[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Proposed Rules]
[Pages 78462-78520]
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: http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0044.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2011-0044, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0044 or in our reading room, which is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Domestic regulatory provisions: Dr. C.
William Hench, Senior Staff Veterinarian, Ruminant Health Programs, VS,
APHIS, 2150 Centre Avenue, Building B-3E20, Fort Collins, CO 80526-
8117; (970) 4947378. Import-related regulatory provisions: Dr. Langston
Hull, National Import Export Services, VS, APHIS, 4700 River Road Unit
39, Riverdale, MD 20737; (301) 851-3300.
SUPPLEMENTARY INFORMATION:
Background
I. Purpose of the Regulatory Action
a. Need for the Regulatory Action
Bovine tuberculosis is a contagious and infectious granulomatous
disease caused by the bacterium Mycobacterium bovis. Although commonly
defined as a chronic debilitating disease, bovine tuberculosis can
occasionally assume an acute, rapidly progressive course. While any
body tissue can be affected, lesions are most frequently observed in
the lymph nodes, lungs, intestines, liver, spleen, pleura, and
peritoneum. Although cattle are considered to be the true hosts of M.
bovis, the disease has been reported in several other species of
livestock, most notably bison and captive cervids. There have also been
instances of infection in other domestic and nondomestic animals, as
well as in humans.
Brucellosis is a contagious disease, caused by bacteria of the
genus Brucella, that affects both animals and humans. The disease
mainly affects cattle, bison, and swine; however, goats, sheep, horses,
and humans are susceptible as well. In its principal animal hosts, it
causes loss of young through spontaneous abortion or birth of weak
offspring, reduced milk production, and infertility. There is no
economically feasible treatment for brucellosis in livestock. In
humans, brucellosis initially causes flu-like symptoms, but the disease
may develop into a variety of chronic conditions, including arthritis.
Humans can be treated for brucellosis with antibiotics.
These diseases were widely prevalent in the United States during
the early 1900s. As recently as 1917, 1 in 20 cattle herds within the
United States was affected with bovine tuberculosis, and, in 1934, 1 in
10 adult cattle within the United States was a reactor (i.e., tested
positive) for brucellosis.
Such prevalence prompted the establishment of a National
Cooperative State/Federal Eradication Program for bovine tuberculosis
(referred to below as the bovine tuberculosis program) and a National
Cooperative State/Federal Eradication Program for brucellosis (referred
to below as the brucellosis program). The programs sought to eradicate
the diseases from the nation's cattle herds by quickly responding to
brucellosis and bovine tuberculosis outbreaks, identifying and
quarantining affected herds, and depopulating these herds. To foster
producer compliance with herd depopulation, the United States
Department of Agriculture (USDA) regularly compensated the owners of
depopulated herds.
In support of these programs, USDA issued regulations. These
regulations established State classification systems for brucellosis
and bovine tuberculosis based on disease prevalence within a State. The
regulations further required that these prevalence levels be supported
by surveillance (inspection and periodic testing) of cattle within the
State and specified that, for a State to maintain its classification,
affected herds within a State had to be depopulated within a certain
period of time. Finally, the regulations specified testing requirements
and movement restrictions for cattle moved interstate from certain
classes of States.
Since their inception, these regulatory programs have proven
extremely successful in reducing the prevalence of brucellosis and
bovine tuberculosis within the United States. Based on routine
inspection conducted by USDA's Food Safety Inspection Service (FSIS) of
cattle slaughtered at slaughtering establishments, brucellosis
currently affects less than 0.001 percent of all domestic program
herds, and bovine tuberculosis less than 0.001 percent of all such
herds. Under the standards of the World Organisation for Animal Health
(OIE), these prevalence levels, excluding consideration of other OIE
standards, are, in and of themselves, consistent with a ``free'' status
for brucellosis and bovine tuberculosis.
However, in recent years, several factors have arisen to impede our
brucellosis and bovine tuberculosis eradication efforts. First,
reservoirs of brucellosis and bovine tuberculosis have been identified
in wildlife populations in certain areas of the
[[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 http://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 http://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
http://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.
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\7\ The Program Standards document is available at the Web
address listed in this document beneath the heading ADDRESSES and at
the following address: http://www.aphis.usda.gov/animal_health/animal_dis_spec/cattle.
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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.
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\8\ To view the Uniform Methods and Rules, go to http://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf.
---------------------------------------------------------------------------
We wish to solicit specific public comment regarding one of these
differences. Currently, if a State has a zone for bovine tuberculosis
or an area covered by a brucellosis management plan, in other words, an
area in which a source of bovine tuberculosis or brucellosis is known
to exist, we allow herds in the area to be accredited for bovine
tuberculosis or certified free of brucellosis.
However, we have discovered bovine tuberculosis or brucellosis in
several accredited herds in such areas, sometimes no more than a few
months after the date of reaccreditation. In each case, there was
evidence that the herds probably became affected through contact with
infected wildlife.
Our standards for accreditation, both our current standards and
those proposed, are based on an evaluation of mitigation measures an
owner has put in place to address the risk of bovine tuberculosis or
brucellosis introduction into his or her herd through the addition of
animals to the herd. Our standards do not evaluate the risk posed to a
herd by wildlife reservoirs of bovine tuberculosis or brucellosis. We
note, moreover, that it is significantly more difficult to mitigate the
risk of disease transmission that is posed by wildlife reservoirs than
it is to mitigate the risk of disease transmission that is posed by
adding animals to a herd. In short, while we have confidence that
accredited or certified herds that do not reside in areas with known
disease reservoirs present a low risk of becoming affected with bovine
tuberculosis or brucellosis, we do not have the same degree of
confidence regarding herds in areas with known reservoirs of disease.
For this reason, our proposed standards would not allow herds in
areas with known reservoirs of disease, which we would term management
areas (see below), to be accredited for bovine tuberculosis or
brucellosis. We also would not allow owners of currently accredited
herds in such areas to seek reaccreditation if this rule is finalized.
We request comment from these owners and all interested parties
regarding the likely impacts to their operations, if any, that this
change in policy would bring about.
Apart from herds in recognized management areas, herds that are
accredited for bovine tuberculosis would continue to be considered
accredited herds if this proposed rule is finalized, and herds that are
certified brucellosis-free herds would be considered accredited herds
for brucellosis. Owners of these herds would not be held to the
differing standards of the Program Standards document until the time
that the herds would have to be tested for reaccreditation. Moreover,
as the definitions of accredited herd for bovine tuberculosis and
accredited herd for brucellosis would provide, States could submit an
alternate accreditation standard to the Administrator for evaluation
and approval at any point by sending a written request to APHIS,
provided that the standard is at least equally stringent to that within
the Program Standards document.
We would define annual report form as the annual report form
authorized by the Administrator for State and Tribal use to fulfill the
requirements of proposed part 76. The report form, which would
consolidate and streamline existing annual report forms for the
brucellosis and bovine tuberculosis programs, would be located on the
APHIS Web site. A draft template for the annual report form is located
in the Program Standards document.
On a related matter, we would define the reporting period covered
by the annual report as October 1 of one year through September 30 of
the following year. This is the current reporting period for annual
reports within the bovine tuberculosis program. (We recognize that the
reporting period for annual reports within the brucellosis program is
currently staggered, and corresponds to the date on which a State was
assigned its current status. If this rule is finalized, we would
collaborate with States to transition them over to this new, uniform
reporting period.)
We would define APHIS as the Animal and Plant Health Inspection
Service of the United States Department of Agriculture.
We would define bison as domestically produced or captive bison. As
provided in the definition of program animals (see below), bison would
be considered one of the species covered by part 76. However, wild
bison are not considered livestock within our proposed regulations, and
our definition of bison would reflect this. We would also include this
definition so that, for the sake of brevity, we may refer to the
species covered by the regulations as bison, rather than domestically
produced or captive bison, throughout part 76.
We would define bovine tuberculosis as the contagious, infectious,
and communicable disease caused by Mycobacterium bovis, which is also
referred to as tuberculosis.
Currently, part 77 refers to the disease as tuberculosis, and
provides, in the definition of tuberculosis, that the disease is also
referred to as bovine tuberculosis. However, in recent years, we have
referred to the disease as bovine tuberculosis in order to provide
clarity regarding the causal agent regulated by the bovine tuberculosis
program and to differentiate between this agent and Mycobacterium
tuberculosis, the most common cause of tuberculosis in humans.
We would define brucellosis as the contagious, infectious, and
communicable disease caused by Brucella abortus, and would specify that
it is also known as Bangs disease, undulant fever, and contagious
abortion. Currently, in the definition of brucellosis in part 78, we
consider all bacteria within the genus Brucella to be causal agents for
brucellosis. However, this is primarily because another species of
Brucella, Brucella suis, which is the most common cause of brucellosis
in swine, is also regulated in part 78. Brucella abortus is the most
common cause of brucellosis in cattle, bison, and captive cervids, the
species that would be regulated under the consolidated brucellosis and
bovine tuberculosis program. Hence, as we stated in the draft
regulatory framework document, Brucella abortus would be the disease
agent regulated under proposed part 76.
(We would continue to regulate Brucella suis in swine under part 78
and would continue to investigate
[[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:
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\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.
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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.
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\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
http://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: http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://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\
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\1\ Minimum requirements for surveillance activities conducted
under an animal health plan are set forth in Sec. 76.6.
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(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\
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\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\
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\3\ See Sec. 76.6(a).
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(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\
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\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 http://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 http://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 http://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 http://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 http://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 http://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 http://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