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Rules and Regulations Federal Register

64245

Vol. 69, No. 213

Thursday, November 4, 2004

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.

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 testeligible 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 § 78.1 to 

describe the circumstances under which 

the FP assay would be approved as a 

stand alone test. 

64246 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Rules and Regulations 

1The ROD can be found at http://

www.planning.nps.gov/document/yellbisonrod.pdf.

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 § 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.

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 crossreactive 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. 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Rules and Regulations 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 § 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) 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 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 

64248 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Rules and Regulations 

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.

■ Accordingly, we are amending 9 CFR 

part 78 as follows:

PART 78—BRUCELLOSIS

■ 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.

■ 2. Section 78.1 is amended as follows:

■ 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’’.

■ 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.

§ 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 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Rules and Regulations 64249

1 28 U.S.C. 2461 note.

2Some of OTS’s CMPs are in a commonly 

administered statute, 12 U.S.C. 1818. Each agency 

that administers this statute is making identical 

adjustments.

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

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 74

Material Control and Accounting of 

Special Nuclear Material

CFR Correction 

In Title 10 of the Code of Federal 

Regulations, Parts 51 to 199, revised as 

of January 1, 2004, in part 74, at the 

beginning of page 466, the following 

text is reinstated:

§ 74.7 Specific exemptions. 

The Commission may, upon 

application of any interested person or 

upon its own initiative, grant such 

exemptions from the requirements of 

the regulations in this part as it 

determines are authorized by law and 

will not endanger life or property or the 

common defense and security, and are 

otherwise in the public interest.

§ 74.8 Information collection 

requirements: OMB approval. 

(a) The Commission has submitted the 

information collection requirements 

contained in this part to the Office of 

Management and Budget (OMB) for 

approval as required by the Paperwork 

Reduction Act (44 U.S.C. 3501 et seq.). 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information if it does 

not display a currently valid OMB 

control number. OMB has approved the 

information collection requirements 

contained in this part under control 

number 3150–0123. 

(b) The approved information 

collection requirements contained in 

this part appear in §§ 74.11, 74.13, 

74.15, 74.17, 74.19, 74.31, 74.33, 74.41, 

74.43, 74.45, 74.51, 74.57, and 74.59. 

(c) This part contains information 

collection requirements in addition to 

those approved under the control 

number specified in paragraph (a) of 

this section. These information 

collection requirements and the control 

numbers under which they are 

approved are as follows: 

(1) In § 74.15, DOE/NRC Form–741 is 

approved under Control No. 3150–0003. 

(2) In § 74.13, DOE/NRC Form–742 is 

approved under Control No. 3150–0004. 

(3) In § 74.13, DOE/NRC Form–742C 

is approved under Control No. 3150–

0058. 

(4) In § 74.17, NRC Form 327 is 

approved under Control No. 3150–0139. 

[50 FR 7579, Feb. 25, 1985, as amended at 

52 FR 10040, Mar. 30, 1987; 52 FR 19305, 

May 22, 1987; 56 FR 55998, Oct. 31, 1991; 

62 FR 52189, Oct. 6, 1997; 67 FR 78144, Dec. 

23, 2002]

Subpart B—General Reporting and 

Recordkeeping Requirements

§ 74.11 Reports of loss or theft or 

attempted theft or unauthorized production 

of special nuclear material. 

(a) Each licensee who possesses one 

gram or more of contained uranium-235, 

uranium-233, or plutonium shall notify 

the NRC Operations Center within 1 

hour of discovery of any loss or theft or 

other unlawful diversion of special 

nuclear material which the licensee is 

licensed to possess, or any incident in 

which an attempt has been made to 

commit a theft or unlawful diversion of 

special nuclear material. The 

requirement to report within 1 hour of 

discovery does not pertain to measured 

quantities of special nuclear material 

disposed of as discards or inventory 

difference quantities. Each licensee who 

operates an uranium enrichment facility 

shall notify the NRC Operations Center 

within 1 hour of discovery of any 

unauthorized production of enriched 

uranium. For centrifuge enrichment 

facilities the requirement to report 

enrichment levels greater than

[FR Doc. 04–55523 Filed 11–3–04; 8:45 am] 

BILLING CODE 1505–01–D

DEPARTMENT OF THE TREASURY

Office of Thrift Supervision 

12 CFR Part 509 

[No. 2004–51] 

RIN 1550–AB95 

Rules of Practice and Procedure in 

Adjudicatory Proceedings; Civil Money 

Penalty Inflation Adjustment

AGENCY: Office of Thrift Supervision, 

Treasury.

ACTION: Final rule.

SUMMARY: The Federal Civil Penalties 

Inflation Adjustment Act of 1990 

requires all federal agencies with 

statutory authority to impose civil 

money penalties (CMPs) to evaluate and 

adjust those CMPs every four years. The 

Office of Thrift Supervision (OTS) last 

adjusted its CMP statutes in 2000. 

Consequently, OTS is issuing this final 

rule to implement the required 

adjustments to OTS’s CMP statutes.

DATES: Effective November 4, 2004.

FOR FURTHER INFORMATION CONTACT:

Timothy P. Leary, Counsel (Banking & 

Finance), (202) 906–7170, Regulations 

and Legislation Division, Office of the 

Chief Counsel, Office of Thrift 

Supervision, 1700 G Street, NW., 

Washington, DC 20552.

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Civil Penalties Inflation 

Adjustment Act of 19901 (FCPIAA) 

requires each agency to make 

inflationary adjustments to the CMPs in 

statutes that it administers.2 Under the