[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: [email protected].

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]
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