[Federal Register Volume 61, Number 179 (Friday, September 13, 1996)]
[Proposed Rules]
[Pages 48430-48431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23495]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 78
[Docket No. 96-033-1]
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 to add
the rapid automated presumptive test to the list of official tests for
determining the brucellosis disease status of test-eligible cattle,
bison, and swine. We believe that this proposed action is warranted
because the rapid automated presumptive test has been shown to provide
an accurate, automated, and cost-effective means of determining the
brucellosis status of test eligible cattle, bison, and swine. Adding
the rapid automated presumptive test to the list of official tests for
brucellosis in cattle, bison, and swine would help to prevent the
spread of brucellosis by making available an additional tool for its
diagnosis in those animals.
DATES: Consideration will be given only to comments received on or
before November 12, 1996.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 96-033-1, Regulatory Analysis and Development, PPD, APHIS,
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 96-033-1. 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. M.J. Gilsdorf, National
Brucellosis Epidemiologist, Brucellosis Eradication Staff, VS, APHIS,
4700 River Road Unit 36, Riverdale, MD 20737-1228, (301) 734-7708; or
E-mail: mgilsdorf@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Brucellosis is a contagious disease affecting 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.
The Animal and Plant Health Inspection Service (APHIS) has
developed a new serologic test for the detection of Brucella
antibodies, and we are proposing to amend the regulations to add this
new presumptive test as an official test. The test, known as the rapid
automated presumptive (RAP) test, provides an accurate, automated, and
cost-effective means of determining the brucellosis status of test
eligible cattle, bison, and swine. The RAP test is as sensitive as the
existing buffered acidified plate antigen (BAPA) test currently used
for cattle and bison and uses the same basic test criteria as the BAPA
test, but the RAP test employs a computer reader and recording device
to assess and report test results.
To conduct the RAP test, a laboratory technician places a serum
sample drawn from a test eligible animal on a microtiter plate, then
measures the amount of light that is transmitted through the microtiter
well using a computer reader and visual processor. The technician then
mixes test antigen with the serum and once again measures the light
transmission through the microtiter well; if Brucella antibodies are
present, there will be an agglutination reaction between the antibodies
and the test antigens, and the agglutination will reduce the amount of
light that is transmitted through the test well. The computer reader
compares the two light measurements and reports whether the blood
sample is positive or negative for Brucella antibodies, based on the
agglutination reaction. If the percentage of agglutination indicated is
measured at less than the established reference level for the test, the
results would be interpreted as negative and the animal from which the
sample was drawn would be considered to be free from brucellosis and
would be classified as such. If the percentage of agglutination is
higher, the results would be interpreted as positive and the animal
would have to be subjected to another, more specific, official test to
determine its brucellosis classification.
The additional official test would be necessary because the RAP
test, like the standard card, BAPA, and rapid screening tests already
in use as official tests, is a presumptive test. A presumptive test is
used as a tool to quickly qualify animals for interstate movement by
establishing their freedom from a specific disease. If an animal tests
positive to a presumptive test, a more specific official test like the
standard tube, standard plate, or complement-fixation test is necessary
to confirm the positive result and establish the animal's specific
disease classification (i.e., reactor or suspect) by measuring
different types of antibodies and varying degrees of agglutination or
fixation in a serum sample at different dilutions (titers).
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
For this action, the Office of Management and Budget has waived its
review process required by Executive Order 12866.
This proposed rule would amend the brucellosis regulations by
adding the RAP test to the list of official tests for determining the
brucellosis disease status of test-eligible cattle, bison, and swine.
The RAP test has been shown to provide an accurate, automated, and
cost-effective means of determining the brucellosis status of test
eligible cattle, bison, and swine. We believe that
[[Page 48431]]
adding the RAP test to the list of official tests for brucellosis in
cattle, bison, and swine would help to prevent the spread of
brucellosis by making available a highly efficient tool for its
diagnosis in those animals.
The equipment needed to run the RAP test is already operational in
some States where it is used for the diagnosis of pseudorabies. We
anticipate that the 15 to 25 States that conduct a higher percentage of
the brucellosis testing would be more likely to use the RAP test. The
cost of equipping the animal health laboratories in those States that
do not already have the equipment would be absorbed by the Cooperative
State/Federal Brucellosis Eradication Program.
Adding the RAP test as an official test is not expected to affect
the market price of the animals tested. Although more rapid testing may
allow faster marketing, the effect on owners of cattle, bison, and
swine would not be significant. Use of the RAP test would be optional,
and other presumptive official tests would remain available for use by
State and Federal animal health officials. However, the cost of the RAP
test is markedly lower than one presumptive official test currently in
use--the particle concentration fluorescence immunoassay (PCFIA) test--
and equal to that of the standard card test, which is another
presumptive official test in wide use. Therefore, if those States
currently using the PCFIA test as a presumptive test were to switch
over to the RAP test, the total testing costs for the Cooperative
State/Federal Brucellosis Eradication Program would be reduced.
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 12988
This proposed rule has been reviewed under Executive Order 12988,
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 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
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, and 134f; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 78.1, in the definition of official test, paragraph
(a)(12) would be redesignated as paragraph (a)(13) and new paragraphs
(a)(12) and (b)(4) would be added to read as set forth below.
Sec. 78.1 Definitions.
* * * * *
Official test.
(a) * * *
(12) Rapid Automated Presumptive (RAP) test. An automated serologic
test to detect the presence of Brucella antibodies in test-eligible
cattle and bison. RAP test results are interpreted as either positive
or negative; the results are interpreted and reported by a scanning
autoreader that measures alterations in light transmission through each
test well and the degree of agglutination present. Cattle and bison
negative to the RAP test are classified as brucellosis negative; cattle
and bison positive to the RAP test shall be subjected to other official
tests to determine their brucellosis disease classification.
* * * * *
(b) * * *
(4) Rapid Automated Presumptive (RAP) test. An automated serologic
test to detect the presence of Brucella antibodies in test-eligible
swine. RAP test results are interpreted as either positive or negative;
the results are interpreted and reported by a scanning autoreader that
measures agglutination based on alterations in light transmission
through each test well. Swine negative to the RAP test are classified
as brucellosis negative; swine positive to the RAP test shall be
subjected to other official tests to determine their brucellosis
disease classification.
* * * * *
Done in Washington, DC, this 9th day of September 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-23495 Filed 9-12-96; 8:45 am]
BILLING CODE 3410-34-P
