[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
