilities would also have to provide sufficient storage space for equipment and supplies used in quarantine operations, including separate, secure storage areas for pesticides and for medical and other biological supplies, as well as a separate storage area for feed and bedding, if feed and bedding are to be stored at the facility.
Medium and minimum security facilities would also have to include work areas for the repair of equipment and for cleaning and disinfecting equipment used in the facility.
Proposed § 93.412(d)(3)(iii) would contain additional physical plant requirements that would apply to medium security facilities only. These additional requirements, which primarily relate to building design, windows and other openings, surfaces, and ventilation and climate control, would help ensure that a medium security facility is capable of providing an indoor environment for ruminants in quarantine that is free of vectors, biologically secure, and safe for the animals.
A medium security facility would have to be constructed so that the quarantine area is located in a secure, self-contained building that includes appropriate control measures against the spread of livestock diseases biologically transmissible by vectors. All entryways into the nonquarantine area of the building would have to be equipped with a secure and lockable door. While ruminants are in quarantine, all access to the quarantine area would have to be from within the building. Each entryway to the quarantine area would have to be equipped with a solid, self-closing door. Separate access would have to be provided within the quarantine area to each lot-holding area so that it is not necessary to move through one lot-holding area to gain access to another lot-holding area. Entryways to each lot-holding area within the quarantine area would also have to be equipped with a solid lockable door. Emergency exits to the outside would be permitted in the quarantine area if required by local fire ordinances. Such emergency exits would have to be constructed so as to permit their opening from the inside of the facility only.
We would require that all windows and other openings in the quarantine area of a medium security facility be double-screened with screening (separated by at least 3 inches or 7.62 centimeters) of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of livestock diseases, as well as provide ventilation sufficient to ensure the comfort and safety of all ruminants in the facility. All screening would have to be easily removable for cleaning, yet 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.
We would also require that the floor, wall, and ceiling surfaces in a medium security facility meet certain standards. The floor surfaces with which the ruminants have contact would have to be nonslip and wear-resistant. In addition, all floor surfaces with which the ruminants, their excrement, or discharges have contact would have to slope gradually to the center, where one or more drains of at least 8 inches in diameter are located for adequate drainage, or alternatively, be of slatted or other floor design that allows for adequate drainage. We are also proposing that any floor and wall surfaces in a medium security facility with which the ruminants, their excrement, or discharges have contact would have to be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Other ceiling and wall surfaces with which the ruminants, their excrement, or discharges do not have contact would have to be able to withstand cleaning and disinfection between shipments of ruminants. Since the animals would be housed in an enclosed building for the duration of the quarantine, the cleaning and disinfection of floor and wall surfaces would be necessary to help maintain the general health of the ruminants in quarantine, as well as reduce the risk of diseases spreading from one lot of ruminants to another. Finally, all floor and wall surfaces would also have to be free of sharp edges that could cause injury to ruminants.
We would also require that a medium security facility be equipped with a heating, ventilation, and air conditioning (HVAC) system that would be capable of controlling and maintaining the ambient temperature, air quality, moisture, and odor at levels not injurious or harmful to the health of ruminants in quarantine. Air supplied to lot-holding areas could not be recirculated or reused for other ventilation needs. The HVAC systems used for lot-holding areas would have to be separate from air handling systems for other operational and administrative areas of the facility. In addition, if a medium security facility is approved to handle more than one lot of ruminants at a time, each lot-holding area would have to be equipped with its own separate HVAC system in order to prevent cross-contamination between the separate lot-holding areas. Physical separation alone is not always an adequate safeguard against the transmission of diseases from one lot to another.
Medium security facilities would have to be adequately illuminated. This would include lighting in the lot-holding areas, as well as other areas where animals would be inspected or examined. We would also require that a medium security facility, including the lot-holding areas, be equipped with a fire alarm and voice communication system so that personnel working in those areas can be readily warned of any potential emergency and vice versa. A medium security facility would also have to provide a television monitoring system or other arrangement sufficient to provide a full view of the lot-holding areas. In addition, we are proposing that a medium security facility would have to be equipped with a communication system between the nonquarantine and quarantine areas of the facility so that persons inside the quarantine area can readily communicate with persons elsewhere in the facility in cases of emergency without necessarily leaving the quarantine area, and vice versa.
Each medium security facility would have to include an area that is of Start Printed Page 51723sufficient size to perform necropsies on ruminants. We would require that the necropsy area have adequate lighting and be equipped with hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment. The necropsy area would be used to perform postmortem inspection of animals that die in the medium security facility and to collect samples for laboratory diagnosis. Having the capability to conduct necropsies at the facility would reduce the risk of diseases being transmitted to animals outside the facility.
In addition to the storage requirements discussed previously, the feed storage areas of a medium security facility would have to be vermin-proof. Also, if the medium security facility has multiple lot-holding areas, we would require that separate storage space for supplies and equipment be provided for each lot-holding area. This would help prevent equipment and supplies used on quarantined ruminants in one lot from coming in contact with ruminants in another lot or with the equipment or supplies used on those other ruminants. Such contact could cause the spread of diseases between lots of ruminants.
Medium security facilities would have to provide adequate shower facilities for use by those individuals who have access to the quarantine area. In a medium security facility, there would have to be a shower at the entrance to the quarantine area. A shower also would have to be located at the entrance to the necropsy area. We would also require that a clothes-storage and clothes-changing area be located at each end of each shower area. In addition, there would have to be one or more receptacles near each shower so that clothing that has been worn into a lot-holding area or elsewhere in the quarantine area can be deposited in the receptacle(s) prior to entering the shower.
Medium security facilities would have to provide permanent restrooms in both the nonquarantine and quarantine areas of the facility, and also provide an area for breaks and meals within the quarantine area. We would also require that medium security facilities provide a separate area for washing and drying clothes, linens, and towels used in the facility.
Proposed § 93.412(d)(3)(iv) would require that all medium and minimum security facilities meet certain sanitation standards as another safeguard against the transmission of livestock diseases into, within, or from the facility. Operators would have to have adequate equipment and supplies on hand to clean, disinfect, and maintain the facility and control pests. If more than one lot of ruminants is to be held in the facility at the same time (applies to medium security facilities only), then the facility would have to maintain separate equipment and supplies for carrying out such tasks in the different lot-holding areas. We would also require that the facility have a sufficient supply of potable water to meet the watering needs of the ruminants, as well as any cleaning needs at the facility. Water faucets for hoses would have to be located throughout the facility so that personnel would not have to drag hoses across areas that have already been cleaned and disinfected. We also would require that facilities maintain an emergency supply of water for the ruminants in quarantine, as well as a supply of disinfectant that is sufficient to disinfect the entire facility. Disinfectants would have to be authorized under 9 CFR part 71, § 71.10(a)(5), or otherwise approved by the Administrator.
Medium and minimum security facilities would have to be capable of disposing of wastes, including urine, manure, and used bedding, by means of burial, incineration, or public sewer. Other waste material would have to be handled in such a manner that would minimize spoilage and the attraction of pests and then disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Waste disposal would have to be carried out under the direct oversight of APHIS representatives. Each facility would also have to be capable of disposing of ruminant carcasses in a manner approved by the Administrator and under conditions that would prevent the spread of disease from the carcasses.
If incineration is to be carried out on the premises of a medium or minimum security facility, we are proposing that the incineration equipment would have to be detached from other facility structures and be capable of burning wastes as required. The incineration site would also have to provide an area sufficient for solid waste holding. Incineration also may occur at a local site away from the facility. All incineration activities would have to take place under the direct oversight of an APHIS representative.
We are proposing that medium and minimum security facilities have the capability to adequately control surface drainage and effluent in order to prevent the spread of disease into, within, and from the facility. If a facility is approved to handle more than one lot of ruminants at the same time, we would require that separate drainage systems be provided for each lot-holding area in order to prevent cross-contamination. A facility's capability to adequately control surface drainage and effluent would depend on a number of factors including the water table, water pressure, angles at which the pipes are placed, number and location of drain openings, and the frequency in cleaning manure and other excreta from drains.
Under proposed § 93.412(d)(3)(v), a medium or minimum security facility would ave to exercise certain security measures in order to prevent unauthorized persons, as well as animals, from coming in contact with quarantined ruminants. The facility and premises would have to be locked and secure at all times while the ruminants are in quarantine. In addition, the facility and premises would have to have posted signs indicating that the facility is a quarantine area and that no visitors are allowed. We would also require that the operator furnish us with one or more telephone numbers at which the operator or his or her agent can be reached at all times.
This paragraph would state that APHIS may place seals on any or all entrances and exits of the facility, as necessary to ensure security, and to take all necessary steps to ensure that the seals are broken only in the presence of an APHIS representative. Should someone other than an APHIS representative break such seals, we would consider such action a breach in security and would carry out an immediate accounting of all ruminants in the facility. If a breach of security occurs, we could extend the quarantine period as long as necessary to determine that the ruminants are free of communicable livestock diseases.
In the event that a communicable livestock disease is diagnosed in quarantined ruminants, the Administrator would have the discretion to order the facility to be guarded by a bonded security company, at the expense of the operator of the facility, in a manner that the Administrator deems is necessary to ensure the biological security of the facility.
In the case of medium security facilities only, we would also require that the facility be guarded at all times by one or more representatives of a bonded security company or, alternatively, the facility have an electronic security system that prevents Start Printed Page 51724the entry of unauthorized persons into the facility and prevents animals outside the facility from having contact with ruminants in quarantine. If an electronic security system is used, we would require that the system be coordinated through or with the local police so that monitoring of the facility is maintained whenever APHIS representatives are not at the facility. The electronic security system would have to be of the “silent type,” approved by Underwriter's Laboratories, and triggered to ring at the monitoring site and, if the operator chooses, at the facility. The operator would have to provide written instructions to the monitoring agency that specify that the police and an APHIS representative designated by APHIS would have to be notified by the monitoring agency if the alarm is triggered. The operator would have to provide a copy of those instructions to the Administrator. The operator would also have to notify the designated APHIS representative whenever a break in security occurs or is suspected of occurring.
Proposed § 93.412(d)(4) would set forth the operating procedures that medium and minimum security facilities would have to observe with respect to APHIS oversight, personnel, authorized access, sanitary practices, handling of quarantined ruminants, and recordkeeping. We would require that these procedures be followed at all times in order to ensure the overall biological security of the quarantine operation, as well as to maintain the health of the animals in quarantine.
In proposed § 93.412(d)(4)(i), we would make clear that while the facility would be owned, operated, and maintained by the operator, the quarantine of ruminants at the facility would be subject to the strict oversight of APHIS representatives. The deployment of APHIS representatives to oversee and provide other professional, technical, and support services at a facility would be determined solely by the Administrator.
APHIS representatives would retain ultimate authority over the quarantine of ruminants at the facility. If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in § 93.412(a), or in accordance with animal health and husbandry standards provided elsewhere in 9 CFR chapter 1, or fails to maintain and operate the facility as provided in proposed § 93.412(d), APHIS representatives would be authorized to furnish such neglected services or make arrangements for the sale or disposal of quarantined ruminants at the operator's expense, as authorized in § 93.412(a).
Under proposed § 93.412(d)(4)(ii), the operator of a medium or minimum security facility would be responsible for hiring personnel to attend to the animals and otherwise maintain, operate, and administer the facility. We would require that the operator provide us with an updated list of all personnel who have access to the facility. The list would have to include the names, current residential addresses, and identification numbers of each person, and must be updated with any changes or additions in advance of such person having access to the quarantine facility. We also would require that the operator provide us with signed statements from all personnel having access to the facility in which the person agrees to comply with proposed § 93.412(d) and other provisions of part 93, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to quarantine operations, including contact with animals both inside and outside the facility. We would require these signed statements so that personnel are made aware of their responsibilities and obligations while working with the animals in quarantine.
To ensure the biological security of medium and minimum security facilities, proposed § 93.412(d)(4)(iii) would restrict facility access to APHIS representatives and other persons specifically authorized to work at the facility. All others would be prohibited from the premises unless specifically granted access by an APHIS representative. We would also require that an APHIS representative accompany at all times any visitors granted access to the facility.
In addition, we would require that all visitors, except veterinary practitioners who enter the facility to provide emergency care, would have to sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 7 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.
Proposed § 93.412(d)(4)(iv) sets forth certain sanitary practices that would need to be followed by all those persons granted access to a medium or minimum security facility. We would require that everyone entering the quarantine area of the facility wear clean protective clothing and footwear. Disposable gloves would have to be worn when handling sick animals. Persons would have to wash their hands after removing the gloves. Persons also would have to change out of protective clothing, footwear, and gloves that have become soiled or contaminated.
If determined necessary by the overseeing APHIS representative, we also would prohibit persons having contact with quarantined ruminants from coming in contact with susceptible animals outside the facility for at least 7 days after their last contact with ruminants in quarantine, or, alternatively, for a longer period of time determined necessary by the overseeing APHIS representative. The period of time may vary, depending on the health status of the quarantined ruminants at the time the person had access to that lot of ruminants. The overseeing APHIS representative would be familiar with the health status of the ruminants under quarantine to determine whether there should be a prohibition against contact with animals outside the facility for a period of 7 days or longer.
We would require that any equipment (including tractors) to be used in the quarantine area of a medium or minimum security facility would first have to be cleaned and disinfected, and would then have to remain dedicated to the facility for the entire quarantine period. In addition, any equipment used with quarantined ruminants would have to remain dedicated to that particular lot of ruminants for the duration of the quarantine period or be cleaned and disinfected before coming in contact with ruminants from another lot. Prior to its use on another lot of ruminants or its removal from the quarantine area, such equipment would have to be cleaned and disinfected to the satisfaction of an APHIS representative.
Vehicles would also have to be cleaned and disinfected immediately prior to entering and leaving the quarantine area of the facility. If the facility utilizes a single loading dock, the loading dock would have to be immediately cleaned and disinfected after each use under the oversight of an APHIS representative. And upon the release of a lot of ruminants from quarantine, the operator would be required to clean and disinfect the lot-Start Printed Page 51725holding area and other portions of the facility in which the ruminants had access before a new lot of ruminants could be placed in that same area of the facility. When disinfecting equipment, vehicles, or other areas of the facility, operators would have to use a disinfectant that is authorized in 9 CFR part 71, § 71.10(a)(5), or is otherwise approved by the Administrator. These measures would be necessary in order to minimize the risk of transmitting diseases into, within, or from the facility.
In addition to the sanitary practices already discussed, medium security facilities would be subject to the following additional requirements. Any persons granted access to the quarantine area would have to shower when entering and leaving the quarantine area, as well as when moving from one lot-holding area to another within the quarantine area. Persons also would have to 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 in the necropsy area. For medium security facilities that handle more than one lot of animals at the same time, all persons entering the quarantine area of the facility would be prohibited, unless specifically allowed otherwise by the overseeing APHIS representative, from coming in contact with any ruminants in quarantine, other than the lot or lots of ruminants to which the person is assigned or granted access.
The operator of a medium security facility would have to provide a sufficient supply of clothing and footwear to ensure that persons with access to the facility's quarantine area have clean, protective clothing and footwear after showering. We would also make the operator responsible for the proper handling, washing, and disposal of soiled and contaminated clothing worn in the quarantine area in a manner approved by an APHIS representative as adequate to preclude the transmission of diseases within and from the facility. At the end of each workday, all work clothing worn into each lot-holding area and other areas of the quarantine area would have to be collected and bagged until the clothing is washed. Used footwear would have to either be left in the clothes changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected as directed by an APHIS representative.
Our standards for the care and handling of ruminants in a medium or minimum security facility would appear in proposed § 93.412(d)(4)(v). Each lot of ruminants would have to be placed in the facility on an “all-in, all-out” basis. Once in quarantine, no ruminants would be removed from the lot except for diagnostic purposes, and no ruminants could be added to the lot during the quarantine period. These requirements would simplify the management of ruminants in the facility while reducing the risk of disease spread. The operator would be responsible for providing adequate feed and bedding from APHIS-approved sources. The feed and bedding would have to be free of vermin and not spoiled. In addition, breeding of ruminants or collection of germ plasm from ruminants would be prohibited during the quarantine period unless required for an import testing procedure.
Ruminants in quarantine in a medium or minimum security facility would be subject to such tests and procedures as directed by the overseeing APHIS representative to determine whether the ruminants are free of communicable livestock diseases. The use of vaccines for ruminants in quarantine would have to be approved by the APHIS representative, licensed in accordance with 9 CFR part 102, and administered by an APHIS veterinarian or an accredited veterinarian under the direct supervision of an APHIS representative.
The death or suspected illness of ruminants in quarantine would have to be reported to the overseeing APHIS representative. The affected ruminants would have to be disposed of as the Administrator may direct or, depending on the nature of the disease, would have to be cared for as directed by APHIS to prevent the spread of disease. We are proposing that animals that require specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. If this occurs, a second quarantine site would be established at the off-site location where the affected animal(s) are being held. In such cases, APHIS could extend the quarantine period until the results of the outstanding tests or postmortems are received.
Should the Administrator determine that an animal health emergency exists at the facility, we would require that arrangements for the final disposition of the infected or exposed lot of ruminants be accomplished within 4 workdays following disease confirmation. The ultimate disposition of the ruminants would then have to occur under the direct oversight of APHIS representatives.
In proposed § 93.412(d)(4)(vi), operators of a medium or minimum security facility would have to follow certain recordkeeping practices while ruminants are in quarantine. For purposes of security, we would require the operator to maintain a current daily log to record the entry and exit of all persons entering and leaving the facility. We would also require that the operator retain the daily security log, as well as any logs maintained by APHIS and deposited with the operator, for at least 2 years following the date of release of the ruminants from quarantine. These logs would have to be made available to APHIS representatives upon request.
To ensure that APHIS would not assent to or facilitate activities that are not in conformance with environmental quality control standards, proposed § 93.412(d)(5) would provide that if APHIS determines that a privately owned medium or minimum security 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.
Proposed § 93.412(d)(6) would put operators of a medium or minimum security facility on notice that they would be responsible for complying with any other applicable Federal, State, and local laws and regulations with respect to the construction, operation, and maintenance of the facility.
In proposed § 93.412(d)(7), we would permit variances from the proposed standards of § 93.412(d) on a case-by-case basis, subject to approval by the Administrator. The Administrator would be authorized to grant a variance to existing facility requirements relating to location, construction and design, sanitation, security, operating procedures, recordkeeping, or other provisions in proposed § 93.412(d), but only if the Administrator determines that there would be no detrimental effect on the health of the ruminants or to the overall biological security of the quarantine operations. The operator would have to submit any request for variance in writing to the Administrator at least 30 days in advance of the arrival of ruminants at the facility. Any variance would also have to be provided for in the compliance agreement. Start Printed Page 51726
Section 93.413 generally restricts visitors from entering the quarantine area of a quarantine facility while ruminants are in quarantine. Section 93.413 does provide that importers whose animals are in quarantine may be admitted to the quarantine area, as necessary, subject to any conditions imposed by the inspector in charge. We are proposing to amend § 93.413 by inserting references to “APHIS representative” alongside “inspector in charge.” “APHIS representative” is the term we propose to use in describing APHIS personnel assigned to oversee and provide other technical services at privately owned medium or minimum security quarantine facilities. We also propose to make a minor technical change by revising “quarantine station” to read “quarantine facility or station.”
Section 93.414 restricts the use of milk or cream from quarantined ruminants. We are proposing to amend § 93.414 by inserting “APHIS representative” alongside “inspector in charge” for the same reason as noted previously for amending § 93.413.
We are also proposing to redesignate the footnote numbers of several footnotes that appear in the regulations. Footnote 7, which appears in the heading “Canada” immediately above § 93.417, would be redesignated as footnote 9. Footnote 8, which appears in the heading “Central America And West Indies” immediately above § 93.422, would be redesignated as footnote 10. And footnote 9, which appears in the heading “Mexico” immediately above § 93.424, would be redesignated as footnote 11. These redesignations would be necessary because of two new footnotes that would be added to the regulations if § 93.412(d) is implemented.
The regulations for the importation of ruminants appear at 9 CFR part 93, subpart D, §§ 93.400 through 93.435 (the regulations). Section 93.411 requires that ruminants arriving in the United States, with certain exceptions, be quarantined upon arrival for at least 30 days. Ruminants from Canada and Mexico are not subject to this quarantine requirement.
Given the current interest in establishing privately owned quarantine facilities for cattle, we are proposing to amend our regulations and publish standards for approval and oversight of such facilities. The standards would have to be consistent with the standards followed at APHIS quarantine facilities to ensure that the health of the U.S. livestock population is not jeopardized by the release of unhealthy animals or communicable disease agents from quarantine facilities.
We are proposing that these standards apply not only to privately owned facilities intended for imported cattle, but for privately owned and operated facilities that wish to handle other imported ruminants, including sheep and goats. Therefore, as part of this proposal, we would remove from our regulations the existing standards for the approval of privately operated quarantine facilities for sheep or goats.
In 2001, about 2,440,000 live cattle worth an estimated $1.1 billion were imported into the United States. Over a 10-year period, 1992-2001, U.S. bovine imports averaged more than 2.2 million head per year, with an annual average value of $1.2 billion. In comparison, the U.S. cattle inventory has averaged about 100 million head over the last 10 years. According to the 1997 Census of Agriculture, the value of U.S. cattle sales in that year was approximately $40.5 billion, based on the sale of 74 million head. Thus, cattle imports represent about 2 percent of the U.S. cattle and calf population, and about 3 percent, by value, of domestic sales.
Almost all U.S. imports of cattle come from Canada and Mexico. In 2001, Canada exported 1,308,670 animals into the United States, while Mexico exported 1,130,168 animals in that same year. The only other sources of imports in 2001 were Norway (350 head) and Australia (12 head). The only other source of imports besides Canada and Mexico in 1999 and 2000 was Australia, which exported a total of 21 and 15 head to the United States in those two years. Based on the historic record, the number of cattle imported into the United States that would be affected by this rule would likely be small, given that ruminants from Canada and Mexico are generally not subject to quarantine as a condition of entry into the United States. However, the number of imports from countries other than Canada and Mexico may be more substantial, depending on the number and type of facilities (medium or minimum security facility) that are approved for operation.
Over the 10-year period, 1991-2000, U.S. sheep imports averaged 39,106 head annually, showing a steady increase from about 23,000 head in 1991, to about 52,000 head in 2000. In 2001, there was a significant increase in sheep imports, to 85,042 head. Canada dominates this market, supplying over 99 percent of U.S. sheep imports over the past 5 years. Very small numbers of sheep are imported from Mexico and New Zealand, and there have been imports previously from Australia, the Republic of South Africa, and the European Union. The annual average value of sheep imports over the 1991-2000 period was approximately $4 million (about $104 per head). Hence, the number of imported sheep affected by this rule would likely be small, given that almost all U.S. imports come from Canada.
Goats imported into the United States numbered only 6 head in 1991, while in 1994, they totaled 28,500 head (27,935 from New Zealand). These extreme import numbers during the early 1990s distort a more steady import pattern over the latter half of the 1990s. Therefore, annual averages over the 6-year period, 1995-2000, are appropriate. During this period, an average of 1,459 goats were imported into the United States yearly. Since 1999, all goat imports have come from Canada. Prior to 1999, Canada dominated the market, but Mexico and New Zealand were also significant in some years. The annual average value of goat imports over the 1996-2001 period was about $535,000 (about $244 per head). Hence, the number of imported goats affected by this rule would likely be small, given that the majority of goats imported into the United States typically come from Canada and Mexico.
U.S. imports of sheep and goats represent a small fraction of total U.S. domestic production of these animals. In 2000, the U.S. sheep population numbered about 7 million, with an Start Printed Page 51727approximate value of $668 million. Based on average sheep imports of 39,106 head per year over the 1991-2000 period, U.S. sheep imports represent less than 1 percent of total U.S. domestic production. In 2000, there were approximately 436,000 Angora goats in the United States with a value of about $17 million. Based on average goat imports of 1,459 head per year over the 1995-2000 period, U.S. goat imports comprise less than 1 percent of total U.S. domestic production, and represent about 3.1 percent of the value of domestically-produced goats (signifying the generally higher value of imported goats).
APHIS and other Federal agencies are required to evaluate whether proposed regulations are likely to have a significant economic impact on a substantial number of small entities. Privately owned and operated quarantine facilities have been used from time to time for the importation of sheep and goats into the United States. However, no such approved facilities are currently in operation. Therefore, the standards contained in this proposed rule would not adversely affect any such entities, large or small. However, should one or more privately owned quarantine facilities be approved for operation, importers should benefit by having additional options for the placement of ruminants to be imported into the United States. And, particularly in the case of minimum security facilities, importers may have the opportunity to import ruminants from certain regions in larger lot sizes as compared to the current situation of having the animals placed in an APHIS indoor quarantine facility.
An environmental assessment has not been prepared for this proposed rule. Because the environmental impacts that could result from implementation of this proposal would vary according to the location and design of the facility being approved, APHIS has determined site-specific environmental assessments must be conducted for each privately owned quarantine facility for ruminants prior to approval of the facility. APHIS will publish a notice in the Federal Register for each environmental assessment we conduct in this regard if this proposed rule is finalized, and we would invite public comment on each site-specific environmental assessment.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. 00-022-1. Please send a copy of your comments to: (1) Docket No. 00-022-1, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.
We are proposing standards for the establishment and operation of privately owned quarantine facilities for imported ruminants prior to their release into the United States. Satisfying the proposed requirements in this rule would entail several information collection activities, including an application for facility approval, a compliance agreement explaining the conditions under which the facility must be operated, certification that the facility meets all applicable environmental regulations, and maintenance of certain records covering quarantine operations.
Estimate of burden: Public reporting burden for this collection of information is estimated to average 9.64 hours per response.
Respondents: Operators of privately owned quarantine facilities for ruminants.
Estimated annual number of responses: 45.
Estimated total annual burden on respondents: 434 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)
Start Part Start Printed Page 51728
2. In part 93, subpart D, footnotes 7, 8, and 9 would be redesignated as footnotes 9, 10, and 11, respectively.
3. Section 93.400 would be amended by revising the footnote and the definition of immediate slaughter and the footnote to recognized slaughtering establishment and by adding, in alphabetical order, new definitions for area veterinarian in charge, Federal veterinarian, lot, lot-holding area, nonquarantine area, Office International des Epizooties (OIE), operator, privately owned medium security quarantine facility (medium security facility), privately owned minimum security quarantine facility (minimum security facility), quarantine area, State veterinarian, and temporary inspection facility to read as follows:
Area veterinarian in charge (AVIC). The veterinary official of the Animal and Plant Health Inspection Service, who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.
Nonquarantine area. That area of a privately owned medium or minimum security quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to ruminants, samples taken from ruminants, and any other objects or substances that have been in the quarantine area during the quarantine of ruminants.
Office International des Epizooties (OIE). The international organization recognized by the World Trade Organization for setting animal health standards, reporting global animal situations and disease status, and presenting guidelines and recommendations on sanitary measures related to animal health.
Operator. A person other than the Federal Government who owns or operates, subject to APHIS' approval and oversight, a privately owned medium or minimum security quarantine facility.
(4) Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
(5) Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services would have to include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.
Recognized slaughtering establishment.[2] * * *
Temporary inspection facility. A facility owned and operated by a person other than the Federal Government that is located within 1 mile of the port of entry and used for the inspection of ruminants imported into the United States in accordance with § 93.408 of this subpart.
4. In § 93.403, paragraph (g) would be revised to read as follows:
(g) Ports and privately owned quarantine facilities. Ruminants may be imported into the United States at any port specified in paragraph (a) of this section, or at any other port designated as an international port or airport by the Bureau of Customs and Border Protection, and quarantined at an APHIS-approved privately owned quarantine facility, provided the applicable provisions of §§ 93.401, Start Printed Page 5172993.404(a), 93.407, 93.408, and 93.412 are met.
5. In § 93.404, paragraph (a)(1) would be amended by adding the words “the name and address of the quarantine facility, if the ruminants are to be quarantined at a privately owned quarantine facility;” after the words “and the port of entry in the United States;”.
6. In § 93.412, paragraphs (a) and (c) would be revised and a new paragraph (d) would be added to read as follows:
(a) Privately owned quarantine facilities. The operator of a privately owned medium or minimum security quarantine facility subject to the regulations in this subpart shall arrange for acceptable transportation from the port to the privately owned quarantine facility and for the care, feeding, and handling of the ruminants from the time of unloading at the port to the time of release from the quarantine facility. Such arrangements shall be agreed to in advance by the Administrator. All expenses related to these activities shall be the responsibility of the operator. The privately owned quarantine facility must be suitable for the quarantine of the ruminants and must be approved by the Administrator prior to the issuance of any import permit. The facilities occupied by the ruminants should be kept clean and sanitary to the satisfaction of the APHIS representatives. If for any cause, the care, feeding, or handling of ruminants, or the sanitation of the facilities is neglected, in the opinion of the overseeing APHIS representative, such services may be furnished by APHIS in the same manner as though arrangements had been made for such services as provided by paragraph (b) of this section, and/or the ruminants may be disposed of as the Administrator may direct, including through their sale in accordance with the procedure described in paragraph (b) of this section. The operator must request in writing inspection and other services as may be required, and shall waive all claims against the United States and APHIS or any employee of APHIS for damages which may arise from such services. The Administrator may prescribe reasonable rates for the services provided under this paragraph. When APHIS finds it necessary to extend the usual minimum quarantine period, APHIS shall advise the operator in writing, and the operator must pay for such additional quarantine and other services required. The operator must pay for all services received in connection with each separate lot of ruminants by certified check or U.S. money order prior to release of the ruminants. If such payment is not made, the ruminants may be sold in accordance with the procedure described in paragraph (b) of this section, or otherwise disposed of as directed by the Administrator.
(c) APHIS collection of payments from the importer, or his or her agent, or the operator, for service rendered shall be deposited so as to be available for defraying the expenses involved in this service.
(d) Standards for privately owned quarantine facilities for ruminants.—(1) APHIS approval of facilities.—(i) Approval procedures. Persons seeking APHIS approval of a privately owned medium or minimum security quarantine facility for ruminants must make written application to the Administrator, c/o National Center for Import and Export, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231. The application 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; copies of all approved State permits for construction and operation of the facility (but not local building permits), as well as copies of all approved Federal, State, and local environmental permits; the anticipated source(s) or origin(s) of ruminants to be quarantined, as well as the expected size and frequency of shipments, and a contingency plan for the possible destruction and disposal of all ruminants capable of being held in the facility.
(A) If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval must agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in § 130.30 of this chapter. If the facility is approved by APHIS, the operator must enter into a compliance agreement in accordance with paragraph (d)(2) of this section.
(A) Before facility approval is denied or withdrawn, APHIS will inform the operator of the proposed or existing facility and include the reasons for the proposed action. If there is a conflict as to any material fact, APHIS will afford Start Printed Page 51730the operator, upon request, the opportunity for a hearing with respect to the merits or validity of such action in accordance with rules of practice that APHIS adopts for the proceeding.
(2) Compliance agreement. (i) A privately owned medium or minimum security quarantine facility must operate in accordance with a compliance agreement executed by the operator or other designated representative of the facility and by the Administrator. The compliance agreement must be signed by both parties before a facility may commence operations. The compliance agreement must provide that:
(i) Location. (A) The medium or minimum security facility must be located at a site approved by the Administrator, and the specific routes for the movement of ruminants from the port must be approved in advance by the Administrator, based on consideration of whether the site or routes would put the animals in a position that could result in their transmitting communicable livestock diseases.
(C) If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator must make arrangements for the imported ruminants to be held in a temporary inspection facility, which is within 1 mile of the port and approved by the Administrator, to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to Start Printed Page 51731the animals' movement to the medium or minimum security facility.
(4) In seeking APHIS approval of the temporary inspection facility, the operator must provide APHIS with the following information: The location and street address, as well as blueprints or a description of the temporary inspection facility; a description of the financial resources available for its construction (if applicable), operation, and maintenance; copies of all approved State and local permits for construction and operation of the temporary inspection facility, as well as copies of all approved Federal, State, and local environmental permits; and the anticipated source(s) or origin(s), lot size, and frequency of shipments of imported ruminants to be handled at the facility. Following APHIS approval of the temporary inspection facility, the operator will also provide APHIS with a copy of the local building permit, when obtained.
(6) APHIS' approval to build and operate medium or minimum security facility outside the immediate vicinity of a designated port is contingent upon APHIS' approval of the temporary inspection facility at the port, as well as approval of the routes for the movement of ruminants from the port to the medium or minimum security facility.
(C) Means of isolation. The facility must provide pens, chutes, and other animal restraining devices, as appropriate, for inspection and identification of each animal, as well as for segregation, treatment, or both, of any ruminant exhibiting signs of illness. The medium or minimum security facility must also have lot-holding areas of sufficient size to prevent overcrowding. A medium security facility may hold more than one lot of ruminants as long as the lots are separated by physical barriers such that ruminants in one lot do not have physical contact with ruminants in another lot or with their excrement or discharges. A minimum security facility may not hold more than one lot of animals at the same time.
(C) Surfaces. The medium security facility must be constructed so that the floor surfaces with which ruminants have contact are nonslip and wear-resistant. All floor surfaces with which the ruminants, their excrement, or discharges have contact must slope gradually to the center, where one or more drains of at least 8 inches in diameter are located for adequate drainage, or, alternatively, must be of slatted or other floor design that allows for adequate drainage. All floor and wall surfaces with which the ruminants, their excrement, or discharges have contact must be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Other ceiling and wall Start Printed Page 51732surfaces with which the ruminants, their excrement, or discharges do not have contact must be able to withstand cleaning and disinfection between shipments of ruminants. All floor and wall surfaces must be free of sharp edges that could cause injury to ruminants.
(iv) Sanitation. To ensure that proper animal health and biological security measures are observed, a privately owned medium or minimum security quarantine facility must provide the following:
(5) In the event that a communicable livestock disease is diagnosed in quarantined ruminants, the Administrator may require that the operator have the facility guarded by a bonded security company, at the expense of the operator of the facility, in a manner that the Administrator deems necessary to ensure the biological security of the facility. Start Printed Page 51733
(2) If an electronic security system is used, the electronic security system must be coordinated through or with the local police so that monitoring of the 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, if the operator chooses, 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 an APHIS representative designated by APHIS must be notified by the monitoring agency if the alarm is triggered. The operator also must submit a copy of those instructions to the Administrator. The operator must notify the designated APHIS representative whenever a break in security occurs or is suspected of occurring.
(B) If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in paragraph (d) of this section, or in accordance with animal health and husbandry standards provided elsewhere in this chapter, or fails to maintain and operate the facility as provided in paragraph (d) of this section, APHIS representatives are authorized to furnish such neglected services or make arrangements for the sale or disposal of quarantined ruminants at the operator's expense, as authorized in paragraph (a) of this section.
(B) All visitors, except veterinary practitioners who enter the facility to provide emergency care, must sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 7 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.
(4) Be prohibited, if determined necessary by the overseeing APHIS representative, from having contact with any susceptible animals outside the facility for at least 7 days after the last contact with ruminants in quarantine, or for a longer period of time determined necessary by the overseeing APHIS representative to prevent the transmission of livestock diseases.
(i) Shower when entering and leaving the quarantine area.
(iii) 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. Start Printed Page 51734
(2) The operator is responsible for providing a sufficient supply of clothing and footwear to ensure that workers and others provided access to the quarantine area of the facility have clean, protective clothing and footwear after showering.
(v) Handling of ruminants in quarantine. (A) Each lot of ruminants to be quarantined must be placed in the facility on an “all-in, all-out” basis. No ruminant may be taken out of a lot while the lot is in quarantine, except for diagnostic purposes, and no ruminant may be added to a lot while in quarantine.
(G) Should the Administrator determine that an animal health emergency exists at the facility, arrangements for the final disposition of the infected or exposed lot of ruminants must be accomplished within 4 workdays following disease confirmation. Subsequent disposition of the ruminants must occur under the direct oversight of APHIS representatives.
(vi) Recordkeeping. (A) The operator must maintain a current daily log, to record the entry and exit of all persons entering and leaving the facility.
7. Section 93.413 would be revised to read as follows:
8. In § 93.414, the first sentence would be amended by adding the words “APHIS representative or” immediately before the words “inspector in charge”.
9. Section 93.434 would be removed and reserved.
1. The name of recognized slaughtering establishments approved under this part may be obtained from the area veterinarian in charge for the State of destination of the shipment. The name and address of the area veterinarian in charge of any State is available from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export, 4700 River Road, Unit 38, Riverdale, MD 20737-1231.
7. The name and address of the area veterinarian in charge of any State is available from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231.
8. A list of approved vaccines is available from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import and Export, 4700 River Road, Unit 38, Riverdale, MD 20737-1231.
[FR Doc. 03-21857 Filed 8-27-03; 8:45 am]