[Federal Register: May 6, 2004 (Volume 69, Number 88)]
[Proposed Rules]
[Page 25338-25340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my04-17]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 25338]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 78
[Docket No. 02-070-1]
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 fluorescence polarization assay to the list of official tests for
determining the brucellosis disease status of test-eligible cattle,
bison, and swine. We believe this proposed action is warranted because
the fluorescence polarization assay has been shown to provide an
efficient, accurate, automated, and cost-effective means of determining
the brucellosis status of test eligible cattle, bison, and swine.
Adding the fluorescence polarization assay 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: We will consider all comments that we receive on or before June
21, 2004.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 02-070-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 02-070-1.
E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 02-070-1'' on the subject
line.
Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html
for a form you can use to submit an e-mail comment through
the APHIS Web site.
Federal eRulemaking Portal: Go to http://www.regulations.gov
and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Arnold Gertonson, National Center
for Animal Health Programs, VS, APHIS, 2150 Centre Avenue, Bldg. B, MSC
3E20, Fort Collins, CO 80526-8117; (970) 494-7363.
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.
Brucellosis has been seen as a serious threat to U.S. agriculture
for decades. Prior to 1934, when the Cooperative State/Federal
Brucellosis Eradication Program (the program) began work to eliminate
the disease from the country, brucellosis control was limited mainly to
individual herds. The program relies heavily on the cooperation of
livestock producers and States; in order for States to achieve
brucellosis Class Free status, none of their cattle or bison can be
found infected for a minimum of 12 consecutive months under an active
surveillance program. Currently, 48 States, plus Puerto Rico and the
U.S. Virgin Islands, hold Class Free status. Two States have a herd
infection rate of less than 0.25 percent and hold Class A status. There
are no States in Class B status (herd infection rates between 0.25
percent and 1.5 percent) or in Class C (herd infection rates greater
than 1.5 percent). We expect the program to achieve the goal of
nationwide eradication of brucellosis from livestock in the near
future.
In order to achieve this goal, surveillance must include the use of
accurate and efficient official brucellosis tests. Official brucellosis
tests are used to determine the brucellosis disease status of cattle,
bison, and swine. The regulations provide 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 payment 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
determined that a rapid diagnostic detection test that uses
fluorescence polarization technology will be highly useful in detecting
the presence of Brucella antibodies, and we are proposing to add this
test as an official test. The test, known as the fluorescence
polarization assay (referred to below as the FP assay), provides a
cost-effective, accurate, quick, and simple-to-perform (both in the
laboratory and in the field) means of determining the brucellosis
status of test eligible cattle, bison, and swine. In trials summarized
in four scientific publications, the FP assay has proven to be faster
and at least as accurate as other official tests used for diagnosis of
brucellosis in cattle, bison, and swine.
Like other brucellosis tests, the purpose of the FP assay is to
determine if the animal in question is infected with the Brucella
bacterium. Brucellosis infection is confirmed by the presence of
antibodies to that bacterium in serum collected from the animal.
Specifically, the FP assay determines any potential
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brucellosis antigen-antibody reaction by measuring changes in the
polarization of fluorescent-labeled molecules. Very few molecules are
fluorophores (naturally fluorescent). In order to make a non-
fluorescent molecule fluorescent, a fluorophore must be attached to it;
the resulting fluorescent molecule is called a ``tracer.''
To conduct the FP assay, a technician adds a sample of animal serum
to a test tube. The technician then mixes the test antigen--in this
case, Brucella bacteria--with fluorophores to create fluorescent
Brucella antigen tracers that he or she adds to the tube containing the
animal serum at a predetermined ratio so that virtually all of the
tracer molecules are bound to Brucella antibodies, if they are present.
The fluorophore tracer is easy to track in solution; its fluorescence
lifetime (the time between absorbing a photon and emitting one) is on
the same scale as the rotation (all molecules rotate in solution) of
the molecule to which it is attached. Therefore, tracers' sizes can be
continuously measured once they are added to the tube containing the
serum. Since the presence of Brucella antibodies in the animal serum
will cause Brucella antigen within the tracer to split from the
fluorophore and attach to the antibody, tracers will decrease in size.
This size decrease, therefore, indicates that the animal from which the
serum sample was drawn is infected with Brucella bacteria, and the test
results would be interpreted as positive. If the fluorophores do not
decrease in size, Brucella antigen-antibody binding has not occurred,
the test results would be interpreted as negative, and the animal from
which the serum sample was drawn would be classified as such.
The FP assay has been shown to be a highly accurate assay for
detection of antibodies to Brucella abortus in cattle and bison sera
and Brucella suis in swine sera. A homogenous immunoassay such as the
FP assay can be accomplished rapidly and does not require repetitive
steps to wash away unbound reagents as other immunoassays require. The
output of the test is objective because it does not require
interpretation on the part of the technician running the sample. In
addition, the ease and rapidity of this testing technology suggest it
is highly adaptable to field application.
Research suggests that the FP performs as well as, or better than,
other serologic tools commonly used to diagnose brucellosis in cattle,
bison, and swine. This research demonstrates that the FP rarely
mistakenly classifies uninfected animals as positive. Therefore, this
test has a high degree of specificity. The research also shows that the
FP rarely mistakenly classifies infected animals as negative.
Therefore, this test has a high degree of sensitivity.
The FP assay has been standardized to use a consistent
concentration of reagents and measurement techniques such that the test
agrees between replicates of known status. The process has been
commercially developed by Viral Antigens, Incorporated, and licensed by
the U.S. Department of Agriculture. Furthermore, the FP technology has
already been developed for numerous other applications such as
detecting illicit drugs and monitoring for drugs and other
macromolecules.
We are confident that the FP assay will be an accurate, cost-
effective, and efficient addition to the list of official tests for
determining the brucellosis status of test-eligible cattle, bison, and
swine. A complete report of field testing trial and testing results for
validation of the FP assay in cattle, bison, and swine is available at
http://www.aphis.usda.gov/vs/nahps/brucellosis/ or by contacting the
person listed above under FOR FURTHER INFORMATION CONTACT.
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 under Executive Order 12866.
We are proposing to amend the brucellosis regulations to add the FP
assay to the list of official tests for determining the brucellosis
disease status of test-eligible cattle, bison, and swine. We believe
this proposed action is warranted because the FP assay has been shown
to provide an efficient, accurate, automated, and cost-effective means
of determining the brucellosis status of test-eligible cattle, bison,
and swine. Adding the FP assay 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.
This new test would help to prevent the spread of brucellosis by
identifying infected cattle, bison, and swine. Preventing the spread of
brucellosis is critical because of its potentially costly consequences
for U.S. herd owners and consumers. In 1952, when brucellosis was
widespread throughout the United States, annual losses from lowered
milk production, aborted calves and pigs, and reduced breeding
efficiency were estimated to total more than $400 million. Since then,
eradication efforts have reduced annual losses due to brucellosis to
less than $1 million. However, studies have shown that if eradication
efforts were stopped, the cost of producing beef and milk would
increase by an estimated $80 million annually in less than 10 years.
While the test would provide long-term benefits by identifying
animals infected with brucellosis, herd owners with animals that are
found to be positive as a result of the FP assay, or any other official
test, may experience some negative consequences. Once an infected herd
is identified, the infection is contained by quarantining all infected
animals and limiting their movement to slaughter only, until the
disease can be eliminated from the herd. Quarantines affect the current
income of herd owners, and depopulation affects their future income.
Depopulation costs are mitigated by the sale of affected animals and
indemnity payments, but, in many cases, indemnification provides only
partial compensation.
However, there is no basis to conclude that the addition of the FP
assay as an official test for brucellosis will result in more positive
finds in privately owned herds than another official test might
indicate. Although research indicates that the FP assay can be a more
accurate test, improved accuracy does not necessarily mean more
positive finds; instead, the FP assay may yield fewer false positives
than other tests, simply because it is more accurate.
We do not expect that adding the FP assay to the list of official
tests for brucellosis would affect the market price of animals tested.
Although more rapid testing may allow faster marketing, the effect on
herd owners is not expected to be significant.
The Regulatory Flexibility Act requires that agencies consider the
economic impact of rule changes on small businesses, organizations, and
governmental jurisdictions. We expect that the entities that would be
affected by the addition of the FP assay to the list of official
brucellosis tests would be herd owners, test reagent and equipment
producers, livestock markets, shows, and exhibitions, and livestock
buyers and sellers. It is anticipated that affected entities would be
positively affected because the use of this test should provide greater
assurance of the brucellosis status of the animals tested.
Affected herd owners are likely to be small in size (when judged by
the U.S. Small Business Administration's (SBA) standards). This
determination is based on composite data for providers of the same and
similar services. The latest Census data show that, in 1997, there were
742,203 farms in the United States
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primarily engaged in beef cattle ranching and farming and dairy cattle
and milk production. In 1997, 98 percent of those farms had sales of
less than $500,000, which is well below the SBA's small entity
threshold of $750,000 for farms in that category. Similarly, in 1997,
there were 46,353 U.S. farms primarily engaged in raising hogs and
pigs. Of those farms, 87 percent had sales that year of less than
$500,000, which is well below the SBA's small entity threshold of
$750,000 for farms in that category. Additionally, in 1997, there were
10,045 farms listed under North American Industry Classification System
code 11299, the classification category that includes farms primarily
engaged in bison farming. The per-farm average sale for those 10,045
farms in 1997 was $105,624, which is well below the SBA's small entity
threshold of $750,000 for farms in that category. Accordingly, most
herd owners potentially affected by this proposed rule would be small
entities.
The test would be performed at Federal/State cooperative
brucellosis laboratories. Depending upon the Federal/State brucellosis
cooperative agreement, APHIS may supply the reagents and equipment for
performing this test. If APHIS supplies the reagents and equipment, it
is anticipated that the test cost to the livestock producer would be
the same as for the other brucellosis test options.
Currently, the reagents are sold in two kit sizes, 1,000 tests kit
($1.00/test) and 10,000 tests kit ($0.50/test). The costs to the
laboratory to perform the test would vary depending upon the number of
tests performed.
An area that may affect the livestock producer may be whether or
not the test is performed by a federally accredited veterinarian at a
livestock market. If the market inspecting veterinarian uses the test,
the cost may vary depending upon the agreement the veterinarian has
with the State to perform brucellosis testing at the market.
It is anticipated that the test reagent and equipment producers
would benefit from increased sales due to increased usage of the test.
With increased usage of the test, the cost of the reagents and
equipment should decline over time.
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, we propose to amend 9 CFR part 78 as follows:
PART 78--BRUCELLOSIS
1. The authority citation for part 78 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
2. In Sec. 78.1, in the definition for official test, paragraph
(a)(13) would be redesignated as paragraph (a)(14) and new paragraphs
(a)(13) and (b)(5) would be added to read as follows.
Sec. 78.1 Definitions.
* * * * *
Official test. (a) * * *
(13) Fluorescence polarization assay (FP assay). An automated
serologic test to determine the brucellosis status of test-eligible
cattle and bison when conducted according to instructions approved by
APHIS. FP assays are interpreted as either positive, negative, or
suspect. If a sample reads < 10 millipolarization units (mP) above the
mean negative control, the sample is considered negative. If a sample
reads >20 mP above the mean negative control, the sample is considered
positive. Samples that read between 10 and 20 mP above the negative
control mean should be retested using 20 microliters of sample. If the
20-microliter sample is >20 mP above the mean negative control, the
sample is considered positive. If the 20-microliter sample is still in
the 10 to 20 mP range above the mean negative control, the sample is
considered suspect. If the 20-microliter sample is < 10 mP above the
mean negative control, the sample is considered negative. Cattle and
bison negative to the FP assay are classified as brucellosis negative.
Cattle and bison with positive FP assay results are classified as
brucellosis reactors, while cattle and bison with suspect FPA results
are classified as brucellosis suspects.
* * * * *
(b) * * *
(5) Fluorescence polarization assay (FP assay). An automated
serologic test to determine the brucellosis status of test-eligible
swine when conducted according to instructions approved by APHIS. FP
assays are interpreted as either positive, negative, or suspect. If a
sample reads < 10 millipolarization units (mP) above the mean negative
control, the sample is considered negative. If a sample reads >20 mP
above the mean negative control, the sample is considered positive.
Samples that read between 10 and 20 mP above the negative control mean
must be retested using 20 microliters of sample. If the 20-microliter
sample is >20 mP above the mean negative control, the sample is
considered positive. If the 20-microliter sample is still in the 10 to
20 mP range above the mean negative control, the sample is considered
suspect. If the 20-microliter sample is < 10 mP above the mean negative
control, the sample is considered negative. Swine with negative FPA
results are classified as brucellosis negative. Swine with positive FP
assay results are classified as brucellosis reactors, while swine with
suspect FPA results are classified as brucellosis suspects.
* * * * *
Done in Washington, DC, this 29th day of April 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-10311 Filed 5-5-04; 8:45 am]
BILLING CODE 3410-34-P