Brucellosis and Bovine Tuberculosis; Update of General Provisions

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 50, 51, 71, 76, 77, 78, 86, 93, and 161

[Docket No. APHIS-2011-0044]

RIN 0579-AD65

Brucellosis and Bovine Tuberculosis; Update of General Provisions

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to consolidate the regulations governing bovine tuberculosis, and those governing brucellosis. As part of this consolidation, we are proposing to transition the tuberculosis and brucellosis programs away from a State classification system based in disease prevalence. Instead, States and Tribes would implement animal health plans that identify sources of the diseases within the State or Tribal lands and specify mitigations to address the risk posed by those sources. The consolidated regulations would also set forth standards for surveillance, epidemiological investigations, and affected herd management that must be incorporated into each animal health plan, with certain limited exceptions; would provide revised conditions for the interstate movement of cattle, bison, and captive cervids; and would provide revised conditions for APHIS approval of tests, testing laboratories, and testers for bovine tuberculosis or brucellosis. Finally, we are proposing to revise the bovine tuberculosis- and brucellosis-related import requirements for cattle and bison to make these requirements clearer and assure that they more effectively mitigate the risk of introduction of these diseases into the United States.

DATES:

We will consider all comments that we receive on or before March 15, 2016.

ADDRESSES:

You may submit comments by either of the following methods:

•

Federal eRulemaking Portal:

Go to:

http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0044.

•

Postal Mail/Commercial Delivery:

Send your comment to Docket No. APHIS-2011-0044, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at

http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0044

or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT:

Domestic regulatory provisions:

Dr. C. William Hench, Senior Staff Veterinarian, Ruminant Health Programs, VS, APHIS, 2150 Centre Avenue, Building B-3E20, Fort Collins, CO 80526-8117; (970) 4947378.

Import-related regulatory provisions:

Dr. Langston Hull, National Import Export Services, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 851-3300.

SUPPLEMENTARY INFORMATION:

Background

I. Purpose of the Regulatory Action

a. Need for the Regulatory Action

Bovine tuberculosis is a contagious and infectious granulomatous disease caused by the bacterium

Mycobacterium bovis.

Although commonly defined as a chronic debilitating disease, bovine tuberculosis can occasionally assume an acute, rapidly progressive course. While any body tissue can be affected, lesions are most frequently observed in the lymph nodes, lungs, intestines, liver, spleen, pleura, and peritoneum. Although cattle are considered to be the true hosts of

M. bovis,

the disease has been reported in several other species of livestock, most notably bison and captive cervids. There have also been instances of infection in other domestic and nondomestic animals, as well as in humans.

Brucellosis is a contagious disease, caused by bacteria of the genus

Brucella,

that affects both animals and humans. The disease mainly affects cattle, bison, and swine; however, goats, sheep, horses, and humans are susceptible as well. In its principal animal hosts, it causes loss of young through spontaneous abortion or birth of weak offspring, reduced milk production, and infertility. There is no economically feasible treatment for brucellosis in livestock. In humans, brucellosis initially causes flu-like symptoms, but the disease may develop into a variety of chronic conditions, including arthritis. Humans can be treated for brucellosis with antibiotics.

These diseases were widely prevalent in the United States during the early 1900s. As recently as 1917, 1 in 20 cattle herds within the United States was affected with bovine tuberculosis, and, in 1934, 1 in 10 adult cattle within the United States was a reactor (

i.e.,

tested positive) for brucellosis.

Such prevalence prompted the establishment of a National Cooperative State/Federal Eradication Program for bovine tuberculosis (referred to below as the bovine tuberculosis program) and a National Cooperative State/Federal Eradication Program for brucellosis (referred to below as the brucellosis program). The programs sought to eradicate the diseases from the nation's cattle herds by quickly responding to brucellosis and bovine tuberculosis outbreaks, identifying and quarantining affected herds, and depopulating these herds. To foster producer compliance with herd depopulation, the United States Department of Agriculture (USDA) regularly compensated the owners of depopulated herds.

In support of these programs, USDA issued regulations. These regulations established State classification systems for brucellosis and bovine tuberculosis based on disease prevalence within a State. The regulations further required that these prevalence levels be supported by surveillance (inspection and periodic testing) of cattle within the State and specified that, for a State to maintain its classification, affected herds within a State had to be depopulated within a certain period of time. Finally, the regulations specified testing requirements and movement restrictions for cattle moved interstate from certain classes of States.

Since their inception, these regulatory programs have proven extremely successful in reducing the prevalence of brucellosis and bovine tuberculosis within the United States. Based on routine inspection conducted by USDA's Food Safety Inspection Service (FSIS) of cattle slaughtered at slaughtering establishments, brucellosis currently affects less than 0.001 percent of all domestic program herds, and bovine tuberculosis less than 0.001 percent of all such herds. Under the standards of the World Organisation for Animal Health (OIE), these prevalence levels, excluding consideration of other OIE standards, are, in and of themselves, consistent with a “free” status for brucellosis and bovine tuberculosis.

However, in recent years, several factors have arisen to impede our brucellosis and bovine tuberculosis eradication efforts. First, reservoirs of brucellosis and bovine tuberculosis have been identified in wildlife populations in certain areas of the

country. These affected wildlife populations pose a risk of transmitting brucellosis or bovine tuberculosis to livestock in the areas on a recurring basis, potentially resulting in brucellosis and bovine tuberculosis becoming endemic in livestock in certain areas of the country.

Second, since USDA established regulatory programs for brucellosis and bovine tuberculosis, the cattle industry within the United States has changed substantially, and other ruminant industries have arisen. Cattle producers have increasingly relied on imported cattle to supplement their domestically raised stock, exposing the domestic herd to animals that originate from regions with diverse risk statuses. Cattle herd sizes have increased significantly, and market channels have become increasingly complex. Additionally, producers of bison and captive cervids, two species that are also susceptible to brucellosis and bovine tuberculosis, have established industries, and interstate movement of bison and captive cervids has increased accordingly.

These industry changes have led us to reevaluate the programs' traditional reliance on whole herd depopulation as the sole means of managing affected herds. As the prevalence levels for brucellosis and bovine tuberculosis have decreased within the United States, funds allocated to Federal and State departments of agriculture to indemnify the owners of depopulated herds have similarly decreased. As a result, because of current herd sizes, which are often significantly larger than when the programs were established, if brucellosis or bovine tuberculosis is detected in a herd and the herd is depopulated, it is often difficult, if not impracticable, to indemnify the owner for all animals that are destroyed. Similarly, because of current marketing practices, USDA has become increasingly aware of the impacts on local and regional markets that may be caused by whole herd depopulation of a large herd. Accordingly, in the past decade, USDA has evaluated the efficacy of other methodologies to deal with affected herds.

In 2009, USDA's Animal and Plant Health Inspection Service (APHIS) issued concept papers that outlined these factors and suggested several modifications to the brucellosis and bovine tuberculosis programs that would address the factors. Suggested modifications included:

• Crafting national surveillance plans for the programs to target areas within the United States where prevalence levels may be higher than the national average.

• Enhancing existing efforts to mitigate disease transmission from wildlife to livestock.

• Developing regulatory alternatives to whole-herd depopulation.

The comment period for each concept paper was 60 days. By the close of the comment period for the brucellosis concept paper, we had received 344 comments, from State departments of agriculture, advocacy groups, livestock producers, and private citizens. By the close of the comment period for the bovine tuberculosis concept paper, we had received 73 comments, from State departments of agriculture, representatives for foreign governments, advocacy groups, representatives for the cattle industry within the United States, cattle producers, and private citizens. While several commenters expressed concern regarding some of the suggested modifications, commenters did not present information that called into question the approaches presented in the two documents.

Accordingly, APHIS subsequently issued a rule and order that modified aspects of the brucellosis and bovine tuberculosis programs in accordance with the concept papers. In April 2010, APHIS issued a Federal Order

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that allows States to retain the highest bovine tuberculosis classification, accredited-free, regardless of the number of affected herds in the State, provided that all affected herds in the State that are not depopulated are quarantined; an affected herd plan is developed for each of these herds to prevent the spread of tuberculosis; the herds are subject to periodic testing and animals that do not test negative are destroyed; and the State conducts sufficient surveillance to identify tuberculosis in other animals. Since most States had accredited-free status at the time the order was issued, the order was meant, in part, to result in depopulation no longer being considered the sole means of dealing with affected herds within the bovine tuberculosis program.

1

To view the Federal Order, go to

http://digitalcommons.unl.edu/cgi/viewcontent.cgi?article=1031&context=michbovinetb.

On December 27, 2010, APHIS published an interim rule

2

in the

Federal Register

(75 FR 81090-81096, Docket No. APHIS-2009-0083). Among other things, this rule required States with the highest classification for brucellosis, Class Free, that also have brucellosis in wildlife to develop and implement a brucellosis management plan approved by APHIS that specifies surveillance and mitigation measures for these wildlife reservoirs. The interim rule was intended, in part, to couple the brucellosis program's traditional focus on response to disease in domestic herds with a new focus on sources of disease introduction.

2

To view the interim rule, go to

http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0083-0001.

Concurrent with the issuance of this order and rule, APHIS also formed a bovine tuberculosis/brucellosis working group. The working group, composed of Federal, State, and Tribal representatives, was tasked with crafting a regulatory framework for consolidating the brucellosis and bovine tuberculosis programs into a single, streamlined program. Using the concept papers, the April 2010 Federal Order, and the December 2010 interim rule as reference points, and after extended discussion and dialogue with stakeholders, the working group drafted a framework comprising eight elements, or interrelated regulatory concepts: Program (State) requirements; zoning; surveillance; affected herd management and epidemiological investigations; indemnity; interstate movement controls; importation requirements; and approval procedures related to official tests and laboratories. On May 5, 2011, APHIS made the draft regulatory framework document available on Regulations.gov for review and comment.

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To view the framework or the comments we received, go to

http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0044.

We took comment on the draft regulatory framework document for 60 days, ending July 5, 2011. We received 37 comments by that date. They were from State departments of agriculture, an organization representing dairy cattle producers throughout the United States, organizations representing the cattle industry, a wildlife conservation organization, and several private citizens. Based on the draft regulatory framework document and the comments we received, we have developed and are issuing this proposed rule.

However, in response to comments received on the framework document and ongoing discussion with stakeholders, this proposed rule does not include several of the regulatory requirements suggested in the framework. We discuss significant divergences immediately below, by element.

Element 1, State (Program) Requirements, suggested creating a control or advisory board of Federal, State, and Tribal experts to provide APHIS with recommendations regarding

State compliance with regulatory requirements as well as recommendations regarding State status classifications.

Many commenters supported the establishment of such a board, but stated that the board should have industry representation. The commenters put forth a number of scenarios in which industry personnel would have specialized expertise that Federal, State, and Tribal personnel would not possess.

We agree that industry personnel often possess such technical expertise, and foresee circumstances where we may need to solicit such expertise under a consolidated brucellosis and tuberculosis program. However, a board with industry representation that provides general recommendations to APHIS would be considered an advisory committee under the Federal Advisory Committee Act (5 U.S.C., appendix, FACA), and would thus be subject to the requirements of that Act. FACA requires advisory committees to follow an extensive protocol before convening a meeting of the committee, and this protocol could, in certain instances, preclude the advisory board from providing APHIS with timely advice regarding program activities.

Accordingly, instead of an advisory board, APHIS would solicit the opinion of technical experts at the Federal, State, Tribal, and industry level as circumstances warrant under the consolidated brucellosis and bovine tuberculosis program.

Element 2, Zoning, suggested that, if reservoirs of bovine tuberculosis or brucellosis are identified in an area of the United States and the outbreak cannot be eradicated within 1 year, then zoning the area for the disease or diseases should be considered as a management method. It further suggested that, if zoning is pursued, the zones should not be limited by geopolitical boundaries unless warranted.

A number of State departments of agriculture pointed out that their jurisdiction over matters of livestock health ends at State boundaries. The commenters expressed concern that, if a single zone was composed of areas in multiple States, and one of the States failed to adhere to the requirements of the regulations, all of States would be subject to remedial measures, even though the other States have no jurisdiction over the activities conducted in that State.

In light of the commenters' concerns, while this proposed rule does allow for zones, which we term recognized management areas, States would request recognition of those areas within their particular State, and the boundaries of the recognized management area would not extend beyond State borders.

Element 5, Indemnity, proposed streamlining the process for the payment of indemnity for animals destroyed because of brucellosis or bovine tuberculosis by means of an appraisal calculator.

Several commenters supported the use of such a calculator in theory, but stated that they would need to see a demonstration of such a calculator in order to assess its accuracy and viability as a means of appraisal.

We agree that streamlining the indemnity regulations in the manner proposed in the framework document presupposes deployment of such a calculator. Since the calculator is still being developed and tested, we have decided not to propose to modify the indemnification process in the manner suggested by the framework document in this proposed rule. As a result, this proposed rule would not modify current indemnity practices, which rely on fair market value as determined by an appraiser, for bovine tuberculosis, and on either a fixed rate or fair market value as determined by an appraiser, for brucellosis.

Finally, element 7, Import Requirements, set forth a number of suggested post-entry requirements for ruminants imported into the United States to address the risk that such ruminants may pose of introducing brucellosis or bovine tuberculosis into the United States.

Several commenters suggested that, in light of our limited resources, APHIS would be better served by evaluating our existing import requirements for ruminants to determine whether, in every instance, they mitigate the risk of introduction of brucellosis or bovine tuberculosis.

We have conducted such a risk evaluation. We have concluded that the current import requirements do not always mitigate such risk, and are proposing to amend them accordingly.

Legal Authority for the Regulatory Action

Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301

et seq.

), the Secretary of Agriculture has the authority to issue orders and promulgate regulations to prevent the introduction into the United States and the dissemination within the United States of any pest or disease of livestock. APHIS' regulations in 9 CFR chapter I, subchapter C contain requirements for the interstate movement of livestock to prevent the dissemination of diseases of livestock within the United States. APHIS' regulations in 9 CFR chapter I, subchapter D contain requirements for the importation of livestock to prevent the introduction or dissemination of diseases of livestock into the United States.

II. Summary of the Major Provisions of the Proposed Rule

This proposed rule would remove the regulations governing the bovine tuberculosis program, currently found in 9 CFR part 77, and those governing the aspects of the brucellosis program that pertain to cattle and bison, currently found in 9 CFR part 78, subparts B and C. In their place, it would add a new part to the regulations, 9 CFR part 76. This part, which would be titled “Part 76—Brucellosis and Bovine Tuberculosis,” would contain regulations governing a national program designed to eradicate both diseases from cattle, bison, and captive cervids (“program animals”) in the United States.

As the regulations in 9 CFR parts 77 and 78 currently do, these proposed regulations would provide a system to classify States for brucellosis and bovine tuberculosis. However, the classification system would no longer be based on the prevalence level of these diseases within a State. Rather, the system would be based on whether a State has drafted an animal health plan to address the diseases, whether APHIS has approved this plan, and whether the State has implemented and is maintaining the activities specified within the plan. We would also allow Tribes to submit plans and request brucellosis and bovine tuberculosis statuses apart from the State in which their Tribal lands are located. In order for APHIS to have adequate assurances that States and Tribes have implemented and are maintaining the activities and measures specified in their plan, the classification system would also be based, in part, on regular and timely submission of reports regarding these activities and measures.

In an animal health plan, the State or Tribe would have to specify whether any known sources of brucellosis or bovine tuberculosis exist within the State or Tribal lands; this is no change from current obligations within the brucellosis and bovine tuberculosis programs with regard to alerting APHIS when new sources of brucellosis or bovine tuberculosis are discovered in State or Tribal lands. If there are known sources of those diseases in the State or Tribal lands, the State or Tribe would have to conduct surveillance of those sources and of the cattle, bison, or captive cervids that may come in

contact with the sources, and would have to specify mitigations that address the risk of disease spread to these at-risk populations.

Regardless of whether there are known sources of disease in the State or Tribal lands, States and Tribes would also have to provide APHIS with demographics regarding cattle, bison, and captive cervids within the State, a list of personnel assigned to implement and perform activities and maintain and enforce measures associated with their animal health plans, and confirmation that the State or Tribe has a legal and regulatory basis for the activities specified within the animal health plan. Additionally, States or Tribes would have to agree to conduct epidemiological investigations and affected herd management in accordance with the protocols set forth in the sections of the regulations that would pertain to these activities, or would have to submit an alternate method to APHIS for evaluation and approval.

The proposed rule includes protocols for epidemiological investigations into an investigation of individual cattle, bison, or captive cervids that have had non-negative test results for brucellosis. This proposal includes protocols for four types of epidemiological investigations:

• Investigations arising because individual cattle, bison, or captive cervids have been determined to be infected with brucellosis or bovine tuberculosis;

• Investigations arising because a herd of cattle, bison, or captive cervids has been determined to be affected with brucellosis or bovine tuberculosis;

• Investigations arising because animals other than cattle, bison, or captive cervids have been determined to be infected with brucellosis or bovine tuberculosis, and cattle, bison, or captive cervids in the area surrounding these animals have been determined by APHIS to be at-risk because of exposure to this source; and

• Investigations arising because brucellosis or bovine tuberculosis has been detected at a calf raiser or feedlot, where cattle or bison from disparate premises of origin are brought together for feeding purposes.

States and Tribes could manage affected herds through whole-herd depopulation or a test-and-remove protocol. The minimum standards for a test-and-remove protocol would be similar to those found in the April 2010 Federal Order.

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See footnote 1.

States and Tribes would have the option of requesting recognition of a management area within the State or Tribal lands. The management area would be a clearly delineated geographical area of the State or Tribal lands in which the State or Tribe has detected brucellosis or bovine tuberculosis, in which the State or Tribe has determined that there is a risk of transmission of brucellosis or bovine tuberculosis to program animals, and in which the State or Tribe has taken or proposes to take measures to control the spread of the brucellosis or bovine tuberculosis within and from the area and/or to eradicate the disease within the area. These measures would have to include restrictions on the movement of cattle, bison, and captive cervids from the recognized management area, as well as certain other measures. Recognized management areas would allow States and Tribes to designate certain areas of the State or Tribal lands as posing a greater risk of brucellosis and bovine tuberculosis spread than other areas within the State or Tribal lands, without risking a possible redesignation of the State or Tribe to a lower State or Tribal classification.

The regulations would also provide conditions for the interstate movement of cattle, bison, and captive cervids. Except for cattle and bison that belong to certain, high-risk categories, the conditions for interstate movement of most cattle and bison would be based on the status of the State or Tribe from which the cattle or bison are moved. Cattle and bison from a State or Tribe with the lowest status would be considered to pose a substantial risk of transmitting brucellosis and/or bovine tuberculosis, and thus would be subject to testing prior to interstate movement.

Captive cervids would be subject to testing for both brucellosis and bovine tuberculosis prior to interstate movement, regardless of the status of the State or Tribe from which they are moved. Such testing would be necessary because FSIS does not currently conduct slaughter inspection of captive cervids and because the actual prevalence of brucellosis and bovine tuberculosis within the domestic captive cervid industry are largely unknown.

Finally, the proposed rule would revise the conditions for the importation of cattle and bison that are contained in 9 CFR part 93 and that address the risk the imported cattle or bison may pose of disseminating brucellosis or bovine tuberculosis. The current regulations, which may be divided into requirements that are generally applicable to most exporting countries and country-specific requirements that are applicable to Canada, Mexico, and Ireland, do not account for changes in disease programs or disease prevalence that could increase or decrease the risk of spread of brucellosis or bovine tuberculosis posed by the importation of cattle or bison from foreign regions.

Accordingly, we evaluated this risk to determine whether to modify the current regulations, and, if so, how. The risk evaluation examines two possible modifications: (1) Adopting international standards developed by the OIE or (2) applying the U.S. prevalence-based requirements delineated in the current Uniform Methods and Rules

5

for the bovine tuberculosis and brucellosis programs within the United States to the importation of bovines from foreign regions.

5

The bovine tuberculosis Uniform Methods and Rules are located here:

https://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf.

The brucellosis Uniform Methods and Rules are located here:

https://www.aphis.usda.gov/animal_health/animal_diseases/brucellosis/downloads/umr_bovine_bruc.pdf.

The risk evaluation finds that, based on current import practices, both the OIE standards and our domestic requirements could help mitigate to a certain extent the risk that cattle and bison imported into the United States may present of spreading brucellosis or bovine tuberculosis. However, only the domestic requirements, applied to foreign regions, would reduce such risk to negligible levels. Additionally, the domestic requirements would mitigate such risk while leaving substantially unchanged our current country-specific requirements regarding the importation of steers and spayed heifers into the United States. Steers and spayed heifers currently account for the majority of live cattle and bison imported into the United States.

The provisions of this proposed rule are based on the findings of this risk evaluation. The proposed rule would remove most of the brucellosis- and bovine tuberculosis-specific requirements for the importation of cattle and bison from the regulations. In their place, the proposed rule would establish a system, modeled on the domestic requirements, that would classify a region

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of the world based

both on its brucellosis or bovine tuberculosis prevalence and on whether it has a program for brucellosis or bovine tuberculosis that meets certain standards. The classifications would be as follows: Level I through V for bovine tuberculosis, and Level I through III for brucellosis. The regulations would allow regions to request evaluation for a particular classification, would establish a process by which APHIS would evaluate such requests, and would allow APHIS to lower a region's classification based on emerging evidence. Finally, the proposed rule would establish conditions for the importation of cattle and bison that correspond to the bovine tuberculosis or brucellosis classification of the region from which the cattle or bison will be exported.

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A region is defined in § 93.400 as “any defined geographic land area identifiable by geological, political, or surveyed boundaries. A region may consist of any of the following: (1) A national entity (country); (2) a part of a national entity (zone, county, department, municipality, parish, Province, State, etc.); (3) parts of several national entities combined into an area; or (4) a group of national entities (countries) combined into a single area.”

III. Costs and Benefits

Economic effects of the proposed rule are not expected to be significant. Bovine tuberculosis affects less than 0.001 percent of domestic program herds, and brucellosis also less than 0.001 percent. There would be few on-the-ground operational changes for States or producers. Most reporting requirements in areas where bovine tuberculosis and brucellosis are not found, as well as surveillance, movement limitations, testing, and reporting in areas where either disease is present, would continue with little alteration.

Certain additional costs incurred by States, Tribes, and producers as a result of this proposed rule are expected to total between $3.0 million and $8.5 million. States and Tribes would incur costs in developing the proposed animal health plans for bovine tuberculosis and brucellosis, which would build significantly on existing operations with respect to these diseases. We anticipate that all 50 States and at least 3 Tribes would develop animal health plans. We estimate that the aggregate one-time cost of developing all of these animal health plans would be between about $750,000 and $2.9 million.

States and Tribes would also be required to report on the results of epidemiological investigations. We expect that the total annual cost for all States and Tribes of this reporting would be between $119,000 and $142,000.

We expect that, under current circumstances, four or five States are likely to develop recognized management area plans as proposed in this rule as part of their animal health plans. We estimate that the aggregate one-time cost of developing these four or five plans would be between $56,000 and $274,000.

The proposed rule would impose new interstate movement restrictions on rodeo, event, and exhibited cattle and bison, as well as additional costs of testing for producers of such cattle and bison. Costs of tuberculosis and brucellosis testing, about $10 to $15 per test, are small when compared to the value of the cattle tested or to production costs.

Given the volume of interstate movement of rodeo, event, and exhibited cattle and bison, the proposed testing requirements could cost owners of these cattle and bison, in aggregate, between about $2.0 million and $4.8 million annually.

Because the testing requirements in this rule are for interstate movement, the annual impact for an individual would depend on the number of animals moved interstate in a given year. It should be noted that there is overlap between APHIS' proposed testing requirements and current State and event requirements for testing of rodeo, event, and exhibition cattle and bison, which would reduce the net impact. A number of States, particularly those on major event circuits, already require tuberculosis and brucellosis testing before cattle can enter the State. There is not, however, consistency across States as to the timing of the testing relative to entry. Additionally, a number of these States have indicated to APHIS that they adopted the requirements because of the lack of Federal requirements. If this proposed rule is finalized and they rescind those requirements, this rule could eliminate that inconsistency. We request public comment from States with such requirements regarding whether they would, in fact, rescind them based on our proposed requirements.

This rule will also impose testing requirements for brucellosis for captive cervids moved interstate for any purpose other than immediate slaughter. We do not currently have information regarding the number of captive cervids moved interstate. However, based on the number of deer farms within the United States, industry estimates that between 5 and 10 percent of captive cervids within the United States are moved interstate annually, and brucellosis testing costs, we estimate the total annual testing costs would range between about $124,000 and $382,000.

The proposed rule would also establish a new system for classifying foreign regions regarding bovine tuberculosis and brucellosis and establishing the conditions under which cattle and bison could be imported into the United States. All foreign regions that currently export cattle to the United States would be evaluated under this new process before the conditions are put into effect. Conditions could change for a particular region following evaluation under this new system.

That being said, based on our knowledge of the current brucellosis and bovine tuberculosis programs and prevalence rates of our trading partners, we do not expect requirements for the importation of cattle and bison from foreign regions to change significantly as a direct result of this proposed rule. There are two specific exceptions to this, however. These exceptions would involve additional testing for breeding cattle from Mexico intended for export to the United States. Because most bovine exporting regions in Mexico do not currently have established brucellosis programs, they would automatically be classified in the lowest brucellosis category in this proposal and an additional whole herd brucellosis test would be required for imports of sexually mature and sexually intact cattle,

i.e.,

breeding cattle, from those regions. In addition, exporting regions currently considered Accreditation Preparatory (AP) for tuberculosis would likely be classified as Level IV under this proposal and an additional whole herd tuberculosis test would be required for imports of breeding cattle from those regions.

The impact of these additional test requirements is expected to be very limited. A very small number of breeding cattle are imported from Mexico. From 2010 through 2014, 26 breeding cattle were imported from Mexico on average annually. An even smaller number come from regions of Mexico that would be subject to additional whole herd tuberculosis testing requirements as well as the additional whole herd brucellosis testing. In 2014, only six breeding cattle were imported from such regions of Mexico. The cost of the additional testing would be dependent on the size of the herd from which bovines destined for export originate and the cost of administering a brucellosis and/or a tuberculosis test within that region of Mexico. The additional cost would represent a small portion of the value of the imported bovines. Assuming the costs of brucellosis and tuberculosis testing in the United States and in Mexico are similar, the combined additional testing would be equivalent to between 1.2 and 1.9 percent of the average per head value ($1,560) of imported Mexican breeding bovines, 2009-2014.

As discussed immediately above, we expect that the economic effects of this rule on foreign producers of cattle and bison would be minimal. With regard to domestic production, we expect that the benefits would justify the costs. While direct effects of this proposed rule for producers should be small, whether the entity affected is small or large, consolidation of the brucellosis and bovine tuberculosis regulations would benefit the affected livestock industries. The use of animal health plans would require States to identify and monitor potential sources of disease transmission in their State, leading to more focused, flexible and responsive disease management and reducing the number of producers that incur costs when disease concerns arise in an area.

The Role of the Program Standards Document

In several instances, the proposed rule provides general standards for activities conducted by a State or Tribe with an animal health plan that has been approved by APHIS, such as surveillance, epidemiological investigations, and affected herd management. In these instances, the proposed regulations do not specify in detail the procedures that would meet these standards in different situations.

To that end, APHIS is also making a Program Standards document available for review and comment along with the proposed rule.

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The Program Standards document is a guidance document to help States and Tribes meet the standards of the proposed regulations. The Program Standards document does this by providing States and Tribes with an APHIS-approved method for conducting certain activities. These APHIS-approved methods would not be requirements, and States and Tribes could submit alternate procedures that they believe to meet the performance standards in the regulations to APHIS for evaluation and approval. However, if a State or Tribe follows the methods in the Program Standards document, they would be assured of complying with the regulations.

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The Program Standards document is available at the Web address listed in this document beneath the heading

ADDRESSES

and at the following address:

http://www.aphis.usda.gov/animal_health/animal_dis_spec/cattle.

The Program Standards document also provides guidance regarding the types of information a State or Tribe should include in its animal health plan, templates for the various reports that we would require, flowcharts regarding the processes by which APHIS would evaluate animal health plans and redesignate States or Tribes to lower classifications for brucellosis or bovine tuberculosis, and other information.

We encourage individuals to read the proposed rule in conjunction with the Program Standards document. We also seek specific comment regarding ways in which the Program Standards document could be amended to make it more useful for potentially regulated entities.

Proposed Part 76

Definitions (§ 76.0)

Section 76.0 would contain definitions of the following terms:

Accredited herd for bovine tuberculosis, accredited herd for brucellosis,

accredited veterinarian, Administrator,

affected herd management plan, animal identification number (AIN),

annual report form, APHIS,

APHIS representative, bison,

bovine tuberculosis, brucellosis,

calf raiser, captive cervid,

depopulate, epidemiologist designated by the District Director,

exposed, feedlot,

herd, herd test,

immediate slaughter, interstate certificate of veterinary inspection (ICVI),

livestock, location-based numbering system,

location identification (LID) number, management area,

National Uniform Eartagging System (NUES), official Brucella vaccine,

official brucellosis vaccination program, official eartag,

official eartag shield, official identification number,

officially identified, official seal,

official test, official tester,

official testing laboratory, owner,

permit for movement of restricted animals, premises identification number (PIN),

program animals, Program Standards document,

qualified accredited veterinarian, quarantine feedlot,

quarantine pen, reactor,

recognized slaughtering establishment, reporting period,

responsible person, spayed heifers,

specifically approved stockyard, State,

State or Tribal animal health official, State or Tribal representative,

steers, suspect,

test-eligible animal, Tribe,

and

United States.

If a definition of one of these terms exists in the AHPA, we would define the term as it is defined in the AHPA. Thus, we would define

livestock, State,

and

United States

as these terms are defined in the AHPA.

Similarly, the AHPA provides that

Indian tribe

has the same meaning within the Act that it has in section 450b of title 25 of the U.S. Code. That title, also referred to as the Indian Self-Determination and Education Assistance Act, defines Indian tribe as “any Indian tribe, band, nation, or other organized group or community, including any Alaska Native village or regional or village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688) [43 U.S.C. 1601

et seq.

], which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians.”

If a term in proposed part 76 is not defined in the AHPA, our next reference points would be the existing definitions in 9 CFR parts 77 and 78. To that end, several terms would have the same meaning as they currently do within parts 77 and 78. We would define

Administrator, animal identification number (AIN),

APHIS representative, location-based numbering system,

National Uniform Eartagging System (NUES), official eartag,

official eartag shield, official identification number,

and

recognized slaughtering establishment

as these terms are currently defined in both part 77 and part 78.

Similarly,

accredited veterinarian

is defined in a substantially similar manner in parts 77 and 78, but with minor differences in syntax and scope. However, the definition in part 78 is more common within 9 CFR. Hence, we would define

accredited veterinarian

as it is defined in that part.

The term

captive cervid

is currently defined in part 77, but not part 78. This is because captive cervids are currently regulated under the bovine tuberculosis program, but not under the brucellosis program. We would therefore define the term

captive cervid

as it is currently defined in part 77.

We would define the remaining terms in the following manner.

We would define an

accredited herd for bovine tuberculosis

as a herd that, in accordance with APHIS' standards for accreditation, has tested negative for bovine tuberculosis using an official test and is subject to measures that lower the risk of bovine tuberculosis introduction into the herd through the addition of animals to the herd. Similarly, we would define an

accredited herd for brucellosis

as a herd that, in accordance with APHIS' standards for accreditation, has tested negative for brucellosis using an official test and is subject to measures that lower the risk of brucellosis introduction into the herd through the addition of animals to the herd. These definitions would further provide that APHIS' standards for accreditation are described in the Program Standards document.

The standards for accreditation for bovine tuberculosis and brucellosis in the Program Standards document would be substantively similar to the current

standards for accreditation of herds within the bovine tuberculosis program, which are found in the document “Bovine Tuberculosis Eradication, Uniform Methods and Rules, Effective January 1, 2005”

8

and the current standards for certification of herds as free of brucellosis, which are found in part 78. However, certain aspects of the existing standards, such as the minimum age of animals that must be tested and the intervals between testing for reaccreditation, are linked to the current prevalence-based State classification system, which would be obsolete under the provisions of this proposed rule. Moreover, the existing standards do not reflect certain practices, such as testing of certain non-natural additions to a herd, that we have long required operationally in order for us to reach a determination that animals in the herd are free of brucellosis or bovine tuberculosis, and which would be included in the standards in the Program Standards document. Thus, there would be several differences between the current standards for herd accreditation or certification and the standards within the Program Standards document.

8

To view the Uniform Methods and Rules, go to

http://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf.

We wish to solicit specific public comment regarding one of these differences. Currently, if a State has a zone for bovine tuberculosis or an area covered by a brucellosis management plan, in other words, an area in which a source of bovine tuberculosis or brucellosis is known to exist, we allow herds in the area to be accredited for bovine tuberculosis or certified free of brucellosis.

However, we have discovered bovine tuberculosis or brucellosis in several accredited herds in such areas, sometimes no more than a few months after the date of reaccreditation. In each case, there was evidence that the herds probably became affected through contact with infected wildlife.

Our standards for accreditation, both our current standards and those proposed, are based on an evaluation of mitigation measures an owner has put in place to address the risk of bovine tuberculosis or brucellosis introduction into his or her herd through the addition of animals to the herd. Our standards do not evaluate the risk posed to a herd by wildlife reservoirs of bovine tuberculosis or brucellosis. We note, moreover, that it is significantly more difficult to mitigate the risk of disease transmission that is posed by wildlife reservoirs than it is to mitigate the risk of disease transmission that is posed by adding animals to a herd. In short, while we have confidence that accredited or certified herds that do not reside in areas with known disease reservoirs present a low risk of becoming affected with bovine tuberculosis or brucellosis, we do not have the same degree of confidence regarding herds in areas with known reservoirs of disease.

For this reason, our proposed standards would not allow herds in areas with known reservoirs of disease, which we would term management areas (see below), to be accredited for bovine tuberculosis or brucellosis. We also would not allow owners of currently accredited herds in such areas to seek reaccreditation if this rule is finalized. We request comment from these owners and all interested parties regarding the likely impacts to their operations, if any, that this change in policy would bring about.

Apart from herds in recognized management areas, herds that are accredited for bovine tuberculosis would continue to be considered accredited herds if this proposed rule is finalized, and herds that are certified brucellosis-free herds would be considered accredited herds for brucellosis. Owners of these herds would not be held to the differing standards of the Program Standards document until the time that the herds would have to be tested for reaccreditation. Moreover, as the definitions of

accredited herd for bovine tuberculosis

and

accredited herd for brucellosis

would provide, States could submit an alternate accreditation standard to the Administrator for evaluation and approval at any point by sending a written request to APHIS, provided that the standard is at least equally stringent to that within the Program Standards document.

We would define

annual report form

as the annual report form authorized by the Administrator for State and Tribal use to fulfill the requirements of proposed part 76. The report form, which would consolidate and streamline existing annual report forms for the brucellosis and bovine tuberculosis programs, would be located on the APHIS Web site. A draft template for the annual report form is located in the Program Standards document.

On a related matter, we would define the

reporting period

covered by the annual report as October 1 of one year through September 30 of the following year. This is the current reporting period for annual reports within the bovine tuberculosis program. (We recognize that the reporting period for annual reports within the brucellosis program is currently staggered, and corresponds to the date on which a State was assigned its current status. If this rule is finalized, we would collaborate with States to transition them over to this new, uniform reporting period.)

We would define

APHIS

as the Animal and Plant Health Inspection Service of the United States Department of Agriculture.

We would define

bison

as domestically produced or captive bison. As provided in the definition of

program animals

(see below), bison would be considered one of the species covered by part 76. However, wild bison are not considered livestock within our proposed regulations, and our definition of

bison

would reflect this. We would also include this definition so that, for the sake of brevity, we may refer to the species covered by the regulations as bison, rather than domestically produced or captive bison, throughout part 76.

We would define

bovine tuberculosis

as the contagious, infectious, and communicable disease caused by

Mycobacterium bovis,

which is also referred to as tuberculosis.

Currently, part 77 refers to the disease as tuberculosis, and provides, in the definition of

tuberculosis,

that the disease is also referred to as bovine tuberculosis. However, in recent years, we have referred to the disease as bovine tuberculosis in order to provide clarity regarding the causal agent regulated by the bovine tuberculosis program and to differentiate between this agent and

Mycobacterium tuberculosis,

the most common cause of tuberculosis in humans.

We would define

brucellosis

as the contagious, infectious, and communicable disease caused by

Brucella abortus,

and would specify that it is also known as Bangs disease, undulant fever, and contagious abortion. Currently, in the definition of

brucellosis

in part 78, we consider all bacteria within the genus

Brucella

to be causal agents for brucellosis. However, this is primarily because another species of

Brucella, Brucella

suis,

which is the most common cause of brucellosis in swine, is also regulated in part 78.

Brucella abortus

is the most common cause of brucellosis in cattle, bison, and captive cervids, the species that would be regulated under the consolidated brucellosis and bovine tuberculosis program. Hence, as we stated in the draft regulatory framework document,

Brucella abortus

would be the disease agent regulated under proposed part 76.

(We would continue to regulate

Brucella suis

in swine under part 78 and would continue to investigate

occurrences of

Brucella suis

infection in ruminants as part of our national program for swine brucellosis. In addition, based on comments received on the draft regulatory framework document, we request specific public comment on whether to initiate rulemaking to establish a certification program for

Brucella melitensis

in goats.)

We would define

calf raiser

as a cattle production operation in which calves, yearlings, and other sexually immature cattle are brought together and maintained until they are of sufficient size or sexual maturity to move to their next stage of production. As we mentioned previously in this document, because cattle from disparate premises of origin are often brought together for feeding purposes at such operations, the provisions of part 76 that pertain to epidemiological investigations, which would be contained in proposed § 76.7, would specify a different protocol for epidemiological investigations arising because an infected animal is discovered at a calf raiser than for epidemiological investigations arising at other premises where such commingling does not occur or is far less frequent.

We would define

program animals,

that is, the species covered by proposed part 76, as cattle, bison, and captive cervids.

We would define

depopulate

as to destroy program animals in a herd at a location, in a manner, and within a timeframe as specified within an affected herd management plan. We would define an

affected herd management plan

as an affected herd management plan designed by the herd owner, the owner's veterinarian if so requested, and a State, Tribal, or APHIS representative to control and eradicate bovine tuberculosis and/or brucellosis within the herd. The definition of

affected herd management plan

would further specify that an affected herd management plan must be approved by a State or Tribal animal health official and the Administrator.

The current definition of

depopulate

within part 77, “to destroy all livestock in a herd by slaughter or by death otherwise,” does not contain a reference to affected herd management plans. However, as a matter of Agency policy, we have generally required affected herd management plans to be put in place prior to depopulation of any brucellosis- or bovine tuberculosis-affected herd. Among other benefits, such plans help ensure that brucellosis- or bovine tuberculosis-affected herds are depopulated in a sanitary manner and owners of depopulated herds put measures in place to prevent the future introduction of brucellosis or bovine tuberculosis into herds at their premises.

The definition in part 77 also specifies that all animals within a herd must be destroyed in order for the herd to be considered depopulated. However, within the brucellosis program, there have been several instances in recent years in which we have considered a herd to be depopulated although certain animals within the herd were removed from the herd for diagnostic purposes, and not destroyed. In such instances, the affected herd management plan established for the affected herd provided the specific conditions under which these animals would be moved in order to ensure that they presented no risk of spreading brucellosis to other animals. Moreover, although the bovine tuberculosis program does not currently allow for such a practice, we can envision instances in which it might prove beneficial in order for us to determine the actual prevalence of the disease within an affected herd. Accordingly, we would not specify that all animals within a herd must be destroyed in order for the herd to be considered depopulated.

On a related matter, part 50, which provides conditions under which the Administrator may pay indemnity for animals destroyed because of bovine tuberculosis, effectively precludes indemnity from being offered if animals are removed from an affected herd prior to depopulation of the herd. Therefore, we are proposing to remove paragraph (f) of § 50.14, which contains this prohibition.

We would define

epidemiologist designated by the District Director

as an epidemiologist selected by the APHIS District Director, in consultation with State or Tribal animal health officials, to perform the function required. This definition is modeled on the definition of

designated epidemiologist

currently found in part 78, but also reflects a recent reorganization of APHIS' Veterinary Services program that changed the manner in which this position is designated.

We would define

exposed

as an animal that has had association with infected program animals, livestock, or other sources of brucellosis or bovine tuberculosis such that an epidemiologist designated by the District Director determines the animal may be infected.

We would define

feedlot

as a facility for assembling and feeding program animals.

We would define

quarantine pen

as an area within a feedlot that is approved by APHIS as having sufficient biosecurity measures in place to assemble and feed exposed program animals, without risk of spread of brucellosis or bovine tuberculosis to other susceptible animals at the facility. Similarly, we would define

quarantine feedlot

as a facility that is approved by APHIS as having sufficient biosecurity measures in place to assemble and feed exposed program animals, without risk of spread of brucellosis or bovine tuberculosis to other susceptible animals at the facility. The definitions of

quarantine pen

and

quarantine feedlot

would also both specify that program animals may only be moved interstate from such facilities if their movement is to a recognized slaughtering establishment, or another quarantine pen or quarantine feedlot.

We recognize that certain subsectors within the cattle industry refer to feedlots as feedyards. We request specific public comment regarding which nomenclature to use.

In proposed § 76.10, we would allow program animals classified as exposed to brucellosis or bovine tuberculosis to be moved interstate to quarantine pens and quarantine feedlots, among other approved locations.

We would define

herd

as all livestock under common ownership or supervision that are grouped on one or more parts of any single premises (lot, farm, or ranch) for at least 4 months; or all livestock under common ownership for at least 4 months on two or more premises which are geographically separated but on which animals from the different premises have been interchanged or had contact with each other. This definition would be modeled on the definition currently found in part 78, but would include a provision, currently found in part 77's definition, that livestock must be under common ownership or supervision for at least 4 months in order to be considered a herd. We consider this provision necessary in order to differentiate herds from animals maintained at a calf raiser's premises or at a feedlot for a short period of time.

Herd test

would have different meanings for brucellosis and bovine tuberculosis. For brucellosis, it would mean the following:

• In any area of a consistent State other than a recognized management area, testing of all sexually intact animals within a herd that are 18 months of age or older, as well as all sexually intact animals in the herd that are less than 18 months of age and were not born into the herd, except those sexually intact animals that are less than 18 months of age and originate directly from a currently accredited herd for brucellosis.

• In any area of a provisionally consistent State other than a recognized management area, testing of all sexually intact animals within a herd that are 12 months of age or older, as well as all sexually intact animals in the herd that are less than 12 months of age and were not born into the herd, except those sexually intact animals that are less than 12 months of age and originate directly from a currently accredited herd for brucellosis.

• In any area of an inconsistent State, or in a recognized management area for brucellosis, testing of all sexually intact animals within a herd that are 6 months of age or older, as well as all sexually intact animals in the herd that are less than 6 months of age and were not born into the herd, except those sexually intact animals that are less than 6 months of age and originate directly from a currently accredited herd for brucellosis.

For bovine tuberculosis,

herd test

would mean the following:

• In any area of a consistent State other than a recognized management area, testing of all animals within a herd that are 18 months of age or older, as well as all animals in the herd that are less than 18 months of age and were not born into the herd, except those animals that are less than 18 months of age and originate directly from a currently accredited herd for bovine tuberculosis.

• In any area of a provisionally consistent State other than a recognized management area, testing of all animals within a herd that are 12 months of age or older, as well as all animals in the herd that are less than 12 months of age and were not born into the herd, except those animals that are less than 12 months of age and originate directly from a currently accredited herd for bovine tuberculosis.

• In any area of an inconsistent State and in a recognized management area for bovine tuberculosis, testing of all animals within a herd that are 6 months of age or older, as well as all animals in the herd that are less than 6 months of age and were not born into the herd, except those animals that are less than 6 months of age and originate directly from a currently accredited herd for bovine tuberculosis.

We would exempt sexually neutered animals from herd tests for brucellosis because there is no scientific evidence suggesting they can transmit brucellosis.

The minimum testing ages specified within this definition correlate to the degree of risk of exposure to brucellosis or bovine tuberculosis that we would associate with the area in which the herd resides. We encourage all interested persons to review this definition within the context of subsequent discussions in this proposed rule regarding our proposed State and Tribal classification system (see “

State or Tribal classifications (§ 76.3)”

below) and recognized management areas (see “

Recognized management areas (§ 76.5)”

below).

We would define

immediate slaughter

as consignment directly to a recognized slaughtering establishment. In proposed §§ 76.14 and 76.15, we would allow cattle and bison to be moved interstate without testing for brucellosis or bovine tuberculosis from States and Tribes with the lowest status for these diseases, inconsistent, provided that the animals are destined for immediate slaughter.

We would define

interstate certificate of veterinary inspection (ICVI)

in a manner that is similar to the definition currently found in parts 77 and 78. However, whereas the current definition specifies that a document other than an ICVI may be used in order to provide an alternative to typing or writing individual animal identification on an ICVI, but still requires an ICVI to accompany this document, we would allow a document to take the place of an ICVI altogether, provided that the following conditions are met:

• The document is agreed upon by the shipping and receiving States or Tribes as an acceptable alternative to an ICVI;

• The document is a State or Tribal form or APHIS form that requires individual identification of animals;

• Each copy of the document identifies each animal to be moved, but any information pertaining to other animals, and any unused space on the document for recording animal identification, is crossed out in ink;

• The following information is written in ink in the identification column on the original and each copy and is circled or boxed, also in ink, so that no additional information can be added: The name of the document and either the unique serial number on the document or, if the document is not imprinted with a serial number, both the name of the person who prepared the document and the date the document was signed; and

• A copy of the document accompanies the program animals during interstate movement.

During the comment period for the rule that proposed to establish animal identification requirements for livestock moving interstate (76 FR 50082-50110, Docket No. APHIS-2009-0091), several commenters urged us to consider whether “event passports” and other similar documents could be used in lieu of ICVIs for animals, such as rodeo steers, that move frequently in interstate commerce. The rule that finalized that proposal specified, in its preamble, that such documents could be used in lieu of ICVIs. Our proposed definition would also allow such documents to be used.

We would define

location identification (LID) number

and

premises identification number (PIN)

as these terms are currently defined in parts 77 and 78, with the following modification: We would remove references to group identification of livestock from the definitions. We would do this because proposed part 76 would not allow for group identification of program animals.

We would define

management area

as a clearly delineated geographical area in which a State or Tribe has detected brucellosis or bovine tuberculosis, has determined that there is a risk of transmission of brucellosis or bovine tuberculosis to program animals, and has taken or proposes to take measures to control the spread of the brucellosis or bovine tuberculosis within and from the area and/or to eradicate the disease within the area. We discuss management areas at length below, in our discussion of proposed § 76.5.

We would define

official brucellosis vaccination program

as a brucellosis vaccination program that consists of, at a minimum:

• Vaccination of program animals with an official

Brucella

vaccine, which we would define as a vaccine for brucellosis that has been approved by the Administrator and produced under license of USDA;

• Tattooing to specify the animals' vaccination status; and

• Identification of the animals with an official eartag designed to specify the animals' vaccination status.

We would define

officially identified:

• For cattle and bison, as identified by means of an official eartag.

• For captive cervids, as identified by an official eartag, by a tattoo containing an official identification number, or by other identification devices acceptable to APHIS and the shipping and receiving States or Tribes.

With regard to cattle and bison, we recognize that parts 77 and 78 currently allow other identification devices to be used as official identification. However, the regulations in those parts were issued during a time when there were not minimal national standards within 9 CFR for identification of cattle and bison that move in interstate commerce. Thus, the official identification requirements in parts 77 and 78 had to function as those standards for the cattle and bison industries within the United States. Accordingly, because the

requirements had to be broadly applicable, we allowed them to incorporate a degree of flexibility regarding the types of identification we would authorize as official identification.

However, 9 CFR now contains minimal national standards for identification of cattle and bison that move in interstate commerce, in part 86; these were added in 2013 (78 FR 2040-2075; Docket No. APHIS-2009-0091). We believe that the identification requirements in that part are sufficient for most cattle and bison that are moved in interstate commerce; hence, we would not include official identification requirements for those animals in part 76, and would instead instruct persons to consult part 86 for the relevant identification requirements. We would only specify identification requirements in part 76 for classes of animals that we believe present a higher-than-average risk of transmitting brucellosis or bovine tuberculosis to other animals. We believe that it is important to be able to effectively trace the movement of such animals in interstate commerce. Because official eartags contain unique identifiers and are tamper-evident, we consider them to provide the most reliable means of achieving this degree of traceability.

While 9 CFR part 86 contains minimal national standards for identification of cattle and bison that move in interstate commerce, it currently defers to part 77, which we are proposing to remove from the regulations, for official identification requirements for captive cervids. Part 77 currently allows captive cervids to be officially identified by means of an official eartag, a brand, or a tattoo providing unique identification of the cervid.

However, we are not aware of any captive cervid producers who brand their cervids for purposes of official identification. Moreover, we are aware of a number of identification devices, such as subcutaneous RFID transponders, that could be used for unique identification of captive cervids. Thus, our proposed definition of

officially identified

for captive cervids would not refer to brands, but would allow for such alternate devices when agreed upon by APHIS and the shipping and receiving States or Tribes to constitute such official identification.

We would define

official seal

as a serially numbered, metal or plastic strip, consisting of a self-locking device on one end and a slot on the other end, which forms a loop when the ends are engaged and which cannot be reused if opened, or a serially numbered, self-locking button. Current definitions of

official seal

within 9 CFR do not specify that a strip used for an official seal may be plastic, and do not allow a serially numbered, self-locking button to be used in lieu of such a strip. However, we have long used both plastic strips and self-locking buttons to seal means of conveyance containing infected, reactor, suspect, or exposed animals, and have found such seals to be as reliable as metal strips.

We would define

official test

as any test that is approved by the Administrator for determining the presence or absence of brucellosis or bovine tuberculosis in program animals that is conducted and reported by an official tester. If an official test is applied to a program animal, it would have to be identified by means of an official eartag. If this eartag uses the National Uniform Eartagging System, one of the official identification systems that has been approved by APHIS, the eartag would have to indicate the State or Tribe in which it was applied; if it uses the Animal Identification Number system, another approved official identification system, it would have to indicate the premises on which it was applied. Finally, if an animal that is tested already has such an eartag, the information on this eartag would have to recorded by the tester. These provisions regarding unique identification of tested animals would codify long-standing Agency policies that we consider necessary to maintain accurate records regarding the application of official tests for program purposes.

We would define

official tester

as any person associated with the conducting and reporting of official tests within an official testing laboratory, or any person authorized by the Administrator to conduct and report official tests outside of a laboratory environment. Proposed § 76.17 would contain the conditions under which the Administrator may authorize a person to conduct and report official tests outside of a laboratory environment.

We would define

official testing laboratory

as a laboratory approved by the Administrator in accordance with part 76 to conduct official tests. Proposed § 76.17 would contain this laboratory approval process.

We would define

owner

as any person who has legal or rightful title to program animals whether or not they are subject to a mortgage. This definition would mirror the definition of

owner

currently provided in parts 50, 51, and 79 of 9 CFR.

We would define

permit for movement of restricted animals

as a document that is issued by an APHIS representative, State or Tribal representative, or accredited veterinarian and that authorizes the restricted interstate movement of livestock to certain specified destinations. In proposed § 76.10, we would require this document, which is currently VS Form 1-27, to accompany reactor, suspect, and exposed program animals that are moved interstate.

We would define

Program Standards document

as a document providing guidance related to the regulations contained in part 76. Substantive changes to Program Standards document would be announced through notices published in the

Federal Register

. These notices would request public comment on the changes.

We would define

qualified accredited veterinarian

as that term is defined in 9 CFR part 160.

We would define

reactor

as:

• For brucellosis, a program animal that has had non-negative test results to an official test such that an epidemiologist designated by the District Director has determined that there is a high likelihood that the animal is infected with brucellosis, and a low likelihood of false positive test results.

• For bovine tuberculosis, a program animal that has had non-negative test results to an official test such that an epidemiologist designated by the District Director has determined that further action is warranted to make a final determination regarding the animal's disease status.

We believe these differing definitions for

reactor

to be warranted because, while reactors for bovine tuberculosis have usually tested non-negative to both an official screening test and secondary (corroboratory) test and must be taken to necropsy or slaughter for a final determination of disease status, reactors for brucellosis often are classified based on test results to a screening test that fell within parameters that strongly suggested the presence of brucellosis in the animal.

We would define

responsible person

as the individual who is immediately responsible for implementation and maintenance of an animal health plan within a State or Tribe, who is authorized to amend the plan as circumstances warrant, and who will assume responsibility for the State or Tribe's compliance with all provisions of the plan and all requirements in part 76.

We would define

spayed heifers

as sexually neutered female cattle or bison, and would define

steers

as sexually neutered male cattle or bison.

We would define

specifically approved stockyard

as premises where program animals are assembled for sale purposes and which meet the standards set forth in § 71.20 and are approved by APHIS. This definition is substantively similar to the definition currently found in part 78, but would add a clarification, currently absent in that definition, that all specifically approved stockyards must be approved by APHIS. Proposed § 76.10 would allow reactor, suspect, and exposed program animals to be moved interstate to specifically approved stockyards, among other approved locations.

We would define

State or Tribal animal health official

as the State or Tribal official responsible for livestock and poultry disease control and eradication programs in a State or Tribe, and would define

State or Tribal representative

as an individual employed in animal health work by a State or Tribe, or a political division of a State or Tribe, and authorized by that State or Tribe to perform the function involved. These definitions would be modeled on the definitions of

State animal health official

and

State representative

that are currently found in multiple parts within 9 CFR, but would reflect the fact that we would now authorize a Tribe to submit an animal health plan and request a brucellosis or bovine tuberculosis classification apart from the State in which the Tribal lands are located.

We would define

suspect

as a program animal that has had non-negative test results to an official test for brucellosis or bovine tuberculosis that lead an epidemiologist designated by the District Director to determine that the animal should not be classified as a reactor, but cannot be classified as free of brucellosis or bovine tuberculosis.

Unless the Administrator specifies or approves an alternate testing age,

test-eligible animal

would mean:

• For brucellosis, all sexually intact program animals in a herd that are 6 months of age or older, and all program animals in the herd that are less than 6 months of age and were not born into the herd, except those program animals that are less than 6 months of age and originate directly from an accredited herd for brucellosis.

• For bovine tuberculosis, all program animals in a herd that are 12 months of age or older, and all program animals in the herd that are less than 12 months of age and were not born into the herd, except those program animals that are less than 12 months of age and originate directly from an accredited herd for bovine tuberculosis; except that, if the herd is located on a calf raiser's premises, all program animals in the herd that are 2 months of age or older are considered test-eligible for bovine tuberculosis.

We consider a definition of

test-eligible animal

to be necessary because, in proposed § 76.7, each protocol for an epidemiological investigation would require States and Tribes to determine the disease status of test-eligible animals in certain herds.

We recognize that currently, in § 78.1, sexually intact cattle and bison are not considered test-eligible for brucellosis until they are at least 18 months of age. However, in part 78, the term test-eligible is applied in a generic sense to animals that are sexually mature and sexually intact. We agree that, in the absence of a known disease risk, 18 months of age is an appropriate threshold for test-eligibility for brucellosis within the United States.

However, in proposed part 76, we would reserve the term

test-eligible

for animals in herds that may have harbored or come in contact with a brucellosis- or bovine tuberculosis-infected animal, and that therefore could potentially be affected with brucellosis and bovine tuberculosis. In such instances, there is a known disease risk, the infected animal, and it would be prudent to determine the disease status of all animals in the herd that could potentially be infected with brucellosis or bovine tuberculosis because of that disease risk. Because animals as young as 6 months of age may transmit brucellosis, we would consider them test-eligible for the purposes of proposed part 76.

Authority of the Administrator (§ 76.1)

Proposed § 76.1 would state that, notwithstanding the provisions of part 76, the Administrator is authorized pursuant to the AHPA to prohibit or restrict the movement in commerce of any animals, if the Administrator considers that prohibition or restriction to be necessary to prevent the dissemination of brucellosis or bovine tuberculosis within the United States. It would further state that, pursuant to the Act, the Administrator may also hold, seize, quarantine, treat, destroy, dispose of, or take other remedial action with respect to any animal, article, or means of conveyance that is moving or has moved in interstate commerce, if the Administrator has reason to believe that animal, article, or means of conveyance may carry, have carried, or have been affected with or exposed to brucellosis or bovine tuberculosis at the time of interstate movement.

While this section would be a restatement of our authority under the AHPA, we consider it necessary to include it within proposed part 76. This is because the regulations in part 76 would be predicated on the low prevalence for brucellosis and bovine tuberculosis within the United States, and would provide adequate mitigations for the majority of instances in which cattle, bison, and captive cervids are moved interstate. There may, however, be certain unlikely scenarios, such as a significant outbreak of brucellosis or bovine tuberculosis within a State or Tribe, which the regulations in part 76 would not be adequate to address.

If such a scenario were to occur, the Administrator would take such action as he or she deems appropriate to address the risk that cattle, bison, or captive cervids moved interstate from the State or Tribe may present of disseminating brucellosis or bovine tuberculosis. This could include issuing an order placing additional restrictions on the interstate movement of cattle, bison, or captive cervids from the State or Tribe, or issuing an order prohibiting the movement of cattle, bison, or captive cervids from that State or Tribe until the outbreak is addressed.

Animal Health Plan Requirements (§ 76.2)

The State and Tribal classification system for brucellosis and bovine tuberculosis within proposed part 76 would be based on whether a State or Tribe has drafted an animal health plan to address the diseases, whether APHIS has approved this plan, and whether the State or Tribe has implemented and is performing the activities and enforcing the measures specified in the plan. (We consider activities to be all actions that a State or Tribe specifies in its animal health plan that are not mitigation measures. We consider measures to be those mitigations specified within the plan.) Proposed § 76.2 would describe the process for States or Tribes to submit an animal health plan, the categories of information that must be contained in any animal health plan, the review process for animal health plans, the notice-based process by which we would make the plans publicly available for review and comment, our follow-up actions on any such notice, the process for requesting amendments to an animal health plan, and providing for compliance reviews and audits following approval of an animal health plan.

Proposed paragraph (a) of § 76.2 would provide that, in order for a State or Tribe to be given the highest classification, consistent, or the intermediate classification, provisionally consistent, in our new

classification system, a State or Tribe would have to submit an animal health plan to APHIS via the mail as provided within the Program Standards document, or submit the plan electronically as specified within the Program Standards document. (Proposed § 76.3 describes the State and Tribal classification system at length.)

At a minimum, in order to be considered complete, each animal health plan would have to contain the following categories of information:

• Confirmation that the State or Tribe has a legal and regulatory basis for the activities and measures specified within the plan.

• A description of the organization and infrastructure of the animal health and wildlife authorities within the State or Tribe. The description would have to include the animal health and wildlife work force within the State or Tribe that is available to implement or perform activities and maintain and enforce measures specified within the animal health plan, and would have to demonstrate that the State or Tribe has sufficient resources to implement, maintain, and enforce its animal health plan.

• The name and contact information for the responsible person that the State or Tribe has designated to oversee implementation, performance, and enforcement of activities and measures carried out under the plan within the State or Tribe, and the name and contact information for the person that the State or Tribe has designated to oversee implementation, performance, and enforcement of wildlife activities and measures carried out under the plan. States or Tribes could designate a single individual to serve in multiple roles.

• A description of program animal demographics within the State or Tribal lands. This description would have to include the approximate number and types of program animal herds within the State or Tribal lands, the approximate number of animals in those herds, and the approximate number and geographic distribution of any animal concentration points within the State or Tribal lands. (The Program Standards document would provide examples of what would constitute an animal concentration point.)

• A description of the surveillance activities for brucellosis or bovine tuberculosis in animals within the State or Tribal lands that are being conducted or would be conducted under the animal health plan. (We would include a footnote, footnote 1, directing individuals to proposed § 76.6 for minimum requirements regarding surveillance activities conducted under an animal health plan.)

• A description of the known sources of brucellosis or bovine tuberculosis that pose a risk of disease introduction into program animals within the State or Tribal lands, and an assessment of the likelihood of transmission of brucellosis or bovine tuberculosis from these sources to program animals within the State or Tribal lands. This description would have to include each of the following:

○ The approximate number of herds or wildlife populations within the State or Tribal lands that are known sources of brucellosis or bovine tuberculosis, and the approximate number of animals in these herds or populations;

○ The approximate prevalence of brucellosis or bovine tuberculosis infection in those populations, the geographic distribution of the populations within the State or Tribal lands, and any other factors that make the populations a potential source of brucellosis or bovine tuberculosis transmission to program animals within the State or Tribal lands;

○ The potential for exposure of program animals within the State or Tribal lands to these known source populations;

○ Factors, other than mitigation measures that are or would be implemented by the State or Tribe, that may influence this potential for exposure (the Program Standards document would provide illustrative examples of such factors); and

○ An assessment of the likelihood of transmission of brucellosis or bovine tuberculosis from known source populations to program animals within the State or Tribal lands.

• If the State or Tribe has identified known source populations of brucellosis or bovine tuberculosis that pose a risk of disease introduction into program animals within the State or Tribal lands, a description of the measures that the State or Tribe has implemented or would implement to prevent and/or mitigate the risk that program animals within the State or Tribal lands will become infected with brucellosis or bovine tuberculosis.

• A description of the epidemiological investigation and affected herd management activities that the State or Tribe has taken or would take in response to occurrences of brucellosis and bovine tuberculosis within program animals in the State or Tribal lands. (We would include a footnote, footnote 2, directing individuals to proposed § 76.7 for minimum requirements regarding epidemiological investigation and affected herd management activities conducted under an animal health plan.)

We recognize that the draft template for an animal health plan in the Program Standards document contains two additional information categories, one pertaining to the bovine tuberculosis program certification offered to qualified accredited veterinarians within the State or Tribe, the other to State and Tribal oversight of the official tests administered by these veterinarians. The information a State or Tribe supplies within these categories would not be directly included in our evaluation of the animal health plan for purposes of determining whether or not to propose to approve it, but rather to aid in the implementation and maintenance of our national program certification for bovine tuberculosis. We discuss this program certification at greater length below, in our discussion under the heading “

Official tests for brucellosis and bovine tuberculosis, official testing laboratories, and official testers (§ 76.17).”

Proposed paragraph (b) of § 76.2 would state that APHIS will review the plan submitted by the State or Tribe for completeness. This initial review would ensure that the State or Tribe has provided information in each of categories listed above, or has provided an explanation regarding why the information category is not applicable to the State or Tribe.

Once we determine a plan to be complete, APHIS would conduct formal review and evaluation of the plan. First, we would determine whether the State or Tribe has identified sources of brucellosis or bovine tuberculosis within the State and Tribal lands. If the State or Tribe has stated that no sources of the disease are known to exist in the State or Tribal lands, we would expect the State or Tribe to provide a justification in support of this statement, including documentation of the surveillance or other activities that led to this conclusion. If we consider the statement to be justified, we would evaluate the epidemiological investigation and affected herd management activities that the State or Tribe states it would take in responses to occurrences of brucellosis or bovine tuberculosis within program animals in the State or on Tribal lands, whether the State or Tribe has legal and regulatory authority for these activities, and whether the State or Tribe has sufficient personnel to implement and, if necessary, effectively carry out these activities and enforce these measures.

If the State or Tribe does identify sources of brucellosis or bovine

tuberculosis in the State or Tribal lands, we would evaluate the likelihood of transmission of brucellosis or bovine tuberculosis from known source populations to program animals in light of the information provided by the State or Tribe regarding the prevalence of the diseases within the sources, potential for exposure of program animals to these sources, and factors that may influence this exposure. We would also evaluate the mitigation measures specified by the State or Tribe to determine whether they are adequate to prevent transmission of brucellosis or bovine tuberculosis from source populations to program animals, and would evaluate the surveillance activities specified by the State or Tribe to determine whether they would be sufficient to detect changes in prevalence levels of disease in the source population, or the presence of disease in program animals exposed to these source populations. Finally, we would evaluate whether the State or Tribe has adequate legal and regulatory authority and personnel to carry out the activities specified within the plan.

If this rule is finalized, it is possible that certain smaller States and Tribes would wish to coordinate brucellosis or bovine tuberculosis program activities or share personnel with neighboring States or Tribes. Guidance regarding how these consolidated efforts should be described in the State or Tribe's animal health plan is provided in the Program Standards document.

There could be instances when APHIS lacks technical expertise to evaluate certain provisions within a State or Tribe's animal health plan. For example, if a State or Tribe identifies free-ranging wildlife as a source population of brucellosis or bovine tuberculosis within the State or Tribal lands, but states that the movement patterns of the wildlife effectively preclude contact with program animals within the State or Tribal lands, that the risk of transmission of brucellosis or bovine tuberculosis from those wildlife populations to these program animals is correspondingly remote, and that mitigation activities to address this risk are therefore not necessary, it is possible that APHIS would not possess the knowledge of the movement patterns necessary to evaluate this claim. In such instances, APHIS would share a copy of the plan with Federal, State, Tribal, and/or industry experts for technical review and comment regarding the issue or issues for which we lack expertise.

Upon conclusion of review of the plan, we would make a determination regarding whether or not to propose to approve the plan. If we determine not to propose to approve the plan, we would contact the State or Tribe that submitted the plan and set forth the deficiencies identified in the plan that preclude us from proposing to approve it.

Proposed paragraph (c) of § 76.2 would provide that we could propose to approve a State or Tribal animal health plan unconditionally, or on the condition that the State or Tribe implement certain provisions of its plan within a specified period of time that it cannot implement immediately upon approval of the plan. We anticipate that this latter, conditional approval would be reserved for plans that set forth what we consider to be adequate activities and effective measures to address the risk of introduction of brucellosis or bovine tuberculosis into program animals within the State or Tribal lands, but that indicate that the State or Tribe will need to amend laws and/or regulations in order to have sufficient legal and regulatory authority to implement the plan. We request specific comment regarding whether there are other scenarios that should lead us to approve a plan conditionally.

Regardless of whether we propose to approve a plan unconditionally, or on the condition that the State or Tribe implement certain provisions of its plan within a specified period of time, we would publish a notice in the

Federal Register

announcing our proposed approval of the plan and making the plan available for public review and comment.

Prior to issuance of this notice, we would consult with the responsible person identified in the plan in order to ensure that the State or Tribe is prepared for us to make the plan, proposed amendments to the plan, and all reports required by the regulations in part 76 publicly available. We consider this provision to be necessary because, as we stated in the draft regulatory framework document, and as several commenters on that document concurred, transparency regarding the regulatory activities for brucellosis and bovine tuberculosis that a State or Tribe is conducting would be a foundation for the success and acceptance of the program both domestically and internationally.

Proposed paragraph (d)(1) of § 76.2 would set forth the determinations that we could make following a notice proposing unconditional approval of an animal health plan. If no comments are received on this notice, or if the comments received do not affect APHIS' conclusion that a plan may be approved unconditionally, we would publish a subsequent notice in the

Federal Register

announcing that the plan has been approved unconditionally, and designating the State or Tribe as a consistent State or Tribe.

If the comments received on the notice suggest the plan should be approved, but that the State or Tribe cannot implement certain provisions of its animal health plan immediately upon approval of the plan, and after reviewing the information, we agree, we would publish a subsequent notice in the

Federal Register

announcing that the plan has been approved conditionally, and designating the State or Tribe as a provisionally consistent State or Tribe. This notice would also specify the provisions of the plan that APHIS has determined cannot be implemented immediately and the time period in which they would have to be implemented. The notice could also specify restrictions on the interstate movement of program animals or other program requirements that would apply to the State or Tribe while it is in provisionally consistent status.

Finally, if the comments received suggest that the plan should not be approved, and, after reviewing the information, we agree, we would publish a subsequent notice in the

Federal Register

describing the comments that we received, our reevaluation of the plan in light of those comments, and our reasons why we cannot approve the plan.

Proposed paragraph (d)(2) of § 76.2 would set forth the determinations that we could make following a notice proposing conditional approval of an animal health plan. If no comments are received on the notice, or if the comments received do not affect our conclusion that the plan may be approved on the condition that the State or Tribe implement certain provisions of its plan within a specified period of time that it cannot implement immediately upon approval of the plan, we would publish a subsequent notice in the

Federal Register

announcing that the plan has been approved conditionally, and designating the State or Tribe as a provisionally consistent State or Tribe. This notice would specify the provisions of the plan that we have determined cannot be implemented immediately and the time period in which they must be implemented. The notice could also specify restrictions on the interstate movement of program animals or other program requirements that apply to the State or Tribe while it is in provisionally consistent status.

Alternatively, if the comments received suggest that the plan should not be approved, and, after reviewing the information, we agree, we would

publish a subsequent notice in the

Federal Register

describing the comments that we received, our reevaluation of the plan in light of those comments, and our reasons why we cannot approve the plan.

Proposed paragraph (e) would provide that, if we approve a State or Tribal animal health plan conditionally, designate the State or Tribe as provisionally consistent, and specify the period of time in which the State or Tribe must implement all provisions of its plan, we would publish a subsequent notice in the

Federal Register

announcing whether the State or Tribe has implemented all provisions of the plan within that period of time. If the State or Tribe has, the notice would announce that we consider the plan unconditionally approved, and have redesignated the State or Tribe as a consistent State or Tribe. If the State or Tribe has not, the notice would announce that we have withdrawn approval of the plan, and have redesignated the State or Tribe as an inconsistent State or Tribe. This second notice would be necessary in order to ensure that States and Tribes take appropriate action to be able to implement all provisions of their animal health plan in a timely manner.

Proposed paragraph (f) of § 76.2 would contain the processes for amendments to an animal health plan. Proposed paragraph (f)(1) of § 76.2 would provide that, if APHIS determines that the activities or measures specified in an approved animal health plan no longer correspond to the risk of spread of brucellosis or bovine tuberculosis, for example, if sources of brucellosis or bovine tuberculosis are discovered in a State or on Tribal lands in which no sources were previously known to exist, we would make ongoing approval of the plan contingent on the State or Tribe amending the plan in a manner that we approve of. The amended plan would have to be submitted to APHIS via the mail as provided within the Program Standards document, or electronically as provided in the Program Standards document.

Alternatively, if a State or Tribe wishes to amend its animal health plan, the State or Tribe would have to submit proposed amendments to the plan to us via the mail or electronically as provided in the Program Standards document. Amendments proposed by the State or Tribe would be subject to the notice-based approach specified in proposed paragraphs (b) through (d) of proposed § 76.2, although we anticipate that provisional approval of an amendment would be used sparingly, if at all.

Proposed paragraph (g) would state that APHIS reserves the right to conduct a review of States or Tribes at any point for compliance with their approved animal health plan. Such a compliance review could include site visits and/or documentation review.

State or Tribal Classifications (§ 76.3)

Proposed § 76.3 would contain the revised three-tier State and Tribal classification system of “consistent,” “provisionally consistent,” and “inconsistent.” It would also contain the considerations that would lead us to initially classify a State or Tribe as a consistent State or Tribe, and those considerations that may lead us to redesignate the State or Tribe to a lower classification. Finally, it would specify the measures that a State or Tribe must take in order to regain consistent status following a redesignation.

Proposed paragraph (a) of § 76.3 would provide that each State is classified as consistent, provisionally consistent, or inconsistent for brucellosis, and consistent, provisionally consistent, or inconsistent for bovine tuberculosis. It would also provide that Tribes are classified as consistent, provisionally consistent, or inconsistent for these diseases, provided that they have submitted a Tribal animal health plan to APHIS and we have approved it.

Proposed paragraph (b) of § 76.3 would set forth the conditions that would lead us to initially designate a State or Tribe as consistent, provisionally consistent, or inconsistent.

We would initially designate a State or Tribe as a consistent State or Tribe for brucellosis and bovine tuberculosis if we approve the State or Tribe's animal health plan unconditionally, that is, without provisos, in accordance with the process set forth in paragraph (d) of proposed § 76.2.

We would initially designate a State or Tribe as a provisionally consistent State or Tribe if we approve the State or Tribe's animal health plan on the condition that it implement certain provisions of its plan within a specified period of time that it cannot implement immediately upon approval of the plan, in accordance with the process set forth in paragraph (d) of proposed § 76.2.

We anticipate that, if this rule is finalized, we would receive animal health plans from all 50 States. We also anticipate that, even if commenters disclose deficiencies in the initial iteration of a State's plan that preclude us from approving it, a subsequent iteration of the plan would be approved.

However, in the event that a State elects not to draft an animal health plan, there would come a time when we would have to designate the State as inconsistent for brucellosis and bovine tuberculosis in order to fully implement the State and Tribal classification system and ascribe the appropriate regulatory requirements for the interstate movement of cattle and bison from that State (see proposed §§ 76.14 and 76.15). The date on which this would occur would be announced through a notice in the

Federal Register

.

If we do not receive an animal health plan from a Tribe, the Tribe would be considered part of the State in which the lands reside for purposes of the regulations in part 76. Hence we would not initially designate a Tribe as inconsistent for opting not to submit an animal health plan to APHIS.

Proposed paragraph (c) would contain the conditions that could lead us to redesignate a State or Tribe to a lower classification. Proposed paragraph (c)(1) would contain conditions that may lead us to redesignate a consistent State or Tribe as a provisionally consistent State or Tribe. We could redesignate the State or Tribe as provisionally consistent if:

• The State or Tribe fails to implement or perform an activity or maintain a measure specified within its animal health plan, and we determine that this failure may result in the spread of brucellosis or bovine tuberculosis.

• The State or Tribe fails to submit an annual report as specified in paragraph (a) of § 76.4.

• The State or Tribe fails to submit an initial epidemiological investigation situation report within 14 days of the period of time specified in paragraph (c) of § 76.4 for submitting such a report.

• The State or Tribe fails to submit an updated epidemiological investigation situation report as specified in paragraph (d) of § 76.4.

• On more than one occasion, the State or Tribe fails to submit a closing report as specified in paragraph (e) of § 76.4.

• The State or Tribe fails to meet national surveillance levels as these are specified within the National Surveillance Plans for brucellosis or bovine tuberculosis or as these are specified within an alternate State or Tribal plan that has been approved by APHIS. (We would include a footnote, footnote 3, directing individuals to paragraph (a) of § 76.6 for further information regarding this regulatory requirement.)

• The State or Tribe fails to conduct targeted surveillance of wildlife source

populations as specified in paragraph (b)(1) of § 76.6.

• The State or Tribe fails to conduct targeted surveillance of at-risk program animals as specified in paragraph (b)(2) of § 76.6.

• The State or Tribe has failed to conduct an investigation of a program animal with non-negative test results for brucellosis in accordance with paragraph (a) of § 76.7, or to send a report regarding those activities as specified in paragraph (b) of § 76.4.

Many of these conditions for redesignation would hinge on a State or Tribe's failure to meet certain regulatory requirements of part 76 either fully or in a timely fashion. Accordingly, we will discuss our rationale for these conditions below, within the context of our discussion of the regulatory requirements themselves. However, generally speaking, we would redesignate a State or Tribe as provisionally consistent if the State or Tribe fails to take or document an action that would otherwise demonstrate that it has fully implemented its animal health plan and is performing the activities and maintaining the measures specified in its animal health plan.

Proposed paragraph (c)(2) of § 76.3 would contain the conditions that may lead us to redesignate a State or Tribe as an inconsistent State or Tribe.

9

We could redesignate the State or Tribe as inconsistent if:

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We acknowledge that many of these conditions are substantially similar to those that could result in redesignation of a State to provisionally consistent status. A side-by-side comparison of the conditions for redesignation of a State to provisionally consistent and inconsistent status is found on pages 33-36 of the Program Standards document that accompanies this proposed rule.

• The State or Tribe fails to implement or perform an activity or maintain a measure specified within its animal health plan, or fails to amend the plan in response to a request from APHIS, and APHIS determines that this failure has resulted or may result in the spread of brucellosis or bovine tuberculosis.

• On more than one occasion, the State or Tribe fails to submit an annual report as specified in paragraph (a) of § 76.4.

• On more than one occasion, the State or Tribe fails to submit an initial epidemiological investigation situation report within 14 days of the period of time specified in paragraph (c) of § 76.4 for submitting such a report.

• On more than one occasion, the State or Tribe fails to submit an updated epidemiological investigation situation report as specified in paragraph (d) of § 76.4.

• APHIS has terminated recognition of the State or Tribe's management area.

• The State or Tribe refuses to participate in or otherwise conduct surveillance as specified in paragraph (a) of § 76.6.

• On more than one occasion, the State or Tribe has failed to conduct an investigation of a program animal with non-negative test results for brucellosis in accordance with paragraph (a) of § 76.7, or to send a report regarding those activities as specified in paragraph (b) of § 76.4.

• The State or Tribe fails to conduct epidemiological investigations as specified in paragraph (b) of § 76.7.

• The State or Tribe fails to conduct affected herd management as specified in paragraph (e) of § 76.7.

Like the conditions that could lead us to redesignate a consistent State or Tribe as provisionally consistent, most of the conditions that could result in us redesignating the State or Tribe as inconsistent would stem from the State or Tribe's failure to meet certain regulatory requirements of part 76, and, therefore, will be discussed within the context of those requirements. However, as a general rule, we would redesignate a consistent State or Tribe as inconsistent if we determine that the State or Tribe has failed to take actions necessary to prevent brucellosis or bovine tuberculosis from being transmitted to program animals within the State or Tribe or necessary in order to prevent infected program animals from being moved interstate without appropriate mitigations. We would also redesignate the State or Tribe as inconsistent if, because of the State or Tribe's repeated failure to submit required reports, we lacked sufficient information regarding regulatory activities conducted in the State or Tribe, and thus had to consider program animals moved interstate from the State or Tribe to present an unknown risk of transmitting brucellosis and/or bovine tuberculosis to other animals.

Proposed paragraph (c)(3) of § 76.3 would contain conditions that could lead us to redesignate a provisionally consistent State or Tribe as inconsistent. In addition to the conditions that could lead us to redesignate a consistent State or Tribe as inconsistent, if the State or Tribe fails to implement provisions of its animal health plan or take required remedial measures within the period of time specified by APHIS for implementing these provisions or taking these measures, we would redesignate the State or Tribe as an inconsistent State or Tribe.

Proposed paragraph (d)(1) of § 76.2 would contain our notice-based redesignation process. It would state that, when APHIS redesignates a consistent State or Tribe as a provisionally consistent State or Tribe, we would publish a notice in the

Federal Register

announcing this redesignation. The notice would also state the reason or reasons that led to the redesignation and the remedial measures we consider necessary for the State or Tribe to complete in order to regain consistent status.

As much as possible, the remedial measures that we would specify in the notice would directly correlate to the reason for the redesignation. For example, if a State or Tribe is delinquent in submitting its annual report, the notice would require the report to be submitted.

Depending on the reason for the redesignation, the notice could also specify restrictions on the interstate movement of program animals or other program requirements that would apply to the State or Tribe while it is in provisionally consistent status. For example, if a State or Tribe is able to determine one of the herds in which a program animal with a non-negative test for brucellosis has resided, but cannot determine whether this herd also represents the herd of origin for the animal, the notice may place restrictions on the interstate movement of that herd, pending further investigation of the matter.

It is possible that, because the conditions that could lead us to redesignate a consistent State or Tribe as provisionally consistent vary, while a State or Tribe is in provisionally consistent status for one reason, such as failing to conduct an investigation of a program animal with non-negative test results for brucellosis, the State or Tribe could act or fail to act in a manner that would have otherwise led us to redesignate it to provisionally consistent status, such as failing to turn in a required report. In such instances, we would publish a notice in the

Federal Register

announcing what has occurred, and specifying additional remedial measures that the State or Tribe must take to regain consistent status.

If a State or Tribe completes the remedial measures we require for it to regain consistent status, we would publish a notice in the

Federal Register

announcing that we have redesignated the State or Tribe as a consistent State or Tribe. If the State or Tribe fails to take the required remedial measures, we would publish a notice in the

Federal Register

announcing that we have redesignated the State or Tribe as an inconsistent State or Tribe. Thus, provisionally consistent status would be

a temporary classification; no State or Tribe would be classified as provisionally consistent indefinitely.

Whenever we immediately redesignate a consistent or provisionally consistent State or Tribe as an inconsistent State or Tribe, we would publish a notice in the

Federal Register

announcing this redesignation. In order for such a State or Tribe to regain consistent status, it would have to take appropriate remedial measures, as determined by APHIS, to address the issue or issues that led to redesignation to inconsistent status. It would also have to submit amendments to its animal health plan that reflect these measures, and submit any outstanding annual reports, initial investigation reports, initial or updated epidemiological investigation situation reports, and closing reports (see our discussion of proposed § 76.4 later in this document).

Finally, proposed paragraph (f) of § 76.3 would provide that lists of all consistent, provisionally consistent, and inconsistent States and Tribes would be located on the APHIS Web site. The lists would also be available at district VS offices.

Reporting Requirements (§ 76.4)

Proposed § 76.4 would contain reporting requirements for the consolidated brucellosis and bovine tuberculosis program. Proposed paragraph (a) of § 76.4 would provide that, within 60 days of the end of the reporting period (September 30), States would have to submit a completed annual report form to APHIS as provided in the Program Standards document.

10

This report form would provide us with information regarding the surveillance activities that the State has taken in the last reporting period.

10

A draft template of the annual report form is found in Appendix 3 of the Program Standards document.

Additionally, if a State has submitted an initial epidemiological situation report to us regarding detection of an affected herd within the State, but not submitted a corresponding closing report regarding this investigation (see below), we would require the State to submit additional information regarding epidemiological activities related to that incident undertaken during the reporting period within the annual report form. Finally, if the information contained in a State's animal health plan is no longer current, and the State has not already submitted proposed amendments to the plan to APHIS that incorporate these changes, the State would have to provide a summary of any changes to the information that have occurred during the reporting period along with the annual report form.

As we mentioned previously in this document, our approval of a State's animal health plan would depend on whether source populations of brucellosis or bovine tuberculosis exist within the State, and, if so, whether the State has specified adequate measures within the plan to address the risk that these sources present of spreading brucellosis and bovine tuberculosis to program animals. For States that do not have known source populations, and thus that do not have mitigation measures specified within their animal health plan, the activities summarized in the annual report form would provide us with evidence supporting the ongoing absence of such source populations and the corresponding lack of need for such mitigations. For States that have such populations, the annual report form would provide information regarding the efficacy of the State's mitigation measures in preventing the introduction of brucellosis and/or bovine tuberculosis into program animals. In a similar vein, by providing us with updated information regarding ongoing epidemiological investigations and, if necessary, updates to its animal health plan, a State would provide assurances to us that it is exercising due diligence in responding to disease outbreaks, and adequate maintenance and oversight of measures carried out under its animal health plan.

Without such information, we could determine that the risk that program animals moved interstate from the State present of transmitting brucellosis and/or bovine tuberculosis is uncertain or unknown. Hence, States that fail to submit an annual report form and supplementary updates in a timely fashion on one occasion could be redesignated to provisionally consistent status, and States that fail to do so on more than one occasion could be redesignated as inconsistent.

Proposed § 76.7 would contain requirements regarding epidemiological investigation activities that a State conducts. Because epidemiological investigations are conducted when animals are determined to be infected with or otherwise fail to test negative for a disease, in the absence of direct APHIS oversight of these investigations, regular reporting regarding the investigations would be of paramount importance to us in determining whether a State is accurately delineating the scope of a potential outbreak and taking adequate measures to preclude disease spread. Thus, proposed paragraphs (b) through (e) of § 76.4 would contain reporting requirements that pertain to epidemiological investigations.

Proposed paragraph (b) would provide that, whenever a State initiates an investigation of an animal with non-negative test results for brucellosis or an animal determined to be infected with brucellosis or bovine tuberculosis in accordance with proposed § 76.7, the State would have to provide a report regarding the investigation within 15 days of initiation of the investigation. Proposed paragraph (b) would differentiate between animals with non-negative test results for brucellosis and animals that are determined to be infected with brucellosis because secondary (corroboratory) tests to determine the presence or absence of brucellosis in program animals sometimes yield results that fall within the range of positive test results, but are sufficiently ambiguous to preclude the individuals conducting the test from making a determination that the animal is infected with brucellosis. We would not make such a differentiation for animals with non-negative test results for bovine tuberculosis, because such animals are customarily taken to necropsy for a determination regarding the presence or absence of infection.

Proposed paragraph (c) of § 76.4 would state that, whenever a State initiates an epidemiological investigation of an affected herd in accordance with § 76.7, the State must provide a report of that epidemiological investigation to APHIS within 15 days of the date when the State is notified that an animal from the herd has been determined to be infected with brucellosis or bovine tuberculosis.

Because, in the absence of such initial reports, APHIS would lack information regarding the discovery of known or potentially infected animals within a State, and thus could be unable to evaluate whether the State is acting in a manner that is likely to delineate the scope of disease infection, States that fail to submit such reports in a timely manner on one occasion could be redesignated as provisionally consistent, and States that fail to submit such reports in a timely manner on multiple occasions could be redesignated as inconsistent.

Epidemiological investigations often take several months to complete, and a particularly complex investigation may take several years. Additionally, activities that a State may take in the first 15 days of an investigation may be inconclusive. Therefore, proposed paragraph (d) of § 76.4 would provide that every 4 weeks following submission

of an initial situation report or initial epidemiological situation report, and more frequently at the Administrator's request, a State would have to submit subsequent reports updating information in the initial situation report or epidemiological investigation situation report. (Generally speaking, we would require States to submit reports on a more frequent basis if the investigation was particularly complex,

e.g.,

when it encompassed many herds or animals or covered a large geographical area.)

Because these reports would help us determine whether a State is taking adequate measures to respond to a disease outbreak, failure to submit such updates on one occasion could result in redesignation to provisionally consistent status; failure to do so on more than one occasion could result in redesignation to inconsistent status.

Proposed paragraph (e) of § 76.4 would state that, within 60 days following the conclusion of an epidemiological investigation of an affected herd, a State must submit a closing report to APHIS. In proposed § 76.7, we consider an epidemiological investigation of an affected herd complete if a State identifies, places interstate and intrastate movement restrictions on, and, determines the disease status of all test-eligible animals in:

• Any herd into which program animals from the affected herd may have been moved;

• Any herd which program animals in the affected herd may have originated from or resided in; and

• Any herd, individual program animals, or other animals that are susceptible to brucellosis or bovine tuberculosis that may have commingled with or otherwise been exposed to the affected herd, as determined by the Administrator and communicated to the State.

Since a State that concludes an epidemiological investigation would have taken measures that we consider adequate to delineate the scope of disease infection in herds of program animals in the State, failure to submit a closing report, unlike failure to submit other reports, would not necessarily lead us to consider program animals in the State an unknown risk of transmitting brucellosis or bovine tuberculosis. Hence, failure to submit a timely closing report on one occasion would not necessarily result in redesignation to provisionally consistent status. However, failure to submit a closing report on more than one occasion could be indicative of greater regulatory lapses; accordingly, it would be likely to result in redesignation to provisionally consistent status.

As we mentioned previously in this document, proposed § 76.5 would allow States to request APHIS recognition of a management area for brucellosis or bovine tuberculosis within the State. Proposed paragraph (f) of § 76.4 would provide that additional reporting requirements for States with such areas are specified in paragraph (f) of § 76.5.

Proposed paragraph (g) of § 76.4 would state that, if a consistent State is redesignated as provisionally consistent, additional reporting requirements for the State may be specified in the notice in the

Federal Register

that announces such redesignation. For example, if a State is redesignated as provisionally consistent for failing to conduct adequate surveillance of wildlife source populations for brucellosis or bovine tuberculosis, we could require the State to provide periodic updates regarding implementation of this surveillance.

Proposed paragraph (h) of § 76.4 would state that the requirements in § 76.4 pertain to Tribes, provided that that they have submitted a Tribal animal health plan to APHIS for review and approval in accordance with the process set forth in § 76.2, and APHIS has approved the animal health plan. Otherwise, we would expect activities conducted on Tribal lands within a State to be reflected in any report that the State submits.

Recognized Management Areas (§ 76.5)

Bovine tuberculosis is known to exist in a portion of Michigan immediately south of the Upper Peninsula and in a portion of Michigan northeast of the Huron National Forest. Because bovine tuberculosis is endemic within wildlife in those areas, there are periodic detections of the disease in program animals in the areas, and Michigan has long had control measures in place to prevent the spread of bovine tuberculosis from these two areas. However, because part 77 relies on a prevalence-based State classification system, if Michigan were considered as a single geographical region, it would not have the highest classification for bovine tuberculosis, accredited-free, although the majority of the State has not detected bovine tuberculosis in program animals.

Hence, part 77 allows a State to request a different classification for zones in the State that have a higher prevalence for bovine tuberculosis than other areas of the State, provided, among other requirements, that the State conducts surveillance of animal species in the zone to detect bovine tuberculosis infection in those animals, has a regulatory framework in which detections of bovine tuberculosis in livestock or wildlife in the zone are reported to State animal health officials, demonstrates to APHIS that it has sufficient financial and legal resources to enforce the zone, and enters into a memorandum of understanding with APHIS regarding any other additional conditions for zone recognition that we determine necessary in order to approve a State's request.

Brucellosis is endemic in wildlife in a geographical area consisting of portions of Montana, Idaho, and Wyoming, referred to below as the Greater Yellowstone Area, or GYA. To prevent the spread of brucellosis from this area, we issued the December 2010 interim rule referenced previously in this document. This rule had the effect of requiring Montana, Idaho, and Wyoming to draft brucellosis management plans in which they specified surveillance of and mitigation measures for wildlife reservoirs within their portion of the GYA.

In the draft regulatory framework document, we proposed an approach that would have consolidated aspects of these two approaches to zoning. We proposed that, if brucellosis or bovine tuberculosis was detected in a region of the United States and the States or Tribes with land in that region were unable to eradicate the disease within a year, the States or Tribes would have to develop a long-term containment plan in order to retain consistent status. We proposed that the containment plan would have to be based on epidemiological information gathered from the outbreak regarding livestock or wildlife populations in the region and extent of disease within these livestock and wildlife populations. We also proposed that the plans would have to consider strategies such as herd testing of program animals within the region, movement restrictions on program animals moved out of the region, and traceability,

i.e.,

official identification and recordkeeping requirements, for these program animals to prevent the spread of disease from the region. Finally, we proposed that all containment plans would have to be eradication-based.

Commenters were generally supportive of the concept of long-term containment plans. However, several commenters had concerns with aspects of our proposed approach. Commenters pointed out that, under the approach, if a region that was covered by a containment plan encompassed a geographical area in multiple States, States could be held accountable for

regulatory lapses in a neighboring State. The commenters pointed out that a State has little authority regarding animal health activities conducted in other States, and that the approach in the framework document could result in States being reclassified to lower statuses for reasons beyond their control.

Similarly, commenters also pointed out that, while most State animal health authorities may monitor wildlife reservoirs of brucellosis or bovine tuberculosis, their authority to conduct such monitoring is limited to instances in which these reservoirs present a risk of transmitting disease to livestock in the State. Accordingly, they expressed concern that the approach in the document would require States to draft containment plans if brucellosis or bovine tuberculosis were discovered in wildlife, in the absence of any demonstrable risk of program animals becoming infected.

Several commenters stated that eradication of brucellosis or bovine tuberculosis in areas in which it has become endemic, particularly in wildlife populations, would prove difficult, if not impracticable, and suggested that containment plans would not necessarily have to be eradication-based to be effective.

Finally, several commenters suggested that States not be forced to draft containment plans, but, rather, have the option to do so upon determining that a containment plan would help prevent the spread of brucellosis or bovine tuberculosis within the State.

In light of these comments, proposed § 76.5 would establish a process for States or Tribes to request recognition of management areas for brucellosis or bovine tuberculosis in the State or Tribal lands. As we mentioned previously in this document, a management area would be a clearly delineated geographical area in which a State or Tribe has detected brucellosis or bovine tuberculosis, has determined that there is a risk of transmission of brucellosis or bovine tuberculosis to program animals, and has taken or proposes to take measures to control the spread of the brucellosis or bovine tuberculosis within and from the area and/or to eradicate the disease within the area.

Proposed paragraph (a) of § 76.5 would state that a State or Tribe may request APHIS recognition of a management area within the State or Tribal lands. Thus States and Tribes would not be required to request recognition of management areas, and could retain consistent status even if they elect not to establish a management area. However, if a source of brucellosis or bovine tuberculosis is known to exist in a State or on Tribal lands, and the State or Tribe elects not to establish and request APHIS recognition of a management area, the State or Tribe would have to provide evidence in their animal health plan that all program animals in the State or Tribal lands are not similarly exposed to this source, or would have to consider all program animals in the State or Tribe commensurate with respect to risk and propose mitigations in their animal health plan accordingly.

Proposed paragraph (b)(1) of § 76.5 would require a State or Tribe without an animal health plan that has been approved by APHIS to request recognition of a management area when it submits an animal health plan to APHIS. Proposed paragraph (b)(2) of § 76.5 would require a State or Tribe with an approved animal health plan to request recognition of a management area by submitting an amendment to its animal health plan regarding the management area.

11

Proposed paragraph (c) of § 76.5 would contain requirements for a request to recognize a management area. Proposed paragraph (c)(1) would contain requirements for States or Tribes without zones for bovine tuberculosis or areas covered by a brucellosis management plan at the time a rule that finalizes this proposed rule becomes effective.

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A template for a request for recognition of a management area is found in Appendix 8 of the Program Standards document.

Such States or Tribes would have to include the following categories of information as part of a request to recognize a management area:

• A description of the geographical area that the State or Tribe requests to be recognized as a management area. The description would have to specify continuous and uninterrupted boundaries for the management area.

• A description of the assessments and activities that the State or Tribe has conducted or plans to conduct to support the specified boundaries for the management area and a timeline of implementation of these activities. At a minimum, the activities specified would have to provide assurances that the boundaries for the management area continually reflect current epidemiological knowledge about the extent of disease and risk of transmission of disease within and from the area, and would have to include:

○ Epidemiological investigations.

○ Surveillance activities within the management area to determine or further delineate sources of brucellosis and/or bovine tuberculosis.

○ Surveillance activities outside the boundaries of the management area sufficient to detect brucellosis or bovine tuberculosis infection in program animals that originate from or are otherwise related to the management area.

The activities would have to include epidemiological investigations because such investigations would be necessary to determine the scope of infection within the area.

The activities would have to include surveillance within the management area to determine or further delineate sources of brucellosis and/or bovine tuberculosis because, in certain instances, epidemiological investigations may not be able, on their own, to discover a disease reservoir of brucellosis or bovine tuberculosis within an area. For example, Federal and State officials within Michigan conducted independent epidemiological investigations for several years before they discovered that wild cervid populations in the northeast of the State were serving as a common source of infection. This discovery played a key role in delineating the geographical area covered by their zone request.

The activities would have to include surveillance activities outside the boundaries of the management area because, historically, after a State has set the initial boundaries of an area in which it knows brucellosis or bovine tuberculosis to exist, affected herds have been discovered beyond these boundaries.

• A description of the known sources of brucellosis or bovine tuberculosis that pose a risk of disease introduction into program animals within and surrounding the management area, and an assessment of the likelihood of spread of brucellosis or bovine tuberculosis from these sources to program animals. This description would have to include:

○ The approximate number of herds, individual program animals, and susceptible wildlife populations within the management area and in the area surrounding the management area as this surrounding area is determined in consultation with an epidemiologist designated by the District Director.

○ The number of affected herds or wildlife populations detected within the management area since the first investigation or surveillance activity specified by the State or Tribe in their request was conducted, the approximate number of animals in these herds or source populations, and the approximate prevalence of brucellosis

or bovine tuberculosis infection in these herds or populations during that time period.

○ The potential for exposure of program animals to these known affected herds or wildlife populations.

○ Any factors, other than mitigation measures maintained by the State or Tribe, that may influence this potential for exposure.

○ An assessment of the likelihood of transmission of brucellosis or bovine tuberculosis from known affected herds or wildlife populations to program animals within and surrounding the management area.

The information that we would require regarding source populations in a request for recognition of a management area is modeled on the information regarding source populations that we would require in an animal health plan. However, while States and Tribes would have to provide the geographic distribution of source populations within their animal health plan, we would not require this information in a request for recognition of a management area. This is because we would expect the boundaries of the management area to reflect the geographic distribution of the source populations.

• A description of the measures that the State or Tribe has implemented or would implement to mitigate the risk that program animals within the State or Tribal lands will become infected with brucellosis or bovine tuberculosis, a timeline for implementation of these measures, and the means by which the State or Tribe has monitored and enforced or plans to monitor and enforce these measures. For all management areas, measures would have to include conditions for the movement of program animals from the management area, herd testing of at least a targeted representative sample of herds of program animals within the area, and change-of-ownership testing of all test-eligible program animals that reside within the area. For management areas for brucellosis, the measures would also have to include an official brucellosis vaccination program.

We would require the State or Tribe to specify conditions for the movement of program animals from the management area because we would not consider the unrestricted movement of program animals from the management area to be appropriate given the presence of brucellosis or bovine tuberculosis within the area. We would require herd testing and change-of-ownership testing within the management area because, although such testing is not a mitigation, it would allow us to evaluate the efficacy of the mitigations implemented within the management area by the State or Tribe. We would require implementation of an official brucellosis vaccination program for management areas for brucellosis because we consider program animals in a management area for brucellosis to be at risk of becoming infected with brucellosis, and vaccination is an effective prophylactic tool to prevent such infection.

• A citation of or hyperlink to the laws and regulations that authorize the State or Tribe's establishment of the management area.

• A description of the personnel that the State or Tribe has used or plans to use in order to implement or perform activities or maintain measures associated with the management area. This description would have to demonstrate that the State or Tribe has sufficient personnel to implement and perform these activities and maintain these measures, and would have to include:

○ The name, contact information, and affiliation of the person within the State or Tribe who would assume responsibility for implementation and performance of activities and maintenance and enforcement of measures associated with the management area.

○ The name, contact information, and affiliation of all personnel assigned to the implementation and performance of activities and maintenance and enforcement of measures associated with the management area.

○ The role or roles assigned to these personnel.

• Information demonstrating that all program animals that are moved from the management area are or will be required to be officially identified prior to movement.

We would require official identification of program animals moved from the area in order to facilitate traceback if any of these animals are determined to be infected with brucellosis or bovine tuberculosis.

Proposed paragraph (c)(2) of § 76.5 would state that, if a State had a geographical area designated as a zone for bovine tuberculosis or covered by a brucellosis management plan prior to the effective date of a rule finalizing this proposed rule, and the State wishes the geographical area to continue to be recognized as a management area, the State's request for recognition of that area as a management area would only need to contain those categories of information that the State has not already submitted to APHIS.

Proposed paragraph (d) of § 76.5 would provide that APHIS would review each proposal for recognition of a management area in accordance with the process set forth in proposed § 76.2 for review of an animal health plan or amendment to an animal health plan.

Proposed paragraph (e) of § 76.5 would provide that, in communicating our determination to approve or not approve an animal health plan or amendment to an animal health plan in accordance with the process set forth in § 76.2, we would also communicate our determination to recognize or not recognize the requested management area. It would also provide that, if we recognize the management area, the request for recognition of the area would be considered to be part of the State or Tribe's animal health plan. Finally, it would provide that we would not recognize a management area in a State or on Tribal lands if we determine not to approve that State or Tribe's animal health plan. We would not recognize the area because, if concerns regarding the approach that the State or Tribe presents in its animal health plan preclude us from approving the plan, these same concerns would preclude us from evaluating the adequacy of the measures specified in the request for recognition of the management area.

As we mentioned previously in this document, proposed paragraph (f) of § 76.5 would contain additional reporting requirements for States and Tribes with recognized management areas. It would require that, in addition to the annual reporting requirements contained in paragraph (a) of § 76.4, States or Tribes with recognized management areas would have to submit a separate annual report form for each recognized management area in the State or Tribe. These reports would provide context for the information contained in the annual report form for the entire State or Tribe by disclosing which portion of the information contained on that form pertains to activities conducted within the management area.

Proposed paragraph (g) of § 76.5 would provide that, if a State or Tribe with a recognized management area wishes to expand or contract the geographical boundaries of the management area, or determines that any information in its request for recognition of the management area has substantively changed, the State or Tribe would have to submit amendments to its animal health plan that reflect these changes to APHIS in accordance with the process set forth in proposed § 76.2.

Proposed paragraph (h) of § 76.5 would deal with termination of management areas. Proposed paragraph (h)(1) would provide that, if a State or Tribe wishes APHIS to recognize the State or Tribe's termination of the management area, it would have to submit amendments to its animal health plan that reflect this termination in accordance with the process set forth in proposed § 76.2. The State or Tribe would also have to provide APHIS with an explanation why the management area was terminated. Depending on the information provided in this explanation, we may also expect the State or Tribe to submit amendments to its animal health plan that address any additional risk of introduction of brucellosis or bovine tuberculosis into program animals that may arise because of termination of the management area.

Proposed paragraph (h)(2) of § 76.5 would provide that, if we determine that a State or Tribe has failed to implement or maintain measures specified within its request for recognition of a management area for brucellosis or bovine tuberculosis, we would terminate recognition of all management areas for the disease or diseases within the State or Tribal lands. We would also redesignate the State or Tribe as an inconsistent State or Tribe for the disease or diseases. This is because States and Tribes with management areas would have known sources of brucellosis or bovine tuberculosis within them, and a State or Tribe's failure to implement or maintain measures to address the risk of disease transmission presented by this source would necessarily lead us to the conclusion that the disease status of program animals within the State or Tribal lands is uncertain or unknown.

If we redesignate a State or Tribe as an inconsistent State or Tribe for brucellosis or bovine tuberculosis, we would also terminate recognition of all management areas for that disease within the State or Tribal lands as part of this redesignation. This is because if we redesignate a State or Tribe as inconsistent, it would indicate that we have significant concerns regarding the control program for brucellosis or bovine tuberculosis within the State or Tribal lands, including activities and measures conducted within the management area.

Proposed paragraph (h)(3) of § 76.5 would provide that, if a State or Tribe requests recognition of termination of a management area, we would review the request in accordance with the process set forth in proposed § 76.2 for review of an amendment to an animal health plan.

Proposed paragraph (h)(4) of § 76.5 would provide that we would communicate our determination regarding termination of a recognized management area in accordance with the process set forth in § 76.2 for communication of a determination regarding amendments to an animal health plan.

Surveillance Requirements (§ 76.6)

As we mentioned in our discussion of proposed § 76.2, States and Tribes would have to provide a description of surveillance activities for brucellosis or bovine tuberculosis in animals within the State or Tribal lands that are being conducted or would be conducted in the State or Tribe. Proposed § 76.6 would provide minimum requirements regarding these surveillance activities.

Proposed paragraph (a) of § 76.6 would require all States to agree to participate in the National Surveillance Plans for Brucellosis and Bovine Tuberculosis, which would be located on the APHIS Web site, or to conduct equivalent surveillance in a manner approved by APHIS.

Participation in the National Surveillance Plan for Bovine Tuberculosis would require States to perform monitoring of slaughter inspection within the State that is conducted by State meat inspection personnel. Pursuant to FSIS regulations, all cattle and bison slaughtered for wholesale or retail purposes at a recognized slaughtering establishment within the United States are inspected for evidence of tuberculosis by either FSIS or State meat inspection personnel.

States would also be required to monitor caudal fold testing for bovine tuberculosis within the State that is conducted by qualified accredited veterinarians (see discussion later in this document, under the heading “Official tests for brucellosis and bovine tuberculosis, official testing laboratories, and official testers (§ 76.17)”).

If we do not require a State to conduct brucellosis surveillance or provide data regarding ongoing brucellosis surveillance conducted in the State, the State would still be considered a participant in the National Surveillance Plan for Brucellosis. Participation for certain States could be made contingent on designated recognized slaughtering establishments in the States collecting blood samples for official testing from a prescribed percentage of cattle and bison slaughtered at the establishments. This slaughter surveillance requirement currently exists in part 78, and we considered it necessary to incorporate it into the National Surveillance Plan in order to maintain an appropriate measure of passive surveillance for brucellosis throughout the United States given the reservoirs of the disease in certain areas of the United States.

APHIS could also request certain States to provide additional data on routine surveillance for brucellosis in their State that is conducted at areas of high concentration and frequent commingling of cattle and bison, such as livestock markets, cattle feeders' premises, and regional exhibitions.

We are aware that States may prefer to draft their own surveillance plan rather than participate in the National Surveillance Plans for Brucellosis and Bovine Tuberculosis. We would allow States to do so, provided that they propose to conduct what we consider to be equivalent surveillance to that specified in the National Plans and we approve the plans.

If a State fails to meet the surveillance levels set forth in the National Surveillance Plans or their own approved plans, this could result in redesignation to provisionally consistent or inconsistent status. We consider the possibility of such redesignations to be appropriate because failure to conduct adequate surveillance could adversely impact our ability to estimate the prevalence levels for brucellosis or bovine tuberculosis within a State. Similarly, surveillance data collected under the plans would be necessary for us to determine the national prevalence for brucellosis and bovine tuberculosis in the United States, and because, as we mentioned previously in this document, the regulations in part 76 would be predicated on the United States having low national prevalence levels for the diseases. Thus, if we were to lack sufficient data to determine these prevalence levels, this would deprive us of our primary means of evaluating the ongoing efficacy of the regulations in part 76.

If a consistent or provisionally consistent State refuses to participate in the plans or draft and implement their own, this would result in redesignation to inconsistent status. Additionally, if an inconsistent State refuses to participate in the plans or draft and implement their own, the interstate movement of program animals from that State would be subject to such restrictions or prohibitions as the Administrator considers necessary to prevent the dissemination of brucellosis or bovine tuberculosis from the State; we would announce such restrictions in a notice in the

Federal Register

.

We believe such remedial measures would be appropriate for three reasons. First, this refusal to conduct

surveillance would significantly and adversely impact our ability to gauge national prevalence levels for brucellosis or bovine tuberculosis. Second, this refusal would render it difficult for us to evaluate whether a State's animal health plan is addressing the risk of spread of brucellosis or bovine tuberculosis within and from the State; as it is today, slaughter surveillance would remain our primary gauge of determining brucellosis or bovine tuberculosis risks within a State under the consolidated brucellosis and bovine tuberculosis program. Third, this refusal would deprive us of assurances that program animals moved interstate from the State do not present a risk of transmitting brucellosis or bovine tuberculosis to other animals.

Proposed paragraph (b) of § 76.6 would contain additional surveillance requirements for States that have known sources of brucellosis or bovine tuberculosis.

Proposed paragraph (b)(1) would contain requirements for surveillance of wildlife source populations. It would state that, if a consistent or provisionally consistent State has identified a known source of brucellosis or bovine tuberculosis transmission within wildlife in the State in its animal health plan and determined that this source population presents a risk of transmitting brucellosis or bovine tuberculosis to program animals, in order to maintain consistent or provisionally consistent status, the State would have to conduct surveillance of that source population in a manner approved by APHIS as sufficient to detect brucellosis or tuberculosis in an animal within the source population. A consistent State that fails to conduct such surveillance would be redesignated as provisionally consistent, while a provisionally consistent State that fails to conduct such surveillance could be redesignated as inconsistent.

Proposed paragraph (b)(2) of § 76.6 would provide requirements for targeted surveillance of at-risk populations, that is, populations that are at risk of becoming infected with brucellosis or bovine tuberculosis because of transmission of the diseases from source populations. It would provide that, if a consistent or provisionally consistent State has identified a known source of brucellosis or bovine tuberculosis transmission in the State in its animal health plan and has determined that this source population presents a risk of transmitting brucellosis or bovine tuberculosis to program animals, in order to maintain consistent or provisionally consistent status, the State would have to conduct annual herd testing of all herds of at-risk program animals, or alternatively, a statistically representative sample of those herds, as determined by APHIS. A consistent State that fails to conduct such surveillance would be redesignated as provisionally consistent. A provisionally consistent State that fails to conduct such surveillance would be redesignated as inconsistent.

Such testing would be necessary in order to help us evaluate the efficacy of any mitigation measures the State has implemented to prevent transmission of brucellosis or bovine tuberculosis from known source populations to program animals. Hence, failure to conduct such testing would result in redesignation.

Proposed paragraph (c) of § 76.6 would provide requirements for surveillance within recognized management areas. It would require States to conduct surveillance within the management area in the manner specified within that section of the State's animal health plan that pertains to the management area. Since States or Tribes would have to specify surveillance activities in any request for APHIS to recognize a management area, failure to conduct such surveillance would constitute failure to implement or maintain a measure specified in the request. Hence failure to conduct such surveillance would result in termination of recognition of the management area and redesignation of the State as an inconsistent State.

Proposed paragraph (d) of § 76.6 would provide that, if a consistent State is redesignated as provisionally consistent, additional surveillance requirements for the State may be specified in the notice in the

Federal Register

that announces this redesignation.

Proposed paragraph (e) of § 76.6 would provide that the requirements in the section pertain to Tribes, provided that they have submitted a Tribal animal health plan to APHIS for review and approval in accordance with the process set forth in § 76.2, and APHIS has approved the animal health plan.

Epidemiological Investigations and Affected Herd Management (§ 76.7)

Proposed § 76.7 would contain minimum requirements regarding epidemiological investigation and affected herd management activities conducted under an animal health plan.

Proposed paragraph (a) of § 76.7 would provide that, if a program animal has a non-negative test result for brucellosis, within 15 days of receiving notification of these results, the State in which the animal was detected would have to initiate an investigation to determine the herd from which the animal originated and all herds in which it has resided.

As we mentioned previously in this document, historically, there have been occasions when secondary (corroboratory) tests to determine the presence or absence of brucellosis in program animals have yielded results that fell within the range of positive test results, but were sufficiently ambiguous to preclude the individuals conducting the test from making a determination that the animals were infected with brucellosis. However, when we have traced such animals back through production channels to their herd of origin, we have discovered animals that are infected with brucellosis.

For this reason, a consistent State that fails to conduct such an investigation on one occasion would be redesignated as provisionally consistent, while a consistent or provisionally consistent State that fails to conduct such an investigation on multiple occasions could be redesignated as inconsistent.

Proposed paragraph (b) § 76.7 would provide protocols related to other epidemiological investigations. These protocols would be consistent with generally accepted best practices for epidemiological investigations.

Proposed paragraph (b)(1) would provide a protocol for epidemiological investigations following a determination that a program animal is infected with brucellosis or bovine tuberculosis, without a concurrent determination that it has belonged to an affected herd. Such investigations would usually be initiated by discovery of an infected animal at slaughter, but could also be initiated when an animal is determined to be infected with brucellosis or bovine tuberculosis after testing positive for the disease at a livestock market, auction barn, exhibition, or other point where the animal is segregated from its herd for commercial purposes.

In such instances, within 15 days of the determination that the program animal is infected, the State in which the infected animal was detected would have to identify the herd from which the infected animal originated and all herds in which it has resided, impose the restrictions specified in proposed §§ 76.9 and 76.10 on the interstate movement of animals from those herds, impose substantially similar restrictions on the intrastate movement of program animals from the herds, and begin determining the disease status of all test-eligible animals in the herds. (Proposed § 76.9 would prohibit the movement of animals from a herd containing a reactor or suspect for brucellosis or tuberculosis, other than

the movement of the reactor or suspect itself, until the disease status of all test-eligible animals in the herd is determined. Proposed § 76.10 would provide conditions for the interstate movement of reactor, suspect, and exposed program animals.)

Proposed paragraph (b)(2) would provide a protocol for epidemiological investigations following a determination that a herd of program animals is affected with brucellosis or bovine tuberculosis. In such instances, within 15 days of this determination, the State in which the herd resides would have to identify and impose the restrictions specified in proposed §§ 76.9 and 76.10 on the interstate movement of the following animals, impose substantially similar restrictions on intrastate movement, and begin determining the disease status of all test-eligible animals in those herds:

• Any herd into which program animals from the affected herd may have been moved; and

• Any herd from which program animals in the affected herd may have originated or in which they may have resided; and

• Any herd, individual program animals, or other animals that are susceptible to brucellosis or bovine tuberculosis that may have commingled with or otherwise been exposed to the affected herd, as determined by the Administrator and communicated to the State.

Proposed paragraph (b)(3) of § 76.7 would require that, if the State in which an infected animal or affected herd was detected determines that any of the herds specified in proposed paragraph (b)(2) are located in a different State than the infected animal or affected herd, the State in which the infected animal or affected herd was detected would have to notify both that State and APHIS, in writing, within 3 days. APHIS notification would have to be submitted to the address provided within the Program Standards document. This notification would allow surrounding States to conduct their own epidemiological investigations in a timely manner, and would help APHIS to oversee and coordinate any aspects of the investigations related to interstate commerce.

Proposed paragraph (b)(4) would provide a protocol for epidemiological investigations following a determination that a non-program animal is infected with brucellosis or bovine tuberculosis, if the Administrator determines that this animal presents a risk of transmitting brucellosis or bovine tuberculosis to program animals. In such instances, the State or States surrounding the detection would have to identify all herds that may have been exposed to brucellosis or bovine tuberculosis because of this detection, as determined by the Administrator and communicated to the States. The States would also have to impose the restrictions specified in §§ 76.9 and 76.10 on the interstate movement of animals from those herds, impose substantially similar restrictions on intrastate movement, and de

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