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contains regulatory documents having general

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are keyed to and codified in the Code of

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Rules and Regulations Federal Register

66591 

Vol. 79, No. 217 

Monday, November 10, 2014 

1To view the interim rule and the comments we 

received, go to http://www.regulations.gov/

#!docketDetail;D=APHIS-2009-0083. 

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. 

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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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. Wholeherd depopulation under such 

circumstances does little to eliminate 

the source of infection. The decision to 

depopulate will be made on a case-bycase 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, brucellosisexposed 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 riskbased 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 


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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 


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66594 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Rules and Regulations 

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 postparturient. 

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 


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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 § 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. 


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66596 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Rules and Regulations 

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 § 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 § 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. 


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

■ 1. The authority citation for part 78 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 2. Section 78.1 is amended as follows: 

■ a. In the 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. 

■ 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. 

■ c. The definition for Class Free State 

or area is amended as follows: 

■ i. In the introductory text, by adding 

a sentence before the third sentence. 

■ ii. By revising paragraph (a)(1)(ii) 

introductory text. 

■ iii. By adding a new paragraph 

(a)(1)(ii)(C). 

■ 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. 

■ v. In paragraph (b)(1), by adding the 

words ‘‘and bison’’ after the word 

‘‘cattle’’. 

■ 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’’. 

■ d. By revising the definition of herd 

blood test. 

The additions and revisions read as 

follows: 

§ 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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