[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Rules and Regulations]
[Pages 61025-61026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20974]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / 
Rules and Regulations

[[Page 61025]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 77

[Docket No. 02-111-2]


Tuberculosis; Amend the Definition of Affected Herd

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations by removing the two different 
definitions of affected herd and replacing them with a single, updated 
definition. This action is necessary to provide more clarity in the 
regulations and because the current definitions are out-of-date and 
inconsistent.

EFFECTIVE DATE: November 21, 2005.

FOR FURTHER INFORMATION CONTACT: Dr. M.J. Gilsdorf, Director, Ruminant 
Health Programs, National Center for Animal Health Programs, VS, APHIS, 
4700 River Road Unit 43, Riverdale, MD 20737-1231; (301) 734-6954.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 77, ``Tuberculosis'' (referred to 
below as the regulations), and the ``Uniform Methods and Rules--Bovine 
Tuberculosis Eradication'' (UMR), January 22, 1999, edition, which is 
incorporated by reference into the regulations, restrict the interstate 
movement of cattle, bison, and captive cervids to prevent the spread of 
bovine tuberculosis. Subpart A of part 77 (Sec. Sec.  77.1-77.4) 
contains general provisions of the tuberculosis regulations such as 
definitions; subpart B (Sec. Sec.  77.5-77.19) contains specific 
provisions regarding cattle and bison; and subpart C (Sec. Sec.  77.20-
77.41) contains specific provisions regarding captive cervids.
    There have been two definitions of affected herd in part 77. In 
Sec.  77.5, affected herd has been defined as ``a herd in which 
tuberculosis has been disclosed in any cattle or bison by an official 
tuberculin test or by post mortem examination.'' In Sec.  77.20, 
affected herd has been defined as ``a herd of captive cervids that 
contains or that has contained one or more captive cervids infected 
with Mycobacterium bovis (determined by bacterial isolation of M. 
bovis) and that has not tested negative to the three whole herd tests 
as prescribed in Sec.  77.39(d) of this part.''
    On July 2, 2004, we published in the Federal Register (69 FR 40329-
40330, Docket No. 02-111-1) a proposal to amend the regulations by 
removing the two inconsistent definitions of affected herd from 
Sec. Sec.  77.5 and 77.20 and replacing them with a new definition of 
the term that would apply to cattle, bison, and captive cervids. Our 
proposed new definition read as follows: ``A herd of livestock in which 
there is strong and substantial evidence that Mycobacterium bovis 
exists. This evidence should include, but is not limited to, any of the 
following: Epidemiologic evidence, histopathology, polymerase chain 
reaction (PCR) assay, bacterial isolation or detection, testing data, 
or association with known sources of infection.''
    We solicited comments concerning our proposal for 60 days ending 
August 31, 2004. We received three comments by that date. They were 
from a State government official and two private citizens. The comments 
are discussed below.
    One commenter stated that the ``strong and substantial evidence'' 
standard in the proposed definition was too high and that potentially 
infected animals could remain unidentified as a result. We disagree and 
believe that the new definition will actually increase the likelihood 
that the disease will be detected. For example, under the new 
definition, cervid herds can be classified as affected without first 
having a diagnosis of tuberculosis confirmed through a culture--a 
procedure that can be difficult and usually requires at least 8 to 12 
weeks to complete. With respect to cattle, the new definition provides 
that a herd can be classified as affected based on broader criteria 
than under the definition in Sec.  77.5, which provided that a 
diagnosis could only be made when an official test or a post mortem 
examination was conducted. Therefore, we expect that the new definition 
will eliminate time constraints, confusion, and differing standards 
between cattle, bison, and cervids. The new definition also will expand 
the types of evidence or information that can be considered by a 
professional veterinary diagnostician when examining herds. Moreover, a 
designated tuberculosis epidemiologist (DTE), which is already defined 
in Sec.  77.2, is designated by the Administrator of the Animal and 
Plant Health Inspection Service to use and interpret diagnostic tests 
for tuberculosis and the management of tuberculosis affected herds. 
Thus, a DTE has the expertise necessary to appropriately apply the new 
definition.
    A second commenter suggested that the words ``in domestic 
livestock'' should be added to the definition after the words 
``association with known sources of infection.'' We disagree and 
believe that this language would hinder the diagnosis of tuberculosis 
as it would eliminate consideration of contacts with infected animals 
outside of domestic livestock, such as wild animals. For example, in 
Michigan, wild deer have passed tuberculosis to domestic livestock. 
Under such circumstances, the suggested limiting language might prevent 
the introduction of evidence indicating tuberculosis in wildlife 
populations and possibly slow or deter the detection of the disease in 
regulated animals.
    Another commenter pointed out that the definition in the proposed 
rule differed slightly from the definition of affected herd set forth 
in a draft update of the UMR, that is currently under consideration. 
The commenter suggested that we revise the definition in the 
regulations to match the definition of affected herd in the draft UMR 
update. We agree that the definitions in the regulations and the draft 
UMR update should be the same. In this final rule, we have slightly 
modified the definition so that it refers to ``epidemiologic evidence 
such as contact with known sources of infection'' rather than naming 
``epidemiologic evidence'' and ``association with known sources of 
infection'' as separate considerations. The definition as presented in 
this final

[[Page 61026]]

rule will be added to the draft UMR update.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

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.
    We are amending the tuberculosis regulations by removing the two 
different definitions of affected herd and replacing them with a 
single, updated definition. This action is necessary because the 
definitions that have appeared in the regulations are out-of-date and 
inconsistent. This action will provide more clarity to the regulations.
    No economic benefits or costs are associated with this action, 
which would simply update and clarify our definition of affected herd. 
This action would have no effect on small entities, other Federal 
agencies, State governments, or local governments.
    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 77

    Animal diseases, Bison, Cattle, Reporting and recordkeeping 
requirements, Transportation, Tuberculosis.


0
Accordingly, we are amending 9 CFR part 77 as follows:

PART 77--TUBERCULOSIS

0
1. The authority citation for part 77 continues to read as follows:

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


0
2. Section 77.2 is amended by adding, in alphabetical order, a 
definition of affected herd to read as follows:


Sec.  77.2  Definitions.

* * * * *
    Affected herd. A herd of livestock in which there is strong and 
substantial evidence that Mycobacterium bovis exists. This evidence 
should include, but is not limited to, any of the following: 
Histopathology, polymerase chain reaction (PCR) assay, bacterial 
isolation or detection, testing data, or epidemiologic evidence such as 
contact with known sources of infection.
* * * * *


Sec. Sec.  77.5 and 77.20  [Amended]

0
3. Sections 77.5 and 77.20 are amended by removing the definitions of 
affected herd.

    Done in Washington, DC, this 14th day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-20974 Filed 10-19-05; 8:45 am]
BILLING CODE 3410-34-P