[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Proposed Rules]
[Pages 74826-74827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21172]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / 
Proposed Rules  

[[Page 74826]]



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: Proposed rule.

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SUMMARY: We are proposing to amend the brucellosis regulations in order 
to facilitate research to be conducted on brucellosis-exposed or 
infected animals. Under the current regulations, such research could 
adversely affect a State's brucellosis classification. For example, the 
criteria for achieving and maintaining Class Free status provide that 
all cattle herds in the State or area must be released from quarantine 
and remain free of brucellosis for 12 consecutive months. Because the 
current definition of herd includes animals held in a research 
facility, a State could lose its Class Free status by allowing such 
research. By providing an exception for brucellosis-exposed or infected 
animals held within federally approved research facilities, this 
proposed rule would enable the initiation of necessary brucellosis 
research in Class Free States.

DATES: We will consider all comments that we receive on or before 
February 12, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0183 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0183, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0183.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Debra Donch, National Brucellosis 
Epidemiologist, National Center for Animal Health Programs, VS, APHIS, 
4700 River Road, Unit 43, Riverdale, MD 20737-1231; (301) 734-5952.

SUPPLEMENTARY INFORMATION: 

Background

    Brucellosis is a contagious disease affecting animals and humans, 
caused by bacteria of the genus Brucella. 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 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.
    The regulations require that, to achieve and retain Class Free 
status, a State or area must have no cattle herds under quarantine. As 
a practical matter, this precludes any 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 the current definition of that term. In Sec.  
78.1, 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).'' Currently, 48 of the 50 States 
are classified as brucellosis Class Free. Since research expertise and 
infrastructure potentially applicable to this country's brucellosis 
eradication efforts can be found in many Class Free States, this 
limitation may impede the progress of brucellosis research and delay 
eradication of the disease in the United States. We are proposing, 
therefore, to amend the definition of herd to specifically exclude 
animals that are contained within a federally approved research 
facility. While primarily intended to facilitate brucellosis research 
in Class Free States, this proposed change to the definition of herd 
would ensure that the presence of infected animals held for brucellosis 
research would not adversely affect the State's brucellosis 
classification.
    In order to gain Federal approval, a research facility must first 
adopt and demonstrate compliance with a series of guidelines 
established by the Animal and Plant Health Inspection Service (APHIS) 
and the Agricultural Research Service. These guidelines address, among 
other things, biological security, recordkeeping, identification, and 
sanitation standards. Additionally, each study conducted in a federally 
approved research facility must be approved by the State animal health 
official and the APHIS Area Veterinarian in Charge. Currently, certain 
facilities in Colorado, Idaho, Iowa, and Louisiana are approved to 
conduct brucellosis research under these guidelines. Our proposed 
change to the definition of

[[Page 74827]]

herd would remove an obstacle to the initiation of brucellosis 
research, primarily in Class Free States, by ensuring that the animals 
held for such research are not considered a ``herd'' for the purposes 
of assigning or renewing a State's brucellosis status.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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 economically damaging 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 proposed action would be 
herd owners and the entities that would operate any brucellosis 
research facilities established in Class Free States. To the extent 
that it would allow for more research with the goal of eradicating 
brucellosis in the United States, this proposed rule would benefit all 
herd owners over time. Brucellosis research facilities in Class Free 
States would be operated by the State in which they were located or 
exist as part of colleges or 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, over 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 
potentially affected by this proposed rule are considered small 
entities. For herd owners, any economic effects stemming from this 
proposed rule would result from advances made toward the eradication of 
brucellosis in the United States. As such, these economic effects would 
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 would 
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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed 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.

    Accordingly, we propose to amend 9 CFR part 78 as follows:

PART 78--BRUCELLOSIS

    1. The authority citation for part 78 would continue to read as 
follows:

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

    2. In Sec.  78.1, the definition of herd would be 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 6th day of December 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E6-21172 Filed 12-12-06; 8:45 am]
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