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

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

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 § 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 § 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 §§ 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 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 § 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 § 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 § 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 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 §§ 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 § 77.10(a) with regard to shipments from modified accredited advanced States or zones and at § 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 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.” 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.

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

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

PART 77—TUBERCULOSIS

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.

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

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