Brucellosis and Bovine Tuberculosis; Update of General Provisions, 78461-78520 [2015-31510]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Proposed Rules]
[Pages 78461-78520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31510]



[[Page 78461]]

Vol. 80

Wednesday,

No. 241

December 16, 2015

Part IV





Department of Agriculture





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Animal and Plant Health Inspection Service





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9 CFR Parts 50, 51, et al.





 Brucellosis and Bovine Tuberculosis; Update of General Provisions; 
Proposed Rule

Federal Register / Vol. 80 , No. 241 / Wednesday, December 16, 2015 / 
Proposed Rules

[[Page 78462]]


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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.

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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: https://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 https://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0044 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Domestic regulatory provisions: Dr. C. 
William Hench, Senior Staff Veterinarian, Ruminant Health Programs, VS, 
APHIS, 2150 Centre Avenue, Building B-3E20, Fort Collins, CO 80526-
8117; (970) 4947378. Import-related regulatory provisions: Dr. Langston 
Hull, National Import Export Services, VS, APHIS, 4700 River Road Unit 
39, Riverdale, MD 20737; (301) 851-3300.

SUPPLEMENTARY INFORMATION: 

Background

I. Purpose of the Regulatory Action

a. Need for the Regulatory Action

    Bovine tuberculosis is a contagious and infectious granulomatous 
disease caused by the bacterium Mycobacterium bovis. Although commonly 
defined as a chronic debilitating disease, bovine tuberculosis can 
occasionally assume an acute, rapidly progressive course. While any 
body tissue can be affected, lesions are most frequently observed in 
the lymph nodes, lungs, intestines, liver, spleen, pleura, and 
peritoneum. Although cattle are considered to be the true hosts of M. 
bovis, the disease has been reported in several other species of 
livestock, most notably bison and captive cervids. There have also been 
instances of infection in other domestic and nondomestic animals, as 
well as in humans.
    Brucellosis is a contagious disease, caused by bacteria of the 
genus Brucella, that affects both animals and humans. The disease 
mainly affects cattle, bison, and swine; however, goats, sheep, horses, 
and humans are susceptible as well. In its principal animal hosts, it 
causes loss of young through spontaneous abortion or birth of weak 
offspring, reduced milk production, and infertility. There is no 
economically feasible treatment for brucellosis in livestock. In 
humans, brucellosis initially causes flu-like symptoms, but the disease 
may develop into a variety of chronic conditions, including arthritis. 
Humans can be treated for brucellosis with antibiotics.
    These diseases were widely prevalent in the United States during 
the early 1900s. As recently as 1917, 1 in 20 cattle herds within the 
United States was affected with bovine tuberculosis, and, in 1934, 1 in 
10 adult cattle within the United States was a reactor (i.e., tested 
positive) for brucellosis.
    Such prevalence prompted the establishment of a National 
Cooperative State/Federal Eradication Program for bovine tuberculosis 
(referred to below as the bovine tuberculosis program) and a National 
Cooperative State/Federal Eradication Program for brucellosis (referred 
to below as the brucellosis program). The programs sought to eradicate 
the diseases from the nation's cattle herds by quickly responding to 
brucellosis and bovine tuberculosis outbreaks, identifying and 
quarantining affected herds, and depopulating these herds. To foster 
producer compliance with herd depopulation, the United States 
Department of Agriculture (USDA) regularly compensated the owners of 
depopulated herds.
    In support of these programs, USDA issued regulations. These 
regulations established State classification systems for brucellosis 
and bovine tuberculosis based on disease prevalence within a State. The 
regulations further required that these prevalence levels be supported 
by surveillance (inspection and periodic testing) of cattle within the 
State and specified that, for a State to maintain its classification, 
affected herds within a State had to be depopulated within a certain 
period of time. Finally, the regulations specified testing requirements 
and movement restrictions for cattle moved interstate from certain 
classes of States.
    Since their inception, these regulatory programs have proven 
extremely successful in reducing the prevalence of brucellosis and 
bovine tuberculosis within the United States. Based on routine 
inspection conducted by USDA's Food Safety Inspection Service (FSIS) of 
cattle slaughtered at slaughtering establishments, brucellosis 
currently affects less than 0.001 percent of all domestic program 
herds, and bovine tuberculosis less than 0.001 percent of all such 
herds. Under the standards of the World Organisation for Animal Health 
(OIE), these prevalence levels, excluding consideration of other OIE 
standards, are, in and of themselves, consistent with a ``free'' status 
for brucellosis and bovine tuberculosis.
    However, in recent years, several factors have arisen to impede our 
brucellosis and bovine tuberculosis eradication efforts. First, 
reservoirs of brucellosis and bovine tuberculosis have been identified 
in wildlife populations in certain areas of the

[[Page 78463]]

country. These affected wildlife populations pose a risk of 
transmitting brucellosis or bovine tuberculosis to livestock in the 
areas on a recurring basis, potentially resulting in brucellosis and 
bovine tuberculosis becoming endemic in livestock in certain areas of 
the country.
    Second, since USDA established regulatory programs for brucellosis 
and bovine tuberculosis, the cattle industry within the United States 
has changed substantially, and other ruminant industries have arisen. 
Cattle producers have increasingly relied on imported cattle to 
supplement their domestically raised stock, exposing the domestic herd 
to animals that originate from regions with diverse risk statuses. 
Cattle herd sizes have increased significantly, and market channels 
have become increasingly complex. Additionally, producers of bison and 
captive cervids, two species that are also susceptible to brucellosis 
and bovine tuberculosis, have established industries, and interstate 
movement of bison and captive cervids has increased accordingly.
    These industry changes have led us to reevaluate the programs' 
traditional reliance on whole herd depopulation as the sole means of 
managing affected herds. As the prevalence levels for brucellosis and 
bovine tuberculosis have decreased within the United States, funds 
allocated to Federal and State departments of agriculture to indemnify 
the owners of depopulated herds have similarly decreased. As a result, 
because of current herd sizes, which are often significantly larger 
than when the programs were established, if brucellosis or bovine 
tuberculosis is detected in a herd and the herd is depopulated, it is 
often difficult, if not impracticable, to indemnify the owner for all 
animals that are destroyed. Similarly, because of current marketing 
practices, USDA has become increasingly aware of the impacts on local 
and regional markets that may be caused by whole herd depopulation of a 
large herd. Accordingly, in the past decade, USDA has evaluated the 
efficacy of other methodologies to deal with affected herds.
    In 2009, USDA's Animal and Plant Health Inspection Service (APHIS) 
issued concept papers that outlined these factors and suggested several 
modifications to the brucellosis and bovine tuberculosis programs that 
would address the factors. Suggested modifications included:
     Crafting national surveillance plans for the programs to 
target areas within the United States where prevalence levels may be 
higher than the national average.
     Enhancing existing efforts to mitigate disease 
transmission from wildlife to livestock.
     Developing regulatory alternatives to whole-herd 
depopulation.
    The comment period for each concept paper was 60 days. By the close 
of the comment period for the brucellosis concept paper, we had 
received 344 comments, from State departments of agriculture, advocacy 
groups, livestock producers, and private citizens. By the close of the 
comment period for the bovine tuberculosis concept paper, we had 
received 73 comments, from State departments of agriculture, 
representatives for foreign governments, advocacy groups, 
representatives for the cattle industry within the United States, 
cattle producers, and private citizens. While several commenters 
expressed concern regarding some of the suggested modifications, 
commenters did not present information that called into question the 
approaches presented in the two documents.
    Accordingly, APHIS subsequently issued a rule and order that 
modified aspects of the brucellosis and bovine tuberculosis programs in 
accordance with the concept papers. In April 2010, APHIS issued a 
Federal Order \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.
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    \1\ To view the Federal Order, go to https://digitalcommons.unl.edu/cgi/viewcontent.cgi?article=1031&context=michbovinetb.
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    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.
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    \2\ To view the interim rule, go to https://www.regulations.gov/#!documentDetail;D=APHIS-2009-0083-0001.
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    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.\3\
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    \3\ To view the framework or the comments we received, go to 
https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0044.
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    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

[[Page 78464]]

State compliance with regulatory requirements as well as 
recommendations regarding State status classifications.
    Many commenters supported the establishment of such a board, but 
stated that the board should have industry representation. The 
commenters put forth a number of scenarios in which industry personnel 
would have specialized expertise that Federal, State, and Tribal 
personnel would not possess.
    We agree that industry personnel often possess such technical 
expertise, and foresee circumstances where we may need to solicit such 
expertise under a consolidated brucellosis and tuberculosis program. 
However, a board with industry representation that provides general 
recommendations to APHIS would be considered an advisory committee 
under the Federal Advisory Committee Act (5 U.S.C., appendix, FACA), 
and would thus be subject to the requirements of that Act. FACA 
requires advisory committees to follow an extensive protocol before 
convening a meeting of the committee, and this protocol could, in 
certain instances, preclude the advisory board from providing APHIS 
with timely advice regarding program activities.
    Accordingly, instead of an advisory board, APHIS would solicit the 
opinion of technical experts at the Federal, State, Tribal, and 
industry level as circumstances warrant under the consolidated 
brucellosis and bovine tuberculosis program.
    Element 2, Zoning, suggested that, if reservoirs of bovine 
tuberculosis or brucellosis are identified in an area of the United 
States and the outbreak cannot be eradicated within 1 year, then zoning 
the area for the disease or diseases should be considered as a 
management method. It further suggested that, if zoning is pursued, the 
zones should not be limited by geopolitical boundaries unless 
warranted.
    A number of State departments of agriculture pointed out that their 
jurisdiction over matters of livestock health ends at State boundaries. 
The commenters expressed concern that, if a single zone was composed of 
areas in multiple States, and one of the States failed to adhere to the 
requirements of the regulations, all of States would be subject to 
remedial measures, even though the other States have no jurisdiction 
over the activities conducted in that State.
    In light of the commenters' concerns, while this proposed rule does 
allow for zones, which we term recognized management areas, States 
would request recognition of those areas within their particular State, 
and the boundaries of the recognized management area would not extend 
beyond State borders.
    Element 5, Indemnity, proposed streamlining the process for the 
payment of indemnity for animals destroyed because of brucellosis or 
bovine tuberculosis by means of an appraisal calculator.
    Several commenters supported the use of such a calculator in 
theory, but stated that they would need to see a demonstration of such 
a calculator in order to assess its accuracy and viability as a means 
of appraisal.
    We agree that streamlining the indemnity regulations in the manner 
proposed in the framework document presupposes deployment of such a 
calculator. Since the calculator is still being developed and tested, 
we have decided not to propose to modify the indemnification process in 
the manner suggested by the framework document in this proposed rule. 
As a result, this proposed rule would not modify current indemnity 
practices, which rely on fair market value as determined by an 
appraiser, for bovine tuberculosis, and on either a fixed rate or fair 
market value as determined by an appraiser, for brucellosis.
    Finally, element 7, Import Requirements, set forth a number of 
suggested post-entry requirements for ruminants imported into the 
United States to address the risk that such ruminants may pose of 
introducing brucellosis or bovine tuberculosis into the United States.
    Several commenters suggested that, in light of our limited 
resources, APHIS would be better served by evaluating our existing 
import requirements for ruminants to determine whether, in every 
instance, they mitigate the risk of introduction of brucellosis or 
bovine tuberculosis.
    We have conducted such a risk evaluation. We have concluded that 
the current import requirements do not always mitigate such risk, and 
are proposing to amend them accordingly.
Legal Authority for the Regulatory Action
    Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et 
seq.), the Secretary of Agriculture has the authority to issue orders 
and promulgate regulations to prevent the introduction into the United 
States and the dissemination within the United States of any pest or 
disease of livestock. APHIS' regulations in 9 CFR chapter I, subchapter 
C contain requirements for the interstate movement of livestock to 
prevent the dissemination of diseases of livestock within the United 
States. APHIS' regulations in 9 CFR chapter I, subchapter D contain 
requirements for the importation of livestock to prevent the 
introduction or dissemination of diseases of livestock into the United 
States.

II. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would remove the regulations governing the 
bovine tuberculosis program, currently found in 9 CFR part 77, and 
those governing the aspects of the brucellosis program that pertain to 
cattle and bison, currently found in 9 CFR part 78, subparts B and C. 
In their place, it would add a new part to the regulations, 9 CFR part 
76. This part, which would be titled ``Part 76--Brucellosis and Bovine 
Tuberculosis,'' would contain regulations governing a national program 
designed to eradicate both diseases from cattle, bison, and captive 
cervids (``program animals'') in the United States.
    As the regulations in 9 CFR parts 77 and 78 currently do, these 
proposed regulations would provide a system to classify States for 
brucellosis and bovine tuberculosis. However, the classification system 
would no longer be based on the prevalence level of these diseases 
within a State. Rather, the system would be based on whether a State 
has drafted an animal health plan to address the diseases, whether 
APHIS has approved this plan, and whether the State has implemented and 
is maintaining the activities specified within the plan. We would also 
allow Tribes to submit plans and request brucellosis and bovine 
tuberculosis statuses apart from the State in which their Tribal lands 
are located. In order for APHIS to have adequate assurances that States 
and Tribes have implemented and are maintaining the activities and 
measures specified in their plan, the classification system would also 
be based, in part, on regular and timely submission of reports 
regarding these activities and measures.
    In an animal health plan, the State or Tribe would have to specify 
whether any known sources of brucellosis or bovine tuberculosis exist 
within the State or Tribal lands; this is no change from current 
obligations within the brucellosis and bovine tuberculosis programs 
with regard to alerting APHIS when new sources of brucellosis or bovine 
tuberculosis are discovered in State or Tribal lands. If there are 
known sources of those diseases in the State or Tribal lands, the State 
or Tribe would have to conduct surveillance of those sources and of the 
cattle, bison, or captive cervids that may come in

[[Page 78465]]

contact with the sources, and would have to specify mitigations that 
address the risk of disease spread to these at-risk populations.
    Regardless of whether there are known sources of disease in the 
State or Tribal lands, States and Tribes would also have to provide 
APHIS with demographics regarding cattle, bison, and captive cervids 
within the State, a list of personnel assigned to implement and perform 
activities and maintain and enforce measures associated with their 
animal health plans, and confirmation that the State or Tribe has a 
legal and regulatory basis for the activities specified within the 
animal health plan. Additionally, States or Tribes would have to agree 
to conduct epidemiological investigations and affected herd management 
in accordance with the protocols set forth in the sections of the 
regulations that would pertain to these activities, or would have to 
submit an alternate method to APHIS for evaluation and approval.
    The proposed rule includes protocols for epidemiological 
investigations into an investigation of individual cattle, bison, or 
captive cervids that have had non-negative test results for 
brucellosis. This proposal includes protocols for four types of 
epidemiological investigations:
     Investigations arising because individual cattle, bison, 
or captive cervids have been determined to be infected with brucellosis 
or bovine tuberculosis;
     Investigations arising because a herd of cattle, bison, or 
captive cervids has been determined to be affected with brucellosis or 
bovine tuberculosis;
     Investigations arising because animals other than cattle, 
bison, or captive cervids have been determined to be infected with 
brucellosis or bovine tuberculosis, and cattle, bison, or captive 
cervids in the area surrounding these animals have been determined by 
APHIS to be at-risk because of exposure to this source; and
     Investigations arising because brucellosis or bovine 
tuberculosis has been detected at a calf raiser or feedlot, where 
cattle or bison from disparate premises of origin are brought together 
for feeding purposes.
    States and Tribes could manage affected herds through whole-herd 
depopulation or a test-and-remove protocol. The minimum standards for a 
test-and-remove protocol would be similar to those found in the April 
2010 Federal Order.\4\
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    \4\ See footnote 1.
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    States and Tribes would have the option of requesting recognition 
of a management area within the State or Tribal lands. The management 
area would be a clearly delineated geographical area of the State or 
Tribal lands in which the State or Tribe has detected brucellosis or 
bovine tuberculosis, in which the State or Tribe has determined that 
there is a risk of transmission of brucellosis or bovine tuberculosis 
to program animals, and in which the State or Tribe has taken or 
proposes to take measures to control the spread of the brucellosis or 
bovine tuberculosis within and from the area and/or to eradicate the 
disease within the area. These measures would have to include 
restrictions on the movement of cattle, bison, and captive cervids from 
the recognized management area, as well as certain other measures. 
Recognized management areas would allow States and Tribes to designate 
certain areas of the State or Tribal lands as posing a greater risk of 
brucellosis and bovine tuberculosis spread than other areas within the 
State or Tribal lands, without risking a possible redesignation of the 
State or Tribe to a lower State or Tribal classification.
    The regulations would also provide conditions for the interstate 
movement of cattle, bison, and captive cervids. Except for cattle and 
bison that belong to certain, high-risk categories, the conditions for 
interstate movement of most cattle and bison would be based on the 
status of the State or Tribe from which the cattle or bison are moved. 
Cattle and bison from a State or Tribe with the lowest status would be 
considered to pose a substantial risk of transmitting brucellosis and/
or bovine tuberculosis, and thus would be subject to testing prior to 
interstate movement.
    Captive cervids would be subject to testing for both brucellosis 
and bovine tuberculosis prior to interstate movement, regardless of the 
status of the State or Tribe from which they are moved. Such testing 
would be necessary because FSIS does not currently conduct slaughter 
inspection of captive cervids and because the actual prevalence of 
brucellosis and bovine tuberculosis within the domestic captive cervid 
industry are largely unknown.
    Finally, the proposed rule would revise the conditions for the 
importation of cattle and bison that are contained in 9 CFR part 93 and 
that address the risk the imported cattle or bison may pose of 
disseminating brucellosis or bovine tuberculosis. The current 
regulations, which may be divided into requirements that are generally 
applicable to most exporting countries and country-specific 
requirements that are applicable to Canada, Mexico, and Ireland, do not 
account for changes in disease programs or disease prevalence that 
could increase or decrease the risk of spread of brucellosis or bovine 
tuberculosis posed by the importation of cattle or bison from foreign 
regions.
    Accordingly, we evaluated this risk to determine whether to modify 
the current regulations, and, if so, how. The risk evaluation examines 
two possible modifications: (1) Adopting international standards 
developed by the OIE or (2) applying the U.S. prevalence-based 
requirements delineated in the current Uniform Methods and Rules \5\ 
for the bovine tuberculosis and brucellosis programs within the United 
States to the importation of bovines from foreign regions.
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    \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.
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    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

[[Page 78466]]

both on its brucellosis or bovine tuberculosis prevalence and on 
whether it has a program for brucellosis or bovine tuberculosis that 
meets certain standards. The classifications would be as follows: Level 
I through V for bovine tuberculosis, and Level I through III for 
brucellosis. The regulations would allow regions to request evaluation 
for a particular classification, would establish a process by which 
APHIS would evaluate such requests, and would allow APHIS to lower a 
region's classification based on emerging evidence. Finally, the 
proposed rule would establish conditions for the importation of cattle 
and bison that correspond to the bovine tuberculosis or brucellosis 
classification of the region from which the cattle or bison will be 
exported.
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    \6\ A region is defined in Sec.  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.''
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III. Costs and Benefits

    Economic effects of the proposed rule are not expected to be 
significant. Bovine tuberculosis affects less than 0.001 percent of 
domestic program herds, and brucellosis also less than 0.001 percent. 
There would be few on-the-ground operational changes for States or 
producers. Most reporting requirements in areas where bovine 
tuberculosis and brucellosis are not found, as well as surveillance, 
movement limitations, testing, and reporting in areas where either 
disease is present, would continue with little alteration.
    Certain additional costs incurred by States, Tribes, and producers 
as a result of this proposed rule are expected to total between $3.0 
million and $8.5 million. States and Tribes would incur costs in 
developing the proposed animal health plans for bovine tuberculosis and 
brucellosis, which would build significantly on existing operations 
with respect to these diseases. We anticipate that all 50 States and at 
least 3 Tribes would develop animal health plans. We estimate that the 
aggregate one-time cost of developing all of these animal health plans 
would be between about $750,000 and $2.9 million.
    States and Tribes would also be required to report on the results 
of epidemiological investigations. We expect that the total annual cost 
for all States and Tribes of this reporting would be between $119,000 
and $142,000.
    We expect that, under current circumstances, four or five States 
are likely to develop recognized management area plans as proposed in 
this rule as part of their animal health plans. We estimate that the 
aggregate one-time cost of developing these four or five plans would be 
between $56,000 and $274,000.
    The proposed rule would impose new interstate movement restrictions 
on rodeo, event, and exhibited cattle and bison, as well as additional 
costs of testing for producers of such cattle and bison. Costs of 
tuberculosis and brucellosis testing, about $10 to $15 per test, are 
small when compared to the value of the cattle tested or to production 
costs.
    Given the volume of interstate movement of rodeo, event, and 
exhibited cattle and bison, the proposed testing requirements could 
cost owners of these cattle and bison, in aggregate, between about $2.0 
million and $4.8 million annually.
    Because the testing requirements in this rule are for interstate 
movement, the annual impact for an individual would depend on the 
number of animals moved interstate in a given year. It should be noted 
that there is overlap between APHIS' proposed testing requirements and 
current State and event requirements for testing of rodeo, event, and 
exhibition cattle and bison, which would reduce the net impact. A 
number of States, particularly those on major event circuits, already 
require tuberculosis and brucellosis testing before cattle can enter 
the State. There is not, however, consistency across States as to the 
timing of the testing relative to entry. Additionally, a number of 
these States have indicated to APHIS that they adopted the requirements 
because of the lack of Federal requirements. If this proposed rule is 
finalized and they rescind those requirements, this rule could 
eliminate that inconsistency. We request public comment from States 
with such requirements regarding whether they would, in fact, rescind 
them based on our proposed requirements.
    This rule will also impose testing requirements for brucellosis for 
captive cervids moved interstate for any purpose other than immediate 
slaughter. We do not currently have information regarding the number of 
captive cervids moved interstate. However, based on the number of deer 
farms within the United States, industry estimates that between 5 and 
10 percent of captive cervids within the United States are moved 
interstate annually, and brucellosis testing costs, we estimate the 
total annual testing costs would range between about $124,000 and 
$382,000.
    The proposed rule would also establish a new system for classifying 
foreign regions regarding bovine tuberculosis and brucellosis and 
establishing the conditions under which cattle and bison could be 
imported into the United States. All foreign regions that currently 
export cattle to the United States would be evaluated under this new 
process before the conditions are put into effect. Conditions could 
change for a particular region following evaluation under this new 
system.
    That being said, based on our knowledge of the current brucellosis 
and bovine tuberculosis programs and prevalence rates of our trading 
partners, we do not expect requirements for the importation of cattle 
and bison from foreign regions to change significantly as a direct 
result of this proposed rule. There are two specific exceptions to 
this, however. These exceptions would involve additional testing for 
breeding cattle from Mexico intended for export to the United States. 
Because most bovine exporting regions in Mexico do not currently have 
established brucellosis programs, they would automatically be 
classified in the lowest brucellosis category in this proposal and an 
additional whole herd brucellosis test would be required for imports of 
sexually mature and sexually intact cattle, i.e., breeding cattle, from 
those regions. In addition, exporting regions currently considered 
Accreditation Preparatory (AP) for tuberculosis would likely be 
classified as Level IV under this proposal and an additional whole herd 
tuberculosis test would be required for imports of breeding cattle from 
those regions.
    The impact of these additional test requirements is expected to be 
very limited. A very small number of breeding cattle are imported from 
Mexico. From 2010 through 2014, 26 breeding cattle were imported from 
Mexico on average annually. An even smaller number come from regions of 
Mexico that would be subject to additional whole herd tuberculosis 
testing requirements as well as the additional whole herd brucellosis 
testing. In 2014, only six breeding cattle were imported from such 
regions of Mexico. The cost of the additional testing would be 
dependent on the size of the herd from which bovines destined for 
export originate and the cost of administering a brucellosis and/or a 
tuberculosis test within that region of Mexico. The additional cost 
would represent a small portion of the value of the imported bovines. 
Assuming the costs of brucellosis and tuberculosis testing in the 
United States and in Mexico are similar, the combined additional 
testing would be equivalent to between 1.2 and 1.9 percent of the 
average per head value ($1,560) of imported Mexican breeding bovines, 
2009-2014.

[[Page 78467]]

    As discussed immediately above, we expect that the economic effects 
of this rule on foreign producers of cattle and bison would be minimal. 
With regard to domestic production, we expect that the benefits would 
justify the costs. While direct effects of this proposed rule for 
producers should be small, whether the entity affected is small or 
large, consolidation of the brucellosis and bovine tuberculosis 
regulations would benefit the affected livestock industries. The use of 
animal health plans would require States to identify and monitor 
potential sources of disease transmission in their State, leading to 
more focused, flexible and responsive disease management and reducing 
the number of producers that incur costs when disease concerns arise in 
an area.
The Role of the Program Standards Document
    In several instances, the proposed rule provides general standards 
for activities conducted by a State or Tribe with an animal health plan 
that has been approved by APHIS, such as surveillance, epidemiological 
investigations, and affected herd management. In these instances, the 
proposed regulations do not specify in detail the procedures that would 
meet these standards in different situations.
    To that end, APHIS is also making a Program Standards document 
available for review and comment along with the proposed rule.\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: https://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 (Sec.  76.0)
    Section 76.0 would contain definitions of the following terms: 
Accredited herd for bovine tuberculosis, accredited herd for 
brucellosis, accredited veterinarian, Administrator, affected herd 
management plan, animal identification number (AIN), annual report 
form, APHIS, APHIS representative, bison, bovine tuberculosis, 
brucellosis, calf raiser, captive cervid, depopulate, epidemiologist 
designated by the District Director, exposed, feedlot, herd, herd test, 
immediate slaughter, interstate certificate of veterinary inspection 
(ICVI), livestock, location-based numbering system, location 
identification (LID) number, management area, National Uniform 
Eartagging System (NUES), official Brucella vaccine, official 
brucellosis vaccination program, official eartag, official eartag 
shield, official identification number, officially identified, official 
seal, official test, official tester, official testing laboratory, 
owner, permit for movement of restricted animals, premises 
identification number (PIN), program animals, Program Standards 
document, qualified accredited veterinarian, quarantine feedlot, 
quarantine pen, reactor, recognized slaughtering establishment, 
reporting period, responsible person, spayed heifers, specifically 
approved stockyard, State, State or Tribal animal health official, 
State or Tribal representative, steers, suspect, test-eligible animal, 
Tribe, and United States.
    If a definition of one of these terms exists in the AHPA, we would 
define the term as it is defined in the AHPA. Thus, we would define 
livestock, State, and United States as these terms are defined in the 
AHPA.
    Similarly, the AHPA provides that Indian tribe has the same meaning 
within the Act that it has in section 450b of title 25 of the U.S. 
Code. That title, also referred to as the Indian Self-Determination and 
Education Assistance Act, defines Indian tribe as ``any Indian tribe, 
band, nation, or other organized group or community, including any 
Alaska Native village or regional or village corporation as defined in 
or established pursuant to the Alaska Native Claims Settlement Act (85 
Stat. 688) [43 U.S.C. 1601 et seq.], which is recognized as eligible 
for the special programs and services provided by the United States to 
Indians because of their status as Indians.''
    If a term in proposed part 76 is not defined in the AHPA, our next 
reference points would be the existing definitions in 9 CFR parts 77 
and 78. To that end, several terms would have the same meaning as they 
currently do within parts 77 and 78. We would define Administrator, 
animal identification number (AIN), APHIS representative, location-
based numbering system, National Uniform Eartagging System (NUES), 
official eartag, official eartag shield, official identification 
number, and recognized slaughtering establishment as these terms are 
currently defined in both part 77 and part 78.
    Similarly, accredited veterinarian is defined in a substantially 
similar manner in parts 77 and 78, but with minor differences in syntax 
and scope. However, the definition in part 78 is more common within 9 
CFR. Hence, we would define accredited veterinarian as it is defined in 
that part.
    The term captive cervid is currently defined in part 77, but not 
part 78. This is because captive cervids are currently regulated under 
the bovine tuberculosis program, but not under the brucellosis program. 
We would therefore define the term captive cervid as it is currently 
defined in part 77.
    We would define the remaining terms in the following manner.
    We would define an accredited herd for bovine tuberculosis as a 
herd that, in accordance with APHIS' standards for accreditation, has 
tested negative for bovine tuberculosis using an official test and is 
subject to measures that lower the risk of bovine tuberculosis 
introduction into the herd through the addition of animals to the herd. 
Similarly, we would define an accredited herd for brucellosis as a herd 
that, in accordance with APHIS' standards for accreditation, has tested 
negative for brucellosis using an official test and is subject to 
measures that lower the risk of brucellosis introduction into the herd 
through the addition of animals to the herd. These definitions would 
further provide that APHIS' standards for accreditation are described 
in the Program Standards document.
    The standards for accreditation for bovine tuberculosis and 
brucellosis in the Program Standards document would be substantively 
similar to the current

[[Page 78468]]

standards for accreditation of herds within the bovine tuberculosis 
program, which are found in the document ``Bovine Tuberculosis 
Eradication, Uniform Methods and Rules, Effective January 1, 2005'' \8\ 
and the current standards for certification of herds as free of 
brucellosis, which are found in part 78. However, certain aspects of 
the existing standards, such as the minimum age of animals that must be 
tested and the intervals between testing for reaccreditation, are 
linked to the current prevalence-based State classification system, 
which would be obsolete under the provisions of this proposed rule. 
Moreover, the existing standards do not reflect certain practices, such 
as testing of certain non-natural additions to a herd, that we have 
long required operationally in order for us to reach a determination 
that animals in the herd are free of brucellosis or bovine 
tuberculosis, and which would be included in the standards in the 
Program Standards document. Thus, there would be several differences 
between the current standards for herd accreditation or certification 
and the standards within the Program Standards document.
---------------------------------------------------------------------------

    \8\ To view the Uniform Methods and Rules, go to https://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf.
---------------------------------------------------------------------------

    We wish to solicit specific public comment regarding one of these 
differences. Currently, if a State has a zone for bovine tuberculosis 
or an area covered by a brucellosis management plan, in other words, an 
area in which a source of bovine tuberculosis or brucellosis is known 
to exist, we allow herds in the area to be accredited for bovine 
tuberculosis or certified free of brucellosis.
    However, we have discovered bovine tuberculosis or brucellosis in 
several accredited herds in such areas, sometimes no more than a few 
months after the date of reaccreditation. In each case, there was 
evidence that the herds probably became affected through contact with 
infected wildlife.
    Our standards for accreditation, both our current standards and 
those proposed, are based on an evaluation of mitigation measures an 
owner has put in place to address the risk of bovine tuberculosis or 
brucellosis introduction into his or her herd through the addition of 
animals to the herd. Our standards do not evaluate the risk posed to a 
herd by wildlife reservoirs of bovine tuberculosis or brucellosis. We 
note, moreover, that it is significantly more difficult to mitigate the 
risk of disease transmission that is posed by wildlife reservoirs than 
it is to mitigate the risk of disease transmission that is posed by 
adding animals to a herd. In short, while we have confidence that 
accredited or certified herds that do not reside in areas with known 
disease reservoirs present a low risk of becoming affected with bovine 
tuberculosis or brucellosis, we do not have the same degree of 
confidence regarding herds in areas with known reservoirs of disease.
    For this reason, our proposed standards would not allow herds in 
areas with known reservoirs of disease, which we would term management 
areas (see below), to be accredited for bovine tuberculosis or 
brucellosis. We also would not allow owners of currently accredited 
herds in such areas to seek reaccreditation if this rule is finalized. 
We request comment from these owners and all interested parties 
regarding the likely impacts to their operations, if any, that this 
change in policy would bring about.
    Apart from herds in recognized management areas, herds that are 
accredited for bovine tuberculosis would continue to be considered 
accredited herds if this proposed rule is finalized, and herds that are 
certified brucellosis-free herds would be considered accredited herds 
for brucellosis. Owners of these herds would not be held to the 
differing standards of the Program Standards document until the time 
that the herds would have to be tested for reaccreditation. Moreover, 
as the definitions of accredited herd for bovine tuberculosis and 
accredited herd for brucellosis would provide, States could submit an 
alternate accreditation standard to the Administrator for evaluation 
and approval at any point by sending a written request to APHIS, 
provided that the standard is at least equally stringent to that within 
the Program Standards document.
    We would define annual report form as the annual report form 
authorized by the Administrator for State and Tribal use to fulfill the 
requirements of proposed part 76. The report form, which would 
consolidate and streamline existing annual report forms for the 
brucellosis and bovine tuberculosis programs, would be located on the 
APHIS Web site. A draft template for the annual report form is located 
in the Program Standards document.
    On a related matter, we would define the reporting period covered 
by the annual report as October 1 of one year through September 30 of 
the following year. This is the current reporting period for annual 
reports within the bovine tuberculosis program. (We recognize that the 
reporting period for annual reports within the brucellosis program is 
currently staggered, and corresponds to the date on which a State was 
assigned its current status. If this rule is finalized, we would 
collaborate with States to transition them over to this new, uniform 
reporting period.)
    We would define APHIS as the Animal and Plant Health Inspection 
Service of the United States Department of Agriculture.
    We would define bison as domestically produced or captive bison. As 
provided in the definition of program animals (see below), bison would 
be considered one of the species covered by part 76. However, wild 
bison are not considered livestock within our proposed regulations, and 
our definition of bison would reflect this. We would also include this 
definition so that, for the sake of brevity, we may refer to the 
species covered by the regulations as bison, rather than domestically 
produced or captive bison, throughout part 76.
    We would define bovine tuberculosis as the contagious, infectious, 
and communicable disease caused by Mycobacterium bovis, which is also 
referred to as tuberculosis.
    Currently, part 77 refers to the disease as tuberculosis, and 
provides, in the definition of tuberculosis, that the disease is also 
referred to as bovine tuberculosis. However, in recent years, we have 
referred to the disease as bovine tuberculosis in order to provide 
clarity regarding the causal agent regulated by the bovine tuberculosis 
program and to differentiate between this agent and Mycobacterium 
tuberculosis, the most common cause of tuberculosis in humans.
    We would define brucellosis as the contagious, infectious, and 
communicable disease caused by Brucella abortus, and would specify that 
it is also known as Bangs disease, undulant fever, and contagious 
abortion. Currently, in the definition of brucellosis in part 78, we 
consider all bacteria within the genus Brucella to be causal agents for 
brucellosis. However, this is primarily because another species of 
Brucella, Brucella suis, which is the most common cause of brucellosis 
in swine, is also regulated in part 78. Brucella abortus is the most 
common cause of brucellosis in cattle, bison, and captive cervids, the 
species that would be regulated under the consolidated brucellosis and 
bovine tuberculosis program. Hence, as we stated in the draft 
regulatory framework document, Brucella abortus would be the disease 
agent regulated under proposed part 76.
    (We would continue to regulate Brucella suis in swine under part 78 
and would continue to investigate

[[Page 78469]]

occurrences of Brucella suis infection in ruminants as part of our 
national program for swine brucellosis. In addition, based on comments 
received on the draft regulatory framework document, we request 
specific public comment on whether to initiate rulemaking to establish 
a certification program for Brucella melitensis in goats.)
    We would define calf raiser as a cattle production operation in 
which calves, yearlings, and other sexually immature cattle are brought 
together and maintained until they are of sufficient size or sexual 
maturity to move to their next stage of production. As we mentioned 
previously in this document, because cattle from disparate premises of 
origin are often brought together for feeding purposes at such 
operations, the provisions of part 76 that pertain to epidemiological 
investigations, which would be contained in proposed Sec.  76.7, would 
specify a different protocol for epidemiological investigations arising 
because an infected animal is discovered at a calf raiser than for 
epidemiological investigations arising at other premises where such 
commingling does not occur or is far less frequent.
    We would define program animals, that is, the species covered by 
proposed part 76, as cattle, bison, and captive cervids.
    We would define depopulate as to destroy program animals in a herd 
at a location, in a manner, and within a timeframe as specified within 
an affected herd management plan. We would define an affected herd 
management plan as an affected herd management plan designed by the 
herd owner, the owner's veterinarian if so requested, and a State, 
Tribal, or APHIS representative to control and eradicate bovine 
tuberculosis and/or brucellosis within the herd. The definition of 
affected herd management plan would further specify that an affected 
herd management plan must be approved by a State or Tribal animal 
health official and the Administrator.
    The current definition of depopulate within part 77, ``to destroy 
all livestock in a herd by slaughter or by death otherwise,'' does not 
contain a reference to affected herd management plans. However, as a 
matter of Agency policy, we have generally required affected herd 
management plans to be put in place prior to depopulation of any 
brucellosis- or bovine tuberculosis-affected herd. Among other 
benefits, such plans help ensure that brucellosis- or bovine 
tuberculosis-affected herds are depopulated in a sanitary manner and 
owners of depopulated herds put measures in place to prevent the future 
introduction of brucellosis or bovine tuberculosis into herds at their 
premises.
    The definition in part 77 also specifies that all animals within a 
herd must be destroyed in order for the herd to be considered 
depopulated. However, within the brucellosis program, there have been 
several instances in recent years in which we have considered a herd to 
be depopulated although certain animals within the herd were removed 
from the herd for diagnostic purposes, and not destroyed. In such 
instances, the affected herd management plan established for the 
affected herd provided the specific conditions under which these 
animals would be moved in order to ensure that they presented no risk 
of spreading brucellosis to other animals. Moreover, although the 
bovine tuberculosis program does not currently allow for such a 
practice, we can envision instances in which it might prove beneficial 
in order for us to determine the actual prevalence of the disease 
within an affected herd. Accordingly, we would not specify that all 
animals within a herd must be destroyed in order for the herd to be 
considered depopulated.
    On a related matter, part 50, which provides conditions under which 
the Administrator may pay indemnity for animals destroyed because of 
bovine tuberculosis, effectively precludes indemnity from being offered 
if animals are removed from an affected herd prior to depopulation of 
the herd. Therefore, we are proposing to remove paragraph (f) of Sec.  
50.14, which contains this prohibition.
    We would define epidemiologist designated by the District Director 
as an epidemiologist selected by the APHIS District Director, in 
consultation with State or Tribal animal health officials, to perform 
the function required. This definition is modeled on the definition of 
designated epidemiologist currently found in part 78, but also reflects 
a recent reorganization of APHIS' Veterinary Services program that 
changed the manner in which this position is designated.
    We would define exposed as an animal that has had association with 
infected program animals, livestock, or other sources of brucellosis or 
bovine tuberculosis such that an epidemiologist designated by the 
District Director determines the animal may be infected.
    We would define feedlot as a facility for assembling and feeding 
program animals.
    We would define quarantine pen as an area within a feedlot that is 
approved by APHIS as having sufficient biosecurity measures in place to 
assemble and feed exposed program animals, without risk of spread of 
brucellosis or bovine tuberculosis to other susceptible animals at the 
facility. Similarly, we would define quarantine feedlot as a facility 
that is approved by APHIS as having sufficient biosecurity measures in 
place to assemble and feed exposed program animals, without risk of 
spread of brucellosis or bovine tuberculosis to other susceptible 
animals at the facility. The definitions of quarantine pen and 
quarantine feedlot would also both specify that program animals may 
only be moved interstate from such facilities if their movement is to a 
recognized slaughtering establishment, or another quarantine pen or 
quarantine feedlot.
    We recognize that certain subsectors within the cattle industry 
refer to feedlots as feedyards. We request specific public comment 
regarding which nomenclature to use.
    In proposed Sec.  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.

[[Page 78470]]

     In any area of a provisionally consistent State other than 
a recognized management area, testing of all sexually intact animals 
within a herd that are 12 months of age or older, as well as all 
sexually intact animals in the herd that are less than 12 months of age 
and were not born into the herd, except those sexually intact animals 
that are less than 12 months of age and originate directly from a 
currently accredited herd for brucellosis.
     In any area of an inconsistent State, or in a recognized 
management area for brucellosis, testing of all sexually intact animals 
within a herd that are 6 months of age or older, as well as all 
sexually intact animals in the herd that are less than 6 months of age 
and were not born into the herd, except those sexually intact animals 
that are less than 6 months of age and originate directly from a 
currently accredited herd for brucellosis.
    For bovine tuberculosis, herd test would mean the following:
     In any area of a consistent State other than a recognized 
management area, testing of all animals within a herd that are 18 
months of age or older, as well as all animals in the herd that are 
less than 18 months of age and were not born into the herd, except 
those animals that are less than 18 months of age and originate 
directly from a currently accredited herd for bovine tuberculosis.
     In any area of a provisionally consistent State other than 
a recognized management area, testing of all animals within a herd that 
are 12 months of age or older, as well as all animals in the herd that 
are less than 12 months of age and were not born into the herd, except 
those animals that are less than 12 months of age and originate 
directly from a currently accredited herd for bovine tuberculosis.
     In any area of an inconsistent State and in a recognized 
management area for bovine tuberculosis, testing of all animals within 
a herd that are 6 months of age or older, as well as all animals in the 
herd that are less than 6 months of age and were not born into the 
herd, except those animals that are less than 6 months of age and 
originate directly from a currently accredited herd for bovine 
tuberculosis.
    We would exempt sexually neutered animals from herd tests for 
brucellosis because there is no scientific evidence suggesting they can 
transmit brucellosis.
    The minimum testing ages specified within this definition correlate 
to the degree of risk of exposure to brucellosis or bovine tuberculosis 
that we would associate with the area in which the herd resides. We 
encourage all interested persons to review this definition within the 
context of subsequent discussions in this proposed rule regarding our 
proposed State and Tribal classification system (see ``State or Tribal 
classifications (Sec.  76.3)'' below) and recognized management areas 
(see ``Recognized management areas (Sec.  76.5)'' below).
    We would define immediate slaughter as consignment directly to a 
recognized slaughtering establishment. In proposed Sec. Sec.  76.14 and 
76.15, we would allow cattle and bison to be moved interstate without 
testing for brucellosis or bovine tuberculosis from States and Tribes 
with the lowest status for these diseases, inconsistent, provided that 
the animals are destined for immediate slaughter.
    We would define interstate certificate of veterinary inspection 
(ICVI) in a manner that is similar to the definition currently found in 
parts 77 and 78. However, whereas the current definition specifies that 
a document other than an ICVI may be used in order to provide an 
alternative to typing or writing individual animal identification on an 
ICVI, but still requires an ICVI to accompany this document, we would 
allow a document to take the place of an ICVI altogether, provided that 
the following conditions are met:
     The document is agreed upon by the shipping and receiving 
States or Tribes as an acceptable alternative to an ICVI;
     The document is a State or Tribal form or APHIS form that 
requires individual identification of animals;
     Each copy of the document identifies each animal to be 
moved, but any information pertaining to other animals, and any unused 
space on the document for recording animal identification, is crossed 
out in ink;
     The following information is written in ink in the 
identification column on the original and each copy and is circled or 
boxed, also in ink, so that no additional information can be added: The 
name of the document and either the unique serial number on the 
document or, if the document is not imprinted with a serial number, 
both the name of the person who prepared the document and the date the 
document was signed; and
     A copy of the document accompanies the program animals 
during interstate movement.
    During the comment period for the rule that proposed to establish 
animal identification requirements for livestock moving interstate (76 
FR 50082-50110, Docket No. APHIS-2009-0091), several commenters urged 
us to consider whether ``event passports'' and other similar documents 
could be used in lieu of ICVIs for animals, such as rodeo steers, that 
move frequently in interstate commerce. The rule that finalized that 
proposal specified, in its preamble, that such documents could be used 
in lieu of ICVIs. Our proposed definition would also allow such 
documents to be used.
    We would define location identification (LID) number and premises 
identification number (PIN) as these terms are currently defined in 
parts 77 and 78, with the following modification: We would remove 
references to group identification of livestock from the definitions. 
We would do this because proposed part 76 would not allow for group 
identification of program animals.
    We would define management area as a clearly delineated 
geographical area in which a State or Tribe has detected brucellosis or 
bovine tuberculosis, has determined that there is a risk of 
transmission of brucellosis or bovine tuberculosis to program animals, 
and has taken or proposes to take measures to control the spread of the 
brucellosis or bovine tuberculosis within and from the area and/or to 
eradicate the disease within the area. We discuss management areas at 
length below, in our discussion of proposed Sec.  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

[[Page 78471]]

requirements had to be broadly applicable, we allowed them to 
incorporate a degree of flexibility regarding the types of 
identification we would authorize as official identification.
    However, 9 CFR now contains minimal national standards for 
identification of cattle and bison that move in interstate commerce, in 
part 86; these were added in 2013 (78 FR 2040-2075; Docket No. APHIS-
2009-0091). We believe that the identification requirements in that 
part are sufficient for most cattle and bison that are moved in 
interstate commerce; hence, we would not include official 
identification requirements for those animals in part 76, and would 
instead instruct persons to consult part 86 for the relevant 
identification requirements. We would only specify identification 
requirements in part 76 for classes of animals that we believe present 
a higher-than-average risk of transmitting brucellosis or bovine 
tuberculosis to other animals. We believe that it is important to be 
able to effectively trace the movement of such animals in interstate 
commerce. Because official eartags contain unique identifiers and are 
tamper-evident, we consider them to provide the most reliable means of 
achieving this degree of traceability.
    While 9 CFR part 86 contains minimal national standards for 
identification of cattle and bison that move in interstate commerce, it 
currently defers to part 77, which we are proposing to remove from the 
regulations, for official identification requirements for captive 
cervids. Part 77 currently allows captive cervids to be officially 
identified by means of an official eartag, a brand, or a tattoo 
providing unique identification of the cervid.
    However, we are not aware of any captive cervid producers who brand 
their cervids for purposes of official identification. Moreover, we are 
aware of a number of identification devices, such as subcutaneous RFID 
transponders, that could be used for unique identification of captive 
cervids. Thus, our proposed definition of officially identified for 
captive cervids would not refer to brands, but would allow for such 
alternate devices when agreed upon by APHIS and the shipping and 
receiving States or Tribes to constitute such official identification.
    We would define official seal as a serially numbered, metal or 
plastic strip, consisting of a self-locking device on one end and a 
slot on the other end, which forms a loop when the ends are engaged and 
which cannot be reused if opened, or a serially numbered, self-locking 
button. Current definitions of official seal within 9 CFR do not 
specify that a strip used for an official seal may be plastic, and do 
not allow a serially numbered, self-locking button to be used in lieu 
of such a strip. However, we have long used both plastic strips and 
self-locking buttons to seal means of conveyance containing infected, 
reactor, suspect, or exposed animals, and have found such seals to be 
as reliable as metal strips.
    We would define official test as any test that is approved by the 
Administrator for determining the presence or absence of brucellosis or 
bovine tuberculosis in program animals that is conducted and reported 
by an official tester. If an official test is applied to a program 
animal, it would have to be identified by means of an official eartag. 
If this eartag uses the National Uniform Eartagging System, one of the 
official identification systems that has been approved by APHIS, the 
eartag would have to indicate the State or Tribe in which it was 
applied; if it uses the Animal Identification Number system, another 
approved official identification system, it would have to indicate the 
premises on which it was applied. Finally, if an animal that is tested 
already has such an eartag, the information on this eartag would have 
to recorded by the tester. These provisions regarding unique 
identification of tested animals would codify long-standing Agency 
policies that we consider necessary to maintain accurate records 
regarding the application of official tests for program purposes.
    We would define official tester as any person associated with the 
conducting and reporting of official tests within an official testing 
laboratory, or any person authorized by the Administrator to conduct 
and report official tests outside of a laboratory environment. Proposed 
Sec.  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 Sec.  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 Sec.  76.10, we would require this document, 
which is currently VS Form 1-27, to accompany reactor, suspect, and 
exposed program animals that are moved interstate.
    We would define Program Standards document as a document providing 
guidance related to the regulations contained in part 76. Substantive 
changes to Program Standards document would be announced through 
notices published in the Federal Register. These notices would request 
public comment on the changes.
    We would define qualified accredited veterinarian as that term is 
defined in 9 CFR part 160.
    We would define reactor as:
     For brucellosis, a program animal that has had non-
negative test results to an official test such that an epidemiologist 
designated by the District Director has determined that there is a high 
likelihood that the animal is infected with brucellosis, and a low 
likelihood of false positive test results.
     For bovine tuberculosis, a program animal that has had 
non-negative test results to an official test such that an 
epidemiologist designated by the District Director has determined that 
further action is warranted to make a final determination regarding the 
animal's disease status.
    We believe these differing definitions for reactor to be warranted 
because, while reactors for bovine tuberculosis have usually tested 
non-negative to both an official screening test and secondary 
(corroboratory) test and must be taken to necropsy or slaughter for a 
final determination of disease status, reactors for brucellosis often 
are classified based on test results to a screening test that fell 
within parameters that strongly suggested the presence of brucellosis 
in the animal.
    We would define responsible person as the individual who is 
immediately responsible for implementation and maintenance of an animal 
health plan within a State or Tribe, who is authorized to amend the 
plan as circumstances warrant, and who will assume responsibility for 
the State or Tribe's compliance with all provisions of the plan and all 
requirements in part 76.
    We would define spayed heifers as sexually neutered female cattle 
or bison, and would define steers as sexually neutered male cattle or 
bison.

[[Page 78472]]

    We would define specifically approved stockyard as premises where 
program animals are assembled for sale purposes and which meet the 
standards set forth in Sec.  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 Sec.  76.10 would allow reactor, suspect, and 
exposed program animals to be moved interstate to specifically approved 
stockyards, among other approved locations.
    We would define State or Tribal animal health official as the State 
or Tribal official responsible for livestock and poultry disease 
control and eradication programs in a State or Tribe, and would define 
State or Tribal representative as an individual employed in animal 
health work by a State or Tribe, or a political division of a State or 
Tribe, and authorized by that State or Tribe to perform the function 
involved. These definitions would be modeled on the definitions of 
State animal health official and State representative that are 
currently found in multiple parts within 9 CFR, but would reflect the 
fact that we would now authorize a Tribe to submit an animal health 
plan and request a brucellosis or bovine tuberculosis classification 
apart from the State in which the Tribal lands are located.
    We would define suspect as a program animal that has had non-
negative test results to an official test for brucellosis or bovine 
tuberculosis that lead an epidemiologist designated by the District 
Director to determine that the animal should not be classified as a 
reactor, but cannot be classified as free of brucellosis or bovine 
tuberculosis.
    Unless the Administrator specifies or approves an alternate testing 
age, test-eligible animal would mean:
     For brucellosis, all sexually intact program animals in a 
herd that are 6 months of age or older, and all program animals in the 
herd that are less than 6 months of age and were not born into the 
herd, except those program animals that are less than 6 months of age 
and originate directly from an accredited herd for brucellosis.
     For bovine tuberculosis, all program animals in a herd 
that are 12 months of age or older, and all program animals in the herd 
that are less than 12 months of age and were not born into the herd, 
except those program animals that are less than 12 months of age and 
originate directly from an accredited herd for bovine tuberculosis; 
except that, if the herd is located on a calf raiser's premises, all 
program animals in the herd that are 2 months of age or older are 
considered test-eligible for bovine tuberculosis.
    We consider a definition of test-eligible animal to be necessary 
because, in proposed Sec.  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 Sec.  78.1, sexually intact cattle 
and bison are not considered test-eligible for brucellosis until they 
are at least 18 months of age. However, in part 78, the term test-
eligible is applied in a generic sense to animals that are sexually 
mature and sexually intact. We agree that, in the absence of a known 
disease risk, 18 months of age is an appropriate threshold for test-
eligibility for brucellosis within the United States.
    However, in proposed part 76, we would reserve the term test-
eligible for animals in herds that may have harbored or come in contact 
with a brucellosis- or bovine tuberculosis-infected animal, and that 
therefore could potentially be affected with brucellosis and bovine 
tuberculosis. In such instances, there is a known disease risk, the 
infected animal, and it would be prudent to determine the disease 
status of all animals in the herd that could potentially be infected 
with brucellosis or bovine tuberculosis because of that disease risk. 
Because animals as young as 6 months of age may transmit brucellosis, 
we would consider them test-eligible for the purposes of proposed part 
76.
Authority of the Administrator (Sec.  76.1)
    Proposed Sec.  76.1 would state that, notwithstanding the 
provisions of part 76, the Administrator is authorized pursuant to the 
AHPA to prohibit or restrict the movement in commerce of any animals, 
if the Administrator considers that prohibition or restriction to be 
necessary to prevent the dissemination of brucellosis or bovine 
tuberculosis within the United States. It would further state that, 
pursuant to the Act, the Administrator may also hold, seize, 
quarantine, treat, destroy, dispose of, or take other remedial action 
with respect to any animal, article, or means of conveyance that is 
moving or has moved in interstate commerce, if the Administrator has 
reason to believe that animal, article, or means of conveyance may 
carry, have carried, or have been affected with or exposed to 
brucellosis or bovine tuberculosis at the time of interstate movement.
    While this section would be a restatement of our authority under 
the AHPA, we consider it necessary to include it within proposed part 
76. This is because the regulations in part 76 would be predicated on 
the low prevalence for brucellosis and bovine tuberculosis within the 
United States, and would provide adequate mitigations for the majority 
of instances in which cattle, bison, and captive cervids are moved 
interstate. There may, however, be certain unlikely scenarios, such as 
a significant outbreak of brucellosis or bovine tuberculosis within a 
State or Tribe, which the regulations in part 76 would not be adequate 
to address.
    If such a scenario were to occur, the Administrator would take such 
action as he or she deems appropriate to address the risk that cattle, 
bison, or captive cervids moved interstate from the State or Tribe may 
present of disseminating brucellosis or bovine tuberculosis. This could 
include issuing an order placing additional restrictions on the 
interstate movement of cattle, bison, or captive cervids from the State 
or Tribe, or issuing an order prohibiting the movement of cattle, 
bison, or captive cervids from that State or Tribe until the outbreak 
is addressed.
Animal Health Plan Requirements (Sec.  76.2)
    The State and Tribal classification system for brucellosis and 
bovine tuberculosis within proposed part 76 would be based on whether a 
State or Tribe has drafted an animal health plan to address the 
diseases, whether APHIS has approved this plan, and whether the State 
or Tribe has implemented and is performing the activities and enforcing 
the measures specified in the plan. (We consider activities to be all 
actions that a State or Tribe specifies in its animal health plan that 
are not mitigation measures. We consider measures to be those 
mitigations specified within the plan.) Proposed Sec.  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 Sec.  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

[[Page 78473]]

classification system, a State or Tribe would have to submit an animal 
health plan to APHIS via the mail as provided within the Program 
Standards document, or submit the plan electronically as specified 
within the Program Standards document. (Proposed Sec.  76.3 describes 
the State and Tribal classification system at length.)
    At a minimum, in order to be considered complete, each animal 
health plan would have to contain the following categories of 
information:
     Confirmation that the State or Tribe has a legal and 
regulatory basis for the activities and measures specified within the 
plan.
     A description of the organization and infrastructure of 
the animal health and wildlife authorities within the State or Tribe. 
The description would have to include the animal health and wildlife 
work force within the State or Tribe that is available to implement or 
perform activities and maintain and enforce measures specified within 
the animal health plan, and would have to demonstrate that the State or 
Tribe has sufficient resources to implement, maintain, and enforce its 
animal health plan.
     The name and contact information for the responsible 
person that the State or Tribe has designated to oversee 
implementation, performance, and enforcement of activities and measures 
carried out under the plan within the State or Tribe, and the name and 
contact information for the person that the State or Tribe has 
designated to oversee implementation, performance, and enforcement of 
wildlife activities and measures carried out under the plan. States or 
Tribes could designate a single individual to serve in multiple roles.
     A description of program animal demographics within the 
State or Tribal lands. This description would have to include the 
approximate number and types of program animal herds within the State 
or Tribal lands, the approximate number of animals in those herds, and 
the approximate number and geographic distribution of any animal 
concentration points within the State or Tribal lands. (The Program 
Standards document would provide examples of what would constitute an 
animal concentration point.)
     A description of the surveillance activities for 
brucellosis or bovine tuberculosis in animals within the State or 
Tribal lands that are being conducted or would be conducted under the 
animal health plan. (We would include a footnote, footnote 1, directing 
individuals to proposed Sec.  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:
    [cir] 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;
    [cir] 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;
    [cir] The potential for exposure of program animals within the 
State or Tribal lands to these known source populations;
    [cir] 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
    [cir] 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 
Sec.  76.7 for minimum requirements regarding epidemiological 
investigation and affected herd management activities conducted under 
an animal health plan.)
    We recognize that the draft template for an animal health plan in 
the Program Standards document contains two additional information 
categories, one pertaining to the bovine tuberculosis program 
certification offered to qualified accredited veterinarians within the 
State or Tribe, the other to State and Tribal oversight of the official 
tests administered by these veterinarians. The information a State or 
Tribe supplies within these categories would not be directly included 
in our evaluation of the animal health plan for purposes of determining 
whether or not to propose to approve it, but rather to aid in the 
implementation and maintenance of our national program certification 
for bovine tuberculosis. We discuss this program certification at 
greater length below, in our discussion under the heading ``Official 
tests for brucellosis and bovine tuberculosis, official testing 
laboratories, and official testers (Sec.  76.17).''
    Proposed paragraph (b) of Sec.  76.2 would state that APHIS will 
review the plan submitted by the State or Tribe for completeness. This 
initial review would ensure that the State or Tribe has provided 
information in each of categories listed above, or has provided an 
explanation regarding why the information category is not applicable to 
the State or Tribe.
    Once we determine a plan to be complete, APHIS would conduct formal 
review and evaluation of the plan. First, we would determine whether 
the State or Tribe has identified sources of brucellosis or bovine 
tuberculosis within the State and Tribal lands. If the State or Tribe 
has stated that no sources of the disease are known to exist in the 
State or Tribal lands, we would expect the State or Tribe to provide a 
justification in support of this statement, including documentation of 
the surveillance or other activities that led to this conclusion. If we 
consider the statement to be justified, we would evaluate the 
epidemiological investigation and affected herd management activities 
that the State or Tribe states it would take in responses to 
occurrences of brucellosis or bovine tuberculosis within program 
animals in the State or on Tribal lands, whether the State or Tribe has 
legal and regulatory authority for these activities, and whether the 
State or Tribe has sufficient personnel to implement and, if necessary, 
effectively carry out these activities and enforce these measures.
    If the State or Tribe does identify sources of brucellosis or 
bovine

[[Page 78474]]

tuberculosis in the State or Tribal lands, we would evaluate the 
likelihood of transmission of brucellosis or bovine tuberculosis from 
known source populations to program animals in light of the information 
provided by the State or Tribe regarding the prevalence of the diseases 
within the sources, potential for exposure of program animals to these 
sources, and factors that may influence this exposure. We would also 
evaluate the mitigation measures specified by the State or Tribe to 
determine whether they are adequate to prevent transmission of 
brucellosis or bovine tuberculosis from source populations to program 
animals, and would evaluate the surveillance activities specified by 
the State or Tribe to determine whether they would be sufficient to 
detect changes in prevalence levels of disease in the source 
population, or the presence of disease in program animals exposed to 
these source populations. Finally, we would evaluate whether the State 
or Tribe has adequate legal and regulatory authority and personnel to 
carry out the activities specified within the plan.
    If this rule is finalized, it is possible that certain smaller 
States and Tribes would wish to coordinate brucellosis or bovine 
tuberculosis program activities or share personnel with neighboring 
States or Tribes. Guidance regarding how these consolidated efforts 
should be described in the State or Tribe's animal health plan is 
provided in the Program Standards document.
    There could be instances when APHIS lacks technical expertise to 
evaluate certain provisions within a State or Tribe's animal health 
plan. For example, if a State or Tribe identifies free-ranging wildlife 
as a source population of brucellosis or bovine tuberculosis within the 
State or Tribal lands, but states that the movement patterns of the 
wildlife effectively preclude contact with program animals within the 
State or Tribal lands, that the risk of transmission of brucellosis or 
bovine tuberculosis from those wildlife populations to these program 
animals is correspondingly remote, and that mitigation activities to 
address this risk are therefore not necessary, it is possible that 
APHIS would not possess the knowledge of the movement patterns 
necessary to evaluate this claim. In such instances, APHIS would share 
a copy of the plan with Federal, State, Tribal, and/or industry experts 
for technical review and comment regarding the issue or issues for 
which we lack expertise.
    Upon conclusion of review of the plan, we would make a 
determination regarding whether or not to propose to approve the plan. 
If we determine not to propose to approve the plan, we would contact 
the State or Tribe that submitted the plan and set forth the 
deficiencies identified in the plan that preclude us from proposing to 
approve it.
    Proposed paragraph (c) of Sec.  76.2 would provide that we could 
propose to approve a State or Tribal animal health plan 
unconditionally, or on the condition that the State or Tribe implement 
certain provisions of its plan within a specified period of time that 
it cannot implement immediately upon approval of the plan. We 
anticipate that this latter, conditional approval would be reserved for 
plans that set forth what we consider to be adequate activities and 
effective measures to address the risk of introduction of brucellosis 
or bovine tuberculosis into program animals within the State or Tribal 
lands, but that indicate that the State or Tribe will need to amend 
laws and/or regulations in order to have sufficient legal and 
regulatory authority to implement the plan. We request specific comment 
regarding whether there are other scenarios that should lead us to 
approve a plan conditionally.
    Regardless of whether we propose to approve a plan unconditionally, 
or on the condition that the State or Tribe implement certain 
provisions of its plan within a specified period of time, we would 
publish a notice in the Federal Register announcing our proposed 
approval of the plan and making the plan available for public review 
and comment.
    Prior to issuance of this notice, we would consult with the 
responsible person identified in the plan in order to ensure that the 
State or Tribe is prepared for us to make the plan, proposed amendments 
to the plan, and all reports required by the regulations in part 76 
publicly available. We consider this provision to be necessary because, 
as we stated in the draft regulatory framework document, and as several 
commenters on that document concurred, transparency regarding the 
regulatory activities for brucellosis and bovine tuberculosis that a 
State or Tribe is conducting would be a foundation for the success and 
acceptance of the program both domestically and internationally.
    Proposed paragraph (d)(1) of Sec.  76.2 would set forth the 
determinations that we could make following a notice proposing 
unconditional approval of an animal health plan. If no comments are 
received on this notice, or if the comments received do not affect 
APHIS' conclusion that a plan may be approved unconditionally, we would 
publish a subsequent notice in the Federal Register announcing that the 
plan has been approved unconditionally, and designating the State or 
Tribe as a consistent State or Tribe.
    If the comments received on the notice suggest the plan should be 
approved, but that the State or Tribe cannot implement certain 
provisions of its animal health plan immediately upon approval of the 
plan, and after reviewing the information, we agree, we would publish a 
subsequent notice in the Federal Register announcing that the plan has 
been approved conditionally, and designating the State or Tribe as a 
provisionally consistent State or Tribe. This notice would also specify 
the provisions of the plan that APHIS has determined cannot be 
implemented immediately and the time period in which they would have to 
be implemented. The notice could also specify restrictions on the 
interstate movement of program animals or other program requirements 
that would apply to the State or Tribe while it is in provisionally 
consistent status.
    Finally, if the comments received suggest that the plan should not 
be approved, and, after reviewing the information, we agree, we would 
publish a subsequent notice in the Federal Register describing the 
comments that we received, our reevaluation of the plan in light of 
those comments, and our reasons why we cannot approve the plan.
    Proposed paragraph (d)(2) of Sec.  76.2 would set forth the 
determinations that we could make following a notice proposing 
conditional approval of an animal health plan. If no comments are 
received on the notice, or if the comments received do not affect our 
conclusion that the plan may be approved on the condition that the 
State or Tribe implement certain provisions of its plan within a 
specified period of time that it cannot implement immediately upon 
approval of the plan, we would publish a subsequent notice in the 
Federal Register announcing that the plan has been approved 
conditionally, and designating the State or Tribe as a provisionally 
consistent State or Tribe. This notice would specify the provisions of 
the plan that we have determined cannot be implemented immediately and 
the time period in which they must be implemented. The notice could 
also specify restrictions on the interstate movement of program animals 
or other program requirements that apply to the State or Tribe while it 
is in provisionally consistent status.
    Alternatively, if the comments received suggest that the plan 
should not be approved, and, after reviewing the information, we agree, 
we would

[[Page 78475]]

publish a subsequent notice in the Federal Register describing the 
comments that we received, our reevaluation of the plan in light of 
those comments, and our reasons why we cannot approve the plan.
    Proposed paragraph (e) would provide that, if we approve a State or 
Tribal animal health plan conditionally, designate the State or Tribe 
as provisionally consistent, and specify the period of time in which 
the State or Tribe must implement all provisions of its plan, we would 
publish a subsequent notice in the Federal Register announcing whether 
the State or Tribe has implemented all provisions of the plan within 
that period of time. If the State or Tribe has, the notice would 
announce that we consider the plan unconditionally approved, and have 
redesignated the State or Tribe as a consistent State or Tribe. If the 
State or Tribe has not, the notice would announce that we have 
withdrawn approval of the plan, and have redesignated the State or 
Tribe as an inconsistent State or Tribe. This second notice would be 
necessary in order to ensure that States and Tribes take appropriate 
action to be able to implement all provisions of their animal health 
plan in a timely manner.
    Proposed paragraph (f) of Sec.  76.2 would contain the processes 
for amendments to an animal health plan. Proposed paragraph (f)(1) of 
Sec.  76.2 would provide that, if APHIS determines that the activities 
or measures specified in an approved animal health plan no longer 
correspond to the risk of spread of brucellosis or bovine tuberculosis, 
for example, if sources of brucellosis or bovine tuberculosis are 
discovered in a State or on Tribal lands in which no sources were 
previously known to exist, we would make ongoing approval of the plan 
contingent on the State or Tribe amending the plan in a manner that we 
approve of. The amended plan would have to be submitted to APHIS via 
the mail as provided within the Program Standards document, or 
electronically as provided in the Program Standards document.
    Alternatively, if a State or Tribe wishes to amend its animal 
health plan, the State or Tribe would have to submit proposed 
amendments to the plan to us via the mail or electronically as provided 
in the Program Standards document. Amendments proposed by the State or 
Tribe would be subject to the notice-based approach specified in 
proposed paragraphs (b) through (d) of proposed Sec.  76.2, although we 
anticipate that provisional approval of an amendment would be used 
sparingly, if at all.
    Proposed paragraph (g) would state that APHIS reserves the right to 
conduct a review of States or Tribes at any point for compliance with 
their approved animal health plan. Such a compliance review could 
include site visits and/or documentation review.
State or Tribal Classifications (Sec.  76.3)
    Proposed Sec.  76.3 would contain the revised three-tier State and 
Tribal classification system of ``consistent,'' ``provisionally 
consistent,'' and ``inconsistent.'' It would also contain the 
considerations that would lead us to initially classify a State or 
Tribe as a consistent State or Tribe, and those considerations that may 
lead us to redesignate the State or Tribe to a lower classification. 
Finally, it would specify the measures that a State or Tribe must take 
in order to regain consistent status following a redesignation.
    Proposed paragraph (a) of Sec.  76.3 would provide that each State 
is classified as consistent, provisionally consistent, or inconsistent 
for brucellosis, and consistent, provisionally consistent, or 
inconsistent for bovine tuberculosis. It would also provide that Tribes 
are classified as consistent, provisionally consistent, or inconsistent 
for these diseases, provided that they have submitted a Tribal animal 
health plan to APHIS and we have approved it.
    Proposed paragraph (b) of Sec.  76.3 would set forth the conditions 
that would lead us to initially designate a State or Tribe as 
consistent, provisionally consistent, or inconsistent.
    We would initially designate a State or Tribe as a consistent State 
or Tribe for brucellosis and bovine tuberculosis if we approve the 
State or Tribe's animal health plan unconditionally, that is, without 
provisos, in accordance with the process set forth in paragraph (d) of 
proposed Sec.  76.2.
    We would initially designate a State or Tribe as a provisionally 
consistent State or Tribe if we approve the State or Tribe's animal 
health plan on the condition that it implement certain provisions of 
its plan within a specified period of time that it cannot implement 
immediately upon approval of the plan, in accordance with the process 
set forth in paragraph (d) of proposed Sec.  76.2.
    We anticipate that, if this rule is finalized, we would receive 
animal health plans from all 50 States. We also anticipate that, even 
if commenters disclose deficiencies in the initial iteration of a 
State's plan that preclude us from approving it, a subsequent iteration 
of the plan would be approved.
    However, in the event that a State elects not to draft an animal 
health plan, there would come a time when we would have to designate 
the State as inconsistent for brucellosis and bovine tuberculosis in 
order to fully implement the State and Tribal classification system and 
ascribe the appropriate regulatory requirements for the interstate 
movement of cattle and bison from that State (see proposed Sec. Sec.  
76.14 and 76.15). The date on which this would occur would be announced 
through a notice in the Federal Register.
    If we do not receive an animal health plan from a Tribe, the Tribe 
would be considered part of the State in which the lands reside for 
purposes of the regulations in part 76. Hence we would not initially 
designate a Tribe as inconsistent for opting not to submit an animal 
health plan to APHIS.
    Proposed paragraph (c) would contain the conditions that could lead 
us to redesignate a State or Tribe to a lower classification. Proposed 
paragraph (c)(1) would contain conditions that may lead us to 
redesignate a consistent State or Tribe as a provisionally consistent 
State or Tribe. We could redesignate the State or Tribe as 
provisionally consistent if:
     The State or Tribe fails to implement or perform an 
activity or maintain a measure specified within its animal health plan, 
and we determine that this failure may result in the spread of 
brucellosis or bovine tuberculosis.
     The State or Tribe fails to submit an annual report as 
specified in paragraph (a) of Sec.  76.4.
     The State or Tribe fails to submit an initial 
epidemiological investigation situation report within 14 days of the 
period of time specified in paragraph (c) of Sec.  76.4 for submitting 
such a report.
     The State or Tribe fails to submit an updated 
epidemiological investigation situation report as specified in 
paragraph (d) of Sec.  76.4.
     On more than one occasion, the State or Tribe fails to 
submit a closing report as specified in paragraph (e) of Sec.  76.4.
     The State or Tribe fails to meet national surveillance 
levels as these are specified within the National Surveillance Plans 
for brucellosis or bovine tuberculosis or as these are specified within 
an alternate State or Tribal plan that has been approved by APHIS. (We 
would include a footnote, footnote 3, directing individuals to 
paragraph (a) of Sec.  76.6 for further information regarding this 
regulatory requirement.)
     The State or Tribe fails to conduct targeted surveillance 
of wildlife source

[[Page 78476]]

populations as specified in paragraph (b)(1) of Sec.  76.6.
     The State or Tribe fails to conduct targeted surveillance 
of at-risk program animals as specified in paragraph (b)(2) of Sec.  
76.6.
     The State or Tribe has failed to conduct an investigation 
of a program animal with non-negative test results for brucellosis in 
accordance with paragraph (a) of Sec.  76.7, or to send a report 
regarding those activities as specified in paragraph (b) of Sec.  76.4.
    Many of these conditions for redesignation would hinge on a State 
or Tribe's failure to meet certain regulatory requirements of part 76 
either fully or in a timely fashion. Accordingly, we will discuss our 
rationale for these conditions below, within the context of our 
discussion of the regulatory requirements themselves. However, 
generally speaking, we would redesignate a State or Tribe as 
provisionally consistent if the State or Tribe fails to take or 
document an action that would otherwise demonstrate that it has fully 
implemented its animal health plan and is performing the activities and 
maintaining the measures specified in its animal health plan.
    Proposed paragraph (c)(2) of Sec.  76.3 would contain the 
conditions that may lead us to redesignate a State or Tribe as an 
inconsistent State or Tribe.\9\ We could redesignate the State or Tribe 
as inconsistent if:
---------------------------------------------------------------------------

    \9\ We acknowledge that many of these conditions are 
substantially similar to those that could result in redesignation of 
a State to provisionally consistent status. A side-by-side 
comparison of the conditions for redesignation of a State to 
provisionally consistent and inconsistent status is found on pages 
33-36 of the Program Standards document that accompanies this 
proposed rule.
---------------------------------------------------------------------------

     The State or Tribe fails to implement or perform an 
activity or maintain a measure specified within its animal health plan, 
or fails to amend the plan in response to a request from APHIS, and 
APHIS determines that this failure has resulted or may result in the 
spread of brucellosis or bovine tuberculosis.
     On more than one occasion, the State or Tribe fails to 
submit an annual report as specified in paragraph (a) of Sec.  76.4.
     On more than one occasion, the State or Tribe fails to 
submit an initial epidemiological investigation situation report within 
14 days of the period of time specified in paragraph (c) of Sec.  76.4 
for submitting such a report.
     On more than one occasion, the State or Tribe fails to 
submit an updated epidemiological investigation situation report as 
specified in paragraph (d) of Sec.  76.4.
     APHIS has terminated recognition of the State or Tribe's 
management area.
     The State or Tribe refuses to participate in or otherwise 
conduct surveillance as specified in paragraph (a) of Sec.  76.6.
     On more than one occasion, the State or Tribe has failed 
to conduct an investigation of a program animal with non-negative test 
results for brucellosis in accordance with paragraph (a) of Sec.  76.7, 
or to send a report regarding those activities as specified in 
paragraph (b) of Sec.  76.4.
     The State or Tribe fails to conduct epidemiological 
investigations as specified in paragraph (b) of Sec.  76.7.
     The State or Tribe fails to conduct affected herd 
management as specified in paragraph (e) of Sec.  76.7.
    Like the conditions that could lead us to redesignate a consistent 
State or Tribe as provisionally consistent, most of the conditions that 
could result in us redesignating the State or Tribe as inconsistent 
would stem from the State or Tribe's failure to meet certain regulatory 
requirements of part 76, and, therefore, will be discussed within the 
context of those requirements. However, as a general rule, we would 
redesignate a consistent State or Tribe as inconsistent if we determine 
that the State or Tribe has failed to take actions necessary to prevent 
brucellosis or bovine tuberculosis from being transmitted to program 
animals within the State or Tribe or necessary in order to prevent 
infected program animals from being moved interstate without 
appropriate mitigations. We would also redesignate the State or Tribe 
as inconsistent if, because of the State or Tribe's repeated failure to 
submit required reports, we lacked sufficient information regarding 
regulatory activities conducted in the State or Tribe, and thus had to 
consider program animals moved interstate from the State or Tribe to 
present an unknown risk of transmitting brucellosis and/or bovine 
tuberculosis to other animals.
    Proposed paragraph (c)(3) of Sec.  76.3 would contain conditions 
that could lead us to redesignate a provisionally consistent State or 
Tribe as inconsistent. In addition to the conditions that could lead us 
to redesignate a consistent State or Tribe as inconsistent, if the 
State or Tribe fails to implement provisions of its animal health plan 
or take required remedial measures within the period of time specified 
by APHIS for implementing these provisions or taking these measures, we 
would redesignate the State or Tribe as an inconsistent State or Tribe.
    Proposed paragraph (d)(1) of Sec.  76.2 would contain our notice-
based redesignation process. It would state that, when APHIS 
redesignates a consistent State or Tribe as a provisionally consistent 
State or Tribe, we would publish a notice in the Federal Register 
announcing this redesignation. The notice would also state the reason 
or reasons that led to the redesignation and the remedial measures we 
consider necessary for the State or Tribe to complete in order to 
regain consistent status.
    As much as possible, the remedial measures that we would specify in 
the notice would directly correlate to the reason for the 
redesignation. For example, if a State or Tribe is delinquent in 
submitting its annual report, the notice would require the report to be 
submitted.
    Depending on the reason for the redesignation, the notice could 
also specify restrictions on the interstate movement of program animals 
or other program requirements that would apply to the State or Tribe 
while it is in provisionally consistent status. For example, if a State 
or Tribe is able to determine one of the herds in which a program 
animal with a non-negative test for brucellosis has resided, but cannot 
determine whether this herd also represents the herd of origin for the 
animal, the notice may place restrictions on the interstate movement of 
that herd, pending further investigation of the matter.
    It is possible that, because the conditions that could lead us to 
redesignate a consistent State or Tribe as provisionally consistent 
vary, while a State or Tribe is in provisionally consistent status for 
one reason, such as failing to conduct an investigation of a program 
animal with non-negative test results for brucellosis, the State or 
Tribe could act or fail to act in a manner that would have otherwise 
led us to redesignate it to provisionally consistent status, such as 
failing to turn in a required report. In such instances, we would 
publish a notice in the Federal Register announcing what has occurred, 
and specifying additional remedial measures that the State or Tribe 
must take to regain consistent status.
    If a State or Tribe completes the remedial measures we require for 
it to regain consistent status, we would publish a notice in the 
Federal Register announcing that we have redesignated the State or 
Tribe as a consistent State or Tribe. If the State or Tribe fails to 
take the required remedial measures, we would publish a notice in the 
Federal Register announcing that we have redesignated the State or 
Tribe as an inconsistent State or Tribe. Thus, provisionally consistent 
status would be

[[Page 78477]]

a temporary classification; no State or Tribe would be classified as 
provisionally consistent indefinitely.
    Whenever we immediately redesignate a consistent or provisionally 
consistent State or Tribe as an inconsistent State or Tribe, we would 
publish a notice in the Federal Register announcing this redesignation. 
In order for such a State or Tribe to regain consistent status, it 
would have to take appropriate remedial measures, as determined by 
APHIS, to address the issue or issues that led to redesignation to 
inconsistent status. It would also have to submit amendments to its 
animal health plan that reflect these measures, and submit any 
outstanding annual reports, initial investigation reports, initial or 
updated epidemiological investigation situation reports, and closing 
reports (see our discussion of proposed Sec.  76.4 later in this 
document).
    Finally, proposed paragraph (f) of Sec.  76.3 would provide that 
lists of all consistent, provisionally consistent, and inconsistent 
States and Tribes would be located on the APHIS Web site. The lists 
would also be available at district VS offices.
Reporting Requirements (Sec.  76.4)
    Proposed Sec.  76.4 would contain reporting requirements for the 
consolidated brucellosis and bovine tuberculosis program. Proposed 
paragraph (a) of Sec.  76.4 would provide that, within 60 days of the 
end of the reporting period (September 30), States would have to submit 
a completed annual report form to APHIS as provided in the Program 
Standards document.\10\ This report form would provide us with 
information regarding the surveillance activities that the State has 
taken in the last reporting period.
---------------------------------------------------------------------------

    \10\ A draft template of the annual report form is found in 
Appendix 3 of the Program Standards document.
---------------------------------------------------------------------------

    Additionally, if a State has submitted an initial epidemiological 
situation report to us regarding detection of an affected herd within 
the State, but not submitted a corresponding closing report regarding 
this investigation (see below), we would require the State to submit 
additional information regarding epidemiological activities related to 
that incident undertaken during the reporting period within the annual 
report form. Finally, if the information contained in a State's animal 
health plan is no longer current, and the State has not already 
submitted proposed amendments to the plan to APHIS that incorporate 
these changes, the State would have to provide a summary of any changes 
to the information that have occurred during the reporting period along 
with the annual report form.
    As we mentioned previously in this document, our approval of a 
State's animal health plan would depend on whether source populations 
of brucellosis or bovine tuberculosis exist within the State, and, if 
so, whether the State has specified adequate measures within the plan 
to address the risk that these sources present of spreading brucellosis 
and bovine tuberculosis to program animals. For States that do not have 
known source populations, and thus that do not have mitigation measures 
specified within their animal health plan, the activities summarized in 
the annual report form would provide us with evidence supporting the 
ongoing absence of such source populations and the corresponding lack 
of need for such mitigations. For States that have such populations, 
the annual report form would provide information regarding the efficacy 
of the State's mitigation measures in preventing the introduction of 
brucellosis and/or bovine tuberculosis into program animals. In a 
similar vein, by providing us with updated information regarding 
ongoing epidemiological investigations and, if necessary, updates to 
its animal health plan, a State would provide assurances to us that it 
is exercising due diligence in responding to disease outbreaks, and 
adequate maintenance and oversight of measures carried out under its 
animal health plan.
    Without such information, we could determine that the risk that 
program animals moved interstate from the State present of transmitting 
brucellosis and/or bovine tuberculosis is uncertain or unknown. Hence, 
States that fail to submit an annual report form and supplementary 
updates in a timely fashion on one occasion could be redesignated to 
provisionally consistent status, and States that fail to do so on more 
than one occasion could be redesignated as inconsistent.
    Proposed Sec.  76.7 would contain requirements regarding 
epidemiological investigation activities that a State conducts. Because 
epidemiological investigations are conducted when animals are 
determined to be infected with or otherwise fail to test negative for a 
disease, in the absence of direct APHIS oversight of these 
investigations, regular reporting regarding the investigations would be 
of paramount importance to us in determining whether a State is 
accurately delineating the scope of a potential outbreak and taking 
adequate measures to preclude disease spread. Thus, proposed paragraphs 
(b) through (e) of Sec.  76.4 would contain reporting requirements that 
pertain to epidemiological investigations.
    Proposed paragraph (b) would provide that, whenever a State 
initiates an investigation of an animal with non-negative test results 
for brucellosis or an animal determined to be infected with brucellosis 
or bovine tuberculosis in accordance with proposed Sec.  76.7, the 
State would have to provide a report regarding the investigation within 
15 days of initiation of the investigation. Proposed paragraph (b) 
would differentiate between animals with non-negative test results for 
brucellosis and animals that are determined to be infected with 
brucellosis because secondary (corroboratory) tests to determine the 
presence or absence of brucellosis in program animals sometimes yield 
results that fall within the range of positive test results, but are 
sufficiently ambiguous to preclude the individuals conducting the test 
from making a determination that the animal is infected with 
brucellosis. We would not make such a differentiation for animals with 
non-negative test results for bovine tuberculosis, because such animals 
are customarily taken to necropsy for a determination regarding the 
presence or absence of infection.
    Proposed paragraph (c) of Sec.  76.4 would state that, whenever a 
State initiates an epidemiological investigation of an affected herd in 
accordance with Sec.  76.7, the State must provide a report of that 
epidemiological investigation to APHIS within 15 days of the date when 
the State is notified that an animal from the herd has been determined 
to be infected with brucellosis or bovine tuberculosis.
    Because, in the absence of such initial reports, APHIS would lack 
information regarding the discovery of known or potentially infected 
animals within a State, and thus could be unable to evaluate whether 
the State is acting in a manner that is likely to delineate the scope 
of disease infection, States that fail to submit such reports in a 
timely manner on one occasion could be redesignated as provisionally 
consistent, and States that fail to submit such reports in a timely 
manner on multiple occasions could be redesignated as inconsistent.
    Epidemiological investigations often take several months to 
complete, and a particularly complex investigation may take several 
years. Additionally, activities that a State may take in the first 15 
days of an investigation may be inconclusive. Therefore, proposed 
paragraph (d) of Sec.  76.4 would provide that every 4 weeks following 
submission

[[Page 78478]]

of an initial situation report or initial epidemiological situation 
report, and more frequently at the Administrator's request, a State 
would have to submit subsequent reports updating information in the 
initial situation report or epidemiological investigation situation 
report. (Generally speaking, we would require States to submit reports 
on a more frequent basis if the investigation was particularly complex, 
e.g., when it encompassed many herds or animals or covered a large 
geographical area.)
    Because these reports would help us determine whether a State is 
taking adequate measures to respond to a disease outbreak, failure to 
submit such updates on one occasion could result in redesignation to 
provisionally consistent status; failure to do so on more than one 
occasion could result in redesignation to inconsistent status.
    Proposed paragraph (e) of Sec.  76.4 would state that, within 60 
days following the conclusion of an epidemiological investigation of an 
affected herd, a State must submit a closing report to APHIS. In 
proposed Sec.  76.7, we consider an epidemiological investigation of an 
affected herd complete if a State identifies, places interstate and 
intrastate movement restrictions on, and, determines the disease status 
of all test-eligible animals in:
     Any herd into which program animals from the affected herd 
may have been moved;
     Any herd which program animals in the affected herd may 
have originated from or resided in; and
     Any herd, individual program animals, or other animals 
that are susceptible to brucellosis or bovine tuberculosis that may 
have commingled with or otherwise been exposed to the affected herd, as 
determined by the Administrator and communicated to the State.
    Since a State that concludes an epidemiological investigation would 
have taken measures that we consider adequate to delineate the scope of 
disease infection in herds of program animals in the State, failure to 
submit a closing report, unlike failure to submit other reports, would 
not necessarily lead us to consider program animals in the State an 
unknown risk of transmitting brucellosis or bovine tuberculosis. Hence, 
failure to submit a timely closing report on one occasion would not 
necessarily result in redesignation to provisionally consistent status. 
However, failure to submit a closing report on more than one occasion 
could be indicative of greater regulatory lapses; accordingly, it would 
be likely to result in redesignation to provisionally consistent 
status.
    As we mentioned previously in this document, proposed Sec.  76.5 
would allow States to request APHIS recognition of a management area 
for brucellosis or bovine tuberculosis within the State. Proposed 
paragraph (f) of Sec.  76.4 would provide that additional reporting 
requirements for States with such areas are specified in paragraph (f) 
of Sec.  76.5.
    Proposed paragraph (g) of Sec.  76.4 would state that, if a 
consistent State is redesignated as provisionally consistent, 
additional reporting requirements for the State may be specified in the 
notice in the Federal Register that announces such redesignation. For 
example, if a State is redesignated as provisionally consistent for 
failing to conduct adequate surveillance of wildlife source populations 
for brucellosis or bovine tuberculosis, we could require the State to 
provide periodic updates regarding implementation of this surveillance.
    Proposed paragraph (h) of Sec.  76.4 would state that the 
requirements in Sec.  76.4 pertain to Tribes, provided that that they 
have submitted a Tribal animal health plan to APHIS for review and 
approval in accordance with the process set forth in Sec.  76.2, and 
APHIS has approved the animal health plan. Otherwise, we would expect 
activities conducted on Tribal lands within a State to be reflected in 
any report that the State submits.
Recognized Management Areas (Sec.  76.5)
    Bovine tuberculosis is known to exist in a portion of Michigan 
immediately south of the Upper Peninsula and in a portion of Michigan 
northeast of the Huron National Forest. Because bovine tuberculosis is 
endemic within wildlife in those areas, there are periodic detections 
of the disease in program animals in the areas, and Michigan has long 
had control measures in place to prevent the spread of bovine 
tuberculosis from these two areas. However, because part 77 relies on a 
prevalence-based State classification system, if Michigan were 
considered as a single geographical region, it would not have the 
highest classification for bovine tuberculosis, accredited-free, 
although the majority of the State has not detected bovine tuberculosis 
in program animals.
    Hence, part 77 allows a State to request a different classification 
for zones in the State that have a higher prevalence for bovine 
tuberculosis than other areas of the State, provided, among other 
requirements, that the State conducts surveillance of animal species in 
the zone to detect bovine tuberculosis infection in those animals, has 
a regulatory framework in which detections of bovine tuberculosis in 
livestock or wildlife in the zone are reported to State animal health 
officials, demonstrates to APHIS that it has sufficient financial and 
legal resources to enforce the zone, and enters into a memorandum of 
understanding with APHIS regarding any other additional conditions for 
zone recognition that we determine necessary in order to approve a 
State's request.
    Brucellosis is endemic in wildlife in a geographical area 
consisting of portions of Montana, Idaho, and Wyoming, referred to 
below as the Greater Yellowstone Area, or GYA. To prevent the spread of 
brucellosis from this area, we issued the December 2010 interim rule 
referenced previously in this document. This rule had the effect of 
requiring Montana, Idaho, and Wyoming to draft brucellosis management 
plans in which they specified surveillance of and mitigation measures 
for wildlife reservoirs within their portion of the GYA.
    In the draft regulatory framework document, we proposed an approach 
that would have consolidated aspects of these two approaches to zoning. 
We proposed that, if brucellosis or bovine tuberculosis was detected in 
a region of the United States and the States or Tribes with land in 
that region were unable to eradicate the disease within a year, the 
States or Tribes would have to develop a long-term containment plan in 
order to retain consistent status. We proposed that the containment 
plan would have to be based on epidemiological information gathered 
from the outbreak regarding livestock or wildlife populations in the 
region and extent of disease within these livestock and wildlife 
populations. We also proposed that the plans would have to consider 
strategies such as herd testing of program animals within the region, 
movement restrictions on program animals moved out of the region, and 
traceability, i.e., official identification and recordkeeping 
requirements, for these program animals to prevent the spread of 
disease from the region. Finally, we proposed that all containment 
plans would have to be eradication-based.
    Commenters were generally supportive of the concept of long-term 
containment plans. However, several commenters had concerns with 
aspects of our proposed approach. Commenters pointed out that, under 
the approach, if a region that was covered by a containment plan 
encompassed a geographical area in multiple States, States could be 
held accountable for

[[Page 78479]]

regulatory lapses in a neighboring State. The commenters pointed out 
that a State has little authority regarding animal health activities 
conducted in other States, and that the approach in the framework 
document could result in States being reclassified to lower statuses 
for reasons beyond their control.
    Similarly, commenters also pointed out that, while most State 
animal health authorities may monitor wildlife reservoirs of 
brucellosis or bovine tuberculosis, their authority to conduct such 
monitoring is limited to instances in which these reservoirs present a 
risk of transmitting disease to livestock in the State. Accordingly, 
they expressed concern that the approach in the document would require 
States to draft containment plans if brucellosis or bovine tuberculosis 
were discovered in wildlife, in the absence of any demonstrable risk of 
program animals becoming infected.
    Several commenters stated that eradication of brucellosis or bovine 
tuberculosis in areas in which it has become endemic, particularly in 
wildlife populations, would prove difficult, if not impracticable, and 
suggested that containment plans would not necessarily have to be 
eradication-based to be effective.
    Finally, several commenters suggested that States not be forced to 
draft containment plans, but, rather, have the option to do so upon 
determining that a containment plan would help prevent the spread of 
brucellosis or bovine tuberculosis within the State.
    In light of these comments, proposed Sec.  76.5 would establish a 
process for States or Tribes to request recognition of management areas 
for brucellosis or bovine tuberculosis in the State or Tribal lands. As 
we mentioned previously in this document, a management area would be a 
clearly delineated geographical area in which a State or Tribe has 
detected brucellosis or bovine tuberculosis, has determined that there 
is a risk of transmission of brucellosis or bovine tuberculosis to 
program animals, and has taken or proposes to take measures to control 
the spread of the brucellosis or bovine tuberculosis within and from 
the area and/or to eradicate the disease within the area.
    Proposed paragraph (a) of Sec.  76.5 would state that a State or 
Tribe may request APHIS recognition of a management area within the 
State or Tribal lands. Thus States and Tribes would not be required to 
request recognition of management areas, and could retain consistent 
status even if they elect not to establish a management area. However, 
if a source of brucellosis or bovine tuberculosis is known to exist in 
a State or on Tribal lands, and the State or Tribe elects not to 
establish and request APHIS recognition of a management area, the State 
or Tribe would have to provide evidence in their animal health plan 
that all program animals in the State or Tribal lands are not similarly 
exposed to this source, or would have to consider all program animals 
in the State or Tribe commensurate with respect to risk and propose 
mitigations in their animal health plan accordingly.
    Proposed paragraph (b)(1) of Sec.  76.5 would require a State or 
Tribe without an animal health plan that has been approved by APHIS to 
request recognition of a management area when it submits an animal 
health plan to APHIS. Proposed paragraph (b)(2) of Sec.  76.5 would 
require a State or Tribe with an approved animal health plan to request 
recognition of a management area by submitting an amendment to its 
animal health plan regarding the management area.\11\ Proposed 
paragraph (c) of Sec.  76.5 would contain requirements for a request to 
recognize a management area. Proposed paragraph (c)(1) would contain 
requirements for States or Tribes without zones for bovine tuberculosis 
or areas covered by a brucellosis management plan at the time a rule 
that finalizes this proposed rule becomes effective.
---------------------------------------------------------------------------

    \11\ A template for a request for recognition of a management 
area is found in Appendix 8 of the Program Standards document.
---------------------------------------------------------------------------

    Such States or Tribes would have to include the following 
categories of information as part of a request to recognize a 
management area:
     A description of the geographical area that the State or 
Tribe requests to be recognized as a management area. The description 
would have to specify continuous and uninterrupted boundaries for the 
management area.
     A description of the assessments and activities that the 
State or Tribe has conducted or plans to conduct to support the 
specified boundaries for the management area and a timeline of 
implementation of these activities. At a minimum, the activities 
specified would have to provide assurances that the boundaries for the 
management area continually reflect current epidemiological knowledge 
about the extent of disease and risk of transmission of disease within 
and from the area, and would have to include:
    [cir] Epidemiological investigations.
    [cir] Surveillance activities within the management area to 
determine or further delineate sources of brucellosis and/or bovine 
tuberculosis.
    [cir] Surveillance activities outside the boundaries of the 
management area sufficient to detect brucellosis or bovine tuberculosis 
infection in program animals that originate from or are otherwise 
related to the management area.
    The activities would have to include epidemiological investigations 
because such investigations would be necessary to determine the scope 
of infection within the area.
    The activities would have to include surveillance within the 
management area to determine or further delineate sources of 
brucellosis and/or bovine tuberculosis because, in certain instances, 
epidemiological investigations may not be able, on their own, to 
discover a disease reservoir of brucellosis or bovine tuberculosis 
within an area. For example, Federal and State officials within 
Michigan conducted independent epidemiological investigations for 
several years before they discovered that wild cervid populations in 
the northeast of the State were serving as a common source of 
infection. This discovery played a key role in delineating the 
geographical area covered by their zone request.
    The activities would have to include surveillance activities 
outside the boundaries of the management area because, historically, 
after a State has set the initial boundaries of an area in which it 
knows brucellosis or bovine tuberculosis to exist, affected herds have 
been discovered beyond these boundaries.
     A description of the known sources of brucellosis or 
bovine tuberculosis that pose a risk of disease introduction into 
program animals within and surrounding the management area, and an 
assessment of the likelihood of spread of brucellosis or bovine 
tuberculosis from these sources to program animals. This description 
would have to include:
    [cir] The approximate number of herds, individual program animals, 
and susceptible wildlife populations within the management area and in 
the area surrounding the management area as this surrounding area is 
determined in consultation with an epidemiologist designated by the 
District Director.
    [cir] The number of affected herds or wildlife populations detected 
within the management area since the first investigation or 
surveillance activity specified by the State or Tribe in their request 
was conducted, the approximate number of animals in these herds or 
source populations, and the approximate prevalence of brucellosis

[[Page 78480]]

or bovine tuberculosis infection in these herds or populations during 
that time period.
    [cir] The potential for exposure of program animals to these known 
affected herds or wildlife populations.
    [cir] Any factors, other than mitigation measures maintained by the 
State or Tribe, that may influence this potential for exposure.
    [cir] An assessment of the likelihood of transmission of 
brucellosis or bovine tuberculosis from known affected herds or 
wildlife populations to program animals within and surrounding the 
management area.
    The information that we would require regarding source populations 
in a request for recognition of a management area is modeled on the 
information regarding source populations that we would require in an 
animal health plan. However, while States and Tribes would have to 
provide the geographic distribution of source populations within their 
animal health plan, we would not require this information in a request 
for recognition of a management area. This is because we would expect 
the boundaries of the management area to reflect the geographic 
distribution of the source populations.
     A description of the measures that the State or Tribe has 
implemented or would implement to mitigate the risk that program 
animals within the State or Tribal lands will become infected with 
brucellosis or bovine tuberculosis, a timeline for implementation of 
these measures, and the means by which the State or Tribe has monitored 
and enforced or plans to monitor and enforce these measures. For all 
management areas, measures would have to include conditions for the 
movement of program animals from the management area, herd testing of 
at least a targeted representative sample of herds of program animals 
within the area, and change-of-ownership testing of all test-eligible 
program animals that reside within the area. For management areas for 
brucellosis, the measures would also have to include an official 
brucellosis vaccination program.
    We would require the State or Tribe to specify conditions for the 
movement of program animals from the management area because we would 
not consider the unrestricted movement of program animals from the 
management area to be appropriate given the presence of brucellosis or 
bovine tuberculosis within the area. We would require herd testing and 
change-of-ownership testing within the management area because, 
although such testing is not a mitigation, it would allow us to 
evaluate the efficacy of the mitigations implemented within the 
management area by the State or Tribe. We would require implementation 
of an official brucellosis vaccination program for management areas for 
brucellosis because we consider program animals in a management area 
for brucellosis to be at risk of becoming infected with brucellosis, 
and vaccination is an effective prophylactic tool to prevent such 
infection.
     A citation of or hyperlink to the laws and regulations 
that authorize the State or Tribe's establishment of the management 
area.
     A description of the personnel that the State or Tribe has 
used or plans to use in order to implement or perform activities or 
maintain measures associated with the management area. This description 
would have to demonstrate that the State or Tribe has sufficient 
personnel to implement and perform these activities and maintain these 
measures, and would have to include:
    [cir] The name, contact information, and affiliation of the person 
within the State or Tribe who would assume responsibility for 
implementation and performance of activities and maintenance and 
enforcement of measures associated with the management area.
    [cir] The name, contact information, and affiliation of all 
personnel assigned to the implementation and performance of activities 
and maintenance and enforcement of measures associated with the 
management area.
    [cir] The role or roles assigned to these personnel.
     Information demonstrating that all program animals that 
are moved from the management area are or will be required to be 
officially identified prior to movement.
    We would require official identification of program animals moved 
from the area in order to facilitate traceback if any of these animals 
are determined to be infected with brucellosis or bovine tuberculosis.
    Proposed paragraph (c)(2) of Sec.  76.5 would state that, if a 
State had a geographical area designated as a zone for bovine 
tuberculosis or covered by a brucellosis management plan prior to the 
effective date of a rule finalizing this proposed rule, and the State 
wishes the geographical area to continue to be recognized as a 
management area, the State's request for recognition of that area as a 
management area would only need to contain those categories of 
information that the State has not already submitted to APHIS.
    Proposed paragraph (d) of Sec.  76.5 would provide that APHIS would 
review each proposal for recognition of a management area in accordance 
with the process set forth in proposed Sec.  76.2 for review of an 
animal health plan or amendment to an animal health plan.
    Proposed paragraph (e) of Sec.  76.5 would provide that, in 
communicating our determination to approve or not approve an animal 
health plan or amendment to an animal health plan in accordance with 
the process set forth in Sec.  76.2, we would also communicate our 
determination to recognize or not recognize the requested management 
area. It would also provide that, if we recognize the management area, 
the request for recognition of the area would be considered to be part 
of the State or Tribe's animal health plan. Finally, it would provide 
that we would not recognize a management area in a State or on Tribal 
lands if we determine not to approve that State or Tribe's animal 
health plan. We would not recognize the area because, if concerns 
regarding the approach that the State or Tribe presents in its animal 
health plan preclude us from approving the plan, these same concerns 
would preclude us from evaluating the adequacy of the measures 
specified in the request for recognition of the management area.
    As we mentioned previously in this document, proposed paragraph (f) 
of Sec.  76.5 would contain additional reporting requirements for 
States and Tribes with recognized management areas. It would require 
that, in addition to the annual reporting requirements contained in 
paragraph (a) of Sec.  76.4, States or Tribes with recognized 
management areas would have to submit a separate annual report form for 
each recognized management area in the State or Tribe. These reports 
would provide context for the information contained in the annual 
report form for the entire State or Tribe by disclosing which portion 
of the information contained on that form pertains to activities 
conducted within the management area.
    Proposed paragraph (g) of Sec.  76.5 would provide that, if a State 
or Tribe with a recognized management area wishes to expand or contract 
the geographical boundaries of the management area, or determines that 
any information in its request for recognition of the management area 
has substantively changed, the State or Tribe would have to submit 
amendments to its animal health plan that reflect these changes to 
APHIS in accordance with the process set forth in proposed Sec.  76.2.

[[Page 78481]]

    Proposed paragraph (h) of Sec.  76.5 would deal with termination of 
management areas. Proposed paragraph (h)(1) would provide that, if a 
State or Tribe wishes APHIS to recognize the State or Tribe's 
termination of the management area, it would have to submit amendments 
to its animal health plan that reflect this termination in accordance 
with the process set forth in proposed Sec.  76.2. The State or Tribe 
would also have to provide APHIS with an explanation why the management 
area was terminated. Depending on the information provided in this 
explanation, we may also expect the State or Tribe to submit amendments 
to its animal health plan that address any additional risk of 
introduction of brucellosis or bovine tuberculosis into program animals 
that may arise because of termination of the management area.
    Proposed paragraph (h)(2) of Sec.  76.5 would provide that, if we 
determine that a State or Tribe has failed to implement or maintain 
measures specified within its request for recognition of a management 
area for brucellosis or bovine tuberculosis, we would terminate 
recognition of all management areas for the disease or diseases within 
the State or Tribal lands. We would also redesignate the State or Tribe 
as an inconsistent State or Tribe for the disease or diseases. This is 
because States and Tribes with management areas would have known 
sources of brucellosis or bovine tuberculosis within them, and a State 
or Tribe's failure to implement or maintain measures to address the 
risk of disease transmission presented by this source would necessarily 
lead us to the conclusion that the disease status of program animals 
within the State or Tribal lands is uncertain or unknown.
    If we redesignate a State or Tribe as an inconsistent State or 
Tribe for brucellosis or bovine tuberculosis, we would also terminate 
recognition of all management areas for that disease within the State 
or Tribal lands as part of this redesignation. This is because if we 
redesignate a State or Tribe as inconsistent, it would indicate that we 
have significant concerns regarding the control program for brucellosis 
or bovine tuberculosis within the State or Tribal lands, including 
activities and measures conducted within the management area.
    Proposed paragraph (h)(3) of Sec.  76.5 would provide that, if a 
State or Tribe requests recognition of termination of a management 
area, we would review the request in accordance with the process set 
forth in proposed Sec.  76.2 for review of an amendment to an animal 
health plan.
    Proposed paragraph (h)(4) of Sec.  76.5 would provide that we would 
communicate our determination regarding termination of a recognized 
management area in accordance with the process set forth in Sec.  76.2 
for communication of a determination regarding amendments to an animal 
health plan.
Surveillance Requirements (Sec.  76.6)
    As we mentioned in our discussion of proposed Sec.  76.2, States 
and Tribes would have to provide a description of surveillance 
activities for brucellosis or bovine tuberculosis in animals within the 
State or Tribal lands that are being conducted or would be conducted in 
the State or Tribe. Proposed Sec.  76.6 would provide minimum 
requirements regarding these surveillance activities.
    Proposed paragraph (a) of Sec.  76.6 would require all States to 
agree to participate in the National Surveillance Plans for Brucellosis 
and Bovine Tuberculosis, which would be located on the APHIS Web site, 
or to conduct equivalent surveillance in a manner approved by APHIS.
    Participation in the National Surveillance Plan for Bovine 
Tuberculosis would require States to perform monitoring of slaughter 
inspection within the State that is conducted by State meat inspection 
personnel. Pursuant to FSIS regulations, all cattle and bison 
slaughtered for wholesale or retail purposes at a recognized 
slaughtering establishment within the United States are inspected for 
evidence of tuberculosis by either FSIS or State meat inspection 
personnel.
    States would also be required to monitor caudal fold testing for 
bovine tuberculosis within the State that is conducted by qualified 
accredited veterinarians (see discussion later in this document, under 
the heading ``Official tests for brucellosis and bovine tuberculosis, 
official testing laboratories, and official testers (Sec.  76.17)'').
    If we do not require a State to conduct brucellosis surveillance or 
provide data regarding ongoing brucellosis surveillance conducted in 
the State, the State would still be considered a participant in the 
National Surveillance Plan for Brucellosis. Participation for certain 
States could be made contingent on designated recognized slaughtering 
establishments in the States collecting blood samples for official 
testing from a prescribed percentage of cattle and bison slaughtered at 
the establishments. This slaughter surveillance requirement currently 
exists in part 78, and we considered it necessary to incorporate it 
into the National Surveillance Plan in order to maintain an appropriate 
measure of passive surveillance for brucellosis throughout the United 
States given the reservoirs of the disease in certain areas of the 
United States.
    APHIS could also request certain States to provide additional data 
on routine surveillance for brucellosis in their State that is 
conducted at areas of high concentration and frequent commingling of 
cattle and bison, such as livestock markets, cattle feeders' premises, 
and regional exhibitions.
    We are aware that States may prefer to draft their own surveillance 
plan rather than participate in the National Surveillance Plans for 
Brucellosis and Bovine Tuberculosis. We would allow States to do so, 
provided that they propose to conduct what we consider to be equivalent 
surveillance to that specified in the National Plans and we approve the 
plans.
    If a State fails to meet the surveillance levels set forth in the 
National Surveillance Plans or their own approved plans, this could 
result in redesignation to provisionally consistent or inconsistent 
status. We consider the possibility of such redesignations to be 
appropriate because failure to conduct adequate surveillance could 
adversely impact our ability to estimate the prevalence levels for 
brucellosis or bovine tuberculosis within a State. Similarly, 
surveillance data collected under the plans would be necessary for us 
to determine the national prevalence for brucellosis and bovine 
tuberculosis in the United States, and because, as we mentioned 
previously in this document, the regulations in part 76 would be 
predicated on the United States having low national prevalence levels 
for the diseases. Thus, if we were to lack sufficient data to determine 
these prevalence levels, this would deprive us of our primary means of 
evaluating the ongoing efficacy of the regulations in part 76.
    If a consistent or provisionally consistent State refuses to 
participate in the plans or draft and implement their own, this would 
result in redesignation to inconsistent status. Additionally, if an 
inconsistent State refuses to participate in the plans or draft and 
implement their own, the interstate movement of program animals from 
that State would be subject to such restrictions or prohibitions as the 
Administrator considers necessary to prevent the dissemination of 
brucellosis or bovine tuberculosis from the State; we would announce 
such restrictions in a notice in the Federal Register.
    We believe such remedial measures would be appropriate for three 
reasons. First, this refusal to conduct

[[Page 78482]]

surveillance would significantly and adversely impact our ability to 
gauge national prevalence levels for brucellosis or bovine 
tuberculosis. Second, this refusal would render it difficult for us to 
evaluate whether a State's animal health plan is addressing the risk of 
spread of brucellosis or bovine tuberculosis within and from the State; 
as it is today, slaughter surveillance would remain our primary gauge 
of determining brucellosis or bovine tuberculosis risks within a State 
under the consolidated brucellosis and bovine tuberculosis program. 
Third, this refusal would deprive us of assurances that program animals 
moved interstate from the State do not present a risk of transmitting 
brucellosis or bovine tuberculosis to other animals.
    Proposed paragraph (b) of Sec.  76.6 would contain additional 
surveillance requirements for States that have known sources of 
brucellosis or bovine tuberculosis.
    Proposed paragraph (b)(1) would contain requirements for 
surveillance of wildlife source populations. It would state that, if a 
consistent or provisionally consistent State has identified a known 
source of brucellosis or bovine tuberculosis transmission within 
wildlife in the State in its animal health plan and determined that 
this source population presents a risk of transmitting brucellosis or 
bovine tuberculosis to program animals, in order to maintain consistent 
or provisionally consistent status, the State would have to conduct 
surveillance of that source population in a manner approved by APHIS as 
sufficient to detect brucellosis or tuberculosis in an animal within 
the source population. A consistent State that fails to conduct such 
surveillance would be redesignated as provisionally consistent, while a 
provisionally consistent State that fails to conduct such surveillance 
could be redesignated as inconsistent.
    Proposed paragraph (b)(2) of Sec.  76.6 would provide requirements 
for targeted surveillance of at-risk populations, that is, populations 
that are at risk of becoming infected with brucellosis or bovine 
tuberculosis because of transmission of the diseases from source 
populations. It would provide that, if a consistent or provisionally 
consistent State has identified a known source of brucellosis or bovine 
tuberculosis transmission in the State in its animal health plan and 
has determined that this source population presents a risk of 
transmitting brucellosis or bovine tuberculosis to program animals, in 
order to maintain consistent or provisionally consistent status, the 
State would have to conduct annual herd testing of all herds of at-risk 
program animals, or alternatively, a statistically representative 
sample of those herds, as determined by APHIS. A consistent State that 
fails to conduct such surveillance would be redesignated as 
provisionally consistent. A provisionally consistent State that fails 
to conduct such surveillance would be redesignated as inconsistent.
    Such testing would be necessary in order to help us evaluate the 
efficacy of any mitigation measures the State has implemented to 
prevent transmission of brucellosis or bovine tuberculosis from known 
source populations to program animals. Hence, failure to conduct such 
testing would result in redesignation.
    Proposed paragraph (c) of Sec.  76.6 would provide requirements for 
surveillance within recognized management areas. It would require 
States to conduct surveillance within the management area in the manner 
specified within that section of the State's animal health plan that 
pertains to the management area. Since States or Tribes would have to 
specify surveillance activities in any request for APHIS to recognize a 
management area, failure to conduct such surveillance would constitute 
failure to implement or maintain a measure specified in the request. 
Hence failure to conduct such surveillance would result in termination 
of recognition of the management area and redesignation of the State as 
an inconsistent State.
    Proposed paragraph (d) of Sec.  76.6 would provide that, if a 
consistent State is redesignated as provisionally consistent, 
additional surveillance requirements for the State may be specified in 
the notice in the Federal Register that announces this redesignation.
    Proposed paragraph (e) of Sec.  76.6 would provide that the 
requirements in the section pertain to Tribes, provided that they have 
submitted a Tribal animal health plan to APHIS for review and approval 
in accordance with the process set forth in Sec.  76.2, and APHIS has 
approved the animal health plan.
Epidemiological Investigations and Affected Herd Management (Sec.  
76.7)
    Proposed Sec.  76.7 would contain minimum requirements regarding 
epidemiological investigation and affected herd management activities 
conducted under an animal health plan.
    Proposed paragraph (a) of Sec.  76.7 would provide that, if a 
program animal has a non-negative test result for brucellosis, within 
15 days of receiving notification of these results, the State in which 
the animal was detected would have to initiate an investigation to 
determine the herd from which the animal originated and all herds in 
which it has resided.
    As we mentioned previously in this document, historically, there 
have been occasions when secondary (corroboratory) tests to determine 
the presence or absence of brucellosis in program animals have yielded 
results that fell within the range of positive test results, but were 
sufficiently ambiguous to preclude the individuals conducting the test 
from making a determination that the animals were infected with 
brucellosis. However, when we have traced such animals back through 
production channels to their herd of origin, we have discovered animals 
that are infected with brucellosis.
    For this reason, a consistent State that fails to conduct such an 
investigation on one occasion would be redesignated as provisionally 
consistent, while a consistent or provisionally consistent State that 
fails to conduct such an investigation on multiple occasions could be 
redesignated as inconsistent.
    Proposed paragraph (b) Sec.  76.7 would provide protocols related 
to other epidemiological investigations. These protocols would be 
consistent with generally accepted best practices for epidemiological 
investigations.
    Proposed paragraph (b)(1) would provide a protocol for 
epidemiological investigations following a determination that a program 
animal is infected with brucellosis or bovine tuberculosis, without a 
concurrent determination that it has belonged to an affected herd. Such 
investigations would usually be initiated by discovery of an infected 
animal at slaughter, but could also be initiated when an animal is 
determined to be infected with brucellosis or bovine tuberculosis after 
testing positive for the disease at a livestock market, auction barn, 
exhibition, or other point where the animal is segregated from its herd 
for commercial purposes.
    In such instances, within 15 days of the determination that the 
program animal is infected, the State in which the infected animal was 
detected would have to identify the herd from which the infected animal 
originated and all herds in which it has resided, impose the 
restrictions specified in proposed Sec. Sec.  76.9 and 76.10 on the 
interstate movement of animals from those herds, impose substantially 
similar restrictions on the intrastate movement of program animals from 
the herds, and begin determining the disease status of all test-
eligible animals in the herds. (Proposed Sec.  76.9 would prohibit the 
movement of animals from a herd containing a reactor or suspect for 
brucellosis or tuberculosis, other than

[[Page 78483]]

the movement of the reactor or suspect itself, until the disease status 
of all test-eligible animals in the herd is determined. Proposed Sec.  
76.10 would provide conditions for the interstate movement of reactor, 
suspect, and exposed program animals.)
    Proposed paragraph (b)(2) would provide a protocol for 
epidemiological investigations following a determination that a herd of 
program animals is affected with brucellosis or bovine tuberculosis. In 
such instances, within 15 days of this determination, the State in 
which the herd resides would have to identify and impose the 
restrictions specified in proposed Sec. Sec.  76.9 and 76.10 on the 
interstate movement of the following animals, impose substantially 
similar restrictions on intrastate movement, and begin determining the 
disease status of all test-eligible animals in those herds:
     Any herd into which program animals from the affected herd 
may have been moved; and
     Any herd from which program animals in the affected herd 
may have originated or in which they may have resided; and
     Any herd, individual program animals, or other animals 
that are susceptible to brucellosis or bovine tuberculosis that may 
have commingled with or otherwise been exposed to the affected herd, as 
determined by the Administrator and communicated to the State.
    Proposed paragraph (b)(3) of Sec.  76.7 would require that, if the 
State in which an infected animal or affected herd was detected 
determines that any of the herds specified in proposed paragraph (b)(2) 
are located in a different State than the infected animal or affected 
herd, the State in which the infected animal or affected herd was 
detected would have to notify both that State and APHIS, in writing, 
within 3 days. APHIS notification would have to be submitted to the 
address provided within the Program Standards document. This 
notification would allow surrounding States to conduct their own 
epidemiological investigations in a timely manner, and would help APHIS 
to oversee and coordinate any aspects of the investigations related to 
interstate commerce.
    Proposed paragraph (b)(4) would provide a protocol for 
epidemiological investigations following a determination that a non-
program animal is infected with brucellosis or bovine tuberculosis, if 
the Administrator determines that this animal presents a risk of 
transmitting brucellosis or bovine tuberculosis to program animals. In 
such instances, the State or States surrounding the detection would 
have to identify all herds that may have been exposed to brucellosis or 
bovine tuberculosis because of this detection, as determined by the 
Administrator and communicated to the States. The States would also 
have to impose the restrictions specified in Sec. Sec.  76.9 and 76.10 
on the interstate movement of animals from those herds, impose 
substantially similar restrictions on intrastate movement, and 
determine the disease status of all test-eligible animals in those 
herds. We would impose this requirement on all States surrounding the 
infected animal, as determined by the Administrator, because, if 
migratory wildlife is discovered to be infected with brucellosis or 
bovine tuberculosis near a State's border, the migration patterns of 
this wildlife could have exposed program animals in other States to the 
disease.
    Proposed paragraph (b)(5) of Sec.  76.7 would provide a protocol 
for epidemiological investigations if an animal infected with 
brucellosis or bovine tuberculosis is discovered on or has been 
determined to have originated from a calf raiser's premises or feedlot, 
that is, a location where there is frequent commingling of cattle or 
bison that originate from different premises. In such instances, the 
State in which the calf raiser's premises or feedlot is located would 
have to conduct an epidemiological investigation of that premises or 
feedlot according to a method that has been approved by the 
Administrator. A draft of an approved method for conducting such an 
investigation is set forth in the Program Standards document.
    While the protocols and procedures set forth in proposed paragraph 
(b) are grounded in generally accepted best practices for conducting 
epidemiological investigations, we recognize that, in certain 
instances, a State may exercise due diligence in conducting such 
investigations, yet either not be able to determine all potentially 
affected herds, or not be able to do so within the timeframe specified 
within the regulations. In such instances, States could submit an 
alternate protocol for conducting an epidemiological investigation to 
APHIS to the address provided in the Program Standards document. If the 
Administrator authorizes this protocol, the State could employ it in 
lieu of the protocols contained in the regulations, without risking a 
possible redesignation to a lower status (see our discussion below of 
proposed paragraph (d) of Sec.  76.7).
    Proposed paragraph (c) would establish conditions for determining 
whether a herd is affected with brucellosis or bovine tuberculosis. If 
all test-eligible program animals in a herd under investigation are 
determined to be negative for brucellosis or bovine tuberculosis, the 
herd would not be an affected herd. In such instances, no further 
action would be required and the State could remove restrictions on the 
movement of animals in those herds. Conversely, if any test-eligible 
animals in a herd under investigation are determined to be infected 
with brucellosis or bovine tuberculosis, the herd would be considered 
to be an affected herd.
    Proposed paragraph (d) of Sec.  76.7 would contain consequences for 
failure to conduct an epidemiological investigation in accordance with 
the section. If a consistent or provisionally consistent State does not 
follow the protocols in Sec.  76.7 or another protocol that APHIS has 
authorized, the State would be redesignated as inconsistent. This is 
because these protocols represent generally accepted best practices for 
all epidemiological investigations. Thus, failure to adhere to them, or 
to submit an alternate protocol to us for evaluation, would necessarily 
lead us to consider the disease status of program animals within the 
State or Tribal lands uncertain or unknown, and to have concerns 
regarding the overall adequacy of the regulatory program for 
brucellosis or bovine tuberculosis in the State.
    For this reason, if an inconsistent State, that is, a State about 
which we already have such concerns, fails to conduct epidemiological 
investigations in accordance with the section, the interstate movement 
of program animals from that State would be subject to such 
restrictions or prohibitions as the Administrator considers necessary 
to prevent the dissemination of brucellosis or bovine tuberculosis from 
the State. In such instances, once imposed by the Administrator, the 
restrictions or prohibitions would be announced through a notice in the 
Federal Register.
    Proposed paragraph (e) of Sec.  76.7 would provide requirements for 
management of affected herds. States would have to manage affected 
herds through depopulation, or through a test-and-remove protocol 
modeled on the protocol contained in the April 2010 Federal Order.\12\ 
The protocol would have to demonstrate that:
---------------------------------------------------------------------------

    \12\ See footnote 1.
---------------------------------------------------------------------------

     The State has implemented and is enforcing movement 
restrictions on the affected herd.

[[Page 78484]]

     The States has implemented and is enforcing an affected 
herd management plan for the affected herd to prevent the spread of 
brucellosis or bovine tuberculosis.
     The State is implementing and is conducting a protocol to 
periodically test program animals in the affected herd for brucellosis 
or bovine tuberculosis and to remove and destroy those animals that do 
not test negative.
     The State has a protocol in place to conduct periodic 
assurance testing of the herd once the test-and-remove protocol is 
complete.
    The test-and-remove protocol would have to place movement 
restrictions on the affected herd because, unless a program animal in 
an affected herd has undergone periodic testing to determine its 
disease status over an extended period of time and has tested negative 
for brucellosis or bovine tuberculosis each time, we consider the 
animal to present a risk of transmitting brucellosis or bovine 
tuberculosis to other program animals. We would require the State to 
implement and maintain an affected herd management plan for this same 
reason.
    We would require removal and destruction of all animals that do not 
test negative to this periodic testing because such animals could be 
infected with brucellosis or bovine tuberculosis and thus could serve 
as an inoculum for the remainder of the herd if they are not removed 
and destroyed.
    We would require assurance testing in order to monitor the herd for 
possible reintroduction of disease following conclusion of the test-
and-remove protocol.
    Proposed paragraph (f) of Sec.  76.7 would contain consequences for 
failure to conduct affected herd management in accordance with the 
section. If a consistent or provisionally consistent State fails to do 
so, it would be redesignated as inconsistent. If an inconsistent State 
fails to do so, the interstate movement of program animals from that 
State would be subject to such restrictions or prohibition as the 
Administrator considers necessary to prevent the dissemination of 
brucellosis or bovine tuberculosis from the State. In such instances, 
the restrictions or prohibitions would be announced through a notice in 
the Federal Register.
    Proposed paragraph (g) would state that the requirements in the 
section pertain to Tribes, provided that they have submitted a Tribal 
animal health plan to APHIS for review and approval in accordance with 
the process set forth in proposed Sec.  76.2, and APHIS has approved 
the animal health plan.
Interstate Movement Requirements--General Categories of Livestock 
(Sec. Sec.  76.8 through 76.10)
Interstate Movement of Infected Livestock Generally Prohibited (Sec.  
76.8)
    Proposed Sec.  76.8 would state that, except as provided in 
paragraph (d)(7) of 9 CFR 71.3, the interstate movement of any 
livestock known to be infected with brucellosis or bovine tuberculosis 
is prohibited. Paragraph (d)(7) of Sec.  71.3 provides that, in certain 
instances, the Administrator may authorize the interstate movement of 
livestock known to be infected with a communicable disease of livestock 
such as brucellosis and bovine tuberculosis, subject to such conditions 
as he or she may prescribe to prevent the spread of that disease. We 
consider such a general prohibition consistent with our mission under 
the AHPA to prevent the dissemination of diseases of livestock within 
the United States.
Interstate Movement of Program Animals from a Herd Containing a Reactor 
or Suspect (Sec.  76.9)
    As we mentioned previously in this document, proposed Sec.  76.9 
would provide that, except as provided in proposed Sec.  76.10, which 
would contain conditions for the interstate movement of reactor, 
suspect, and exposed program animals, the interstate movement of 
program animals from a herd containing a reactor or suspect animal for 
brucellosis or bovine tuberculosis is prohibited, until the disease 
status of all test-eligible animals in that herd is determined.
    If a herd contains a reactor or suspect for brucellosis or bovine 
tuberculosis, there is a possibility that the herd is affected with 
that disease. Hence, allowing an animal to move interstate from the 
herd before the disease status of all animals in the herd is known 
could contribute to the dissemination of brucellosis or bovine 
tuberculosis within the United States, and would be inconsistent with 
our mission under the AHPA.
Interstate Movement of Reactor, Suspect, and Exposed Program Animals 
(Sec.  76.10)
    This section would state that, notwithstanding the other provisions 
of part 76, program animals that have been classified as brucellosis or 
bovine tuberculosis reactors, suspects, or exposed animals could be 
moved interstate if:
     The animals are officially identified.
     The animals are accompanied by a permit for movement of 
restricted animals issued by an APHIS or State or Tribal 
representative.
     The permit for movement of restricted animals clearly 
specifies the brucellosis or bovine tuberculosis classification of the 
animals.
     The animals are moved for diagnostic testing, immediate 
slaughter, necropsy, or other use as approved by the Administrator.
     The animals are moved to a location specified as an 
approved location for reactor, suspect, or exposed animals. (We would 
include a footnote, footnote 4, stating that locations include 
recognized slaughtering establishments, specifically approved 
stockyards, official testing laboratories, research facilities, and, 
for exposed animals that have tested negative for brucellosis or bovine 
tuberculosis, quarantine feedlots and quarantine pens. Additionally, 
the footnote would provide that a State may request approval of 
alternate locations by specifying the locations within its animal 
health plan or proposing to amend the health plan to specify the 
locations.)
     The animals are moved in a means of conveyance containing 
only animals not susceptible to brucellosis and/or bovine tuberculosis 
or animals destined for immediate slaughter or necropsy.
     The means of conveyance in which the animals are moved 
interstate is secured with official seals applied and removed by an 
authorized APHIS representative, FSIS inspector, State or Tribal 
representative, accredited veterinarian, or other individual authorized 
for this purpose by an APHIS representative; or the animals are 
accompanied during movement by an APHIS representative, FSIS inspector, 
State or Tribal representative, or other individual authorized for this 
purpose by an APHIS representative.
     After shipment, each means of conveyance in which the 
animals have been transported is cleaned and disinfected by the carrier 
in accordance with 9 CFR part 71, under the supervision of an APHIS 
representative, FSIS inspector, State or Tribal representative, 
accredited veterinarian, or other person designated by the 
Administrator. (Section 71.7 provides methods for conducting cleaning 
and disinfection of a means of conveyance, if the means of conveyance 
is required within 9 CFR to be cleaned and disinfected.)
    We consider reactor, suspect, and exposed program animals to 
potentially be infected with brucellosis or bovine tuberculosis, and 
thus to pose a risk of transmitting the disease to other program 
animals. The interstate movement requirements for reactor,

[[Page 78485]]

suspect, or exposed animals would be based on this consideration.
    Accordingly, we would require the animals to be officially 
identified in order to ensure that the appropriate animals arrived at 
their designated destination, and to facilitate traceback and 
epidemiological investigations in the event that they are determined to 
be infected. We would require the animals to be accompanied by a permit 
for movement of restricted animals that specifies the animals' 
brucellosis or bovine tuberculosis classification so that individuals 
who ship, handle, transport, or receive the animals would be adequately 
informed that the animals pose a potential risk of transmitting 
brucellosis or bovine tuberculosis.
    We would require the animals to be moved for diagnostic testing, 
immediate slaughter, or necropsy, unless the Administrator approves 
another use, because such uses are terminal. By terminal, we mean that 
they allow a final determination of the animals' disease status to be 
made, result in the destruction of the animal, or both.
    We do envision that there may be a non-terminal use that the 
Administrator may approve for exposed dairy heifers in certain 
instances. If a dairy herd were to become affected with brucellosis or 
bovine tuberculosis, in order for the dairy to remain operational, it 
could be necessary to move exposed heifers from that herd interstate to 
non-terminal locations for care and feeding, and then return them to 
the affected dairy. However, we also recognize that allowing exposed 
animals to move to a non-terminal location without adequate 
restrictions or mitigations could result in the spread of brucellosis 
or bovine tuberculosis. We therefore request comment regarding whether 
to allow such movement of dairy heifers, and, if so, under what 
conditions to allow it.
    We would require the animals to be moved to certain approved 
locations because we believe that any location that receives reactor, 
suspect, or exposed program animals must have structures and/or 
procedures in place to address the risk that the animals may pose of 
transmitting brucellosis or bovine tuberculosis.
    We would require the animals to be moved with animals that are not 
susceptible to brucellosis and/or bovine tuberculosis or animals 
destined for immediate slaughter or necropsy, because, if a reactor, 
suspect, or exposed animal is, in fact, infected with brucellosis or 
bovine tuberculosis, prolonged contact with animals that are 
susceptible to the disease and are not destined to a terminal location 
could result in the dissemination of brucellosis or bovine 
tuberculosis.
    We would require the means of conveyance to be sealed, or the 
animals to be accompanied by an APHIS representative, FSIS inspector, 
or State or Tribal representative, in order to prevent the diversion of 
the animals en route to a location that has not been approved by the 
Administrator, and that may not have appropriate structures and/or 
procedures to mitigate any risks that the animals may pose of 
transmitting brucellosis or bovine tuberculosis.
    Finally, because surfaces can be contaminated with the bacteria 
that cause brucellosis and bovine tuberculosis and serve as articles 
that convey infection, we would require the means of conveyances in 
which the animals have been transported to be cleaned and disinfected 
after shipment.
Commuter Herds
    Commuter herds are herds of cattle or bison that move interstate 
during the course of normal livestock operations and without change of 
ownership between premises that are owned or leased by the same person, 
as provided in a commuter herd agreement. A commuter herd agreement, in 
turn, is a written agreement between the owner of such a herd and the 
animal health officials of the State of origin and destination 
specifying, at a minimum, the testing, identification, and 
recordkeeping requirements for the interstate movement of animals in a 
commuter herd from one premises to another in the course of normal 
livestock management operations. If a commuter herd is moved interstate 
under a commuter herd agreement, it is not subject to the requirements 
of the regulations that would otherwise apply to the interstate 
movement of cattle and bison from that State. We allow for such an 
arrangement because we consider commuter herds to present a very low 
risk of transmitting brucellosis or bovine tuberculosis to other 
animals, based on the fact that a commuter herd has never tested 
positive for bovine tuberculosis and only one commuter herd has tested 
positive for brucellosis.
    This arrangement was helpful to owners of commuter herds when many 
States did not have the highest classifications for brucellosis or 
bovine tuberculosis within the current State classification systems in 
parts 77 and 78. However, as more and more States have achieved the 
highest classifications for brucellosis and bovine tuberculosis, the 
need for such arrangements has become increasingly unnecessary.
    Accordingly, in this proposed rule, we have elected not to include 
specific provisions for the interstate movement of commuter herds. We 
believe that the requirements specified in proposed Sec. Sec.  76.11 
through 76.15 (see immediately below) would either be less restrictive 
or substantially equivalent to the terms and conditions currently 
specified within commuter herd agreements, and would provide adequate 
mitigations for the interstate movement of most commuter herds. We also 
believe that exempting commuter herds from the requirements in proposed 
Sec. Sec.  76.8 through 76.10 would potentially allow for the 
interstate movement of infected animals without appropriate 
mitigations.
    We request public comment regarding whether to include specific 
conditions for the interstate movement of commuter herds within part 
76, and, if so, what those conditions should be.
Interstate Movement Requirements--Cattle and Bison (Sec. Sec.  76.11 
through 76.15)
Interstate Movement of Cattle and Bison Generally Restricted (Sec.  
76.11)
    Section 76.11 would provide that, unless cattle or bison belong to 
one of the categories in Sec. Sec.  76.8 through 76.10, or the 
Administrator has provided public notification of alternate conditions 
for movement of the cattle or bison, cattle or bison could only be 
moved interstate in accordance with Sec. Sec.  76.11 through 76.15.
    As we mentioned previously in this document in our discussion of 
proposed Sec.  76.1, the Administrator would rarely specify such 
alternate conditions, and only when he or she had determined that the 
regulations in part 76 did not address the risk of transmission of 
brucellosis or bovine tuberculosis associated with the interstate 
movement of certain cattle or bison.
Interstate Movement of Cattle and Bison From Consistent States or 
Tribes for Brucellosis and Bovine Tuberculosis (Sec.  76.12)
    Proposed Sec.  76.12 would contain requirements for the interstate 
movement of cattle and bison from consistent States or Tribes for 
brucellosis and bovine tuberculosis. The requirements would cover three 
types of movements: Movement of rodeo, event, or exhibited cattle or 
bison; movement of all other cattle or bison from any area of the State 
or Tribe other than a recognized management area; and movement of all 
other cattle or bison from a recognized management area.
    Proposed paragraph (a) of Sec.  76.12 would contain requirements 
for the

[[Page 78486]]

interstate movement of rodeo, event, or exhibited cattle or bison. We 
consider such animals to be a distinct risk category because such 
animals tend to move frequently in interstate commerce and commingle 
with animals from many different regions, both domestically and 
internationally. Thus, the risk that rodeo, event, or exhibited cattle 
or bison that are moved interstate may be exposed to brucellosis or 
bovine tuberculosis is considerably higher than the risk that cattle or 
bison that are moved interstate for other purposes may be exposed to 
these diseases.
    We would allow rodeo, event, or exhibited cattle and bison to be 
moved interstate from a consistent State for brucellosis or bovine 
tuberculosis provided that:
     The cattle or bison are tested for bovine tuberculosis 
using an individual official test no more than 60 days prior to initial 
interstate movement from the premises of origin, with negative results. 
(We would include a footnote, footnote 5, stating that the requirements 
of this and the following paragraph apply not only to rodeo, event, or 
exhibited cattle and bison that have been produced within the United 
States, but also rodeo, event, or exhibited cattle and bison of foreign 
origin after they have arrived at their destination within the United 
States.)
     If the cattle or bison are sexually intact and 6 months of 
age or older, they are tested for brucellosis using an individual 
official test no more than 60 days prior to initial interstate movement 
from the premises of origin, with negative results.
     The cattle or bison are tested for bovine tuberculosis 
using an individual official test no more than 180 days prior to any 
subsequent interstate movement, with negative results.
     If the cattle or bison are sexually intact and 6 months of 
age or older, they are tested for brucellosis using an individual 
official test no more than 180 days prior to any subsequent interstate 
movement, with negative results.
     The cattle or bison are accompanied during interstate 
movement by an ICVI with a statement regarding the date, location, and 
test results of the official tests for bovine tuberculosis and, if 
applicable, brucellosis administered prior to initial interstate 
movement, and the date, location, and test results of the last official 
test for bovine tuberculosis and, if applicable, brucellosis 
administered to the animals.
     The cattle or bison are officially identified.
    We would require the cattle or bison to be tested for bovine 
tuberculosis, and, if they are sexually intact and 6 months of age or 
older, brucellosis prior to initial interstate movement from the 
premises of origin, with negative results, because, if cattle or bison 
from that premises become infected with brucellosis or bovine 
tuberculosis at a rodeo, event, or exhibit, and are moved back to the 
premises following the rodeo, event, or exhibit, they could infect 
animals at the premises that have not yet moved interstate. We would 
require this testing to take place no more than 60 days prior to 
movement, because 60 days has historically been the maximum amount of 
time that we consider negative test results for brucellosis or bovine 
tuberculosis to provide assurances that an animal is not infected at 
the time it is initially moved interstate.
    We would require the cattle or bison to be tested for bovine 
tuberculosis, and, if they are capable of transmitting the disease, 
brucellosis, no more than 180 days prior to any subsequent interstate 
movement, with negative results, because this testing would provide 
assurances that the cattle or bison have not contracted brucellosis or 
bovine tuberculosis at a particular rodeo, event, or exhibit. The 
testing would be at 180-day intervals because rodeo, event, and 
exhibited cattle are often moved frequently over a 24 to 30-month 
period, starting with initial movement from their premises of origin. 
If they were tested more frequently during that time period, there 
would be a risk of anergy for bovine tuberculosis, that is, erroneous 
results due to a lack of sensitivity to a test.
    We would require the animals to be accompanied by an ICVI with 
statements regarding the date, location, and test results of the 
official tests administered prior to initial interstate movement and 
the last such official tests in order to provide assurances to 
individuals that handle, ship, or receive the animals that they have 
been moved in accordance with the regulations. We would require the 
animals to be officially identified because official identification 
facilitates traceability of the animals in the event of disease 
outbreak at a rodeo, event, or exhibit.
    Proposed paragraph (b) of Sec.  76.12 would contain conditions for 
the movement of all other cattle and bison from a consistent State or 
Tribe. Proposed paragraph (b)(1) would contain conditions for the 
movement of all other cattle or bison from any area of the State or 
Tribe other than a recognized management area. Such animals could be 
moved without restriction under part 76.
    Paragraph (b)(1) would contain a footnote, footnote 6, stating that 
the cattle and bison would still be subject to all other applicable 
restrictions of 9 CFR chapter 1, including those of Sec. Sec.  71.3, 
71.17, 86.4, and 86.5. Among other prohibitions, Sec.  71.3 generally 
prohibits the interstate movement of cattle and bison infected with 
Johne's disease and anthrax, dangerous and communicable diseases of 
ruminants. Section 71.17 prohibits live cattle or bison from being 
moved interstate in the same car as dead cattle, bison, poultry, or 
other animals. Section 86.4 requires most cattle and bison that are 
moved interstate to be officially identified; Sec.  86.5 requires most 
cattle and bison that are moved interstate to be accompanied by an 
ICVI.
    Proposed paragraph (b)(2) of Sec.  76.12 would contain conditions 
for the movement of all other cattle or bison from a recognized 
management area in a consistent State or Tribe. These cattle or bison 
would have to be moved in accordance with the conditions for movement 
of program animals from the recognized management area specified in the 
State or Tribe's animal health plan.
Interstate Movement of Cattle and Bison From a Provisionally Consistent 
State or Tribe (Sec.  76.13)
    Section 76.13 would contain conditions for the interstate movement 
of cattle and bison from a State that is provisionally consistent for 
brucellosis or bovine tuberculosis.
    As we mentioned previously in this document in our discussion of 
proposed Sec. Sec.  76.2 and 76.3, whenever we redesignate a consistent 
State or Tribe as a provisionally consistent State or Tribe, we would 
publish a notice in the Federal Register announcing this redesignation. 
Proposed paragraph (a) of Sec.  76.13 would provide that, unless this 
notice specifies restrictions on the interstate movement of cattle and 
bison arising from this redesignation, cattle or bison that are moved 
interstate from a provisionally consistent State or Tribe would be 
subject to the relevant conditions for movement in proposed Sec.  
76.12. Thus, the interstate movement of rodeo, event, or exhibited 
cattle and bison would be subject to the provisions of paragraph (a) of 
proposed Sec.  76.12; cattle and bison that are not rodeo, event, or 
exhibited cattle or bison, and that are moved from any area in the 
State or Tribe other than a recognized management area, would be 
subject to the provisions of paragraph (b)(1) of that section; and 
cattle and bison that are not rodeo, event, or exhibited cattle or 
bison, and that are moved from a recognized management area, would be

[[Page 78487]]

subject to the provisions of paragraph (b)(2) of that section.
    Proposed paragraph (b) of Sec.  76.13 would provide that, if the 
notice announcing redesignation of the State or Tribe specifies 
restrictions on the interstate movement of cattle or bison, and these 
restrictions differ from the conditions for interstate movement 
specified in proposed Sec.  76.12, the interstate movement of such 
cattle or bison would be subject to the restrictions specified in the 
notice.
Interstate Movement of Cattle and Bison from Inconsistent States or 
Tribes for Brucellosis (Sec.  76.14)
    This section would contain conditions for the interstate movement 
of cattle and bison from a State or Tribe that is inconsistent for 
brucellosis. We would consider all cattle and bison moved interstate 
from an inconsistent State or Tribe to present at least an unknown risk 
of disseminating disease. The conditions in proposed Sec.  76.14 would 
be based on this consideration.
    Proposed paragraph (a) of Sec.  76.14 would contain conditions for 
the interstate movement of sexually intact cattle or bison that are 6 
months of age or older, that is, animals for which there is strong 
scientific evidence supporting their ability to transmit brucellosis.
    If the animals are destined for immediate slaughter, they could be 
moved interstate provided that they are officially identified and 
accompanied by an ICVI. We do not consider additional mitigations to be 
necessary because slaughtering an animal at a recognized slaughtering 
establishment is an effective mitigation to prevent that animal from 
disseminating brucellosis.
    If the animals are not destined for immediate slaughter, they could 
be moved interstate provided that they meet the following requirements:
     The herd from which the cattle or bison originate has been 
subjected to a herd test using an official test for brucellosis no more 
than 1 year and no less than 120 days prior to movement, with negative 
results.
     The cattle or bison are additionally tested using an 
individual official test no more than 60 days prior to movement, with 
negative results.
     Since being individually tested, the cattle or bison have 
not commingled with non-natural additions to the herd that are of 
unknown brucellosis status or animals that have had a non-negative test 
for brucellosis.
     The cattle or bison are officially identified.
     The cattle or bison are accompanied by an ICVI documenting 
the negative test results.
    The initial herd test would provide assurances that the herd from 
which the animals originate is not affected with brucellosis. The 
subsequent individual test would provide assurances that the cattle or 
bison have not become infected with brucellosis since the time of the 
herd test. Isolation from non-natural additions to the herd that are of 
unknown brucellosis status or from animals that have had a non-negative 
test for brucellosis following this individual test would preclude 
contact with cattle or bison that are potentially infected with 
brucellosis. Requiring the animals to be officially identified and 
accompanied by an ICVI with a statement regarding their negative test 
results would facilitate their traceability, provide assurances to 
those handling, transporting, or receiving the animals that they do not 
present a risk of disseminating brucellosis, and help document that the 
appropriate animals arrived at their designated destination.
    Proposed paragraph (b) of Sec.  76.14 would provide conditions for 
the interstate movement of cattle that are less than 6 months of age, 
steers, and spayed heifers, that is, animals for which there is no 
scientific evidence suggesting that they are a source of transmission 
of brucellosis. Such animals could be moved interstate from an 
inconsistent State for brucellosis if they are officially identified 
and accompanied by an ICVI.
Interstate Movement of Cattle and Bison From Inconsistent States or 
Tribe for Bovine Tuberculosis (Sec.  76.15)
    Section 76.15 would provide conditions for the interstate movement 
of cattle or bison from a State that is inconsistent for bovine 
tuberculosis. If the cattle or bison are destined for immediate 
slaughter, they could be moved interstate provided that they are 
officially identified and accompanied by an ICVI. We consider 
slaughtering an animal at a recognized slaughtering establishment to be 
an effective mitigation to prevent that animal from disseminating 
bovine tuberculosis.
    If the cattle or bison are not destined for immediate slaughter, 
they could be moved interstate provided that:
     The cattle or bison originate from a herd that was 
subjected to a herd test using an official test for bovine tuberculosis 
no more than 1 year and no less than 120 days prior to the movement of 
the cattle or bison, with negative results.
     The cattle or bison are additionally tested for bovine 
tuberculosis using an individual official test no more than 60 days 
prior to movement, with negative results.
     Since being individually tested, the cattle or bison have 
not commingled with non-natural additions to the herd that are of 
unknown bovine tuberculosis status or animals that have had a non-
negative test for bovine tuberculosis.
     The cattle or bison are officially identified.
     The cattle or bison are accompanied by an ICVI documenting 
the negative test results.
    These conditions, which would be nearly identical to the movement 
from an inconsistent State for brucellosis of cattle or bison that are 
capable of transmitting brucellosis, would serve a purpose that is 
analogous to those conditions. The herd test would provide assurances 
that the herd from which the cattle or bison originate is not affected 
with bovine tuberculosis. The subsequent individual test would provide 
assurances that the cattle or bison have not become infected with 
bovine tuberculosis since the time of the herd test. Isolation from 
non-natural additions to the herd that are of unknown bovine 
tuberculosis status or animals that have had a non-negative test for 
bovine tuberculosis following this individual test would preclude 
contact with cattle or bison that are potentially infected with bovine 
tuberculosis. Finally, requiring the animals to be officially 
identified and accompanied by an ICVI with a statement regarding their 
negative test results would facilitate their traceability, provide 
assurances to those handling, transporting, or receiving the animals 
that they do not present a risk of disseminating bovine tuberculosis, 
and help document that the appropriate animals arrived at their 
designated destination.
Interstate Movement of Captive Cervids (Sec.  76.16)
    Because of routine inspections conducted by FSIS inspectors or 
State meat inspection personnel at recognized slaughtering 
establishments, in conjunction with surveillance conducted pursuant to 
the current prevalence-based State classification systems for 
brucellosis and bovine tuberculosis, we have confidence in the 
approximate prevalence levels for brucellosis and bovine tuberculosis 
in the domestic cattle and bison populations within the United States.
    There is, however, no routine slaughter inspection of or 
surveillance activities for captive cervids. Moreover, many captive 
cervids that are slaughtered for meat purposes are slaughtered at 
custom slaughter establishments that are not under Federal or State 
oversight. Accordingly,

[[Page 78488]]

APHIS does not have the same degree of certainty regarding the 
approximate prevalence levels of brucellosis and bovine tuberculosis in 
the domestic captive cervid population within the United States.
    For this reason, under part 77, we currently require captive 
cervids that are moved interstate to be tested for bovine tuberculosis, 
unless the captive cervids originate directly from a herd that has 
undergone sufficient testing and monitoring to provide assurances that 
animals from the herd will not transmit bovine tuberculosis.
    We currently do not regulate captive cervids for brucellosis. 
Because captive cervids are not regulated for brucellosis, testing of 
the animals for brucellosis prior to interstate movement is currently 
limited. Captive cervids are, however, susceptible to brucellosis, and 
sexually mature and intact cervids can transmit the disease. 
Additionally, in recent years, wild elk populations in the GYA have 
been determined to be infected with brucellosis. For these reasons, we 
believe it would be prudent to regulate the interstate movement of 
captive cervids for brucellosis at least until such time as we have 
greater knowledge of the prevalence for the disease in the domestic 
captive cervid population within the United States.
    Proposed Sec.  76.16 would contain conditions for the interstate 
movement of captive cervids. The section would generally continue our 
existing policy of requiring captive cervids to be tested for bovine 
tuberculosis prior to interstate movement, unless the cervids originate 
from a herd which has undergone sufficient testing and monitoring to 
provide assurances that cervids from the herd pose no risk of 
transmitting bovine tuberculosis. We would, however, also allow captive 
cervids to be moved interstate without testing for bovine tuberculosis 
if they are moved for immediate slaughter; this is because, as we 
mentioned previously in this document, we consider slaughtering an 
animal at a recognized slaughtering establishment to mitigate the risk 
that the animal may pose of disseminating bovine tuberculosis.
    The section would also require captive cervids to be tested for 
brucellosis prior to interstate movement, unless we have similar 
assurances regarding the herd from which the cervids originate, or 
unless the cervids are moved for immediate slaughter.
    The introductory text of the section would state that, except as 
provided in Sec. Sec.  76.8 through 76.10, captive cervids could only 
be moved interstate in accordance with the section.
    Proposed paragraph (a) of Sec.  76.16 would provide conditions for 
the interstate movement of captive cervids that originate directly from 
herds that are currently accredited for both brucellosis and bovine 
tuberculosis. Such cervids could be moved interstate if they are 
officially identified and accompanied by an ICVI with a statement that 
the cervids originate directly from herds that are currently accredited 
for both brucellosis and bovine tuberculosis.
    Proposed paragraph (b) would provide conditions for the interstate 
movement of all other cervids. Paragraph (b)(1) would provide 
conditions for the interstate movement of such cervids, if they are 
destined for immediate slaughter. Captive cervids that do not originate 
directly from herds that are currently accredited for brucellosis and 
bovine tuberculosis and that are destined for immediate slaughter could 
be moved interstate, provided that the cervids are officially 
identified and accompanied by an ICVI.
    Proposed paragraph (b)(2)(i) of Sec.  76.16 would provide general 
conditions for the interstate movement of captive cervids that do not 
originate directly from herds that are currently accredited for 
brucellosis and bovine tuberculosis and that are not destined for 
immediate slaughter. The paragraph would require that:
     The cervids originate from a herd that was subject to a 
herd test using an official test for brucellosis and an official test 
for bovine tuberculosis no more than 1 year and no less than 120 days 
prior to movement, with negative results.
     The cervids are additionally tested for brucellosis and 
bovine tuberculosis using an individual official test no more than 60 
days prior to movement, with negative results.
     The cervids are officially identified.
     The cervids are accompanied by an ICVI.
    Proposed paragraph (b)(2)(ii) would contain additional conditions 
for captive cervids moved interstate from an inconsistent State or 
Tribe for brucellosis and/or bovine tuberculosis. Because we would have 
significant concerns about an inconsistent State or Tribe's regulatory 
program for brucellosis and/or bovine tuberculosis, in order for a 
captive cervids to be moved interstate from the State or Tribe, we 
would require additional assurances that the cervids have not come in 
contact with an infected cervid after individual testing. Accordingly, 
we would require that, since being individually tested, the cervids do 
not commingle with non-natural additions to the herd that are of 
unknown disease status or animals that have had a non-negative test for 
brucellosis or bovine tuberculosis.
    Finally, if we finalize this section, there is a possibility that a 
captive cervid will have non-negative test results to a brucellosis 
test administered prior to the animal's interstate movement that are 
such that that we must order its destruction to prevent the possible 
spread of brucellosis.
    In such instances, under section 10407 of the AHPA, we are required 
to indemnify the owner of the cervid at fair market value minus 
salvage, with certain, limited exceptions. However, no regulations 
currently exist in 9 CFR regarding the payment of indemnity for such 
captive cervids. We therefore request public comment from all 
interested parties, and, in particular, captive cervid producers, 
regarding how an equitable appraisal process for the payment of such 
indemnity may be established.
    If we finalize this section, we will add regulations to 9 CFR that 
take into consideration the comments we receive regarding how best to 
establish such a process.
Official Tests for Brucellosis and Bovine Tuberculosis, Official 
Testing Laboratories, and Official Testers (Sec.  76.17)
    Proposed paragraph (a) of Sec.  76.17 would require all testing for 
the presence or absence of brucellosis and bovine tuberculosis that is 
conducted in accordance with part 76 to be conducted using an official 
test. A list of all official tests would be found on the Internet, at 
https://www.aphis.usda.gov/animal_health/animal_dis_spec/cattle.
    If this rule is finalized, the list of official tests for 
brucellosis would, at a minimum, be those that are currently in use 
within the brucellosis program: The standard card test, the manual 
complement-fixation test, the Rivanol test, the buffered acidified 
plate antigen test, the rapid automated presumptive test, the 
fluorescence polarization assay, the brucellosis ring test, and the 
heat inactivation ring test. Similarly, the list of official tests for 
bovine tuberculosis would, at a minimum, be those that are currently in 
use within the bovine tuberculosis program: The caudal fold test, the 
bovine interferon gamma assay, the cervical tuberculin test, the 
comparative cervical tuberculin test, the IDEXX Antibody serological 
test, the single cervical tuberculin test, and, for elk, red deer, 
white-tailed deer, fallow deer, and reindeer, the DPP[supreg] test.
    If we determine that a test can reliably determine the presence or 
absence of

[[Page 78489]]

brucellosis or bovine tuberculosis in animals, we would add it to the 
list of official tests. Whenever a test is added to the list, we would 
publish a notice in the Federal Register advising the public of this 
addition.
    If we determine at any point that an official test can no longer be 
considered to provide reliable results regarding the presence or 
absence of brucellosis or bovine tuberculosis in animals, we would 
remove it from the list of official tests. Whenever an official test is 
removed from the list, we would publish a notice in the Federal 
Register alerting the public to and setting forth the reasons for the 
removal.
    Proposed paragraph (b) of Sec.  76.17 would provide the process by 
which a laboratory could request APHIS recognition as an official 
testing laboratory, the conditions under which APHIS might withdraw 
such approval, and the appeal process for any laboratory that has had 
its approval withdrawn. Paragraph (b)(1) would state that, in order to 
be considered an official testing laboratory, a Federal, State, or 
university laboratory, or any other laboratory approved by the National 
Animal Health Laboratory Network \13\, would have to submit a written 
application to its district APHIS VS office. A standard format for such 
an application would be found in the Program Standards document.
---------------------------------------------------------------------------

    \13\ The National Animal Health Laboratory Network (NAHLN) is a 
network of laboratories that is overseen by APHIS and USDA's 
National Institute of Food and Agriculture and comprises sets of 
laboratories that focus on different diseases but use common testing 
methods and software platforms to process diagnostic requests and 
share information. More information regarding NAHLN may be found at 
the following Web site: https://www.aphis.usda.gov/animal_health/nahln/.
---------------------------------------------------------------------------

    Proposed paragraph (b)(2) would describe APHIS' evaluation process 
for applications. First, we would review the submitted application to 
determine if it is complete. Then, when we determine it is complete, we 
would conduct formal review and evaluation of the application. 
Evaluation would be based on the following:
     Whether a need exists at the national level for an 
additional laboratory to be authorized by APHIS to conduct official 
tests for brucellosis and bovine tuberculosis. (This is because APHIS 
must exercise oversight of official testing laboratories, and has 
limited resources to do so.)
     Whether the laboratory has facilities, safety equipment, 
and standard microbiological practices appropriate for the testing 
specified on the application.
     Whether the personnel at the laboratory are qualified to 
conduct the activities specified on the application, as determined by 
proficiency testing.
     Whether the individual at the laboratory with oversight of 
serological testing or final determination of test results has adequate 
experience in the fields of immunology, microbiology, veterinary 
medicine, or a similar discipline.
    Proposed paragraph (b)(3) of Sec.  76.17 would provide that, 
following our evaluation, we would communicate our approval or denial 
of the laboratory's application to the laboratory. If this approval or 
denial is oral, we would subsequently communicate the approval or 
denial in writing.
    If we approve a laboratory, it would be considered an official 
testing laboratory. An official testing laboratory could conduct 
official tests using official testers in the manner set forth in its 
application and approved by APHIS. A list of all official testing 
laboratories would be located on the APHIS Web site.
    Proposed paragraph (b)(4) of Sec.  76.17 would specify how an 
official testing laboratory would be required to maintain approval. In 
order for the laboratory to maintain approval, it would have to 
demonstrate, by means of annual proficiency testing, that it 
continually meets or exceeds the standards under which it was approved.
    Proposed paragraph (b)(5) of Sec.  76.17 would provide that, if 
circumstances have changed at the laboratory such that the information 
supplied on its application for approval is no longer accurate, the 
laboratory would have to provide updated information to APHIS within 30 
days. In response to such notification, we could conduct another 
evaluation of the facility. Failure by a facility to notify us in a 
timely manner could result in revocation of its approval.
    Proposed paragraph (b)(6) of Sec.  76.17 would provide the 
conditions under which we may revoke a laboratory's approval as an 
official testing laboratory. It would state that we could revoke the 
approval of an official testing laboratory if it is determined to have 
falsified information on its application or to no longer meet the 
standards under which it was approved.
    Paragraph (b)(6) would also contain the appeal process for any 
laboratory whose approval is revoked. Any laboratory whose approval is 
revoked could appeal the decision in writing to the Administrator 
within 14 days after receiving the written notification of the 
revocation. The appeal would have to state all of the reasons on which 
the laboratory relies to show that approval was wrongfully revoked. The 
Administrator would grant or deny the appeal, in writing, stating the 
reasons for the decision as soon as circumstances allow.
    Proposed paragraph (b)(7) of Sec.  76.17 would contain the process 
by which a laboratory whose approval has been revoked could seek 
reapproval. In order to do so, the laboratory would have to submit a 
written justification for reapproval to APHIS to the address specified 
within the Program Standards document. The justification would have to 
demonstrate that the issue that resulted in the revocation has been 
resolved.
    We envision that secondary (corroboratory) testing for brucellosis 
or bovine tuberculosis that is conducted for purposes of the 
consolidated brucellosis and bovine tuberculosis program would be 
conducted at official testing laboratories. However, as they are today, 
most initial tests for the diseases would be conducted outside of a 
laboratory environment. Hence, paragraph (c) of Sec.  76.17 would 
provide the conditions under which we would allow official testers to 
conduct official tests outside of such an environment. Proposed 
paragraph (c)(1) would continue our existing policy of allowing 
regulatory personnel to conduct such tests, at the discretion of a 
District VS office and a State or Tribal animal health official, and 
under the conditions specified by the office and the official.
    Within the bovine tuberculosis program, we allow veterinarians that 
are accredited under APHIS' National Veterinary Accreditation Program 
(NVAP) to conduct caudal fold tests for cattle and bison and the single 
cervical tuberculin (SCT) test for captive cervids outside of a 
laboratory environment. In recent years, based on low response rates to 
caudal fold tests administered by certain of these veterinarians, we 
have begun to have concerns that those veterinarians may be incorrectly 
administering the caudal fold test. Because the SCT test is 
administered and interpreted in a similar manner to the caudal fold 
test, we also have similar concerns regarding consistent administration 
of the SCT. Accordingly, we have initiated a process to establish a 
``program certification,'' that is, specialized training for accredited 
veterinarians, within NVAP for the correct administration of official 
tests for bovine tuberculosis. Proposed paragraph (c)(2) of Sec.  76.17 
would allow such certified veterinarians to operate as official testers 
for bovine tuberculosis outside of a laboratory environment within the 
State or States in which they are accredited under NVAP. If this 
proposed rule is finalized and an

[[Page 78490]]

accredited veterinarian did not attain such a program certification, he 
or she could no longer conduct such tests.
    The regulations governing program certifications under NVAP are 
found in 9 CFR 161.5. That section contains the process for obtaining 
and maintaining a program certification, but does not contain 
provisions regarding decertification of a program certification. 
However, because widespread incorrect administration of official tests 
for bovine tuberculosis could compromise the integrity of the bovine 
tuberculosis program, we believe that a qualified accredited 
veterinarian who consistently administers official tests for bovine 
tuberculosis in a manner at variance with his or her program 
certification should be decertified for that program certification and 
no longer be able to administer such tests for program purposes. We 
also believe that, in certain instances, deliberate or egregious 
misapplication of official tests should be considered grounds for 
suspending or revoking that veterinarian's accreditation. We would 
amend Sec.  161.5 accordingly.
Miscellaneous Harmonizing Modifications to the Regulations in 9 CFR 
Chapter I, Subchapter C
    As we mentioned at the beginning of this document, the regulations 
in proposed part 76 would supplant the current regulations governing 
the bovine tuberculosis program in 9 CFR part 77, and those governing 
the aspects of the brucellosis program that pertain to cattle and 
bison, found in 9 CFR part 78, subparts B and C. Therefore, we would 
remove part 77 from the regulations in its entirety, and would remove 
subparts B and C from part 78. We would also remove the definitions in 
part 78 that pertain to terms only found in subpart B or C.
    As we mentioned in our discussion of the definition of depopulate, 
the regulations in 9 CFR part 50 contain conditions under which the 
Administrator may pay indemnity for animals destroyed because of bovine 
tuberculosis. Similarly, the regulations in 9 CFR part 51 contain 
conditions under which the Administrator may pay indemnity for animals 
destroyed because of brucellosis. Since these conditions are often 
dependent, in part, on the regulations contained in parts 77 and 78, 
there are, accordingly, a number of references to parts 77 and 78 
within parts 50 and 51. For example, in Sec.  51.9, paragraph (b) 
currently provides that the Administrator will not pay a claim for 
indemnity for an animal destroyed because of brucellosis, if the 
existence of brucellosis in the animal was determined based on the 
results of an official test as defined in Sec.  78.1 and specific 
instructions for the administration of the test had not previously been 
issued to the individual performing the test by APHIS and a State 
animal health official. We would either modify these references to have 
them refer to part 76, or, if they refer to provisions in parts 77 or 
78 for which no analogous provisions exist in part 76, remove the 
references altogether.
    On a related matter, we would also modify a number of definitions 
in parts 50 and 51 to make them consistent with the definitions in 
proposed part 76. In part 50, we would amend the definitions of 
Administrator, APHIS representative, approved herd plan, destroyed, 
herd depopulation, State, State animal health official, and State 
representative for that reason. In part 51, we would amend the 
definitions of Administrator, herd depopulation, official seal, State, 
State animal health official, and State representative for that reason. 
To explain the definition of herd depopulation, we would also add a 
definition of herd plan to the regulations.
    Part 71 of 9 CFR contains general requirements regarding the 
interstate movement of livestock within the United States. Several of 
these requirements, most notably those governing the approval of 
livestock facilities to receive animals that move interstate, contain 
multiple references to parts 77 and 78. We would modify these 
references to have them refer to part 76, or remove them from part 71. 
We would also update several of the definitions in part 71 to make them 
consistent with the definitions in part 76. Specifically, we would 
update the definitions of Administrator, APHIS representative, State, 
State animal health official, and State representative for that reason. 
(Similarly, we would revise the definition of interstate commerce in 
that part to make it consistent with the definition contained within 
the AHPA.)
    As we mentioned previously in this document, 9 CFR part 86 contains 
identification and recordkeeping requirements for livestock that move 
in interstate commerce. Part 86 contains several references to parts 77 
and 78 that would become obsolete if this proposed rule is finalized. 
We would modify these references to refer to part 76.
    Finally, in reviewing parts 50 and 51 in developing this proposed 
rule, we determined that parts 50 and 51 of 9 CFR did not reference a 
long-standing Agency policy that APHIS does not provide indemnity for 
cattle, bison, or captive cervids that are publicly owned, that is, 
owned by the Federal Government, a State or Tribe, or any regional or 
local community. We would amend parts 50 and 51 to codify this policy.
Part 93 (Imports)
    The regulations in 9 CFR part 93, subpart D (Sec. Sec.  93.400-
93.436, referred to below as part 93 or the subpart), contain 
requirements for the importation of ruminants into the United States to 
address the risk of introducing or disseminating diseases of livestock 
within the United States. Part 93 currently contains provisions that 
address the risk that imported bovines (cattle or bison) may introduce 
or disseminate brucellosis or bovine tuberculosis within the United 
States. As we mentioned in the Executive Summary at the beginning of 
this document, these provisions may be divided into two categories: 
General requirements for the importation of bovines from most 
countries, and country-specific requirements for Canada, Mexico, and 
Ireland.
    The general requirements for bovines from most countries are 
contained in Sec.  93.406. Bovines that are capable of transmitting 
brucellosis (bovines that are 6 months of age or older and sexually 
intact) must be tested for brucellosis within 30 days prior to the date 
of their exportation to the United States, unless the bovines are 
destined for immediate slaughter or imported from Australia or New 
Zealand, which we have evaluated and determined to be free of Brucella 
abortus. (We consider the results of this evaluation to still be 
accurate. We discuss this matter at greater length later in this 
document, under the section heading titled ``Brucellosis status of 
foreign regions (Sec.  93.440)''.)
    Additionally, with limited exceptions, bovines that are imported 
into the United States must originate from a herd that tested negative 
to a herd test for tuberculosis within 1 year prior to the date of 
their exportation into the United States and must test negative to an 
individual test conducted within 60 days of their exportation. (In part 
93, bovine tuberculosis is referred to as tuberculosis; accordingly, 
the remainder of this preamble will use the terms interchangeably.) 
Sexually intact bovines may be imported into the United States without 
such testing if they originate from a herd that was certified as an 
accredited herd within 1 year prior to export.
    The regulations that are specific to bovines from Canada are 
contained in Sec.  93.418. Bovines that are from an affected herd for 
brucellosis or bovine

[[Page 78491]]

tuberculosis may not be imported into the United States. Bovines that 
are not from an affected herd may be imported into the United States if 
they are destined for immediate slaughter, or if they are moved to a 
feedlot and then to slaughter and meet certain conditions that provide 
assurances that they will not transmit brucellosis or bovine 
tuberculosis to other animals at those feedlots.
    The regulations that are specific to bovines from Mexico are 
contained in Sec.  93.427. Under these regulations, bovines that are 
capable of transmitting brucellosis and that are not destined for 
immediate slaughter or movement directly to a quarantine feedlot must 
originate from a herd in which all test-eligible animals have been 
tested for brucellosis no more than 90 and no less than 30 days prior 
to the exportation of the bovines to the United States, with negative 
results, and must be subjected to an additional test for brucellosis at 
the port of entry into the United States, with negative results. 
Additionally, steers and spayed heifers that are not destined for 
immediate slaughter must be branded with an ``M'' or ``Mx'' 
bovine tuberculosis brand, respectively, while sexually intact bovines 
from Mexico must be detained at the port of entry into the United 
States and subjected to a test for bovine tuberculosis, with negative 
results.
    The regulations also specify additional requirements for the 
importation of bovines from a herd in which animals have been 
determined to be reactors or suspects for brucellosis or reactors for 
bovine tuberculosis. Finally, based on the historically high prevalence 
levels of bovine tuberculosis infection in the breeds, the regulations 
prohibit the importation of Holstein steers and spayed heifers and 
Holstein cross steers and spayed heifers from Mexico.
    The regulations that are specific to Ireland are contained in Sec.  
93.432. Under these regulations, bovines that are imported into the 
United States must originate from a herd that has been subjected to two 
consecutive annual whole herd tests for brucellosis, with negative 
results, must be subjected to an additional test for brucellosis no 
more than 120 and no less than 60 days prior to export, with negative 
results, and must be subjected to a third test for brucellosis within 
30 days prior to export, with negative results.
    The general requirements in part 93 predate the establishment of 
APHIS, and reflect what was considered at the time to be adequate 
mitigations for the risk of imported bovines introducing or 
disseminating brucellosis and bovine tuberculosis within the United 
States. Similarly, the country-specific requirements reflect individual 
assessments that we conducted at particular points in time of the risk 
that cattle imported from Canada, Mexico, or Ireland posed at that time 
of disseminating brucellosis and/or bovine tuberculosis within the 
United States.
    The general requirements were predicated on assumptions at the time 
that foreign countries had regulatory programs for brucellosis and 
bovine tuberculosis that were comparable to our own, and the country-
specific requirements were predicated on the assumption that all 
regions within Canada, Mexico, and Ireland have roughly equivalent 
bovine tuberculosis and brucellosis programs and prevalence rates for 
brucellosis and/or bovine tuberculosis.
    We have discovered, however, that regulatory programs for 
brucellosis and bovine tuberculosis are not uniform throughout the 
world. While some of these programs are equivalent to or exceed those 
within the United States, others lack controls that we consider 
integral components of any regulatory program for brucellosis or bovine 
tuberculosis.
    Moreover, even within a particular foreign country, we have 
discovered that regulatory programs for brucellosis and bovine 
tuberculosis can vary considerably among geopolitical regions, and 
that, accordingly, prevalence rates for brucellosis or bovine 
tuberculosis can likewise vary considerably from region to region. For 
example, in Mexico, herd prevalence rates for bovine tuberculosis vary 
significantly among exporting regions (States and zones within States), 
from less than 0.01 percent to as high as 14 percent.
    Finally, we have discovered that regulatory programs for 
brucellosis and bovine tuberculosis in particular regions should not be 
considered static. Several regions have modified their programs in 
recent years in order to more aggressively pursue eradication of the 
diseases in their region, while other regions have had to divert 
resources once allocated to their regulatory programs to address the 
introduction or dissemination of other diseases of livestock within the 
region.
    For these reasons, we have evaluated the risk associated with the 
importation of cattle and bison from foreign regions to determine 
whether to modify the current regulations, and, if so, how. The risk 
evaluation, titled ``Bovine Tuberculosis and Brucellosis: Evaluation of 
Import Risk and Mitigation Strategies,'' \14\ finds that the existing 
requirements, both those that are general and those that are country-
specific, sometimes provide insufficient risk mitigation for bovines 
from higher-prevalence regions and a barrier to trade from low-
prevalence regions, and should therefore be modified. The risk 
evaluation examines two possible modifications: (1) Adopting 
international standards developed by the OIE or (2) applying the U.S. 
prevalence-based requirements currently delineated in the Uniform 
Methods and Rules for the bovine tuberculosis and brucellosis programs 
within the United States, to the importation of bovines from foreign 
regions. The risk evaluation recommends the latter approach.
---------------------------------------------------------------------------

    \14\ The evaluation is available on Regulations.gov (see 
ADDRESSES above) or by contacting the persons listed under FOR 
FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

    Accordingly, based on the recommendations of the risk evaluation, 
we would establish a system to classify foreign regions \15\ as a 
particular status level for bovine tuberculosis and a status for 
brucellosis. The status would be based on our assessment of the 
regulatory programs for tuberculosis or brucellosis within the region 
and the prevalence of tuberculosis or brucellosis among bovine herds 
within the region.
---------------------------------------------------------------------------

    \15\ As we mentioned earlier in this document, a region is 
defined in Sec.  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.'' Thus 
a foreign country could request a classification for a particular 
province, State, or department within that country, or could request 
that a zone within a province, State, or department receive a 
different classification than the rest of the province, State, or 
department.
---------------------------------------------------------------------------

    Since regulatory programs and disease status may change, we also 
would establish provisions for modifying the tuberculosis or 
brucellosis classification of a foreign region. Regions could request a 
higher classification for either or both of the diseases, and we would 
make these requests publicly available for review and comment. Based on 
the comments received, we would issue a follow-up notice specifying 
whether we were granting or denying the request for reclassification. 
Conversely, we would also reserve the right to downgrade a region's 
status based on emerging evidence.
    Finally, we would establish conditions for the importation of 
cattle and bison from regions with the various classifications that we 
consider commensurate with the degree of risk of

[[Page 78492]]

dissemination of bovine tuberculosis or brucellosis associated with the 
importation of cattle and bison imported from such regions.
Tuberculosis Status of Foreign Regions (Sec.  93.437)
    Proposed Sec.  93.437 would contain the classification system for 
the bovine tuberculosis status of foreign regions. There would be five 
levels of classification.
    Proposed paragraph (a) of Sec.  93.437 would describe the highest 
classification, Level I. Level I foreign regions would be regions of 
the world that have a program that meets our requirements for bovine 
tuberculosis classification, which would be set forth in proposed Sec.  
93.438, and a prevalence of bovine tuberculosis in their domestic 
bovine (cattle and bison) herds of less than 0.001 percent over at 
least the previous 2 years (24 consecutive months). This prevalence 
threshold would correspond to our highest State or zone classification 
level for bovine tuberculosis, accredited-free. However, while we 
currently require a State or zone to have a zero percent herd 
prevalence rate for bovine tuberculosis in the State or zone's cattle 
and bison herds in order to qualify for accredited-free status, we 
would require foreign regions to have a prevalence of bovine 
tuberculosis in their domestic bovine herds of less than 0.001 percent 
over at least the previous 2 years. We are proposing this slightly less 
stringent standard to reflect the overall prevalence of tuberculosis in 
the United States.
    Proposed paragraph (b) of Sec.  93.437 would describe the next 
highest classification, Level II. Level II regions would have a program 
that meets APHIS requirements for tuberculosis classification in 
accordance with proposed Sec.  93.438, and a prevalence of tuberculosis 
in their domestic bovine herds equal to or greater than 0.001 percent, 
but less than 0.01 percent, over the previous 2 years (24 consecutive 
months). This prevalence threshold would correspond to the second 
highest State or zone classification, modified accredited advanced, in 
our current prevalence-based system for the domestic bovine 
tuberculosis program.
    Proposed paragraph (c) of Sec.  93.437 would describe the third 
classification, Level III. Level III regions would be regions that have 
a program that meets APHIS' proposed requirements for tuberculosis 
classification in accordance with Sec.  93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.01 percent, but less than 0.1 percent, over the previous year (12 
consecutive months). This would correspond to the third highest State 
or zone classification, modified accredited, in our current prevalence-
based system for the domestic bovine tuberculosis program.
    Proposed paragraph (d) of Sec.  93.437 would describe the fourth 
classification, Level IV. Level IV regions would be regions that have a 
program that meets APHIS' requirements for tuberculosis classification 
in accordance with Sec.  93.438, and a prevalence of tuberculosis in 
their domestic bovine herds equal to or greater than 0.1 percent, but 
less than 0.5 percent, over the previous year (12 consecutive months). 
This would correspond to the fourth highest State or zone 
classification, accreditation preparatory.
    Proposed paragraph (e) of Sec.  93.437 would describe the fifth and 
final classification, Level V. Level V regions would be regions that do 
not have a program that meets APHIS' requirements for tuberculosis 
classification, have a prevalence of tuberculosis in their domestic 
bovine herds equal to our greater than 0.5 percent, or are unassessed 
by APHIS with regard to tuberculosis prevalence.
    Proposed paragraph (f) of Sec.  93.437 would provide that lists of 
all Level I regions, Level II regions, Level III regions, Level IV, and 
Level V regions for tuberculosis are found online, at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml, and that 
changes to the lists would be made in accordance with proposed Sec.  
93.438.
Process for Requesting Regional Classification for Tuberculosis (Sec.  
93.438)
    Proposed Sec.  93.438 would set forth the process by which a region 
could request a classification for bovine tuberculosis.
    Proposed paragraph (a) of Sec.  93.438 would state that a 
representative of the competent veterinary authority of any country or 
countries could request that APHIS classify a region for tuberculosis. 
Requests for classification or reclassification would have to be 
submitted to APHIS electronically or through the mail to the address as 
provided at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to complete a request in a 
manner that will allow APHIS to review it expeditiously would be 
available at https://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and could also be obtained by contacting APHIS in 
writing at the address listed in the regulations. At a minimum, in 
order for APHIS to consider the request complete, it would have to 
define the boundaries of the region, specify the prevalence level for 
tuberculosis within the region, and demonstrate the following:
     That there is effective veterinary control and oversight 
within the region.
     That tuberculosis is a notifiable disease within the 
region.
     That the region has a program in place for tuberculosis 
that includes, at a minimum: Epidemiological investigations following 
the discovery of any infected animals or affected herds, or any animals 
that have had non-negative test results following a test for 
tuberculosis, and documentation of these investigations; management of 
affected herds in a manner designed to eradicate tuberculosis from 
those herds, and documentation regarding this management; regulatory 
controls on the movement of livestock into, within, and from the region 
that correspond to the risk of dissemination of tuberculosis associated 
with such movement; and access to, oversight of, and quality controls 
for diagnostic testing for tuberculosis within the region.
     That the region has surveillance in place that is 
equivalent to or exceeds federal standards for surveillance within the 
United States.
    We recognize that the draft regulatory framework document suggested 
that we would require regions to submit a request in accordance with 
Sec.  92.2 in order to be evaluated for bovine tuberculosis status. 
That section provides eight elements that must make up a region's 
request for evaluation of its animal health status with regard to 
certain disease agents.
    After deliberation, we decided that directly applying the eight 
factors described in Sec.  92.2 would not suffice for the evaluation of 
the tuberculosis or brucellosis status of a foreign region. Although 
many of the factors are germane, others--such as emergency preparedness 
and response--are more appropriate for exotic diseases rather than 
tuberculosis and brucellosis, which are often endemic within regions. 
More importantly, the eight factors do not fully reflect the specific 
information we require to evaluate a foreign region's regulatory 
programs for tuberculosis or brucellosis. We would therefore request 
that foreign regions provide the above information supporting a request 
for tuberculosis classification, which incorporates both relevant 
elements of Sec.  92.2 and critical factors such as information 
regarding epidemiological investigations, affected herd management, and 
controls on diagnostic testing within the region. (The format

[[Page 78493]]

and content of requests for brucellosis classification, discussed 
below, would be similar.)
    Proposed paragraph (b) of Sec.  93.438 would provide that, if we 
consider a request complete, we would publish a notice in the Federal 
Register proposing to classify the region according to Sec.  93.437, 
and making available to the public the information upon which this 
proposed classification is based. The notice would request public 
comment.
    Proposed paragraph (c)(1) of Sec.  93.438 would provide that, if no 
comments are received on the notice, or if comments are received but do 
not affect our proposed classification, we would publish a subsequent 
notice in the Federal Register announcing that classification to be 
final and adding the region to the appropriate list on the Internet.
    Proposed paragraph (c)(2) of Sec.  93.438 would provide that, if 
comments received on the notice suggest that the region be classified 
according to a different tuberculosis classification, and we agree with 
the comments, we would publish a subsequent notice in the Federal 
Register making the information supplied by commenters available to the 
public, and proposing to classify the region according to this 
different classification. This notice would also request public 
comment.
    Proposed paragraph (c)(3) of Sec.  93.438 would provide that, if 
comments received on the notice suggest that insufficient information 
was supplied on which to base a tuberculosis classification, and we 
agree with the comments, we would publish a subsequent notice in the 
Federal Register specifying the additional information needed before we 
could classify the region.
    Proposed paragraph (d) of Sec.  93.438 would provide that, if a 
region is classified under the provisions of the section, that region 
may be required to submit additional information or allow APHIS to 
conduct additional information collection activities in order for that 
region to maintain its classification. It would also provide that, if 
we determine that a region's classification for tuberculosis is no 
longer accurate, we would publish a notice in the Federal Register 
announcing the revised classification and setting forth the reasons for 
this reclassification.
Importation of Ruminants From Certain Regions of the World; 
Tuberculosis (Sec.  93.439)
    Proposed Sec.  93.439 would contain our revised requirements for 
the importation of bovines to address the risk that they could present 
of disseminating tuberculosis within the United States.
    Proposed paragraph (a) of Sec.  93.439 would prohibit the 
importation of ruminants that are known to be infected with or exposed 
to tuberculosis and ruminants that have had a non-negative response to 
any test for tuberculosis. Allowing the importation of known or 
potentially infected ruminants would not be in keeping with our 
responsibility under the AHPA to prevent the dissemination of bovine 
tuberculosis within the United States.
    Pursuant to this paragraph, we would continue our existing 
prohibition on the importation of Holstein steers and spayed heifers 
and Holstein cross steers and spayed heifers from Mexico. Based on 
information obtained from veterinary authorities within Mexico, it is 
not uncommon for a significant percentage of the cattle in a herd of 
Holstein steers and spayed heifers or Holstein cross steers and spayed 
heifers to be infected with tuberculosis.
    Proposed paragraph (b) of Sec.  93.439 would contain conditions for 
the importation of bovines from Level I regions. Unless specified 
otherwise by the Administrator, bovines could be imported into the 
United States from a Level I region for tuberculosis without further 
restriction under the section.
    Paragraph (b) would contain a footnote, footnote 11 within the 
subpart, stipulating that the importation of the bovines, as well as 
that of all other bovines covered by the section, would still be 
subject to all other relevant restrictions of part 93. For example, the 
importation of the bovines would still be subject to the restrictions 
of Sec.  93.404, which requires, with limited exceptions, that a permit 
be issued for the importation of a ruminant before that ruminant is 
imported into the United States.
    Proposed paragraph (c) of Sec.  93.439 would contain conditions for 
the importation of bovines for immediate slaughter from Level II, III, 
and IV regions for tuberculosis. Such bovines could be imported into 
the United States provided that the bovines are officially identified 
and accompanied by a certificate, issued in accordance with the general 
requirements for issuance of certificates contained in paragraph (a) of 
Sec.  93.405, with an additional statement that the bovines are 
officially identified. In the event that a bovine imported for 
immediate slaughter is determined to be infected with bovine 
tuberculosis, official identification would aid us in conducting 
traceback of the animal and could potentially trigger a review of the 
exporting region's classification for bovine tuberculosis.
    Proposed paragraph (d) of Sec.  93.439 would contain conditions for 
the importation of bovines for purposes other than immediate slaughter 
from a Level II region for tuberculosis. Proposed paragraph (d)(1) of 
Sec.  93.439 would provide conditions for the importation of bovines 
directly from currently accredited herds for tuberculosis. (As we 
discuss below, for purposes of part 93, an accredited herd for 
tuberculosis would be a herd that meets APHIS' standards for 
accreditation for tuberculosis status, as specified in an import 
protocol.) Such bovines could be imported into the United States, 
provided that:
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    These requirements would be consistent with the conditions for 
interstate movement of cattle from a currently accredited herd in a 
modified accredited advanced State or zone that are in the current 
Uniform Methods and Rules for the domestic bovine tuberculosis program.
    Paragraph (d)(2) of Sec.  93.439 would provide conditions for the 
importation of sexually intact bovines that do not originate directly 
from a currently accredited herd for bovine tuberculosis. Such bovines 
could be imported into the United States from a Level II region for 
tuberculosis for purposes other than immediate slaughter, provided 
that:
     If the bovines are 6 months of age or older, the bovines 
are subjected to an individual test for tuberculosis at the port of 
entry into the United States or during post-arrival quarantine in 
accordance with Sec.  93.411, with negative results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
animals are officially identified.
    These requirements are generally consistent with the current 
provisions in the Uniform Methods and Rules for the interstate movement 
of breeding cattle from a modified accredited advanced State or zone. 
(The risk evaluation explains why we consider sexually intact cattle 
imported into the United States to be equivalent to breeding cattle 
produced within the United States.) However, while the Uniform Methods 
and Rules for the bovine tuberculosis program specifies that individual 
tuberculosis tests must

[[Page 78494]]

take place at the premises of origin prior to interstate movement, we 
would require them at the port of entry or during post-arrival 
quarantine for imported sexually intact cattle. This discrepancy is 
because we need assurances that tuberculosis tests of sexually intact 
bovines are accurately administered and interpreted; among other 
reasons, the life spans of sexually intact animals tend to be 
significantly longer than those of steers and spayed heifers, which 
affords a significantly longer window of opportunity for infected 
animals to expose other animals in their herd to the pathogen. 
Standardized training regarding tuberculosis testing provides such 
assurances for sexually intact bovines moved interstate within the 
United States. Testing at the port of entry or during post-arrival 
quarantine of the bovines would provide such assurances for imported 
sexually intact bovines.
    Finally, we would exempt cattle less than 6 months of age from this 
testing requirement based on long-standing Agency policy regarding when 
a bovine from a foreign region becomes test-eligible for tuberculosis.
    Proposed paragraph (d)(3) of Sec.  93.439 would contain 
requirements for the importation of steers and spayed heifers that do 
not originate directly from a currently accredited herd for bovine 
tuberculosis. Such bovines could be imported into the United States 
from a Level II region for tuberculosis for purposes other than 
immediate slaughter, provided that:
     The steers or spayed heifers are officially identified; 
and
     The steers or spayed heifers are accompanied by a 
certificate, issued in accordance with Sec.  93.405, with an additional 
statement that the bovines are officially identified.
    These requirements correspond to the provisions in the Uniform 
Methods and Rules for the domestic bovine tuberculosis program for 
interstate movement of steers and spayed heifers from modified 
accredited advanced States and zones.
    Proposed paragraph (e) of Sec.  93.439 would contain conditions for 
the importation of bovines for purposes other than immediate slaughter 
from a Level III region for tuberculosis. Proposed paragraph (e)(1) of 
Sec.  93.439 would provide conditions for the importation of bovines 
directly from currently accredited herds for tuberculosis. Such bovines 
could be imported into the United States, provided that:
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    These requirements would be consistent with the conditions for 
interstate movement of cattle from a currently accredited herd in a 
modified accredited State or zone that are in the current Uniform 
Methods and Rules for the domestic bovine tuberculosis program.
    Proposed paragraph (e)(2) of Sec.  93.439 would provide conditions 
for the importation of sexually intact bovines that do not originate 
directly from a currently accredited herd for bovine tuberculosis. Such 
bovines could be imported into the United States from a Level III 
region for tuberculosis for purposes other than immediate slaughter, 
provided that:
     The bovines originate from a herd that was subjected to a 
whole herd test for tuberculosis on its premises of origin no more than 
1 year prior to export of the bovines to the United States, with 
negative results; and
     If the bovines are 2 months of age or older, the bovines 
are subjected to an additional individual test for tuberculosis on the 
premises of origin no more than 60 days prior to export of the bovines 
to the United States, with negative results, except that this test is 
not required if the bovines are exported within 60 days of the whole 
herd test and were included in that test; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
animals meet the conditions for importation in the section.
    These requirements would be consistent with the provisions for 
interstate movement of breeding cattle and bison from a modified 
accredited State or zone that are currently in the Uniform Methods and 
Rules for the domestic bovine tuberculosis program.
    Proposed paragraph (e)(3) of Sec.  93.439 would contain 
requirements for the importation of steers and spayed heifers that do 
not originate directly from a currently accredited herd for 
tuberculosis. Such bovines could be imported into the United States 
from a Level III region for tuberculosis for purposes other than 
immediate slaughter, provided that:
     If the steers or spayed heifers are 6 months of age or 
older, the steers or spayed heifers are subjected to an individual test 
for tuberculosis on the premises of origin no more than 60 days prior 
to export of the bovines to the United States, with negative results; 
and
     The steers or spayed heifers are officially identified; 
and
     The steers or spayed heifers are accompanied by a 
certificate, issued in accordance with Sec.  93.405, with an additional 
statement that the animals meet the conditions for importation in 
paragraph (e)(3) of Sec.  93.439.
    These requirements would be consistent with the conditions for 
interstate movement of steers and spayed heifers from a modified 
accredited State or zone that are currently in the Uniform Methods and 
Rules for the domestic bovine tuberculosis program.
    Proposed paragraph (f) of Sec.  93.439 would contain conditions for 
the importation of bovines for purposes other than immediate slaughter 
from a Level IV region for tuberculosis. Proposed paragraph (f)(1) of 
Sec.  93.439 would provide conditions for the importation of bovines 
directly from currently accredited herds for tuberculosis. Such bovines 
could be imported into the United States, provided that:
     The bovines are subjected to an individual test for 
tuberculosis at the port of entry into the United States or during 
post-arrival quarantine in accordance with Sec.  93.411, with negative 
results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    These requirements would be generally consistent with the 
requirements for interstate movement of cattle from a currently 
accredited herd in an accreditation preparatory State or zone that are 
currently in the Uniform Methods and Rules. However, while the Uniform 
Methods and Rules requires an individual tuberculosis test to take 
place on the premises of origin, we would require it to take place at 
the port of entry or during post-arrival quarantine. This would be in 
order to have assurances that the test was reliably administered and 
interpreted.
    Proposed paragraph (f)(2) of Sec.  93.439 would provide conditions 
for the importation of sexually intact bovines that do not originate 
directly from a currently accredited herd for bovine tuberculosis. Such 
bovines could be imported into the United States from a Level IV region 
for tuberculosis for purposes other than immediate slaughter, provided 
that:

[[Page 78495]]

     The bovines originate from a herd that was subjected to 
two whole herd tests for tuberculosis on its premises of origin 
conducted no less than 9 months and no more than 15 months apart, with 
the second test conducted no less than 60 days prior to the export of 
the bovines to the United States, with negative results; and
     If the bovines are 2 months of age or older, the bovines 
are subjected to an additional individual test for tuberculosis at the 
port of entry into the United State or during post-arrival quarantine 
in accordance with Sec.  93.411, with negative results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines meet the requirements in this paragraph.
    The testing requirements in part 77 for the interstate movement of 
sexually intact cattle and bison from non-accredited herds in 
accreditation preparatory States and zones require a herd test followed 
by two individual tuberculosis tests. However, the Uniform Methods and 
Rules for the bovine tuberculosis program currently limit the 
interstate movement of breeding cattle from accreditation preparatory 
States and zones to cattle that originate directly from currently 
accredited herds, and the herd testing protocol for accreditation in 
the Uniform Methods and Rules requires whole herd tests administered at 
no less than 9 and no more than 15 months apart, with negative test 
results. The Uniform Methods and Rules also specify that the cattle 
must be subsequently individually tested for tuberculosis prior to 
movement, with negative results. These proposed import requirements 
would be consistent with that testing protocol.
    Proposed paragraph (f)(3) of Sec.  93.439 would contain 
requirements for the importation of steers and spayed heifers that do 
not originate directly from a currently accredited herd for bovine 
tuberculosis. Such bovines could be imported into the United States 
from a Level IV region for tuberculosis for purposes other than 
immediate slaughter, provided that:
     The bovines originate from a herd that was subjected to a 
whole herd test for tuberculosis on its premises of origin no more than 
1 year prior to the export of the bovines to the United States, with 
negative results; and
     If the bovines are 2 months of age or older, the bovines 
are subjected to an additional individual test for tuberculosis on the 
premises of origin no more than 60 days prior to export of the bovines 
to the United States, with negative results, except that this 
additional test is not required if the bovines are exported within 60 
days of the whole herd test and were included in that test; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines meet the requirements in paragraph (f)(3) of Sec.  93.439.
    These proposed requirements would be consistent with the current 
conditions in the Uniform Methods and Rules for the interstate movement 
of steers and spayed heifers from an accreditation preparatory State or 
zone.
    Currently, the Uniform Methods and Rules for the bovine 
tuberculosis program prohibit the movement of cattle from a 
nonaccredited State or zone to an accredited free State or zone. If we 
were to apply this principle to the importation of bovines, based on 
the prevalence of bovine tuberculosis within the United States, the 
importation of cattle from Level V regions for tuberculosis would be 
prohibited. However, as the risk evaluation points out, there could be 
reasons why an importer would want to import cattle from such a region, 
such as in order to improve the genetic diversity of his or her 
domestic herd. We are therefore proposing the following requirements 
for the importation of bovines for any purpose from a Level V region 
for tuberculosis; these requirements would be contained in paragraph 
(g) of Sec.  93.439:
     APHIS and the importer have entered into a Cooperative and 
Trust Fund Agreement, and the importer has deposited funds with APHIS 
in an amount determined by APHIS to cover all costs incurred by APHIS 
in providing services in accordance with the Cooperative and Trust Fund 
Agreement; and
     The bovines originate from a herd that was subjected to 
two whole herd tests for tuberculosis on its premises of origin and 
conducted no less than 9 months and no more than 15 months apart, with 
at least the second whole herd test administered by an APHIS 
veterinarian and conducted no less than 60 days prior to export, with 
negative results; and
     The bovines are subjected to an additional individual test 
for tuberculosis at the port of entry into the United States or during 
post-arrival quarantine in accordance with Sec.  93.411, with negative 
results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines meet the requirements in paragraphs (g)(1), (g)(2), and (g)(4) 
of Sec.  93.439.
    We would require at least one of the whole herd tests to be 
administered by an APHIS veterinarian because foreign regions with a 
Level V classification for tuberculosis may either not have a control 
program for bovine tuberculosis, may have a control program for 
tuberculosis that APHIS has determined not to be equivalent to that 
within the United States, or may have a bovine tuberculosis prevalence 
rate that is an order of magnitude higher than that of the United 
States.
Brucellosis Status of Foreign Regions (Sec.  93.440)
    Proposed Sec.  93.440 would contain our classification system for 
the brucellosis status of foreign regions. There would be the three 
levels of classification.
    Proposed paragraph (a) of Sec.  93.440 would describe the higher 
classification, Level I. A Level I region for brucellosis would be a 
region that has a program that meets APHIS requirements for brucellosis 
classification in accordance with proposed Sec.  93.441, and a 
prevalence of brucellosis in their domestic bovine herds of less than 
0.001 percent over at least the previous two years (24 consecutive 
months). This prevalence threshold would correspond to the highest 
State classification level for brucellosis in the Uniform Methods and 
rules for that program, Class Free, which requires a zero prevalence 
rate for brucellosis within a State. However, as we do not believe that 
we can hold foreign regions to a standard for bovine tuberculosis 
prevalence that is more stringent than the actual prevalence of bovine 
tuberculosis within the United States, so we similarly believe that we 
cannot hold foreign regions to a higher standard for brucellosis than 
the actual prevalence of brucellosis within the United States.
    Proposed paragraph (b) of Sec.  93.440 would describe the second 
classification, Level II. A Level II region for brucellosis would be a 
region that has a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.  93.441, and that has a 
prevalence of brucellosis in their domestic bovine herds equal to or 
greater than 0.001 percent, but less than 0.01 percent, over the 
previous 2 years. This corresponds to the second highest State 
classification for brucellosis in the Uniform Methods

[[Page 78496]]

and Rules for the domestic brucellosis program, Class A.
    Proposed paragraph (c) of Sec.  93.440 would describe the third 
classification, Level III. A Level III region would be a region that 
has a program that does not meet APHIS requirements for brucellosis 
classification in accordance with Sec.  93.441, that has a herd 
prevalence equal to or greater than .01 percent, or that is unassessed 
by APHIS with regard to brucellosis prevalence. This would correspond 
to the third and lowest State classification for brucellosis in the 
Uniform Methods and Rules for the domestic brucellosis program, Class 
B.
    Proposed paragraph (d) of Sec.  93.440 would state that lists of 
all Level I, Level II, and Level III regions for brucellosis are found 
online, at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. It would further state that changes to the lists 
would be made in accordance with proposed Sec.  93.441.
    As we mentioned previously in this document, the general 
requirements for importation of bovines to address the risk of 
introducing and disseminating brucellosis within the United States 
currently exempt Australia and New Zealand from having to follow the 
requirements; this is because we have evaluated both Australia and New 
Zealand and determined them to be free of Brucella abortus. For that 
reason, if this rule is finalized, both Australia and New Zealand would 
be categorized as Level I regions for brucellosis.
Process for Requesting Regional Classification for Brucellosis (Sec.  
93.441)
    Proposed Sec.  93.441 would set forth the process by which a region 
could request a classification for brucellosis. This process would be 
very similar to the process described in proposed Sec.  93.438 for 
requesting a classification for bovine tuberculosis.
    Proposed paragraph (a) of Sec.  93.441 would state that a 
representative of the competent veterinary authority of any country or 
countries could request that APHIS classify for brucellosis. Requests 
for classification would have to be submitted to APHIS electronically 
or through the mail as provided at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance regarding how to 
complete a request in a manner that will allow APHIS to review it 
expeditiously would be available at https://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and could also be obtained by 
contacting APHIS in writing at the address listed in the regulations. 
At a minimum, in order for APHIS to consider the request complete, it 
would have to define the boundaries of the region, specify the 
prevalence level for brucellosis within the region, and demonstrate the 
following:
     That there is effective veterinary control and oversight 
within the region.
     That brucellosis is a notifiable disease within the 
region.
     That the region has a program for brucellosis in place 
that includes, at a minimum: Epidemiological investigations following 
the discovery of any infected animals or affected herds, or any animals 
or herds that have had non-negative test results following a test for 
brucellosis, and documentation of these investigations; management of 
affected herds in a manner designed to eradicate brucellosis from those 
herds, and documentation regarding this management; regulatory controls 
on the movement of livestock into, within, and from the region that 
correspond to the risk of dissemination of brucellosis associated with 
such movement; and access to, oversight of, and quality controls on 
diagnostic testing for brucellosis within the region.
     That the region has surveillance in place that is 
equivalent to or exceeds Federal standards for brucellosis surveillance 
within the United States.
     That, if the region vaccinates for brucellosis, it is in a 
manner that has been approved by APHIS.
    Like the proposed information requirements for a regional 
classification for tuberculosis, these requirements would be aimed at 
obtaining specific information from a foreign region sufficient to 
evaluate the regulatory program for brucellosis within the region.
    Proposed paragraph (b) of Sec.  93.441 would provide that, if we 
consider the request complete, APHIS would publish a notice in the 
Federal Register proposing to classify the region for brucellosis, and 
making available to the public the information upon which this proposed 
classification is based. The notice would request public comment.
    Proposed paragraph (c) of Sec.  93.441 would set out our process 
for notifying the public of our determination. If no comments are 
received on the initial notice, or if comments are received but do not 
affect our proposed classification, we would publish a subsequent 
notice in the Federal Register announcing the classification to be 
final and adding the region to the list of such regions on the 
Internet.
    If comments received on the initial notice suggest that the region 
be classified according to a different brucellosis classification, and 
we agree with the comments, we would publish a subsequent notice in the 
Federal Register making the information supplied by the commenters 
available to the public, and proposing to classify the region according 
to this different classification. This notice would also request public 
comment.
    Finally, if comments received on the notice suggest that 
insufficient information was supplied on which to base brucellosis 
classification, and we agree with the comments, we would publish a 
subsequent notice in the Federal Register specifying the additional 
information needed before we could classify the region.
    Proposed paragraph (d) would provide that, if a region is 
classified under the provisions of the section, that region may be 
required to submit additional information or allow APHIS to conduct 
additional information collection activities in order for that region 
to maintain its classification. It would also provide that if APHIS 
determines that a region's classification for brucellosis is no longer 
accurate, we will publish a notice in the Federal Register announcing 
that revised classification, as well as the reasons for it.
Importation of Ruminants From Certain Regions of the World; Brucellosis 
(Sec.  93.442)
    Proposed Sec.  93.442 would contain our revised requirements for 
the importation of bovines to address the risk that they could present 
of disseminating brucellosis within the United States.
    Proposed paragraph (a) of Sec.  93.442 would prohibit the 
importation of ruminants that are known to be infected with or exposed 
to brucellosis and ruminants that have had a non-negative response to 
any test for Brucella spp. Allowing the importation of known or 
potentially infected ruminants would not be in keeping with our 
responsibility under the AHPA to prevent the dissemination of 
brucellosis within the United States.
    Proposed paragraph (b) of Sec.  93.442 would provide that, unless 
specified otherwise by the Administrator, bovines could be imported 
into the United States from a Level I region for brucellosis without 
further restriction under the section. Paragraph (b) would contain a 
footnote, footnote 12 within the subpart, stipulating that the 
importation of such bovines would still be subject to all other 
relevant restrictions within 9 CFR.
    Proposed paragraph (c) of Sec.  93.442 would contain conditions for 
the importation of bovines for immediate slaughter from Level II or 
Level III regions. Such bovines could be

[[Page 78497]]

imported into the United States, provided that they are officially 
identified and accompanied by a certificate, issued in accordance with 
Sec.  93.405(a), with an additional statement that the bovines are 
officially identified.
    Proposed paragraph (d) of Sec.  93.442 would contain conditions for 
the importation of sexually intact bovines from a Level II region for 
brucellosis for purposes other than immediate slaughter. Proposed 
paragraph (d)(1) of Sec.  93.442 would contain conditions for the 
importation of bovines that originate directly from currently 
accredited herds for brucellosis. Such bovines could be imported into 
the United States from a Level II region for brucellosis, provided 
that:
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, in 
accordance with Sec.  93.405, with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for brucellosis.
    These requirements would consistent with the conditions for the 
interstate movement of cattle directly from currently certified 
brucellosis-free herds in Class A States that are contained in the 
current Uniform Methods and Rules for the domestic brucellosis program.
    Proposed paragraph (d)(2) of Sec.  93.442 would contain conditions 
for the importation of sexually intact bovines that do not originate 
directly from a currently accredited herd for brucellosis. Such bovines 
could be imported into the United States from a Level II region for 
brucellosis for purposes other than immediate slaughter, provided that:
     The bovines originate from a herd that was subjected to a 
whole herd test for brucellosis on its premises of origin no more than 
90 days and no less than 30 days prior to the export of the bovines to 
the United States, with negative results; and
     If the bovines are 6 months of age or older, the bovines 
are subjected to an additional individual test for brucellosis at the 
port of entry into the United States or during post-arrival quarantine 
in accordance with Sec.  93.411, with negative results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.406, with an additional statement that the 
bovines meet the relevant requirements in the paragraph.
    These requirements would be consistent with the conditions for the 
importation of breeding bovines from Mexico that are currently 
contained in part 93. We have evaluated those requirements and 
determined that they are appropriate mitigations, provided that a 
foreign region has a brucellosis prevalence of less than 0.01 percent.
    Proposed paragraph (d)(3) of Sec.  93.442 would contain provisions 
for the importation of steers and spayed heifers from Level II regions 
for brucellosis. Steers and spayed heifers could be imported to the 
United States from such regions, provided that:
     The steers or spayed heifers are officially identified; 
and
     The steers or spayed heifers are accompanied by a 
certificate, issued in accordance with Sec.  93.405, with an additional 
statement that the steers or spayed heifers are officially identified.
    We would not require the steers or spayed heifers to be tested for 
brucellosis because there is no evidence that steers or spayed heifers 
can transmit brucellosis. However, we would require them to be 
identified. In the event that a shipment of bovines destined to the 
United States is determined to contain infected animals, knowing the 
origin of each of the bovines in that shipment would facilitate a 
timely epidemiological investigation.
    Proposed paragraph (e) of Sec.  93.442 would contain conditions for 
the importation of cattle from Level III regions for brucellosis. 
Paragraph (e)(1) Sec.  93.442 would contain standards for the 
importation of bovines directly from currently accredited herds for 
brucellosis in a Level III region for brucellosis:
     If sexually intact, the bovines are subjected to an 
individual test for brucellosis at the port of entry into the United 
States or during post-arrival quarantine in accordance with Sec.  
93.411, with negative results; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for brucellosis.
    It is important to note that these cattle would have to come from 
herds that are accredited according to our standards for accreditation, 
as these are specified in an import protocol with the foreign region. 
In order for us to enter into such an import protocol with a Level III 
region for brucellosis, we would have to evaluate their veterinary 
infrastructure and determine it to be sufficient to have assurances 
that it can implement the standards that would be specified in the 
protocol document. It is therefore possible that the conditions in this 
paragraph will not be applicable for certain Level III regions for 
brucellosis.
    Proposed paragraph (e)(2) of Sec.  93.442 would contain conditions 
for the importation of sexually intact bovines from a Level III region 
for brucellosis for purposes other than immediate slaughter. Such 
bovines could be imported into the United States, provided that:
     The bovines originate from a herd that was subjected to 
two whole herd tests for brucellosis on its premises of origin, with 
the second test taking place no more than 90 days and no less than 30 
days prior to the export of the bovines to the United States, with 
negative results each time; and
     If the bovines are 6 months of age or older, the bovines 
are subjected to an additional individual test for brucellosis at the 
port of entry into the United States or during post-arrival quarantine 
in accordance with Sec.  93.411; and
     The bovines are officially identified; and
     The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405, with an additional statement that the 
bovines meet the relevant requirements of the paragraph.
    These requirements would be consistent with the conditions for the 
movement of breeding cattle from Class B States that are specified in 
the current Uniform Methods and Rules for the domestic brucellosis 
program.
    Proposed paragraph (e)(3) of Sec.  93.442 would set forth 
conditions for the importation of steers and spayed heifers from a 
Level III region for purposes other than immediate slaughter. Because 
there is no scientific evidence suggesting that they are a source of 
transmission of brucellosis, steers or spayed heifers would not have to 
be tested for the disease in order to be imported into the United 
States. They would, however, need to be officially identified and 
accompanied by a certificate, issued in accordance with Sec.  
93.405(a), with an additional statement that they are officially 
identified.
Existing General Requirements
    We would remove paragraphs (a), (c), and (d) of Sec.  93.406, which 
contain the existing brucellosis and bovine tuberculosis testing 
requirements for bovines imported from all countries other than Canada, 
Mexico, and Ireland.
Existing Country-Specific Requirements
    As we mentioned previously in this document, the regulations in 
part 93 that address the risk that bovines from Canada may present of 
disseminating

[[Page 78498]]

bovine tuberculosis or brucellosis within the United States are 
contained in Sec.  93.418. We are proposing to remove paragraphs (b) 
and (c) of Sec.  93.418, which contain the tuberculosis and brucellosis 
testing or certification requirements for such bovines.
    As we also mentioned previously in this document, Sec.  93.427 
contains regulations that address the risk that bovines from Mexico may 
present of disseminating bovine tuberculosis or brucellosis within the 
United States. We would remove paragraphs (c) and (d) of Sec.  93.427, 
which contain the bovine tuberculosis- and brucellosis-specific 
requirements for the importation of cattle from Mexico.
    We would, however, retain one of the existing provisions in 
paragraph (c)(1) of that section, which requires steers and spayed 
heifers that are not destined for immediate slaughter to be branded 
with an ``M'' or ``Mx'' bovine tuberculosis brand, by 
incorporating this provision into the general requirements for the 
importation of bovines from Mexico in paragraph (a) of the section. We 
are retaining this branding requirement because steers and spayed 
heifers from Mexico constitute a large portion of the total cattle 
imported into the United States, because tracing such animals using 
solely their official identification is commensurately harder, and 
because we believe it is therefore necessary to have additional 
identification of such animals regarding their country of origin in the 
unlikely event that steers or spayed heifers of Mexican origin that 
have been imported into the United States are determined to be infected 
with bovine tuberculosis.
    Section 93.424 requires an import permit to be issued for most 
ruminants that are imported into the United States from Mexico. 
Paragraph (b) of Sec.  93.424 requires, for most cattle imported from 
Mexico, an official record of brucellosis testing conducted pursuant to 
Sec.  93.427 to be presented at inspection at the port of entry. We are 
amending paragraph (b) to reflect the fact that Sec.  93.427 no longer 
has such testing requirements.
    Section 93.429 contains conditions for the importation of ruminants 
from Mexico for immediate slaughter. Since cattle imported from Mexico 
for immediate slaughter would now be subject to the relevant 
importation requirements in Sec. Sec.  93.439 and 93.442, we are 
removing references to cattle from Sec.  93.429.
    As we mentioned previously in this document, Sec.  93.432 contains 
conditions for the importation of cattle from Ireland. We are removing 
this section in its entirety.
    We are not proposing at this time to assign a tuberculosis or 
brucellosis classification to Canada, Mexico, or Ireland, or any 
portion of those countries. Rather, if this proposed rule is finalized, 
we would stagger the effective dates of various sections. Sections 
93.438 and 93.441, which contain the process by which to request a 
regional classification for brucellosis or bovine tuberculosis, and 
Sec. Sec.  93.437 and 93.442, which contain the classification systems 
themselves, would be effective before the importation requirements for 
bovines from regions with those classifications or the removal of the 
existing country-specific import requirements. Before the new 
importation requirements go into effect, we would evaluate the 
information that we currently have regarding Mexico, Canada, and 
Ireland, then gather any additional information that we would need in 
order to propose tuberculosis or brucellosis statuses for these 
countries, or portions thereof.
Definitions
    Section 93.400 contains definitions of terms used with the 
following sections of subpart D of part 93. We would amend this section 
by adding several definitions, removing several definitions, and 
modifying one definition.
    We would add definitions of the following terms: Accredited herd 
for brucellosis, accredited herd for tuberculosis, import protocol, 
individual test, non-negative test results, notifiable disease, spayed 
heifer, steer, tuberculosis, whole herd test for brucellosis, and whole 
herd test for tuberculosis.
    We would define import protocol as a document issued by APHIS and 
provided to officials of the competent veterinary authority of an 
exporting region that specifies in detail the mitigation measures that 
will comply with APHIS' regulations regarding the import of certain 
animals or commodities. We have long used such import protocols to 
assist exporting countries in complying with our regulations; in this 
manner import protocols serve an analogous function for exporting 
countries that the Program Standards document would serve for States 
and Tribes.
    On a related matter, we would define an accredited herd for 
tuberculosis as a herd that meets APHIS' standards for accreditation 
for tuberculosis status, and accredited herd for brucellosis as a herd 
that meets APHIS' standards for accreditation for brucellosis status. 
Both definitions would specify that standards for accreditation are 
specified in import protocols.
    We would define brucellosis as infection with or disease caused by 
Brucella abortus.
    We would define individual test as a test for brucellosis or 
tuberculosis that is approved by the Administrator and that is 
administered individually in accordance with part 93 to ruminants that 
are susceptible to brucellosis or tuberculosis. The definition would 
specify that, for purposes of part 93, testing of individual animals as 
part of a whole herd test does not constitute an individual test.
    We would define non-negative test results as any test results for 
tuberculosis or brucellosis within the suspect or positive range 
parameters of a pathogen assay that has been approved by the 
Administrator.
    We would define notifiable disease as a disease for which confirmed 
or suspected occurrences within a region must be reported to the 
competent veterinary authority or other competent authority of that 
region. This would be consistent with the meaning of the term 
notifiable disease as it is used within various OIE standards.
    We would define spayed heifer as a female bovine that has been 
neutered in a manner approved by the Administrator and specified in an 
import protocol. The definition would require the female bovine to be 
neutered in a specific manner because, on occasion, bovines that have 
been imported into the United States under the conditions reserved for 
spayed heifers have given birth.
    We would define steer as a sexually neutered male bovine.
    We would define tuberculosis as infection with or disease caused by 
Mycobacterium bovis.
    We would define whole herd test for brucellosis as a brucellosis 
test that has been approved by APHIS of all bovines in a herd of origin 
that are 6 months of age or older, and of all bovines in the herd of 
origin that are less than 6 months of age and were not born into the 
herd of origin, except those bovines that are less than 6 months of age 
and originate directly from a currently accredited herd for 
brucellosis.
    Likewise, whole herd test for tuberculosis would mean a 
tuberculosis test that has been approved by APHIS of all bovines in a 
herd of origin that are 6 months of age or older, and of all bovines in 
the herd of origin that are less than 6 months of age and were not born 
into the herd of origin, except those bovines that are less than 6 
months of age and originate directly

[[Page 78499]]

from a currently accredited herd for tuberculosis.
    The scope of these definitions would be generally consistent with 
the definition of test-eligible animal within proposed part 76. 
However, we would set the minimum age for whole herd testing for 
tuberculosis at 6 months, rather than 12, as it would be in part 76, 
because this reflects long-standing agency policy regarding the minimum 
testing age for tuberculosis for foreign regions with prevalence levels 
that are greater than our own.
    We would remove the definitions of brucellosis certified-free 
province or territory of Canada, official tuberculin test, 
tuberculosis-free herd, and whole herd test. These definitions would 
either no longer be found in part 93, or would be superseded by the 
definitions that we are proposing to add.
    Finally, the definition of herd of origin in Sec.  93.400 currently 
is written in a manner that conflates two distinct understandings of 
that term: The herd in which an animal was born, and any herd in which 
the animal was continually maintained for at least 4 months. Both of 
these understandings are correct, therefore we would retain them within 
the definition. We would, however, modify the definition to make it 
clearer that there are two distinct understandings of the term.
Miscellaneous Provisions
    Section 93.401 contains general prohibitions regarding the 
importation of ruminants. We have long required that a means of 
conveyance be cleaned and disinfected prior to use to transport a 
ruminant for importation; if it is not, we consider the means of 
conveyance to present an unknown risk of harboring diseases of 
ruminants, and prohibit the entry of animals into the United States in 
that means of conveyance. However, Sec.  93.401 does not currently 
contain that prohibition. We would amend the section to add it.
    Section 93.423 contains conditions for the importation of ruminants 
from Central America and the West Indies. As written, the section could 
be construed to exempt ruminants from those regions from the 
requirements in proposed Sec. Sec.  93.439 and 93.442. We would amend 
Sec.  93.423 accordingly.
    Finally, in reviewing part 93 during the preparation of this 
proposed rule, we noted an erroneous citation in Sec.  93.408. We would 
remove the citation.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis are available on the 
Regulations.gov Web site (see ADDRESSES above for instructions for 
accessing Regulations.gov) or by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT.
    Bovine tuberculosis and brucellosis are contagious diseases 
affecting cattle as well as other livestock species. Cooperative State-
Federal-Industry programs to eliminate bovine tuberculosis and 
brucellosis have been administered by APHIS, State animal health 
agencies, and U.S. livestock producers. The United States has made 
great strides in recent years toward eradication of brucellosis and 
bovine tuberculosis. As a result, occurrences of these diseases within 
the United States have become increasingly rare.
    However, in recent years, several factors have arisen that make 
changes to the programs necessary. These factors include the 
identification of reservoirs of brucellosis and bovine tuberculosis in 
wildlife populations in certain areas of the country, significant 
changes to the cattle industry within the United States, and the 
establishment of bison and captive cervid industries.
    This rule would consolidate the regulations governing bovine 
tuberculosis, and those governing brucellosis. Under these changes, 
States and/or Tribes would implement animal health plans that identify 
sources of the diseases within the State or Tribe and specify 
mitigations to address the risk posed by these 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 and/or brucellosis. 
Finally, the proposal would also revise the import requirements for 
cattle and bison that pertain to the risk the cattle or bison may 
present of transmitting bovine tuberculosis or brucellosis, to make 
these conditions clearer and assure that they more effectively mitigate 
the risk of introduction of the diseases into the United States.
    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. 
Additionally, 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, and where they do change they will 
affect very few producers or importers.
    Specific costs associated with this rule are discussed in the 
Executive Summary at the beginning of this document, under the heading 
``Costs and Benefits.''
    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. Under these 
circumstances, the APHIS Administrator has determined that this 
proposed rule, if promulgated, will not have a significant economic 
impact on a substantial number of small entities.

[[Page 78500]]

Executive Order 12988
    The provisions of this proposed rule concerning the importation of 
ruminants have been reviewed under Executive Order 12988, Civil Justice 
Reform. If this proposed rule is adopted: (1) All State and local laws 
and regulations that are inconsistent with those provisions will be 
preempted; (2) no retroactive effect will be given to the provisions; 
and (3) administrative proceedings will not be required before parties 
may file suit in court challenging the provisions.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2011-0044. Please send a copy of your comments to: (1) Docket No. 
APHIS-2011-0044, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and 
Independence Avenue SW., Washington, DC 20250. A comment to OMB is best 
assured of having its full effect if OMB receives it within 30 days of 
publication of this proposed rule.
    This rule would require States, and if they so choose, Tribes, to 
submit animal health plans to APHIS that identify sources of the 
diseases within the State or Tribal lands and specify mitigations to 
address the risk posed by these sources. It would also require States 
to submit certain reports.
    In certain instances, foreign governments could have to enter into 
trust fund agreements with APHIS so that cattle may be exported to the 
United States from their region as a result of this rule.
    Additionally, there may be instances in which producers would 
request alternate affected herd management protocols from those 
specified within the rule.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 163.45 hours per response.
    Respondents: States, Tribes, foreign governments, producers of 
cattle, bison, and captive cervids.
    Estimated annual number of respondents: 68.
    Estimated annual number of responses per respondent: 3.514.
    Estimated annual number of responses: 239.
    Estimated total annual burden on respondents: 39,063 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.
E-Government Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the EGovernment Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects

9 CFR Part 50

    Animal diseases, Bison, Cattle, Hogs, Indemnity payments, Reporting 
and recordkeeping requirements, Tuberculosis.

9 CFR Part 51

    Animal diseases, Cattle, Hogs, Indemnity payments, Reporting and 
recordkeeping requirements.

9 CFR Part 71

    Animal diseases, Cattle, Quarantine, Transportation.

9 CFR Part 76

    Bison, Bovine tuberculosis, Brucellosis, Captive cervids, Cattle, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 77

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

9 CFR Part 78

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

9 CFR Part 86

    Animal diseases, Bison, Cattle, Interstate movement, Livestock, 
Official identification, Reporting and recordkeeping requirements, 
Traceability.

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 161

    Reporting and recordkeeping requirements, Veterinarians.

    Accordingly, under the authority of 7 U.S.C. 8301 et seq., we 
propose to amend 9 CFR chapter I as follows:

PART 50--ANIMALS DESTROYED BECAUSE OF TUBERCULOSIS

0
1. The authority citation for part 50 continues to read as follows:

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

0
2. Section 50.1 is amended as follows:
0
a. By revising the definitions for Administrator, APHIS representative, 
approved herd plan, destroyed, and herd depopulation.
0
b. By adding, in alphabetical order, a definition for publicly owned.
0
c. By revising the definitions for quarantined feedlot, reactor cattle, 
bison, and captive cervids, State, State animal health official, and 
State representative.
    The addition and revisions read as follows:

[[Page 78501]]

Sec.  50.1  Definitions.

* * * * *
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
* * * * *
    APHIS representative. An individual employed by APHIS who is 
authorized to perform that function involved.
    Approved herd plan. 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 tuberculosis 
within the herd. The herd plan must be approved by the State or Tribal 
animal health official and the Administrator.
* * * * *
    Destroyed. Condemned under State authority and either destroyed by 
slaughter or otherwise euthanized.
* * * * *
    Herd depopulation. Destruction of animals within a herd at a 
location, in a manner, and within a timeframe as specified within an 
approved herd plan.
* * * * *
    Publicly owned. Owned by the Federal government, a State or Tribe, 
or any regional or local community.
    Quarantined feedlot. A facility that is approved by APHIS and/or a 
State or Tribal animal health official as meeting the standards for 
such feedlots as these are specified by the Administrator, and that 
accordingly is authorized to assemble and feed reactor, suspect, or 
exposed program animals prior to their movement to a recognized 
slaughtering establishment, another quarantine feedlot, or a quarantine 
pen.
    Reactor cattle, bison, and captive cervids. Cattle, bison, or 
captive cervids that, for tuberculosis, fall within the scope of the 
definition of reactor, as this is set forth in Sec.  76.0 of this 
chapter.
* * * * *
    State. Any of the States, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern 
Mariana Islands, the U.S. Virgin Islands, or any territory or 
possession of the United States.
    State animal health official. The State official responsible for 
livestock and poultry disease control and eradication programs in a 
State.
    State representative. An individual employed in animal health work 
by a State or a political subdivision of a State and authorized by that 
State to perform the function involved.
* * * * *
0
3. In Sec.  50.3, paragraph (c) is added to read as follows:


Sec.  50.3  Payment to owners for animals destroyed.

* * * * *
    (c) The Department will not pay indemnity for publicly owned 
cattle, bison, or captive cervids.
0
4. In Sec.  50.4, paragraphs (b) and (c) are revised to read as 
follows:


Sec.  50.4  Classification of cattle, bison, captive cervids, and other 
livestock as infected, exposed, or suspect.

* * * * *
    (b) Cattle, bison, and captive cervids are considered to be exposed 
to tuberculosis when, for tuberculosis, they fall within the scope of 
the definition of exposed, as this is set forth in Sec.  76.0 of this 
chapter.
    (c) Cattle, bison, and captive cervids are considered to be 
suspects for tuberculosis when, for tuberculosis, they fall within the 
scope of the definition of suspect, as this is set forth in Sec.  76.0 
of this chapter.
* * * * *


Sec.  50.14  [Amended]

0
5. Section 50.14 is amended as follows:
0
a. In paragraph (e)(1), by removing the citation ``Sec.  77.1'' and 
adding the citation ``Sec.  76.0'' in its place.
0
b. In paragraphs (e)(2)(i) and (e)(2)(ii), by removing the words ``an 
official tuberculin test, as defined in Sec.  77.1'' and adding the 
words ``an official test, as defined in Sec.  76.0'' in their place.
0
c. By removing and reserving paragraph (f).

PART 51--ANIMALS DESTROYED BECAUSE OF BRUCELLOSIS

0
6. The authority citation for part 51 continues to read as follows:

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

0
7. Section 51.1 is amended as follows:
0
a. By revising the definitions for Administrator, brucellosis exposed 
animal, and brucellosis reactor animal.
0
b. By removing the definition of complete herd test.
0
c. By revising the definitions for destroyed and herd depopulation.
0
d. By adding, in alphabetical order, a definition for herd plan.
0
e. By revising the definition of official seal.
0
f. By adding, in alphabetical order, the definition for publicly owned.
0
g. By revising the definitions for State, State animal health official, 
and State representative.
0
h. By removing the definition of unofficial vaccinate.
    The additions and revisions read as follows:


Sec.  51.1  Definitions.

* * * * *
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
* * * * *
    Brucellosis exposed animal. An animal that, for brucellosis, falls 
within the scope of the definition of exposed, as this is set forth in 
Sec.  76.0 of this chapter.
    Brucellosis reactor animal. An animal that, for brucellosis, falls 
within the scope of the definition of reactor, as this is set forth in 
Sec.  76.0 of this chapter.
* * * * *
    Destroyed. Condemned under State authority and either destroyed by 
slaughter or otherwise euthanized.
* * * * *
    Herd depopulation. Destruction of animals within a herd at a 
location, in a manner, and within a timeframe as specified within a 
herd plan.
* * * * *
    Herd plan. 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 brucellosis within the 
herd. The herd plan must be approved by the State animal health 
official and the Administrator.
* * * * *
    Official seal. 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.
* * * * *
    Publicly owned. Owned by the Federal Government, a State or Tribe, 
or any regional or local community.
* * * * *
    State. Any of the States, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern 
Mariana Islands, the U.S. Virgin Islands, or any territory or 
possession of the United States.
    State animal health official. The State official responsible for 
livestock and poultry disease control and eradication programs in a 
State.
    State representative. An individual employed in animal health work 
by a State or a political subdivision of a State and authorized by that 
State to perform the function involved.
* * * * *
0
8. In Sec.  51.3, paragraphs (a)(1) introductory text and (a)(1)(i) are 
revised to read as follows:

[[Page 78502]]

Sec.  51.3  Payment to owners for animals destroyed.

    (a) * * *
    (1) Owners of the following types of animals destroyed because of 
brucellosis are eligible to receive Federal indemnity for their 
animals; except that, indemnity will not be paid for the animals if 
they are publicly owned.
    (i) Cattle and bison classified as reactors for brucellosis;
* * * * *


Sec.  51.4  [Amended]

0
9. Section 51.4 is amended by removing the words ``, including the 
reactor tag number of each brucellosis reactor animals and the 
registration name and number of each brucellosis reactor registered 
animal''.


Sec.  51.5  [Amended]

0
10. In Sec.  51.5, paragraph (b) is removed and reserved.


Sec.  51.9  [Amended]

0
11. Section 51.9 is amended as follows:
0
a. In paragraph (b), by removing the citation ``Sec.  78.1'' and adding 
the citation ``Sec.  76.0'' in its place.
0
b. In paragraph (i)(2), by removing the words ``(as defined in Sec.  
78.1 of this chapter)''.


Sec.  51.20  [Amended]

0
12. In Sec.  51.20, in the definition of brucellosis reactor animal, 
paragraph (3) is amended by removing the words ``as provided in the 
definition of official test in Sec.  78.1 of this chapter'' and adding 
the words ``by APHIS'' in their place.

PART 71--GENERAL PROVISIONS

0
13. The authority citation for part 71 continues to read as follows:

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

0
14. Section 71.1 is amended by revising the definitions of 
Administrator, APHIS representative, interstate commerce, State, State 
animal health official, and State representative to read as follows:


Sec.  71.1  Definitions.

* * * * *
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
* * * * *
    APHIS representative. An individual employed by APHIS who is 
authorized to perform that function involved.
* * * * *
    Interstate commerce. Trade, traffic, or other commerce in animals 
between a place in a State and a place in another State or between 
places in the same State but through any place outside that State; or 
trade, traffic, or other commerce in animals within the District of 
Columbia or any territory or possession of the United States.
* * * * *
    State. Any of the States, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern 
Mariana Islands, the U.S. Virgin Islands, or any territory or 
possession of the United States.
    State animal health official. The State official responsible for 
livestock and poultry disease control and eradication programs in a 
State.
    State representative. An individual employed in animal health work 
by a State or a political subdivision of a State and authorized by that 
State to perform the function involved.
* * * * *


Sec.  71.3  [Amended]

0
15. Section 71.3 is amended as follows:
0
a. In paragraph (c)(1), by removing the words ``part 78'' and adding 
the words ``part 76'' in their place.
0
b. In paragraph (c)(3), by removing the words ``the tuberculin test'' 
and adding the words ``an official test for tuberculosis'' in their 
place, and by removing the words ``the provisions of Sec.  77.17'' and 
adding the words ``part 76'' in their place.


Sec.  71.20  [Amended]

0
16. Section 71.20 is amended as follows:
0
a. In paragraph (a)(3), by removing the words ``9 CFR parts 71, 75, 78, 
79, and 85'' and adding the words ``9 CFR parts 71, 75, 76, 79, and 
85'' in their place.
0
b. In paragraph (a)(6), by removing the words ``9 CFR parts 71, 75, 78, 
79, and 85'' and adding the words ``9 CFR parts 71, 75, 76, 79, and 
85'' in their place.
0
c. In paragraph (a)(8), by removing the words ``9 CFR parts 71, 75, 78, 
79, 85, and 86'' and adding the words ``9 CFR parts 71, 75, 76, 79, 85, 
and 86'' in their place.
0
d. In paragraph (a)(14)(i), by removing the words ``parts 71 and 78'' 
and adding the words ``parts 71 and 76'' in their place.
0
e. In paragraphs (a)(14)(ii),(iii), and (iv), by removing the words 
``part 78'' each time they appear, and adding the words ``part 76'' in 
their place.
0
f. By removing and reserving paragraphs (a)(14)(v) through (a)(14)(ix).
0
g. In paragraph (a)(18), by removing the words ``9 CFR parts 71, 75, 
78, 79, and 85'' each time they appear, and adding the words ``9 CFR 
parts 71, 75, 76, 79, 85, and 86'' in their place.
0
17. Part 76 is added to subchapter C to read as follows:

PART 76--BRUCELLOSIS AND BOVINE TUBERCULOSIS

Sec.
76.0 Definitions.
76.1 Authority of the Administrator.
76.2 Animal health plan requirements.
76.3 State or Tribal classifications.
76.4 Reporting requirements.
76.5 Recognized management areas.
76.6 Surveillance requirements.
76.7 Epidemiological investigations and affected herd management.
Subpart A--General Categories of Livestock
76.8 Interstate movement of infected livestock generally prohibited.
76.9 Interstate movement of program animals from a herd containing a 
reactor or suspect.
76.10 Interstate movement of reactor, suspect, and exposed program 
animals.
Subpart B--Cattle and Bison
76.11 Interstate movement of cattle and bison generally restricted.
76.12 Interstate movement of cattle and bison from consistent States 
or Tribes for brucellosis and bovine tuberculosis.
76.13 Interstate movement of cattle and bison from a provisionally 
consistent State or Tribe.
76.14 Interstate movement of cattle and bison from inconsistent 
States or Tribes for brucellosis.
76.15 Interstate movement of cattle and bison from inconsistent 
States or Tribes for bovine tuberculosis.
Subpart C--Interstate Movement of Captive Cervids
76.16 Interstate movement of captive cervids.
76.17 Official tests for brucellosis and bovine tuberculosis, 
official testing laboratories, and official testers.

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


Sec.  76.0  Definitions.

    The following definitions apply to this part:
    Accredited herd for bovine tuberculosis. 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. APHIS' standards for 
accreditation are described in the Program Standards document. States 
may submit an alternate accreditation standard to the Administrator for 
evaluation and approval by sending a written request to the address 
provided in the Program Standards document.

[[Page 78503]]

This standard must be at least equally stringent to that within the 
Program Standards document.
    Accredited herd for brucellosis. 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. APHIS' standards for accreditation are described 
in the Program Standards document. States may submit an alternate 
accreditation standard to the Administrator for evaluation and approval 
by sending a written request to the address provided in the Program 
Standards document. This standard must be at least equally stringent to 
that within the Program Standards document.
    Accredited veterinarian. A veterinarian approved by the 
Administrator in accordance with the provisions of part 161 of this 
title to perform functions specified in parts 1, 2, 3, and 11 of this 
chapter, and to perform functions required by cooperative State-Federal 
disease control and eradication programs.
    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Affected herd management plan. 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 affected 
herd management plan must be approved by a State or Tribal animal 
health official and the Administrator.
    Animal identification number (AIN). A numbering system for the 
official identification of individual animals in the United States that 
provides a nationally unique identification number for each animal. The 
AIN consists of 15 digits, with the first 3 being the country code (840 
for the United States or a unique country code for any U.S. territory 
that has such a code and elects to use it in place of the 840 code). 
The alpha characters USA or the numeric code assigned to the 
manufacturer of the identification device by the International 
Committee on Animal Recording may be used as an alternative to the 840 
or other prefix representing a U.S. territory; however, only the AIN 
beginning with the 840 or other prefix representing a U.S. territory 
will be recognized as official for use on AIN tags applied to animals 
on or after March 11, 2015. The AIN beginning with the 840 prefix may 
not be applied to animals known to have been born outside the United 
States.
    Annual report form. The annual report form authorized by the 
Administrator for State and Tribal use to fulfill the requirements of 
this part. The report form is located on the Web at [address to be 
added in final rule].
    APHIS. The Animal and Plant Health Inspection Service of the United 
States Department of Agriculture.
    APHIS representative. An individual employed by APHIS who is 
authorized to perform the function involved.
    Bison. Domestically produced or captive bison.
    Bovine tuberculosis. The contagious, infectious, and communicable 
disease caused by Mycobacterium bovis. It is also referred to as 
tuberculosis.
    Brucellosis. The contagious, infectious, and communicable disease 
caused by Brucella abortus. It is also known as Bangs disease, undulant 
fever, and contagious abortion.
    Calf raiser. 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.
    Captive cervid. All species of deer, elk, moose, and all other 
members of the family Cervidae raised or maintained in captivity for 
the production of meat and other agricultural products, for sport, or 
for exhibition, including time such animals are moved interstate; or 
any wild cervid that is moved interstate, during the period of time 
from capture until release into the wild. A captive cervid that escapes 
continues to be considered a captive cervid as long as it bears an 
official eartag or other official identification approved by the 
Administrator as unique and traceable with which to trace the animal 
back to its herd of origin.
    Depopulate. 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.
    Epidemiologist designated by the District Director. An 
epidemiologist selected by the APHIS District Director, in consultation 
with State or Tribal animal health officials, to perform the function 
required.
    Exposed. 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.
    Feedlot. A facility for assembling and feeding program animals.
    Herd. 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.
    Herd test.
    (1) For brucellosis:
    (i) 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.
    (ii) 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.
    (iii) 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.
    (2) For bovine tuberculosis:
    (i) 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.
    (ii) 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

[[Page 78504]]

those animals that are less than 12 months of age and originate 
directly from a currently accredited herd for bovine tuberculosis.
    (iii) 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.
    Immediate slaughter. Consignment directly to a recognized 
slaughtering establishment.
    Interstate certificate of veterinary inspection (ICVI). An official 
document issued by a Federal, State, Tribal, or accredited veterinarian 
certifying the inspection of animals in preparation for interstate 
movement.
    (1) The ICVI must show the species of animals covered by the ICVI; 
the number of animals covered by the ICVI; the purpose for which the 
animals are to be moved; the address at which the animals were loaded 
for interstate movement; the address to which the animals are destined; 
and the names of the consignor and the consignee and their addresses if 
different from the address at which the animals were loaded or the 
address to which the animals are destined. Additionally, the ICVI must 
list the official identification number of each animal or group of 
animals moved that is required to be officially identified, or, if an 
alternative form of identification has been agreed upon by the sending 
and receiving States or Tribes, the ICVI must include a record of that 
identification. If the animals are not required by the regulations to 
be officially identified, the ICVI must state the exemption that 
applies (e.g., the cattle and bison belong to one of the classes of 
cattle and bison exempted under Sec.  86.4 of this chapter from the 
official identification requirements of 9 CFR part 86 during the 
initial stage of the phase-in of those requirements). If the animals 
are required to be officially identified but the identification number 
does not have to be recorded on the ICVI, the ICVI must state that all 
animals to be moved under the ICVI are officially identified. An ICVI 
may not be issued for any animal that is not officially identified if 
official identification is required.
    (2) As an alternative to an ICVI, another document may be used to 
provide this information, but only under the following conditions:
    (i) The document is agreed upon by the shipping and receiving 
States or Tribes as an acceptable alternative to an ICVI; and
    (ii) The document is a State or Tribal form or APHIS form that 
requires individual identification of animals; and
    (iii) 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; and
    (iv) 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:
    (A) The name of the document; and
    (B) 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.
    (v) A copy of the document accompanies the program animals during 
interstate movement.
    Livestock. All farm-raised animals.
    Location-based numbering system. The location-based number system 
combines a State or Tribal issued location identification (LID) number 
or a premises identification number (PIN) with a producer's unique 
livestock production numbering system to provide a nationally unique 
and herd-unique identification number for an animal.
    Location identification (LID) number. A nationally unique number 
issued by a State, Tribal, and/or Federal animal health authority to a 
location as determined by the State or Tribe in which it is issued. The 
LID number may be used in conjunction with a producer's own unique 
livestock production numbering system to provide a nationally unique 
and herd-unique identification number for an animal.
    Management area. 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.
    National Uniform Eartagging System (NUES). A numbering system for 
the official identification of individual animals in the United States 
that provides a nationally unique identification number for each 
animal.
    Official Brucella vaccine. A vaccine for brucellosis that has been 
approved by the Administrator and produced under license of the United 
States Department of Agriculture.
    Official brucellosis vaccination program. A brucellosis vaccination 
program that consists of, at a minimum:
    (1) Vaccination of program animals with an official Brucella 
vaccine.
    (2) Tattooing to specify the animals' vaccination status.
    (3) Identification of the animals with an official eartag designed 
to specify the animals' vaccination status.
    Official eartag. An identification tag approved by APHIS that bears 
an official identification number for individual animals. Beginning 
March 11, 2014, all official eartags manufactured must bear an official 
eartag shield. Beginning March 11, 2015, all official eartags applied 
to animals must bear an official eartag shield. The design, size, 
shape, color, and other characteristics of the official eartag will 
depend on the needs of the users, subject to the approval of the 
Administrator. The official eartag must be tamper-evident and have a 
high retention rate in the animal.
    Official eartag shield. The shield[hyphen]shaped graphic of the 
U.S. Route Shield with ``U.S.'' or the State postal abbreviation or 
Tribal alpha code imprinted within the shield.
    Official identification number. A nationally unique number that is 
permanently associated with an animal or group of animals and that 
adheres to one of the following systems:
    (1) National Uniform Eartagging System (NUES).
    (2) Animal identification number (AIN).
    (3) Flock-based number system.
    (4) Location-based numbering system.
    (5) Any other numbering system approved by the Administrator for 
the official identification of animals.
    Officially identified.
    (1) For cattle and bison: Identified by means of an official 
eartag.
    (2) For captive cervids: Identified by means of 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.
    Official seal. 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.
    Official test. Any test that is approved by the Administrator for 
determining the presence or absence of brucellosis or

[[Page 78505]]

bovine tuberculosis in program animals and that is conducted and 
reported by an official tester. If an official test is applied to a 
program animal, it must be identified by means of an official eartag. 
If this eartag uses the NUES system, the eartag must indicate the State 
or Tribe in which it was applied; if the AIN system, the identification 
number of the premises on which it was applied. If an animal that is 
tested already has such an eartag, the information on this eartag must 
be recorded by the tester.
    Official tester. 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.
    Official testing laboratory. A laboratory approved by the 
Administrator in accordance with part 76 of this chapter to conduct 
official tests.
    Owner. Any person who has legal or rightful title to program 
animals whether or not the animals are subject to a mortgage.
    Permit for movement of restricted animals. 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.
    Premises identification number (PIN). A nationally unique number 
assigned by a State, Tribal, and/or Federal animal health authority to 
a premises that is, in the judgment of the State, Tribal, and/or 
Federal animal health authority, a geographically distinct location 
from other premises. The PIN may be used in conjunction with a 
producer's own livestock production numbering system to provide a 
nationally unique and herd-unique identification number for an animal.
    Program animals. Cattle, bison, and captive cervids.
    Program Standards document. A document providing guidance related 
to the regulations contained in this part. The Program Standards 
document is available on the Internet at https://www.aphis.usda.gov/animal_health/animal_dis_spec/cattle, or at district VS offices, the 
addresses for which are located in local telephone directories. 
Substantive changes to the Program Standards document are announced 
through notices published in the Federal Register. These notices 
request public comment on the changes.
    Qualified accredited veterinarian. An accredited veterinarian who 
has been granted a program certification by the Administrator pursuant 
to Sec.  161.5 of this chapter based on completion of an APHIS-approved 
orientation or training program.
    Quarantine feedlot. 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. Program 
animals may only be moved interstate from a quarantine feedlot if their 
movement is to a recognized slaughtering establishment, another 
quarantine feedlot, or a quarantine pen.
    Quarantine pen. 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. 
Program animals may only be moved interstate from a quarantine feedlot 
if their movement is to a recognized slaughtering establishment, 
another quarantine pen, or a quarantine feedlot.
    Reactor.
    (1) 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.
    (2) 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.
    Recognized slaughtering establishment. Any slaughtering facility 
operating under the Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or 
State meat or poultry inspection acts that is approved in accordance 
with 9 CFR 71.21.
    Reporting period. October 1 of one year through September 30 of the 
following year.
    Responsible person. 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 this 
part.
    Spayed heifers. Sexually neutered female cattle or bison.
    Specifically approved stockyard. Premises where program animals are 
assembled for sale purposes and which meet the standards set forth in 
Sec.  71.20 of this subchapter and are approved by APHIS.
    State. Any of the States, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern 
Mariana Islands, the U.S. Virgin Islands, or any territory or 
possession of the United States.
    State or Tribal animal health official. The State or Tribal 
official responsible for livestock and poultry disease control and 
eradication programs in a State or Tribe.
    State or Tribal representative. An individual employed in animal 
health work by a State or Tribe, or a political subdivision of a State 
or Tribe, and authorized by that State or Tribe to perform the function 
involved.
    Steers. Sexually neutered male cattle or bison.
    Suspect. 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.
    Test-eligible animal. Unless the Administrator specifies or 
approves an alternate testing age, test-eligible animal means:
    (1) 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.
    (2) 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.
    Tribe. 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.], that is 
recognized as eligible for the special

[[Page 78506]]

programs and services provided by the United States to Indians because 
of their status as Indians.
    United States. All of the States.


Sec.  76.1  Authority of the Administrator.

    Notwithstanding the provisions of this part, the Administrator is 
authorized pursuant to the Animal Health Protection Act (7 U.S.C. 8301 
et seq.) 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. Moreover, 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.


Sec.  76.2  Animal health plan requirements.

    (a) In order to be considered a consistent or provisionally 
consistent State or Tribe, a State or Tribe must submit an animal 
health plan to APHIS via the mail as provided within the Program 
Standards document, or submit the plan electronically as specified 
within the Program Standards document. At a minimum, in order to be 
considered complete, each animal health plan must contain the following 
categories of information:
    (1) Confirmation that the State or Tribe has a legal and regulatory 
basis for the activities and measures specified within the animal 
health plan.
    (2) A description of the organization and infrastructure of the 
animal health and wildlife authorities within the State or Tribe. The 
description must 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 must demonstrate that the State or Tribe has 
sufficient resources to implement, maintain, and enforce its animal 
health plan.
    (3) 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 has designated to oversee 
implementation, performance, and enforcement of wildlife activities and 
measures carried out under the plan. States or Tribes may designate a 
single individual to serve in multiple roles.
    (4) A description of program animal demographics within the State 
or Tribal lands. The description must include:
    (i) The approximate number and types of program animal herds within 
the State or Tribal lands, and the approximate number of animals in 
those herds; and
    (ii) The approximate number and geographic distribution of any 
animal concentration points within the State or Tribal lands.
    (5) 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.\1\
---------------------------------------------------------------------------

    \1\ Minimum requirements for surveillance activities conducted 
under an animal health plan are set forth in Sec.  76.6.
---------------------------------------------------------------------------

    (6) 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. The 
description must include:
    (i) 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; and
    (ii) 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; and
    (iii) The potential for exposure of program animals within the 
State or Tribal lands to these known source populations; and
    (iv) Factors, other than mitigation measures that are or would be 
implemented by the State or Tribe, that may influence this potential 
for exposure; and
    (v) 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.
    (7) 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 mitigate the risk that program animals within the 
State or Tribal lands will become infected with brucellosis or bovine 
tuberculosis.
    (8) 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.\2\
---------------------------------------------------------------------------

    \2\ Minimum requirements for epidemiological investigation and 
affected herd management activities conducted under an animal health 
plan are set forth in Sec.  76.7.
---------------------------------------------------------------------------

    (b) Review. APHIS will review the plan submitted by the State or 
Tribe for completeness. When APHIS determines that the plan is 
complete, it will conduct review and evaluation of the plan. This may 
include sharing a copy of the plan with persons for technical review 
and comment. If, based on its review, APHIS determines not to propose 
to approve the plan, APHIS will contact the State or Tribe that 
submitted the plan and set forth the deficiencies identified in the 
plan that preclude APHIS from proposing to approve the plan.
    (c) Proposal of approval; public notification. Based on its review, 
APHIS may 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. In either 
instance, APHIS will publish a notice in the Federal Register 
announcing proposed approval of the plan and making the plan available 
for public review and comment. Prior to issuance of this notice, APHIS 
will ensure that the State or Tribe is prepared for APHIS to make the 
plan, proposed amendments to the plan, and all reports required by this 
part publicly available.
    (d) APHIS determination--(1) Following a notice proposing 
unconditional approval of an animal health plan. (i) If no comments are 
received on the notice, or if the comments received do not affect 
APHIS' conclusion that the plan may be approved unconditionally, APHIS 
will publish a subsequent notice in the Federal Register announcing 
that the plan has been approved

[[Page 78507]]

unconditionally, and designating the State or Tribe as a consistent 
State or Tribe.
    (ii) If the comments received on the notice suggest that 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, APHIS agrees, APHIS 
will 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. The notice 
will also specify the provisions of the plan that APHIS has determined 
cannot be implemented immediately and the time period in which they 
must be implemented. The notice may 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.
    (iii) If the comments received suggest that the plan should not be 
approved, and, after reviewing the information, APHIS agrees, APHIS 
will publish a subsequent notice in the Federal Register describing the 
comments that it received, its reevaluation of the plan in light of 
those comments, and its reasons why it cannot approve the plan.
    (2) Following a notice proposing conditional approval of an animal 
health plan. (i) If no comments are received on the notice, or if the 
comments received do not affect APHIS' 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, APHIS will 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. The notice will also specify 
the provisions of the plan that APHIS has determined cannot be 
implemented immediately and the time period in which they must be 
implemented. The notice may 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.
    (ii) If the comments received suggest that the plan should not be 
approved, and, after reviewing the information, APHIS agrees, APHIS 
will publish a subsequent notice in the Federal Register describing the 
comments that it received, its reevaluation of the plan in light of 
those comments, and its reasons why it cannot approve the plan.
    (e) Subsequent notification regarding conditionally approved plans. 
If APHIS approves a State or Tribal animal health plan 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, APHIS will publish a subsequent notice in the 
Federal Register announcing whether the State or Tribe has implemented 
all provisions of its plan within that period of time.
    (1) If the State or Tribe has implemented the provisions, the 
notice will also announce that APHIS now considers the plan 
unconditionally approved, and has redesignated the State or Tribe as a 
consistent State or Tribe.
    (2) If the State or Tribe has not implemented all the provisions, 
the notice will also announce that APHIS has withdrawn approval of the 
plan, and has redesignated the State or Tribe as an inconsistent State 
or Tribe.
    (f) Amendments--(1) Amendments initiated by APHIS. 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, APHIS will make ongoing approval of 
the plan contingent on the State or Tribe amending the plan in a manner 
that APHIS approves of. The amended plan must be submitted to APHIS via 
the mail as provided within the Program Standards document, or 
electronically as provided within the Programs Standards document.
    (2) Amendments initiated by a State or Tribe. If a State or Tribe 
wishes to amend its animal health plan, the State or Tribe must submit 
proposed amendments to the plan to APHIS via the mail as provided 
within the Program Standards document, or submit the proposed 
amendments electronically as provided within the Programs Standards 
document. Amendments will be subject to the review process specified in 
paragraphs (b) through (d) of this section.
    (g) Compliance reviews. APHIS reserves the right to conduct a 
review of States or Tribes at any point for compliance with their 
approved animal health plan. Such a compliance review may include site 
visits and/or documentation review.


Sec.  76.3  State or Tribal classifications.

    (a) Each State within the United States is classified according to 
one of the classifications for brucellosis and bovine tuberculosis 
listed below. Tribes will be classified according to these 
classifications, provided that they have submitted a Tribal animal 
health plan to APHIS for review and approval in accordance with the 
process set forth in Sec.  76.2, and APHIS has approved the animal 
health plan. A State or Tribal classification for brucellosis and 
bovine tuberculosis may differ.
    (1) Consistent.
    (2) Provisionally consistent.
    (3) Inconsistent.
    (b) Initial designation of status--(1) Consistent. APHIS will 
initially designate a State or Tribe as a consistent State or Tribe if 
APHIS approves the State's or Tribe's animal health plan 
unconditionally, in accordance with the process set forth in Sec.  
76.2.
    (2) Provisionally consistent. APHIS will initially designate a 
State or Tribe as a provisionally consistent State or Tribe if APHIS 
approves the State or Tribe's animal health plan on the condition that 
it implement certain provisions of its plan within a specified period 
of time that it cannot implement immediately upon approval of the plan, 
in accordance with the process set forth in Sec.  76.2.
    (3) Inconsistent--(i) States. If a State does not have an animal 
health plan that has been approved by APHIS by [Date of publication of 
notice in the Federal Register], the State will be considered an 
inconsistent State.
    (ii) Tribes. Tribes will not initially be designated as 
inconsistent.
    (c) Conditions for redesignation to a lower classification--(1) 
From consistent to provisionally consistent. If any of the following 
occurs, APHIS may redesignate a consistent State or Tribe as a 
provisionally consistent State or Tribe:
    (i) The State or Tribe fails to implement or perform an activity or 
maintain a measure specified within its animal health plan, and APHIS 
has determined that this failure may result in the spread of 
brucellosis or bovine tuberculosis.
    (ii) The State or Tribe fails to submit an annual report as 
specified in Sec.  76.4(a).
    (iii) The State or Tribe fails to submit an initial epidemiological 
investigation situation report within 14 days of the period of time 
specified in Sec.  76.4(c) for submitting such a report.
    (iv) The State or Tribe fails to submit an updated epidemiological 
investigation situation report as specified in Sec.  76.4(d).
    (v) On more than one occasion, the State or Tribe fails to submit a 
closing report as specified in Sec.  76.4(e).
    (vi) The State or Tribe fails to meet national surveillance levels 
as these are specified within the National

[[Page 78508]]

Surveillance Plans for brucellosis or bovine tuberculosis or as these 
are specified within an alternate State or Tribal plan that has been 
approved by APHIS.\3\
---------------------------------------------------------------------------

    \3\ See Sec.  76.6(a).
---------------------------------------------------------------------------

    (vii) The State or Tribe fails to conduct targeted surveillance of 
wildlife source populations as specified in Sec.  76.6(b)(1).
    (viii) The State or Tribe fails to conduct targeted surveillance of 
at-risk program animals as specified in Sec.  76.6(b)(2).
    (ix) The State or Tribe has failed to conduct an investigation of a 
program animal with non-negative test results for brucellosis in 
accordance with Sec.  76.7(a), or to send a report regarding those 
activities as specified in Sec.  76.4(b).
    (2) From consistent to inconsistent. If any of the following 
occurs, APHIS may redesignate a consistent State or Tribe as an 
inconsistent State or Tribe:
    (i) The State or Tribe fails to implement or perform an activity or 
maintain a measure specified within its animal health plan, or fails to 
amend the plan in response to a request from APHIS, and APHIS 
determines that this failure has resulted or may result in the spread 
of brucellosis or bovine tuberculosis.
    (ii) On more than one occasion, the State or Tribe fails to submit 
an annual report as specified in Sec.  76.4(a).
    (iii) On more than one occasion, the State or Tribe fails to submit 
an initial epidemiological investigation situation report within 14 
days of the period of time specified in Sec.  76.4(c) for submitting 
such a report.
    (iv) On more than one occasion, the State or Tribe fails to submit 
an updated epidemiological investigation situation report as specified 
in Sec.  76.4(d).
    (v) APHIS has terminated recognition of the State or Tribe's 
management area.
    (vi) The State or Tribe refuses to participate in or otherwise 
conduct surveillance as specified in Sec.  76.6(a).
    (vii) On more than one occasion, the State or Tribe has failed to 
conduct an investigation of a program animal with non-negative test 
results for brucellosis in accordance with Sec.  76.7(a), or to send a 
report regarding those activities as specified in Sec.  76.4(b).
    (viii) The State or Tribe fails to conduct epidemiological 
investigations as specified in Sec.  76.7(b).
    (ix) The State or Tribe fails to conduct affected herd management 
as specified in Sec.  76.7(e).
    (3) From provisionally consistent to inconsistent. A provisionally 
consistent State or Tribe may be redesignated to inconsistent for any 
of the reasons specified in paragraph (c)(2) of this section. 
Additionally, if a provisionally consistent State or Tribe fails to 
implement provisions of its animal health plan or take required 
remedial measures within the period of time specified by APHIS for 
implementing these provisions or taking these measures, APHIS will 
redesignate the State or Tribe as an inconsistent State or Tribe.
    (d) Notification of redesignation--(1)(i) Notice regarding 
redesignation from consistent to provisionally consistent status. 
Whenever APHIS redesignates a consistent State or Tribe as a 
provisionally consistent State or Tribe, APHIS will publish a notice in 
the Federal Register announcing this redesignation. The notice will 
also state the reason or reasons that led to the redesignation and the 
remedial measures APHIS considers necessary for the State or Tribe to 
complete in order to regain consistent status. The notice may 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. While a State or Tribe is in 
provisionally consistent status, APHIS may publish an additional notice 
in the Federal Register announcing additional remedial measures, as 
circumstances warrant.
    (ii) Notice regarding termination of provisionally consistent 
status. (A) If the State or Tribe completes the required remedial 
measures, APHIS will publish a notice in the Federal Register 
announcing that it has redesignated the State or Tribe as a consistent 
State or Tribe.
    (B) If the State or Tribe fails to take the required remedial 
measures, APHIS will publish a notice in the Federal Register 
announcing that it has redesignated the State or Tribe as an 
inconsistent State or Tribe.
    (2) Notice regarding immediate redesignation from consistent or 
provisionally consistent to inconsistent status. Whenever APHIS 
immediately redesignates a consistent or provisionally consistent State 
or Tribe as an inconsistent State or Tribe, APHIS will publish a notice 
in the Federal Register announcing this redesignation.
    (e) Inconsistent status; conditions for regaining consistent 
status. If a State or Tribe has been redesignated to inconsistent 
status, in order to regain consistent status, the State or Tribe must:
    (1) Take appropriate remedial measures, as determined by APHIS, to 
address the issue or issues that led to redesignation to inconsistent 
status;
    (2) Submit amendments to its animal health plan to APHIS for review 
and approval in accordance with the process set forth in Sec.  76.2; 
and
    (3) Submit any additional outstanding annual reports, initial 
investigation reports, initial or updated epidemiological investigation 
situation reports, and closing reports.
    (f) Listing. Lists of all consistent, provisionally consistent, and 
inconsistent States and Tribes are located on the Internet, at [address 
to be added in final rule]. The lists are also available at district 
APHIS Veterinary Services (VS) offices, addresses for which are located 
in local telephone directories. The lists specify a State or Tribe's 
classification for brucellosis, and its classification for bovine 
tuberculosis.


Sec.  76.4  Reporting requirements.

    States must submit the following reports:
    (a) Annual reports. Within 60 days of the end of the reporting 
period, a State must submit a completed annual report form to APHIS as 
provided in the Program Standards document. Additionally:
    (1) If the State has submitted an initial epidemiological 
investigation situation report to APHIS, but has not yet submitted a 
corresponding closing report, the State must submit additional 
information regarding epidemiological activities related to that 
incident undertaken during the reporting period within the annual 
report form.
    (2) If the State has an animal health plan that has been approved 
by APHIS, the State must submit a summary of any changes to the 
categories of information in that plan that have occurred during the 
reporting period along with the annual report form, unless the State 
has already submitted amendment requests to APHIS that incorporate 
these changes to its plan.
    (b) Initial investigation reports. Whenever a State initiates an 
investigation of an animal with non-negative test results for 
brucellosis or an animal determined to be infected with brucellosis or 
bovine tuberculosis in accordance with Sec.  76.7, the State must 
provide a report regarding the investigation within 15 days of 
initiation of the investigation.
    (c) Initial epidemiological investigation situation reports. 
Whenever a State initiates an epidemiological investigation of an 
affected herd in accordance with Sec.  76.7, the State must provide a 
report of that epidemiological investigation to APHIS within 15 days of 
the date when the State is notified that an animal from the herd has 
been determined to be infected

[[Page 78509]]

with brucellosis or bovine tuberculosis. The report must be sent to 
APHIS as provided within the Program Standards document.
    (d) Updated epidemiological investigation situation reports. Every 
4 weeks following submission of an initial situation report or initial 
epidemiological situation report, and more frequently at the 
Administrator's request, a State must submit subsequent reports 
updating information in the initial situation report or initial 
epidemiological investigation situation report. The reports must be 
sent to APHIS as provided within the Program Standards document.
    (e) Closing reports. Within 60 days following the conclusion of an 
epidemiological investigation of an affected herd, a State must submit 
a closing report to APHIS. The report must be sent to APHIS as provided 
within the Program Standards document.
    (f) Additional reporting requirements for States with recognized 
management areas. Additional reporting requirements for States with 
recognized management areas are specified in Sec.  76.5(f).
    (g) Additional reporting requirements as part of redesignation to 
provisionally consistent status. If a consistent State is redesignated 
as provisionally consistent, additional reporting requirements for the 
State may be specified in the notice in the Federal Register that 
announces such redesignation.
    (h) Reporting requirements; applicability to Tribes. The 
requirements in this section pertain to Tribes, provided that they have 
submitted a Tribal animal health plan to APHIS for review and approval 
in accordance with the process set forth in Sec.  76.2, and APHIS has 
approved the animal health plan.


Sec.  76.5  Recognized management areas.

    (a) A State or Tribe may request APHIS recognition of a management 
area within the State or Tribal lands.
    (b) Process for requesting recognition of a management area--(1) 
States or Tribes without an approved animal health plan. If a State or 
Tribe does not have an animal health plan that has been approved by 
APHIS and wishes to request APHIS recognition of a management area, the 
State or Tribe must submit a request for recognition of the management 
area when it submits an animal health plan to APHIS in accordance with 
the process set forth in Sec.  76.2.
    (2) States or Tribes with an approved animal health plan. If a 
State or Tribe has an animal health plan that has been approved by 
APHIS and wishes to request APHIS recognition of a management area, the 
State or Tribe must submit a request for recognition of the management 
area by submitting an amendment to its animal health plan in accordance 
with the process set forth in Sec.  76.2.
    (c) Requirements for a request to recognize a management area. (1) 
Except as provided in paragraph (c)(2) of this section, any request to 
recognize a management area must contain the following categories of 
information.
    (i) A description of the geographical area that the State or Tribe 
requests to be recognized as a management area. The description must 
specify continuous and uninterrupted boundaries for the management 
area.
    (ii) A description of the assessments and activities that the State 
or Tribe has conducted or plans to conduct to support the specified 
boundaries for the management area and a timeline of implementation of 
these activities. At a minimum, the activities specified must provide 
assurances that the boundaries for the management area continually 
reflect current epidemiological knowledge about the extent of disease 
and risk of transmission of disease within and from the area, and must 
include:
    (A) Epidemiological investigations.
    (B) Surveillance activities within the management area to determine 
or further delineate sources of brucellosis and/or bovine tuberculosis.
    (C) Surveillance activities outside of the boundaries of the 
management area sufficient to detect brucellosis or bovine tuberculosis 
infection in program animals that originate from or are otherwise 
related to the management area.
    (iii) A description of the known sources of brucellosis or bovine 
tuberculosis that pose a risk of disease introduction into program 
animals within and surrounding the management area, and an assessment 
of the likelihood of spread of brucellosis or bovine tuberculosis from 
these sources to program animals. This description must include:
    (A) The approximate number of herds, individual program animals, 
and susceptible wildlife populations within the management area and in 
the area surrounding the management area as this surrounding area is 
determined in consultation with an epidemiologist designated by the 
District Director; and
    (B) The number of affected herds or wildlife populations detected 
within the management area since the first investigation or 
surveillance activity specified by the State or Tribe in order to 
fulfill the requirements of paragraph (c)(1)(ii) of this section was 
conducted, the approximate number of animals in these herds or source 
populations, and the approximate prevalence of brucellosis or bovine 
tuberculosis infection in these herds or populations during that time 
period; and
    (C) The potential for exposure of program animals to these known 
affected herds or wildlife populations; and
    (D) Any factors, other than mitigation measures maintained by the 
State or Tribe, that may influence this potential for exposure; and
    (E) An assessment of the likelihood of transmission of brucellosis 
or bovine tuberculosis from known affected herds or wildlife 
populations to program animals within and surrounding the management 
area.
    (iv) A description of the measures that the State or Tribe has 
implemented or would implement to mitigate the risk that program 
animals within the State or Tribal lands will become infected with 
brucellosis or bovine tuberculosis, a timeline for implementation of 
these measures, and the means by which the State or Tribe has monitored 
and enforced or plans to monitor and enforce these measures. For all 
management areas, measures must include conditions for the movement of 
program animals from the management area, herd testing of at least a 
targeted representative sample of herds of program animals within the 
area, and change-of-ownership testing of all test-eligible program 
animals that reside within the area. For management areas for 
brucellosis, the measures must also include an official brucellosis 
vaccination program.
    (v) A citation of or hyperlink to the laws and regulations that 
authorize the State or Tribe's establishment of the management area.
    (vi) A description of the personnel that the State or Tribe has 
used or plans to use in order to implement or perform activities or 
maintain measures associated with the management area. This description 
must demonstrate that the State or Tribe has sufficient personnel to 
implement and perform these activities and maintain these measures, and 
must include:
    (A) The name, contact information, and affiliation of the person 
within the State or Tribe who will assume responsibility for 
implementation and performance of activities and maintenance and 
enforcement of measures associated with the management area; and
    (B) The name, contact information, and affiliation of all personnel 
assigned

[[Page 78510]]

to the implementation and performance of activities and maintenance and 
enforcement of measures associated with the management area; and
    (C) The role or roles assigned to these personnel.
    (vii) Information demonstrating that all program animals that are 
moved from the management area are or will be required to be officially 
identified prior to movement.
    (2) If a State had a geographical area designated as a zone for 
bovine tuberculosis or covered by a brucellosis management plan prior 
to (Effective date of final rule), and the State wishes the 
geographical area to continue to be recognized as a management area, 
the State's request for recognition of that area as a management area 
only needs to contain those categories of information that the State 
has not already submitted to APHIS.
    (d) APHIS review. APHIS will review each proposal for recognition 
of a management area in accordance with the process set forth in Sec.  
76.2 for review of an animal health plan or amendment to an animal 
health plan.
    (e) APHIS determination. In communicating its determination to 
approve or not approve an animal health plan or amendment to an animal 
health plan in accordance with the process set forth in Sec.  76.2, 
APHIS will also communicate its determination to recognize or not 
recognize the requested management area. If APHIS recognizes the 
requested management area, the request for recognition of the area will 
be considered part of the State or Tribe's animal health plan. APHIS 
will not recognize a management area in a State or on Tribal lands if 
it determines not to approve that State or Tribe's animal health plan.
    (f) Annual reporting. In addition to the annual reporting 
requirements contained in Sec.  76.4(a), States or Tribes with 
recognized management areas must submit a separate annual report form 
for each recognized management area in the State or Tribe.
    (g) Amendments to recognized management areas. If a State or Tribe 
with a recognized management area wishes to expand or contract the 
geographical boundaries of the management area, or determines that any 
information in its request for recognition of the management area has 
substantively changed, the State or Tribe must submit amendments to its 
animal health plan that reflect these changes to APHIS in accordance 
with the process set forth in Sec.  76.2.
    (h) Termination of management areas--(1) Termination initiated by 
the State or Tribe. In order for APHIS to recognize termination of a 
management area, a State or Tribe must submit amendments to its animal 
health plan that reflect this termination in accordance with the 
process set forth in Sec.  76.2. Additionally, the State or Tribe must 
provide an explanation of the reasons for the termination.
    (2) Termination initiated by APHIS. (i) If APHIS determines that a 
State or Tribe has failed to implement or maintain measures specified 
within its proposal for recognition of a management area for 
brucellosis or bovine tuberculosis, APHIS will terminate recognition of 
all management areas for the disease or diseases within the State or 
Tribal lands, and will redesignate the State or Tribe an inconsistent 
State or Tribe for the disease or diseases.
    (ii) If APHIS redesignates a State or Tribe as an inconsistent 
State or Tribe for brucellosis or bovine tuberculosis, APHIS will also 
terminate recognition of all management areas for that disease within 
the State or Tribal lands as part of this redesignation.
    (3) APHIS review of State or Tribal requests. If a State or Tribe 
requests recognition of termination of a management area, APHIS will 
review the request in accordance with the process set forth in Sec.  
76.2 for review of an amendment to an animal health plan.
    (4) APHIS determination. APHIS will communicate its determination 
regarding termination of a recognized management area in accordance 
with the process set forth in Sec.  76.2 for communication of a 
determination regarding amendments to an animal health plan.


Sec.  76.6  Surveillance requirements.

    (a) National surveillance. All States must agree to participate in 
the National Surveillance Plans for Brucellosis and Bovine 
Tuberculosis, found online at [address to be added in final rule], or 
must conduct equivalent surveillance in a manner approved by APHIS.
    (1) Failure to meet surveillance levels. If a State fails to meet 
the surveillance levels set forth in the National Surveillance Plans or 
otherwise approved by APHIS, the State may be redesignated to a lower 
State classification.
    (2)(i) Refusal to participate in or otherwise conduct such 
surveillance. If a consistent or provisionally consistent State refuses 
to participate in or otherwise conduct such surveillance, the State 
will be redesignated as an inconsistent State.
    (ii) If an inconsistent State refuses to participate in or 
otherwise conduct such surveillance, the interstate movement of program 
animals from that State will be subject to such restrictions or 
prohibitions as the Administrator considers necessary to prevent the 
dissemination of brucellosis or bovine tuberculosis from the State. In 
such instances, the restrictions or prohibitions will be announced 
through a notice in the Federal Register.
    (b) Targeted surveillance within a State. (1) Surveillance of 
source populations. If a consistent or provisionally consistent State 
has identified a known source of brucellosis or bovine tuberculosis 
transmission within wildlife in the State in its animal health plan and 
determined that this source population presents a risk of transmitting 
brucellosis or bovine tuberculosis to program animals, in order to 
maintain consistent or provisionally consistent status, the State must 
conduct surveillance of that source population in a manner approved by 
APHIS as sufficient to detect brucellosis or tuberculosis in an animal 
within the source population. A consistent State that fails to conduct 
such surveillance will be redesignated as provisionally consistent. A 
provisionally consistent State that fails to conduct such surveillance 
may be redesignated as inconsistent.
    (2) Surveillance of at-risk populations. If a consistent or 
provisionally consistent State has identified a known source of 
brucellosis or bovine tuberculosis transmission in the State in its 
animal health plan and has determined that this source population 
presents a risk of transmitting brucellosis or bovine tuberculosis to 
program animals, in order to maintain consistent or provisionally 
consistent status, the State must conduct annual herd testing of all 
herds of at-risk program animals, or alternatively, a statistically 
representative sample of those herds, as determined by APHIS. A 
consistent State that fails to conduct such surveillance will be 
redesignated as provisionally consistent. A provisionally consistent 
State that fails to conduct such surveillance will be redesignated as 
inconsistent.
    (c) Surveillance within recognized management areas. States must 
conduct surveillance within a recognized management area in the manner 
specified within that section of the State's animal health plan that 
pertains to the management area. Failure to conduct such surveillance 
will result in termination of recognition of the management area and 
redesignation of the State as an inconsistent State.
    (d) Additional surveillance as part of redesignation to 
provisionally consistent status. If a consistent State is

[[Page 78511]]

redesignated as provisionally consistent, additional surveillance 
requirements for the State may be specified in the notice in the 
Federal Register that announces such redesignation.
    (e) Surveillance requirements; applicability to Tribes. The 
requirements in this section pertain to Tribes, provided that they have 
submitted a Tribal animal health plan to APHIS for review and approval 
in accordance with the process set forth in Sec.  76.2, and APHIS has 
approved the animal health plan.


Sec.  76.7  Epidemiological investigations and affected herd 
management.

    (a) Investigations of animals with non-negative test results for 
brucellosis. If a program animal has a non-negative test result for 
brucellosis, within 15 days of receiving notification of these results, 
the State in which the animal was detected must initiate an 
investigation to determine the herd from which the animal originated 
and all herds in which it has resided. A consistent State that fails to 
conduct such an investigation on one occasion may be redesignated as 
provisionally consistent. A consistent or provisionally consistent 
State that fails to conduct such an investigation on multiple occasions 
may be redesignated as inconsistent.
    (b) Epidemiological investigations. Unless a State has submitted an 
alternate protocol to APHIS by submitting a written request to the 
address provided in the Program Standards document, and the 
Administrator has authorized this alternate protocol:
    (1) If a program animal is determined to be infected with 
brucellosis or bovine tuberculosis, within 15 days of this 
determination, the State in which the infected animal was detected must 
identify the herd from which the infected animal originated and all 
herds in which it has resided, impose the restrictions specified in 
Sec. Sec.  76.9 and 76.10 on the interstate movement of animals from 
those herds, impose substantially similar restrictions on intrastate 
movement, and begin determining the disease status of all test-eligible 
animals in those herds.
    (2) If a herd of program animals is determined to be affected with 
brucellosis or bovine tuberculosis, within 15 days of this 
determination, the State in which the herd resides must identify and 
impose the restrictions specified in Sec. Sec.  76.9 and 76.10 on the 
interstate movement of animals from the following herds, impose 
substantially similar restrictions on intrastate movement, and begin 
determining the disease status of all test-eligible animals in those 
herds.
    (i) Any herd into which program animals from the affected herd may 
have been moved; and
    (ii) Any herd from which program animals in the affected herd may 
have originated or in which they may have resided; and
    (iii) Any herd, individual program animals, or other animals that 
are susceptible to brucellosis or bovine tuberculosis that may have 
commingled with or otherwise been exposed to the affected herd, as 
determined by the Administrator and communicated to the State.
    (3) If the State in which an infected animal or affected herd was 
detected determines that any of these herds or animals are located in a 
different State than the infected animal or affected herd, the State in 
which the infected animal or affected herd was detected must notify 
both that State and APHIS, in writing, within 3 days. APHIS 
notification must be submitted to the address specified in the Program 
Standards document.
    (4) If a non-program animal within a State is determined to be 
infected with brucellosis or bovine tuberculosis and the Administrator 
determines that this animal presents a risk of transmitting brucellosis 
or bovine tuberculosis to program animals, the State or States 
surrounding the detection must identify all herds that may have been 
exposed to brucellosis or bovine tuberculosis because of this 
detection, as determined by the Administrator and communicated to the 
States, impose the restrictions specified in Sec. Sec.  76.9 and 76.10 
on the interstate movement of animals from those herds, impose 
substantially similar restrictions on intrastate movement, and must 
determine the disease status of all test-eligible animals in those 
herds.
    (5) If an animal infected with brucellosis or bovine tuberculosis 
is discovered on or has been determined to have originated from a calf 
raiser's premises or feedlot, the State in which the calf raiser's 
premises or feedlot is located must conduct an epidemiological 
investigation of that premises or feedlot according to a method that 
has been approved by the Administrator. An approved method for 
conducting such an investigation is set forth in the Program Standards 
document.
    (c) Conditions for determining whether a herd is affected with 
brucellosis or bovine tuberculosis. (1) If all test-eligible program 
animals in a herd under investigation are determined to be negative for 
brucellosis or bovine tuberculosis, the herd is not an affected herd. 
No further action is required and the State may remove the restrictions 
on the movement of those animals.
    (2) If any test-eligible animals in a herd under investigation are 
determined to be infected with brucellosis or bovine tuberculosis, the 
herd is considered an affected herd.
    (d) Failure to conduct an epidemiological investigation in 
accordance with this section. (1) If a consistent or provisionally 
consistent State fails to conduct an epidemiological investigation in 
accordance with this section, that State will be redesignated as 
inconsistent.
    (2) If an inconsistent State fails to conduct an epidemiological 
investigation in accordance with this section, the interstate movement 
of program animals from that State will be subject to such restrictions 
or prohibitions as the Administrator considers necessary to prevent the 
dissemination of brucellosis or bovine tuberculosis from the State. In 
such instances, the restrictions or prohibitions will be announced 
through a notice in the Federal Register.
    (e) Affected herd management. States must manage affected herds 
through one of the following methods:
    (1) Depopulation.
    (2) A test-and-remove protocol approved by the Administrator. In 
order to be approved by the Administrator, the protocol must 
demonstrate that:
    (i) The State has implemented and is enforcing movement 
restrictions on the affected herd.
    (ii) The State has implemented and is enforcing an affected herd 
management plan for the affected herd to prevent the spread of 
brucellosis or bovine tuberculosis.
    (iii) The State has implemented and is conducting a protocol to 
periodically test program animals in the affected herd for brucellosis 
or bovine tuberculosis and to remove and destroy those animals that do 
not test negative.
    (iv) The State has a protocol in place to conduct periodic 
assurance testing of the herd once the test-and-remove protocol is 
complete.
    (f) Failure to conduct affected herd management in accordance with 
this section. (1) If a consistent or provisionally consistent State 
fails to manage an affected herd through one of the methods specified 
in paragraph (e) of this section, the State will be redesignated as 
inconsistent.
    (2) If an inconsistent State fails to manage an affected herd 
through one of the methods specified in paragraph (e) of this section, 
the interstate movement of program animals from that State will

[[Page 78512]]

be subject to such restrictions or prohibitions as the Administrator 
considers necessary to prevent the dissemination of brucellosis or 
bovine tuberculosis from the State. In such instances, the restrictions 
or prohibitions will be announced through a notice in the Federal 
Register.
    (g) Epidemiological investigation and affected herd management 
requirements; applicability to Tribes. The requirements in this section 
pertain to Tribes, provided that they have submitted a Tribal animal 
health plan to APHIS for review and approval in accordance with the 
process set forth in Sec.  76.2, and APHIS has approved the animal 
health plan.

Subpart A--General Categories of Livestock


Sec.  76.8  Interstate movement of infected livestock generally 
prohibited.

    Except as provided for in Sec.  71.3(d)(7) of this subchapter, the 
interstate movement of any livestock known to be infected with 
brucellosis or bovine tuberculosis is prohibited.


Sec.  76.9  Interstate movement of program animals from a herd 
containing a reactor or suspect.

    Except as provided in Sec.  76.10, the interstate movement of 
program animals from a herd containing a reactor or suspect for 
brucellosis or bovine tuberculosis is prohibited, until the disease 
status of all test-eligible animals in that herd is determined.


Sec.  76.10  Interstate movement of reactor, suspect, and exposed 
program animals.

    Notwithstanding the other provisions of this part, program animals 
that have been classified as brucellosis or bovine tuberculosis 
reactors, suspects, or exposed animals may be moved interstate if:
    (a) The animals are officially identified; and
    (b) The animals are accompanied by a permit for movement of 
restricted animals issued by an APHIS or State or Tribal 
representative; and
    (c) The permit for movement of restricted animals clearly specifies 
the brucellosis or bovine tuberculosis classification of the animals; 
and
    (d) The animals are moved for diagnostic testing, immediate 
slaughter, necropsy, or other use as approved by the Administrator; and
    (e) The animals are moved to a location specified by the 
Administrator as an approved location for reactor, suspect, or exposed 
animals; \4\ and
---------------------------------------------------------------------------

    \4\ Approved locations include recognized slaughtering 
establishments, specifically approved stockyards, official testing 
laboratories, research facilities, and, for exposed animals that 
have tested negative for brucellosis or bovine tuberculosis, 
quarantine feedlots and quarantine pens. A State may request 
approval of alternate locations by specifying the locations within 
its animal health plan or proposing to amend the health plan to 
specify the locations.
---------------------------------------------------------------------------

    (f) The animals are moved in a means of conveyance containing only 
animals not susceptible to brucellosis and/or bovine tuberculosis or 
animals destined for immediate slaughter or necropsy; and
    (g)(1) The means of conveyance in which the animals are moved 
interstate is secured with official seals applied and removed by an 
authorized APHIS representative, Food Safety and Inspection Service 
inspector, State or Tribal representative, accredited veterinarian, or 
other individual authorized for this purpose by an APHIS 
representative; or
    (2) The animals are accompanied during movement by an APHIS 
representative, Food Safety and Inspection Service inspector, State or 
Tribal representative, or other individual authorized for this purpose 
by an APHIS representative; and
    (h) After shipment, each means of conveyance in which the animals 
have been transported is cleaned and disinfected by the carrier in 
accordance with part 71 of this subchapter, under the supervision of an 
APHIS representative, Food Safety and Inspection Service inspector, 
State or Tribal representative, accredited veterinarian, or other 
person designated by the Administrator.

Subpart B--Cattle and Bison


Sec.  76.11  Interstate movement of cattle and bison generally 
restricted.

    Except as provided in Sec. Sec.  76.8 through 76.10, unless the 
Administrator has provided public notification of alternate conditions 
for movement, cattle and bison may only be moved interstate in 
accordance with this subpart.


Sec.  76.12  Interstate movement of cattle and bison from consistent 
States or Tribes for brucellosis and bovine tuberculosis.

    (a) Rodeo, event, or exhibited cattle or bison. Rodeo, event, or 
exhibited cattle or bison may be moved interstate from a consistent 
State or Tribe for brucellosis and bovine tuberculosis provided that:
    (1) The cattle or bison are tested for bovine tuberculosis using an 
individual official test no more than 60 days prior to initial 
interstate movement from the premises of origin, with negative results; 
\5\ and
---------------------------------------------------------------------------

    \5\ The requirements of this and the following paragraph apply 
not only to rodeo, event, or exhibited cattle or bison that have 
been produced within the United States, but also rodeo, event, or 
exhibited cattle and bison of foreign origin after they have arrived 
at their destination within the United States.
---------------------------------------------------------------------------

    (2) If the cattle or bison are sexually intact and 6 months of age 
or older, they are tested for brucellosis using an individual official 
test no more than 60 days prior to initial interstate movement from the 
premises of origin, with negative results; and
    (3) The cattle or bison are tested for bovine tuberculosis using an 
individual official test no more than 180 days prior to any subsequent 
interstate movement, with negative results; and
    (4) If the cattle or bison are sexually intact and 6 months of age 
or older, they are tested for brucellosis using an individual official 
test no more than 180 days prior to any subsequent interstate movement, 
with negative results; and
    (5) The cattle or bison are accompanied during interstate movement 
by an ICVI with a statement regarding the date, location, and test 
results of the official tests for bovine tuberculosis and, if 
applicable, brucellosis administered prior to initial interstate 
movement, and the date, location, and test results of the last official 
test for bovine tuberculosis and, if applicable, brucellosis 
administered to the animals; and
    (6) The cattle or bison are officially identified.
    (b) Movement of all other cattle or bison--(1) Movement from all 
areas of a consistent State or Tribe other than a recognized management 
area. Cattle or bison that are not rodeo, event, or exhibited cattle or 
bison may be moved from any area of a consistent State or Tribe for 
brucellosis and bovine tuberculosis, other than from a recognized 
management area in the State or Tribe, without further restriction 
under this part.\6\
---------------------------------------------------------------------------

    \6\ The cattle or bison are still subject to all other 
applicable restrictions of 9 CFR chapter I, including those of 
Sec. Sec.  71.3, 71.17, 86.4, and 86.5.
---------------------------------------------------------------------------

    (2) Movement from a recognized management area within a consistent 
State or Tribe. Cattle or bison that are not rodeo, event, or exhibited 
cattle or bison may be moved interstate from a recognized management 
area within a consistent State or Tribe for brucellosis and bovine 
tuberculosis if the cattle or bison are moved in accordance with the 
conditions for movement of program animals from the recognized 
management area specified in the State or Tribe's animal health plan.

[[Page 78513]]

Sec.  76.13  Interstate movement of cattle and bison from a 
provisionally consistent State or Tribe.

    (a) Unless specified otherwise in the notice in the Federal 
Register designating the State or Tribe as a provisionally consistent 
State or Tribe, cattle or bison that are moved interstate from a 
provisionally consistent State or Tribe are subject to the relevant 
conditions for movement in Sec.  76.12.
    (b) If the notice in the Federal Register designating the State or 
Tribe as a provisionally consistent State or Tribe specifies 
restrictions on the interstate movement of cattle or bison from the 
State or Tribe, and these restrictions differ from the conditions for 
interstate movement specified in Sec.  76.12, the interstate movement 
of such cattle or bison is subject to the restrictions specified in the 
notice in the Federal Register.


Sec.  76.14  Interstate movement of cattle and bison from inconsistent 
States or Tribes for brucellosis.

    (a) Sexually intact cattle or bison that are 6 months of age or 
older--(1) Cattle or bison destined for immediate slaughter. Sexually 
intact cattle or bison that are 6 months of age or older and are 
destined for immediate slaughter may be moved interstate from an 
inconsistent State or Tribe for brucellosis, if:
    (i) The cattle or bison are officially identified; and
    (ii) The cattle or bison are accompanied by an ICVI.
    (2) Cattle or bison not destined for immediate slaughter. Sexually 
intact cattle or bison that are 6 months of age or older and that are 
not destined for immediate slaughter may be moved interstate from an 
inconsistent State or Tribe for brucellosis if:
    (i) The herd from which the cattle or bison originate has been 
subjected to a herd test using an official test for brucellosis no more 
than 1 year and no less than 120 days prior to movement, with negative 
results;
    (ii) The cattle or bison are additionally tested using an 
individual official test no more than 60 days prior to movement, with 
negative results;
    (iii) Since being individually tested, the cattle or bison have not 
commingled with non-natural additions to the herd that are of unknown 
brucellosis status or animals that have had a non-negative test for 
brucellosis;
    (iv) The cattle or bison are officially identified; and
    (v) The cattle or bison are accompanied by an ICVI documenting the 
negative test results.
    (b) Cattle or bison that are less than 6 months of age, steers, and 
spayed heifers. Sexually intact cattle or bison that are less than 6 
months of age, steers, and spayed heifers may be moved interstate from 
an inconsistent State or Tribe for brucellosis if:
    (1) The cattle or bison are officially identified; and
    (2) The cattle or bison are accompanied by an ICVI.


Sec.  76.15  Interstate movement of cattle and bison from inconsistent 
States or Tribes for bovine tuberculosis.

    (a)(1) Cattle or bison destined for immediate slaughter. Cattle or 
bison that are destined for immediate slaughter may only be moved 
interstate from an inconsistent State or Tribe for bovine tuberculosis, 
if:
    (i) The cattle or bison are officially identified; and
    (ii) The cattle or bison are accompanied by an ICVI.
    (2) Cattle or bison not destined for immediate slaughter. Cattle or 
bison that are not destined for immediate slaughter may only be moved 
interstate from an inconsistent State or Tribe for bovine tuberculosis, 
if:
    (i) The cattle or bison originate from a herd that was subjected to 
a herd test using an official test for bovine tuberculosis no more than 
1 year and no less than 120 days prior to the movement of the cattle or 
bison, with negative results.
    (ii) The cattle or bison are additionally tested for bovine 
tuberculosis using an individual official test no more than 60 days 
prior to movement, with negative results.
    (iii) Since being individually tested, the cattle or bison have not 
commingled with non-natural additions to the herd that are of unknown 
bovine tuberculosis status or animals that have had a non-negative test 
for bovine tuberculosis.
    (iv) The cattle or bison are officially identified.
    (v) The cattle or bison are accompanied by an ICVI documenting the 
negative test results.
    (b) [Reserved]

Subpart C--Interstate Movement of Captive Cervids


Sec.  76.16  Interstate movement of captive cervids

    Except as provided in Sec. Sec.  76.8 through 76.10, captive 
cervids may only be moved interstate in accordance with this section.
    (a) Captive cervids that originate directly from accredited herds. 
Captive cervids that originate directly from herds that are currently 
accredited for both brucellosis and bovine tuberculosis may be moved 
interstate if:
    (1) The cervids are officially identified; and
    (2) The cervids are accompanied by an ICVI with a statement that 
the cervids originate directly from herds that are currently accredited 
for both brucellosis and bovine tuberculosis.
    (b) All other captive cervids--(1) Captive cervids destined for 
immediate slaughter. Captive cervids that are destined for immediate 
slaughter may be moved interstate, provided that:
    (i) The cervids are officially identified; and
    (ii) The cervids are accompanied by an ICVI.
    (2) Captive cervids not destined for immediate slaughter--(i) 
General conditions. Captive cervids that are not destined for immediate 
slaughter may be moved interstate provided that:
    (A) The cervids originate from a herd that was subjected to a herd 
test using an official test for brucellosis and an official test for 
bovine tuberculosis no more than 1 year and no less than 120 days prior 
to movement, with negative results; and
    (B) The cervids are additionally tested for brucellosis and bovine 
tuberculosis using an individual official test no more than 60 days 
prior to movement, with negative results; and
    (C) The cervids are officially identified; and
    (D) The cervids are accompanied by an ICVI.
    (ii) Additional conditions for captive cervids moved from an 
inconsistent State or Tribe for brucellosis and/or bovine tuberculosis. 
In addition to all general conditions for the interstate movement of 
captive cervids specified in paragraph (a)(2)(i) of this section, 
captive cervids that are not destined for immediate slaughter may only 
be moved interstate from an inconsistent State or Tribe for brucellosis 
or bovine tuberculosis if, since being individually tested for 
brucellosis and bovine tuberculosis, the cervids have not commingled 
with non-natural additions to the herd that are of unknown disease 
status or animals that have had a non-negative test for brucellosis or 
bovine tuberculosis.


Sec.  76.17  Official tests for brucellosis and bovine tuberculosis, 
official testing laboratories, and official testers.

    (a) Official tests. All testing for the presence or absence of 
brucellosis and bovine tuberculosis in animals that is conducted in 
accordance with this part must be conducted using an official test. A 
list of all official tests is found on the Internet, at https://www.aphis.usda.gov/animal_health/animal_dis_spec/cattle.
    (1) If APHIS determines that a test can reliably determine the 
presence or

[[Page 78514]]

absence of brucellosis or bovine tuberculosis in animals, APHIS will 
add it to the list of official tests. Whenever a test is added to the 
list, APHIS will publish a notice in the Federal Register advising the 
public of this addition.
    (2) If APHIS determines at any point that an official test can no 
longer be considered to provide reliable results regarding the presence 
or absence of brucellosis or bovine tuberculosis in animals, APHIS will 
remove it from the list of official tests. Whenever an official test is 
removed from the list, APHIS will publish a notice in the Federal 
Register alerting the public to and setting forth the reasons for the 
removal.
    (b) Official testing laboratories--(1) Application for approval. In 
order to be considered an official testing laboratory, a Federal, 
State, or university laboratory, or any other laboratory approved by 
the National Animal Health Laboratory Network, must submit a written 
application to its district APHIS Veterinary Services office. A 
standard format for such an application is found in the Program 
Standards document.
    (2) Evaluation process. APHIS will review the submitted application 
to determine if it is complete. When APHIS determines that the 
application is complete, it will conduct formal review and evaluation 
of the application. Evaluation will be based on the following 
considerations:
    (i) Whether a need exists at the national level for an additional 
laboratory to be authorized by APHIS to conduct official tests for 
brucellosis and bovine tuberculosis;
    (ii) Whether the laboratory has facilities, safety equipment, and 
standard microbiological practices appropriate for the testing 
specified on the application;
    (iii) Whether the personnel at the laboratory are qualified to 
conduct the activities specified on the application, as determined by 
proficiency testing; and
    (iv) Whether the individual at the laboratory with oversight of 
serological testing or final determination of test results has adequate 
experience in the fields of immunology, microbiology, veterinary 
medicine, or a similar discipline.
    (3) Approval or denial. APHIS will communicate its approval or 
denial of the laboratory's application to the laboratory. If this 
approval or denial is oral, APHIS will subsequently communicate the 
approval or denial in writing. If APHIS approves a laboratory, it will 
be considered an official testing laboratory. An official testing 
laboratory may conduct official tests using official testers in the 
manner set forth in its application and approved by APHIS. A list of 
all official testing laboratories is found on the Internet at [address 
to be added in final rule].
    (4) Maintaining approval. In order for a laboratory to maintain 
approval as an official testing laboratory, it must demonstrate, by 
means of annual proficiency testing, that it continually meets or 
exceeds the standards under which it was approved.
    (5) Changes to approval. (i) If circumstances have changed at the 
laboratory such that the information supplied on its application for 
approval is no longer accurate, the laboratory must provide updated 
information to APHIS within 30 days. In response to such notification, 
APHIS may conduct another evaluation of the facility. Failure by a 
facility to notify APHIS in a timely manner may result in revocation of 
its approval.
    (ii) A facility may provide additional information to APHIS for 
evaluation and approval at any point.
    (6) Revocation of approval. APHIS may revoke the approval of an 
official testing laboratory if it is determined to have falsified 
information on its application or to no longer meet the standards under 
which it was approved. Any laboratory whose approval is revoked may 
appeal the decision in writing to the Administrator within 14 days 
after receiving the written notification of the revocation. The appeal 
must state all of the reasons on which the laboratory relies to show 
that approval was wrongfully revoked. The Administrator shall grant or 
deny the appeal, in writing, stating the reasons for the decision as 
soon as circumstances allow.
    (7) Reapproval. In order to be reapproved, any laboratory whose 
approval has been revoked must submit a written justification for 
reapproval to APHIS to the address specified within the Program 
Standards document. The justification must demonstrate that the issue 
that resulted in the revocation has been resolved.
    (c) Official testers outside of a laboratory environment--(1) 
State, Federal, and Tribal animal health and wildlife officials. At the 
discretion of a district APHIS Veterinary Services office and a State 
or Tribal animal health official, regulatory personnel may conduct 
official tests outside of a laboratory environment and under the 
conditions specified by the VS office and State or Tribal official.
    (2) Qualified accredited veterinarians. A qualified accredited 
veterinarian with a program certification for bovine tuberculosis is 
authorized to operate as an official tester for bovine tuberculosis 
outside of a laboratory environment within the State or States in which 
he or she is accredited.

PART 77--[REMOVED AND RESERVED]

0
18. Part 77 is removed and reserved.

PART 78--BRUCELLOSIS

0
19. The authority citation for part 78 continues to read as follows:

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

0
20. Section 78.1 is amended as follows:
0
a. By removing the definitions for animal identification number, 
approved brucella vaccine, approved individual herd plan, approved 
intermediate handling facility, area, ``B'' branded, brucellosis, 
brucellosis exposed, brucellosis reactor, brucellosis ring test, 
brucellosis suspect, certified brucellosis-free herd, Class A State or 
area, Class B State or area, Class C State or area, Class Free State or 
area, dairy cattle, farm of origin, finished fed cattle, herd blood 
test, market cattle identification test cattle, official adult 
vaccinate, official brand inspection certificate, official brand 
recording agency, official calfhood vaccinate, official eartag, 
official vaccinate, official vaccination eartag, permit for entry, 
qualified herd, quarantined area, quarantined feedlot, quarantined 
pasture, ``S'' branded, ``S'' brand permit, specifically approved 
stockyard, successfully closed case, test-eligible cattle and bison, 
United States Department of Agriculture backtag, and whole herd 
vaccination.
0
b. In the definition of official test, by removing and reserving 
paragraph (a).
0
c. By revising the definitions of animals, originate, and permit.
    The revisions read as follows:


Sec.  78.1  Definitions.

* * * * *
    Animals. Swine.
* * * * *
    Originate. (1) Animals will have the status of the herd from which 
they were moved if:
    (i) They were born and maintained in that herd since birth; or
    (ii) They have been in the herd for at least 120 days.
    (2) Animals will have the status of the State from which they were 
moved if:
    (i) They were born and maintained in the State since birth; or
    (ii) They were previously moved from a State of equal or higher 
class to the State; or
    (iii) They were previously moved from a State of lower class to the 
State

[[Page 78515]]

where they are now located and have been in the new State for at least 
120 days.
* * * * *
    Permit. A document issued by an APHIS representative, State 
representative, or accredited veterinarian and authorizing the 
restricted interstate movement of livestock to certain specified 
destinations.
* * * * *


Sec.  78.2  [Amended]

0
21. Section 78.2 is amended as follows:
0
a. In paragraph (a), in the first sentence, by removing the words 
``ICVI, permit, or `S' brand permit'' and adding the words ``ICVI or 
permit'' in their place.
0
b. In paragraph (b), by removing the words ``, except for permits for 
entry and `S' brand permits,''.


Sec.  78.3  [Removed and reserved]

0
22. Section 78.3 is removed and reserved.

Subpart B--[Removed and reserved]

0
23. Subpart B, consisting of Sec. Sec.  78.5 through 78.14, is removed 
and reserved.

Subpart C--[Removed and reserved]

0
24. Subpart C, consisting of Sec. Sec.  78.20 through 78.25, is removed 
and reserved.

PART 86--ANIMAL DISEASE TRACEABILITY

0
25. The authority citation for part 86 continues to read as follows:

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


Sec.  86.4  [Amended]

0
26. Section 86.4 is amended as follows:
0
a. In paragraph (a)(6), by removing the words ``part 77'' and adding 
the words ``part 76'' in their place.
0
b. In paragraph (b)(6), by removing the words ``part 77'' and adding 
the words ``part 76'' in their place.
0
c. In paragraph (c)(4), by removing the words ``part 78'' and adding 
the words ``part 76'' in their place.


Sec.  86.5  [Amended]

0
27. In Sec.  86.5, paragraph (h) is amended as by removing the words 
``part 77'' and adding the words ``part 76'' in their place.

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, 
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR 
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

0
28. The authority citation for part 93 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
29. Section 93.400 is amended as follows:
0
a. By removing the definitions of brucellosis certified-free province 
or territory of Canada, official tuberculin test, tuberculosis-free 
herd, and whole herd test.
0
b. By revising the definition of herd of origin.
0
c. By adding, in alphabetical order, definitions for accredited herd 
for brucellosis, accredited herd for tuberculosis, brucellosis, import 
protocol, individual test, non-negative test results, notifiable 
disease, spayed heifer, steer, tuberculosis, whole herd test for 
brucellosis, and whole herd test for tuberculosis.
    The additions and revision read as follows:


Sec.  93.400  Definitions.

* * * * *
    Accredited herd for brucellosis. A herd that meets APHIS' standards 
for accreditation for brucellosis status. Standards for accreditation 
are specified in import protocols.
    Accredited herd for tuberculosis. A herd that meets APHIS' 
standards for accreditation for bovine tuberculosis status. Standards 
for accreditation are specified in import protocols.
* * * * *
    Brucellosis. Infection with or disease caused by Brucella abortus.
* * * * *
    Herd of origin.
    (1) The herd within which an individual animal was born and raised; 
or
    (2) Any herd in which an individual animal has been continually 
maintained for at least 4 months prior to shipment to the United 
States.
* * * * *
    Import protocol. A document issued by APHIS and provided to 
officials of the competent veterinary authority of an exporting region 
that specifies in detail the mitigation measures that will comply with 
the regulations in 9 CFR part 93 regarding the import of certain 
animals or commodities.
    Individual test. A test for brucellosis or tuberculosis that is 
approved by the Administrator and that is administered individually in 
accordance with this part to ruminants that are susceptible to 
brucellosis or tuberculosis. For purposes of this part, testing of 
individual animals as part of a whole herd test does not constitute an 
individual test.
* * * * *
    Non-negative test results. Any test results for tuberculosis or 
brucellosis within the suspect or positive range parameters of a 
pathogen assay that has been approved by the Administrator.
* * * * *
    Notifiable disease. A disease for which confirmed or suspected 
occurrences within a region must be reported to the competent 
veterinary authority or other competent authority of that region.
* * * * *
    Spayed heifer. A female bovine that has been neutered in a manner 
otherwise approved by the Administrator and specified in an import 
protocol.
* * * * *
    Steer. A sexually neutered male bovine.
* * * * *
    Tuberculosis. Infection with or disease caused by Mycobacterium 
bovis.
* * * * *
    Whole herd test for brucellosis. A brucellosis test that has been 
approved by APHIS of all bovines in a herd of origin that are 6 months 
of age or older, and of all bovines in the herd of origin that are less 
than 6 months of age and were not born into the herd of origin, except 
those bovines that are less than 6 months of age and originate directly 
from a currently accredited herd for brucellosis.
    Whole herd test for tuberculosis. A tuberculosis test that has been 
approved by APHIS of all bovines in a herd of origin that are 6 months 
of age or older, and of all bovines in the herd of origin that are less 
than 6 months of age and were not born into the herd of origin, except 
those bovines that are less than 6 months of age and originate directly 
from a currently accredited herd for tuberculosis.
* * * * *
0
30. Section 93.401 is amended by adding paragraph (d) to read as 
follows:


Sec.  93.401  General prohibitions; exceptions.

* * * * *
    (d) Cleaning and disinfection prior to shipment. Unless a means of 
conveyance was cleaned and disinfected in a manner specified within an 
import protocol prior to being used to transport an animal for 
importation in accordance

[[Page 78516]]

with this subpart, or unless an exemption has been granted by the 
Administrator, the transport of the animal to the United States in that 
means of conveyance is prohibited.


Sec.  93.406  [Amended]

0
31. Section 93.406 is amended by removing and reserving paragraphs (a), 
(c), and (d).


Sec.  93.408  [Amended]

0
32. In Sec.  93.408, the first sentence is amended by removing the 
words ``Sec. Sec.  93.421 and 93.426'' and adding in their place 
``Sec.  93.421''.


Sec.  93.418  [Amended]

0
33. Section 93.418 is amended as follows:
0
a. By removing and reserving paragraphs (b) and (c).
0
b. In paragraph (d), introductory text, by removing the words ``the 
requirements of paragraphs (a) through (c)'' and adding the words ``the 
other requirements'' in their place.


Sec.  93.423  [Amended]

0
34. In Sec.  93.423, the first sentence in paragraph (a) is amended by 
removing the words ``Ruminants intended for'' and adding the words ``In 
addition to all other applicable requirements of the regulations in 
this part, ruminants intended for'' in their place.
0
35. In Sec.  93.424, paragraph (b) is revised to read as follows:


Sec.  93.424  Import permits and applications for inspection of 
ruminants.

* * * * *
    (b) For ruminants intended for importation into the United States 
from Mexico, the importer or his or her agent shall deliver to the 
veterinary inspector at the port of entry an application, in writing, 
for inspection, so that the veterinary inspector and customs 
representatives may make mutual satisfactory arrangements for the 
orderly inspection of the animals. The veterinary inspector at the port 
of entry will provide the importer or his or her agent with a written 
statement assigning a date when the animals may be presented for import 
inspection.
0
36. Section 93.427 is amended as follows:
0
a. By revising paragraph (a).
0
b. By removing and reserving paragraphs (c) and (d).
    The revision reads as follows:


Sec.  93.427  Cattle from Mexico.

    (a) Cattle from Mexico, except animals being transported in bond 
for immediate return to Mexico or animals imported for immediate 
slaughter, may be detained at the port of entry, and there subjected to 
such disinfection, blood tests, other tests, and dipping as required in 
this part to determine their freedom from any communicable disease or 
infection of such disease. The importer shall be responsible for the 
care, feed, and handling of the animals during the period of detention. 
In addition, all steers from Mexico that arrive at a port of entry into 
the United States, except animals being transported in bond for 
immediate return to Mexico or animals imported for immediate slaughter, 
must be identified on the right hip with a distinct, permanent, and 
legible ``M'' mark applied with a freeze brand, hot iron, or other 
method approved by APHIS, and all spayed heifers from Mexico that 
arrive at a port of entry into the United States, except animals being 
transported in bond for immediate return to Mexico or animals imported 
for immediate slaughter, must be identified on the right hip with a 
distinct, permanent, and legible ``MX'' mark applied with a 
freeze brand, hot iron, or other method approved by APHIS.
* * * * *
0
37. Section 93.429 is revised to read as follows:


Sec.  93.429  Ruminants for immediate slaughter.

    Ruminants, other than bovines, sheep, and goats, may be imported 
from Mexico subject to the applicable provisions of Sec. Sec.  93.424, 
93.425, and 93.426 for immediate slaughter if accompanied by a 
certificate issued in accordance with Sec.  93.405(a) and stating that 
the veterinarian who issued the certificate has inspected the animals 
in the herd from which the ruminants will be imported and found them 
free of evidence of communicable disease, and that, so far as it has 
been possible to determine, they have not been exposed to any such 
disease common to animals of their kind during the preceding 60 days, 
and if the ruminants are shipped by rail or truck, the certificate 
shall further specify that the ruminants were loaded into cleaned and 
disinfected cars or trucks for transportation directly to the port of 
entry. Such ruminants shall be moved from the port of entry in 
conveyances sealed with seals of the United States Government. Bovines, 
sheep, and goats, may be imported only in compliance with other 
applicable sections in this part.


Sec.  93.432  [Removed and reserved]

0
38. Section 93.432 is removed and reserved.
0
39. Section 93.437 is added to subpart D to read as follows:


Sec.  93.437  Tuberculosis status of foreign regions.

    (a) Level I regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.  93.438, and a prevalence of 
tuberculosis in their domestic bovine herds of less than 0.001 percent 
over at least the previous 2 years (24 consecutive months).
    (b) Level II regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.  93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.001 percent, but less than 0.01 percent, over the previous 2 years 
(24 consecutive months).
    (c) Level III regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.  93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.01 percent, but less than 0.1 percent, over the previous year (12 
consecutive months).
    (d) Level IV regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.  93.438, and a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.1 percent, but less than 0.5 percent, over the previous year (12 
consecutive months).
    (e) Level V regions. APHIS considers certain regions of the world 
not to have a program that meets APHIS requirements for tuberculosis 
classification in accordance with Sec.  93.438, to have a prevalence of 
tuberculosis in their domestic bovine herds equal to or greater than 
0.5 percent, or to be unassessed by APHIS with regard to tuberculosis 
prevalence.
    (f) Listing of regions. Lists of all Level I regions, Level II 
regions, Level III regions, Level IV, and Level V regions for 
tuberculosis are found online, at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to the lists will be 
made in accordance with Sec.  93.438.
0
40. Section 93.438 is added to subpart D to read as follows:


Sec.  93.438  Process for requesting regional classification for 
tuberculosis.

    (a) Request for regional classification; requirements. A 
representative of the competent veterinary authority of any country or 
countries may request that APHIS classify a region for tuberculosis.

[[Page 78517]]

Requests for classification or reclassification must be submitted to 
APHIS electronically or through the mail as provided at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance 
regarding how to complete a request in a manner that will allow APHIS 
to review it expeditiously is available at https://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by 
contacting the National Director, Regionalization Evaluation Services, 
National Import Export Services, VS, APHIS, 4700 River Road Unit 38, 
Riverdale, MD 20737. At a minimum, in order for APHIS to consider the 
request complete, it must define the boundaries of the region, specify 
the prevalence level for tuberculosis within the region, and 
demonstrate the following:
    (1) That there is effective veterinary control and oversight within 
the region;
    (2) That tuberculosis is a notifiable disease within the region; 
and
    (3) That the region has a program in place for tuberculosis that 
includes, at a minimum:
    (i) Epidemiological investigations following the discovery of any 
infected animals or affected herds, or any animals or herds that have 
had non-negative test results following a test for tuberculosis, and 
documentation of these investigations;
    (ii) Management of affected herds in a manner designed to eradicate 
tuberculosis from those herds, and documentation regarding this 
management;
    (iii) Regulatory controls on the movement of livestock into, 
within, and from the region that correspond to the risk of 
dissemination of tuberculosis associated with such movement; and
    (iv) Access to, oversight of, and quality controls for diagnostic 
testing for tuberculosis within the region.
    (4) That the region has surveillance in place that is equivalent to 
or exceeds Federal standards for surveillance within the United States.
    (b) APHIS evaluation. If APHIS considers the request complete, 
APHIS will publish a notice in the Federal Register proposing to 
classify the region according to Sec.  93.437, and making available to 
the public the information upon which this proposed classification is 
based. The notice will request public comment.
    (c) APHIS determination. (1) If no comments are received on the 
notice, or if comments are received but do not affect APHIS' proposed 
classification, APHIS will publish a subsequent notice in the Federal 
Register announcing that classification to be final and adding the 
region to the appropriate list on the Internet.
    (2) If comments received on the notice suggest that the region be 
classified according to a different tuberculosis classification, and 
APHIS agrees with the comments, APHIS will publish a subsequent notice 
in the Federal Register making the information supplied by commenters 
available to the public, and proposing to classify the region according 
to this different classification. The notice will request public 
comment.
    (3) If comments received on the notice suggest that insufficient 
information was supplied on which to base a tuberculosis 
classification, and APHIS agrees with the comments, APHIS will publish 
a subsequent notice in the Federal Register specifying the additional 
information needed before APHIS can classify the region.
    (d) Maintaining classification and reclassification initiated by 
APHIS. If a region is classified under the provisions of this section, 
that region may be required to submit additional information or allow 
APHIS to conduct additional information collection activities in order 
for that region to maintain its classification. Moreover, if APHIS 
determines that a region's classification for tuberculosis is no longer 
accurate, APHIS will publish a notice in the Federal Register 
announcing the revised classification and setting forth the reasons for 
this reclassification.
0
41. Section 93.439 is added to subpart D to read as follows:


Sec.  93.439  Importation of ruminants from certain regions of the 
world; tuberculosis.

    (a) Importation of certain ruminants prohibited. Notwithstanding 
any other provisions of this section, ruminants that are known to be 
infected with or exposed to tuberculosis and ruminants that have had a 
non-negative response to any test for tuberculosis are prohibited 
importation into the United States.
    (b) Importation of bovines from Level I regions. Unless specified 
otherwise by the Administrator, bovines may be imported into the United 
States from a Level I region for tuberculosis without further 
restriction under this section.\11\
---------------------------------------------------------------------------

    \11\ The importation of such bovines, as well as that of all 
other bovines covered by this section, is still subject to all other 
relevant restrictions of this part.
---------------------------------------------------------------------------

    (c) Importation of bovines for immediate slaughter from Level II, 
III, or IV regions. Bovines may be imported into the United States for 
immediate slaughter from a Level II, III, or IV region for tuberculosis 
provided that:
    (1) The bovines are officially identified; and
    (2) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified.
    (d) Importation of other bovines from a Level II region--(1) 
Bovines directly from currently accredited herds for tuberculosis. 
Bovines may be imported into the United States for purposes other than 
immediate slaughter directly from a currently accredited herd for 
tuberculosis in a Level II region for tuberculosis, provided that:
    (i) The bovines are officially identified; and
    (ii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for tuberculosis. Sexually intact bovines 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level II 
region for tuberculosis for purposes other than immediate slaughter 
provided that:
    (i) If the bovines are 6 months of age or older, the bovines are 
subjected to an individual test for tuberculosis at the port of entry 
into the United States or during post-arrival quarantine in accordance 
with Sec.  93.411, with negative results; and
    (ii) The bovines are officially identified; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
animals are officially identified.
    (3) Steers or spayed heifers that do not originate directly from a 
currently accredited herd for tuberculosis. Steers or spayed heifers 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level II 
region for tuberculosis for purposes other than immediate slaughter 
provided that:
    (i) The steers or spayed heifers are officially identified; and
    (ii) The steers or spayed heifers are accompanied by a certificate, 
issued in accordance with Sec.  93.405(a), with an additional statement 
that the steers or spayed heifers are officially identified.
    (e) Importation of other bovines from a Level III region--(1) 
Bovines directly from currently accredited herds for

[[Page 78518]]

tuberculosis. Bovines may be imported into the United States for 
purposes other than immediate slaughter directly from a currently 
accredited herd for tuberculosis in a Level III region for 
tuberculosis, provided that:
    (i) The bovines are officially identified; and
    (ii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for tuberculosis. Sexually intact bovines 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level III 
region for tuberculosis for purposes other than immediate slaughter, 
provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for tuberculosis on its premises of origin no more than 1 
year prior to the export of the bovines to the United States, with 
negative results; and
    (ii) If the bovines are 2 months of age or older, the bovines are 
subjected to an additional individual test for tuberculosis on the 
premises of origin no more than 60 days prior to export of the bovines 
to the United States, with negative results, except that this 
additional test is not required if the bovines are exported within 60 
days of the whole herd test and were included in that test; and
    (iii) The bovines are officially identified; and
    (iv) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
animals meet the conditions for importation in paragraphs (e)(2)(i) 
through (iii) of this section.
    (3) Steers or spayed heifers that do not originate directly from a 
currently accredited herd for tuberculosis. Steers or spayed heifers 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level III 
region for tuberculosis for purposes other than immediate slaughter 
provided that:
    (i) If the steers or spayed heifers are 6 months of age or older, 
the steers or spayed heifers are subjected to an individual test for 
tuberculosis on the premises of origin no more than 60 days prior to 
export of the bovines to the United States, with negative results; and
    (ii) The steers or spayed heifers are officially identified; and
    (iii) The steers or spayed heifers are accompanied by a 
certificate, issued in accordance with Sec.  93.405(a), with an 
additional statement that the animals meet the conditions for 
importation in this paragraph (e)(3).
    (f) Importation of other bovines from a Level IV region--(1) 
Bovines directly from currently accredited herds for tuberculosis. 
Bovines may be imported into the United States for purposes other than 
immediate slaughter directly from a currently accredited herd for 
tuberculosis in a Level IV region for tuberculosis, provided that:
    (i) The bovines are subjected to an individual test for 
tuberculosis at the port of entry into the United States or during 
post-arrival quarantine in accordance with Sec.  93.411, with negative 
results; and
    (ii) The bovines are officially identified; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for tuberculosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for tuberculosis. Sexually intact bovines 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level IV 
region for tuberculosis for purposes other than immediate slaughter, 
provided that:
    (i) The bovines originate from a herd that was subjected to two 
whole herd tests for tuberculosis on its premises of origin and 
conducted no less than 9 months and no more than 15 months apart, with 
the second whole herd test conducted no less than 60 days prior the 
export of the bovines to the United States, with negative results each 
time; and
    (ii) If the bovines are 2 months of age or older, the bovines are 
subjected to an additional individual test for tuberculosis at the port 
of entry into the United States or during post-arrival quarantine in 
accordance with Sec.  93.411, with negative results; and
    (iii) The bovines are officially identified; and
    (iv) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines meet the requirements in paragraphs (f)(2)(i) and (iii) of this 
section.
    (3) Steers or spayed heifers that do not originate directly from a 
currently accredited herd for tuberculosis. Steers or spayed heifers 
that do not originate directly from a currently accredited herd for 
tuberculosis may be imported into the United States from a Level IV 
region for tuberculosis for purposes other than immediate slaughter 
provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for tuberculosis on its premises of origin no more than 1 
year prior to the export of the bovines, with negative results; and
    (ii) If the bovines are 2 months of age or older, the bovines are 
subjected to an additional individual test for tuberculosis on the 
premises of origin no more than 60 days prior to export of the bovines 
to the United States, with negative results, except that this 
additional test is not required if the bovines are exported within 60 
days of the whole herd test and were included in that test; and
    (iii) The bovines are officially identified; and
    (iv) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines meet the requirements in this paragraph (f)(3).
    (g) Importation of bovines from a Level V region. Bovines may be 
imported from a Level V region for tuberculosis, provided that:
    (1) APHIS and the importer have entered into a Cooperative and 
Trust Fund Agreement, and the importer has deposited funds with APHIS 
in an amount determined by APHIS to cover all costs incurred by APHIS 
in providing services in accordance with the Cooperative and Trust Fund 
Agreement; and
    (2) The bovines originate from a herd that was subjected to two 
whole herd tests for tuberculosis on its premises of origin and 
conducted no less than 9 months and no more than 15 months apart, with 
at least the second whole herd test administered by an APHIS 
veterinarian and conducted no less than 60 days prior to export, with 
negative results; and
    (3) The bovines are subjected to an additional individual test for 
tuberculosis at the port of entry into the United States or during 
post-arrival quarantine in accordance with Sec.  93.411, with negative 
results; and
    (4) The bovines are officially identified; and
    (5) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that 
bovines meet the requirements in paragraphs (g)(1), (2), and (4) of 
this section.

[[Page 78519]]

0
42. Section 93.440 is added to subpart D to read as follows:


Sec.  93.440  Brucellosis status of foreign regions.

    (a) Level I regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.  93.441, and a prevalence of 
brucellosis in their domestic bovine herds of less than 0.001 percent 
over at least the previous 2 years (24 consecutive months).
    (b) Level II regions. APHIS considers certain regions of the world 
to have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.  93.441, and a prevalence of 
brucellosis in their domestic bovine herds equal to or greater than 
0.001 percent, but less than 0.01 percent over at least the previous 2 
years (24 consecutive months).
    (c) Level III regions. APHIS considers certain regions of the world 
not to have a program that meets APHIS requirements for brucellosis 
classification in accordance with Sec.  93.441, to have a herd 
prevalence equal to or greater than 0.01 percent, or to be unassessed 
by APHIS with regard to brucellosis prevalence.
    (d) Listing of regions. Lists of all Level I, Level II, and Level 
III regions for brucellosis are found online, at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Changes to 
the lists will be made in accordance with Sec.  93.441.
0
43. Section 93.441 is added to subpart D to read as follows:


Sec.  93.441  Process for requesting regional classification for 
brucellosis.

    (a) Request for regional classification; requirements. A 
representative of the competent veterinary authority of any country or 
countries may request that APHIS classify a region for brucellosis. 
Requests for classification or reclassification must be submitted to 
APHIS electronically or through the mail as provided at https://www.aphis.usda.gov/import_export/animals/live_animals.shtml. Guidance 
regarding how to complete a request in a manner that will allow APHIS 
to review it expeditiously is available at https://www.aphis.usda.gov/import_export/animals/reg_request.shtml, and may also be obtained by 
contacting the National Director, Regionalization Evaluation Services, 
National Import Export Services, VS, APHIS, 4700 River Road Unit 38, 
Riverdale, MD, 20737. At a minimum, in order for APHIS to consider the 
request complete, it must define the boundaries of the region, specify 
the prevalence level for brucellosis within the region, and demonstrate 
the following:
    (1) That there is effective veterinary control and oversight within 
the region;
    (2) That brucellosis is a notifiable disease within the region; and
    (3) That the region has a program for brucellosis in place that 
includes, at a minimum:
    (i) Epidemiological investigations following the discovery of any 
infected animals or affected herds, or any animals or herds that have 
had non-negative test results following a test for brucellosis, and 
documentation of these investigations;
    (ii) Management of affected herds in a manner designed to eradicate 
brucellosis from those herds, and documentation regarding this 
management;
    (iii) Regulatory controls on the movement of livestock into, 
within, and from the region that correspond to the risk of 
dissemination of brucellosis associated with such movement; and
    (iv) Access to, oversight of, and quality controls on diagnostic 
testing for brucellosis within the region.
    (4) That the region has surveillance in place that is equivalent to 
or exceeds Federal standards for brucellosis surveillance within the 
United States; and
    (5) That, if the region vaccinates for brucellosis, it is in a 
manner that has been approved by APHIS.
    (b) APHIS evaluation. If APHIS considers the request complete, 
APHIS will publish a notice in the Federal Register proposing to 
classify the region according to Sec.  93.440, and making available to 
the public the information upon which this proposed classification is 
based. The notice will request public comment.
    (c) APHIS determination. (1) If no comments are received on the 
notice, or if comments are received but do not affect APHIS' proposed 
classification, APHIS will publish a subsequent notice in the Federal 
Register announcing that classification to be final and adding the 
region to the appropriate list on the Internet.
    (2) If comments received on the notice suggest that the region be 
classified according to a different brucellosis classification, and 
APHIS agrees with the comments, APHIS will publish a subsequent notice 
in the Federal Register making the information supplied by commenters 
available to the public, and proposing to classify the region according 
to this different classification. The notice will request public 
comment.
    (3) If comments received on the notice suggest that insufficient 
information was supplied on which to base a brucellosis classification, 
and APHIS agrees with the comments, APHIS will publish a subsequent 
notice in the Federal Register specifying the additional information 
needed before APHIS can classify the region.
    (d) Maintaining classification and reclassification initiated by 
APHIS. If a region is classified under the provisions of this section, 
that region may be required to submit additional information or allow 
APHIS to conduct additional information collection activities in order 
for that region to maintain its classification. Moreover, if APHIS 
determines that a region's classification for brucellosis is no longer 
accurate, APHIS will publish a notice in the Federal Register 
announcing the revised classification and setting forth the reasons for 
this reclassification.
0
44. Section 93.442 is added to subpart D to read as follows:


Sec.  93.442  Importation of ruminants from certain regions of the 
world; brucellosis.

    (a) Importation of certain ruminants prohibited. Notwithstanding 
any other provisions of this section, ruminants that are known to be 
infected with or exposed to brucellosis and ruminants that have had a 
non-negative response to any test for Brucella spp. are prohibited 
importation into the United States.
    (b) Importation of bovines from Level I regions. Unless specified 
otherwise by the Administrator, bovines may be imported into the United 
States from a Level I region for brucellosis without further 
restriction under this section.\12\
---------------------------------------------------------------------------

    \12\ The importation of such bovines, as well as that of all 
other bovines covered by this section, is still subject to all other 
relevant restrictions of this chapter.
---------------------------------------------------------------------------

    (c) Bovines for slaughter. Bovines may be imported for slaughter 
from a Level II or Level III region for brucellosis provided that:
    (1) The bovines are officially identified; and
    (2) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified.
    (d) Importation of other bovines from a Level II region for 
purposes other than immediate slaughter--(1) Bovines directly from 
currently accredited herds for brucellosis. Bovines may be imported 
into the United States for purposes other than immediate slaughter from 
a currently accredited herd for brucellosis in a Level II region for 
brucellosis, provided that:

[[Page 78520]]

    (i) The bovines are officially identified; and
    (ii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for brucellosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for brucellosis. Sexually intact bovines that 
do not originate directly from a currently accredited herd for 
brucellosis may be imported into the United States from a Level II 
region for brucellosis for purposes other than immediate slaughter, 
provided that:
    (i) The bovines originate from a herd that was subjected to a whole 
herd test for brucellosis on its premises of origin no more than 90 
days and no less than 30 days prior to the export of the bovines to the 
United States, with negative results; and
    (ii) If the bovines are 6 months of age or older, the bovines are 
subjected to an additional individual test for brucellosis at the port 
of entry into the United States or during post-arrival quarantine in 
accordance with Sec.  93.411, with negative results; and
    (iii) The bovines are officially identified; and
    (iv) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines meet the requirements in paragraphs (d)(2)(i) and (iii) of this 
section.
    (3) Steers and spayed heifers that do not originate directly from a 
currently accredited herd for brucellosis. Steers or spayed heifers 
that do not originate directly from a currently accredited herd for 
brucellosis may be imported into the United States from a Level II 
region for brucellosis for purposes other than immediate slaughter, 
provided that:
    (i) The steers or spayed heifers are officially identified; and
    (ii) The steers or spayed heifers are accompanied by a certificate, 
issued in accordance with Sec.  93.405(a), with an additional statement 
that the steers or spayed heifers are officially identified.
    (e) Importation of other bovines from a Level III region for 
purposes other than immediate slaughter--(1) Bovines directly from 
currently accredited herds for brucellosis. Bovines may be imported 
into the United States for purposes other than immediate slaughter from 
a currently accredited herd for brucellosis in a Level III region for 
brucellosis, provided that:
    (i) If sexually intact, the bovines are subjected to an individual 
test for brucellosis at the port of entry into the United States or 
during post-arrival quarantine in accordance with Sec.  93.411, with 
negative results; and
    (ii) The bovines are officially identified; and
    (iii) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines are officially identified and originate directly from a 
currently accredited herd for brucellosis.
    (2) Sexually intact bovines that do not originate directly from a 
currently accredited herd for brucellosis. Sexually intact bovines that 
do not originate directly from a currently accredited herd for 
brucellosis may be imported into the United States from a Level III 
region for brucellosis for purposes other than immediate slaughter, 
provided that:
    (i) The bovines originate from a herd that was subjected to two 
whole herd tests for brucellosis on its premises of origin, with the 
second test taking place no more than 90 days and no less than 30 days 
prior to the export of the bovines to the United States, with negative 
results each time; and
    (ii) If the bovines are 6 months of age or older, the bovines are 
subjected to an additional individual test for brucellosis at the port 
of entry into the United States or during post-arrival quarantine in 
accordance with Sec.  93.411; and
    (iii) The bovines are officially identified; and
    (iv) The bovines are accompanied by a certificate, issued in 
accordance with Sec.  93.405(a), with an additional statement that the 
bovines meet the requirements in paragraphs (e)(2)(i) and (iii) of this 
section.
    (3) Steers and spayed heifers that do not originate directly from a 
currently accredited herd for brucellosis. Steers or spayed heifers 
that do not originate directly from a currently accredited herd for 
brucellosis may be imported into the United States from a Level III 
region for brucellosis for purposes other than immediate slaughter, 
provided that:
    (i) The steers or spayed heifers are officially identified; and
    (ii) The steers or spayed heifers are accompanied by a certificate, 
issued in accordance with Sec.  93.405(a), with an additional statement 
that the steers or spayed heifers are officially identified.

PART 161--REQUIREMENTS AND STANDARDS FOR ACCREDITED VETERINARIANS 
AND SUSPENSION OR REVOCATION OF SUCH ACCREDITATION

0
45. The authority citation for part 161 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 
2.80, and 371.4.

0
46. Section 161.5 is amended by removing the last two sentences of the 
section and adding five new sentences in their place to read as 
follows:


Sec.  161.5  Program certifications.

    * * * A QAV will be accredited to perform those specific accredited 
duties related to the program certification he or she has been granted; 
accredited veterinarians not granted a program certification will not 
be permitted to perform accredited duties related to that particular 
program certification. In order to retain a program certification, a 
QAV must meet standards set forth by APHIS regarding performance of 
accredited duties identified for that certification. APHIS may 
decertify a QAV for a specific program certification if that QAV does 
not perform accredited duties in accordance with that program 
certification standard. APHIS may also suspend or revoke the 
accreditation of the QAV, if warranted. Finally, if a QAV allows his or 
her Category II accreditation to expire, the QAV's program 
certification expires as well, and the QAV must be qualified for the 
program certification again in accordance with this section.

    Done in Washington, DC, this 9th day of December 2015.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2015-31510 Filed 12-15-15; 8:45 am]
 BILLING CODE 3410-34-P