Brucellosis Surveillance; MCI Reactor Prevalence Rates

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 93-024-3]

Brucellosis Surveillance; MCI Reactor Prevalence Rates

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the brucellosis regulations to eliminate the

requirement that States maintain specified Market Cattle Identification

(MCI) reactor prevalence rates to maintain their official

classifications. We are instead requiring the States to successfully

close (epidemiologically investigate and resolve) certain percentages

of cases detected through the MCI program. We believe these amendments

will better serve Federal and State animal health officials in their

efforts to prevent the interstate spread of brucellosis.

EFFECTIVE DATE: August 12, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. M.J. Gilsdorf, National

Brucellosis Epidemiologist, Cattle Diseases and Surveillance Staff,

Veterinary Services, APHIS, USDA, room 731, Federal Building, 6505

Belcrest Road, Hyattsville, MD 20782, (301) 436-4918.

SUPPLEMENTARY INFORMATION:

Background

Brucellosis is an infectious disease of certain animals and humans.

In its principal animal hosts, it is characterized by abortion and

impaired fertility. Through a cooperative Federal-State effort, the

United States is now approaching total eradication of the field strain

Brucella abortus in domestic cattle and bison herds. As of June 1994,

there were only 235 known infected cattle and bison herds, and the U.S.

Department of Agriculture (USDA) had declared 33 States, Puerto Rico,

and the U.S. Virgin Islands free of the disease. Fewer than 400 new

infected herds were identified last year.

The regulations in 9 CFR part 78 (referred to below as the

regulations) govern the interstate movement of cattle, bison, and swine

to prevent the spread of brucellosis.

On January 14, 1994, we published in the Federal Register (59 FR

2312-2316, Docket No. 93-024-1) a proposal to eliminate the requirement

in the regulations that States meet specific MCI reactor prevalence

rates to maintain their official classifications. We also proposed to

require that to maintain their official classifications, States must

successfully close a specified percentage of MCI reactor cases.

We solicited comments concerning our proposal for a 30-day comment

period ending February 14, 1994. On February 11, 1994, we published in

the Federal Register a notice extending the comment period to March 14,

1994 (59 FR 6593, Docket No. 93-024-2). We received four comments by

that date, three from Federal veterinarians and one from the American

Veterinary Medical Association (AVMA). We carefully considered all of

the comments we received. They are discussed below:

The AVMA comment supported the proposal as written. The other three

comments all suggested that language in a particular paragraph in the

proposal be deleted.

The language in question occurs in the definition of ``Class A

State or area'' in Sec. 78.1(a)(2)(ii)(B)(2), and is repeated in the

definitions ``Class B State or area,'' ``Class C State or area,'' and

``Class Free State or area.'' The issue at hand is what action a

designated epidemiologist must take after determining that brucellosis

reactors are present in a herd. The regulations require that such herds

must be subjected to herd blood tests or quarantined unless:

(2) Evidence indicates that the brucellosis reactor is from a

herd that no longer presents a risk of spreading brucellosis, or is

from a herd that is unlikely to be infected with brucellosis. Such

evidence could include, but is not limited to, situations where:

(i) The brucellosis reactor is traced back to a herd that has

been sold for slaughter in entirety;

(ii) The brucellosis reactor is traced back to a herd that is

certified brucellosis free and is 100-percent vaccinated; or,

(iii) The brucellosis reactor showed a low titer in the MCI test

and is traced back to a dairy herd that is 100 percent vaccinated

and has tested negative to the most recent brucellosis ring test

required by this section for herds producing milk for sale.

Three commenters opposed inclusion of the language in (i), (ii),

and (iii) that provides guidance to designated epidemiologists on how

to determine that a herd where a positive MCI blood sample was

collected no longer presents a risk of spreading brucellosis, or is

unlikely to be infected with brucellosis.

The commenters made the point that designated epidemiologists are

highly trained professionals who are responsible, among other duties,

for determining when a herd situation presents a risk of spreading

brucellosis. The commenters believe that designated epidemiologists are

fully capable of determining what evidence is relevant to such a

decision, and interpreting the evidence. As one commenter put it,

``each individual situation should be evaluated with sound

epidemiological principles which cannot be adequately enumerated by a

`predetermined list'.''

We agree that no list of risk scenarios in the regulations, however

extensive, could substitute for the professional judgment and

experience of a designated epidemiologist. We rely on continuing

education programs the Animal and Plant Health Inspection Service

(APHIS) mandates for designated epidemiologists, and review of their

decisions by other USDA epidemiologists, to ensure they make reasonable

determinations with regard to brucellosis risks. We did not attempt to

provide a ``cookbook'' list in the regulations to substitute for this

system of professional judgment backed by continuing education and

review by professional peers.

The proposed language cites three situations that could provide

evidence that a herd that no longer presents a risk of spreading

brucellosis, or is unlikely to be infected with brucellosis. These

examples were provided by epidemiologists from their own experience as

examples of frequently occurring situations where the risk of spreading

brucellosis is mitigated. The proposed language specifically says that

``evidence could include, but is not limited to'' the described

situations. The examples were provided not for the benefit of

designated epidemiologists, who are well aware of their relevance, but

for the benefit of members of the public who may be affected by the

regulations. We believe it will aid public understanding of the

regulations to see some examples of situations that could provide

evidence that a herd with an MCI reactor no longer presents a risk of

spreading brucellosis, or is unlikely to be infected with brucellosis.

Therefore, based on the rationale set forth in the proposed rule

and in this document, we are adopting the provisions of the proposed

rule as a final rule, without change.

Executive Order 12866 and Regulatory Flexibility Act

This final rule has been reviewed under Executive Order 12866. The

rule has been determined to be not significant for purposes of

Executive Order 12866 and, therefore, has not been reviewed by the

Office of Management and Budget.

Only State animal health agencies will be affected by this rule; it

will have no effect on the private sector. State animal health

officials will need to provide other States with information on only

the MCI reactors detected each month instead of total numbers of MCI

test cattle slaughtered. They will also need to maintain records of the

numbers of MCI reactor cases that are successfully closed and report

the percentage of successfully closed cases annually to APHIS. The

States are already required to carry out the activities that constitute

successful case closure.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action will

not have a significant economic impact on a substantial number of small

entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12778

This rule has been reviewed under Executive Order 12778, Civil

Justice Reform. This rule: (1) Preempts all State and local laws and

regulations that are in conflict with it; (2) has no retroactive

effect; and (3) does not require administrative proceedings before

parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.), the information collection or recordkeeping requirements

included in this rule have been submitted for approval to the Office of

Management and Budget.

List of Subjects in 9 CFR Part 78

Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and

recordkeeping requirements, Transportation.

Accordingly, 9 CFR part 78 is amended as follows:

PART 78--BRUCELLOSIS

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

Authority: 21 U.S.C. 111-114a-1, 114g, 115, 117, 120, 121, 123-

126, 134b, 134f; 7 CFR 2.17, 2.51, and 371.2(d).

2. Section 78.1 is amended as follows:

a. In the definition of Class A State or area, paragraph (a)(2)(ii)

is revised to read as set forth below and paragraph (c) is removed.

b. In the definition of Class B State or area, paragraph (a)(2)(ii)

is revised to read as set forth below and paragraph (c) is removed.

c. In the definition of Class C State or area, paragraph (a)(2)(ii)

is revised to read as set forth below, paragraph (c) is removed, and

paragraph (d) is redesignated as paragraph (c).

d. In the definition of Class Free State or area, paragraph

(a)(2)(ii) is revised to read as set forth below and paragraph (c) is

removed.

e. A new definition of Successfully closed case is added, in

alphabetical order, to read as set forth below.

Sec. 78.1 Definitions.

* * * * *

Class A State or area. * * *

(a) * * *

(2) * * *

(ii) Brucellosis reactors.

(A) Tracebacks. At least 90 percent of all brucellosis reactors

found in the course of MCI testing must be traced to the farm of

origin.

(B) Successfully closed cases. The State or area must successfully

close at least 95 percent of the MCI reactor cases traced to the farm

of origin during the 12-consecutive-month period immediately prior to

the most recent anniversary of the date the State or area was

classified Class A. To successfully close an MCI reactor case, State

representatives or APHIS representatives must conduct an epidemiologic

investigation at the farm of origin within 15 days after notification

by the cooperative State-Federal laboratory that brucellosis reactors

were found on the MCI test. Herd blood tests must be conducted or the

herd must be confined to the premises under quarantine within 30 days

after notification that brucellosis reactors were found on the MCI

test, unless a designated epidemiologist determines that:

(1) The brucellosis reactor is located in a herd in a different

State than the State where the MCI blood sample was collected. In such

cases a State representative or APHIS representative must give written

notice of the MCI test results to the State animal health official in

the State where the brucellosis reactor is located; or

(2) Evidence indicates that the brucellosis reactor is from a herd

that no longer presents a risk of spreading brucellosis, or is from a

herd that is unlikely to be infected with brucellosis. Such evidence

could include, but is not limited to, situations where:

(i) The brucellosis reactor is traced back to a herd that has been

sold for slaughter in entirety;

(ii) The brucellosis reactor is traced back to a herd that is

certified brucellosis free and is 100-percent vaccinated; or

(iii) The brucellosis reactor showed a low titer in the MCI test

and is traced back to a dairy herd that is 100 percent vaccinated and

has tested negative to the most recent brucellosis ring test required

by this section for herds producing milk for sale.

* * * * *

Class B State or area. * * *

(a) * * *

(2) * * *

(ii) Brucellosis reactors.

(A) Tracebacks. At least 80 percent of all brucellosis reactors

found in the course of MCI testing must be traced to the farm of

origin.

(B) Successfully closed cases. The State or area must successfully

close at least 90 percent of the MCI reactor cases traced to the farm

of origin during the 12-consecutive-month period immediately prior to

the most recent anniversary of the date the State or area was

classified Class B. To successfully close an MCI reactor case, State

representatives or APHIS representatives must conduct an epidemiologic

investigation at the farm of origin within 30 days after notification

by the cooperative State-Federal laboratory that brucellosis reactors

were found on the MCI test. Herd blood tests must be conducted or the

herd must be confined to the premises under quarantine within 30 days

after notification that brucellosis reactors were found on the MCI

test, unless a designated epidemiologist determines that:

(1) The brucellosis reactor is located in a herd in a different

State than the State where the MCI blood sample was collected. In such

cases a State representative or APHIS representative must give written

notice of the MCI test results to the State animal health official in

the State where the brucellosis reactor is located; or

(2) Evidence indicates that the brucellosis reactor is from a herd

that no longer presents a risk of spreading brucellosis, or is from a

herd that is unlikely to be infected with brucellosis. Such evidence

could include, but is not limited to, situations where:

(i) The brucellosis reactor is traced back to a herd that has been

sold for slaughter in entirety;

(ii) The brucellosis reactor is traced back to a herd that is

certified brucellosis free and is 100-percent vaccinated; or

(iii) The brucellosis reactor showed a low titer in the MCI test

and is traced back to a dairy herd that is 100 percent vaccinated and

has tested negative to the most recent brucellosis ring test required

by this section for herds producing milk for sale.

* * * * *

Class C State or area. * * *

(a) * * *

(2) * * *

(ii) Brucellosis reactors.

(A) Tracebacks. At least 80 percent of all brucellosis reactors

found in the course of MCI testing must be traced to the farm of

origin.

(B) Successfully closed cases. The State or area must successfully

close at least 90 percent of the MCI reactor cases traced to the farm

of origin during the 12-consecutive-month period immediately prior to

the most recent anniversary of the date the State or area was

classified Class C. To successfully close an MCI reactor case, State

representatives or APHIS representatives must conduct an epidemiologic

investigation at the farm of origin within 30 days after notification

by the cooperative State-Federal laboratory that brucellosis reactors

were found on the MCI test. Herd blood tests must be conducted or the

herd must be confined to the premises under quarantine within 30 days

after notification that brucellosis reactors were found on the MCI

test, unless a designated epidemiologist determines that:

(1) The brucellosis reactor is located in a herd in a different

State than the State where the MCI blood sample was collected. In such

cases a State representative or APHIS representative must give written

notice of the MCI test results to the State animal health official in

the State where the brucellosis reactor is located; or

(2) Evidence indicates that the brucellosis reactor is from a herd

that no longer presents a risk of spreading brucellosis, or is from a

herd that is unlikely to be infected with brucellosis. Such evidence

could include, but is not limited to, situations where:

(i) The brucellosis reactor is traced back to a herd that has been

sold for slaughter in entirety;

(ii) The brucellosis reactor is traced back to a herd that is

certified brucellosis free and is 100-percent vaccinated; or

(iii) The brucellosis reactor showed a low titer in the MCI test

and is traced back to a dairy herd that is 100 percent vaccinated and

has tested negative to the most recent brucellosis ring test required

by this section for herds producing milk for sale.

* * * * *

Class Free State or area. * * *

(a) * * *

(2) * * *

(ii) Brucellosis reactors.

(A) Tracebacks. At least 90 percent of all brucellosis reactors

found in the course of MCI testing must be traced to the farm of

origin.

(B) Successfully closed cases. The State or area must successfully

close at least 95 percent of the MCI reactor cases traced to the farm

of origin during the 12-consecutive-month period immediately prior to

the most recent anniversary of the date the State or area was

classified Class Free. To successfully close an MCI reactor case, State

representatives or APHIS representatives must conduct an epidemiologic

investigation at the farm of origin within 15 days after notification

by the cooperative State-Federal laboratory that brucellosis reactors

were found on the MCI test. Herd blood tests must be conducted or the

herd must be confined to the premises under quarantine within 30 days

after notification that brucellosis reactors were found on the MCI

test, unless a designated epidemiologist determines that:

(1) The brucellosis reactor is located in a herd in a different

State than the State where the MCI blood sample was collected. In such

cases a State representative or APHIS representative must give written

notice of the MCI test results to the State animal health official in

the State where the brucellosis reactor is located; or

(2) Evidence indicates that the brucellosis reactor is from a herd

that no longer presents a risk of spreading brucellosis, or is from a

herd that is unlikely to be infected with brucellosis. Such evidence

could include, but is not limited to, situations where:

(i) The brucellosis reactor is traced back to a herd that has been

sold for slaughter in entirety;

(ii) The brucellosis reactor is traced back to a herd that is

certified brucellosis free and is 100-percent vaccinated; or

(iii) The brucellosis reactor showed a low titer in the MCI test

and is traced back to a dairy herd that is 100 percent vaccinated and

has tested negative to the most recent brucellosis ring test required

by this section for herds producing milk for sale.

* * * * *

Successfully closed case. Follow up of an MCI reactor traceback

with an epidemiologic investigation which results in brucellosis

testing or quarantine of the herd of origin, or a determination by a

designated brucellosis epidemiologist that justification exists for not

testing or quarantining the herd of origin.

* * * * *

Done in Washington, DC, this 7th day of July 1994.

Lonnie J. King,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 94-16967 Filed 7-12-94; 8:45 am]

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