[Federal Register Volume 59, Number 39 (Monday, February 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4487]


[Federal Register: February 28, 1994]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 

------------------------------------------------------------------------
                 Percent inhibition                     Classification  
------------------------------------------------------------------------
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.          
------------------------------------------------------------------------

* * * * *
    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]
BILLING CODE 3410-34-P