[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4724]


[[Page Unknown]]

[Federal Register: March 2, 1994]


                                                    VOL. 59, NO. 41

                                           Wednesday, March 2, 1994
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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 93-120-1]

 

Official Brucellosis Tests

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the brucellosis regulations by 
revising standards established for the brucellosis testing of cattle 
and bison with the particle concentration fluorescence immunoassay 
test. By revising the standards for this test, we believe we would help 
designated epidemiologists to avoid incorrectly classifying cattle and 
bison as brucellosis suspects.

DATES: Consideration will be given only to comments received on or 
before May 2, 1994.

ADDRESSES: Please send an original and three copies of your comments to 
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804, 
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please 
state that your comments refer to Docket No. 93-120-1. 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. John Kopec, Senior Staff 
Veterinarian, Cattle Diseases Staff, Veterinary Services, APHIS, USDA, 
room 730, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, 
(301) 436-6188.

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is a serious infectious and contagious disease, caused 
by bacteria of the genus Brucella, that affects animals and man. The 
Secretary of Agriculture is authorized to cooperate with the States in 
conducting a brucellosis eradication program and in preventing the 
interstate spread of brucellosis. 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 
status of cattle, bison, and swine. The regulations stipulate that 
testing negative to an official brucellosis test is a condition for 
certain interstate movements. Additionally, official tests are used to 
determine eligibility for indemnity payments for animals destroyed 
because of brucellosis.
    One official test is the particle concentration fluorescence 
immunoassay (PCFIA) test, an automated serologic test for brucellosis 
in cattle, bison, and swine. Results of the PCFIA test are expressed as 
an S/N value, which is the ratio of the test sample to a negative 
control. Currently, under the definition of Official test in 
Sec. 78.1(a)(10) of the regulations, cattle and bison are considered: 
(1) reactors when the S/N value of their PCFIA test results is less 
than or equal to 0.25; (2) suspects when the S/N value is greater than 
or equal to 0.26, but less than or equal to 0.70; and (3) negative when 
the S/N value is greater than 0.70.
    We believe that the spectrum of S/N ratios indicating suspect 
status in cattle and bison is too broad. We have determined that tested 
cattle and bison with S/N values between 0.60 and 0.70, and thus 
classified under the regulations as brucellosis suspects, almost always 
prove to be noninfected after supplemental testing. Moreover, we have 
also determined that the vast majority of tested cattle and bison with 
S/N values between 0.25 and 0.30, and thus classified as brucellosis 
suspects, prove to be brucellosis reactors in subsequent testing.
    We propose, therefore, to revise the PCFIA test standards to 
reflect this new information. This would allow the brucellosis disease 
status of test-eligible cattle and bison to be more accurately 
determined. Under this proposal, cattle and bison tested with the PCFIA 
test would be considered: (1) reactors when the S/N value of their test 
results is less than or equal to 0.30; (2) suspects when the S/N value 
is greater than 0.30, and less than or equal to 0.60; and (3) negative 
when the S/N value is greater than 0.60.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866.
    We are proposing to amend the brucellosis regulations by revising 
standards established for the brucellosis testing of cattle and bison 
with the PCFIA test. We believe that the test result standards in the 
current regulations which indicate the disease status of tested animals 
can be improved.
    Incorrect brucellosis classification of cattle and bison as a 
result of the current PCFIA test standards creates marketing delays and 
unnecessary costs for farmers. Under the regulations, cattle and bison 
classified as brucellosis suspects must either be quarantined and 
retested within 30 days or sold for slaughter (usually at a loss). 
Consequently, farmers may unnecessarily quarantine or slaughter, at a 
loss, incorrectly classified cattle and bison. Therefore, we believe 
our proposal to revise the PCFIA test result standards would save 
farmers both time and money.
    Though we believe that the economic impact of this proposal would 
be positive, we also believe it would be minimal. We anticipate that 
only about 7,200 cattle and bison in 560 herds (less than one 
thousandth of a percent of all cattle and bison in the United States) 
are classified incorrectly as brucellosis suspects under our current 
regulations. We estimate that all of the cattle and bison affected by 
this proposal would be owned by farms classified as small entities 
under Small Business Administration standards.
    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 12778

    This proposed rule has been reviewed under Executive Order 12778, 
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 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, would be amended 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, 134f; 7 CFR 2.17, 2.51, and 371.2(d).


    2. In Sec. 78.1, the definition of Official test, paragraph 
(a)(10), the table would be revised to read as follows:


Sec. 78.1  Definitions.

* * * * *
    Official test.
    (a) * * *
    (10) * * *

------------------------------------------------------------------------
                    S/N ratio                          Classification   
------------------------------------------------------------------------
Greater than .60..................................  Negative.           
Greater than .30 but less than or equal to .60....  Suspect.            
.30 or less.......................................  Positive.           
------------------------------------------------------------------------

* * * * *
    Done in Washington, DC, this 23rd day of February 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-4724 Filed 3-1-94; 8:45 am]
BILLING CODE 3410-34-P