# 80 FR 78462: Brucellosis and Bovine Tuberculosis; Update of General Provisions

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URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-31510

## Section

- **Citation:** 80 FR 78462
- **Heading:** Brucellosis and Bovine Tuberculosis; Update of General Provisions
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 80 / 80 FR 78462

## Text

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
fore 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
uberculosis 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
eferred 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
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
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
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
ate 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 1 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)
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
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. 3
3 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
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
ave 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
heir 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
n 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
. 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
losis 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
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
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. 4
4 See footnote 1.
States and Tribes would have the option of requesting recognition of a management area within the State or Tribal lands
ether 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. 4
4 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
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
odify 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 6 of the world based
6 A region is defined in § 93.400 as “any defined geographic land area identifiable by geological, political, or surveyed boundaries
cellosis- 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 6 of the world based
6 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
gnificantly 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
terstate 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
gions 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
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
n 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. 7 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.
7 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
lations 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.
7 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, o
pection (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
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
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 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
hat 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
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
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
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
uld 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 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
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
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
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
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
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
lowing:
• 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
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
nk;
• 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
sis 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
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)
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
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
dentified 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
e 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
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
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
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
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
e 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
r 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
uld 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
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
s 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
istribution 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 anim
e 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
imal 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
r 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
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
osis 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
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
lable. 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
ate 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
sionally 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 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
ithdrawn 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 provide

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- [80 FR 926 Federal Employees Health Benefits Program; Rate Setting for Community-Rated Plans](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2014-30633.md)
- [80 FR 1476 Improved Identification Techniques Against Alkali-Silica Reaction Concrete Degradation at Nuclear Power Plants](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00199.md)
- [80 FR 1477 Energy Efficiency Program for Commercial and Industrial Equipment: Energy Conservation Standards for Commercial and Industrial Fans and Blowers](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00234.md)
- [80 FR 1478 Coordination of the Scheduling Processes of Interstate Natural Gas Pipelines and Public Utilities](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00263.md)
- [80 FR 1491 Endangered and Threatened Wildlife and Plants; Proposed Endangered Status for 21 Species and Proposed Threatened Status for 2 Species in Guam and the Commonwealth of the Northern Mariana Islands](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00259.md)
- [80 FR 1872 Clarification of Content Eligibility for Standard Mail Marketing Parcels](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00401.md)
- [80 FR 1873 Lead-Based Paint Programs; Amendment to Jurisdiction-Specific Certification and Accreditation Requirements and Renovator Refresher Training Requirements](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00473.md)
- [80 FR 1881 Pacific Island Fisheries; Pacific Remote Islands Marine National Monument Expansion](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00444.md)
- [80 FR 2065 Digital Performance Right in Sound Recordings and Ephemeral Recordings for a New Subscription Service](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00203.md)
- [80 FR 2067 National Emission Standards for Hazardous Air Pollutants: Primary Aluminum Reduction Plants; Extension of Comment Period](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-00461.md)
- [80 FR 2078 Promoting Innovation and Competition in the Provision of Multichannel Video Programming Distribution Services](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2014-30777.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-31510. Check the current official text before relying on it. Not legal advice.