[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Rules and Regulations]
[Pages 81090-81096]
From the Federal Register Online via the Government Publishing 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