[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
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Greater than .60.................................. Negative.
Greater than .30 but less than or equal to .60.... Suspect.
.30 or less....................................... Positive.
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* * * * *
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
