[Federal Register Volume 69, Number 88 (Thursday, May 6, 2004)]
[Proposed Rules]
[Pages 25338-25340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10311]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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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  Federal Register / Vol. 69, No. 88 / Thursday, May 6, 2004 / Proposed 
Rules  

[[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 
[email protected]. 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

[[Page 25339]]

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

[[Page 25340]]

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