[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Proposed Rules]
[Page 74826-74827]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-16]
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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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[[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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