Brucellosis; Procedures for Retaining Class Free State Status

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 98-060-2]

Brucellosis; Procedures for Retaining Class Free State Status

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending 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

include quarantining, testing, and depopulating the affected herd and

conducting an investigation to ensure that brucellosis has not spread

from the affected herd, will 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 will 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 change in the regulations, a State could lose its Class Free

status following the detection of a single affected herd and will 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.

EFFECTIVE DATE: April 30, 1999.

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.

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.

On September 17, 1998, we published in the Federal Register (63 FR

49670-49673, Docket No. 98-060-1) a proposed rule to amend the

brucellosis regulations to allow a State to retain its Class Free

status following the detection of a single affected herd if the State

met certain conditions. As described in the proposed rule, those

conditions, which 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 solicited comments concerning our proposal for 60 days ending on

November 2, 1998. We received five comments by that date. They were

from a State office of Federal land policy, a State game and fish

agency, a State livestock board, a veterinary medical association, and

a national milk producers association. All five commenters supported

the proposed rule, although three of them asked for clarification of

the following points:

Applicability. Two commenters asked that we clearly state that the

provisions of the proposed rule would apply only to domestic livestock

and not to wildlife.

The commenters' understanding of the applicability of these

provisions is correct. The conditions that would have to be met for a

State to retain its Class Free status--i.e., quarantining, testing, and

depopulating the affected herd and investigating all adjacent, source,

and contact herds to ensure the disease has not spread from the

affected herd--simply could not be practically applied to wildlife. The

provisions of this rule are applicable only to situations where a herd

of domestic livestock in a Class Free State is found to be affected.

Start of the 60-day period. Because a State would be given 60 days

following the identification of an infected animal to complete the

requirements for retaining Class Free status, one commenter asked that

we clearly define the phrase ``identification of the infected animal.''

This commenter pointed out that in some cases, a reactor classification

test occurs in which organisms cannot be cultured to differentiate

whether Strain 19 or field strain Brucella abortus is involved, and

those cases must be resolved by an epidemiological investigation. The

commenter suggested that the 60-day

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period should not begin until an investigation determines that an

animal is infected with the field strain of Brucella abortus and is not

reacting to an official brucellosis test due to its having been

vaccinated with a Strain 19 vaccine.

The commenter's understanding of when the 60-day period would begin

is correct. If an animal reacts to an official brucellosis test and we

are able to determine, through culturing, that the animal is infected

with field strain Brucella abortus, then the 60-day period would begin

on the date of that laboratory confirmation. If culturing proves

inconclusive and an investigation is necessary to resolve the case,

then the 60-day period would not begin until the date that the

investigating epidemiologist reports that the animal is a Brucella

abortus reactor. If further investigation leads the epidemiologist to

conclude that the animal is a Strain 19 associated reactor, the herd

will not be considered an affected herd. To make this clearer, we have

changed new paragraph Sec. 78.1(b)(4) in this final rule so that it

uses the words ``within 60 days of the date an animal in the herd is

determined to be infected'' rather than ``within 60 days of the

identification of the infected animal.''

Therefore, for the reasons given in the proposed rule and in this

document, we are adopting the proposed rule as a final rule with the

changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This 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 rule amends 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

include depopulating the affected herd and taking measures to ensure

that brucellosis has not spread from the affected herd, will 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 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 the United States was

approximately 101.4 million in 1997, and was 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 can 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 will 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 will mean

that herd owners in the State can 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

rule will 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 is

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

costs of that depopulation may 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 for bison and

nonregistered cattle other than dairy cattle and $750 per animal for

registered cattle and nonregistered dairy cattle.

Class Free States will not be required to pursue the option offered

by this rule for retaining Class Free status following the detection of

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

benefits that a State can realize by taking action to avoid being

downgraded to Class A status will far outweigh the costs of the herd

depopulation, epidemiological investigation, and testing that will be

required to retain Class Free status.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action will

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 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

This 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

[[Page 15298]]

recordkeeping requirements, Transportation.

Accordingly, we are amending 9 CFR part 78 as follows:

PART 78--BRUCELLOSIS

1. The authority citation for part 78 continues 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) is 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 date an animal in the herd is determined to be

infected:

(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 date an

animal in the herd is determined to be infected, 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 24th day of March 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-7804 Filed 3-30-99; 8:45 am]

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