[Federal Register: August 28, 2003 (Volume 68, Number 167)]
[Proposed Rules]
[Page 51716-51734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au03-21]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 93
[Docket No. 00-022-1]
Standards for Privately Owned Quarantine Facilities for Ruminants
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: 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.
DATES: We will consider all comments that we receive on or before
October 27, 2003.
ADDRESSES: 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.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Arnaldo Vaquer, Senior Staff
Veterinarian, National Center for Import and Export, VS, APHIS, USDA,
4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 734-3277.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 93 govern the importation into the
United States of specified animals and animal products in order to help
prevent the introduction of various animal diseases into the United
States. The regulations in part 93 require, among other things, that
certain animals, as a condition of entry, be quarantined upon arrival
in the United States. The Animal and Plant Health Inspection Service
(APHIS) of the U.S. Department of Agriculture operates animal
quarantine facilities. We also authorize the use of quarantine
facilities that are privately owned and operated for certain animal
importations.
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 Sec. 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
[[Page 51717]]
for 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.
Definitions
We are proposing to add to Sec. 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:
[sbull] Is owned, operated, and financed by a person other than the
Federal Government;
[sbull] Is subject to the strict oversight of APHIS
representatives;
[sbull] Is constructed, operated, and maintained in accordance with
the requirements for medium security facilities in Sec. 93.412(d); and
[sbull] 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:
[sbull] Is owned, operated, and financed by a person other than the
Federal Government;
[sbull] Is subject to the strict oversight of APHIS
representatives;
[sbull] Is constructed, operated, and maintained in accordance with
the requirements for minimum security facilities in Sec. 93.412(d);
[sbull] 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
[sbull] 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
[[Page 51718]]
subdivision 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 Sec. 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.
Ports of Entry
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 Sec. 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 Sec. 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 Sec. 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 Sec. 93.403(g).
First, for purposes of clarity, we would amend the phrase ``may be
entered'' in Sec. 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 Sec. 93.433 and Sec. 93.434 that appear in Sec.
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.
Import Permits
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 Sec. 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.
Privately Owned Quarantine Facilities
Paragraph (a) of Sec. 93.412 authorizes the establishment of
privately operated quarantine facilities, subject to APHIS approval and
oversight. We are proposing to amend Sec. 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 Sec. 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 Sec. 93.412(d). We also would make other minor technical
changes, either to be consistent with proposed Sec. 93.412(d), or for
stylistic purposes.
Paragraph (c) of Sec. 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 Sec. 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
Sec. 93.412(a) and importers of ruminants who utilize the services of
APHIS quarantine facilities under Sec. 93.412(b).
Standards for Privately Owned Quarantine Facilities for Ruminants
We are proposing to add a new paragraph (d) to Sec. 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
[[Page 51719]]
and 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 Sec. 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 Sec. 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.
APHIS Approval of Facilities
We would provide information in Sec. 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 Sec. 93.404 and elsewhere in the
regulations.
Approval Procedures
Under proposed Sec. 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:
[sbull] The full name and mailing address of the applicant;
[sbull] The location and street address of the facility for which
approval is sought;
[sbull] Blueprints of the facility;
[sbull] A description of the financial resources available for
construction, operation, and maintenance of the facility;
[sbull] 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;
[sbull] The anticipated source(s) and origin(s) of ruminants to be
quarantined, as well as the expected size and frequency of shipments;
and
[sbull] 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.
Requests for approval of a proposed facility would be evaluated on
a first-come, first-served basis.
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 Sec. 93.412(d).
Proposed Sec. 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 Sec. 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 Sec. 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
[[Page 51720]]
APHIS personnel. The Administrator would have sole discretion in
determining the number of APHIS personnel to be assigned to a facility.
Proposed Sec. 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 Sec.
93.412(d), as well as the terms of the compliance agreement, in order
for the facility to maintain its approved status.
Proposed Sec. 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 Sec. 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 Sec. 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.
Compliance Agreement
We are proposing that all medium and minimum security facilities
operate in accordance with a compliance agreement required under Sec.
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
Sec. 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 Sec. 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.
Physical Plant Requirements
Proposed Sec. 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.
Location
Proposed Sec. 93.412(d)(3)(i) would require that imported
ruminants arrive at a port designated for the importation of ruminants
under Sec. 93.403(g) (discussed earlier under ``Ports of Entry'').
Proposed Sec. 93.412(d)(3)(i) also would require that a medium or
[[Page 51721]]
minimum 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 Sec. 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 Sec.
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.
Construction
Proposed Sec. 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, Sec. 71.10(a)(5), or is otherwise
approved by the Administrator. Paragraph (a)(5) of Sec. 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.
[[Page 51722]]
A 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.
Additional Construction Requirements for Medium Security Facilities
Proposed Sec. 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
[[Page 51723]]
sufficient 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.
Sanitation
Proposed Sec. 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, Sec. 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.
Security
Under proposed Sec. 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
[[Page 51724]]
the 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.
Operating Procedures
Proposed Sec. 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.
APHIS Oversight
In proposed Sec. 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 Sec. 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
Sec. 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
Sec. 93.412(a).
Personnel
Under proposed Sec. 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 Sec. 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.
Authorized Access
To ensure the biological security of medium and minimum security
facilities, proposed Sec. 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.
Sanitary Practices
Proposed Sec. 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-
[[Page 51725]]
holding 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, Sec. 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
[deg]F minimum) and detergent and disinfected as directed by an APHIS
representative.
Handling of Quarantined Ruminants
Our standards for the care and handling of ruminants in a medium or
minimum security facility would appear in proposed Sec.
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.
Recordkeeping
In proposed Sec. 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.
Environmental Quality
To ensure that APHIS would not assent to or facilitate activities
that are not in conformance with environmental quality control
standards, proposed Sec. 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.
Other Laws
Proposed Sec. 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.
Variances
In proposed Sec. 93.412(d)(7), we would permit variances from the
proposed standards of Sec. 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 Sec.
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.
[[Page 51726]]
Miscellaneous Changes
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 Sec. 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 Sec. 93.414 by inserting ``APHIS
representative'' alongside ``inspector in charge'' for the same reason
as noted previously for amending Sec. 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 Sec. 93.417, would
be redesignated as footnote 9. Footnote 8, which appears in the heading
``Central America And West Indies'' immediately above Sec. 93.422,
would be redesignated as footnote 10. And footnote 9, which appears in
the heading ``Mexico'' immediately above Sec. 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
Sec. 93.412(d) is implemented.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
The regulations for the importation of ruminants appear at 9 CFR
part 93, subpart D, Sec. Sec. 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.
Section 93.412, paragraph (a), authorizes the establishment of
privately operated quarantine facilities for ruminants, subject to
APHIS approval and oversight. Section 93.434 contains standards for the
approval, operation, and oversight of privately operated quarantine
facilities for sheep or goats. After these standards were first
established in 1988, privately operated quarantine facilities were
briefly used for the importation of sheep and goats into the United
States. However, there are currently no approved private quarantine
facilities for sheep or goats, or for other ruminants. Therefore,
imported ruminants subject to quarantine must enter the United States
through facilities maintained by APHIS.
We have received requests to import cattle into the United States
through quarantine facilities that are privately owned and operated.
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
[[Page 51727]]
approximate 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.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
National Environmental Policy Act
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.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your 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.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 9.64 hours per response.
Respondents: Operators of privately owned quarantine facilities for
ruminants.
Estimated annual number of respondents: 25.
Estimated annual number of responses per respondent: 1.8.
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.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this proposed rule, please contact Mrs. Celeste
Sickles, APHIS'' Information Collection Coordinator, at (301) 734-7477.
List of Subjects in 9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 9 CFR part 93 as follows:
[[Page 51728]]
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
1. The authority citation for part 93 would continue to read as
follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
2. 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:
Sec. 93.400 Definitions.
* * * * *
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.
* * * * *
Federal veterinarian. A veterinarian employed and authorized by the
Federal Government to perform the tasks required by this subpart.
* * * * *
Immediate slaughter. Consignment directly from the port of entry to
a recognized slaughtering establishment \1\ and slaughtered within 2
weeks from the date of entry.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
* * * * *
Lot. 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.
Lot-holding area. That area in a privately owned medium or minimum
security quarantine facility in which a single lot of ruminants is held
at one time.
* * * * *
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.
* * * * *
Privately owned medium security quarantine facility (medium
security facility). A facility that:
(1) Is owned, operated, and financed by a person other than the
Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the
requirements for medium security facilities in Sec. 93.412(d); and
(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.
Privately owned minimum security quarantine facility (minimum
security facility). A facility that:
(1) Is owned, operated, and financed by a person other than the
Federal Government;
(2) Is subject to the strict oversight of APHIS representatives;
(3) Is constructed, operated, and maintained in accordance with the
requirements for minimum security facilities in Sec. 93.412(d);
(4) 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
(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.
Quarantine area. 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, and any areas used to conduct examinations of
ruminants and take samples and any areas where samples are processed or
examined.
Recognized slaughtering establishment.\2\ * * *
---------------------------------------------------------------------------
\2\ See footnote 1.
---------------------------------------------------------------------------
* * * * *
State veterinarian. A veterinarian employed and authorized by a
State or political subdivision of a State to perform the tasks required
by this subpart.
* * * * *
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 Sec. 93.408 of this subpart.
* * * * *
4. In Sec. 93.403, paragraph (g) would be revised to read as
follows:
Sec. 93.403 Ports designated for the importation of ruminants.
* * * * *
(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 Sec. Sec.
93.401,
[[Page 51729]]
93.404(a), 93.407, 93.408, and 93.412 are met.
Sec. 93.404 [Amended]
5. In Sec. 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 Sec. 93.412, paragraphs (a) and (c) would be revised and a
new paragraph (d) would be added to read as follows:
Sec. 93.412 Ruminant quarantine facilities.
(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 Sec. 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.
(B) Requests for approval must be submitted at least 120 days prior
to the date of application for local building permits. Requests for
approval will be evaluated on a first-come, first-served basis.
(ii) Criteria for approval. Before a facility may be built to
operate as a privately owned medium or minimum security quarantine
facility for ruminants, it must be approved by APHIS. To be approved:
(A) APHIS must find, based on an environmental assessment, and
based on any required Federal, State, and local environmental permits
or evaluations secured by the operator and copies of which are provided
to APHIS, that the operation of the facility will not have significant
environmental effects;
(B) The facility must meet all the requirements of paragraph (d) of
this section;
(C) The facility must meet any additional requirements that may be
imposed by the Administrator in each specific case, as specified in the
compliance agreement required under paragraph (d)(2) of this section,
to ensure that the quarantine of ruminants in the facility will be
adequate to enable determination of their health status, as well as to
prevent the transmission of livestock diseases into, within, and from
the facility; and
(D) The Administrator must determine whether sufficient personnel,
including one or more APHIS veterinarians and other professional,
technical, and support personnel, are available to serve as APHIS
representatives at the facility and provide continuous oversight and
other technical services to ensure the biological security of the
facility, if approved. APHIS will assign personnel to facilities
requesting approval in the order that the facilities meet all of the
criteria for approval. The Administrator has sole discretion on the
number of APHIS personnel to be assigned to the facility.
(iii) Maintaining approval. To maintain APHIS approval, the
operator must continue to comply with all the requirements of paragraph
(d) of this section as well as the terms of the compliance agreement
executed in accordance with paragraph (d)(2) of this section.
(iv) Withdrawal or denial of approval. Approval of a proposed
privately owned medium or minimum security quarantine facility may be
denied or approval of a facility already in operation may be withdrawn
at any time by the Administrator for any of the reasons provided in
paragraph (d)(1)(iv)(C) 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
[[Page 51730]]
the 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.
(B) Withdrawal of approval of an existing facility will become
effective pending final determination in the proceeding when the
Administrator determines that such action is necessary to protect the
public health, interest, or safety. Such withdrawal will be effective
upon oral or written notification, whichever is earlier, to the
operator of the facility. In the event of oral notification, APHIS will
give written confirmation to the operator of the facility as promptly
as circumstances allow. This withdrawal will continue in effect pending
the completion of the proceeding and any judicial review, unless
otherwise ordered by the Administrator. In addition to withdrawal of
approval for the reasons provided in paragraph (d)(1)(iv)(C) of this
section, the Administrator will also automatically withdraw approval
when the operator of any approved facility notifies the area
veterinarian in charge for the State in which the facility is located,
in writing, that the facility is no longer in operation.\7\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
(C) The Administrator may deny or withdraw the approval of a
privately owned medium or minimum security quarantine facility if:
(1) Any requirement of paragraph (d) of this section or the
compliance agreement is not met; or
(2) The facility has not been in use to quarantine ruminants for a
period of at least 1 year; or
(3) The operator fails to remit any charges for APHIS services
rendered; or
(4) The operator or a person responsibly connected with the
business of the facility is or has been convicted of any crime under
any law regarding the importation or quarantine of any animal; or
(5) The operator or a person responsibly connected with the
business of the facility is or has been convicted of a 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; or
(6) Any other requirement under the Animal Health Protection Act (7
U.S.C. 8301-8317) or the regulations thereunder are not met.
(D) For the purposes of paragraph (d)(1)(iv) of this section, a
person is deemed to be responsibly connected with the business of the
facility if such person has an ownership, mortgage, or lease interest
in the facility, 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.
(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:
(A) The facility must meet all applicable requirements of paragraph
(d) of this section;
(B) The facility's quarantine operations are subject to the strict
oversight of APHIS representatives;
(C) The operator agrees to be responsible for the cost of building
the facility; all costs associated with its maintenance and operation;
all costs associated with the hiring of personnel to attend to the
ruminants, as well as to maintain and operate the facility; all costs
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 APHIS
charges for the services of APHIS representatives in accordance with
this section and part 130 of this chapter;
(D) The operator obtained, prior to execution of this 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, including
a worst case scenario in which all quarantined ruminants must be
destroyed and disposed of because of an animal health emergency, as
determined by the Administrator.
(E) The operator will deposit with the Administrator, prior to
commencing quarantine operations, a certified check or U.S. money order
to cover the estimated costs, as determined by the Administrator, of
professional, technical, and support services to be provided by APHIS
at the facility over the duration of the quarantine. If actual costs
incurred by APHIS over the quarantine period exceed the deposited
amount, the operator will pay for any additional costs incurred by
APHIS, based on official accounting records. Payment for all services
received in connection with each lot of ruminants in quarantine shall
be made prior to release of the ruminants. The operator must pay for
any other costs incurred by APHIS 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. APHIS
will return to the operator any unobligated funds deposited with APHIS,
after the release of the lot of ruminants from the facility and
termination or expiration of the compliance agreement, or, if
requested, credit to the operator's account such funds to be applied
towards payment of APHIS services at a future date.
(ii) Prior to the entry of each subsequent lot of ruminants into
the medium or minimum security facility, a new compliance agreement
must be executed, and a certified check or U.S. money order to the
Administrator must be deposited to cover the estimated costs, as
determined by the Administrator, of professional, technical, and
support services to be provided by APHIS at the facility over the
duration of the quarantine.
(3) Physical plant requirements. A privately owned medium or
minimum security quarantine facility must meet the following
requirements as determined by an APHIS inspection before ruminants may
be admitted to it.
(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.
(B) In the case of a medium security facility, the facility must be
located at least one-half mile from any premises holding livestock. In
the case of a minimum security facility, the Administrator will
establish the required minimum distance between the facility and other
premises holding livestock on a case-by-case basis.
(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
[[Page 51731]]
the animals' movement to the medium or minimum security facility.
(1) The temporary inspection facility must have adequate space for
Federal or State veterinarians to conduct examinations and testing of
the imported ruminants.
(2) The examination space of the temporary inspection facility must
be equipped with appropriate animal restraining devices for the safe
inspection of ruminants.
(3) The temporary inspection facility may not hold more than one
lot of animals at the same time.
(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.
(5) 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 animals will be
refused entry. Ruminants refused entry remain the responsibility of the
operator, but subject to further handling or disposition as directed by
the Administrator in accordance with Sec. 93.408 of this subpart.
(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.
(ii) Construction. The medium or minimum security facility must be
of sound construction, in good repair, and properly designed to prevent
the escape of quarantined ruminants. It must have adequate capacity to
receive and hold a shipment of ruminants as a lot on an ``all-in, all-
out'' basis and must include the following:
(A) Loading docks. The facility must include separate docks for
animal receiving and releasing and for general receiving and pickup,
or, alternatively, a single dock may be used for both purposes if the
dock is cleaned and disinfected after each use in accordance with
paragraph (d)(4)(iv)(D) of this section.
(B) Perimeter fencing. The facility 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 any ruminants in quarantine.
(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.
(D) APHIS space. The facility must have adequate space for APHIS
representatives to conduct examinations and draw samples for testing of
ruminants in quarantine, prepare and package samples for mailing, and
store duplicate samples and the necessary equipment and supplies for
each lot of ruminants. The examination space must be equipped with
appropriate animal restraining devices for the safe inspection of
ruminants. The facility must also provide a secure, lockable office for
APHIS use with enough room for a desk, chair, and filing cabinet.
(E) Storage. The facility must have sufficient storage space for
equipment and supplies used in quarantine operations. Storage space
must include separate, secure storage for pesticides and for medical
and other biological supplies, as well as a separate storage area for
feed and bedding, if feed and bedding are stored at the facility.
(F) Other work areas. The facility must include work areas for the
repair of equipment and for cleaning and disinfecting equipment used in
the facility.
(iii) Additional construction requirements for medium security
facilities. For medium security facilities only, the following
requirements must also be met:
(A) Self-contained building. The medium security facility must be
constructed so that the quarantine area is located in a secure, self-
contained building that contains appropriate control measures against
the spread of livestock diseases biologically transmissible by vectors.
All entryways into the nonquarantine area of the building must be
equipped with a secure and lockable door. While ruminants are in
quarantine, all access to the quarantine area must be from within the
building. Each entryway to the quarantine area must be equipped with a
solid self-closing door. Separate access must 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 may exist in the quarantine area if required by
local fire ordinances. Such emergency exits must be constructed so as
to permit their opening from the inside of the facility only.
(B) Windows and other openings. Any windows or other openings in
the quarantine area must be double-screened with screening of
sufficient gauge and mesh to prevent the entry or exit of insects and
other vectors of livestock diseases and to provide ventilation
sufficient to ensure the comfort and safety of all ruminants in the
facility. The interior and exterior screens must be separated by at
least 3 inches (7.62 cm). All screening of windows or other openings
must be easily removable for cleaning, 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.
(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
[[Page 51732]]
surfaces 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.
(D) Ventilation and climate control. The medium security facility
must be constructed with a heating, ventilation, and air conditioning
(HVAC) system capable of controlling and maintaining the ambient
temperature, air quality, moisture, and odor at levels that are not
injurious or harmful to the health of ruminants in quarantine. Air
supplied to lot-holding areas must not be recirculated or reused for
other ventilation needs. HVAC systems for lot-holding areas must be
separate from air handling systems for other operational and
administrative areas of the facility. In addition, if the facility is
approved to handle more than one lot of ruminants at a time, each lot-
holding area must have its own separate HVAC system that is designed to
prevent cross-contamination between the separate lot-holding areas.
(E) Lighting. The medium security facility must have adequate
lighting throughout, including in the lot-holding areas and other areas
used to examine ruminants and conduct necropsies.
(F) Fire protection. The medium security facility, including the
lot-holding areas, must have a fire alarm and voice communication
system.
(G) Monitoring system. The medium security facility must have a
television monitoring system or other arrangement sufficient to provide
a full view of the lot-holding areas.
(H) Communication system. The medium security facility must have a
communication system between the nonquarantine and quarantine areas of
the facility.
(I) Necropsy area. The medium security facility must have an area
that is of sufficient size to perform necropsies on ruminants and that
is equipped with adequate lighting, hot and cold running water, a
drain, a cabinet for storing instruments, a refrigerator-freezer for
storing specimens, and an autoclave to sterilize veterinary equipment.
(J) Additional storage requirements. Feed storage areas in the
medium security facility must be vermin-proof. Also, if the medium
security facility has multiple lot-holding areas, then separate storage
space for supplies and equipment must be provided for each lot-holding
area.
(K) Showers. In a medium security facility, there must be a shower
at the entrance to the quarantine area. A shower also must be located
at the entrance to the necropsy area. A clothes-storage and clothes-
changing area must be provided at each end of each shower area. There
also must be one or more receptacles near each shower so that clothing
that has been worn in a lot-holding area or elsewhere in the quarantine
area can be deposited in the receptacle(s) prior to entering the
shower.
(L) Restrooms. The medium security facility must have permanent
restrooms in both the nonquarantine and quarantine areas of the
facility.
(M) Break room. The medium security facility must have an area
within the quarantine area for breaks and meals.
(N) Laundry area. The medium security facility must have an area
for washing and drying clothes, linens, and towels.
(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:
(A) Equipment and supplies necessary to maintain the facility in a
clean and sanitary condition, including pest control equipment and
supplies and cleaning and disinfecting equipment with adequate capacity
to disinfect the facility and equipment.
(B) Separately maintained sanitation and pest control equipment and
supplies for each lot-holding area if the facility will hold more than
one lot of ruminants at a time (applicable to medium security
facilities only).
(C) A supply of potable water adequate to meet all watering and
cleaning needs, with water faucets for hoses located throughout the
facility. An emergency supply of water for ruminants in quarantine also
must be maintained.
(D) A stock of disinfectant authorized in Sec. 71.10(a)(5) of this
chapter or otherwise approved by the Administrator that is sufficient
to disinfect the entire facility.
(E) The capability to dispose of wastes, including manure, urine,
and used bedding, by means of burial, incineration, or public sewer.
Other waste material must be handled in such a manner that minimizes
spoilage and the attraction of pests and must be disposed of by
incineration, public sewer, or other preapproved manner that prevents
the spread of disease. Disposal of wastes must be carried out under the
direct oversight of APHIS representatives.
(F) The capability to dispose of ruminant carcasses in a manner
approved by the Administrator and under conditions that prevent the
spread of disease from the carcasses.
(G) For incineration to be carried out at the facility,
incineration equipment that is detached from other facility structures
and is capable of burning wastes or carcasses as required. The
incineration site must include an area sufficient for solid waste
holding. Incineration may also take place at a local site away from the
facility premises. All incineration activities must be carried out
under the direct oversight of an APHIS representative.
(H) The capability to control surface drainage and effluent into,
within, and from the facility in a manner that prevents the spread of
disease into, within, and from the facility. If the facility is
approved to handle more than one lot of ruminants at the same time,
there must be separate drainage systems for each lot-holding area in
order to prevent cross contamination.
(v) Security.
(A) A privately owned medium or minimum security quarantine
facility must provide the following security measures:
(1) The facility and premises must be kept locked and secure at all
times while the ruminants are in quarantine.
(2) The facility and premises must have signs indicating that the
facility is a quarantine area and no visitors are allowed.
(3) The operator must furnish a telephone number or numbers to
APHIS at which the operator or his or her agent can be reached at all
times.
(4) APHIS is authorized to place seals on any or all entrances and
exits of the facility, when determined necessary by APHIS to ensure
security, and to take all necessary steps to ensure that the seals are
broken only in the presence of an APHIS representative. If the seals
are broken by someone other than an APHIS representative, it will be
considered a breach in security, and an immediate accounting of all
ruminants in the facility will be made by an APHIS representative. If a
breach in security occurs, APHIS may extend the quarantine period as
long as necessary to determine that the ruminants are free of
communicable livestock diseases.
(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.
[[Page 51733]]
(B) A privately owned medium security facility also must provide
the following security measures:
(1) The medium security facility and premises must be guarded at
all times by one or more representatives of a bonded security company,
or, alternatively, the medium security facility must have an electronic
security system that prevents the entry of unauthorized persons into
the facility and prevents animals outside the facility from having
contact with ruminants in quarantine;
(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.
(4) Operating procedures. The following procedures must be followed
at a privately owned medium or minimum security quarantine facility at
all times:
(i) APHIS oversight. (A) The quarantine of ruminants at the
facility will be subject to the strict oversight of APHIS
representatives authorized to perform the services required by this
subpart.
(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.
(ii) Personnel. (A) The operator must provide adequate personnel to
maintain the facility and care for the ruminants in quarantine,
including attendants to care for and feed ruminants, and other
personnel as needed to maintain, operate, and administer the facility.
(B) The operator must provide APHIS with an updated list of all
personnel who have access to the facility. The list must include the
names, current residential addresses, and identification numbers of
each person, and must be upd