[Federal Register Volume 59, Number 77 (Thursday, April 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9593]


[[Page Unknown]]

[Federal Register: April 21, 1994]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 92-044-3]

 

Brucellosis; Interstate Movement of Swine

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the swine brucellosis regulations by 
standardizing and simplifying the testing requirements for States 
seeking validation as swine brucellosis-free, and by extending to 2 
years the period during which breeding swine in States must be tested 
to qualify States for brucellosis-free status. We are also amending the 
testing requirements for validation and maintenance of brucellosis-free 
herd status and are restricting the interstate movement of feral swine 
because of swine brucellosis. These actions are necessary to achieve 
the goal of swine brucellosis eradication in the United States.

EFFECTIVE DATE: May 23, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. Joseph Annelli, Epidemiologist, 
Swine Health Staff, Veterinary Services, APHIS, USDA, room 204, 
Presidential Building, 6525 Belcrest Road, Hyattsville, MD 20782, 301-
436-7781.

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is a contagious disease affecting animals and man, 
caused by bacteria of the genus Brucella. Brucellosis in swine is 
characterized by abortion, infertility, orchitis, posterior paralysis, 
and lameness. The brucellosis regulations in 9 CFR part 78 (referred to 
below as the regulations) prescribe, among other things, conditions for 
the interstate movement of swine. The purpose of the regulations is to 
control, and ultimately to eradicate, brucellosis in the United States.
    On July 23, 1993, we published in the Federal Register (58 FR 
39458-39462, Docket No. 92-044-1) a proposed rule to amend the 
regulations by standardizing and simplifying the options regarding 
testing that are available to States seeking validation as swine 
brucellosis-free, and by extending to 2 years the period during which 
validated brucellosis-free herds must be tested to maintain 
brucellosis-free status. We also proposed to restrict the interstate 
movement of feral swine. On September 8, 1993, we published in the 
Federal Register (58 FR 47222, Docket No. 92-044-2) an editorial 
correction to the Summary and Background sections of the July 23 
proposed rule.
    We solicited comments concerning our proposal for a 60-day comment 
period ending September 21, 1993. We received 3 comments by that date. 
They were from State and Federal governments and a professional 
association. All responses were in favor of our proposal. Two 
commenters, however, suggested modifications or clarifications. Those 
suggestions are discussed below.
    One commenter recommended that we require positive, permanent 
identification of all domestic and feral swine for traceback purposes. 
That action is outside the scope of this rulemaking and, therefore, is 
not discussed in this document. Any changes made as a result of that 
comment would be proposed as part of a separate rulemaking proceeding.
    Another commenter expressed confusion over the proposed rules 
regarding maintenance of validated brucellosis-free status for herds. 
This commenter supported the flexibility of the testing schedules we 
proposed, but was uncertain about the status of herds for which all 
testing had not been completed at the end of the 12-month validation 
period. In addition, the commenter recommended that the Administrator 
approve alternative testing schedules that, in exceptional 
circumstances, might extend to 420 days.
    We agree with the commenter that the testing schedule, as proposed, 
is unclear. It was our intention to give producers a measure of 
flexibility within the 365-day testing cycle for the incremental 
complete herd test (CHT), so we proposed to allow the 25-percent 
incremental tests to be conducted every 80-105 days, and the 10-percent 
incremental tests every 25-35 days. However, if a producer were to 
conduct each increment of the 25-percent incremental CHT on the 105th 
day, which the proposed regulations would have allowed, the testing 
would not be completed until 420 days had passed, thus leaving a 2-
month gap between the end of the 365-day validation period and the 
completion of the incremental testing required to maintain validation. 
While the commenter agreed that there should be some measure of 
flexibility in the testing cycle, she was concerned about whether a 
herd would retain its validated brucellosis-free status during that 
time.
    In order to address the commenter's concerns and clarify the intent 
of the regulations, we have rewritten portions of paragraph (b) of the 
definition of validated brucellosis-free herd. The new text of 
paragraph (b)(1), ``Validation,'' makes it clear that the 25-percent 
incremental testing is to be conducted at 90-day intervals, thus 
ensuring that the testing is completed within the 365-day testing 
cycle. To allow some flexibility, though, we have included a provision 
under which the Administrator could give a producer an additional 15 
days in which to conduct an incremental test when unforeseen 
circumstances warrant an extension. Even if an extension were granted, 
however, the next test would be due on the day specified on the 
original schedule, not 90 days after the test for which an extension 
was granted was actually conducted. This way, the 25-percent 
incremental testing would be kept on schedule and completed within the 
365-day testing cycle (unless an extension were granted for the final 
incremental test, which would mean the testing would be completed 
within 375 days).
    The new text of paragraph (b)(2), which concerns maintenance of 
validated-free status, provides that, when unforeseen circumstances 
warrant such an extension, the Administrator may approve an alternative 
testing schedule under which an incremental CHT would be completed 
within 420 days. A herd tested under an alternative testing schedule 
would retain its validation until the testing has been completed. This 
provides the flexibility sought by the commenter by allowing a producer 
to maintain validated brucellosis-free status in situations where 
circumstances make it impossible to complete the required herd testing 
within the specified 365-day testing cycle.
    In addition to the changes discussed above, we are making one 
nonsubstantive editorial change to the rule.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule, with the changes discussed in this document.

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 the purposes of 
Executive Order 12866, and, therefore, has not been reviewed by the 
Office of Management and Budget.
    The changes in this rule should result in direct benefits for 
producers through testing requirements either being relaxed or removed 
entirely, and in indirect benefits through more standardized testing 
procedures. Requiring fewer tests, which cost an estimated $5 per head, 
will not only save herd owners money, but will also be less disruptive 
to normal herd operations. Similarly, savings will be realized by the 
removal of the requirement for routine herd testing in validated 
brucellosis-free States.
    The more stringent standard for validated brucellosis-free State 
status will disqualify any State with more than one confirmed 
brucellosis-infected herd. We expect that this new standard will 
provide States or producers with an incentive to depopulate the 
relatively few brucellosis-infected herds of domestic swine that, 
although sources of disease perpetuation and spread, are currently 
tolerated in some States. We expect, therefore, that this provision 
will expedite the eradication of swine brucellosis in domestic herds in 
all States in the United States. Once eradication has been achieved, as 
has been done in 40 States, fewer tests must be conducted. Producers 
will immediately benefit, both operationally and economically, from the 
reduced testing requirements.
    More than 90 percent of all domestic swine producers are classified 
as small businesses. Based on the 1991 marketing year figures, sales of 
fewer than 4,000 head place a producer in the ``small business'' 
category (gross receipts below $500,000). Of the 238,819 swine 
producers in the United States identified in the most recent Census of 
Agriculture, fewer than 24,000, or 10 percent, sell more than 1,000 
head per year; precise figures above 1,000 are not available. We expect 
that large and small producers alike will benefit to a limited extent 
from relaxed testing requirements in States applying for validation and 
in States already validated as swine brucellosis-free. Producers in 
other States will be unaffected by these changes to the regulations.
    Feral swine have a capacity for harboring and transmitting swine 
brucellosis to domestic herds. Feral swine moved interstate (not 
intended for immediate slaughter) are presumably sold to hunting 
preserves or at livestock auctions. However, State records indicate 
minimal interstate movement of feral swine. Therefore, it is likely 
that few small entities will be affected by the provisions of this 
final rule regarding the interstate movement of feral swine.
    We know of no other small entities that might be affected by this 
rule.
    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 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

    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 final rule will be 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. In Sec. 78.1, the term Herd blood test is amended by removing 
and reserving paragraph (b); the terms Validated brucellosis-free herd 
and Validated brucellosis-free State are revised; and the terms 
Complete herd test (CHT), Confirmatory test, Feral swine, Market swine 
test (MST) reactor, Monitored-negative feral swine population, and 
Swine brucellosis are added, in alphabetical order, as follows:


Sec. 78.1  Definitions.

* * * * *
    Complete herd test (CHT). An official swine brucellosis test of all 
swine on a premises that are 6 months of age or older and maintained 
for breeding purposes.
    Confirmatory test. A follow-up test to verify any official test 
results. Confirmatory tests include the standard tube test, the Rivanol 
test, the complement fixation test (CF), the particle concentration 
fluorescence immunoassay (PCFIA), the semen plasma test, and the 
standard plate test.
* * * * *
    Feral swine. Free-roaming swine. Formerly free-roaming swine could 
qualify for reclassification as domestic swine upon testing negative to 
an official swine brucellosis test after a period of at least 60 days' 
confinement in isolation from other feral swine.
* * * * *
    Market swine test (MST) reactor. Market swine test swine with a 
positive reaction to a swine brucellosis confirmatory test or other 
official test, if no confirmatory test is performed.
* * * * *
    Monitored-negative feral swine population. Feral swine indicating 
no evidence of infection (indicators would include positive blood tests 
or clinical signs, such as abortion) and originating from a specified, 
geographically isolated area (a forest area, hunting preserve, or 
swamp, for example) may be classified by the designated epidemiologist 
as a monitored-negative feral swine population.
* * * * *
    Swine brucellosis. The communicable disease of swine caused by 
Brucella suis (B. suis) biovar 1 or 3.
* * * * *
    Validated brucellosis-free herd. (a) A swine herd not known to be 
infected with swine brucellosis, located in a validated brucellosis-
free State; or
    (b) a swine herd in a State that has not been validated as 
brucellosis-free, provided the herd meets the conditions for 
validation, as follows:
    (1) Validation. A swine herd may be validated as brucellosis-free 
if it has been found brucellosis negative after either a complete-herd 
test (CHT) or an incremental CHT. The incremental CHT may be conducted 
by testing all breeding swine 6 months of age or older with negative 
results within 365 days, either in four 25-percent increments, with 
those tests being conducted on the 90th, 180th, 270th, and 360th days 
of the testing cycle, or in 10-percent increments every 25-35 days 
until 100 percent of those swine have been tested. In cases where 
unforseen circumstances warrant such action, the Administrator may 
approve an extension of up to 15 days of the date on which a test under 
the 25-percent incremental herd test is to be conducted, thus allowing 
a test to be conducted no later than the 105th, 195th, 285th, or 375th 
day of the testing cycle. No swine may be tested twice during the 
testing cycle to comply with either the 25 percent requirement or the 
10 percent requirement. No further testing is required once 100 percent 
of the breeding swine have been tested. After all breeding swine have 
tested brucellosis negative, a herd may be validated as brucellosis-
free. Unless the Administrator has approved an alternative testing 
schedule, which might extend the testing cycle, a herd retains 
validated brucellosis-free status for a maximum of 365 days.
    (2) Maintaining validation. Validation may be continuously 
maintained if a complete herd test (CHT) is performed once every 365 
days, with negative results, or an incremental CHT is performed. The 
incremental CHT may be conducted by testing all breeding swine 6 months 
of age or older, with negative results, within 365 days in either four 
25-percent increments, with those tests being conducted on the 90th, 
180th, 270th, and 360th days of the testing cycle, or in 10-percent 
increments every 25-35 days until 100 percent of those swine have been 
tested. In cases where unforeseen circumstances warrant such action, 
the Administrator may approve an alternative testing schedule under 
which the 25 percent or 10 percent incremental CHT would be completed, 
with negative results, within 420 days, during which time the herd's 
validated brucellosis-free status would be continued. No swine may be 
tested twice during the testing cycle to comply with these 
requirements. No further testing is required once 100 percent of the 
breeding swine have been tested.
    Validated brucellosis-free State. A State may apply for validated-
free status when:
    (a) Any herd found to have swine brucellosis during the 2-year 
qualification period preceding the application has been depopulated. 
More than one finding of a swine brucellosis-infected herd during the 
qualification period disqualifies the State from validation as 
brucellosis-free; and
    (b) During the 2-year qualification period, the State has completed 
surveillance, annually, as follows:
    (1) Complete herd testing. Subjecting all swine in the State that 
are 6 months of age or older and maintained for breeding purposes to an 
official swine brucellosis test; or
    (2) Market swine testing. Subjecting 20 percent of the State's 
swine 6 months of age or older and maintained for breeding purposes to 
an official swine brucellosis test, and demonstrating successful 
traceback of at least 80 percent of market swine test (MST) reactors to 
the herd of origin. Blood samples may be collected from MST swine if 
the swine can be identified to their herd of origin, in accordance with 
Sec. 71.19(b) of this subchapter. All MST reactor herds are subject to 
a CHT within 30 days of the MST laboratory report date, as determined 
by a designated epidemiologist; or
    (3) Statistical analysis. Demonstrating, by a statistical analysis 
of all official swine brucellosis test results (including herd 
validation, MST, change-of-ownership, diagnostic) during the 2-year 
qualification period, a surveillance level equivalent or superior to 
CHT and MST testing programs discussed in this paragraph.
    (c) To maintain validation, a State must annually survey at least 5 
percent of its breeding swine, and demonstrate traceback to herd of 
origin of at least 80 percent of all MST reactors. A State must 
demonstrate its continuing ability to meet the criteria set forth in 
paragraph (c) of this definition within 36-40 months of receiving 
validated brucellosis-free State status to retain that status.
* * * * *


Sec. 78.30  [Amended]

    3. In Sec. 78.30, paragraph (a) is amended by removing the words 
``and sows'' after ``brucellosis exposed swine'' and adding, in their 
place, the words ``feral swine, sows,''.
    4. In Sec. 78.30, a new paragraph (c) is added to read as follows:


Sec. 78.30  General restrictions.

* * * * *
    (c) (1) Feral swine may be moved interstate directly to slaughter 
if they do not come into physical contact with any domestic swine or 
other livestock.
    (2) Feral swine from monitored-negative populations may be moved 
interstate other than directly to slaughter if accompanied by a permit 
issued by the APHIS representative or the State animal health official 
in the State of origin.
    (3) Feral swine found negative to an official test within the 30 
days prior to the interstate movement may be moved interstate other 
than directly to slaughter if accompanied by a permit issued by the 
APHIS representative or the State animal health official in the State 
of origin.

    Done in Washington, DC, this 15th day of April 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-9593 Filed 4-20-94; 8:45 am]
BILLING CODE 3410-34-P