[Federal Register Volume 59, Number 10 (Friday, January 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-994]


[[Page Unknown]]

[Federal Register: January 14, 1994]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 93-024-1]

 

Brucellosis Surveillance; MCI Reactor Prevalence Rates

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend 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 proposing instead to require the 
States to successfully close (epidemiologically investigate and 
resolve) certain percentages of cases detected through the MCI program. 
We believe these amendments would better serve Federal and State animal 
health officials in their efforts to prevent the interstate spread of 
brucellosis.

DATES: Consideration will be given only to comments received on or 
before February 14, 1994.

ADDRESSES: Please send an original and three copies of your comments to 
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804, 
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please 
state that your comments refer to Docket No. 93-024-1. Comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are encouraged to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. M.J. Gilsdorf, National 
Brucellosis Epidemiologist, Cattle Diseases and Surveillance Staff, VS, 
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 May 1993, 
there were only 337 known infected cattle and bison herds, and the U.S. 
Department of Agriculture (USDA) had declared 32 States, Puerto Rico, 
and the U.S. Virgin Islands free of the disease. Fewer than 500 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. Section 78.1 defines the terms 
used in the regulations. In accordance with Sec. 78.1, States and areas 
can be classified as Class Free, Class A, Class B, or Class C. These 
terms refer to stages of the eradication process as determined by the 
USDA's Animal and Plant Health Inspection Service (APHIS) and State 
animal health officials. Class Free States and areas are considered to 
be free of Brucella abortus in all domestic livestock, and Class C 
States and areas have the highest levels of brucellosis infection. 
Section 78.1 sets forth the standards States or areas must meet to 
achieve and maintain each of the classifications.
    One standard for classification is the Market Cattle Identification 
(MCI) reactor prevalence rate. Under the MCI program, slaughtering 
establishments must collect blood samples from 95 percent of all cows 
and bulls 2 years of age and older (known as MCI test cattle). The 
samples are then subjected to an official brucellosis test. Animals 
that have serologically positive results to the official brucellosis 
test administered under the MCI program are MCI reactors. The 
regulations require animal health officials to trace MCI reactors to 
the farm of origin and conduct an epidemiologic investigation, to 
evaluate the risk that brucellosis could spread from the farm of 
origin. Class Free and Class A States and areas must trace at least 90 
percent of all MCI reactors to the farm of origin, and Class B and 
Class C States and areas must trace at least 80 percent to the farm of 
origin. When required by the results of the epidemiologic 
investigation, herd blood tests must be conducted or the herds must be 
confined to the premises under quarantine. Examples of when herd 
testing or quarantine may not be necessary include cases where 
epidemiologic investigation reveals the MCI reactor results were not 
caused by field strains of Brucella, or that the herd has been or will 
be sent to slaughter.
    The MCI reactor prevalence rate is the rate of infection in a State 
or area's cattle population based on the percentage of MCI reactors 
found in the total number of MCI tested cattle. Under the regulations, 
Class Free States and areas must maintain a 12-consecutive-month MCI 
reactor prevalence rate not to exceed 0.050 percent. For Class A States 
and areas, the rate must not exceed 0.10 percent, and for Class B 
States and areas, the rate must not exceed 0.30 percent. Class C States 
and areas have an MCI reactor prevalence rate that exceeds 0.30 
percent. Class Free, Class A, and Class B States and areas that exceed 
the required percentages may be reclassified to a lower classification.
    Tests used to identify MCI reactors detect not only serum titers 
caused by brucellosis infection but also serum titers caused by certain 
other organisms and by vaccination. As a result of such spurious 
titers, an estimate of brucellosis prevalence based solely on the MCI 
reactor prevalence rate in a State or area would overestimate the rate 
of brucellosis infection. Nevertheless, the MCI reactor data has been 
helpful to Federal and State animal health officials who use the rates 
of the individual States and areas to reveal trends and to compare 
their progress in eradicating brucellosis.
    When the United States had thousands of infected herds, we did not 
consider the effect of spurious titers on the States' and areas' MCI 
reactor prevalence rates to be significant. However, as the level of 
brucellosis infection in this country has declined, the proportion of 
spurious titers in the MCI reactor prevalence rates has increased. As a 
result, in Class Free States and areas, the MCI reactor prevalence rate 
may consist entirely of spurious titers. Therefore, we no longer 
believe a State or area's MCI reactor prevalence rate is a good 
indication of its eradication progress, and we are proposing to 
eliminate the requirement in the regulations that States and areas meet 
specific MCI reactor prevalence rates to maintain their official 
classifications.
    If States no longer need to meet specific MCI reactor prevalence 
rates, we believe it is even more important for the States to 
concentrate on the activities required following identification of an 
MCI reactor (tracebacks, epidemiologic investigations, and, usually, 
herd testing or quarantine). The epidemiologic investigation and herd 
testing can reveal whether an MCI reaction is a spurious titer or a 
valid indication of brucellosis. If herd testing reveals one or more 
animals that test positive to the official test for brucellosis 
(brucellosis reactors), all other animals in the herd are considered 
brucellosis exposed. Brucellosis reactor cattle and brucellosis exposed 
cattle may move interstate only in accordance with subpart B of part 78 
(Secs. 78.5 through 78.14), to control the spread of brucellosis.
    If a herd is quarantined in lieu of testing following epidemiologic 
investigation of an MCI reactor herd, the quarantine protects against 
the possibility that the herd may be infected and could spread 
brucellosis.
    Herd testing or quarantine only occur for MCI reactor cases that 
are ``successfully closed'' (defined below). The larger the number of 
MCI reactor cases that are not successfully closed, the greater the 
possibility that brucellosis could spread from herds associated with 
the uninvestigated MCI reactors. Therefore, we are proposing to require 
that a minimum percentage of MCI reactor cases must be successfully 
closed.
    We would consider MCI reactor cases that have been traced to the 
farm of origin to be successfully closed when: (1) An epidemiologic 
investigation is completed within specified time limits; and (2) the 
herd is tested, or State or APHIS animal health officials confine the 
animals to their premises under quarantine; or (3) State or APHIS 
animal health officials determine there is justification for not 
testing the herd or quarantining it. We propose to add to Sec. 78.1 a 
definition of ``successfully closed case'' that reflects this standard 
for successful closure.
    For Class Free and Class A States, animal health officials would 
have to complete the epidemiologic investigation within 15 days after 
they are notified by the cooperative State-Federal laboratory that 
brucellosis reactors were found on an MCI test. For Class B and Class C 
States, the time limit would be 30 days. This time standard for 
completing the epidemiologic investigation is the same standard 
required in the current regulations. Experience with brucellosis 
program operations has shown the time limits to be long enough to be 
workable for animal health officials, and short enough to support 
effective controls on the spread of brucellosis.
    We believe there are circumstances that would constitute acceptable 
justification for not testing or quarantining a herd following an MCI 
reactor traceback. The current regulations merely state that herd 
testing or quarantine will be employed ``[W]hen required by the results 
of the epidemiologic investigation.'' We would like to provide more 
specific guidance concerning when it would be justified to forego herd 
testing or quarantine.
    We are proposing to require that herd blood tests be conducted or 
the herd 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:
    a. The brucellosis reactor is traced back to a herd that has been 
sold for slaughter in entirety. In this case, the potential for the 
herd to spread brucellosis no longer exists.
    b. The brucellosis reactor is traced back to a herd that is 
certified brucellosis free and is 100-percent vaccinated. In such cases 
it is probable that the MCI test was a false positive, due to a titer 
caused by the vaccine.
    c. The brucellosis reactor showed a low titer on 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 
the regulations. This is another case where the probability of a false 
positive or other error in the MCI test is far greater than the 
probability that the herd of origin is affected by brucellosis.
    Animal health officials could report a traceback to a farm of 
origin in another State as a successfully closed case because we do not 
expect animal health officials to conduct epidemiologic investigations 
and herd testing in another State. However, as part of successfully 
closing the case we would require them to notify in writing the State 
animal health official in the State where the farm of origin is located 
so officials in that State could take proper follow-up action.
    Under this proposal, Class Free and Class A States and areas would 
need to successfully close at least 95 percent of the MCI reactor cases 
traced to the farm of origin, and Class B and Class C States and areas 
would need to successfully close at least 90 percent of such cases. 
This means that 1 in 20 MCI reactor cases could be left unclosed in 
Class Free and Class A States, and 1 in 10 reactor cases could be left 
unclosed in Class B and Class C States.
    If adopted, this proposal would reduce current recordkeeping 
requirements for the States. While State officials would still need to 
compile data, the time involved should be much less than what is 
currently required for computing the MCI reactor prevalence rate. Under 
our proposal, States would focus their recordkeeping on a fairly small 
number of MCI reactors, rather than the much larger number of cattle 
with negative MCI test results. States would no longer need to count 
all cattle tested, separate out cattle from other States, and then 
calculate an MCI reactor prevalence rate based on the number of their 
State's cattle that were tested and the number of MCI reactors found 
through such testing. Instead, each State would need to include in its 
annual report to APHIS the percentage of MCI reactor cases it 
successfully closes.

Executive Order 12866 and Regulatory Flexibility Act

    We are issuing this proposed rule in conformance with Executive 
Order 12866. Based on information compiled by the Department, we have 
determined that this proposed rule:
    (1) Would have an effect on the economy of less than $100 million;
    (2) Would not adversely affect in a material way the economy, a 
sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities;
    (3) Would not create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency;
    (4) Would not alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or rights and obligations of recipients 
thereof; and
    (5) Would not raise novel legal or policy issues arising out of 
legal mandates, the President's priorities, or principles set forth in 
Executive Order 12866.
    Only State animal health agencies would be affected by this 
proposed rule; it would have no effect on the private sector. State 
animal health officials would need to provide information on only the 
MCI reactors detected each month instead of total numbers of MCI test 
cattle slaughtered. They would 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 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 12778

    This proposed rule has been reviewed under Executive Order 12778, 
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

    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 proposed rule will be submitted for approval to the 
Office of Management and Budget. Please send written comments to the 
Office of Information and Regulatory Affairs, OMB, Attention: Desk 
Officer for APHIS, Washington, DC 20503. Please send a copy of your 
comments to:
    (1) Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, 
room 804, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782; 
and
    (2) Clearance Officer, OIRM, USDA, room 404-W, 14th Street and 
Independence Avenue SW., Washington, DC 20250.

List of Subjects in 9 CFR Part 78

    Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and 
recordkeeping requirements, Transportation.
    Accordingly, 9 CFR part 78, subpart A, would be amended as follows:

PART 78--BRUCELLOSIS

    1. The authority citation for part 78 would continue 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 would be amended as follows:
    a. A new definition of Successfully closed case would be added, in 
alphabetical order, to read as set forth below.
    b. In the definition of Class A State or area, paragraph (a)(2)(ii) 
would be revised to read as set forth below and paragraph (c) would be 
removed.
    c. In the definition of Class B State or area, paragraph (a)(2)(ii) 
would be revised to read as set forth below and paragraph (c) would be 
removed.
    d. In the definition of Class C State or area, paragraph (a)(2)(ii) 
would be revised to read as set forth below and paragraph (c) would be 
removed.
    e. In the definition of Class Free State or area, paragraph 
(a)(2)(ii) would be revised to read as set forth below and paragraph 
(c) would be removed.


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 10th day of January 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-994 Filed 1-13-94; 8:45 am]
BILLING CODE 3410-34-P