[Federal Register Volume 73, Number 38 (Tuesday, February 26, 2008)]
[Rules and Regulations]
[Pages 10137-10138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3591]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. APHIS-2006-0183]
RIN 0579-AC21


Brucellosis in Cattle; Research Facilities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending brucellosis regulations by providing an 
exception in the definition of herd for animals held within a federally 
approved brucellosis research facility, in order to facilitate research 
on brucellosis-exposed or infected animals in those facilities. Prior 
to this rule, such animals constituted a herd, and the presence of 
brucellosis-positive herds within a State can adversely affect that 
State's brucellosis classification. By providing an exception for 
brucellosis-exposed or infected animals held within federally approved 
research facilities, this rule will enable initiation of necessary 
brucellosis research in Class Free States.

DATES: Effective Date: March 27, 2008.

FOR FURTHER INFORMATION CONTACT: Dr. Debra Donch, National Brucellosis 
Epidemiologist, National Center for Animal Health Programs, VS, APHIS, 
4700 River Road, Unit 136, Riverdale, MD 20737-1231; (301) 734-5952.

SUPPLEMENTARY INFORMATION: 

Background

    Brucellosis is a contagious disease affecting animals and humans 
and caused by bacteria of the genus Brucella. The brucellosis 
regulations 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 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 are required to be placed 
under Federal quarantine.
    The brucellosis Class Free classification is based on a finding of 
no known brucellosis in cattle for the 12 months preceding 
classification as Class Free. The Class C classification is for States 
or areas with the highest rate of brucellosis. Class A and Class B fall 
between these two extremes. Restrictions on moving cattle interstate 
become less stringent as a State approaches or achieves Class Free 
status.
    In Sec.  78.1, the regulations require that, to achieve and retain 
Class Free status, a State or area must have no cattle herds under 
quarantine. In the same section, herd is defined, in part, as ``all 
animals under common ownership or supervision that are grouped on one 
or more parts of any single premises (lot, farm, or ranch).'' Such a 
definition effectively precludes brucellosis research in Class Free 
States or areas, since infected animals may be used for such research, 
and the animals held in a research facility would be considered a herd 
under that definition of the term. Since expertise and infrastructure 
that could potentially benefit this country's brucellosis eradication 
efforts can be found in many Class Free States, this definition may 
impede the progress of brucellosis research and delay the eradication 
of the disease within the United States.
    On December 13, 2006, we published in the Federal Register (71 FR 
74826-74827) a proposal \1\ to amend the definition of herd to create 
an exception for brucellosis-exposed or infected animals held within 
federally approved research facilities, so that such animals would no 
longer be considered a herd. We proposed this change to allow States to 
undertake brucellosis research

[[Page 10138]]

without adversely impacting their Class Free status.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0183.
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    We solicited comments concerning our proposal for 60 days, ending 
February 12, 2007. We received eight comments by that date, from six 
members of a brucellosis research team at a State university, a State 
department of agriculture and forestry, and a national scientific 
society.
    All of the commenters supported the proposed rule. However, one of 
the commenters, noting our reference in the proposed rule to a series 
of guidelines established by the Animal and Plant Health Inspection 
Service (APHIS) and the Agricultural Research Service (ARS), 
recommended that those guidelines be integrated into the existing 
Federal approval guidelines for agricultural research facilities rather 
than creating a new Federal process.
    This rule pertains solely to the system for classifying States or 
portions of States according to the rate of Brucella infection present 
and the general effectiveness of a brucellosis control and eradication 
program. It is not our intent to modify or replace the series of 
guidelines established by APHIS and ARS for approval of research 
facilities at this time.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    Brucellosis is a contagious, costly disease of ruminants that also 
affects humans. Although brucellosis can infect other animals, it is 
primarily a threat to cattle, bison, and swine. In animals, the disease 
causes weight loss, decreased milk production, loss of young, 
infertility, and lameness. There is no cure for brucellosis in animals, 
nor is there a preventative vaccine that is 100 percent effective.
    Given the potential for costly consequences related to an outbreak 
of brucellosis, additional research is needed in order to eradicate 
this disease. In 1952, when brucellosis was widespread throughout the 
United States, annual losses from lowered milk production, aborted 
calves and pigs, and reduced breeding efficiency were estimated at $400 
million. Subsequent studies show that if eradication efforts were 
stopped, the costs of producing beef and milk would increase by an 
estimated $80 million annually in less than 10 years.
    We expect that the groups affected by this action will be herd 
owners and entities that operate brucellosis research facilities in 
Class Free States. To the extent that this rule allows for more 
research with the goal of eradicating brucellosis in the United States, 
it will benefit all herd owners over time. Brucellosis research 
facilities in Class Free States will be operated by the State in which 
they are located or exist as part of colleges and universities that 
have government contracts to conduct brucellosis research.
    The latest agricultural census data show that there were 732,660 
farms in the United States primarily engaged in beef cattle ranching 
and farming and dairy cattle and milk production that reported sales in 
2002. Of those farms, more than 99 percent were classified as small 
entities according to Small Business Association (SBA) standards. There 
were 82,028 farms in the United States primarily engaged in raising 
hogs and pigs that reported sales in 2002. Of those farms, over 90 
percent were classified as small entities by the SBA. Most, if not all, 
of the farms primarily engaged in bison production are classified as 
small entities under SBA standards. Accordingly, the majority of herd 
owners affected by this rule are considered small entities. For herd 
owners, any economic effects stemming from this rule will result from 
advances made toward the eradication of brucellosis in the United 
States. As such, these economic effects will be positive, but long-term 
and generalized.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This final rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, 
et seq.).

List of Subjects in 9 CFR Part 78

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

0
Accordingly, we are amending 9 CFR part 78 as follows:

PART 78--BRUCELLOSIS

0
1. The authority citation for part 78 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


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2. In Sec.  78.1, the definition of herd is revised to read as follows:


Sec.  78.1  Definitions.

* * * * *
    Herd. (a) All animals under common ownership or supervision that 
are grouped on one or more parts of any single premises (lot, farm, or 
ranch); or
    (b) All animals under common ownership or supervision on two or 
more premises which are geographically separated but on which animals 
from the different premises have been interchanged or had contact with 
each other.
    (c) For the purposes of this part, the term herd does not include 
animals that are contained within a federally approved research 
facility.
* * * * *

    Done in Washington, DC, this 20th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-3591 Filed 2-25-08; 8:45 am]
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