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[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Rules and Regulations]
[Pages 66591-66597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26580]

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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / 
Rules and Regulations

[[Page 66591]]

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: Final rule.

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SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that amended the brucellosis regulations to, among other things, 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. This document amends the interim rule to change 
the age at which cattle and domestic bison are included in herd blood 
tests from 6 months to 18 months of age for all sexually intact cattle 
and domestic bison, except when conducting herd blood tests as part of 
affected herd investigations or other epidemiological investigations. 
In addition, the rule allows certain States the option of either 
conducting brucellosis ring tests and participating in the slaughter 
surveillance program or developing an alternative surveillance plan 
that would have to meet or exceed the level of disease detection 
provided by combined brucellosis ring testing and slaughter 
surveillance testing. The rule also makes several minor changes in 
order to clarify the regulations. These changes are necessary to create 
flexibility in the brucellosis program, 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: Effective Date: December 10, 2014.

FOR FURTHER INFORMATION CONTACT: Dr. Mike Carter, Assistant Director, 
Cattle Health Center, Surveillance, Preparedness and Response Services, 
VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231; (301) 
851-3510.

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.
    Previously, the brucellosis Class Free classification had been 
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 that were in place required Class Free 
States or areas to conduct surveillance by carrying out as many 
brucellosis ring tests per year as were necessary to ensure that all 
cattle herds producing milk for sale were tested at least twice per 
year at approximately 6-month intervals. In addition, the regulations 
had 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 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 was 
found to be affected with brucellosis, the herd was required to be 
depopulated within 60 days of an infected animal being detected. If two 
or more herds were found to be affected with brucellosis within a 2-
year period or if an affected herd was not depopulated within 60 days, 
the State or area lost its Class Free status. The regulations provided 
no exceptions to these requirements for reclassification.
    In an interim rule \1\ effective and published in the Federal 
Register (75 FR 81090-81096, Docket No. APHIS-2009-0083) on December 
27, 2010, we amended the 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 B. abortus in wildlife. The 
interim rule also removed 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, 
the interim rule reduced the age at which most cattle are included in 
herd blood tests and also added a requirement that any Class Free State 
or area with B. abortus in wildlife develop and implement a brucellosis 
management plan (BMP) approved by the Administrator in order to 
maintain Class Free status. Finally, the interim rule provided an 
alternative testing protocol for maintaining the certified brucellosis-
free status of dairy herds, to give dairy producers more flexibility 
for the herd certification process. These changes were 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.
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    \1\ To view the interim rule and the comments we received, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0083.

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[[Page 66592]]

    We solicited comments concerning the interim rule for 60 days 
ending February 25, 2011. We extended the deadline for comments until 
March 11, 2011, in a document published in the Federal Register on 
February 4, 2011 (76 FR 6322-6323). We received 30 comments by that 
date. They were from private citizens, State agencies, industry groups, 
animal welfare organizations, environmental groups, and members of 
Congress. The commenters raised a number of issues, which are discussed 
below by topic.

Depopulation and Indemnity

    As stated in the interim rule, the Animal and Plant Health 
Inspection Service (APHIS) no longer uniformly recommends whole herd 
depopulation for disease management for various reasons, including the 
fact that the number of brucellosis-infected animals found in a herd is 
often small. When depopulation and indemnity are not considered 
appropriate, affected herds may be maintained under quarantine and 
periodically tested. Those animals that do not test negative for 
brucellosis will be removed and destroyed.
    Many of the commenters stated that, in some cases, depopulation may 
be the most cost-effective option for reducing the spread of 
brucellosis, for example when herd quarantine conditions prevent access 
to public grazing sites. Therefore, they stated that depopulation 
should remain an option and that APHIS should pay indemnity at fair 
market value for depopulating herds in such situations.
    Depopulation with indemnity remains an option for mitigating the 
risk of spread of brucellosis. However, there is little fiscal or 
scientific justification to depopulate, for example, a herd in an area 
where brucellosis is endemic in wildlife and wildlife is considered the 
most likely source of infection. Whole-herd depopulation under such 
circumstances does little to eliminate the source of infection. The 
decision to depopulate will be made on a case-by-case basis as a joint 
decision between State animal health officials and APHIS and will be 
based on the specific herd situation, epidemiologic factors, herd owner 
considerations, the ability to devise and execute an acceptable 
affected herd plan, and the availability of indemnity funds.
    We are continuing to work toward a new direction for both the 
bovine brucellosis and bovine tuberculosis programs and are developing 
a rule to revise the regulations regarding both programs.
    Two commenters asked that, in the event that herds are quarantined, 
APHIS consider ways to help livestock producers remain economically 
viable if their herds are unable to access public grazing land for long 
periods of time. The commenters suggested providing alternate food 
sources or providing other land that could be used for grazing.
    While APHIS does not have jurisdiction over land use, we continue 
to work with other State and Federal agencies to explore ways to assist 
livestock producers in complying with the regulations and will consider 
the specific herd situation when determining the best course of action 
upon discovering brucellosis in a herd.
    In the interim rule, we stated as part of our reasoning for 
reevaluating our universal recommendation for whole herd depopulation 
that, in addition to changing social values, the ``recognition of the 
environmental consequences of animal disposal and the value of proteins 
derived from livestock'' impel us to consider new approaches to disease 
control. One commenter asked APHIS to clarify these statements, stating 
that they are misleading given that brucellosis reactors and 
depopulated animals enter the food chain.
    We recognize that, upon depopulation, test-negative, brucellosis-
exposed animals may go through normal slaughter channels and enter the 
food chain. For animals exposed to brucellosis, as opposed to other 
diseases such as bovine tuberculosis, this has been and remains an 
acceptable disposal option. However, we continue to believe that it is 
difficult to justify the depopulation of an entire herd of valuable 
breeding or dairy cattle when only a few animals in the herd may be 
brucellosis reactors. A viable alternative to whole herd depopulation 
is a risk-based affected-herd management plan that includes test-and-
removal protocols and mitigation strategies to prevent intraherd 
transmission of disease.

Reclassification

    As stated in the interim rule, when a Class Free 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, 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. 
Therefore, we removed 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.
    Two commenters expressed concerns regarding the removal of the 
requirement that a Class Free State or area may have no more than one 
affected herd in a 2-year period in order to maintain its status. 
Several commenters asked for specifics of when a State would be 
reclassified from Class Free to a lower status. One commenter said it 
was not appropriate to designate a State or area as Class Free if a 
number of herds within the State or area are being held under 
quarantine and suggested a new designation for such States or areas. 
One commenter stated that APHIS should adopt a process similar to that 
already in place for the bovine tuberculosis program for determining 
when to release herds from quarantine.
    Reclassification from Class Free to a lower status will occur on a 
case-by-case basis when we determine that additional restrictions on 
the movement of all cattle from a State are necessary to prevent the 
interstate spread of B. abortus. However, in general, we intend to use 
a science-based, designated surveillance area approach that addresses 
disease risk more effectively than the geopolitical, State-based 
approach we had previously used. This change also reflects the World 
Organization for Animal Health (OIE) concept of regionalization by 
designating disease management areas to facilitate disease risk 
mitigation, allow flexibility in modifying boundaries, and provide 
confidence in the United States' disease-free designation. In addition, 
it enables APHIS to focus resources on geographic areas where B. 
abortus actually exists, while minimizing the economic impact on 
producers. New designations for State status based on risk and risk 
mitigation is one of the components under discussion in the development 
of the comprehensive bovine brucellosis and tuberculosis rulemaking.
    A process similar to the process in place for releasing herds from 
quarantine for tuberculosis is already in place for releasing herds 
from quarantine for brucellosis in paragraph (b)(4)(i) under the 
definition for Class Free State or area.

Slaughter Surveillance

    In the interim rule, we removed 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

[[Page 66593]]

amended the regulations to require all recognized slaughtering 
establishments in States or areas that have been Class Free for 5 or 
more years and have no B. abortus in wildlife, upon request by APHIS, 
to agree to participate in slaughter surveillance testing as part of a 
new national bovine brucellosis surveillance plan being developed by 
APHIS.
    Several commenters asked how adequate slaughter surveillance would 
be achieved given that the majority of cattle from States that have B. 
abortus in wildlife or that have been Class Free for less than 5 years 
move interstate for slaughter to facilities in States that have been 
Class Free for 5 years or more and that do not have B. abortus in 
wildlife. The commenters expressed concern that there would be a 
disincentive to accept cattle from States that have brucellosis in 
wildlife or that have been Class Free for less than 5 years.
    We recognize that the majority of cattle from States that have B. 
abortus in wildlife go to slaughter in States that have been Class Free 
for 5 years or more and that do not have B. abortus in wildlife. 
However, the revised slaughter surveillance sampling strategy will not 
impact the adequacy of surveillance since all recognized slaughter 
establishments, regardless of duration of Class Free status or presence 
of B. abortus in wildlife, must agree to participate in surveillance 
testing upon request by APHIS as part of the national brucellosis 
surveillance plan. Slaughter establishments that will be receiving 
cattle from States or areas that have B. abortus in wildlife or that 
have been Class Free for less than 5 years were chosen to participate 
in the testing because they already accept such cattle, and it is 
important to continue surveillance in these higher-risk populations. As 
there is no difference in the collection of samples at slaughter from 
cattle from States that have been Class Free for 5 years or more and 
that do not have B. abortus in wildlife and samples taken from cattle 
from other States, or the proportion of cattle from which samples are 
taken, there will not be a disincentive for slaughter plants to accept 
certain cattle.
    One commenter stated that a standardized testing protocol should 
allow for the use of additional brucellosis tests when deemed 
necessary.
    The standardized testing protocol being implemented as part of the 
new national bovine brucellosis surveillance strategy is specifically 
for the initial testing of all bovine brucellosis slaughter 
surveillance samples. Any samples that test other than negative for 
bovine brucellosis will be appropriately classified and subjected to 
additional testing and epidemiological investigation at the discretion 
of a designated brucellosis epidemiologist. This would include the use 
of other official brucellosis serology tests.
    One commenter expressed concern regarding the removal through the 
interim rule of the requirement for twice-yearly brucellosis ring 
testing of dairy cattle herds producing milk for sale in States that 
have been Class Free for 5 or more years and do not have brucellosis in 
wildlife.
    In 2006, the National Surveillance Unit (NSU) of Veterinary 
Services' (VS) Centers for Epidemiology and Animal Health (CEAH) 
evaluated the brucellosis program surveillance activities and 
identified redundancies and imbalances in surveillance testing. In 
2007, NSU provided recommendations based on this evaluation to a 
Federal-State Working Group on National Brucellosis Surveillance 
Planning. The NSU evaluation determined that first point testing and 
brucellosis ring testing were redundant when combined with slaughter 
surveillance because, often, market and dairy cattle are tested 
repeatedly, providing no greater value over the original negative test. 
This finding led to our decision to remove the requirement for twice-
yearly brucellosis ring testing of dairy cattle herds producing milk 
for sale in States that have been Class Free for 5 or more years and do 
not have brucellosis in wildlife. A document titled ``National 
Brucellosis Surveillance Strategy,'' available at http://www.aphis.usda.gov/animal_health/animal_diseases/brucellosis/downloads/natl_bruc_surv_strategy.pdf, describes the new national brucellosis 
surveillance strategy, its goals and objectives, and the basis and 
rationale for the surveillance activities used.
    One commenter expressed the hope that APHIS will publish the draft 
of the new national bovine brucellosis surveillance plan and solicit 
public comment, stating that APHIS is likely legally obligated to do so 
under the Administrative Procedure Act.
    In the ``Concept Paper for a New Direction for the Bovine 
Brucellosis Program,'' which we made available for public comment in a 
notice published in the Federal Register on October 5, 2009 (74 FR 
51115-51116, Docket No. APHIS-2009-0006), we announced our intention to 
develop a national surveillance strategy for brucellosis, which would 
involve revisions to the brucellosis regulations. Any further revisions 
to the brucellosis regulations will also be made available for public 
comment.
    Approved backtags provide unique identification for individual 
animals. One commenter asked how the reduced slaughter surveillance 
sampling will affect the brucellosis back-tagging program.
    Use of U.S. Department of Agriculture (USDA) approved backtags will 
continue to be a viable option for identifying cattle moving to 
slaughter. The use of USDA approved backtags is independent of the 
brucellosis program; therefore, the decrease in bovine brucellosis 
slaughter surveillance detailed in the interim rule will not affect the 
option of using backtags to identify cattle moving to slaughter.

Brucellosis Management Plans and Memorandum of Understanding

    One commenter asked for specifics of the memorandum of 
understanding (MOU) required in the interim rule and stated that 
Federal wildlife agencies must also work toward controlling 
brucellosis, since most infected wildlife occurs on Federal lands, and 
State wildlife agencies do not have the resources to control 
brucellosis on their own.
    The MOU is an agreement signed by the State and APHIS indicating 
that the State will develop a BMP. As stated in the interim rule, it is 
the BMP that must define and explain the basis for the geographic area 
in which the disease risk exists and to which the BMP activities apply; 
describe epidemiologic assessment and surveillance activities to 
identify occurrence of B. abortus in domestic livestock and wildlife 
and potential risks for spread of disease; and 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. We would expect that States' animal health and 
wildlife agencies would work cooperatively with their Federal agency 
counterparts in the development of BMPs.
    One commenter asked if the Department of the Interior's National 
Park Service would be included in the MOU, given that a number of 
brucellosis-infected elk and bison reside within the Yellowstone and 
Grand Teton National Parks.
    The MOU and accompanying BMP are an agreement between APHIS and the 
State. APHIS does not have jurisdiction or authority over national park 
lands. Therefore, we cannot require that the National Park Service sign 
the MOU. As noted, we would expect that States' animal health and 
wildlife agencies would work cooperatively with their

[[Page 66594]]

Federal agency counterparts, such as the National Park Service, in the 
development of BMPs.
    Several commenters expressed concern about who holds legal 
authority over wildlife. One commenter stated that APHIS does not have 
legal authority over wildlife and that, therefore, requiring BMPs to be 
approved by the Administrator is illegal and usurps the authority of 
individual States. One commenter stated that, in most cases, State 
agriculture or animal health officials do not have authority over 
wildlife; therefore, the commenter asked whether it would be acceptable 
if the Commissioner of Agriculture of the State submits the MOU.
    APHIS has the authority to require livestock moving in interstate 
commerce to be safeguarded from exposure to B. abortus in wildlife if 
such requirements are necessary to prevent the spread of B. abortus. In 
addition, APHIS is authorized under the Animal Health Protection Act 
(AHPA, 7 U.S.C. 8301 et seq.) to cooperate and enter into contracts, 
cooperative agreements, MOUs, or other agreements with other Federal 
agencies, States or political subdivisions of States, national or local 
governments of foreign countries, domestic or international 
organizations or associations, Indian tribes and other persons in order 
to promulgate regulations and issue orders as deemed necessary to 
protect animal health, the health and welfare of the people of the 
United States, the economic interests of livestock and related 
industries of the United States, the environmental health of the United 
States, and interstate commerce and foreign commerce of the United 
States in animals and other related articles. As stated in the interim 
rule, the State must sign an MOU with the APHIS Administrator that 
describes its BMP. The term ``State'' refers to all State agencies with 
the appropriate authority over management plan activities. In certain 
States this may mean that multiple signatures may be needed on the MOU. 
States will determine, based on their individual State government 
structures, the appropriate authority to submit the MOU.
    One commenter asked what would be acceptable as a BMP and how the 
Administrator would determine whether a BMP was implemented 
appropriately. One commenter asked what the appeals process would be if 
APHIS does not approve a State's BMP.
    As stated previously, the BMP must define and explain the basis for 
the geographic area in which the disease risk exists and to which the 
BMP activities apply; describe epidemiologic assessment and 
surveillance activities to identify occurrence of B. abortus in 
domestic livestock and wildlife and potential risks for spread of 
disease; and 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. We anticipate that APHIS, 
State wildlife agencies, and Federal wildlife agencies would work 
cooperatively to develop and implement the State's BMP. Once submitted, 
APHIS would review the BMP along with the State and would discuss and 
resolve any concerns together prior to approval. The MOU for the BMP 
would then be signed by the Administrator. States would have to submit 
annual reports that would reflect implementation of the activities 
described in the BMP. States are provided the opportunity to respond to 
and provide additional information if necessary to address any 
deficiencies or concerns noted in APHIS' review of the annual report.
    Several commenters stated that the wildlife agencies of Wyoming, 
Idaho, and Montana already have established brucellosis management 
protocols. One commenter stated that these should only be revised if 
appropriate. A second commenter stated that if APHIS wants revisions to 
Wyoming's plan, then APHIS needs to offset the costs associated with 
the revisions. One commenter detailed Wyoming's surveillance program 
for wildlife and asked whether APHIS believes it meets the definition 
of ``adequate surveillance'' as mentioned in the interim rule.
    We recognize that these three States in the Greater Yellowstone 
Area (GYA) have already developed brucellosis management protocols. In 
fact, the protocols served as the basis for the development of the BMPs 
required under paragraph (c) under the definition for Class Free State 
or area for all three GYA States, which have been approved and are now 
in place. APHIS understands and shares the concerns regarding the 
development and funding of cooperative agreements to support 
brucellosis activities, including BMP activities, in the GYA States. We 
are committed to continuing to explore all possible funding options for 
GYA brucellosis efforts and to frequently communicating with the State 
animal health officials regarding available resources.

Resources and Funding

    Many commenters asked for specifics regarding the availability and 
allocation of resources, including personnel and Federal funding, for 
implementing surveillance and BMP activities mentioned in the interim 
rule.
    We are committed to providing all available Federal funding, 
continuing to explore all possible funding options, and frequently 
communicating with State animal health officials regarding available 
resources. We continue to work with States to effectively and 
efficiently apply these limited resources.

Testing Age

    Prior to the 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. However, because 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, the interim rule amended 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). This change was intended 
to ensure that brucellosis is detected in younger animals that may be 
infected.
    Many commenters expressed concern regarding the reduction in 
testing age to 6 months because they felt that the testing would not be 
practical or necessary, or would present a financial burden to 
producers. Two commenters asked for clarification of whether this 
reduction in testing age to 6 months pertains only to cattle tested 
during an epidemiological investigation or whether it also applies to 
cattle tested prior to interstate movement. One commenter suggested 
that if the reduction in testing age to 6 months was onerous to 
producers, the testing age should be reduced to 12 months.
    Based on the commenters' concerns, we have reevaluated the change. 
In this final rule, we are changing the age of cattle and bison to be 
included when conducting herd blood tests in order to

[[Page 66595]]

harmonize it with the age of testing for test-eligible cattle and bison 
for interstate movement that are not official vaccinates or that are 
official calfhood vaccinates which are parturient or postparturient. 
Currently, test-eligible cattle and bison are defined in Sec.  78.1 as:
     Cattle and bison which are not official vaccinates and 
which have lost their first pair of temporary incisors (18 months of 
age or over), except steers and spayed heifers;
     Official calfhood vaccinates 18 months of age or over 
which are parturient or postparturient;
     Official calfhood vaccinates of beef breeds or bison with 
the first pair of permanent incisors fully erupted (2 years of age or 
over); and
     Official calfhood vaccinates of dairy breeds with partial 
eruption of the first pair of permanent incisors (20 months of age or 
over).
    Harmonizing these ages so that whole herd blood testing includes 
cattle 18 months of age or over is desirable because it provides a 
standard testing age, thereby preventing confusion. In addition, 
raising the age at which cattle and bison are required to be included 
in whole herd blood tests would address some of the concerns raised by 
commenters. Testing all cattle and bison 18 months old and older 
targets sexually mature animals, which present the greatest risk for 
transmission of brucellosis. Steers and spayed heifers are exempt from 
testing when conducting herd blood tests. Therefore, we are changing 
the age of cattle and bison to be included in the herd blood tests to 
18 months of age and older for all sexually intact cattle and domestic 
bison, except when conducting herd blood tests as part of affected herd 
investigations or other epidemiological investigations or when the 
Administrator determines testing at a younger age is necessary to 
prevent the spread of brucellosis.
    We are also changing the age of testing for test-eligible cattle 
and bison for interstate movement that are official calfhood vaccinates 
and that are beef or dairy breeds. As previously stated, the B. abortus 
Strain 19 vaccine had the propensity to cause false positive test 
results in younger vaccinated animals. This was particularly a problem 
for beef and dairy breeds, which led to the current required testing 
ages. As the propensity for false positive test results has been 
eliminated, we are now able to lower the age at which beef and dairy 
breeds are eligible for testing. Besides ensuring that more animals are 
included in brucellosis testing, this change will add further 
consistency to the age at which cattle and bison are tested for 
brucellosis, further preventing confusion.

Surveillance Activities

    One commenter stated that blood testing for cattle leaving 
surveillance areas should be maintained, but that tattooing and random 
blood testing within a surveillance area is counterproductive and 
unnecessary given that it has yet to detect an infection that is not 
related to traceback from an already known infection. One commenter 
stated that requiring a herd test prior to interstate movement would be 
an undue burden on producers and that the State of Wyoming's 
requirement for a test within 30 days of movement is sufficient to 
prevent disease spread. One commenter stated that testing regimens 
should follow standard acceptable testing intervals such as those 
outlined in the Brucellosis Uniform Methods and Rules or as part of an 
approved herd plan for that particular herd.
    We disagree with the commenter that tattooing and random blood 
testing within a surveillance area (the geographic area described in a 
State's BMP) are unnecessary and counterproductive. The recent case of 
brucellosis in a domestic bison herd within Montana was found due to 
blood testing as part of Montana's designated surveillance area herd 
management plan. This rulemaking does not include any changes to the 
current interstate movement requirements as reflected in 9 CFR part 78. 
This rulemaking does require a State, under certain conditions, to 
develop a brucellosis management plan that includes mitigation 
activities to prevent the spread of B. abortus from domestic livestock 
and/or wildlife, as applicable, within or from the brucellosis 
management area. As part of the plan, the individual State may include 
requirements for testing prior to movement of animals. Testing animals 
prior to movement is intended to reduce the potential for disease 
transmission and to mitigate risk. We agree that standard acceptable 
testing intervals and testing as part of an approved herd plan are 
important brucellosis risk mitigations.

Wildlife

    One commenter did not support test and remove strategies as a 
general brucellosis management tool for wildlife species. Another 
commenter stated that, rather than focusing on removal of infected 
wildlife, it makes more sense to focus financial resources and efforts 
on brucellosis testing of live animals moving out of, or even into, 
designated surveillance areas, but that testing should not only be 
focused on the GYA.
    The test-and-remove strategy mentioned in the interim rule is 
intended for use in herds of domestic livestock and not on wildlife. We 
expect that States will develop appropriate strategies to mitigate the 
possible risk involved in the intrastate movement of livestock and 
wildlife into or out of designated surveillance areas. States that 
present a higher risk of the spread of brucellosis (i.e., those that 
have not been Class Free for 5 or more years and/or that have 
brucellosis in wildlife) are expected to address the risk of the spread 
of brucellosis between domestic livestock and wildlife in their BMP 
required by the regulations.
    Several commenters expressed concern about the transmission of 
brucellosis from elk to cattle in the GYA. Three commenters stated that 
studies should be undertaken in collaboration with wildlife agencies to 
determine the cause behind the increase in frequency of brucellosis 
transmission from elk to cattle. Two of these commenters stated that 
APHIS should shut down elk feeding grounds, as they contribute to high 
brucellosis prevalence in elk.
    We agree that more research is needed regarding the transmission of 
brucellosis from elk to cattle. APHIS participates in the Consortium 
for the Advancement of Brucellosis Science, whose mission includes 
identifying research priorities, securing funding, and generating 
requests for short- and long-term projects. This consortium is composed 
of wildlife agency officials, university researchers, and others, 
including many officials from the GYA. We believe that this consortium 
is an ideal forum to work collaboratively to study the transmission of 
brucellosis from elk to cattle within the GYA.
    While we recognize the commenters' concern regarding the 
possibility of transmission of brucellosis from elk to domestic cattle 
and bison via elk feeding grounds, elk feeding grounds are under State 
rather than Federal jurisdiction. Therefore, APHIS does not have the 
authority to shut down these elk feeding grounds.

Miscellaneous

    Several commenters asked that APHIS work with other agencies and 
organizations to develop a more effective brucellosis vaccine.
    We agree with the commenters regarding the development of more 
effective brucellosis vaccines. As mentioned previously, APHIS 
participates in the Consortium for the Advancement of Brucellosis 
Science.

[[Page 66596]]

We believe that this consortium is an ideal forum for brucellosis 
vaccine research.
    One commenter stated that the reference to calfhood vaccination in 
the definition for Class Free State or area should be removed because 
those references encourage cattle owners in Class Free States to 
vaccinate their calves in order to limit the amount of blood testing on 
the herd. The commenter further stated that calfhood vaccination should 
only be encouraged in areas with brucellosis in wildlife.
    We disagree with the commenter that the regulations encourage 
cattle owners in Class Free States to vaccinate calves in order to 
limit herd blood testing. While APHIS recommends calfhood vaccination 
in high risk areas, such as States or areas that have been Class Free 
for less than 5 years and/or that have brucellosis in wildlife, the 
Federal brucellosis program does not require vaccination. In addition, 
we are harmonizing the age of testing for herd blood tests and test-
eligible cattle and bison for interstate movement to require that all 
sexually intact cattle and domestic bison 18 months of age and older, 
regardless of vaccination status, be included in herd blood testing, 
except in specific circumstances previously described. This change will 
eliminate any possible incentive for cattle owners to vaccinate their 
calves in order to limit herd blood testing.
    One commenter stated that APHIS must provide an explanation of how 
we complied with the National Environmental Policy Act of 1964 (NEPA) 
in preparing the interim rule, whether that is making the environmental 
assessment available or, if categorically excluded, providing an 
explanation of why the rule was excluded from analysis.
    As required under NEPA, agencies must consider the potential 
environmental effects of Federal actions, including potential effects 
on human health. Under APHIS' NEPA implementing procedures in 7 CFR 
372.5(c)(1), certain measures are categorically excluded from the need 
for an environmental assessment or environmental impact statement due 
to their routine nature. These routine measures include monitoring, 
inspections, quarantines, testing and identification of animal herds 
for disease, and permanent identification of animals. Because the 
interim rule involved routine activities related to the regulation of 
the interstate movement of domestic cattle and bison to prevent the 
spread of brucellosis and presented negligible environmental impact, 
the interim rule was categorically excluded from NEPA review.
    One commenter stated that, under the definition for Class Free 
State or area in paragraph (a)(2)(iii) involving epidemiological 
surveillance, the word ``bison'' should be included whenever cattle are 
referenced. One commenter stated that we should clarify that the 
testing and movement requirements in the regulations apply to domestic 
bison and that the terms ``herd'' and ``bison'' need to be clearly 
defined to refer to either domestic or wild bison, as appropriate. 
Another commenter stated that, except for the first reference to bison 
within the interim rule, all other references to bison should be 
changed to domestic bison.
    The provisions of the AHPA apply only to livestock, and thus only 
to cattle and domestic bison, for purposes of interstate movement. 
Therefore, we do not believe it is necessary to amend the regulations 
to specifically refer to domestic bison. However, we agree that the 
word ``bison,'' referring to domestic bison, should be included 
whenever cattle are referenced. Therefore, we are amending 9 CFR part 
78 to include the word ``bison'' where appropriate.
    The definition of Class Free State or area in Sec.  78.1, as 
revised by the interim rule, states that ``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'' in order to maintain Class Free 
State status. These actions are intended to ensure that no foci of 
brucellosis in any species of domestic livestock are left uncontrolled. 
Two commenters asked that we define ``other herds or species.''
    These other species of domestic livestock would include those 
species of domestic livestock, such as swine or captive cervids, that 
are susceptible to and pose a risk of further spread of B. abortus. We 
do not believe it is necessary to define other herds or species in the 
regulations.
    Paragraph (b)(4) of the definition for Class Free State or area 
involves herd infection rates. One commenter stated that the words 
``continued detection'' in that paragraph should be clarified as, 
according to the commenter, continued detection of brucellosis in the 
GYA is proof that the surveillance system is working as intended.
    The words ``continued detection'' refer to an increasing herd 
infection rate within a State or area during any 12 consecutive months, 
which could potentially indicate the need for reclassification to a 
lower status. Traditionally, a State's brucellosis class status has 
been predicated on a set herd infection rate. The interim rule removed 
the requirement for the reclassification of a State's Class Free status 
to a lower status based strictly on a herd infection rate and provides 
flexibility in reclassifying States or areas based on risk. To clarify 
this intent, we are moving the provision in paragraph (b)(4) under the 
definition for Class Free State or area 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 to the introductory paragraph of the definition for Class 
Free State or area before the words ``Any reclassification will be made 
in accordance with Sec.  78.40 of this part.'' Section 78.40 describes 
the process by which States may be reclassified to a lower status.
    In paragraph (a)(1)(ii) of the definition of Class Free State or 
area, the interim rule required States or areas that have not been 
Class Free for 5 consecutive years or more or that have brucellosis in 
wildlife to carry out brucellosis ring testing or other official 
brucellosis milk testing approved by the Administrator, and participate 
in slaughter surveillance. However, some of those States or areas may 
be able to achieve the same level of surveillance through means other 
than brucellosis ring testing and slaughter surveillance, which could 
be more efficient for these States or areas. To account for this 
situation, we are adding a paragraph (a)(1)(ii)(C) under the definition 
for Class Free State or area to allow States or areas that have not 
been Class Free for 5 consecutive years or longer or that have B. 
abortus in wildlife to develop an alternative surveillance plan in 
conjunction with the State animal health official and the area 
veterinarian in charge. Therefore, these States would have the option 
of either conducting brucellosis ring tests and participating in the 
slaughter surveillance program or they must develop an alternative 
surveillance plan that would have to meet or exceed the level of 
disease detection provided by combined brucellosis ring testing and 
collection of blood samples from at least 95 percent of test eligible 
slaughter cattle slaughtered within the States. The alternative 
surveillance plan would have to be approved by the Administrator. 
Making this change will create flexibility in the brucellosis program.
    Therefore, for the reasons given in the interim rule and in this 
document, we are adopting the interim rule as a final rule, with the 
changes discussed in this document.

[[Page 66597]]

    This final rule also affirms the information contained in the 
interim rule concerning Executive Orders 12866, 12372, and 12988.
    Further, this action 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.

Regulatory Flexibility Act

    This final rule follows an interim rule that amended the 
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. The interim rule also removed 
the provision for automatic reclassification from Class Free to Class A 
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. One of the changes that the interim rule made to the 
brucellosis regulations contained in 9 CFR part 78 was to require that 
all sexually intact cattle and bison 6 months of age and older be 
included in all herd blood tests. This final rule changes the age at 
which all sexually intact cattle and domestic bison are included in 
herd blood tests from 6 months to 18 months.
    With this rule, producers will forgo payment of testing fees for 
sexually intact animals between 6 and 18 months of age when performing 
whole herd tests. For both elective and program-required herd blood 
tests, increasing the minimum testing age will benefit producers by (i) 
reducing the number of animals required to be tested and therefore the 
time and labor expended in gathering and handling animals for testing, 
and (ii) eliminating any stress-induced weight loss related to herd 
blood testing of sexually intact animals between 6 and 18 months of 
age. In recent years, about 500,000 head of cattle have been included 
in herd blood tests annually. Approximately 70 to 80 percent of this 
testing has been elective.
    Based on Small Business Administration standards and data from the 
2012 Census of Agriculture, the majority of beef and dairy operations 
are small. This rule will result in cost savings for many of these 
operations, and will not have a significant economic impact on a 
substantial number of small entities.
    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.

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 final rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
When OMB notifies us of its decision, we will publish a document in the 
Federal Register.

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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects in 9 CFR Part 78

    Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and 
recordkeeping requirements, Transportation.

    Accordingly, the interim rule amending 9 CFR part 78 that was 
published at 75 FR 81090-81096 on December 27, 2010, is adopted as a 
final rule with the following changes:

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 definitions for official brand inspection certificate, 
official brand recording agency, and originate, by adding the words 
``or bison'' after the word ``cattle'' each time it appears.
0
b. In the definitions for Class A State or area, Class B State or area, 
and Class C State or area, in paragraphs (a)(3) and (b)(1), by adding 
the words ``or bison'' after the word ``cattle'' each time it appears.
0
c. The definition for Class Free State or area is amended as follows:
0
i. In the introductory text, by adding a sentence before the third 
sentence.
0
ii. By revising paragraph (a)(1)(ii) introductory text.
0
iii. By adding a new paragraph (a)(1)(ii)(C).
0
iv. In paragraphs (a)(2)(iii)(A) and (a)(2)(iii)(B), by adding the 
words ``or bison'' after the word ``cattle'' each time it appears.
0
v. In paragraph (b)(1), by adding the words ``and bison'' after the 
word ``cattle''.
0
vi. In paragraph (b)(4) introductory text, by removing the words ``; 
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''.
0
d. By revising the definition of herd blood test.
    The additions and revisions read as follows:

Sec.  78.1  Definitions.

* * * * *
    Class Free State or area. * * * 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. * * *
    (a) * * *
    (1) * * *
    (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) or (a)(1)(ii)(C) of this definition:
* * * * *
    (C) Alternative surveillance plan. As an alternative to the testing 
described in paragraphs (a)(1)(ii)(A) and (a)(1)(ii)(B) of this 
definition, the State or area may develop an alternative surveillance 
plan that would have to meet or exceed the level of disease detection 
provided by combined brucellosis ring testing and collection of blood 
samples from at least 95 percent of test eligible slaughter cattle 
slaughtered within the State. The alternative surveillance plan must be 
developed in conjunction with the State animal health official and the 
area veterinarian in charge.
* * * * *
    Herd blood test. A blood test for brucellosis conducted in a herd 
on all cattle and bison 18 months of age, except for steers and spayed 
heifers, and except when conducting herd blood tests as part of 
affected herd investigations or other epidemiological investigations or 
when the Administrator determines testing at a younger age is necessary 
to prevent the spread of brucellosis.
* * * * *

    Done in Washington, DC, this 3rd day of November 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-26580 Filed 11-7-14; 8:45 am]
BILLING CODE 3410-34-P
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