Brucellosis; Interstate Movement of Swine

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]

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