Official Brucellosis Tests

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 93-044-2]

Official Brucellosis Tests

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the brucellosis regulations by adding the D-

Tec Brucella A test to the list of official tests for

determining the brucellosis disease status of test-eligible cattle and

bison. We are taking this action because the D-Tec Brucella A

test has exhibited a high degree of specificity in identifying Brucella

abortus antibodies. Adding the D-Tec Brucella A test to the

list of official tests for brucellosis in cattle and bison will help

prevent the spread of the disease by making available an additional

means by which animal health personnel may obtain timely and accurate

diagnoses of brucellosis.

EFFECTIVE DATE: March 30, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. John D. Kopec, Senior Staff

Veterinarian, Cattle Diseases and Surveillance Staff, Veterinary

Services, APHIS, USDA, room 731, Federal Building, 6505 Belcrest Road,

Hyattsville, MD 20782, (301) 436-6188.

SUPPLEMENTARY INFORMATION:

Background

Brucellosis is an infectious disease of animals and humans caused

by bacteria of the genus Brucella. In its principal animal hosts--

cattle, bison, and swine--brucellosis is characterized by abortion and

impaired fertility. The regulations in 9 CFR part 78 (referred to below

as the regulations) govern the interstate movement of cattle, bison,

and swine in order to help prevent the spread of brucellosis.

Official brucellosis tests are used to determine the brucellosis

disease status of cattle, bison, and swine. The regulations stipulate

that certain cattle, bison, and swine must, among other requirements,

test negative to an official brucellosis test prior to interstate

movement. Official brucellosis tests are also used to determine

eligibility for indemnity payments for animals destroyed because of

brucellosis. In Sec. 78.1 of the regulations, the definition of

official test lists those tests that have been designated as official

tests for determining the brucellosis disease status of cattle, bison,

and swine.

On September 27, 1993, we published in the Federal Register (58 FR

50290-50291, Docket No. 93-044-1) a proposal to amend the regulations

by adding the D-Tec Brucella A test to the list of official

tests for determining the brucellosis disease status of test-eligible

cattle and bison.

We solicited comments concerning our proposal for a 30-day comment

period ending October 27, 1993. We received one comment by that date,

from a veterinary medical association. The commenter supported our

proposed rule.

Therefore, based on the rationale set forth in the proposed rule,

we are adopting the provisions of the proposal as a final rule without

change.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866.

The rule change will not add any costs for agricultural producers.

It will, however, benefit farmers and ranchers who, without access to

this or the other available diagnostic tests, quarantine or destroy

animals on the basis of ``false positive'' reactions to presumptive

tests. We estimate that between 200 and 300 animals are unnecessarily

slaughtered or quarantined each year after having falsely tested

positive on presumptive tests. These losses could be prevented by the

use of diagnostic tests. The addition of the D-Tec Brucella A

test as an official test will prevent losses to farmers and ranchers if

they opt to use it. While losses resulting from false positives affect

only a few farmers and ranchers each year, this rule could modestly

benefit all those entities that avail themselves of the D-Tec

Brucella A test.

This rule is expected to have a beneficial effect on the producer

of the D-Tec Brucella A test and a negligible negative impact

on the only other producer of diagnostic tests. Both producers are

small entities.

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 12778

This rule has been reviewed under Executive Order 12778, 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 information collection or recordkeeping

requirements under the Paperwork Reduction Act of 1980 (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, 9 CFR part 78 is amended 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, 134f; 7 CFR 2.17, 2.51, and 371.2(d).

Subpart A--[Amended]

2. In Sec. 78.1, in the definition of official test, paragraph

(a)(11) is redesignated as (a)(12), and a new paragraph (a)(11) is

added to read as follows:

Sec. 78.1 Definitions.

* * * * *

Official test.

(a) * * *

(11) D-Tec Brucella A test. An automated serologic test

to determine the brucellosis disease status of test-eligible cattle and

bison when conducted according to instructions approved by APHIS. The

degree of reactivity is measured by the ratio of the average optical

density of the sample to that of the Negative Control (S/N) and is

expressed as Percent Inhibition (1-S/N) x 100. The brucellosis

disease status of the animals is classified according to the following

established criteria:

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Percent inhibition Classification

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Less than or equal to 40 percent.................... Negative.

Greater than 40 percent and less than or equal to 70 Suspect.

percent.

Greater than 70 percent............................. Reactor.

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* * * * *

Done in Washington, DC, this 18th day of February 1994.

Patricia Jensen,

Acting Assistant Secretary, Marketing and Inspection Services.

[FR Doc. 94-4487 Filed 2-25-94; 8:45 am]

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