Tuberculosis in Cattle and Bison; State Designations

Federal RegisterNov 1, 1999

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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

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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

publication of this rule in the Federal Register. After the comment

period closes, we will publish another document in the Federal

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

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).

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.

or zone in an animal not specifically regulated by this part and a risk