[Federal Register Volume 64, Number 210 (Monday, November 1, 1999)]
[Rules and Regulations]
[Pages 58769-58780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27746]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 77
[Docket No. 99-008-1]
Tuberculosis in Cattle and Bison; State Designations
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are amending the bovine tuberculosis regulations to allow
zones within a State to be assigned different risk statuses and to
clarify the conditions for assigning a particular risk status for
bovine tuberculosis. We are also amending the regulations to increase
the amount of testing that must be done before certain cattle and bison
may be moved interstate. These changes are necessary to help prevent
the spread of tuberculosis and to further the progress of the domestic
bovine tuberculosis eradication program.
DATES: This interim rule is effective October 20, 1999. We invite you
to comment on this docket. We will consider all comments that we
receive by January 3, 2000.
The incorporation by reference listed in this rule is approved by
the Director of the Federal Register as of October 20, 1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 99-
008-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road, Unit 118, Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 99-008-1.
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 rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Joseph Van Tiem, Senior Staff
Veterinarian, VS, APHIS, USDA, 4700 River Road Unit 43, Riverdale, MD
20737-1231; (301) 734-7716.
SUPPLEMENTARY INFORMATION:
Background
Bovine tuberculosis is a contagious, infectious, and communicable
disease caused by Mycobacterium bovis. It affects cattle, bison, deer,
elk, goats, and other species, including humans. Bovine tuberculosis in
infected animals and humans manifests itself in lesions of the lung,
bone, and other body parts, causes weight loss and general
debilitation, and can be fatal.
At the beginning of this century, bovine tuberculosis caused more
losses of livestock than all other livestock diseases combined. This
prompted the establishment of the National Cooperative State/Federal
Bovine Tuberculosis Eradication Program for bovine tuberculosis in
livestock.
Federal regulations implementing this program are contained in 9
CFR part 77, ``Tuberculosis'' (referred to below as the regulations),
and in the ``Uniform
[[Page 58770]]
Methods and Rules--Bovine Tuberculosis Eradication'' (UMR), which is
incorporated by reference into the regulations. (This interim rule
updates the edition that is incorporated, as discussed below under the
heading ``UMR.'') The regulations restrict the interstate movement of
cattle, bison, and captive cervids to prevent the spread of bovine
tuberculosis.
Restrictions on the interstate movement of cattle and bison not
known to be affected with or exposed to tuberculosis have been based on
whether the animals are moved from States designated as accredited-free
States, accredited-free (suspended) States, modified accredited States,
or nonmodified accredited States. Although the restrictions on the
interstate movement of captive cervids are currently not based on the
tuberculosis status of a State, we are developing regulations that
would establish such a relationship.
The status of a State is based on its freedom from evidence of
tuberculosis in cattle and bison, the effectiveness of the State's
tuberculosis eradication program, and the degree of the State's
compliance with the standards for cattle and bison contained in the
UMR. Currently, a State's tuberculosis status is not determined or
affected by evidence of tuberculosis in cervids.
Section 77.1 of the regulations has defined and listed accredited-
free, accredited-free (suspended), modified accredited, and nonmodified
accredited States. Prior to this interim rule, these terms were defined
in the regulations as follows:
Accredited-free State. An accredited-free State was defined as a
State that has had no findings of tuberculosis in any cattle or bison
anywhere in the State for at least 5 years. (As noted above, there are
currently no defined State tuberculosis statuses with regard to
cervids.) The definition also provided that a State must comply with
all the provisions of the UMR regarding accredited-free States. These
provisions include a requirement that the State demonstrate annually
that an adequate amount of testing and slaughter surveillance is done
in that State to discover any bovine tuberculosis that might be
present. The definition of accredited-free State provided that
detection of tuberculosis in any cattle or bison in the State would
result in suspension of the State's accredited-free status, and that,
if tuberculosis were detected in two or more herds anywhere in the
State within a 48-month period, the State's accredited-free status
would be downgraded.
Accredited-free (suspended) State. An accredited-free (suspended)
State was defined as an accredited-free State in which tuberculosis has
been detected in any cattle or bison.
Modified accredited State. A modified accredited State was defined
as a State that complies with all the provisions of the UMR regarding
modified accredited States. The UMR requires that, to retain modified
accredited status, a State must demonstrate annually that an adequate
amount of testing and slaughter surveillance is done in that State to
discover any bovine tuberculosis that might be present. The UMR also
provides that disclosure of tuberculosis in the State or failure of the
State to take progressive steps to comply with the UMR to seek out and
eliminate bovine tuberculosis will be cause for downgrading of the
modified accredited status. Further, the regulations provided that if
any livestock other than cattle or bison were included in a newly
assembled herd on a premises where a tuberculous herd had been
depopulated, the State must apply the UMR herd test requirements for
such newly assembled herds to those other livestock as well as to
cattle and bison in the new herd.
Nonmodified accredited State. A nonmodified accredited State was
defined as a State that has not received accredited-free status or
modified accredited status.
Need for this Interim Rule
Prior to this interim rule, the regulations did not provide for
different areas, or zones, within a State to be assigned different
tuberculosis risk statuses. There have historically been a number of
reasons for not considering areas smaller than a State for regulatory
purposes. Generally, the legal authority to issue and enforce
regulations concerning tuberculosis under the animal quarantine laws is
limited to interstate, rather than intrastate, movement of regulated
products and animals. Additionally, each State has in place its own
administrative and veterinary infrastructure and legal authority for
monitoring, detecting, recording, controlling, and eradicating animal
diseases in that State. This centralization of veterinary efforts at
the State level has made it natural to consider one uniform disease
status for each State. Further, because State borders are clearly
defined legal boundaries, they have lent themselves to delineating a
readily identifiable area for disease risk.
However, just as the United States has recently begun to recognize
regions smaller than a country when considering the risk of disease
from imports from a foreign country,1 there are compelling
reasons for considering areas smaller than a State when considering
tuberculosis risk in the United States.
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\1\ See, for example, ``64 FR 34155-34168, Docket No. 97-086-2,
Recognition of Animal Disease Status of Regions in the European
Union,'' published June 25, 1999, and ``64 FR 8755-8761, Docket No.
97-079-1, Importation of Pork and Pork Products from Yucatan and
Sonora, Mexico,'' published February 23, 1999.
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Under the regulations prior to this interim rule, if tuberculosis
was determined to exist in any part of a State, the entire State was
designated as being at risk. This ``all or nothing'' approach did not
always provide sufficient incentive for a State to restrict movement of
tuberculosis-susceptible animals from high-risk areas within the State
and to otherwise rapidly contain the disease and move toward
eradication. Failure to rapidly identify and address high-risk areas
significantly increased the risk of tuberculosis spread among
livestock.
In this interim rule, we establish requirements (discussed below)
for achieving APHIS recognition of zones within a State for the purpose
of tuberculosis status. Providing for zones will allow for APHIS
recognition of distinct tuberculosis risk levels within a State. For
example, a State that contains several herds that are affected with
tuberculosis in an identifiable area might nonetheless qualify for
accredited-free status in the rest of the State, provided it meets
certain conditions, discussed below, to ensure containment and
eradication of the disease in the affected area. This will give States
the incentive to isolate affected areas from the rest of the State and
to implement effective containment and eradication measures, thereby
decreasing tuberculosis risk intrastate and interstate.
The key criteria in establishing a ``zone'' for the purpose of
tuberculosis risk status are that the boundary of the zone be
identifiable and that it be located where factors such as physical
barriers, distance, lack of livestock, or animal movement controls make
it unlikely that tuberculosis will be transmitted across the boundary.
The criteria we will apply to identify a zone within a State are the
same criteria we use to identify regions in foreign countries.
In Sec. 77.1 of this interim rule, we define zone as a defined
geographic land area identifiable by geological, political, manmade, or
surveyed boundaries, with mechanisms of disease spread, epidemiological
characteristics, and the ability to control the movement
[[Page 58771]]
of animals across the boundaries of the zone taken into account. By
``mechanisms of disease spread,'' we mean the ways in which
tuberculosis can be transmitted to animals, such as in aerosol fashion
or through ingestion of contaminated food or water. ``Epidemiological
characteristics'' include factors such as the presence or absence of
livestock in a zone, the distance between animals within and outside a
zone, the prevalence of disease within a zone, and the density of
potential wildlife hosts within a zone.
We consider mechanisms of disease spread and epidemiological
characteristics important components in how the boundaries of a zone
will be determined, because a zone by its nature should present a
different level of disease risk than the zone from which it is
distinguished. Therefore, the distance between livestock in two
different zones and the manner in which the disease is transmitted need
to be considered in determining where to draw a boundary that clearly
divides two areas with differing tuberculosis risks.
In Sec. 77.8 of this interim rule, we set forth conditions and
procedures for requesting that the Administrator of APHIS designate
part of a State as a zone that has a different tuberculosis status than
the rest of the State. We provide that a State animal health official
may request such designation of a distinct zone if the State has the
legal and financial resources to implement and enforce a tuberculosis
eradication program; has the infrastructure, laws, and regulations to
require and ensure tuberculosis cases are reported to State and Federal
regulatory authorities; and maintains or will maintain clinical and
epidemiological surveillance of animal species at risk of tuberculosis
at a rate that allows detection of tuberculosis in the overall
population of livestock herds in each zone at a 2 percent prevalence
rate (the average prevalence in a herd containing infected animals)
with 95 percent confidence. We require that the zone being requested be
delineated by State animal health authorities, subject to approval of
the zone by the Administrator. Because of the amount of monitoring and
movement controls necessary for a State to adequately administer
different status zones, we are limiting the number of zones allowable
in each State to two.
Definitions
The definitions for terms used in part 77 are contained in
Sec. 77.1. We are revising the definitions of accredited-free State,
accredited-free (suspended) State, modified accredited State, and
nonmodified accredited State, so that each category applies to zones as
well as to entire States. Additionally, we are making some formatting
changes to those definitions, such as moving lists of States and the
requirements for applying for status redesignation or renewal from the
definitions section to other sections of the regulations. We are also
including in the definition of accredited-free State or zone a
provision that was previously set forth in the UMR and that was
incorporated by reference into the regulations. Under this provision, a
modified accredited or nonmodified accredited State or zone that was
previously accredited-free can regain accredited-free status in 2 years
provided it meets the following requirements: The State or zone has
zero prevalence of affected cattle and bison herds; all herds of cattle
and bison affected with tuberculosis have been depopulated; there have
been no findings of tuberculosis in cattle or bison for 2 years from
the depopulation of the last infected herd in the State or zone; and
the State or zone complies with the provisions of the UMR. Because this
provision was included in the UMR, which has been incorporated by
reference into the regulations, it was in effect prior to this interim
rule. We are also making certain substantive changes to the
definitions, which we discuss below.
Accredited-free State or zone. The definition of accredited-free
State until now has provided that to establish or maintain such status,
a State must have no findings of tuberculosis in any cattle or bison in
the State for at least 5 years and must comply with all of the
provisions of the UMR. In this interim rule, we are retaining that
requirement and are further defining an accredited-free State or zone
as one that has zero percent prevalence of affected cattle and bison
herds. Although zero percent prevalence may be self-evident in a State
or zone in which no affected herds have been diagnosed, we consider it
useful to include such a criterion to be consistent with our use of
disease prevalence in defining modified accredited State or zone,
discussed below. In this interim rule, we add a definition of zero
percent prevalence in Sec. 77.1 to mean ``no finding of tuberculosis in
any cattle or bison herd in the State or zone.''
Accredited-free (suspended) State or zone. We are not revising the
definition of accredited-free (suspended) State, except to apply it to
zones as well as States and to move the requirements for regaining
accredited-free status to Sec. 77.3.
Modified accredited State or zone. The regulations until now
defined a modified accredited State as one that complies with all of
the provisions of the UMR regarding modified accredited States. Under
the regulations prior to this interim rule, it was not always clear
what standards a State needed to meet to achieve modified accredited
status. With the establishment of zones under this interim rule, it is
essential to the prevention of tuberculosis spread in States that this
lack of clarity be rectified so that States are clear regarding the
standards for achieving status and, consequently, regarding the
restrictions they must impose on the movement of livestock from zones
that do not meet the standards for modified accredited or accredited-
free status.
In this interim rule, we are specifying that, in addition to
complying with the UMR, a modified accredited State or zone is one in
which tuberculosis has been prevalent in less than 0.01 percent of the
total number of herds of cattle and bison in the State or zone for the
most recent 2 years. However, because it is likely that some zones will
contain a relatively small number of herds, we are also providing, as
discussed below, that in a State or zone with fewer than 30,000 herds,
the Administrator, upon his or her review, may allow the State or zone
to have up to 3 affected herds for each of the most recent 2 years, if
the Administrator determines that the veterinary infrastructure,
livestock demographics, and tuberculosis control and eradication
measures in the State or zone are adequate to prevent the spread of
tuberculosis.
We are using 0.01 percent of the total number of herds in the State
or zone as the standard maximum allowable percentage of affected herds.
This number represents a progression from the requirements of the
tuberculosis eradication program of the 1940's, when 0.5 percent was
considered an acceptable maximum percentage of prevalence of affected
herds. Since that time, significant gains in the tuberculosis
eradication program have consistently reduced the national percentage
of herds affected with tuberculosis, so that today the national
percentage stands at approximately 0.0002 percent. With such minimal
tuberculosis prevalence, we consider it appropriate to set the
allowable maximum prevalence percentage at 0.01 percent, which we
believe will contribute to continued progress in the tuberculosis
program, while not being so impractically stringent that States will
lose incentive to achieve or retain modified accredited status.
[[Page 58772]]
Although we consider a maximum of 0.01 percent to be appropriate in
most cases, we recognize there are situations where the circumstances
in a State or zone might warrant some deviation from that standard. For
instance, the requirement for less than 0.01 percent prevalence means
that, for every 10,000 herds in the State or zone, no more than 1 herd
can be affected. In a State or zone with fewer than 10,000 herds, even
the presence of 1 affected herd would cause the prevalence rate to
exceed the allowable maximum. We do not necessarily consider one
affected herd to pose a disease risk significant enough to disqualify a
State or zone from modified accredited status. Additionally, in some
States or zones that do not have a relatively large number of herds (by
comparison, some States have as many as 140,000 herds), it is possible
that circumstances might warrant a modified accredited State or zone
having up to 3 affected herds. The factors the Administrator will
consider in determining whether a prevalence level in excess of 0.01
percent is acceptable include (1) how effectively the veterinary
infrastructure in the State or zone could respond to the discovery of
an affected herd and (2) the risk of transmission of the disease from
an affected herd to other herds, based on factors such as the density
of the livestock population and patterns of herd distribution. If the
Administrator determines that such factors in a State or zone are
adequate to prevent the spread of tuberculosis, a State or zone with
fewer than 30,000 herds will qualify for modified accredited status
even if the percentage of affected herds exceeds 0.01 percent of the
total number of herds.
Nonmodified accredited State or zone. We are making no substantive
changes to the definition of nonmodified accredited State, other than
to make the definition applicable to zones as well as to States.
In addition to the changes to the definitions in Sec. 77.1 that are
described above, we are revising that section by adding other
definitions. We discuss each of these added terms below as part of our
discussion of the regulatory requirements in which they appear.
Designation of Bovine Tuberculosis Status: Sec. 77.2
In Sec. 77.2 of this interim rule, we provide that the
Administrator will designate the tuberculosis status of each State
according to the criteria listed in subpart A of part 77. The section
also provides that the Administrator will give only part of a State a
particular designation, upon request of the State, if the Administrator
determines that the State meets the requirements of the regulations for
establishing zones (discussed below) and enforces restrictions on the
intrastate movement of cattle and bison that are substantially the same
as our restrictions on the interstate movement of those animals.
Additionally, Sec. 77.2 provides that designation of partial State
status is dependent on the Administrator's determination that such
designation will otherwise be adequate to prevent the interstate spread
of tuberculosis.
It is essential that a State that is requesting recognition of a
zone have in place effective regulations governing intrastate movement
because, in most cases, our authority to regulate the movement of
animals and animal products is limited to interstate movement.
Therefore, we must be confident that the State will effectively enforce
movement between zones within State borders.
Accredited-Free State or Zone Status: Sec. 77.3
In Sec. 77.3(a), we list those States and zones designated as
accredited-free. The list of States is the same as that in the
regulations in effect prior to this interim rule, except for the
addition of an accredited-free zone in Michigan. We discuss below our
rationale for designating the zone in Michigan as accredited-free. (See
``Recognition of Tuberculosis Status Zones in Michigan.'')
In Sec. 77.3(c), we include the provision that formerly appeared in
the definition of accredited-free State that the accredited-free status
of a State will be suspended if tuberculosis is detected in any one
cattle or bison herd in the State and are expanding it to apply to
zones as well as States. Similarly, we are moving from the definitions
section to Sec. 77.3(c) the provision that if two or more affected
herds are detected in an accredited-free State within a 48-month
period, the State will be removed from the list of accredited-free
States. We are also amending that provision to include zones. We are
also amending the requirements for renewing accredited-free status to
include zones and are moving the renewal requirements from the
definitions in Sec. 77.1 to Sec. 77.3(f).
We are providing in Sec. 77.3(e) that if tuberculosis is diagnosed
within an accredited-free State or zone in an animal not specifically
included in the regulations and a risk assessment conducted by APHIS
determines that the outbreak poses a tuberculosis risk to livestock
within the State or zone, the State or zone must adopt a tuberculosis
management plan, approved jointly by the State animal health official
and the Administrator, within 6 months of the diagnosis. The management
plan must include provisions for immediate investigation of
tuberculosis in livestock and wildlife, the prevention of the spread of
the disease to other wildlife and livestock, increased surveillance of
tuberculosis in wildlife, eradication of tuberculosis from individual
herds, a timeline for tuberculosis eradication, and performance
standards by which to measure yearly progress toward eradication. If a
State or zone does not adopt such a plan within the required 6 months,
the State or zone will lose its accredited-free status. We consider
this requirement necessary because of the risk of wildlife coming into
contact with domestic livestock, both through free-ranging wildlife and
wildlife held by the growing number of exhibitors in the United States.
Modified Accredited States or Zones: Sec. 77.4
In Sec. 77.4, we list those States and zones designated as modified
accredited and provide the criteria for renewing modified accredited
status. The list of States is the same as the list in the regulations
in effect prior to this interim rule. The criteria for renewing
modified accredited status are also the same, except that they apply to
zones as well as States. However, we are adding a provision that if
tuberculosis is diagnosed within a modified accredited State or zone in
an animal not specifically included in the regulations and a risk
assessment conducted by APHIS determines that the outbreak poses a
tuberculosis risk to livestock within the State or zone, the State or
zone must adopt a tuberculosis management plan, approved jointly by the
State animal health official and the Administrator, within 6 months of
the diagnosis. If a State or zone does not adopt such a plan within the
required 6 months, the State or zone will be reclassified as
nonmodified accredited.
Nonmodified Accredited States or Zones: Sec. 77.5
Any nonmodified accredited States or zones will be listed in
Sec. 77.5. In this interim rule, we are listing one zone in Michigan as
nonmodified accredited (discussed below under the heading ``Recognition
of Tuberculosis Status Zones in Michigan'').
Interstate Movement from Accredited-Free States and Zones:
Sec. 77.6
Consistent with the regulations in Sec. 77.3 in effect prior to
this interim rule, we are providing in new Sec. 77.6 that cattle and
bison that are not known to
[[Page 58773]]
be infected with or exposed to tuberculosis and that originate in a
State or zone listed as accredited-free, accredited-free (suspended),
or modified accredited may be moved interstate without restriction.
Interstate Movement from Nonmodified Accredited States and Zones:
Sec. 77.7
Under Sec. 77.4 of the regulations in effect prior to this interim
rule, cattle and bison not known to be affected with or exposed to
tuberculosis that originated in a nonmodified accredited State could be
moved interstate only if they met one of the following conditions:
1. The cattle and bison were certified as testing negative to an
official tuberculin test conducted within 30 days prior to movement and
were identified as specified in the regulations;
2. The cattle and bison were certified as coming from an accredited
herd; or
3. The cattle and bison were moved directly to a qualifying
slaughtering establishment.
In Sec. 77.7 of this interim rule, we are retaining the second two
conditions regarding movement from an accredited herd and movement to
slaughter. However, we are revising and clarifying the condition
regarding the testing of animals intended for movement and are making
testing requirements dependent on the type of animal involved, as
discussed below, in order to help prevent the spread of tuberculosis
and to further the progress of the tuberculosis eradication program.
As set forth in this interim rule, if the cattle or bison to be
moved interstate from a nonmodified accredited State or zone are
breeding animals that are not from an accredited herd, they will need
to be individually identified and be accompanied by a certificate
stating that they have been classified negative to two official
tuberculin tests conducted at least 60 days apart and no more than 6
months apart, with the second test conducted within 30 days prior to
the date of movement. Until now, such animals had to be tested only
once within 30 days prior to the date of movement. However, we consider
one test to be insufficient because of the combination of the high or
unknown risk of tuberculosis in a nonmodified accredited State or zone
and the possibility that an animal that tested negative to one
tuberculosis test may have been incubating the disease agent at the
time of testing and could develop clinical signs of the disease
following the first test.
Under this interim rule, if the cattle or bison are steers or
spayed heifers, or are officially identified sexually intact heifers
moved to an approved feedlot, they must be accompanied by a certificate
stating they have been classified negative to an official tuberculin
test that was conducted within 30 days prior to the date of movement.
Because of the high or unknown risk of the presence of tuberculosis in
a nonmodified accredited State or zone, we consider it necessary that
such animals test negative to an official tuberculin test before they
are moved interstate so that if they are later found to be infected
with the disease, they can be traced back to the source herd. However,
we consider one negative test to be sufficient for animals moved
through slaughter channels, which reduces the risk of disease spread.
Although our statutory authority is generally limited to interstate
movement, one of the conditions for APHIS recognition of zones within a
State is that the State has adopted and is enforcing regulations that
impose restrictions on the intrastate movement of cattle and bison that
are substantially the same as those in the regulations for the
interstate movement of cattle and bison. Therefore, for a State to
achieve and retain APHIS recognition of zones, it will need to impose
requirements on intrastate movement from any nonmodified zone that are
substantially the same as the testing requirements described above. We
consider such requirements within a State necessary to control any
outbreaks of tuberculosis.
In Sec. 77.1, we define approved feedlot as a confined area
approved jointly by the State animal health official and the
Administrator for feeding cattle and bison for slaughter, with no
provisions for pasturing or grazing. We define State animal health
official as the State official responsible for livestock and poultry
disease control and eradication programs.
In the condition for movement described above, we refer to heifers
that are ``officially identified.'' In the definitions in Sec. 77.1, we
define officially identified to mean identified by means of an official
eartag, individual tattoo, or individual hot brand. We define official
eartag to mean an eartag approved by the Administrator as providing
unique identification for each individual animal by conforming to the
alpha-numeric National Uniform Eartagging System.
Movement of Captive Cervids
The regulations in subpart A of part 77 with regard to tuberculosis
apply to cattle and bison. The regulations in subpart B of part 77
apply to captive cervids. As noted above, under Sec. 77.2(b) of this
interim rule, one of the conditions for a State to be eligible for
APHIS recognition of zones is that it imposes restrictions on the
intrastate movement of cattle and bison that are substantially the same
as those in the regulations for the interstate movement of cattle and
bison. However, as evidenced by the regulations regarding captive
cervids in part 77, subpart B, in addition to cattle and bison, captive
cervids infected with tuberculosis also pose a significant risk of
transmitting tuberculosis to other livestock. Therefore, in
Sec. 77.2(b) of this interim rule, we provide that, as a condition for
APHIS recognition of zones, a State must also impose intrastate
restrictions on the movement of captive cervids that are substantially
the same as those in place in part 77, subpart B, for the interstate
movement of captive cervids.
Classes or Species of Greater Risk
Although at this time we are applying the provisions of this
interim rule in the same way to all cattle and bison, it is possible
the Administrator will in the future determine that a specific breed or
usage type of cattle or bison poses a significantly greater risk of
being a reservoir of tuberculosis than other cattle or bison. For
instance, regulations in 9 CFR 93.427(c)(5) prohibit the importation of
Holstein steers and Holstein spayed heifers from Mexico. This is
because APHIS determined that such dairy cattle pose a greater risk
than other cattle of being infected with tuberculosis. In any case
where a particular breed or usage type of cattle or bison presents a
greater tuberculosis risk than other cattle or bison, it may be
necessary to establish requirements for interstate movement for that
breed or usage type that are more restrictive than those for other
cattle and bison, or it may be necessary to prohibit interstate
movement altogether. If such restrictions are necessary, we will
publish a rulemaking document to that effect in the Federal Register.
Application for Recognition of Tuberculosis Status Zones
In Sec. 77.8(a) of this interim rule, we set forth conditions a
State must meet to receive APHIS recognition of an area in the State as
a separate zone for tuberculosis status. Unless requested otherwise by
a State, we will continue to designate entire States with regard to
tuberculosis status. However, we provide that a State animal health
official may request at any time that the Administrator designate part
of the State as having a different tuberculosis status than the rest of
the State, with the
[[Page 58774]]
limitation that each State may be divided into no more than two
different zones (i.e., one area that differs in status from the rest of
the State).
Under the procedures in this interim rule for requesting
recognition of a zone, the State will be responsible for delineating
the boundaries of the requested zone, subject to approval by the
Administrator. As defined in Sec. 77.1, a zone is a defined geographic
land area identifiable by geological, political, manmade, or surveyed
boundaries, with mechanisms of disease spread, epidemiological
characteristics, and the ability to control the movement of animals
across the boundaries of the zone taken into account.
To qualify for APHIS recognition of a zone, the State must
demonstrate in its request that it has in place an infrastructure,
laws, and regulations that require and ensure that State and Federal
animal health authorities are notified of tuberculosis cases in
domestic livestock or outbreaks in wildlife. Additionally, the State in
which the zone is located must have the legal and financial resources
to implement and enforce a tuberculosis eradication program.
Further, the State must maintain clinical and epidemiological
surveillance of animal species at risk of tuberculosis in each zone in
the State, at a rate that allows detection of tuberculosis in the
overall population of livestock at a 2 percent prevalence rate with 95
percent confidence. Because 2 percent is the average prevalence in a
herd that contains animals infected with tuberculosis, being able to
detect such prevalence with 95 percent certainty gives adequate
assurance that herds in which tuberculosis is present will be
identified. The designated tuberculosis epidemiologist must review
reports of all testing for each zone within the State within 30 days of
the testing. (In the definitions in Sec. 77.1, we define designated
tuberculosis epidemiologist to mean ``a State or Federal epidemiologist
designated by the Administrator to make decisions concerning the use
and interpretation of diagnostic tests for tuberculosis and the
management of tuberculosis affected herds.'')
In Sec. 77.8(a)(3) of this interim rule, we provide that a State
seeking APHIS recognition of a zone with regard to tuberculosis must
enter into a memorandum of understanding with APHIS in which the State
agrees to adhere to any conditions for zone recognition particular to
that request. Such a memorandum of understanding is necessary to
address epidemiological circumstances that apply to that particular
State. For instance, in a State in which free-ranging wildlife may be a
reservoir of tuberculosis, it may be necessary to conduct baseline
surveillance among such wildlife; whereas in a State with less of a
risk of tuberculosis in wildlife, such surveillance may not be
necessary.
Retention of Recognition of Tuberculosis Status Zones
In Sec. 77.8(b) we provide that designation of zones within a State
will be subject to annual review by the Administrator and that, in
order to retain APHIS recognition of a zone, a State must continue to
meet the requirements for achieving recognition of the zone and must
retain for 2 years all certificates that are required by the
regulations for the movement of cattle, bison, and captive cervids.
Recognition of Tuberculosis Status Zones in Michigan
The conditions for obtaining APHIS recognition of a tuberculosis
status zone within a State are discussed above. In this interim rule,
we are recognizing such zones in Michigan. Michigan has demonstrated to
APHIS that it has the resources to enforce a tuberculosis eradication
program and to ensure that diagnoses of tuberculosis are reported to
State and Federal authorities. Additionally, Michigan has demonstrated
it is capable of maintaining surveillance that allows detection of
tuberculosis in the overall population of livestock at a 2 percent
prevalence rate with 95 percent confidence. Michigan will enter into a
memorandum of understanding with APHIS regarding any conditions for
zone recognition particular to that State's circumstances.
Michigan: In Michigan, the smaller of two zones in the State is
bounded as follows: Starting at the juncture of State Route 55 and
Interstate 75, head northwest and north along Interstate 75 to the
Straits of Mackinac, then southeast and south along the shoreline of
Michigan to the eastern terminus of State Route 55, then west along
State Route 55 to Interstate 75. The second zone in Michigan is
comprised of the rest of the State.
State animal health officials in Michigan have demonstrated to
APHIS that, except for the smaller zone, the State meets the criteria
for accredited-free status set forth in the definition of accredited
free in this interim rule. Except for the smaller zone, Michigan has
zero percent prevalence of affected cattle or bison herds and has had
no findings of tuberculosis in any cattle or bison for the past 5
years. Additionally, the State complies with the provisions of the UMR.
Because the smaller zone in Michigan does not meet the requirements for
either accredited-free or modified accredited, it is being listed as
nonmodified accredited.
UMR
Among the definitions in Sec. 77.1 is a definition of Uniform
Methods and Rules--Bovine Tuberculosis Eradication. The edition of the
UMR referred to in that definition was approved by APHIS on February 3,
1989, and was approved for incorporation by reference into the Code of
Federal Regulations (CFR) by the Director of the Federal Register. On
January 22, 1999, an updated edition of the UMR was approved by APHIS.
Among other provisions, the updated edition includes changes to the
tuberculosis eradication program discussed in this interim rule with
regard to split-State tuberculosis status. This interim rule revises
the definition of Uniform Methods and Rules--Bovine Tuberculosis
Eradication to reflect the incorporation by reference of the January
22, 1999, edition of the UMR.
Emergency Action
The Administrator of the Animal and Plant Health Inspection Service
has determined that an emergency exists that warrants publication of
this interim rule without prior opportunity for public comment. We
believe that failure to provide the option for ``split-State status''
would hinder the progress of the tuberculosis eradication program in
this country and increase the likelihood of the spread of the disease.
Under the regulations prior to this interim rule, if tuberculosis was
determined to exist in any part of a State, the entire State was
designated as being at risk. This ``all or nothing'' approach did not
always provide sufficient incentive for a State to stringently restrict
movement of tuberculosis-susceptible animals from high-risk areas
within the State and to otherwise rapidly contain the disease and move
toward eradication. Failure to rapidly identify and address high-risk
areas has significantly increased the risk of tuberculosis spread among
livestock.
In this interim rule, we establish requirements for achieving APHIS
recognition of zones within a State for the purpose of tuberculosis
status. Providing for zones will allow APHIS to recognize areas of
distinct tuberculosis risk levels within a State. This will encourage
States to rapidly isolate affected areas from the rest of the State and
to implement effective containment and eradication measures, thereby
decreasing tuberculosis risk in the State.
[[Page 58775]]
The regulations until now defined a modified accredited State as
one that complies with all of the provisions of the UMR regarding
modified accredited States. Under the regulations prior to this interim
rule, it was not always clear what standards a State needed to meet to
achieve modified accredited status. With the establishment of zones
under this interim rule, it is essential to the prevention of
tuberculosis spread in States that this lack of clarity be rectified so
that States are clear regarding the standards for achieving status and,
consequently, regarding the restrictions they must impose on the
movement of livestock from zones that do not qualify for modified
accredited or accredited-free status.
As set forth in this interim rule, if cattle or bison to be moved
interstate from a nonmodified accredited State or zone are breeding
animals that are not from an accredited herd, they will need to be
accompanied by a certificate stating that they have been classified
negative to two official tuberculin tests. Based on our experience
enforcing the regulations, we have determined that requiring less than
two negative tests before such potentially high-risk animals may be
moved interstate creates an unacceptable risk that the animals will
transmit tuberculosis to other livestock, due to the possibility that
an animal that tests negative to one test could be incubating the
tuberculosis disease agent at the time of that first test.
Under this interim rule, if the cattle or bison to be moved from a
nonmodified accredited State or zone are steers or spayed heifers or
are officially identified sexually intact heifers moved to an approved
feedlot, they must be accompanied by a certificate stating they have
been classified negative to an official tuberculin test that was
conducted within 30 days prior to the date of movement. Because of the
high or unknown risk of the presence of tuberculosis in a nonmodified
accredited State or zone, we consider it necessary that such animals
test negative to an official tuberculin test before they are moved
interstate so that if they are found to be infected with the disease,
they can be traced back to the source herd. Inclusion of this
requirement in the interstate regulations will ensure that States
seeking recognition of zones impose like requirements on intrastate
movement of livestock and thus more rapidly control any outbreaks of
tuberculosis within the State.
Because prior notice and other public procedures with respect to
this action are impracticable and contrary to the public interest under
these conditions, we find good cause under 5 U.S.C. 553 to make this
action effective less than 30 days after publication in the Federal
Register. We will consider comments that are received within 60 days of
publication of this rule in the Federal Register. After the comment
period closes, we will publish another document in the Federal
Register. The document will include a discussion of any comments we
receive and any amendments we are making to the rule as a result of the
comments.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. This 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.
Statutory authorities including 21 U.S.C. 111, 114, 114a, and 120
authorize the Secretary of Agriculture to conduct programs and
promulgate regulations to prevent the dissemination of any contagious,
infectious, or communicable disease of animals from one State to
another.
In this interim rule, we are allowing for APHIS recognition of
zones within a State that have different risk statuses for
tuberculosis, are clarifying the conditions for assigning a particular
risk status, and are increasing the amount of testing that must be done
before certain cattle and bison may be moved interstate.
In considering this rulemaking, we considered three options. The
first was to retain the regulations already in place and make no
changes. We did not consider this an acceptable option because it would
have had the effect of increasing the risk of the interstate
transmission of tuberculosis, while at the same time retaining
unnecessarily stringent disease status designations for parts of some
States. A second option would have been to expand the number of
possible tuberculosis status levels for States and zones to more
precisely reflect the potential gradations of eradication efforts and
disease risk among different areas. We believe this option is one that
should be pursued, and we are in the process of developing rulemaking
that would propose such changes to the regulations. However, because we
believe such substantive changes to the tuberculosis eradication
program should be presented to the public for comment before being
implemented, we did not include such extensive changes in this interim
rule. The option we chose was to implement the provisions of this
interim rule that establish criteria for our recognition of two zones
within a State for tuberculosis status and to address immediately those
provisions of the regulations that, because of lack of clarity or
insufficient safeguards, unacceptably increased the risk of the spread
of tuberculosis among livestock in this country.
Below is an analysis of the potential effects of this rule on small
entities as required by the Regulatory Flexibility Act. We do not have
enough data for a comprehensive analysis of the economic effects of
this rule on small entities. Therefore, in accordance with 5 U.S.C.
603, we have performed an initial regulatory flexibility analysis for
this rule. We are inviting comments about this rule as it relates to
small entities. In particular, we are interested in determining the
number and kind of small entities that may incur benefits or costs from
implementation of this rule and the economic effects of those benefits
or costs.
Economic Analysis
In 1998, the total number of cattle and bison in the United States
was approximately 99.5 million, valued at approximately $58.6 billion.
There were 1,115,650 U.S. operations with cattle and bison. Over 99
percent of these operations had gross cash value of less than $500,000.
These holdings vary in size and degree of commercialization, with many
producers relying on other sources of income.
The cattle industry plays a very significant role in international
trade. In 1998, the total earnings from exports of live cattle, beef,
and veal was approximately $2.6 billion. The competitiveness of the
United States in international markets depends to a great degree upon
its reputation for producing high quality animals, a reputation that
would be enhanced if bovine tuberculosis were permanently eradicated.
The actual product, as well as the purchasers' perception of the
quality of the product, contribute to continued world market
acceptance. Thus, efforts to maintain an effective tuberculosis
program, to clarify the regulations, and to secure the health of the
cattle industry will continue to serve the best economic interests of
the Nation.
Under the regulations, each State is designated as having one of
the following tuberculosis statuses: Accredited-free, accredited-free
(suspended), modified accredited, and nonmodified accredited. Prior to
this rule, there were 48 accredited-free States (including Puerto Rico
and the
[[Page 58776]]
Virgin Islands of the United States), 2 States that were modified
accredited States, and one State that was accredited-free (suspended).
There were no nonmodified accredited States.
We are changing the testing requirements for moving breeding
animals interstate from a nonmodified accredited State or zone. Under
this interim rule, breeding animals from a nonmodified accredited State
or zone require a certificate stating that the animals tested negative
twice to an official tuberculin test. This represents one more test
than has been required and, therefore, will result in additional cost
for owners moving breeding animals from a nonmodified accredited State
or zone. The average cost of the test is about $380 per herd. The per
animal cost varies depending on the size of the herd. For an average-
sized herd of 90 animals, the average cost per animal would be
approximately $4.22. The total cost for testing will depend on the
number of animals that are being moved interstate.
Prior to this interim rule, there were no States or zones
designated as nonmodified accredited. In this interim rule, we are
listing a small portion of Michigan as being a nonmodified accredited
zone. This zone includes approximately 100 herds of cattle and bison.
Breeding animals from this zone will have to test negative twice to an
official tuberculin test prior to interstate movement. However, we do
not anticipate this testing will impose a significant burden on
entities in that zone because very few animals are moved from that area
of Michigan.
The provisions of this interim rule establishing mechanisms for
defining ``zones'' within a State with regard to tuberculosis will
benefit the United States at minimal or no cost because they will allow
quicker response to tuberculosis outbreaks and will establish a way to
manage the disease in regional zones, rather than penalize entire
States. It is expected that enhanced international trade will result
from establishing a regionalized approach to tuberculosis in the United
States.
Prior to this interim rule, the accredited-free (suspended) State
was Michigan. As of result of this rule, Michigan will assume a split
status, with a small section of Michigan being assigned nonmodified
accredited status, and the remainder of Michigan being assigned
accredited-free status. We expect that the assignment of accredited-
free status to most of the area of Michigan will have a positive
economic effect on the State. Many States impose movement restrictions
on livestock from States that are not accredited-free. Under this rule,
of 15,000 cattle herds in Michigan, only 100 herds will be located in a
nonmodified accredited zone. All other herds will be located in an
accredited-free zone.
The changes to the regulations in this interim rule will result in
new information collection or recordkeeping requirements, as described
below under the heading ``Paperwork Reduction Act.''
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This interim rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with 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 interim rule have received
emergency approval from the Office of Management and Budget (OMB). OMB
has assigned control number 0579-0146 to the information collection and
recordkeeping requirements.
We plan to request continuation of that approval for 3 years.
Please send written comments on the 3-year approval request to the
following addresses: (1) Docket No. 99-008-1, 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.
Please state that your comments refer to Docket No. 99-008-1 and send
your comments within 60 days of publication of this rule.
This interim rule amends the bovine tuberculosis regulations to
allow zones within a State to be assigned different risk statuses and
to clarify the conditions for assigning a particular risk status for
bovine tuberculosis. Additionally, it amends the regulations to
increase the amount of testing that must be done before certain cattle
and bison may be moved interstate.
In order to apply for APHIS designation of zones within a State, a
State animal health official submits a request to the APHIS
Administrator demonstrating that the State complies with the criteria
for recognition of a zone. Additionally, the State must enter into a
memorandum of understanding with APHIS in which the State agrees to
adhere to any conditions for zone recognition particular to that
request. To retain recognition of zones, the State must retain for 2
years a certificate that documents the movement of cattle, bison, and
captive cervids into and out of the zones.
In accordance with this interim rule, if tuberculosis is diagnosed
within an accredited-free State or zone or a modified accredited State
or zone and a risk assessment conducted by APHIS determines that the
outbreak poses a tuberculosis risk to livestock within the State or
zone, the State or zone must adopt a tuberculosis management plan,
approved jointly by the State animal health official and the APHIS
Administrator.
We are soliciting comments from the public concerning our
information collection and recordkeeping requirements. These comments
will help us:
(1) Evaluate whether the 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 .575 hours per response.
Respondents: State animal health authorities, including State
veterinarians and designated State tuberculosis epidemiologists.
Estimated annual number of respondents: 56.
Estimated annual number of responses per respondent: 3.785.
[[Page 58777]]
Estimated annual number of responses: 212.
Estimated total annual burden on respondents: 122 hours.
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue, SW., Washington, DC 20250.
List of Subjects in 9 CFR Part 77
Animal diseases, Bison, Cattle, Incorporation by reference,
Reporting and recordkeeping requirements, Transportation, Tuberculosis.
Accordingly, we are amending 9 CFR part 77 as follows:
PART 77--TUBERCULOSIS
1. The authority citation for part 77 continues to read as follows:
Authority: 21 U.S.C. 111, 114, 114a, 115-117, 120, 121, 134b,
and 134f; 7 CFR 2.22, 2.80, and 371.2(d).
2. Section 77.1 is amended as follows:
a. The following definitions are revised to read as set forth
below: Accredited herd, Negative cattle and bison, Official tuberculin
test, Reactor cattle and bison, Suspect cattle and bison, and Uniform
Methods and Rules--Bovine Tuberculosis Eradication.
b. The following definitions are removed: Accredited-free state,
Accredited-free (suspended) State, Modified accredited State, and
Nonmodified accredited state.
c. The following definitions are added in alphabetical order to
read as set forth below: Accredited-free State or zone, Accredited-free
(suspended) State or zone, Approved feedlot, Designated tuberculosis
epidemiologist, Modified accredited State or zone, Nonmodified
accredited State or Zone, Official eartag, Officially identified, State
animal health official, Zero percent prevalence, and Zone.
Sec. 77.1 Definitions.
* * * * *
Accredited-free State or zone. A State or zone that has zero
percent prevalence of affected cattle and bison herds, that has had no
findings of tuberculosis in any cattle or bison in the State or zone
for the previous 5 years, and that complies with the provisions of the
``Uniform Methods and Rules--Bovine Tuberculosis Eradication,'' except
that the requirement of freedom from tuberculosis is 2 years from the
depopulation of the last infected herd in States or zones that were
previously accredited-free and in which all herds affected with
tuberculosis were depopulated.
Accredited-free (suspended) State or zone. A State or zone with the
status of an accredited-free State is designated as accredited-free
(suspended) if tuberculosis is detected in any cattle or bison in the
State or zone.
Accredited herd. To establish or maintain accredited herd status,
the herd owner must comply with all of the provisions of the ``Uniform
Methods and Rules--Bovine Tuberculosis Eradication'' regarding
accredited herds. All cattle and bison in a herd must be free from
tuberculosis.
* * * * *
Approved feedlot. A confined area approved jointly by the State
animal health official and the Administrator for feeding cattle and
bison for slaughter, with no provisions for pasturing or grazing.
* * * * *
Designated tuberculosis epidemiologist. A State or Federal
epidemiologist designated by the Administrator to make decisions
concerning the use and interpretation of diagnostic tests for
tuberculosis and the management of tuberculosis affected herds.
* * * * *
Modified accredited State or zone. A State or zone that complies
with the provisions of the ``Uniform Methods and Rules--Bovine
Tuberculosis Eradication'' and in which tuberculosis has been prevalent
in less than 0.01 percent of the total number of herds of cattle and
bison in the State or zone for the most recent 2 years, except that the
Administrator, upon his or her review, may allow a State or zone with
fewer than 30,000 herds to have up to 3 affected herds for each of the
most recent 2 years, depending on the veterinary infrastructure,
livestock demographics, and tuberculosis control and eradication
measures in the State or zone.
* * * * *
Negative cattle and bison. Cattle and bison that are classified
negative for tuberculosis in accordance with the ``Uniform Methods and
Rules--Bovine Tuberculosis Eradication,'' based on the results of an
official tuberculin test.
Nonmodified accredited State or zone. A State or zone that has not
received accredited-free State or zone status or modified accredited
State or zone status.
Official eartag. An eartag approved by the Administrator as
providing unique identification for each individual animal by
conforming to the alpha-numeric National Uniform Eartagging System.
* * * * *
Official tuberculin test. Any test for tuberculosis conducted on
cattle or bison in accordance with the ``Uniform Methods and Rules--
Bovine Tuberculosis Eradication.''
Officially identified. Identified by means of official eartag,
individual tattoo, or individual hot brand.
* * * * *
Reactor cattle and bison. Cattle and bison that are classified as
reactors for tuberculosis in accordance with the ``Uniform Methods and
Rules--Bovine Tuberculosis Eradication.''
* * * * *
State animal health official. The State official responsible for
livestock and poultry disease control and eradication programs.
* * * * *
Suspect cattle and bison. Cattle and bison that are classified as
suspects for tuberculosis in accordance with the ``Uniform Methods and
Rules--Bovine Tuberculosis Eradication.''
* * * * *
Uniform Methods and Rules--Bovine Tuberculosis Eradication. Uniform
methods and rules for eradicating bovine tuberculosis in the United
States approved by APHIS on January 22, 1999. The Uniform Methods and
Rules--Bovine Tuberculosis Eradication, January 22, 1999, edition was
approved for incorporation by reference into the Code of Federal
Regulations by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51.1
---------------------------------------------------------------------------
\1\ Copies may be obtained from the National Animal Health
Programs, Veterinary Services, APHIS, 4700 River Road Unit 43,
Riverdale, Maryland 20737-1231. You may inspect a copy at the APHIS
reading room, room 1141, USDA South Building, 14th Street and
Independence Avenue, SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., Suite 700,
Washington, DC.
---------------------------------------------------------------------------
Zero percent prevalence. No finding of tuberculosis in any cattle
or bison herd in a State or zone.
Zone. A defined geographic land area identifiable by geological,
political, manmade, or surveyed boundaries, with mechanisms of disease
spread, epidemiological characteristics, and the ability to control the
movement of animals across the boundaries of the zone taken into
account.
3. Section 77.2 is revised to read as follows:
Sec. 77.2 Bovine tuberculosis status of States and zones.
The Administrator shall designate each State in accordance with
this subpart according to its tuberculosis status. A defined zone
comprised of a portion of an entire State will be given
[[Page 58778]]
a particular status designation upon request of the State only if the
Administrator determines that:
(a) The State meets the requirements of this subpart for
establishment of disease status zones;
(b) The State has adopted and is enforcing regulations that impose
restrictions on the intrastate movement of cattle and bison that are
substantially the same as those in place under this subpart for the
interstate movement of cattle and bison, and has adopted and is
enforcing regulations that impose restrictions on the intrastate
movement of captive cervids that are substantially the same as those in
place under subpart B of this part for the interstate movement of
captive cervids; and
(c) The designation of part of a State as a zone will otherwise be
adequate to prevent the interstate spread of tuberculosis.
4. Section 77.3 is revised to read as follows:
Sec. 77.3 Accredited-free States or zones.
(a) The following are accredited-free States: Alabama, Alaska,
Arizona, Arkansas, California, Colorado, Connecticut, Delaware,
Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas,
Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota,
Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New
Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon,
Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota,
Tennessee, Utah, Vermont, Virginia, the Virgin Islands of the United
States, Washington, West Virginia, Wisconsin, and Wyoming.
(b) The following are accredited-free zones: A zone in Michigan
consisting of that part of the State outside the zone in Michigan
described in Sec. 77.5(b).
(c) Detection of tuberculosis in any one herd of cattle or bison in
an accredited-free State or zone will result in suspension of
accredited-free State or zone status. If two or more accredited herds
are detected in an accredited-free State or zone within a 48-month
period, the State or zone will be removed from the list of accredited-
free States or zones and will be reclassified as either a modified
accredited State or zone or a nonmodified accredited State or zone.
(d) If the accredited-free status of a State or zone has been
suspended, the State or zone may qualify for redesignation of
accredited-free status after the herd in which tuberculosis is detected
has been quarantined, an epidemiological investigation has confirmed
that the disease has not spread from the herd, and all reactor cattle
and bison have been destroyed. If any livestock other than cattle or
bison are included in a newly assembled herd on a premises where a
tuberculous herd has been depopulated, the State or zone must apply the
herd test requirements contained in the ``Uniform Methods and Rules--
Bovine Tuberculosis Eradication'' January 22, 1999, edition, which was
approved for incorporation by reference into the Code of Federal
Regulations by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51,2 for such newly assembled
herds to those other livestock in the same manner as to cattle and
bison. Failure to do so will result in reclassification of the State or
zone as either a modified accredited State or zone or a nonmodified
accredited State or zone.
---------------------------------------------------------------------------
\2\ Copies may be obtained from the National Animal Health
Programs, Veterinary Services, APHIS, 4700 River Road Unit 43,
Riverdale, Maryland 20737-1231. You may inspect a copy at the APHIS
reading room, room 1141, USDA South Building, 14th Street and
Independence Ave., SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., Suite 700,
Washington, DC.
---------------------------------------------------------------------------
(e) If tuberculosis is diagnosed within an accredited-free State or
zone in an animal not specifically regulated by this part and a risk
assessment conducted by APHIS determines that the outbreak poses a
tuberculosis risk to livestock within the State or zone, the State or
zone must adopt a tuberculosis management plan, approved jointly by the
State animal health official and the Administrator, within 6 months of
the diagnosis. The management plan must include provisions for
immediate investigation of tuberculosis in livestock and wildlife, the
prevention of the spread of the disease to other wildlife and
livestock, increased surveillance of tuberculosis in wildlife,
eradication of tuberculosis from individual herds, a timeline for
tuberculosis eradication, and performance standards by which to measure
yearly progress toward eradication. If a State or zone does not adopt
such a plan within the required 6 months, the State or zone will lose
its accredited-free status and will be reclassified as either a
modified accredited State or zone or a nonmodified accredited State or
zone.
(f) Accredited-free State or zone status must be renewed annually.
To qualify for renewal of accredited-free State or zone status, a State
must submit an annual report to APHIS certifying that the State or zone
within the State complies with all the provisions of the ``Uniform
Methods and Rules--Bovine Tuberculosis Eradication'' regarding
accredited-free States. The report must be submitted to APHIS each year
between October 1 and November 30.
5. Section 77.4 is revised to read as follows:
Sec. 77.4 Modified accredited States or zones.
(a) The following are modified accredited States: New Mexico and
Texas.
(b) The following are modified accredited zones: None.
(c) If tuberculosis is diagnosed within a modified accredited State
or zone in an animal not specifically regulated by this part and a risk
assessment conducted by APHIS determines that the outbreak poses a
tuberculosis risk to livestock within the State or zone, the State or
zone must adopt a tuberculosis management plan, approved jointly by the
State animal health official and the Administrator, within 6 months of
the diagnosis. The management plan must include provisions for
immediate investigation of tuberculosis in livestock and wildlife, the
prevention of the spread of the disease to other wildlife and
livestock, increased surveillance of tuberculosis in wildlife,
eradication of tuberculosis from individual herds, a timeline for
tuberculosis eradication, and performance standards by which to measure
yearly progress toward eradication. If a State or zone does not adopt
such a plan within the required 6 months, the State or zone will be
reclassified as nonmodified accredited.
(d) If any livestock other than cattle or bison are included in a
newly assembled herd on a premises where a tuberculous herd has been
depopulated, the State or zone must apply the herd test requirements
contained in the ``Uniform Methods and Rules--Bovine Tuberculosis
Eradication, January 22, 1999 edition,'' which was approved for
incorporation by reference into the Code of Federal Regulations by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51,3 for such newly assembled herds to those
other livestock in the same manner as to cattle and bison. Failure to
do so will result in the removal of the State or zone from the list of
modified accredited States or zones and its being reclassified as a
nonmodified accredited State or zone.
---------------------------------------------------------------------------
\3\ Copies may be obtained from the National Animal Health
Programs, Veterinary Services, APHIS, 4700 River Road Unit 43,
Riverdale, Maryland 20737-1231. You may inspect a copy at the APHIS
reading room, room 1141, USDA South Building, 14th Street and
Independence Ave., SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., Suite 700,
Washington, DC.
---------------------------------------------------------------------------
(e) Modified accredited State or zone status must be renewed
annually. To qualify for renewal of a modified
[[Page 58779]]
accredited State or zone status, a State must submit an annual report
to APHIS certifying that the State or zone complies with all the
provisions of the ``Uniform Methods and Rules--Bovine Tuberculosis
Eradication'' regarding modified accredited States. The report must be
submitted to APHIS each year between October 1 and November 30.
(f) To qualify for accredited-free status, a modified accredited
State or zone must demonstrate to the Administrator that it has zero
percent prevalence of affected cattle and bison herds, has had no
findings of tuberculosis in any cattle or bison in the State or zone
for the previous 5 years, and complies with the provisions of the
``Uniform Methods and Rules--Bovine Tuberculosis Eradication,'' except
that the requirement of freedom from tuberculosis is 2 years from the
depopulation of the last infected herd in States or zones that were
previously accredited-free and in which all herds affected with
tuberculosis were depopulated.
Secs. 77.10 and 77.14 [Amended]
6. Section 77.10 is amended by redesignating footnote 3 as footnote
5, and Sec. 77.14 is amended by redesignating footnote 4 as footnote 6.
Secs. 77.5-77.18 [Redesignated Secs. 77.9-77.22]
7. Sections 77.5, 77.6, 77.7, 77.8, 77.9, 77.10, 77.11, 77.12,
77.13, 77.14, 77.15, 77.16, 77.17, and 77.18 are redesignated as
Secs. 77.9, 77.10, 77.11, 77.12, 77.13, 77.14, 77.15, 77.16, 77.17,
77.18, 77.19, 77.20, 77.21, and 77.22, respectively, and new
Secs. 77.5, 77.6, 77.7, and 77.8 are added to read as follows:
Sec. 77.5 Nonmodified accredited States or zones.
(a) The following are nonmodified accredited States: None.
(b) The following are nonmodified accredited zones: A zone in
Michigan delineated by starting at the juncture of State Route 55 and
Interstate 75, then heading northwest and north along Interstate 75 to
the Straits of Mackinac, then southeast and south along the shoreline
of Michigan to the eastern terminus of State Route 55, then west along
State Route 55 to Interstate 75.
(c) To qualify for accredited-free status, a nonmodified accredited
State or zone must demonstrate to the Administrator that it has zero
percent prevalence of affected cattle and bison herds, has had no
findings of tuberculosis in any cattle or bison in the State or zone
for the previous 5 years, and complies with the provisions of the
``Uniform Methods and Rules--Bovine Tuberculosis Eradication, January
22, 1999 edition,'' which was incorporated by reference into the Code
of Federal Regulations by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51,4 except
that the requirement of freedom from tuberculosis is 2 years from the
depopulation of the last infected herd in States or zones that were
previously accredited-free and in which all herds affected with
tuberculosis were depopulated.
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\4\ Copies may be obtained from the National Animal Health
Programs, Veterinary Services, APHIS, 4700 River Road Unit 43,
Riverdale, Maryland 20737-1231. You may inspect a copy at the APHIS
reading room, room 1141, USDA South Building, 14th Street and
Independence Ave., SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., Suite 700,
Washington, DC.
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(d) To qualify for modified accredited status, a nonmodified
accredited State or zone must demonstrate that it complies with the
provisions of the ``Uniform Methods and Rules--Bovine Tuberculosis
Eradication,'' and that tuberculosis has been prevalent in less than
0.01 percent of the total number of herds of cattle and bison in the
State or zone for the most recent 2 years, except that the
Administrator, upon his or her review, may allow a State or zone with
fewer than 30,000 herds to have up to 3 affected herds for each of the
most recent 2 years, depending on the veterinary infrastructure,
livestock demographics, and tuberculosis control and eradication
measures in the State or zone.
Sec. 77.6 Interstate movement from accredited-free, accredited-free
(suspended), and modified accredited States and zones.
Cattle and bison that originate in an accredited-free State or
zone, an accredited-free (suspended) State or zone, or a modified
accredited State or zone and that are not known to be infected with or
exposed to tuberculosis may be moved interstate without restriction.
Sec. 77.7 Interstate movement from nonmodified accredited States and
zones.
Cattle or bison that originate in a nonmodified accredited State or
zone, and that are not known to be infected with or exposed to
tuberculosis, may be moved interstate only under the following
conditions:
(a) The cattle or bison are moved interstate directly to slaughter
to an establishment operating under the provisions of the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) or to a State-inspected
slaughtering establishment that has inspection by a State inspector at
the time of slaughter;
(b) If the cattle or bison are steers or spayed heifers, or are
officially identified sexually intact heifers moved to an approved
feedlot, they must be accompanied by a certificate stating that they
have been classified negative to an official tuberculin test that was
conducted within 30 days prior to the date of movement. All cattle and
bison so moved that are not individually identified by a registration
name and number must be individually identified by an APHIS-approved
metal eartag or tattoo;
(c) Cattle and bison that are breeding animals from an accredited
herd may be moved interstate if they are accompanied by a certificate
showing the cattle or bison are from such a herd; or
(d) If the cattle or bison are breeding animals that are not from
an accredited herd, they must be accompanied by a certificate stating
that they have been classified negative to two official tuberculin
tests conducted at least 60 days apart and no more than 6 months apart,
with the second test conducted within 30 days prior to the date of
movement. All cattle and bison so moved that are not individually
identified by a registration name and number must be individually
officially identified.
Sec. 77.8 Application for and retention of recognition of tuberculosis
status zones.
(a) A State animal health official may request at any time that the
Administrator designate part of a State as having a different
tuberculosis status under this subpart than the rest of the State,
except that each State may be divided into no more than two different
zones. The requested zone must be delineated by the State animal health
authorities, subject to approval by the Administrator. The request from
the State must demonstrate that the State complies with the following
requirements:
(1) The State must have the legal and financial resources to
implement and enforce a tuberculosis eradication program and must have
in place an infrastructure, laws, and regulations that require and
ensure that State and Federal animal health authorities are notified of
tuberculosis cases in domestic livestock or outbreaks in wildlife;
(2) The State in which the intended zones are located must
maintain, in each intended zone, clinical and epidemiological
surveillance of animal species at risk of tuberculosis, at a rate that
allows detection of tuberculosis in
[[Page 58780]]
the overall population of livestock at a 2 percent prevalence rate with
95 percent confidence. The designated tuberculosis epidemiologist must
review reports of all testing for each zone within the State within 30
days of the testing; and
(3) The State must enter into a memorandum of understanding with
APHIS in which the State agrees to adhere to any conditions for zone
recognition particular to that request.
(b) Retention of APHIS recognition of a tuberculosis status zone is
subject to annual review by the Administrator. To retain recognition of
a zone, a State must continue to comply with the requirements of
paragraphs (a)(1), (a)(2), and (a)(3) of this section, and must retain
for 2 years all certificates required under this part for the movement
of cattle, bison, and captive cervids.
Sec. 77.12 [Amended]
8. Newly redesignated Sec. 77.12 is amended as follows:
a. In the definition of Accredited herd, by removing the reference
to ``Sec. 77.10(f)'' and adding in its place a reference to
``Sec. 77.14(f)'', and by removing the reference to ``Sec. 77.12'' and
adding in its place a reference to ``Sec. 77.16''.
b. In the definition of Affected herd, by removing the reference to
``Sec. 77.16(d)'' and adding in its place a reference to
``Sec. 77.20(d)''.
c. In the definition of Monitored herd, by removing the reference
to ``Sec. 77.14'' and adding in its place a reference to
``Sec. 77.18''.
d. In the definition of Qualified herd, by removing the reference
to ``Sec. 77.10(f)'' and adding in its place a reference to
``Sec. 77.14(f)''.
Sec. 77.13 [Amended]
9. Newly redesignated Sec. 77.13 is amended as follows:
a. In paragraph (a), by removing the reference to ``Sec. 77.12''
and adding in its place a reference to ``Sec. 77.16''.
b. In paragraph (b), by removing the reference to ``Sec. 77.17''
and adding in its place a reference to ``Sec. 77.21''.
c. In paragraph (c), by removing the reference to ``Sec. 77.17''
and adding in its place a reference to ``Sec. 77.21''.
Sec. 77.14 [Amended]
10. Newly redesignated Sec. 77.14 is amended as follows:
a. In paragraph (a)(1), by removing the reference to
``Sec. 77.11(a)(2)'' and adding in its place a reference to
``Sec. 77.15(a)(2)'', and by removing the reference to
``Sec. 77.16(e)'' and adding in its place a reference to
``Sec. 77.20(e)''.
b. In paragraph (e)(1), by removing the reference to
``Sec. 77.11(a)'' and adding in its place a reference to
``Sec. 77.15(a)''
c. In paragraph (e)(2), by removing the reference to
``Sec. 77.11(b)'' and adding in its place a reference to
``Sec. 77.15(b)''.
d. In paragraph (e)(3), by removing the reference to
``Sec. 77.11(c)'' and adding in its place a reference to
``Sec. 77.15(c)''.
e. In paragraph (f), by removing the reference to
``Sec. 77.12(a)(1)'' and adding in its place a reference to
``Sec. 77.16(a)(1)'', and by removing the reference to
``Sec. 77.13(a)(1)'' and adding in its place a reference to
``Sec. 77.17(a)(1)''.
Sec. 77.15 [Amended]
11. In newly redesignated Sec. 77.15, paragraph (c)(2) is amended
by removing the reference to ``Sec. 77.16(e)'' and replacing it with a
reference to ``Sec. 77.20(e)''.
Sec. 77.16 [Amended]
12. In newly redesignated Sec. 77.16, paragraph (a)(1) is amended
by removing the reference to ``Sec. 77.10(f)'' and adding in its place
a reference to ``Sec. 77.14(f)'', and paragraph (b) is amended by
removing the reference to ``Sec. 77.9(c)'' and adding in its place a
reference to ``Sec. 77.13(c)''.
Sec. 77.17 [Amended]
13. In newly redesignated Sec. 77.17, paragraph (a)(1) is amended
by removing the reference to ``Sec. 77.10(f)'' and adding in its place
a reference to ``Sec. 77.14(f)'', and paragraph (b)(2) is amended by
removing the reference to ``Sec. 77.9(c)'' and adding in its place a
reference to ``Sec. 77.13(c)''.
Sec. 77.18 [Amended]
14. In newly redesignated Sec. 77.18, paragraph (b)(2) is amended
by removing the reference to ``Sec. 77.9(c)'' and adding in its place a
reference to ``Sec. 77.13(c)''.
Sec. 77.20 [Amended]
15. Newly redesignated Sec. 77.20 is amended as follows:
a. In paragraph (a)(2), by removing the reference to
``Sec. 77.16(b)'' and adding in its place a reference to
``Sec. 77.20(b)''.
b. In the introductory text to paragraph (b), by removing the
reference to ``Sec. 77.16(e)'' and adding in its place a reference to
``Sec. 77.20(e)''.
c. In paragraph (b)(2), by removing the reference to ``Sec. 77.17''
and adding in its place a reference to ``Sec. 77.21''.
d. In paragraph (b)(2)(i), by removing the reference to
``Sec. 77.16(c)'' and adding in its place a reference to
``Sec. 77.20(c)''.
e. In paragraph (b)(2)(ii), by removing the reference to
``Sec. 77.16(d)'' and adding in its place a reference to
``Sec. 77.20(d)''.
f. In paragraph (c), by removing the reference to ``Sec. 77.16(a)''
and adding in its place a reference to ``Sec. 77.20(a)''.
g. In paragraph (d), by removing the reference to ``Sec. 77.15''
and adding in its place a reference to ``Sec. 77.19''.
h. In paragraph (e), by removing the reference to ``Sec. 77.16(d)''
and adding in its place a reference to ``Sec. 77.20(d)''.
i. In paragraph (e)(1), by removing the reference to
``Sec. 77.16(d)'' and adding in its place a reference to
``Sec. 77.20(d)''.
j. In paragraph (g)(2), by removing the reference to
``Sec. 77.16(a)'' and adding in its place a reference to
``Sec. 77.20(a)''.
Sec. 77.21 [Amended]
16. In newly redesignated Sec. 77.21, paragraph (a)(3) is amended
by removing the reference to ``Sec. 77.8'' and adding in its place a
reference to ``Sec. 77.12''.
Done in Washington, DC, this 20th day of October 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-27746 Filed 10-29-99; 8:45 am]
BILLING CODE 3410-34-U
