Brucellosis; Procedures for Retaining Class Free State Status

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 98-060-1]

Brucellosis; Procedures for Retaining Class Free State Status

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the brucellosis regulations to allow

a State to retain its Class Free status following the detection of an

affected herd if the State meets certain conditions. These conditions,

which would include quarantining, testing, and depopulating the

affected herd and conducting an investigation to ensure that

brucellosis has not spread from the affected herd, would allow a State

to avoid losing its Class Free status due to an isolated case of

infection being detected in the State. We believe that providing this

option to States would encourage the prompt resolution of isolated

cases of brucellosis and thus ensure the continued progress of State

and Federal efforts toward the eradication of brucellosis in domestic

cattle and bison herds. Without this proposed change in the

regulations, a State could lose its Class Free status following the

detection of a single affected herd and would not have as great an

incentive to take swift and decisive action to determine the source of

the infection, eliminate the affected herd, and ensure that the disease

had not spread to other herds in the State.

DATES: Consideration will be given only to comments received on or

before November 2, 1998.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 98-060-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 98-060-1. Comments

received may be inspected at USDA, room 1141, South Building, 14th

Street and Independence Avenue SW., Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday, except holidays. Persons wishing to

inspect comments are requested to call ahead on (202) 690-2817 to

facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Valerie Ragan, Senior Staff

Veterinarian, National Animal Health Programs, VS, APHIS, 4700 River

Road Unit 36, Riverdale, MD 20737-1231, (301) 734-7708.

SUPPLEMENTARY INFORMATION:

Background

Brucellosis is a contagious disease affecting animals and humans,

caused by bacteria of the genus Brucella. In its principal animal

hosts, brucellosis is characterized by abortion and impaired fertility.

Through a cooperative State and Federal effort, the United States

is now approaching total eradication of the field strain Brucella

abortus in domestic cattle and bison herds. As of July 31, 1998, there

were only 9 known infected domestic cattle and bison herds, and the

U.S. Department of Agriculture's (USDA's) Animal and Plant Health

Inspection Service (APHIS) had declared 43 States, Puerto Rico, and the

U.S. Virgin Islands free of the disease.

The brucellosis regulations contained in 9 CFR part 78 (referred to

below as the regulations) provide a system for classifying States or

portions of States (areas) according to the rate of Brucella abortus

infection present and the general effectiveness of the brucellosis

control and eradication program conducted in the State or area. The

classifications are Class Free, Class A, Class B, and Class C; States

or areas that do not meet the minimum standards for Class C may be

placed under Federal quarantine. At this point in the cooperative

State/Federal brucellosis eradication program, all States have achieved

either Class Free or Class A status.

To maintain Class Free status, the regulations require, among other

things, that a State must have a herd infection rate of 0.0 percent or

0 herds per 1,000. A State's herd infection rate is based on the number

of herds found to have brucellosis reactors within the State during any

12 consecutive months due to field strain Brucella abortus. The

required 0.0 percent herd infection rate means that a Class Free State

would no longer qualify for Class Free status if a single brucellosis-

affected herd was detected in the State. A downgrade in status from

Class Free to Class A results in increased costs for States and their

livestock owners, with most of those added costs arising from the

increased testing requirements that accompany Class A status.

The cooperative State/Federal brucellosis eradication program is

nearing its conclusion, with eradication of the disease in domestic

cattle and bison herds being projected by the end of 1998. With the

eradication program entering its latter stages, several States that

historically had significant levels of brucellosis have been able to

attain Class Free status. Although these States have successfully

eliminated the remaining known infected herds within their borders, we

believe that it is possible that some of these States may find an

isolated herd affected with brucellosis. That was the case recently

with Louisiana. Louisiana attained Class Free status in October 1996,

but, due to the detection of brucellosis in two herds within the State,

was downgraded to Class A in an interim rule effective on June 16,

1998, and published in the Federal Register on June 24, 1998 (63 FR

34264-34266, Docket No. 98-068-1).

State and Federal animal health officials have recognized the need

for a procedure that would allow a brucellosis Class Free State to

maintain its status if an isolated case of brucellosis infection occurs

and it can be confirmed that the disease did not spread outside of the

herd. We agree that such a strategy is appropriate at this stage of the

brucellosis eradication program, when each new herd found to be

affected with brucellosis is handled in an emergency action mode in

order to quickly resolve the case and ensure continued progress toward

eradication. We believe that a procedure that gives a Class Free State

the opportunity to retain its status following the detection of an

affected herd would be a powerful incentive that would encourage a

State in that situation to take swift and decisive action to determine

the source of the infection, eliminate the affected

[[Page 49671]]

herd, and ensure that the disease has not spread to other herds in the

State.

Therefore, we are proposing to amend the definition of Class Free

State or area in Sec. 78.1 of the regulations by adding a new paragraph

(b)(4) that would explain the conditions that a State would have to

meet in order to retain its Class Free status after the detection of an

affected herd within the State.

This proposed procedure is intended to address cases in which a

Class Free State encounters an isolated incident in which a herd

affected with brucellosis is discovered; it is not intended to be a

regular feature of a State's maintenance of its Class Free status.

Therefore, the introductory text of new paragraph (b)(4) would provide

that a State could use the procedure only in cases where a single herd

is found to be affected with brucellosis, and only once in any 2-year

period. We would impose these limitations because we believe that the

detection of more than one affected herd within a 2-year period is

indicative of a brucellosis problem that is more widespread than the

isolated cases this proposed procedure is intended to address.

The steps that a State would have to take to retain its Class Free

status would be clear-cut and consistent with the goals of emergency

disease management: Within 60 days of identifying the initial infected

animal, the State would have to eliminate the affected herd and ensure

that infection has not spread. To attain these goals, we would require

that the State immediately quarantine the affected herd upon its

disclosure. After quarantining the herd to ensure that there is no

potential for further spread of the disease from the herd, all the

animals in the herd would have to be tested for brucellosis and

slaughtered as soon as possible within the 60-day period. Testing the

herd prior to, or at the time of, depopulation would provide

epidemiologists with information as to the extent of the brucellosis

infection in the herd and other information of that nature that would

be useful as animal health personnel pursue the other aspect of the

State's response to the detection of the affected herd, i.e., a

complete epidemiological investigation of the herd to attempt to

determine the source of the infection and ensure that brucellosis has

not spread.

The epidemiological investigation that would be required would

involve the identification and investigation of all herds on premises

adjacent to the affected herd (adjacent herds), all herds from which

animals may have been brought into the affected herd (source herds),

and all herds that may have had contact with or accepted animals from

the affected herd (contact herds). Once all adjacent, source, and

contact herds had been identified, each of those herds would have to be

placed under an approved individual herd plan.

An approved individual herd plan, as defined in 78.1, is a herd

management and testing plan designed by the herd owner, the owner's

veterinarian if requested, and a State representative or APHIS

representative to determine the disease status of the animals in the

herd and, in those cases where the disease is found to be present, to

control and eradicate brucellosis within the herd. An individual herd

plan must be jointly approved by the State animal health official and

the APHIS Veterinarian in Charge. The use of an approved individual

herd plan under the circumstances envisioned in this proposed rule

would ensure that any testing or other measures determined to be

necessary could be instituted after being agreed upon by the herd

owner, the State, and APHIS.

In most cases, the approved individual herd plan will require herd

blood tests--i.e., the brucellosis testing of all test-eligible animals

in a herd--for each of the adjacent, source, and contact herds

identified in the course of the epidemiological investigation. However,

we acknowledge that there may be some instances in which a herd blood

test may not be necessary given the facts of the situation. For

example, a herd may be identified as a contact herd on the basis of its

having received animals from the affected herd. If, however, it was

determined that the only animals the contact herd received from the

affected herd were steers, which pose no threat of disseminating

brucellosis, then it would serve little practical purpose from an

epidemiological standpoint to require a herd blood test for the contact

herd. Another example of this type of situation would be a case in

which a herd is identified as a source herd on the basis of its having

provided a heifer to the affected herd. If it was determined that the

heifer left the source herd 8 years ago to join the affected herd, and

the source herd has been a certified brucellosis-free herd for the last

10 years, then once again it would likely be unnecessary from an

epidemiological standpoint to require that source herd to undergo a

herd blood test.

Given that situations such as those described in the previous

paragraph may occur, we are proposing to allow the epidemiologist

investigating the affected herd to place an adjacent, source, or

contact herd under an individual herd plan that does not require a herd

blood test if he or she determines that such testing is not warranted.

That determination, along with the reasons supporting it, would have to

be documented in the individual herd plan, which, as noted above, must

be jointly approved by the State animal health official and the APHIS

Veterinarian in Charge.

If additional herds affected with brucellosis were detected during

the course of the epidemiological investigation and subsequent testing,

the State would not be eligible to retain its Class Free status under

this proposed procedure, but the identification of those herds would

nonetheless aid the State in its efforts to eliminate brucellosis and

begin the process of requalifying for Class Free status.

At the close of the 60-day period during which the State conducted

the activities described in the preceding paragraphs, APHIS would

review the actions taken by the State in response to the detection of

the affected herd to confirm that the State had met all the conditions

necessary to retain its Class Free status.

Alternatives Considered

The criteria for retaining Class Free status proposed in this

document are similar in scope and substance to the requirements found

in the definition of accredited-free (suspended) State in Sec. 77.1 of

our tuberculosis regulations in 9 CFR part 77. Specifically, an

accredited free (suspended) State may regain its accredited-free status

after quarantining the herd in which tuberculosis was detected,

conducting an epidemiological investigation to determine that the

infection has not spread from the herd, and destroying all reactor

cattle and bison. The similarity of our proposed criteria for retaining

Class Free status to those requirements led us to consider the

possibility of establishing a new classification such as ``Class Free

(suspended) State'' in the brucellosis regulations. However, for the

reasons explained below, we have determined that an entirely new State

classification would not be necessary in order for the objectives of

this proposed rule to be accomplished.

Under the tuberculosis regulations, two herds must be found to be

affected with tuberculosis within a 48-month period before a State's

accredited-free status will be revoked. Without the accredited-free

(suspended) classification, the detection of a single tuberculosis-

affected herd in a State would have little effect other than to start

the 48-month clock; there would not necessarily be an incentive for a

State to act quickly to quarantine the

[[Page 49672]]

affected herd and ensure that tuberculosis has not and will not spread

from that herd. The accredited-free (suspended) classification provides

that incentive by allowing a State to qualify for redesignation as

accredited-free as soon as the required quarantine, investigation, and

destruction of reactors has been completed.

The brucellosis regulations, on the other hand, provide that a

State may lose its Class Free status at any time upon the detection of

a single brucellosis-affected cattle or bison herd. Given that

immediacy, there is no need to provide for an interim downgrading of

State status in order for a Class Free State to have an incentive for

reacting quickly to the detection of brucellosis within its borders;

any necessary incentive for quick action would be provided by this

proposed rule's provisions for retaining Class Free status.

Another consideration in our rejection of the ``Class Free

(suspended)'' alternative is the fact that the requirements of this

proposed rule would have to be satisfied within 60 days in order for a

State to retain its Class Free status. That necessarily brief window

for action means that any rulemaking giving notice of a suspension in

status would have to be followed in short order by another rulemaking

returning the State to Class Free status or lowering it to Class A

status. Given that this proposed rule would not place any additional

requirements on the State's herds in general, we believe that adding a

``suspended'' classification would have little effect other than to

cause a short-term shuffling of State status.

One benefit of adding a ``suspended'' classification would be that

it would serve as a mechanism to notify other States of the detection

of a brucellosis-affected herd in a Class Free State. However, that

notification can also be accomplished through normal reporting methods,

so we see no need to add a new classification simply to ensure that

other States are made aware of a particular situation. Under current

procedures, whenever a herd is found to be affected with brucellosis

and the epidemiological investigation leads to an adjacent, source, or

contact herd in another State, that other State is immediately notified

and joins in the investigation. For States that are not directly

affected in that way, notification of the situation is accomplished

through the monthly reports that APHIS sends to the animal health

officials in every State. The need for a more immediate all-States

notification mechanism was not identified by the State and Federal

animal health officials who suggested the procedure for retaining Class

Free status that led to this proposed rule. However, we encourage State

animal health officials and others to offer their suggestions regarding

this notification issue in any comments they may wish to submit on this

proposed rule.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

The rule has been determined to be not significant for the purposes of

Executive Order 12866 and, therefore, has not been reviewed by the

Office of Management and Budget.

Producers and consumers have realized great financial savings from

the success of the Cooperative State/Federal Brucellosis Eradication

Program. Annual losses from lowered milk production, aborted calves and

pigs, and reduced breeding efficiency have decreased from more than

$400 million in 1952 to less than $1 million today. Studies indicate

that if the brucellosis eradication program efforts were stopped, the

costs of producing beef and milk could increase by an estimated $80

million annually in less than 10 years with the gradual spread of

brucellosis.

This proposed rule would amend the brucellosis regulations to allow

a State to retain its Class Free status following the detection of an

affected herd if the State meets certain conditions. These conditions,

which would include depopulating the affected herd and taking measures

to ensure that brucellosis has not spread from the affected herd, would

allow a State to avoid losing its Class Free status due to an isolated

case of infection being detected in the State.

The entities potentially affected by this proposed rule are the 43

States, Puerto Rico, and the U.S. Virgin Islands that currently hold

Class Free status and the producers of livestock in those States and

territories. The total number of cattle and bison in United States was

approximately 101.4 million in 1997, valued at about $53.2 billion.

There were 1,167,910 U.S. operations with cattle and bison in 1997.

Over 97 percent of these operations are considered to be small

entities, with gross cash value of less than $500,000 each (USDA,

National Agricultural Statistics Service, ``Agricultural Statistics

1997,'' Washington, DC, 1997).

Allowing a State to retain its Class Free status under certain

conditions could be expected to have an overall positive economic

effect for several reasons. First, when a State's status is upgraded

from Class A to Class Free, the State realizes a cost savings through

the reduction in the required level of brucellosis ring test (BRT)

surveillance. The BRT must be conducted in a Class A State or area at

least four times per year at approximately 90-day intervals, with all

herds producing milk for sale in the State being required to be

included in at least three of the four brucellosis ring tests conducted

each year. When a State attains Class Free status, the level of BRT

surveillance is lowered to two brucellosis ring tests per year for each

herd producing milk for sale in the State. Thus, allowing a State to

retain its Class Free status would enable the State to avoid the added

testing and personnel costs associated with the higher level of BRT

surveillance required of Class A States.

Second, allowing a State to retain its Class Free status would mean

that herd owners in the State could continue to avoid the costs of pre-

movement testing of their test-eligible cattle and bison. In a Class A

State, test-eligible cattle and bison offered for sale interstate from

other than certified-free herds must test negative for brucellosis

prior to movement. Because that testing is not required for test-

eligible cattle and bison in Class Free States, herd owners in a State

allowed to retain its Class Free status under the provisions of this

proposed rule would continue to be able to move their cattle or bison

interstate without incurring the approximately $3.25 per-head cost of

testing.

Finally, in those cases in which a brucellosis-affected herd was

depopulated in order for a State to retain its Class Free status, the

costs of that depopulation could be largely offset through the payment

of Federal indemnity for the destroyed animals. Under the brucellosis

indemnity regulations in 9 CFR part 51, any owner whose herd of cattle

or bison is destroyed because of brucellosis is eligible for the

payment of Federal indemnity. The rate of indemnity is set as either:

(1) The appraised value of each animal, minus its salvage value, or (2)

a fixed rate of no more than $250 per animal.

Class Free States would not be required to pursue the option

offered by this proposed rule for retaining Class Free status following

the detection of a brucellosis-affected herd. However, we believe that

the economic benefits that a State would realize by taking action to

avoid being downgraded to Class A status would far outweigh the costs

of the herd depopulation, epidemiological investigation, and testing

that would be required to retain Class Free status.

[[Page 49673]]

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action would

not have a significant economic impact on a substantial number of small

entities.

Executive Order 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 proposed rule has been reviewed under Executive Order 12988,

Civil Justice Reform. If this proposed rule is adopted: (1) All State

and local laws and regulations that are in conflict with this rule will

be preempted; (2) no retroactive effect will be given to this rule; and

(3) administrative proceedings will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

This proposed rule contains no new information collection or

recordkeeping requirements under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 78

Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and

recordkeeping requirements, Transportation.

Accordingly, we propose to amend 9 CFR part 78 as follows:

PART 78--BRUCELLOSIS

1. The authority citation for part 78 would continue to read as

follows:

Authority: 21 U.S.C. 111-114a-1, 114g, 115, 117, 120, 121, 123-

126, 134b, and 134f; 7 CFR 2.22, 2.80, and 371.2(d).

2. In Sec. 78.1, in the definition of Class Free State or area, a

new paragraph (b)(4) would be added to read as follows:

Sec. 78.1 Definitions.

* * * * *

Class free State or area. * * *

(b) * * *

(4) Retaining Class Free status. (i) If a single herd in a Class

Free State is found to be affected with brucellosis, the State may

retain its Class Free status if it meets the conditions of this

paragraph. A State may retain its status in this manner only once

during any 2-year period. The following conditions must be satisfied

within 60 days of the identification of the infected animal:

(A) The affected herd must be immediately quarantined, tested for

brucellosis, and depopulated; and

(B) An epidemiological investigation must be performed and the

investigation must confirm that brucellosis has not spread from the

affected herd. All herds on premises adjacent to the affected herd

(adjacent herds), all herds from which animals may have been brought

into the affected herd (source herds), and all herds that may have had

contact with or accepted animals from the affected herd (contact herds)

must be epidemiologically investigated, and each of those herds must be

placed under an approved individual herd plan. If the investigating

epidemiologist determines that a herd blood test for a particular

adjacent herd, source herd, or contact herd is not warranted, the

epidemiologist must include that determination, and the reasons

supporting it, in the individual herd plan.

(ii) After the close of the 60-day period following the

identification of the infected animal, APHIS will conduct a review to

confirm that the requirements of paragraph (b)(4)(i) have been

satisfied and that the State is in compliance with all other applicable

provisions.

* * * * *

Done in Washington, DC, this 11th day of September 1998.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-24950 Filed 9-16-98; 8:45 am]

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