[Federal Register Volume 69, Number 75 (Monday, April 19, 2004)]
[Rules and Regulations]
[Pages 20805-20809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8751]



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  Federal Register / Vol. 69, No. 75 / Monday, April 19, 2004 / Rules 
and Regulations  

[[Page 20805]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 77

[Docket No. 02-112-3]


Tuberculosis in Cattle and Bison; State and Zone Designations; 
Michigan

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the bovine tuberculosis regulations by 
establishing two separate zones with different tuberculosis risk 
classifications in the State of Michigan and raising the designation of 
one of those zones from modified accredited to modified accredited 
advanced.
    We are taking this action based on our determination that Michigan 
meets the requirements for zone recognition and that one of the zones 
meets the criteria for designation as modified accredited advanced.

EFFECTIVE DATE: April 19, 2004.

FOR FURTHER INFORMATION CONTACT: Dr. Terry Beals, Senior Staff 
Veterinarian, Eradication and Surveillance Team, National Center for 
Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, 
MD 20737-1231; (301) 734-5467.

SUPPLEMENTARY INFORMATION:

Background

    The regulations contained in 9 CFR part 77, ``Tuberculosis'' 
(referred to below as the regulations), and the ``Uniform Methods and 
Rules-Bovine Tuberculosis Eradication'' (UMR), which is incorporated by 
reference into the regulations, restrict the interstate movement of 
cattle, bison, and captive cervids to prevent the spread of 
tuberculosis.
    On April 7, 2003, we published in the Federal Register (68 FR 
16733-16735, Docket No. 02-112-1) a proposal to amend the bovine 
tuberculosis regulations by establishing two separate zones with 
different risk classifications in the State of Michigan and raising the 
designation of one of those zones from modified accredited to modified 
accredited advanced.
    We solicited comments concerning our proposal for 60 days ending 
June 6, 2003. We reopened the comment period and extended the deadline 
for comments until July 25, 2003, in a document published in the 
Federal Register on June 25, 2003 (68 FR 37774, Docket No. 02-112-2). 
We received 77 comments by the close of the extended comment period. 
They were from State and local government officials, livestock 
producers, industry associations, veterinarians, and a consumer 
organization. We have carefully considered all of the comments we 
received. They are discussed below by topic.


    Note: Shortly after the proposed rule was published, a 
tuberculosis-infected beef cow was discovered in Antrim County, 
which was one of the counties included in the proposed modified 
accredited advanced zone. The affected herd has been depopulated, 
and a complete epidemiological investigation into the potential 
sources of the disease was conducted. However, because of that 
finding, we have removed Antrim County from the modified accredited 
advanced zone in this final rule, and that county will retain its 
current modified accredited status. Also, due to its inseparability 
from the modified accredited area (i.e., it is surrounded on three 
sides by modified accredited counties), we have removed Charlevoix 
County from the modified accredited advanced zone in this final 
rule; that county will also retain its current modified accredited 
status. We anticipate that, given the nature of Michigan's bovine 
tuberculosis eradication program, Antrim and Charlevoix Counties, as 
well as Emmet County, will be the first counties in the modified 
accredited zone that will become eligible for increased bovine 
tuberculosis status under the standards set forth in Sec.  77.11(f) 
and the UMR, given that the current infection levels in those 
counties are much lower than the infection levels throughout the 
rest of the modified accredited zone.

Boundary Designation

    One commenter suggested that the AuSable River, being a more 
impenetrable natural boundary than the Huron National Forest, is a 
better choice for defining the southernmost edge of the modified 
accredited zone.
    Under Sec.  77.4(a), separate zones of bovine tuberculosis 
classification within a State must be delineated by the animal health 
authorities in the State making the request for zone recognition, 
subject to approval by the Animal and Plant Health Inspection Service 
(APHIS). The division as outlined in our proposed rule was that 
developed by Michigan in accordance with the regulations in Sec. Sec.  
77.3 and 77.4. Another of Michigan's proposed alternatives would have 
utilized the AuSable River as a boundary as suggested by the commenter. 
Our review team, consisting of representatives of State and Federal 
agricultural agencies as well as private contractors, considered each 
option and ultimately recommended against the use of the AuSable River 
as a boundary since it may be forded easily during certain periods of 
the year. We believe that the Huron National Forest is a better choice, 
since it is a fairly vast expanse of uninhabited land where deer are 
not drawn together unnaturally through feeding and baiting.
    Another commenter said that the best way to achieve split State 
status is to utilize the Great Lakes as a boundary, designating the 
Upper Peninsula as modified accredited advanced and the Lower Peninsula 
as modified accredited.
    Geographically, we agree that a division utilizing the Great Lakes 
as a boundary would be desirable and effective. The 15 counties in 
Michigan's Upper Peninsula are included in the modified accredited 
advanced zone, however, there are 55 counties in the Lower Peninsula 
that meet our requirements for modified accredited advanced status. 
Exclusion from the modified accredited advanced zone of cattle 
producers, processors, and associated entities in those 55 counties 
solely on the basis of geographical factors would not be appropriate in 
our view.
    One commenter stated that since bovine tuberculosis has been 
detected in free-ranging deer in Mecosta, Osceola, and Antrim Counties, 
these counties should be included in the zone designated as modified 
accredited. The commenter additionally said that the dividing line 
between the modified accredited and modified accredited advanced zones 
should lie at the

[[Page 20806]]

northern boundaries of Oceana, Newaygo, Mecosta, Isabella, Midland, and 
Bay Counties.
    The incidence of free ranging deer testing positive for bovine 
tuberculosis in Mecosta and Osecola Counties is a total of one per 
county during the nine years that sampling has occurred. Such a rate 
does not justify alteration of the proposed boundaries to include 14 
additional counties and their associated producers, livestock, and 
related industries. As previously stated, in this final rule, we are 
expanding the modified accredited zone beyond what was proposed to also 
include Antrim and Charlevoix Counties.
    Another commenter said that the zone division should occur solely 
along county lines since it will prove difficult for those receiving 
cattle in other States to determine from which part of the divided 
counties those cattle originated.
    Much of the boundary is defined by county lines, with the exception 
of the southern boundary line in Iosco and Ogemaw Counties, which 
utilizes the Huron National Forest and the Au Sable State Forest. We 
have determined that the use of State and Federal forest land is the 
best boundary option in this case, since it serves as a far more 
impenetrable boundary than an imaginary county line.

Wild Deer Controls

    Several commenters stated that, before split State status is 
granted, there needs to be more done on a statewide basis to eliminate 
tuberculosis in the wild deer population and decrease the wild deer 
population as a whole. The commenters further said that splitting the 
State into two zones of classification would exacerbate the problem 
since the relatively small size of the modified accredited area will 
provide no incentive for such disease elimination or depopulation 
initiatives.
    Much is being accomplished to control bovine tuberculosis in 
wildlife reservoirs. The boundaries as described in this final rule 
include a vast area of forest land, which will facilitate existing 
wildlife control programs. In our view, rather than resulting in 
reduction of attention and financial resources, the relatively small 
size of the modified accredited area will allow available resources to 
be concentrated and applied to a localized area, thus increasing the 
efficacy of the programs.
    One commenter said that split State status should not be considered 
since the tuberculosis infection rates in sampled deer have not 
declined, but remained static, and infection rates have increased for 
yearling deer.
    While we recognize that both of the commenter's points are correct 
with regard to infection levels in deer for 2002, we do not consider 
the figures, especially the increase in tuberculosis among yearling 
deer, to be significant. Recently released statistics for 2003 show 
that the prevalence of bovine tuberculosis in all classes of deer, 
including yearling deer, declined in 2003. In addition, the relatively 
small increase in previous infection levels makes it difficult to 
determine what factors may have led to the situation as described by 
the commenter. Included in our requirements for maintenance of zones 
within States found at Sec.  77.4(a)(3), a State is required to 
maintain or improve the tuberculosis classification of lower status 
areas. However, the maintenance or improvement is required to be shown 
in the domestic livestock population only, not in wildlife. Among the 
factors we consider as improvement are lowering the level of 
tuberculosis infection in whitetail deer and reducing the number of 
transmissions from wildlife to cattle. These requirements serve to 
ensure that tuberculosis eradication programs within States are 
preserved. In the long run, this approach may help States by allowing 
funds to be focused on smaller problem areas.

Eradication Programs

    Several commenters were concerned with the discovery of the bovine 
tuberculosis infected herd in Antrim County. They asked that a full 
investigation be conducted prior to our decision regarding split State 
status, since the find raised questions regarding testing and movement 
standards and controls.
    We agree with the commenters' initial point. As stated above, 
Antrim County has been removed from the proposed modified accredited 
advanced zone in this final rule and added to the modified accredited 
zone. Subsequent to the finding of bovine tuberculosis in Antrim 
County, a full investigation was conducted with no regulatory 
violations found. In our view, the animal in question was incubating 
the disease prior to its entry into Antrim County, testing negative at 
the time of movement. It is to the credit of the Michigan bovine 
tuberculosis eradication program that the animal was detected and 
depopulated with no subsequent spread of the disease.
    Several commenters stated that Michigan should first be required to 
show progress in its bovine tuberculosis eradication program, 
particularly in the areas of surveillance and control, before split 
State status is granted.
    We believe Michigan has shown marked progress in all areas of their 
program. Discovery of the infected herd in Antrim County is a result of 
Michigan's active surveillance and testing program. We agree that 
movement control is critical to the success of split State status and 
have communicated this necessity to the Michigan Department of 
Agriculture. We have recently completed a review of the UMR and have 
identified a number of pertinent changes regarding wildlife reservoirs 
that we intend to consider in order to completely update the UMR. In 
addition, APHIS is working in cooperation with the State of Michigan to 
identify strategies that will allow us to isolate potentially infected 
wildlife from domestic cattle herds. These developments will allow us 
to realize more effective methods of bovine tuberculosis control.
    One commenter said that the UMR needs to be reevaluated in order to 
establish new standards related to bovine tuberculosis risk criteria.
    As stated previously, we are in the process of revising the UMR. 
New and more stringent standards are proposed for incorporation in 
several areas, including those related to bovine tuberculosis 
surveillance and the requirements necessary to achieve and maintain 
each level of classification for freedom from bovine tuberculosis. We 
expect to publish a proposed rule detailing these changes in the coming 
months.

Zone Classification Requirements

    Several commenters said that, if split State status is granted to 
Michigan, APHIS should conduct an annual review of that State's 
management of its areas of bovine tuberculosis classification.
    The regulations at Sec.  77.4(b) state that retention of split 
State status is subject to annual review by the Administrator. This 
review is currently conducted in the form of the Annual State Report, 
which incorporates followup, onsite State reviews when necessary. The 
Annual State Report is a significant component of our determination of 
a State's bovine tuberculosis status. Additionally, in order to retain 
zone recognition, a State must continue to demonstrate its compliance 
with Sec.  77.4(a)(1) through (a)(3) as well as the requirements for 
maintaining or improving the tuberculosis risk classification of each 
zone in the State, and retaining for at least 2 years all certificates 
required for the movement of cattle, bison, and captive cervids.
    Several commenters stated that bovine tuberculosis testing and

[[Page 20807]]

surveillance should be conducted to ensure that 100 percent of herds 
within the modified accredited advanced area are tested within the 6-
year testing span.
    The State of Michigan planned, and has nearly completed, a 
statewide area test of all herds. Michigan has also upgraded its 
slaughter surveillance. Further, Michigan is pursuing an active 
surveillance strategy focused on quickly identifying infected herds 
while they are still at a low level of infection via regular annual 
testing of all herds in the modified accredited area. Based on our 
research and experience, subsequent random sampling and surveillance 
within the modified accredited advanced zone need only occur in 2-year 
cycles. A continual policy of 100 percent testing within the modified 
accredited advanced zone would prove both costly and inefficient.
    Further, in the next 3 years, the State of Michigan has agreed to 
implement a surveillance system with biased sampling, which would 
weight areas based on the frequency of intrastate movements of cattle 
from the modified accredited zone as well as their proximity to the 
modified accredited zone. We have found that such targeted surveillance 
programs prove most effective in quickly and accurately assessing a 
State's bovine tuberculosis infection levels.
    One commenter said that strict monitoring of intrastate cattle 
movements should be a necessary component of operations for any State 
with split status.
    Under Sec. Sec.  77.3 and 77.4 of the regulations, in order to 
qualify for zone classification, States must, among other things, adopt 
and enforce regulations that impose restrictions on the intrastate 
movement of cattle, bison, and captive cervids that are substantially 
the same as those in place in part 77 for the interstate movement of 
those animals. Michigan has implemented stringent identification and 
intrastate movement permit requirements and is working in cooperation 
with the Michigan Department of Transportation in order to monitor 
these movements.
    Two commenters suggested that untested cattle from the modified 
accredited zone should be required to be moved only in sealed vehicles 
accompanied by a VS-127 permit.
    We typically require VS-127 permits only for transport of known 
diseased animals or exposed animals. Control at this level would 
involve a great amount of time, personnel, and expense for all affected 
parties. As such, this approach is not cost effective. We believe that 
the procedures currently in place, properly administered and executed, 
will be adequate to reduce the risk of disease transmission to 
acceptable levels.
    One commenter said that all intrastate movement procedures should 
be required to conform to a nationally applicable standard.
    While APHIS does establish interstate movement requirements and, as 
stated previously, require State intrastate movement regulations to be 
substantially the same, the particulars of intrastate movement are 
governed by State authorities. Establishment of the suggested national 
standard would require a wide-ranging regulatory change, and is 
therefore outside the scope of this rulemaking.
    One commenter stated that the proposed change to split State status 
will cause sizable economic harm to breeders as a result of increased 
recordkeeping and registration requirements.
    We are in the process of gathering data related to testing and 
identification costs in order to reevaluate our current information on 
those subjects. Our proposed rule contained a detailed analysis of the 
potential costs to entities associated with the cattle industry in 
Michigan, including breeders, wherein we determined that the proposed 
action would not have a significant economic impact on a substantial 
number of small entities. We consider ``significant impact'' to mean 
that the cost of a given action is equal to or greater than the small 
business's profit margin (5 to 10 percent of annual sales). By these 
standards, given the size and profitability of the cattle industry in 
Michigan, this action does not represent a significant impact on a 
substantial number of small entities. Given that, currently, the entire 
State of Michigan is classified as modified accredited for bovine 
tuberculosis, those producers within the designated modified accredited 
zone should experience no change in those costs associated with 
interstate movement. A more detailed analysis of this issue can be 
found later in this document under the heading ``Executive Order 12866 
and Regulatory Flexibility Act.''

Movement to Slaughter

    Two commenters discussed the need for recordkeeping, audits, and 
information sharing to ensure that cattle and bison from the modified 
accredited zone that are moving in slaughter channels are not diverted 
for other purposes. One of those commenters stated that slaughter 
facilities should be required to record identification information for 
all such cattle and bison, and the other commenter asked what record 
auditing was done at slaughter facilities that are not equipped with 
electronic identification readers.
    We agree that it is important to have checks in place to ensure 
that cattle and bison moving in slaughter channels are not diverted for 
other purposes. Traditionally, compliance activity in this regard has 
been accomplished by investigating potential or reported diversions and 
taking action in specific cases. Beyond that, there are simply not 
enough Federal or State personnel available to track every animal in 
slaughter channels to ensure that they are not diverted. As noted 
previously, Michigan has implemented stringent identification and 
intrastate movement permit requirements; those permit requirements 
apply to animals moving to slaughter, so there is an opportunity to 
confirm that all the animals listed on a permit arrive at the 
slaughtering facility as intended. In federally inspected slaughtering 
facilities, the U.S. Department of Agriculture's Food Safety and 
Inspection Service collects all manmade identification and correlates 
it with any blood or tissue specimens submitted for surveillance 
testing purposes. We recognize that the level of record auditing at 
various slaughtering facilities will not always be sufficient to 
prevent or detect the diversion of animals from slaughter, and intend 
to continue our work with State authorities in Michigan to make 
improvements in this area.
    A commenter said that, under split State status, it is necessary to 
ensure that cattle from the modified accredited zone are moved directly 
to slaughter facilities, without stopping.
    The regulations currently require movement of cattle to be direct 
to slaughter without offloading. These provisions are found at Sec.  
77.10(a) with regard to shipments from modified accredited advanced 
States or zones and at Sec.  77.12(a) with regard to shipments from 
modified accredited States or zones.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.
    This rule establishes two separate zones with different 
tuberculosis risk classifications in the State of Michigan and raises 
the designation of one of those zones from modified accredited to 
modified accredited advanced. This will

[[Page 20808]]

eliminate certain testing requirements for those cattle from the higher 
status zone, thus reducing the burden on producers and veterinarians. 
Therefore, the Administrator of the Animal and Plant Health Inspection 
Service has determined that this rule should be effective upon 
publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review under 
Executive Order 12866.
    Bovine tuberculosis is a communicable disease of cattle, bison, 
cervids and other species, including humans, and results in losses of 
meat and milk production among infected animals. As part of the 
Cooperative State/Federal Tuberculosis Eradication Program, which has 
virtually eliminated bovine tuberculosis from the Nation's livestock 
populations, the regulations classify each State according to its 
tuberculosis risk and place certain restrictions on the movement of 
cattle and bison from States with high-risk classifications.
    Previously, the State of Michigan was classified as modified 
accredited for cattle and bison. We are amending the regulations to 
establish two classification zones within Michigan. A zone consisting 
of Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford, Emmet, 
Montmorency, Oscoda, Otsego, and Presque Isle Counties and those 
portions of Iosco and Ogemaw Counties that are north of the 
southernmost boundary of the Huron National Forest and the Au Sable 
State Forest is classified as modified accredited. The designation of 
the remaining counties in the State is raised from modified accredited 
to modified accredited advanced. We discuss below the projected 
economic effects of this action.
    On January 1, 2002, there were approximately 15,000 cattle 
operations in Michigan, totaling 990,000 head of cattle. According to 
the National Agricultural Statistics Service, in Michigan each head of 
cattle is worth approximately $930, with a reported total cash value of 
$920.7 million. Of the 15,000 operations, over 98 percent are 
considered small entities under criteria established by the Small 
Business Association. Consequently, this analysis of the economic 
effects of the proposed rule change for the entire State is also 
sufficient for analyzing the small entity impact.
    The boost in status for all Michigan counties except those 13 
counties listed previously, from modified accredited to modified 
accredited advanced will result in fewer intrastate movement 
restrictions and one less tuberculin test for interstate movement. 
Decreased testing will result in decreased production costs for those 
producers in those areas whose status is raised to modified accredited 
advanced, thus providing a monetary benefit. As such, this analysis 
will focus on the cost savings of testing cattle and bison for movement 
captured by those elevated to modified accredited advanced status.
    For those 13 counties that will retain modified accredited status, 
there will be no change in production costs. These 13 counties 
contribute approximately 69,600 head of cattle to the statewide total, 
representing only 7 percent of total cattle production in Michigan. 
Consequently, the benefits of this regulation will be realized by the 
majority of producers in the State.
    An official tuberculin test for an average herd is about $380, 
which equates to approximately $6.33 per animal based on an average 
herd size in Michigan of 60 animals. The cost savings of the tuberculin 
test are not economically significant to cattle and bison producers. 
Considering that, on January 1, 2002, the average value per head of 
cattle was $930, the cost savings of reduced testing represent less 
than 1 percent of the per head value. In general practice we assume a 
regulation that has compliance costs which equal a small business' 
profit margin, or 5 to 10 percent of annual sales, pose an impact which 
can be considered ``significant.''\1\ For the purposes of illustration 
and analysis of the small entity impact, if we assume a cattle producer 
owns only 1 average herd of about 60 animals, with annual sales of 
approximately $56,000, compliance costs totaling between $2,800 and 
$5,600 would qualify as posing a ``significant'' economic impact on 
this entity. In the case of cattle producers in Michigan, the average 
compliance costs of TB testing for an entire herd would total about 
$380. Thus, for producers located in counties whose status will be 
raised to modified accredited advanced, the cost savings from reduced 
testing, while beneficial, will not represent a significant monetary 
savings. Of course, the more a particular herd owner is involved in 
interstate movement, the greater the cost savings will be. 
Unfortunately, the exact number of herd owners involved in interstate 
movement is unknown. However, it is clear that this change in status 
will not represent an economically significant benefit for those 
producers operating in counties whose status is raised to modified 
accredited advanced. This final rule will constitute no change in 
operational procedures for those counties that will remain under 
modified accredited status.
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    \1\ Verkuil, Paul R. ``A Critical Guide to the Regulatory 
Flexibility Act,'' Duke Law Journal, Apr. 1982: 928.
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    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 12988

    This final rule has been reviewed under Executive Order 12988, 
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

    This final 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 77

    Animal diseases, Bison, Cattle, Reporting and recordkeeping 
requirements, Transportation, Tuberculosis.


0
Accordingly, we are amending 9 CFR part 77 as follows:

PART 77--TUBERCULOSIS

0
1. The authority citation for part 77 is revised to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 77.9 is amended by revising paragraph (b) to read as 
follows:


Sec.  77.9  Modified accredited advanced States or zones.

* * * * *
    (b) The following are modified accredited advanced zones: All of 
the State of Michigan except for the zone that comprises those counties 
or

[[Page 20809]]

portions of counties in Michigan described in Sec.  77.11(b).
* * * * *

0
3. Section 77.11 is amended by revising paragraphs (a) and (b) to read 
as follows:


Sec.  77.11  Modified accredited States or zones.

    (a) The following are modified accredited States: None.
    (b) The following are modified accredited zones: A zone in Michigan 
that comprises Alcona, Alpena, Antrim, Charlevoix, Cheboygan, Crawford, 
Emmet, Montmorency, Oscoda, Otsego, and Presque Isle Counties and those 
portions of Iosco and Ogemaw Counties that are north of the 
southernmost boundary of the Huron National Forest and the Au Sable 
State Forest.
* * * * *

    Done in Washington, DC, this 13th day of April, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-8751 Filed 4-16-04; 8:45 am]
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