[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Rules and Regulations]
[Page 64245-64249]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-1]
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Rules and Regulations
Federal Register
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[[Page 64245]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 78
[Docket No. 02-070-3]
Official Brucellosis Tests
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations by adding the fluorescence
polarization assay to the lists of confirmatory and official tests for
determining the brucellosis disease status of test-eligible cattle,
bison, and swine. This 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 lists of confirmatory and
official tests for brucellosis in cattle, bison, and swine will help to
prevent the spread of brucellosis by making available an additional
tool for its diagnosis in those animals.
DATES: Effective December 6, 2004.
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
govern the interstate movement of cattle, bison, and swine in order to
help prevent the spread of brucellosis.
On May 6, 2004, we published in the Federal Register (69 FR 25338-
25340, Docket No. 02-070-1) a proposal to amend the regulations by
adding the fluorescence polarization (FP) assay to the list of official
tests for determining the brucellosis disease status of test-eligible
cattle, bison, and swine. In our proposed rule, we made available a
complete report of field trial and testing results for validation of
the FP assay in cattle, bison, and swine; that information may be
viewed on the Internet at http://www.aphis.usda.gov/vs/nahps/brucellosis/
or obtained from the person listed under FOR FURTHER
INFORMATION CONTACT.
We solicited comments concerning our proposal for 60 days ending
June 21, 2004. We subsequently reopened the comment period until July
21, 2004, in a document published in the Federal Register on July 6,
2004 (69 FR 40556, Docket No. 02-070-2). We received nine comments by
that date. The comments were from researchers, test equipment
manufacturers, representatives of State governments, animal welfare
organizations, and private citizens. They are discussed below by topic.
Some commenters stated that the Animal and Plant Health Inspection
Service's (APHIS's) intentions regarding testing on wild bison were
unclear in the proposed rule and that a statement should be added in
the final rule clarifying that we do not intend to use the FP assay on
wild bison. The commenters requested that APHIS provide additional
information, including an additional disclosure of all FP assay
validation data for bison, an analysis of FP assay data from
Yellowstone National Park bison sampled in the winter of 2002-2003, and
a description of the specific FP assay procedures that would be used on
Yellowstone bison. The commenters stated that even if APHIS were to
provide this additional information to their satisfaction, APHIS would
need to prove that it had legal authority over wild bison. The
commenters admitted that while ``animal,'' as defined by the Animal
Health Protection Act (AHPA), includes wild animals, the Act limits
APHIS's authority to domestic livestock and other animals that are
under human control. The commenters contended that the FP assay cannot
be applied to wild animals because their movements are not associated
with interstate trade or importation. The commenters added that the
only circumstances in which APHIS would have control over wildlife is
if the Secretary determines that an extraordinary emergency exists
because of the presence in the United States of a pest or disease that
threatens U.S. livestock. The commenters note that the Secretary has
not done so for brucellosis to date.
With respect to the commenters' request for additional information,
we note that the data and analyses sought by the commenters are
summarized in the report we made available with the proposed rule. As
noted earlier in this document, the report may be viewed on the
Internet at http://www.aphis.usda.gov/vs/nahps/brucellosis/ and may be
obtained from the person listed under FOR FURTHER INFORMATION CONTACT.
We believe the data provided is adequate to support our addition of the
FP assay to the list of official and confirmatory tests for
brucellosis. The commenters have been informed in the past that they
may request the specific data they are seeking from its source (i.e.,
the Montana Veterinary Diagnostic Lab).
We do not agree with the commenters' characterization of APHIS's
authority under the AHPA. For example, the AHPA gives APHIS broad
authority ``to carry out operations and measures to detect, control, or
eradicate any pest or disease of livestock (including the drawing of
blood and diagnostic testing of animals)'' (7 U.S.C. 8308). This
provision clearly includes testing of wild animals if it is determined
that such animals pose a threat of spreading disease to U.S. livestock.
As the commenter noted, the term ``animal'' is defined to include any
member of the animal kingdom. In the past wild bison and elk have been
identified as the source of brucellosis infection in domestic
livestock, and we will test such animals when we believe it is
necessary to prevent the further spread of brucellosis in livestock.
One commenter suggested that we amend our proposed changes to the
definition of official test in Sec. 78.1 to describe the circumstances
under which the FP assay would be approved as a stand alone test.
[[Page 64246]]
We are approving the FP assay as an official test, meaning it can
be carried out whenever it is considered necessary to test cattle,
bison, and swine for brucellosis. We agree with this commenter that the
FP assay is also recognized as a confirmatory test, but rather than
amending paragraph (a)(13) of the definition of official test as the
commenter suggested, we have amended the definition of confirmatory
test in Sec. 78.1 in this final rule by adding the FP assay to the
list of confirmatory tests. This change will allow for the FP assay to
be used as a stand alone test or in combination with other serologic
tests. In addition, because the FP assay's performance characteristics
compare favorably to the complement-fixation test (CFT), and because
the CFT is already recognized by APHIS as a confirmatory test, the FP
assay is also considered a reliable confirmatory test for brucellosis.
Nevertheless, the decision as to which diagnostic tests to use depends
on the situation and the State where the testing is done. Ultimately,
the standard serologic protocol used in each Federal/State cooperative
brucellosis laboratory depends on the laboratory's cooperative
agreement.
Some commenters stated that APHIS and/or other agencies involved in
Yellowstone bison management must first evaluate the potential impacts
of the FP assay on bison in the Greater Yellowstone Area before using
the test on wild bison. They requested an environmental assessment be
conducted evaluating potential environmental effects on using the test
on wild bison in the Yellowstone area.
We have determined that an environmental assessment is not needed
in connection with our addition of the FP assay to the lists of
official and confirmatory tests. With respect to bison, by adding the
FP assay to the lists of official and confirmatory tests, we are merely
saying that it is a tool that can be used for test-eligible bison (with
no distinction between domestic and wild bison) without requiring its
use. The record of decision (ROD) for the environmental impact
statement (EIS) prepared for the Bison Management Plan \1\ contemplates
the use of more efficient and effective tests as they become available.
It will result in a more effective means of identifying animals that
are likely carriers of brucellosis. By using the FP assay, we will be
making the program more effective.
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\1\ The ROD can be found at http://www.planning.nps.gov/document/yellbisonrod.pdf
.
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Some commenters requested proof that the test's validation process
is consistent with Office of International Epizooties (OIE) standards.
The commenters contended that APHIS did not follow the appropriate
process, as set by OIE, in validating the FP assay, which includes
conducting an estimate of the disease prevalence in the specific
population and ensuring that diagnostic sensitivity and specificity
estimates are as accurate as possible.
We believe that the FP assay validation process was consistent with
OIE standards. In fact, the FP assay is recognized by OIE as one of
four serologic tests recommended for use in diagnosing bovine
brucellosis. According to OIE's Manual of Diagnostic Tests and Vaccines
for Terrestrial Animals, ``The diagnostic performance characteristics
of some enzyme-linked immunosorbent assays (ELISAs) and the
fluorescence polarisation assay (FPA) are comparable with or better
than that of the CFT, and as they are technically simpler to perform
and more robust, their use may be preferred.'' In addition, the manual
recognizes the FP Assay as a screening and/or confirmatory test for
brucellosis in swine.
Evidence has previously been presented in the FP assay validation
report regarding the performance of the FP assay among cattle, bison,
and swine populations in several countries, including Canada and the
United States. OIE's Manual of Diagnostic Tests and Vaccines for
Terrestrial Animals states that B. abortus infection follows a similar
course in buffaloes (Bubalus bubalus), bison (Bison bison), yak (Bos
grunniens), elk (Cerves canadensis), camels (Camelus bactrianus and C.
dromedarius), and cattle. The manual adds that the same serological
procedures may be used for these species, but each test should be
validated in the species under study. Given this criterion, the
evidence presented in the report sufficiently establishes the validity
of the FP assay for brucellosis in cattle, bison, and swine.
Furthermore, the criterion does not suggest that a separate validation
is necessary for wild populations of bison.
Some commenters stated that the FP assay suffers from the same flaw
that other brucellosis tests do in that it can only detect exposure,
not infection. The commenters stated that no research was done
regarding the potential for cross-reactive antibodies in wild bison
that might result in false-positive results and contended that the use
of this test on wild bison will lead to the additional slaughter of
bison that were only exposed but not infected.
Research shows the FP assay to be highly accurate, easily
performed, and more effective than other brucellosis tests. We believe
this will lead to animals being more accurately diagnosed and prevent
the unnecessary slaughter of uninfected bison.
The FP assay validation report contained data showing the FP assay,
in one study, to have 100 percent sensitivity. Some commenters took
issue with this conclusion. The commenters noted that some data in the
report indicated that a large number of serologically positive animals
were later found to have been slaughtered unnecessarily because they
were culture-negative and therefore not infected.
The commenters are incorrect in their calculations of sensitivity.
Sensitivity is determined by calculating the proportion of infected
animals that are positive to the test under consideration. One hundred
percent of the animals that were culture-positive were positive to the
FP assay, for a sensitivity of 100 percent. And 100 percent of the
animals that were serologically positive to other tests were positive
to the FP assay, again a sensitivity of 100 percent. Nevertheless,
these results are from one study of the FP assay's performance. Another
study cited in our technical report found the FP assay to have a 92
percent sensitivity (Gall 2000). It is not expected that any serologic
test is truly 100 percent sensitive, but in comparison with other
serologic brucellosis assays, the studies show that the FP assay has
consistently high sensitivity. As stated in our response to the
previous comment, we believe the accuracy, ease of use, and
effectiveness of the FP assay will lead to more accurate diagnoses of
brucellosis and prevent the unnecessary slaughter of uninfected
animals.
Two commenters took issue with the description of the testing
procedure we provided in the proposed rule's supplementary information
section. The commenters stated that we described an indirect binding or
competitive binding assay, but the FP assay is actually a direct
binding assay. Both commenters recommended we describe the procedure as
follows:
The brucellosis FP diagnostic assay is a direct binding assay
that uses fluorescence polarization technology to determine the
presence of Brucella abortus antibody in serum indicating current or
previous infection. The diagnostic test uses as its conjugate a
fluorescent antigen that is composed of the O-polysaccharide (OPS)
extracted from Brucella abortus cells and labeled with fluorescein.
A fluorescence polarization instrument is used to measure the
polarization state of the OPS conjugate.
[[Page 64247]]
A quantitative score indicates the presence of the antibody or no
presence of the antibody.
The technician performs the test as follows. A specific quantity
of a sample of animal serum is added to a glass test tube or
microtitre plate well containing a specified amount of buffer
solution. The fluorescence polarization measurement instrument is
used to determine the natural fluorescence of the sample in the
buffer solution. Then, the technician adds a specific quantity of
fluorescent conjugate antigen. And then the fluorescence
polarization instrument measures the change in fluorescence
polarization of the conjugate which indicates if the antibody is
present in the sample.
We agree that the text suggested by the commenters clarifies the FP
assay's binding type. However, because the paragraphs pointed out by
the commenters appeared only in the proposed rule's supplementary
information section, it is not necessary to make any changes in the
regulatory text of this final rule in response to the comments.
One commenter suggested that we retain the provisions that were
found in paragraph (a)(13) of the definition of official test in Sec.
78.1 regarding the authority of the designated epidemiologist in each
State to act on his/her best judgment when making diagnoses of
brucellosis based on an assessment of all relevant information. In
addition, the commenter recommended adding the same statement with
respect to swine in the definition of official test be consistent with
the provisions concerning cattle and bison.
It appears that the commenter misunderstood; we did not propose to
remove the text of paragraph (a)(13) in the definition of official test
from the current regulations, but instead to redesignate the paragraph
as (a)(14). With respect to the commenter's suggestion that we add a
similar statement regarding the role of designated epidemiologists in
making diagnoses of brucellosis in swine, we agree with the commenter
and have added such a statement in this final rule as a new paragraph
(b)(6) in the definition of official test.
Some commenters stated that while the assay interpretation for
swine is the same as that for bison and cattle, the FP assay for swine
uses 40 microliters of sample instead of the 10 microliters of sample
used for cattle and bison. For suspect swine samples, the test is
repeated using a 40-microliter sample, whereas the sample size is
doubled (to 20 microliters) when repeating the test for suspect cattle
and bison samples.
We agree with these commenters and have changed all references to
sample amounts to 40 microliters in paragraph (b)(5) of the definition
of official test. In addition, we have added sentences to paragraphs
(a)(13) and (b)(5) of that definition to explain that 10 microliters
and 40 microliters, respectively, of sample are used in the initial
testing.
The supplementary information of our proposal described a test tube
being used to perform the FP assay. Two commenters noted that the FP
assay can be conducted in either a test tube or a microtiter plate
format.
We agree with these commenters and acknowledge so in this final
rule. However, this information appeared in the background information
of the proposed rule and did not appear in the text of the proposed
regulations.
One commenter suggested adding a sentence to the background
information stating that FP assay technology has been developed for
numerous human applications.
We believe it is unnecessary to describe human applications of FP
assay technology in this rule concerning brucellosis in cattle, bison,
and swine.
One commenter stated that the concentration immunoassay technology
(CITE[reg]) test is no longer being manufactured and
references to it should be removed and the FP assay should be put in
their place.
We are not removing the CITE[reg] test at this time
because while it may no longer be manufactured, it is possible that it
will be available sometime in the future. Rather than undergo the
process of adding it to the regulations again, we will leave it on the
list of official tests.
One commenter suggested adding the following sentence to the
economic analysis's discussion of the price of the FP assay: ``A
smaller test kit size is being planned. High volume purchases are
expected to have pricing discounts.''
We have added a statement to the economic analysis indicating the
possibility of smaller kits in the future and the possible effects on
test kit prices. The addition of this statement has no effect on the
conclusions of our economic analysis, however.
One commenter stated that cattle should be kept out of areas where
bison live. The commenter added that we should perform brucellosis
tests on all cattle within 20 miles of bison. The commenter also
suggested that all cattle movement between States stop.
We do not believe that such extreme steps are warranted or
necessary to prevent the spread of brucellosis in the United States.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This 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 amending the regulations by adding the FP assay to the lists
of confirmatory and official tests for determining the brucellosis
disease status of test-eligible cattle, bison, and swine. This 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 lists of confirmatory and official tests for
brucellosis in cattle, bison, and swine will help to prevent the spread
of brucellosis by making available an additional tool for its diagnosis
in those animals.
This new test will 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 will 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 for
slaughter 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 and confirmatory test for brucellosis will result
in more positive finds in privately owned herds
[[Page 64248]]
than another official or confirmatory 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 lists of official
and confirmatory tests for brucellosis will 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 will be
affected by the addition of the FP assay to the lists of official and
confirmatory tests will be herd owners, test reagent and equipment
producers, livestock markets, shows, and exhibitions, and livestock
buyers and sellers. It is anticipated that affected entities will 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 2002, there were
736,968 farms in the United States primarily engaged in beef cattle
ranching and farming and dairy cattle and milk production. In 2002, 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 2002, there were 33,655 U.S. farms primarily
engaged in raising hogs and pigs. Of those farms, 81 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 2002, there were 41,238 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
sales for those 41,238 farms in 2002 was $39,868, 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
rule will be small entities.
The test will 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 will be the
same as for the other brucellosis test options.
Currently, the reagents are sold in two kit sizes, a 1,000-test kit
($1.00/test) and a 10,000-test kit ($0.50/test). The costs to the
laboratory to perform the test will vary, depending upon the number of
tests performed. The test kit manufacturer has indicated that a smaller
test kit size is being planned and that high volume purchases are
expected to have pricing discounts. However, we currently have no
information indicating what those discounts may be.
A consideration that may affect the livestock producer is whether
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
will 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 will
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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final 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.
0
Accordingly, we are amending 9 CFR part 78 as follows:
PART 78--BRUCELLOSIS
0
1. The authority citation for part 78 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 78.1 is amended as follows:
0
a. In the definition of confirmatory test, in the second sentence, by
adding the words, ``the fluorescence polarization assay (FP assay),''
before the words ``the particle''.
0
b. In the definition of official test, by redesignating paragraph
(a)(13) as paragraph (a)(14) and by adding new paragraphs (a)(13),
(b)(5), and (b)(6) to read as set forth below.
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. A 10-microliter sample is used. 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 FP assay results are classified as brucellosis
suspects.
* * * * *
(b) * * *
(5) Fluorescence polarization assay (FP assay). An automated
serologic test to determine the brucellosis status of
[[Page 64249]]
test-eligible swine when conducted according to instructions approved
by APHIS. FP assays are interpreted as either positive, negative, or
suspect. A 40-microliter sample is used. 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 40 microliters of sample. If the 40-microliter sample is >20 mP
above the mean negative control, the sample is considered positive. If
the 40-microliter sample is still in the 10 to 20 mP range above the
mean negative control, the sample is considered suspect. If the 40-
microliter sample is < 10 mP above the mean negative control, the sample
is considered negative. Swine with negative FP assay results are
classified as brucellosis negative. Swine with positive FP assay
results are classified as brucellosis reactors, while swine with
suspect FP assay results are classified as brucellosis suspects.
(6) The evaluation of test results for all swine shall be the
responsibility of a designated epidemiologist in each State. The
designated epidemiologist shall consider the animal and herd history
and other epidemiologic factors when determining the brucellosis
classification of swine. Deviations from the brucellosis classification
criteria as provided in this definition of official test are acceptable
when made by the designated epidemiologist.
* * * * *
Done in Washington, DC, this 29th day of October 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-24646 Filed 11-3-04; 8:45 am]
BILLING CODE 3410-34-P