[Federal Register Volume 59, Number 133 (Wednesday, July 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16967]


[[Page Unknown]]

[Federal Register: July 13, 1994]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 93-024-3]

 

Brucellosis Surveillance; MCI Reactor Prevalence Rates

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the brucellosis regulations to eliminate the 
requirement that States maintain specified Market Cattle Identification 
(MCI) reactor prevalence rates to maintain their official 
classifications. We are instead requiring the States to successfully 
close (epidemiologically investigate and resolve) certain percentages 
of cases detected through the MCI program. We believe these amendments 
will better serve Federal and State animal health officials in their 
efforts to prevent the interstate spread of brucellosis.

EFFECTIVE DATE: August 12, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. M.J. Gilsdorf, National 
Brucellosis Epidemiologist, Cattle Diseases and Surveillance Staff, 
Veterinary Services, APHIS, USDA, room 731, Federal Building, 6505 
Belcrest Road, Hyattsville, MD 20782, (301) 436-4918.

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is an infectious disease of certain animals and humans. 
In its principal animal hosts, it is characterized by abortion and 
impaired fertility. Through a cooperative Federal-State effort, the 
United States is now approaching total eradication of the field strain 
Brucella abortus in domestic cattle and bison herds. As of June 1994, 
there were only 235 known infected cattle and bison herds, and the U.S. 
Department of Agriculture (USDA) had declared 33 States, Puerto Rico, 
and the U.S. Virgin Islands free of the disease. Fewer than 400 new 
infected herds were identified last year.
    The regulations in 9 CFR part 78 (referred to below as the 
regulations) govern the interstate movement of cattle, bison, and swine 
to prevent the spread of brucellosis.
    On January 14, 1994, we published in the Federal Register (59 FR 
2312-2316, Docket No. 93-024-1) a proposal to eliminate the requirement 
in the regulations that States meet specific MCI reactor prevalence 
rates to maintain their official classifications. We also proposed to 
require that to maintain their official classifications, States must 
successfully close a specified percentage of MCI reactor cases.
    We solicited comments concerning our proposal for a 30-day comment 
period ending February 14, 1994. On February 11, 1994, we published in 
the Federal Register a notice extending the comment period to March 14, 
1994 (59 FR 6593, Docket No. 93-024-2). We received four comments by 
that date, three from Federal veterinarians and one from the American 
Veterinary Medical Association (AVMA). We carefully considered all of 
the comments we received. They are discussed below:
    The AVMA comment supported the proposal as written. The other three 
comments all suggested that language in a particular paragraph in the 
proposal be deleted.
    The language in question occurs in the definition of ``Class A 
State or area'' in Sec. 78.1(a)(2)(ii)(B)(2), and is repeated in the 
definitions ``Class B State or area,'' ``Class C State or area,'' and 
``Class Free State or area.'' The issue at hand is what action a 
designated epidemiologist must take after determining that brucellosis 
reactors are present in a herd. The regulations require that such herds 
must be subjected to herd blood tests or quarantined unless:

    (2) Evidence indicates that the brucellosis reactor is from a 
herd that no longer presents a risk of spreading brucellosis, or is 
from a herd that is unlikely to be infected with brucellosis. Such 
evidence could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has 
been sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or,
    (iii) The brucellosis reactor showed a low titer in the MCI test 
and is traced back to a dairy herd that is 100 percent vaccinated 
and has tested negative to the most recent brucellosis ring test 
required by this section for herds producing milk for sale.

    Three commenters opposed inclusion of the language in (i), (ii), 
and (iii) that provides guidance to designated epidemiologists on how 
to determine that a herd where a positive MCI blood sample was 
collected no longer presents a risk of spreading brucellosis, or is 
unlikely to be infected with brucellosis.
    The commenters made the point that designated epidemiologists are 
highly trained professionals who are responsible, among other duties, 
for determining when a herd situation presents a risk of spreading 
brucellosis. The commenters believe that designated epidemiologists are 
fully capable of determining what evidence is relevant to such a 
decision, and interpreting the evidence. As one commenter put it, 
``each individual situation should be evaluated with sound 
epidemiological principles which cannot be adequately enumerated by a 
`predetermined list'.''
    We agree that no list of risk scenarios in the regulations, however 
extensive, could substitute for the professional judgment and 
experience of a designated epidemiologist. We rely on continuing 
education programs the Animal and Plant Health Inspection Service 
(APHIS) mandates for designated epidemiologists, and review of their 
decisions by other USDA epidemiologists, to ensure they make reasonable 
determinations with regard to brucellosis risks. We did not attempt to 
provide a ``cookbook'' list in the regulations to substitute for this 
system of professional judgment backed by continuing education and 
review by professional peers.
    The proposed language cites three situations that could provide 
evidence that a herd that no longer presents a risk of spreading 
brucellosis, or is unlikely to be infected with brucellosis. These 
examples were provided by epidemiologists from their own experience as 
examples of frequently occurring situations where the risk of spreading 
brucellosis is mitigated. The proposed language specifically says that 
``evidence could include, but is not limited to'' the described 
situations. The examples were provided not for the benefit of 
designated epidemiologists, who are well aware of their relevance, but 
for the benefit of members of the public who may be affected by the 
regulations. We believe it will aid public understanding of the 
regulations to see some examples of situations that could provide 
evidence that a herd with an MCI reactor no longer presents a risk of 
spreading brucellosis, or is unlikely to be infected with brucellosis.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposed 
rule as a final rule, without change.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been reviewed under Executive Order 12866. The 
rule has been determined to be not significant for purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    Only State animal health agencies will be affected by this rule; it 
will have no effect on the private sector. State animal health 
officials will need to provide other States with information on only 
the MCI reactors detected each month instead of total numbers of MCI 
test cattle slaughtered. They will also need to maintain records of the 
numbers of MCI reactor cases that are successfully closed and report 
the percentage of successfully closed cases annually to APHIS. The 
States are already required to carry out the activities that constitute 
successful case closure.
    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 12778

    This rule has been reviewed under Executive Order 12778, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are in conflict with it; (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

    In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been submitted for approval to the Office of 
Management and Budget.

List of Subjects in 9 CFR Part 78

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

    Accordingly, 9 CFR part 78 is amended as follows:

PART 78--BRUCELLOSIS

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

    Authority: 21 U.S.C. 111-114a-1, 114g, 115, 117, 120, 121, 123-
126, 134b, 134f; 7 CFR 2.17, 2.51, and 371.2(d).

    2. Section 78.1 is amended as follows:
    a. In the definition of Class A State or area, paragraph (a)(2)(ii) 
is revised to read as set forth below and paragraph (c) is removed.
    b. In the definition of Class B State or area, paragraph (a)(2)(ii) 
is revised to read as set forth below and paragraph (c) is removed.
    c. In the definition of Class C State or area, paragraph (a)(2)(ii) 
is revised to read as set forth below, paragraph (c) is removed, and 
paragraph (d) is redesignated as paragraph (c).
    d. In the definition of Class Free State or area, paragraph 
(a)(2)(ii) is revised to read as set forth below and paragraph (c) is 
removed.
    e. A new definition of Successfully closed case is added, in 
alphabetical order, to read as set forth below.


Sec. 78.1  Definitions.

* * * * *
    Class A State or area. * * *
    (a) * * *
    (2) * * *
    (ii) Brucellosis reactors.
    (A) Tracebacks. At least 90 percent of all brucellosis reactors 
found in the course of MCI testing must be traced to the farm of 
origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 95 percent of the MCI reactor cases traced to the farm 
of origin during the 12-consecutive-month period immediately prior to 
the most recent anniversary of the date the State or area was 
classified Class A. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
were found on the MCI test. Herd blood tests must be conducted or the 
herd must be confined to the premises under quarantine within 30 days 
after notification that brucellosis reactors were found on the MCI 
test, unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test 
and is traced back to a dairy herd that is 100 percent vaccinated and 
has tested negative to the most recent brucellosis ring test required 
by this section for herds producing milk for sale.
* * * * *
    Class B State or area. * * *
    (a) * * *
    (2) * * *
    (ii) Brucellosis reactors.
    (A) Tracebacks. At least 80 percent of all brucellosis reactors 
found in the course of MCI testing must be traced to the farm of 
origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 90 percent of the MCI reactor cases traced to the farm 
of origin during the 12-consecutive-month period immediately prior to 
the most recent anniversary of the date the State or area was 
classified Class B. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 30 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
were found on the MCI test. Herd blood tests must be conducted or the 
herd must be confined to the premises under quarantine within 30 days 
after notification that brucellosis reactors were found on the MCI 
test, unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test 
and is traced back to a dairy herd that is 100 percent vaccinated and 
has tested negative to the most recent brucellosis ring test required 
by this section for herds producing milk for sale.
* * * * *
    Class C State or area. * * *
    (a) * * *
    (2) * * *
    (ii) Brucellosis reactors.
    (A) Tracebacks. At least 80 percent of all brucellosis reactors 
found in the course of MCI testing must be traced to the farm of 
origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 90 percent of the MCI reactor cases traced to the farm 
of origin during the 12-consecutive-month period immediately prior to 
the most recent anniversary of the date the State or area was 
classified Class C. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 30 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
were found on the MCI test. Herd blood tests must be conducted or the 
herd must be confined to the premises under quarantine within 30 days 
after notification that brucellosis reactors were found on the MCI 
test, unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test 
and is traced back to a dairy herd that is 100 percent vaccinated and 
has tested negative to the most recent brucellosis ring test required 
by this section for herds producing milk for sale.
* * * * *
    Class Free State or area. * * *
    (a) * * *
    (2) * * *
    (ii) Brucellosis reactors.
    (A) Tracebacks. At least 90 percent of all brucellosis reactors 
found in the course of MCI testing must be traced to the farm of 
origin.
    (B) Successfully closed cases. The State or area must successfully 
close at least 95 percent of the MCI reactor cases traced to the farm 
of origin during the 12-consecutive-month period immediately prior to 
the most recent anniversary of the date the State or area was 
classified Class Free. To successfully close an MCI reactor case, State 
representatives or APHIS representatives must conduct an epidemiologic 
investigation at the farm of origin within 15 days after notification 
by the cooperative State-Federal laboratory that brucellosis reactors 
were found on the MCI test. Herd blood tests must be conducted or the 
herd must be confined to the premises under quarantine within 30 days 
after notification that brucellosis reactors were found on the MCI 
test, unless a designated epidemiologist determines that:
    (1) The brucellosis reactor is located in a herd in a different 
State than the State where the MCI blood sample was collected. In such 
cases a State representative or APHIS representative must give written 
notice of the MCI test results to the State animal health official in 
the State where the brucellosis reactor is located; or
    (2) Evidence indicates that the brucellosis reactor is from a herd 
that no longer presents a risk of spreading brucellosis, or is from a 
herd that is unlikely to be infected with brucellosis. Such evidence 
could include, but is not limited to, situations where:
    (i) The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety;
    (ii) The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated; or
    (iii) The brucellosis reactor showed a low titer in the MCI test 
and is traced back to a dairy herd that is 100 percent vaccinated and 
has tested negative to the most recent brucellosis ring test required 
by this section for herds producing milk for sale.
* * * * *
    Successfully closed case. Follow up of an MCI reactor traceback 
with an epidemiologic investigation which results in brucellosis 
testing or quarantine of the herd of origin, or a determination by a 
designated brucellosis epidemiologist that justification exists for not 
testing or quarantining the herd of origin.
* * * * *
    Done in Washington, DC, this 7th day of July 1994.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-16967 Filed 7-12-94; 8:45 am]
BILLING CODE 3410-34-P