[Federal Register Volume 63, Number 180 (Thursday, September 17, 1998)]
[Proposed Rules]
[Pages 49670-49673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24950]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 63, No. 180 / Thursday, September 17, 1998 / 
Proposed Rules  

[[Page 49670]]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 98-060-1]


Brucellosis; Procedures for Retaining Class Free State Status

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: We are proposing to amend the brucellosis regulations to allow 
a State to retain its Class Free status following the detection of an 
affected herd if the State meets certain conditions. These conditions, 
which would include quarantining, testing, and depopulating the 
affected herd and conducting an investigation to ensure that 
brucellosis has not spread from the affected herd, would allow a State 
to avoid losing its Class Free status due to an isolated case of 
infection being detected in the State. We believe that providing this 
option to States would encourage the prompt resolution of isolated 
cases of brucellosis and thus ensure the continued progress of State 
and Federal efforts toward the eradication of brucellosis in domestic 
cattle and bison herds. Without this proposed change in the 
regulations, a State could lose its Class Free status following the 
detection of a single affected herd and would not have as great an 
incentive to take swift and decisive action to determine the source of 
the infection, eliminate the affected herd, and ensure that the disease 
had not spread to other herds in the State.

DATES: Consideration will be given only to comments received on or 
before November 2, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-060-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 98-060-1. 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 requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Valerie Ragan, Senior Staff 
Veterinarian, National Animal Health Programs, VS, APHIS, 4700 River 
Road Unit 36, Riverdale, MD 20737-1231, (301) 734-7708.

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is a contagious disease affecting animals and humans, 
caused by bacteria of the genus Brucella. In its principal animal 
hosts, brucellosis is characterized by abortion and impaired fertility.
    Through a cooperative State and Federal effort, the United States 
is now approaching total eradication of the field strain Brucella 
abortus in domestic cattle and bison herds. As of July 31, 1998, there 
were only 9 known infected domestic cattle and bison herds, and the 
U.S. Department of Agriculture's (USDA's) Animal and Plant Health 
Inspection Service (APHIS) had declared 43 States, Puerto Rico, and the 
U.S. Virgin Islands free of the disease.
    The brucellosis regulations contained in 9 CFR part 78 (referred to 
below as the regulations) provide a system for classifying States or 
portions of States (areas) according to the rate of Brucella abortus 
infection present and the general effectiveness of the brucellosis 
control and eradication program conducted in the State or area. The 
classifications are Class Free, Class A, Class B, and Class C; States 
or areas that do not meet the minimum standards for Class C may be 
placed under Federal quarantine. At this point in the cooperative 
State/Federal brucellosis eradication program, all States have achieved 
either Class Free or Class A status.
    To maintain Class Free status, the regulations require, among other 
things, that a State must have a herd infection rate of 0.0 percent or 
0 herds per 1,000. A State's herd infection rate is based on the number 
of herds found to have brucellosis reactors within the State during any 
12 consecutive months due to field strain Brucella abortus. The 
required 0.0 percent herd infection rate means that a Class Free State 
would no longer qualify for Class Free status if a single brucellosis-
affected herd was detected in the State. A downgrade in status from 
Class Free to Class A results in increased costs for States and their 
livestock owners, with most of those added costs arising from the 
increased testing requirements that accompany Class A status.
    The cooperative State/Federal brucellosis eradication program is 
nearing its conclusion, with eradication of the disease in domestic 
cattle and bison herds being projected by the end of 1998. With the 
eradication program entering its latter stages, several States that 
historically had significant levels of brucellosis have been able to 
attain Class Free status. Although these States have successfully 
eliminated the remaining known infected herds within their borders, we 
believe that it is possible that some of these States may find an 
isolated herd affected with brucellosis. That was the case recently 
with Louisiana. Louisiana attained Class Free status in October 1996, 
but, due to the detection of brucellosis in two herds within the State, 
was downgraded to Class A in an interim rule effective on June 16, 
1998, and published in the Federal Register on June 24, 1998 (63 FR 
34264-34266, Docket No. 98-068-1).
    State and Federal animal health officials have recognized the need 
for a procedure that would allow a brucellosis Class Free State to 
maintain its status if an isolated case of brucellosis infection occurs 
and it can be confirmed that the disease did not spread outside of the 
herd. We agree that such a strategy is appropriate at this stage of the 
brucellosis eradication program, when each new herd found to be 
affected with brucellosis is handled in an emergency action mode in 
order to quickly resolve the case and ensure continued progress toward 
eradication. We believe that a procedure that gives a Class Free State 
the opportunity to retain its status following the detection of an 
affected herd would be a powerful incentive that would encourage a 
State in that situation to take swift and decisive action to determine 
the source of the infection, eliminate the affected

[[Page 49671]]

herd, and ensure that the disease has not spread to other herds in the 
State.
    Therefore, we are proposing to amend the definition of Class Free 
State or area in Sec. 78.1 of the regulations by adding a new paragraph 
(b)(4) that would explain the conditions that a State would have to 
meet in order to retain its Class Free status after the detection of an 
affected herd within the State.
    This proposed procedure is intended to address cases in which a 
Class Free State encounters an isolated incident in which a herd 
affected with brucellosis is discovered; it is not intended to be a 
regular feature of a State's maintenance of its Class Free status. 
Therefore, the introductory text of new paragraph (b)(4) would provide 
that a State could use the procedure only in cases where a single herd 
is found to be affected with brucellosis, and only once in any 2-year 
period. We would impose these limitations because we believe that the 
detection of more than one affected herd within a 2-year period is 
indicative of a brucellosis problem that is more widespread than the 
isolated cases this proposed procedure is intended to address.
    The steps that a State would have to take to retain its Class Free 
status would be clear-cut and consistent with the goals of emergency 
disease management: Within 60 days of identifying the initial infected 
animal, the State would have to eliminate the affected herd and ensure 
that infection has not spread. To attain these goals, we would require 
that the State immediately quarantine the affected herd upon its 
disclosure. After quarantining the herd to ensure that there is no 
potential for further spread of the disease from the herd, all the 
animals in the herd would have to be tested for brucellosis and 
slaughtered as soon as possible within the 60-day period. Testing the 
herd prior to, or at the time of, depopulation would provide 
epidemiologists with information as to the extent of the brucellosis 
infection in the herd and other information of that nature that would 
be useful as animal health personnel pursue the other aspect of the 
State's response to the detection of the affected herd, i.e., a 
complete epidemiological investigation of the herd to attempt to 
determine the source of the infection and ensure that brucellosis has 
not spread.
    The epidemiological investigation that would be required would 
involve the identification and investigation of all herds on premises 
adjacent to the affected herd (adjacent herds), all herds from which 
animals may have been brought into the affected herd (source herds), 
and all herds that may have had contact with or accepted animals from 
the affected herd (contact herds). Once all adjacent, source, and 
contact herds had been identified, each of those herds would have to be 
placed under an approved individual herd plan.
    An approved individual herd plan, as defined in 78.1, is a herd 
management and testing plan designed by the herd owner, the owner's 
veterinarian if requested, and a State representative or APHIS 
representative to determine the disease status of the animals in the 
herd and, in those cases where the disease is found to be present, to 
control and eradicate brucellosis within the herd. An individual herd 
plan must be jointly approved by the State animal health official and 
the APHIS Veterinarian in Charge. The use of an approved individual 
herd plan under the circumstances envisioned in this proposed rule 
would ensure that any testing or other measures determined to be 
necessary could be instituted after being agreed upon by the herd 
owner, the State, and APHIS.
    In most cases, the approved individual herd plan will require herd 
blood tests--i.e., the brucellosis testing of all test-eligible animals 
in a herd--for each of the adjacent, source, and contact herds 
identified in the course of the epidemiological investigation. However, 
we acknowledge that there may be some instances in which a herd blood 
test may not be necessary given the facts of the situation. For 
example, a herd may be identified as a contact herd on the basis of its 
having received animals from the affected herd. If, however, it was 
determined that the only animals the contact herd received from the 
affected herd were steers, which pose no threat of disseminating 
brucellosis, then it would serve little practical purpose from an 
epidemiological standpoint to require a herd blood test for the contact 
herd. Another example of this type of situation would be a case in 
which a herd is identified as a source herd on the basis of its having 
provided a heifer to the affected herd. If it was determined that the 
heifer left the source herd 8 years ago to join the affected herd, and 
the source herd has been a certified brucellosis-free herd for the last 
10 years, then once again it would likely be unnecessary from an 
epidemiological standpoint to require that source herd to undergo a 
herd blood test.
    Given that situations such as those described in the previous 
paragraph may occur, we are proposing to allow the epidemiologist 
investigating the affected herd to place an adjacent, source, or 
contact herd under an individual herd plan that does not require a herd 
blood test if he or she determines that such testing is not warranted. 
That determination, along with the reasons supporting it, would have to 
be documented in the individual herd plan, which, as noted above, must 
be jointly approved by the State animal health official and the APHIS 
Veterinarian in Charge.
    If additional herds affected with brucellosis were detected during 
the course of the epidemiological investigation and subsequent testing, 
the State would not be eligible to retain its Class Free status under 
this proposed procedure, but the identification of those herds would 
nonetheless aid the State in its efforts to eliminate brucellosis and 
begin the process of requalifying for Class Free status.
    At the close of the 60-day period during which the State conducted 
the activities described in the preceding paragraphs, APHIS would 
review the actions taken by the State in response to the detection of 
the affected herd to confirm that the State had met all the conditions 
necessary to retain its Class Free status.

Alternatives Considered

    The criteria for retaining Class Free status proposed in this 
document are similar in scope and substance to the requirements found 
in the definition of accredited-free (suspended) State in Sec. 77.1 of 
our tuberculosis regulations in 9 CFR part 77. Specifically, an 
accredited free (suspended) State may regain its accredited-free status 
after quarantining the herd in which tuberculosis was detected, 
conducting an epidemiological investigation to determine that the 
infection has not spread from the herd, and destroying all reactor 
cattle and bison. The similarity of our proposed criteria for retaining 
Class Free status to those requirements led us to consider the 
possibility of establishing a new classification such as ``Class Free 
(suspended) State'' in the brucellosis regulations. However, for the 
reasons explained below, we have determined that an entirely new State 
classification would not be necessary in order for the objectives of 
this proposed rule to be accomplished.
    Under the tuberculosis regulations, two herds must be found to be 
affected with tuberculosis within a 48-month period before a State's 
accredited-free status will be revoked. Without the accredited-free 
(suspended) classification, the detection of a single tuberculosis-
affected herd in a State would have little effect other than to start 
the 48-month clock; there would not necessarily be an incentive for a 
State to act quickly to quarantine the

[[Page 49672]]

affected herd and ensure that tuberculosis has not and will not spread 
from that herd. The accredited-free (suspended) classification provides 
that incentive by allowing a State to qualify for redesignation as 
accredited-free as soon as the required quarantine, investigation, and 
destruction of reactors has been completed.
    The brucellosis regulations, on the other hand, provide that a 
State may lose its Class Free status at any time upon the detection of 
a single brucellosis-affected cattle or bison herd. Given that 
immediacy, there is no need to provide for an interim downgrading of 
State status in order for a Class Free State to have an incentive for 
reacting quickly to the detection of brucellosis within its borders; 
any necessary incentive for quick action would be provided by this 
proposed rule's provisions for retaining Class Free status.
    Another consideration in our rejection of the ``Class Free 
(suspended)'' alternative is the fact that the requirements of this 
proposed rule would have to be satisfied within 60 days in order for a 
State to retain its Class Free status. That necessarily brief window 
for action means that any rulemaking giving notice of a suspension in 
status would have to be followed in short order by another rulemaking 
returning the State to Class Free status or lowering it to Class A 
status. Given that this proposed rule would not place any additional 
requirements on the State's herds in general, we believe that adding a 
``suspended'' classification would have little effect other than to 
cause a short-term shuffling of State status.
    One benefit of adding a ``suspended'' classification would be that 
it would serve as a mechanism to notify other States of the detection 
of a brucellosis-affected herd in a Class Free State. However, that 
notification can also be accomplished through normal reporting methods, 
so we see no need to add a new classification simply to ensure that 
other States are made aware of a particular situation. Under current 
procedures, whenever a herd is found to be affected with brucellosis 
and the epidemiological investigation leads to an adjacent, source, or 
contact herd in another State, that other State is immediately notified 
and joins in the investigation. For States that are not directly 
affected in that way, notification of the situation is accomplished 
through the monthly reports that APHIS sends to the animal health 
officials in every State. The need for a more immediate all-States 
notification mechanism was not identified by the State and Federal 
animal health officials who suggested the procedure for retaining Class 
Free status that led to this proposed rule. However, we encourage State 
animal health officials and others to offer their suggestions regarding 
this notification issue in any comments they may wish to submit on this 
proposed rule.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    Producers and consumers have realized great financial savings from 
the success of the Cooperative State/Federal Brucellosis Eradication 
Program. Annual losses from lowered milk production, aborted calves and 
pigs, and reduced breeding efficiency have decreased from more than 
$400 million in 1952 to less than $1 million today. Studies indicate 
that if the brucellosis eradication program efforts were stopped, the 
costs of producing beef and milk could increase by an estimated $80 
million annually in less than 10 years with the gradual spread of 
brucellosis.
    This proposed rule would amend the brucellosis regulations to allow 
a State to retain its Class Free status following the detection of an 
affected herd if the State meets certain conditions. These conditions, 
which would include depopulating the affected herd and taking measures 
to ensure that brucellosis has not spread from the affected herd, would 
allow a State to avoid losing its Class Free status due to an isolated 
case of infection being detected in the State.
    The entities potentially affected by this proposed rule are the 43 
States, Puerto Rico, and the U.S. Virgin Islands that currently hold 
Class Free status and the producers of livestock in those States and 
territories. The total number of cattle and bison in United States was 
approximately 101.4 million in 1997, valued at about $53.2 billion. 
There were 1,167,910 U.S. operations with cattle and bison in 1997. 
Over 97 percent of these operations are considered to be small 
entities, with gross cash value of less than $500,000 each (USDA, 
National Agricultural Statistics Service, ``Agricultural Statistics 
1997,'' Washington, DC, 1997).
    Allowing a State to retain its Class Free status under certain 
conditions could be expected to have an overall positive economic 
effect for several reasons. First, when a State's status is upgraded 
from Class A to Class Free, the State realizes a cost savings through 
the reduction in the required level of brucellosis ring test (BRT) 
surveillance. The BRT must be conducted in a Class A State or area at 
least four times per year at approximately 90-day intervals, with all 
herds producing milk for sale in the State being required to be 
included in at least three of the four brucellosis ring tests conducted 
each year. When a State attains Class Free status, the level of BRT 
surveillance is lowered to two brucellosis ring tests per year for each 
herd producing milk for sale in the State. Thus, allowing a State to 
retain its Class Free status would enable the State to avoid the added 
testing and personnel costs associated with the higher level of BRT 
surveillance required of Class A States.
    Second, allowing a State to retain its Class Free status would mean 
that herd owners in the State could continue to avoid the costs of pre-
movement testing of their test-eligible cattle and bison. In a Class A 
State, test-eligible cattle and bison offered for sale interstate from 
other than certified-free herds must test negative for brucellosis 
prior to movement. Because that testing is not required for test-
eligible cattle and bison in Class Free States, herd owners in a State 
allowed to retain its Class Free status under the provisions of this 
proposed rule would continue to be able to move their cattle or bison 
interstate without incurring the approximately $3.25 per-head cost of 
testing.
    Finally, in those cases in which a brucellosis-affected herd was 
depopulated in order for a State to retain its Class Free status, the 
costs of that depopulation could be largely offset through the payment 
of Federal indemnity for the destroyed animals. Under the brucellosis 
indemnity regulations in 9 CFR part 51, any owner whose herd of cattle 
or bison is destroyed because of brucellosis is eligible for the 
payment of Federal indemnity. The rate of indemnity is set as either: 
(1) The appraised value of each animal, minus its salvage value, or (2) 
a fixed rate of no more than $250 per animal.
    Class Free States would not be required to pursue the option 
offered by this proposed rule for retaining Class Free status following 
the detection of a brucellosis-affected herd. However, we believe that 
the economic benefits that a State would realize by taking action to 
avoid being downgraded to Class A status would far outweigh the costs 
of the herd depopulation, epidemiological investigation, and testing 
that would be required to retain Class Free status.

[[Page 49673]]

    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 12988

    This proposed rule has been reviewed under Executive Order 12988, 
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

    This proposed rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 78

    Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and 
recordkeeping requirements, Transportation.

    Accordingly, we propose to amend 9 CFR part 78 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, and 134f; 7 CFR 2.22, 2.80, and 371.2(d).

    2. In Sec. 78.1, in the definition of Class Free State or area, a 
new paragraph (b)(4) would be added to read as follows:


Sec. 78.1  Definitions.

* * * * *
    Class free State or area. * * *
    (b) * * *
    (4) Retaining Class Free status. (i) If a single herd in a Class 
Free State is found to be affected with brucellosis, the State may 
retain its Class Free status if it meets the conditions of this 
paragraph. A State may retain its status in this manner only once 
during any 2-year period. The following conditions must be satisfied 
within 60 days of the identification of the infected animal:
    (A) The affected herd must be immediately quarantined, tested for 
brucellosis, and depopulated; and
    (B) An epidemiological investigation must be performed and the 
investigation must confirm that brucellosis has not spread from the 
affected herd. All herds on premises adjacent to the affected herd 
(adjacent herds), all herds from which animals may have been brought 
into the affected herd (source herds), and all herds that may have had 
contact with or accepted animals from the affected herd (contact herds) 
must be epidemiologically investigated, and each of those herds must be 
placed under an approved individual herd plan. If the investigating 
epidemiologist determines that a herd blood test for a particular 
adjacent herd, source herd, or contact herd is not warranted, the 
epidemiologist must include that determination, and the reasons 
supporting it, in the individual herd plan.
    (ii) After the close of the 60-day period following the 
identification of the infected animal, APHIS will conduct a review to 
confirm that the requirements of paragraph (b)(4)(i) have been 
satisfied and that the State is in compliance with all other applicable 
provisions.

* * * * *
    Done in Washington, DC, this 11th day of September 1998.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-24950 Filed 9-16-98; 8:45 am]
BILLING CODE 3410-34-P