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[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Rules and Regulations]
[Pages 81090-81096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32371]

[[Page 81090]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. APHIS-2009-0083]
RIN 0579-AD22

Brucellosis Class Free States and Certified Brucellosis-Free 
Herds; Revisions to Testing and Certification Requirements

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the brucellosis regulations to reduce the 
amount of testing required to maintain Class Free status for States 
that have been Class Free for 5 or more years and have no Brucella 
abortus in wildlife. We are also removing the provision for automatic 
reclassification of any Class Free State or area to a lower status if 
two or more herds are found to have brucellosis within a 2-year period 
or if a single brucellosis-affected herd is not depopulated within 60 
days. Further, we are reducing the age at which cattle are included in 
herd blood tests. We are also adding a requirement that any Class Free 
State or area with Brucella abortus in wildlife must develop and 
implement a brucellosis management plan approved by the Administrator 
in order to maintain Class Free status. Finally, we are providing an 
alternative testing protocol for maintaining the certified brucellosis-
free status of dairy herds, which will give producers more flexibility 
for the herd certification process. These changes are necessary to 
refocus resources to control and prevent the spread of brucellosis and 
to protect and maintain the economic viability of the domestic 
livestock industry.

DATES: This interim rule is effective December 27, 2010. We will 
consider all comments that we receive on or before February 25, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0083 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2009-0083, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2009-0083.
    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: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Debbi Donch, National Brucellosis 
Epidemiologist and Program Manager, National Center for Animal Health 
Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231; 
(301) 734-6954.

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is a contagious disease, caused by bacteria of the 
genus Brucella that affects both animals and humans. The disease mainly 
affects cattle, bison, and swine; however, goats, sheep, horses, and 
humans are susceptible as well. In its principal animal hosts, it 
causes loss of young through spontaneous abortion or birth of weak 
offspring, reduced milk production, and infertility. There is no 
economically feasible treatment for brucellosis in livestock. In 
humans, brucellosis initially causes flu-like symptoms, but the disease 
may develop into a variety of chronic conditions, including arthritis. 
Humans can be treated for brucellosis with antibiotics.
    The brucellosis regulations, contained in 9 CFR part 78 (referred 
to below as the regulations), provide a system for classifying States 
or portions of States according to the rate of Brucella abortus (B. 
abortus) infection present and the general effectiveness of a 
brucellosis control and eradication program. The classifications are 
Class Free, Class A, Class B, and Class C. States or areas that do not 
meet the minimum standards for Class C status are required to be placed 
under Federal quarantine. Restrictions on moving cattle and bison 
interstate become less stringent as a State or area approaches or 
achieves Class Free status.
    APHIS' regulations support a cooperative Federal-State-industry 
program that has made considerable progress in eradicating brucellosis 
from the United States. By 2007, the national brucellosis program had 
achieved an all-time low national herd prevalence of 0.0001 percent 
(one affected herd in approximately 1 million cattle herds). In 
February 2008, every State, along with Puerto Rico and the U.S. Virgin 
Islands, achieved Class Free status for the first time in the program's 
74-year history. Currently, all States, including Puerto Rico and the 
U.S. Virgin Islands, are Class Free for brucellosis. In addition, every 
State except Montana, Idaho, Wyoming, and Texas has been classified as 
free from brucellosis for at least 5 consecutive years. Each of the 
three States in the Greater Yellowstone Area, Idaho, Montana and 
Wyoming, experienced a temporary loss of Class Free status for a period 
of time during the past 7 years. The source of disease in these three 
States is attributable to exposure to brucellosis-affected wildlife in 
the Greater Yellowstone Area.
    The brucellosis Class Free classification is based on a finding of 
no known brucellosis in cattle for the 12 months preceding 
classification as Class Free. In order to maintain Class Free 
classification, the regulations have required Class Free States or 
areas to conduct surveillance by carrying out as many brucellosis ring 
tests per year as are necessary to ensure that all cattle herds 
producing milk for sale are tested at least twice per year at 
approximately 6-month intervals. In addition, the regulations have 
required Class Free States or areas to collect blood samples from at 
least 95 percent of all cows and bulls 2 years of age or over at each 
recognized slaughtering establishment and subject the samples to an 
official brucellosis test. The regulations have further provided that a 
Class Free State or area may have no more than one herd determined to 
be affected with brucellosis within a 2-year period, and if a herd is 
found to be affected with brucellosis, the herd must be depopulated 
within 60 days of an infected animal being detected. If two or more 
herds are found to be affected with brucellosis within a 2-year period 
or if an affected herd is not depopulated within 60 days, the State or 
area loses its Class Free status. The regulations have provided no 
exceptions to these requirements for reclassification.
    These requirements have encouraged producers to depopulate 
brucellosis-affected herds to prevent a reclassification of State 
status. Cattle and bison from States or areas reclassified to a lower 
status--usually Class A--are subject to testing requirements for 
interstate movement. Furthermore, the regulations in 9 CFR

[[Page 81091]]

part 51 authorize APHIS to pay indemnity to owners of animals destroyed 
because of brucellosis. These payments provide a financial incentive 
for owners to elect depopulation instead of maintaining a herd under 
quarantine.
    APHIS has reevaluated this approach and no longer uniformly 
recommends whole herd depopulation for disease management. The number 
of brucellosis-infected animals found in a herd is often small and test 
and removal of the infected animals will often mitigate transmission of 
brucellosis within and from the herd. In such circumstances, it is 
difficult to justify depopulation. Limited indemnity funds also make 
herd depopulation a less viable option, especially as herd sizes 
continue to increase. In addition, the public perceives whole-herd 
depopulation as a less acceptable approach for disease management. 
Changing social values concerning the care and well-being of livestock, 
the recognition of the environmental consequences of animal disposal, 
and the value of proteins derived from livestock also drive the need to 
develop new approaches to disease control.
    APHIS has announced its intention to take a new approach to 
managing the bovine brucellosis eradication program that will allow 
APHIS and States to apply limited resources effectively and efficiently 
and focus on current program disease-risk issues. The new approach for 
the program, which includes strategies for surveillance and 
depopulation and would involve revisions to the brucellosis 
regulations, is described in the brucellosis concept paper that was 
made available for public comment on October 5, 2009. (See ``A Concept 
Paper for a New Direction for the Bovine Brucellosis Program,'' 74 FR 
51115-51116; Docket No. APHIS-2009-0006). In the meantime, the 
requirements for maintaining Class Free status give APHIS little 
flexibility in reclassifying States or areas based on risk. This lack 
of flexibility is an obstacle to effectively addressing the current 
challenges of the brucellosis program. When a Class Free State is 
reclassified to a lower status, APHIS and the State expend scarce 
resources to enable the State to regain its status or to establish 
split-State status. These resources could be applied more effectively 
to program activities that would have a greater impact on disease 
management and elimination. Additionally, many producers in Class Free 
States that are reclassified incur additional costs to meet testing and 
other interstate movement requirements associated with the 
reclassification, regardless of the risk associated with their 
particular herd.
    As we proceed to develop this new approach, APHIS intends to 
continue making decisions regarding the disposition of each 
brucellosis-affected herd after evaluating the circumstances 
surrounding each herd. APHIS will continue to offer indemnity 
(depending on the availability of funding) to compensate producers 
considering depopulation when the evaluation indicates that other 
options will not mitigate disease spread, there is an imminent public 
or animal health risk, and/or it is cost-beneficial to do so. Where 
depopulation and indemnity are not considered appropriate, APHIS will 
continue to rely on State animal health agencies to maintain affected 
herds under quarantine and implement a program to periodically test the 
animals for brucellosis and remove and destroy those that do not test 
negative. ``Test and remove'' strategies can be an effective 
alternative to depopulation provided that the State or area maintains 
all affected herds under quarantine and applies adequate measures 
within the State to detect and prevent the spread of brucellosis, 
including from infected wildlife. When a Class Free State or area 
implements all of these measures, APHIS does not believe it is 
necessary to reclassify the State or area to a lower status or to 
restrict the interstate movement of all cattle and bison from the State 
or area in order to prevent the interstate spread of brucellosis.

Changes to Requirements for Maintaining Class Free Status

    For the reasons given above, we are removing the requirement that a 
Class Free State or area must lose its Class Free status if two or more 
herds are found to have brucellosis within 24 months or if a 
brucellosis-affected herd is not depopulated within 60 days. We will 
allow a Class Free State or area to maintain its Class Free status if:
     The affected herds are maintained under quarantine;
     A herd plan has been implemented for each affected herd to 
prevent the spread of brucellosis;
     The animals under quarantine are periodically tested for 
brucellosis as required by the Administrator and all animals that do 
not test negative are removed and destroyed until there is no evidence 
of brucellosis within the herd; and
     The State conducts surveillance adequate to detect 
brucellosis if it is present in other herds or species.
    We are retaining the provision that an epidemiological 
investigation must be performed and that herds adjacent to the affected 
herd, herds from which animals may have been brought into the affected 
herd, and herds which may have had contact with or accepted animals 
from affected herds, must be epidemiologically investigated to confirm 
that brucellosis has not spread.
    The Administrator may reclassify a State or area to a lower status 
if these conditions are not met or under any other circumstances if the 
Administrator determines it is necessary to do so to prevent the spread 
of brucellosis.
    Cattle and bison from Class Free States or areas that maintain 
affected herds under quarantine without loss of Class Free status would 
be subject to the same interstate movement requirements as cattle and 
bison from Class Free States or areas with 0.0 percent of field strain 
brucellosis, except as otherwise required by a brucellosis management 
plan, as discussed below.
    Consistent with this change in the regulations, APHIS is allowing 
Idaho to use a test and remove strategy on a brucellosis-affected herd 
identified in November 2009 without loss of Class Free status.
    Another change to the requirements for maintaining Class Free 
status concerns brucellosis management plans. We are requiring any 
Class Free State or area in which the Administrator has determined 
wildlife are infected with B. abortus to develop and implement a 
brucellosis management plan approved by the Administrator. The 
existence of B. abortus in wildlife will be determined by the 
Administrator, based on, but not limited to, histopathology, testing 
data, or epidemiology. The Administrator may also require a Class Free 
State or area to develop and implement a brucellosis management plan 
under any other circumstances if the Administrator determines it is 
necessary to prevent the spread of brucellosis. The State must sign a 
memorandum of understanding (MOU) with the Administrator that describes 
its brucellosis management plan. The brucellosis management plan must 
define and explain the basis for the geographic area in which a disease 
risk exists from B. abortus and to which the brucellosis management 
plan applies. The brucellosis management plan must also describe the 
surveillance activities that the State will conduct to identify 
occurrence of B. abortus in domestic livestock and wildlife and 
potential risks for spread of the disease. The brucellosis management 
plan must also describe mitigation activities to prevent the spread of 
B. abortus from domestic livestock and/or wildlife, as applicable. The 
Administrator may reclassify to a lower status any State or area that 
has

[[Page 81092]]

not implemented an approved brucellosis management plan within 6 months 
of being required to develop one.
    For States or areas that have been Class Free for 5 or more years 
and do not have B. abortus in wildlife, we are also revising 
requirements for maintaining Class-Free status by removing the 
requirement for twice-yearly brucellosis ring testing of dairy cattle 
herds producing milk for sale and the requirement for each State to 
collect blood samples from at least 95 percent of all cows and bulls 2 
years of age or over at each recognized slaughtering facility and 
subject the samples to an official brucellosis test. Instead, we will 
require that all recognized slaughtering establishments in such States 
or areas must, upon request by APHIS, agree to participate in slaughter 
surveillance testing as part of a new national bovine brucellosis 
surveillance plan being developed by APHIS. The new plan, along with 
the changes made in this interim rule, will allow us to reduce the 
level of surveillance testing in States or areas that have been Class 
Free for 5 or more years and do not have B. abortus in wildlife. This 
will eliminate redundancies in slaughter surveillance testing and 
increase the efficiency of the bovine brucellosis slaughter 
surveillance program, allowing us to focus activities on States and 
areas of greater risk for spreading brucellosis (i.e., States and areas 
that have B. abortus in wildlife). The slaughter surveillance sampling 
strategy APHIS is developing as part of the new national bovine 
brucellosis surveillance plan provides 95 percent confidence of 
detecting brucellosis at a prevalence level of less than 1 infected 
animal per 1 million animals (0.0001 percent) in the National dairy and 
beef cattle populations. Information about the statistical analysis and 
the new national brucellosis surveillance plan is available to the 
public on APHIS' brucellosis Web site (http://www.aphis.usda.gov/animal_health/animal_diseases/brucellosis/).

Changes to Requirements for Herd Blood Tests

    The regulations include, in some cases, requirements for blood 
testing of herds from which cattle and bison intended for interstate 
movement originate or blood testing of herds identified as adjacent, 
source, or contact herds in an epidemiologic investigation. In the 
definition for herd blood test, the regulations list cattle and bison 
to be included in herd blood tests. Prior to this interim rule, we 
required the following sexually intact cattle and bison to be included 
in herd blood tests:
     Cattle and bison 6 months of age and older if not 
vaccinated;
     Cattle and bison 20 months of age and older if vaccinated 
and a dairy breed;
     Cattle and bison 24 months of age and older if vaccinated 
and a beef breed; and
     Cattle and bison of any age if vaccinated and parturient 
or post-parturient.
    These age requirements were established because the previously used 
B. abortus Strain 19 vaccine had the propensity to cause false positive 
test results in younger vaccinated animals. The B. abortus RB 51 
vaccine that is now in use, and that has been in use for the past 13 
years, does not have the propensity to cause false positive test 
results. Therefore, we are making a change in our definition of herd 
blood test to require that all sexually intact cattle and bison 6 
months of age and older be included in all herd blood tests (vaccinated 
cattle and bison of any age that are parturient or post-parturient will 
continue to be included in herd blood tests). When herd blood tests are 
required, the inclusion of official vaccinates 6 months of age and 
older will ensure that brucellosis is detected in younger animals that 
may be infected.

Changes to Requirements for Certified Brucellosis-Free Herds

    Under the current regulations, interstate movement restrictions for 
cattle or bison from certified brucellosis-free herds may be less 
restrictive than those applied to other cattle or bison moving from the 
State or area. The requirements for achieving certified brucellosis-
free herd status are contained in the definition of certified 
brucellosis-free herd. For dairy herds, the regulations have provided 
that certification may be achieved through negative results to two herd 
blood tests or through negative results to a series of brucellosis ring 
tests, followed by a negative herd blood test.
    The brucellosis ring test is conducted on milk from dairy animals. 
Additional types of brucellosis tests for milk are under development 
and may be approved for use in the brucellosis program. To allow for 
use of new milk tests, if approved, we are amending the provisions for 
certifying dairy herds to provide for use of either the brucellosis 
ring test or another official brucellosis milk test approved by the 
Administrator.
    To maintain certification, the regulations have required that dairy 
herds must test negative to a herd blood test conducted within a 
certain period of time following the initial certification. As an 
alternative, this rule will allow dairy herds to maintain certification 
through negative results to a series of four brucellosis ring tests, or 
through another testing protocol if the Administrator finds that the 
protocol is adequate to determine there is no evidence of brucellosis 
in the herd.
    These changes will give producers more options for achieving and 
maintaining certified brucellosis-free status for dairy herds.

Miscellaneous Changes

    As explained earlier, the regulations require Class Free States or 
areas to conduct certain surveillance testing in order to maintain 
Class Free status. Under this interim rule, States that have not been 
Class Free for 5 or more years or that have B. abortus in wildlife must 
continue to conduct the same level of surveillance testing as in the 
past. However, as an alternative to conducting brucellosis ring tests, 
this interim rule will allow use of another official brucellosis milk 
test if one is approved by the Administrator for use in the brucellosis 
program. This change is in the definition of Class Free State or area, 
paragraph (a)(1)(ii)(A).
    We are also making several other minor changes to the regulations. 
We are correcting an oversight in paragraph (d) under the definition 
for approved intermediate handling facility by extending the period of 
time from 1 year to 2 years for retaining documents related to cattle 
and bison that are or have been in the facility. We are making this 
change to be consistent with current record-keeping practices required 
under Sec.  71.20 of the regulations, which contains provisions for 
stockyards, livestock facilities, buying stations, concentration 
points, or ``any other premises under State or Federal veterinary 
supervision where livestock are assembled'' to acquire and retain 
status as approved facilities. One of the requirements for qualifying 
as an approved facility, including an approved intermediate handling 
facility, is the retention, for a period of 2 years, of all documents 
such as weight tickets, sales slips, and records of origin, 
identification, and destination that relate to livestock that are in, 
or that have been in, the facility. When the 2-year record requirement 
was established in Sec.  71.20 on October 31, 1996 (61 FR 56155-56165, 
Docket No. 96-041-1), we neglected to make the corresponding change in 
the definition of approved intermediate handling facilities. We are 
correcting that oversight now.

[[Page 81093]]

    In addition, in paragraph (c)(1) under the definition for 
certificate, we are correcting a typographical error by replacing the 
word ``stabled'' with the word ``stapled.''
    Finally, we are reorganizing the requirements under the definitions 
for Certified brucellosis-free herd and Class Free State or area to 
make them clearer to read.

Immediate Action

    Immediate action is warranted to remove requirements that present 
an obstacle to effectively managing the brucellosis program. Changes to 
the requirements for maintaining Class Free status, in particular, are 
necessary so that APHIS and States can use available resources on 
program activities that will have the greatest impact on disease 
management and disease risk mitigation. The changes in age requirements 
for sexually intact vaccinates to be included in herd blood testing are 
necessary to ensure that brucellosis is detected in younger animals 
that may be infected. Under these circumstances, the Administrator has 
determined that prior notice and opportunity for public comment are 
contrary to the public interest and that there is good cause under 5 
U.S.C. 553 for making this action effective less than 30 days after 
publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

    This interim rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis identifies beef cattle and dairy operations as the small 
entities most likely to be affected by this action and considers the 
effects of the rule on the beef and dairy industry. Based on the 
information presented in the analysis, the Administrator has certified 
that this action will not have a significant economic impact on a 
substantial number of small entities. The full economic analysis may be 
viewed on the Regulations.gov Web site (see ADDRESSES for instructions 
for accessing Regulations.gov). Copies of the economic analysis are 
also available from the person listed under FOR FURTHER INFORMATION 
CONTACT.

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 rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Has no retroactive effect; and (2) does 
not require administrative proceedings before parties may file suit in 
court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this interim rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2009-0083. Please send a copy of your comments to: (1) Docket No. 
APHIS-2009-0083, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A 03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, Rroom 404 W, 14th Street and 
Independence Avenue, SW., Washington, DC 20250. A comment to OMB is 
best assured of having its full effect if OMB receives it within 60 
days of publication of this interim rule.
    The APHIS bovine brucellosis program regulations in 9 CFR part 78 
provide a system for classifying States or portions of States according 
to the rate of Brucella abortus infection present and the general 
effectiveness of a brucellosis control and eradication program. The 
program also provides for the creation of brucellosis management areas 
within a State and for testing and movement mitigation activities 
before regulated animals are permitted to move interstate. This system 
enhances the ability of States to move healthy, brucellosis-free cattle 
and bison interstate and internationally. This management area and 
testing system also enhances the effectiveness of the Bovine 
Brucellosis Eradication Program by decreasing the likelihood that 
infected animals will be moved interstate or internationally.
    The creation of brucellosis management areas allow States that have 
found B. abortus in wildlife (which are nonregulated animals) to 
mitigate the risk of transmission and spread of disease while 
maintaining the State's disease-free status in regulated domestic 
livestock. The State must sign a memorandum of understanding (MOU) with 
the Administrator that describes its brucellosis management plan. The 
brucellosis management plan developed by the State must define the 
geographic brucellosis management area and describe the surveillance 
and mitigation activities that the State will conduct to identify 
occurrence of B. abortus in domestic livestock and wildlife and 
potential risks for spread of the disease.
    The information provided by these documents is critical to APHIS' 
mission to prevent the introduction or spread of bovine brucellosis. 
APHIS is asking the Office of Management and Budget (OMB) to approve 
the use of these information-gathering activities for 3 years in 
connection with APHIS' bovine brucellosis program.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our information collection and recordkeeping 
requirements. These comments will help us:
    (1) Evaluate whether the information collection is necessary for 
the proper performance of our agency's functions, including whether the 
information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
information collection, including the validity of the methodology and 
assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 300 hours per response.
    Respondents: State animal health and wildlife officials.
    Estimated annual number of respondents: 3.
    Estimated annual number of responses per respondent: 2.
    Estimated annual number of responses: 6

[[Page 81094]]

    Estimated total annual burden on respondents: 1,800 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this interim rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

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 Approved intermediate handling facility, by 
revising paragraph (d) to read as set forth below.
0
b. In the definition of Certificate, by revising paragraph (c)(1) to 
read as set forth below.
0
c. By revising the definitions of Certified brucellosis-free herd, 
Class Free State or area, and Herd blood test to read as set forth 
below.

Sec.  78.1  Definitions.

* * * * *
    Approved intermediate handling facility.
* * * * *
    (d) Any document relating to cattle or bison which are or have been 
in the facility shall be maintained by the facility for a period of 2 
years;
* * * * *
    Certificate.
* * * * *
    (c) * * *
    (1) A legible copy of the official brand inspection certificate 
must be stapled to the original and each copy of the certificate;
* * * * *
    Certified brucellosis-free herd. A herd of cattle or bison which 
has qualified for and whose owner has been issued a certified 
brucellosis-free herd certificate signed by the appropriate State 
animal health official and the Veterinarian in Charge.
    (a) Certification. The following methods may be used to qualify a 
herd:
    (1) By conducting at least two consecutive negative herd blood 
tests not less than 10 months nor more than 14 months apart; or
    (2) As an alternative for dairy cattle, by conducting a minimum of 
four consecutive negative brucellosis ring tests, or other official 
brucellosis milk test approved by the Administrator, at not less than 
90-day intervals, followed by a negative herd blood test within 90 days 
after the last negative brucellosis ring test or other official 
brucellosis milk test approved by the Administrator.
    (b) Maintaining certification. Certified brucellosis-free herd 
status will remain in effect for 1 year beginning with the date of 
issuance of the certified brucellosis-free herd certificate. The 
following methods may be used to maintain herd certification:
    (1) A negative herd blood test must be conducted within 10 to 12 
months of the last certification date for continuous status. Lapsed 
certification may be reinstated if a herd blood test is conducted 
within 14 months of the last certification date. A new recertification 
test date may be established if requested by the owner and if the herd 
is negative to a herd blood test on that date, provided that date is 
within 1 year of the previous certification date.
    (2) As an alternative for dairy cattle, a minimum of four 
consecutive negative brucellosis ring tests, or other official 
brucellosis milk test approved by the Administrator, must be conducted 
at approximately 90-day intervals, with the fourth test conducted 
within 60 days before the 1-year anniversary of the previous 
certification date.
    (3) The Administrator may allow another testing protocol to be used 
if the Administrator determines that such a protocol is adequate to 
determine there is no evidence of brucellosis in the herd.
    (c) Loss of certification. A herd which loses certified 
brucellosis-free herd status because a brucellosis reactor is found in 
the herd may be recertified only by repeating the certification 
process, except that certified brucellosis-free herd status may be 
reinstated without repeating the certification process if 
epidemiological studies and bacteriological cultures conducted by an 
APHIS representative or State representative show that the herd was not 
affected with Brucella abortus.
* * * * *
    Class Free State or area. A State or area which meets standards for 
classification as a Class Free State or area and is certified as such 
on initial classification or on reclassification by the State animal 
health official, the Veterinarian in Charge, and the Administrator. For 
initial classification or reclassification, all cattle herds in the 
State or area must have remained free of Brucella abortus for 12 
consecutive months, based on surveillance and epidemiologic 
investigations as required for Class A States or areas, and the State 
or area must have a cattle herd infection rate, based on the number of 
herds found to have brucellosis reactors within the State or area 
during any 12 consecutive months due to Brucella abortus, of 0.0 
percent or 0 herds per 1,000. Any reclassification will be made in 
accordance with Sec.  78.40 of this part. All cattle herds in the State 
or area in which brucellosis has been known to exist must be released 
from any State or Federal brucellosis quarantine prior to 
classification. In addition, if any herds of other species of domestic 
livestock have been found to be affected with brucellosis, they must be 
subjected to an official test and found negative, slaughtered, or 
quarantined so that no foci of brucellosis in any species of domestic 
livestock are left uncontrolled. The following are the standards to 
maintain Class Free status.
    (a) Surveillance. (1) Testing requirements. (i) States or areas 
that have been Class Free for 5 consecutive years or longer and that do 
not have B. abortus in wildlife. All recognized slaughtering 
establishments in the State or area, upon request by APHIS, must agree 
to participate in market cattle identification (MCI) testing as part of 
the national brucellosis surveillance plan.
    (ii) States or areas that have not been Class Free for 5 
consecutive years or longer or that have B. abortus in wildlife. The 
State or area must carry out testing as provided in paragraphs 
(a)(1)(ii)(A) and (a)(1)(ii)(B) of this definition:
    (A) Brucellosis ring test. The State or area shall conduct as many 
brucellosis ring tests per year as are necessary to ensure that all 
herds producing milk for sale are tested at least twice per year at 
approximately 6-month intervals. Another official brucellosis milk test

[[Page 81095]]

may be used as approved by the Administrator.
    (B) Market Cattle Identification (MCI) program. All recognized 
slaughtering establishments in the State or area must participate in 
the MCI program. Blood samples shall be collected from at least 95 
percent of all cows and bulls 2 years of age or over at each recognized 
slaughtering establishment and subjected to an official test.
    (2) Brucellosis reactors. All Class Free States or areas must 
comply with the following requirements upon detection of a brucellosis 
reactor:
    (i) Tracebacks. The State or area must trace at least 90 percent of 
all brucellosis reactors found in the course of MCI testing to the farm 
of origin.
    (ii) Successfully closed cases. The State or area must successfully 
close at least 95 percent of the MCI reactor cases traced to the farm 
of origin during the 12-consecutive-month period immediately prior to 
the most recent anniversary of the date the State or area was 
classified Class Free. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
were found on the MCI test. Herd blood tests must be conducted or the 
herd must be confined to the premises under quarantine within 30 days 
after notification that brucellosis reactors were found on the MCI 
test, unless a designated epidemiologist determines that:
    (A) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (B) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (1) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (2) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (3) The brucellosis reactor showed a low titer in the MCI test and 
is traced back to a dairy herd that is 100 percent vaccinated and has 
tested negative to the most recent brucellosis ring test required by 
this section for herds producing milk for sale.
    (iii) Epidemiologic surveillance. (A) Adjacent herds. All adjacent 
herds or other herds having contact with cattle in a herd known to be 
affected shall be placed under quarantine and have an approved 
individual herd plan in effect within 15 days after notification of 
brucellosis in the herd known to be affected;
    (B) Epidemiologically traced herds. All herds from which cattle are 
moved into a herd known to be affected and all herds which have 
received cattle from a herd known to be affected shall be placed under 
quarantine and have an approved individual herd plan in effect within 
15 days of locating the source herd or recipient herd. Each State shall 
ensure that such approved individual herd plans are effectively 
complied with, as determined by the Administrator.
    (b) Herd infection rate. (1) Affected herds. Except as provided in 
paragraph (b)(4) of this definition, all cattle herds in the State or 
area must remain free of Brucella abortus.
    (2) Epidemiologic investigation. Within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
have been found in any herd, State representatives or APHIS 
representatives shall investigate that herd to identify possible 
sources of brucellosis. All possible sources of brucellosis identified 
shall be contacted within an additional 15 days to determine 
appropriate action.
    (3) Approved herd plans. All herds known to be affected shall have 
approved individual herd plans in effect within 15 days after 
notification by a State representative or APHIS representative of a 
brucellosis reactor in the herd. Each State shall ensure that such 
approved individual herd plans are effectively complied with, as 
determined by the Administrator.
    (4) Affected herd. If any herd in a Class Free State or area is 
found to be affected with brucellosis, the State or area may retain its 
Class Free status if it meets the conditions of this paragraph; 
provided that the Administrator may reclassify a State or area to a 
lower status upon finding that continued detection of brucellosis 
presents a risk that the disease will spread.
    (i) The affected herd. (A) The affected herd must be quarantined 
immediately, and, within 60 days, tested for brucellosis and 
depopulated; or
    (B) The affected herd must be quarantined immediately and tested 
for brucellosis as required by the Administrator until there is no 
evidence of brucellosis in the herd; and
    (ii) Other herds. An epidemiological investigation must be 
performed within 60 days of the detection of an infected animal in a 
herd. All herds on premises adjacent to the affected herd (adjacent 
herds), all herds from which animals may have been brought into the 
affected herd (source herds), and all herds that may have had contact 
with or accepted animals from the affected herd (contact herds) must be 
epidemiologically investigated, and each of those herds must be placed 
under an approved individual herd plan. If the investigating 
epidemiologist determines that a herd blood test for a particular 
adjacent herd, source herd, or contact herd is not warranted, the 
epidemiologist must include that determination, and the reasons 
supporting it, in the individual herd plan.
    (iii) APHIS review. After the close of the 60-day period following 
the date an animal in the herd is determined to be infected, APHIS will 
conduct a review to confirm that the requirements of paragraphs 
(b)(4)(i) and (b)(4)(ii) of this definition have been satisfied and 
that the State or area is in compliance with all other applicable 
provisions.
    (c) Brucellosis management plans. (1) Any State in which the 
Administrator has determined wildlife are infected with B. abortus must 
develop and implement a brucellosis management plan approved by the 
Administrator. The existence of B. abortus in wildlife will be 
determined by the Administrator, based on, but not limited to, 
histopathology, testing data, or epidemiology. The Administrator may 
also require a Class Free State or area to develop and implement a 
brucellosis management plan under any other circumstances if the 
Administrator determines it is necessary to prevent the spread of 
brucellosis. The State must sign a memorandum of understanding (MOU) 
with the Administrator that describes its brucellosis management plan. 
The MOU must be updated annually. The Administrator may reclassify to a 
lower status any State or area that has not implemented an approved 
brucellosis management plan within 6 months of being required to 
develop one.
    (2) The brucellosis management plan reflected in the MOU must:
    (i) Define and explain the basis for the geographic area in which a 
disease risk exists from B. abortus and to which the brucellosis 
management plan activities apply;
    (ii) Describe epidemiologic assessment and surveillance activities 
to identify occurrence of B. abortus in

[[Page 81096]]

domestic livestock and wildlife and potential risks for spread of 
disease; and
    (iii) Describe mitigation activities to prevent the spread of B. 
abortus from domestic livestock and/or wildlife, as applicable, within 
or from the brucellosis management area.
* * * * *
    Herd blood test. A blood test for brucellosis conducted in a herd 
on all cattle or bison 6 months of age or over, except steers and 
spayed heifers.
* * * * *

    Done in Washington, DC, this 17th day of December 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-32371 Filed 12-22-10; 8:45 am]
BILLING CODE 3410-34-P
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