Federal Register, Volume 85 Issue 181 (Thursday, September 17, 2020)

[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Rules and Regulations]
[Pages 57944-57956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20552]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 93

[Docket No. APHIS-2011-0044]
RIN 0579-AD65

Brucellosis and Bovine Tuberculosis: Importation of Cattle and
Bison

AGENCY: Animal and Plant Health Inspection Service, Agriculture
Department (USDA).

ACTION: Final rule.

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SUMMARY: We are amending the regulations governing the importation of
cattle and bison with respect to bovine tuberculosis and brucellosis to
establish a system to classify foreign regions as a particular status
level for bovine tuberculosis and a particular status level for
brucellosis. We are also establishing provisions for modifying the
bovine tuberculosis or brucellosis classification of a foreign region.
Finally, we are establishing conditions for the importation of cattle
and bison from regions with the various classifications. The changes
will make the requirements clearer and assure that they more
effectively mitigate the risk of introduction of these diseases into
the United States.

DATES: Effective October 19, 2020.

FOR FURTHER INFORMATION CONTACT: Dr. Kelly Rhodes, Senior Staff
Veterinarian, Regionalization Evaluation Services, VS, APHIS, 4700
River Road, Unit 38, Riverdale, MD 20737-1236; (301) 851-3300.

SUPPLEMENTARY INFORMATION:

Background

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 (referred to below as
tuberculosis) within the United States. The current regulations, which
may be divided into requirements that are generally applicable to most
exporting countries and specific requirements that are applicable to
Canada, Mexico, and the Republic of 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.
On December 16, 2015, we published in the Federal Register (80 FR
78461-78520, Docket No. APHIS-2011-0044) a proposal \1\ to amend the
regulations by consolidating the domestic regulations governing
tuberculosis and those governing brucellosis, as well as to revise the
tuberculosis- and brucellosis-related import requirements for cattle
and bison to make these requirements clearer and ensure that they more
effectively mitigate the risk of introduction of these diseases into
the United States.
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\1\ To view the proposed rule, supporting documents, and the
comments we received, go to https://www.regulations.gov/docket?D=APHIS-2011-0044.
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We solicited comments concerning our proposal for 90 days ending
March 15, 2016. We extended the deadline for comments until May 16,
2016, in a document published in the Federal Register on March 11, 2016
(81 FR 12832-12833). We received 164 comments by the close of the
extended comment period. Of those comments, 122 addressed the domestic
provisions of the proposed rule and 42 addressed

[[Page 57945]]

the import-related provisions. The comments were from captive cervid
producers and captive cervid breeders' associations, cattle industry
groups, State agriculture departments, State game and fish departments,
veterinarians, representatives of foreign governments, and private
citizens.

Domestic Regulations

After considering all the comments we received, we concluded that
it is necessary to reexamine the proposed changes to the domestic
tuberculosis and brucellosis programs. Therefore, in a document
published in the Federal Register on March 27, 2019 (84 FR 11448-11449,
Docket No. APHIS-2011-0044), we withdrew the proposed amendments to
parts 50, 51, 71, 76, 77, 78, 86, and 161 in our December 16, 2015,
proposed rule.

Import Regulations

We proposed to establish a system that would classify regions for
tuberculosis or brucellosis based on whether the region has a program
for tuberculosis or brucellosis control that meets certain standards
and on the prevalence of the disease. We proposed the following
classifications: Levels I through V for tuberculosis and Levels I
through III for brucellosis. The classification system is based on
prevalence as an indicator of risk. Level I regions have the lowest
prevalence and bovine animals from these regions may be imported
without testing. Prevalence increases with each successive level, as do
the associated import requirements. The specific requirements for each
level are set out in Sec. 93.437 for tuberculosis, and in Sec. 93.440
for brucellosis.
We further proposed to allow regions to request evaluation for a
particular classification, to establish a process by which the United
States Department of Agriculture's (USDA's) Animal and Plant Health
Inspection Service (APHIS) would evaluate such requests, and to allow
APHIS to lower a region's classification based on emerging evidence.
Finally, we proposed to establish conditions for the importation of
cattle and bison that correspond to the tuberculosis or brucellosis
classification of the region from which the cattle or bison would be
exported. APHIS recognizes that there are three countries that enjoy
particular status under the current part 93 regulations. These regions
will continue to be able to trade with the United States under the
terms of the status they currently hold until this final rule is
effective and we act to adjust their status using the new approach
spelled out in this final rule.
Commenters raised a number of concerns about the proposed rule.
They are discussed below by topic.

International Standards

Some commenters asked whether the proposed import standards would
be consistent with international guidelines for tuberculosis and
brucellosis developed by the World Organization for Animal Health
(OIE).
APHIS considered several alternative regulatory approaches to
revising regulations governing the importation of cattle and bison with
respect to bovine tuberculosis and brucellosis, including following OIE
guidance on tuberculosis and brucellosis. The Terrestrial Animal Health
Code of the OIE lays out three options for safe trade in bovine animals
with regard to tuberculosis and brucellosis. These options can be
categorized as (1) free country; (2) free herd; and (3) not free,
respectively. APHIS conducted an analysis that compared adopting the
OIE standards with the adaptation of U.S. domestic regulations for
importation, as in this final rule.\2\ APHIS concluded in that analysis
that the adapted U.S. regulations are more restrictive in some cases
than the OIE Terrestrial Code and less restrictive in others, depending
on the classification level. APHIS further concluded that both the OIE
Terrestrial Code and U.S. regulations adapted to importation would
substantially mitigate import risk. However, the U.S. regulations
reduce the risk to negligible levels; import risk under the OIE
Terrestrial Code may exceed the U.S. appropriate level of protection.
Unlike the adapted U.S. regulations, the OIE Terrestrial Code does not
take into account the difference in tuberculosis risk between feeder
animals and breeding animals, or factors that influence the ability of
the exporting region to accurately comply with diagnostic testing and
certification requirements. APHIS concluded in its analysis that the
OIE Terrestrial Code is not sufficiently flexible to address the
variable bovine tuberculosis prevalence levels reported by U.S. trading
partners without either jeopardizing the status of U.S. eradication
programs or constituting an unnecessary burden for the exporting
country. Applying the adapted U.S. regulations would provide
considerable flexibility in addressing the wide range of prevalence
levels and programmatic approaches in exporting regions. Applying the
adapted regulations is also consistent with the regionalization
approach that APHIS takes for other diseases. Therefore, we determined
from our analysis of relevant scientific data that risks to U.S.
production were better addressed through the approach developed in this
rule than through adoption of OIE Terrestrial Code.
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\2\ The risk assessment can be viewed at https://www.regulations.gov/document?D=APHIS-2011-0044-0046.
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Requesting Regional Classification for Tuberculosis

One commenter stated that the classification for a region should
take into account the prevalence of both tuberculosis and brucellosis
in the region. The commenter did not explain why they believed
classification for one disease should be based on prevalence of both
diseases.
APHIS disagrees with the commenter. Tuberculosis and brucellosis
are different diseases with different risk factors, different
transmission mechanisms, and differences in our ability to detect them.
The existence of one has little influence on presence or absence of the
other. However, foreign regions will need to be evaluated for both in
order to export cattle to the United States other than for direct
slaughter. Keeping disease evaluations and classifications separate is
also consistent with our domestic policy.
One commenter stated that Sec. 93.438 needs to clarify that it is
period prevalence, and herd prevalence, rather than in-herd prevalence.
We agree. Prevalence is calculated over the time period described
for each level, based on the number of affected herds. In some
instances, the Administrator may allow calculation of period prevalence
based on affected herd-years to avoid penalizing regions with small
herd numbers. We have added a definition of prevalence to Sec. 93.400
to clarify this.
Two commenters asked if a large regional request could mask pockets
of high prevalence of tuberculosis.
APHIS agrees that there is potential to artificially dilute the
apparent prevalence in large regions. Each region must therefore
satisfy the regulatory requirements outlined in Sec. 93.438, not just
meet a certain prevalence level. Regions that satisfy the requirements
have a strong tuberculosis program and demonstrated ability to
effectively detect and contain tuberculosis infection, thereby limiting
the risk to the United States. Regions that do not satisfy the
requirements would be classified as Level V. All tuberculosis cases
originating from a given region will be used in the prevalence
calculations.
One commenter asked if Level I countries will need to supply

[[Page 57946]]

information equivalent to an animal health plan required of a State or
Tribe as described under the proposed rule.
APHIS notes that we proposed the requirement for an animal health
plan as a change to the domestic tuberculosis regulations and we are
making no changes to those regulations at this time. However, foreign
regions seeking classification at any level would have to supply a
detailed description of tuberculosis program activities. The region
would generally also undergo a site visit, during which APHIS would
evaluate and document compliance with the evaluation criteria outlined
in Sec. 93.438.
One commenter stated that the proposed criteria for requesting
regional classification for tuberculosis do not work for biologically
free countries. This commenter also stated that Australia has
successfully eradicated tuberculosis and should be recognized as free
of the disease.
We designed this rule to efficiently address the wide range of risk
posed by U.S. trading partners with regard to tuberculosis and
brucellosis. Australia is the only country that we are aware of that
has made claims to biological freedom from tuberculosis. We are not
making any changes based on this comment because we do not see a direct
benefit to exporting regions, since cattle from Level I regions are
already exempt from tuberculosis testing, and also because creating a
classification for biologically free regions (i.e., zero prevalence)
would lead to trade disruptions should an outbreak occur. Our review of
Australia's status is ongoing.
One commenter stated that surveillance should be required for all
countries submitting a request for classification. However, another
commenter expressed concern that the proposed requirements for
surveillance do not recognize regions whose status for tuberculosis
exceeds that of the United States, for example, those with a claim to
biological freedom from the disease.
APHIS agrees that surveillance should be required for all regions
submitting a request for a classification other than Level V, although
the degree and intensity of surveillance may vary depending on regional
conditions including past surveillance and findings. We anticipate that
most such regions will have surveillance in place similar to the United
States, involving a combination of slaughter surveillance and live
animal testing. In rare instances, a region may have reached the point
that they are confident that reducing active live animal and slaughter
surveillance will not ultimately lead to a resurgence of the disease.
In evaluating such regions, APHIS would still assess whether the
historical and current surveillance measures provide equivalent
assurance of tuberculosis detection to that in the United States.
One commenter noted that the proposed rule stated that guidance on
how to complete a request for classification in a manner that will
allow APHIS to review it expeditiously would be available on the APHIS
website. The commenter asked what timeframe would be considered
expeditious, and stated that it should be defined as meaning weeks or
months, not years.
The time to complete the process from receipt of the initial
request to publication of the final notice may vary considerably based
on several factors, some of which are not under APHIS control. For
example, the initial request might not be accompanied by sufficient
information, so we would need to gather additional information. The
length of time this takes would depend on the completeness of the
initial submission, the complexity of the situation, and the
responsiveness of the foreign region to requests for additional
information.
After the initial request and information gathering, we would then
conduct a site visit, which we consider to be a necessary component of
an evaluation. Planning and scheduling the site visit takes at least 2
to 3 months. After the site visit, it takes at least 1 month to
complete the report, longer if we need to request follow-up information
or clarification.
In some instances, we will be able to classify a region after the
first site visit, in which case we could use either the site visit
report or a summary as the supporting document for the notice. However,
in some cases we may not be able to classify the region at the status
level it desires. In those cases we might proceed in one of several
ways. For example, we might classify the region at a lower status level
(higher risk level) based on our findings. Other possibilities could
include not proceeding further with the evaluation, or working with the
region to improve their tuberculosis program and status before
proceeding. In these cases, there may be progress reports, additional
information, and possibly another site visit, all of which would need
to be compiled into a summary document to support a notice if we moved
forward to that step.
A commenter noted that the proposed rule stated if we consider a
request for classification complete, we would publish a notice in the
Federal Register proposing to classify the region, and making available
to the public the information upon which this proposed classification
is based. The notice would request public comment. The commenter asked
how APHIS intends to more quickly and efficiently publish these
classification changes. The commenter also asked what the expected
timeframe for the notices would be, and stated that the final rule
needs to identify these timeframes.
Classification and reclassification would occur through publication
of a notice in the Federal Register as described in Sec. 93.438(c) and
(d). The notice-based process offers substantial time savings over
traditional rulemaking. It is the fastest method for making such
changes available to APHIS that still provides the public opportunity
to comment on each proposed action. However, there are factors outside
our control that can affect the timing of publication and that make
specifying the timeframes in the regulations infeasible. If we believe
that the time required for reclassification via the notice-based
process would result in a real and substantial increase in risk to
animal health in the United States, we would act administratively to
mitigate the risk while pursuing the notice-based process.

Import Requirements/Tuberculosis

Two commenters expressed support for the proposed requirements for
the importation of bovines from foreign regions with respect to
tuberculosis.
Several commenters asked if the Governments of Canada and Mexico
supported the proposed requirements.
APHIS discussed the proposed tiered classification system and
anticipated impact on cattle trade with representatives of the
Governments of Canada and Mexico while developing the proposed rule.
Neither expressed opposition to the proposed changes to the import
requirements during these meetings nor in comments received on the
proposed rule.\3\
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\3\ The comment submitted by the Government of Canada on the
proposed rule can be viewed online at https://www.regulations.gov/document?D=APHIS-2011-0044-0096. The comment submitted by the
Government of Mexico can be viewed online at https://www.regulations.gov/document?D=APHIS-2011-0044-0205.
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Several commenters asked whether APHIS has the resources to carry
out the proposed port-of-entry testing and expressed concern that the
testing could cause logistical problems. The commenters stated that the
requirements should be reconsidered.

[[Page 57947]]

APHIS disagrees. The proposed port-of-entry testing is very similar
to that currently required for cattle from Canada and Mexico, which
contribute nearly 100 percent of cattle imported into the United
States. We do not anticipate that the proposed port-of-entry testing
would cause logistical problems in excess of those currently
experienced.
Two commenters asked if APHIS would provide additional resources to
support port-of- entry testing for tuberculosis and support management
of cattle held there pending test results when inspections are done on
the U.S. side of the border.
As we explained above, the testing requirements we proposed are
very close to those currently in place for cattle from Canada and
Mexico. Since the requirements are not changing significantly, we do
not anticipate that the resource needs will change significantly.
Two commenters asked if an APHIS veterinarian or a veterinarian
from Mexico would be responsible for testing imported cattle at the
port of entry.
When testing cattle at the port of entry is required by APHIS
regulations, APHIS veterinarians would conduct the testing.
Several commenters questioned the scientific basis for setting the
minimum testing age at 6 months for imported steers and spayed heifers.
Setting the minimum test age at 6 months is based on historic
precedent in our domestic program. However, we agree with the
commenters that since animals presented for import may only receive a
single test to determine tuberculosis status, all ages should be test
eligible. We are amending Sec. 93.439 to remove the specified minimum
test ages in response to this comment.
One commenter asked if the prohibition on Holsteins and Holstein
crosses also extends to bovines exposed to Holsteins and Holstein
crosses.
No. There is no practical way to accurately certify to this
requirement.
One commenter stated that Level I status appears to require herd
testing for animals and germplasm.
That is not the case. This rule set forth the requirements for
importation of live cattle into the United States. Herd testing is not
required for live cattle from regions that qualify as Level I for
tuberculosis or brucellosis. Requirements for germplasm are contained
in 9 CFR part 98, which we are not amending in this rulemaking.
One commenter stated that the definition of immediate slaughter
should specify that these cattle are transported in sealed conveyances
directly to the slaughterhouse and killed within 3 days of arrival.
We agree that bovines imported for immediate slaughter should be
transported from the port of entry to the slaughtering establishment in
a conveyance sealed with seals of the U.S. Government. Only bovines
from Canada and Mexico are eligible for immediate slaughter, since
bovines from other regions must undergo quarantine. The provisions for
immediate slaughter bovines from Canada and Mexico appear in Sec. Sec.
93.420 and 93.429, respectively. These sections specify travel in a
sealed conveyance as well as other mitigation measures. While we had
proposed to exempt bovines from the provisions of Sec. 93.429, we
neglected to specify appropriate mitigation measures for immediate
slaughter cattle elsewhere in part 93. As a result, we do not intend to
make the proposed change to Sec. 93.429, which will preserve not only
the requirement for travel in sealed conveyances but other mitigation
measures specified for immediate slaughter bovines from Mexico. As a
corollary, we are not adopting the provisions for bovines for immediate
slaughter proposed in Sec. 93.442(c) concerning brucellosis.
APHIS notes that the definition of immediate slaughter in Sec.
93.400 specifies that the consignment is slaughtered within 2 weeks of
entry. Only bovines from Canada and Mexico may be imported for
slaughter without first undergoing quarantine. The 2 weeks allow time
for slaughter and, in the case of Mexico, address residue concerns due
to dipping. We are making no changes based on this portion of the
comment.
Two commenters asked if official identification numbers of the
animals will need to be written on the certificate for Level II
accredited herds.
Yes. APHIS notes that Sec. 93.439 as proposed says in 11 separate
places that bovines must be (1) officially identified and (2)
accompanied by a certificate that says that they are officially
identified. To address this unnecessary repetition, we are amending
Sec. 93.439 to include a blanket statement in Sec. 93.439(b) that all
bovines imported under this section must be officially identified and
accompanied by a certificate, issued in accordance with Sec.
93.405(a), that indicates that they are officially identified. We will
also amend Sec. 93.439 to require that the certificate must record the
means by which the bovines are officially identified. This action would
also apply the requirements for official identification and
certifications to bovines from Level I, which the proposal
inadvertently omitted.
We are making matching changes for brucellosis by including a
blanket statement in Sec. 93.442(b) regarding official identification
and certification, to apply also to bovines from Level I regions, and
by amending paragraphs (d) and (e) in Sec. 93.442 to remove the
repetitive references to these requirements.
One commenter asked if animals from a Level II region under 6
months of age are allowed to be imported into the United States.
Yes. Animals from a Level II region under 6 months of age may be
imported in accordance with Sec. 93.439(d). These animals would be
eligible for any required testing for tuberculosis under the provisions
of that section, since we are removing the minimum age as described
above.
Some commenters stated that animals from a Level II region under 6
months of age need to be tested in the United States when they reach
maturity.
APHIS disagrees. As we explained above, we have amended several
sections in Sec. 93.439 to clarify that bovines of all ages are test
eligible if testing for tuberculosis is required for importation.
Retesting of bovines from Level II regions is not supported by our risk
analysis or in line with current practice.
Some commenters stated that the proposed testing and movement
requirements from States with Inconsistent status were more restrictive
than the requirements for animals imported from Level III regions.
As we explained above, we have amended Sec. 93.439 to clarify the
testing requirements for imported cattle, including those from Level
III regions. APHIS notes that the testing requirements we are adopting
for importation from Level III regions are consistent with those
currently required for domestic cattle moving from modified accredited
States, as set out in 9 CFR 77.12(b). We also note that Inconsistent
status was a term of art we proposed for our domestic tuberculosis
regulations, and we are making no changes to the domestic tuberculosis
regulations at this time. We will take this comment into consideration
if we proceed with changes to the domestic regulations in the future.
Some commenters expressed concern that Level III requirements are
not sufficiently stringent to address disease risk.
APHIS disagrees. As we explained above, the testing requirements
for cattle imported from Level III regions are consistent with the
testing requirements for domestic cattle moving from modified
accredited States domestically.

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These testing requirements have been demonstrated to be sufficient to
prevent the spread of disease within the United States and we are
confident they will prevent disease introduction from Level III
regions.
Some commenters stated that Level III regions should not have
accredited herds.
We note that Level III regions are subject to APHIS evaluation of
the tuberculosis program and must meet the evaluation criteria
specified in Sec. 93.438. They cannot attain Level III status without
demonstrating sufficient program strength to, among other things,
maintain accreditation and supervision of accredited herds. We are
making no changes in response to this comment.
Some commenters stated that cattle from accredited herds in Level
III regions should have a negative test for tuberculosis within 60 days
prior to importation.
APHIS disagrees with regard to steers and spayed heifers from
accredited herds in Level III regions. As we explained above, Level III
regions must meet evaluation criteria and demonstrate program strength.
However, we agree that sexually intact bovines present a greater risk
for introduction and dissemination of Mycobacterium bovis. Our risk
assessment supports an individual negative test at the port of entry or
during post-arrival quarantine, with negative results, for all sexually
intact animals from Levels II-IV. We included this requirement in the
proposed Sec. 93.439(f)(1) for sexually intact bovines from accredited
herds in Level IV regions but not for Levels II and III. We are
therefore amending paragraphs (d)(1) and (e)(1) in Sec. 93.439 to
require testing at the port of entry or during post-arrival quarantine
for sexually intact bovines from accredited herds in Level II and III,
respectively.
Some commenters stated that Level III animals not from accredited
herds and not destined for immediate slaughter need to be test eligible
and at least individually tested.
APHIS agrees with the commenters. We have amended Sec.
93.439(e)(2) to provide for testing of sexually intact animals from
non-accredited herds in Level III regions at the border. As we
explained above, we are also removing minimum age for individual
testing, meaning all steers, spayed heifers, and sexually intact cattle
from these herds will be eligible for testing.
Four commenters asked if it is necessary for cattle from Level III
regions to be tested at the farm of origin.
No. We mistakenly proposed to require premises of origin testing
for steers and spayed heifers from Level III regions, as well as steers
and spayed heifers from Level IV regions. We have amended paragraphs
(e)(3)(ii) and (f)(3)(ii) in Sec. 93.439 to remove the requirement for
testing to occur on the premises of origin.
One commenter asked if Level IV regions need to have an acceptable
tuberculosis program in place.
Yes, as specified in Sec. 93.437(d), Level IV regions would need
to have an acceptable tuberculosis program in place.
One commenter stated that Level IV steers and spayed heifers not
from accredited herds and not destined for immediate slaughter need to
be test eligible and at least individually tested.
We agree with this commenter. Section 93.439(f)(3)(ii) requires a
negative individual test of steers and spayed heifers from non-
accredited herds in Level IV regions within 60 days prior to export,
unless the bovines are exported within 60 days of the whole herd test
and were included in that test. As noted above, we have amended this
section to remove the proposed minimum test age of 2 months so that all
bovines are test eligible.
Five commenters stated that the testing interval for whole herd
tests for Level IV sexually intact non-accredited bovines needs to be
specified. The commenters were specifically concerned about the lack of
a declared maximum limit for the time between the second test and time
of movement.
We agree with the commenters. The proposed rule specified an
interval of 9 to 15 months between the whole herd tests but not the
amount of time that can pass between the second whole herd test and
export. We have amended Sec. 93.439(f)(2)(i) to specify that the
second whole herd test must be administered no less than 60 days and no
more than 12 months before export.
One commenter asked how individual animal testing will be
administered for cattle from accredited herds in Level IV regions.
The proposed rule did not distinguish between sexually intact and
steers and spayed heifers from accredited herds in Level IV regions
with regard to testing, which was an oversight. An individual test at
the port of entry is only required for sexually intact cattle from
accredited herds; steers and spayed heifers need a test within 60 days
prior to export. We have amended Sec. 93.439(f)(1) to correct this
oversight. Actual testing would follow the procedures currently in
place for animals from Mexico; for virtually all other countries,
testing would take place during quarantine.
Nine commenters stated that Level V bovines should be prohibited
importation into the United States.
We foresee three types of regions that APHIS would classify as
Level V for tuberculosis. The first would be regions that APHIS
determines to have an adequate tuberculosis program, but a prevalence
rate over 0.5 percent. Because of the high prevalence, we would only
allow limited quantities of animals with documented genetic histories
(pedigrees, breed registries, genetic documentation, etc.). In general,
we foresee a preclearance program with mitigations equivalent to those
in the proposed rule being adequate for such imports, but could see
instances in which additional mitigations (such as more extensive APHIS
oversight in-country) may be necessary. Section 93.401(a) provides that
the Administrator may in specific cases prescribe conditions for
ruminants or products to be brought into or through the United States
and we would establish such conditions for regions that need additional
mitigations.
The second would be regions that can demonstrate a low prevalence
based on surveillance, but do not request a full evaluation of their
tuberculosis programs. These countries would eschew evaluation simply
as being too much work based on expected levels of exports. We consider
a preclearance program with mitigation equivalent to those in the
proposed rule to be adequate for such imports, but could foresee
instances in which alternate strategies (such as having the region
provide documentation of accreditation standards or adherence to
transnational animal health regulations) obviate the need for some of
the requirements. As a result, we would allow limited imports from such
regions with additional mitigations in accordance with the provisions
of Sec. 93.401(a), and post import protocols relevant to the countries
on the APHIS website.
The third scenario would be when a region requests an evaluation
from us, and APHIS determines that the region does not have an adequate
tuberculosis program. In such instances, we foresee a preclearance
program with mitigations equivalent to those in the proposed rule, but
in which APHIS administers all in-country tests, as the only way of
adequately mitigating disease risk.
We are amending Sec. 93.439(g) to clarify this point and allow for
the various scenarios above by stating that importation of bovines for
purposes other than immediate slaughter may occur at the
Administrator's discretion, subject to a preclearance program
administered by APHIS and detailed in

[[Page 57949]]

an import protocol that we would post on the APHIS website. Such
bovines would still be subject to an individual test for tuberculosis
at the port of entry or during post-arrival quarantine, with negative
results, as well as all applicable identification and certification
requirements of part 93.
Finally, through a drafting error, the rule failed to consider
bovines for immediate slaughter from Level V regions. As discussed
above, this would only apply to parts of Mexico and is provided for in
existing Sec. 93.429.
Four commenters stated that Level V countries need to at least have
a veterinary infrastructure and tuberculosis control program.
APHIS disagrees that these are necessarily requirements. As we
discussed above, we consider preclearance programs with mitigation
equivalent to those in the proposed rule to be adequate for such
imports in most cases, and we have the ability to establish additional
mitigations as needed.
Two commenters stated that embryos should be authorized for
importation from Level V countries.
As we explained above, the requirements for germplasm are contained
in part 98, which we are not amending in this rulemaking. As long as
embryos meet the relevant requirements in part 98, they could be
imported into the United States.

Requesting Regional Classification for Brucellosis

One commenter stated that Level I regions should be required to
have been free for 2 years and in a country with a low prevalence.
APHIS notes that Sec. 93.440(a) specifies that a region recognized
as Level I for brucellosis must have a prevalence less than 0.001
percent for at least 2 years (24 consecutive months). Regions eligible
for Level I or II must have demonstrated 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. We are confident that these requirements will effectively
mitigate the risk of introducing brucellosis into the United States.
One commenter stated that the process and timeframe for
reclassification of a region for brucellosis should be specified in the
regulations. The commenter also asked how APHIS intends to carry out
the classification and reclassification in a timely manner.
The process for classification and reclassification of a region for
brucellosis is the same as the process for classification and
reclassification of a region for tuberculosis we described above, and
is provided for in Sec. 93.441(b) and (c). As we explained, the time
to complete the process from receipt of the initial request to
publication of the notice may vary considerably based on several
factors, some of which are not under APHIS control. It is therefore not
feasible to specify timeframes in the regulations. As with the process
for tuberculosis, if we believed that the time required for
reclassification via the notice-based process would result in a real
and substantial increase in risk to animal health in the United States,
we would act administratively to mitigate the risk while pursuing the
notice-based process.

Import Requirements/Brucellosis

Two commenters stated that sexually intact cattle under 6 months of
age should be prohibited importation.
APHIS disagrees. However, as discussed above for tuberculosis, we
believe that all ages should be test eligible since some animals may
only receive a single test to determine brucellosis status. We are
therefore amending paragraphs (d) and (e) in Sec. 93.442 to remove the
specified minimum test ages for brucellosis as for tuberculosis.
We are also amending paragraph (a) in Sec. 93.442 to remove the
prohibition on importation of ruminants who have had a non-negative
test response to any test for Brucella spp. at any time. This provision
was not in line with procedures to export cattle from the United
States. We allow animals that were non-negative on a Brucella spp. test
to be exported provided that they had negative responses on subsequent
testing. This change will provide consistency between our import and
export requirements.

Miscellaneous

One commenter expressed concern that the definition of herd of
origin, as proposed, could allow a constant flow of additional animals
of disparate status into a herd, and these animals could still move as
if they originated from that herd.
We agree with the commenter and are amending the definition of herd
of origin by defining a herd of origin as a herd of one or more sires
and dams and their offspring from which animals in a consignment
presented for export to the United States originate, and by specifying
that a herd of origin may be the birth herd or the herd where the
animal has resided for a minimum 4-month period immediately prior to
movement, unless otherwise specified in an import protocol. We are also
amending the definition to allow additional animals to be moved into a
herd of origin during or after the 4-month qualifying period only if
they originate from an accredited herd or originate from a herd of
origin that tested negative to a whole herd test conducted within the
last 12 months and the individual animals being moved into the herd
also tested negative to any additional individual tests for
tuberculosis and brucellosis required by the Administrator. These
changes are consistent with the definition that appears in the Bovine
Tuberculosis Eradication Uniform Methods and Rules, effective January
1, 2005,\4\ and with current requirements for live animals and
germplasm.
---------------------------------------------------------------------------

\4\ This document may be accessed on the APHIS website at
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-tuberculosis-eradication-program.
---------------------------------------------------------------------------

We are amending the definition of individual test in Sec. 93.401
to remove the words ``for purposes of this part, testing of individual
animals as part of a whole herd test does not constitute an individual
test'' because this requirement is not necessary in the context of this
final rule and could cause confusion.
We are amending the definition of whole herd test for brucellosis
in Sec. 93.401 to specify that only sexually intact bovines need to be
tested for brucellosis. There is no evidence that sexually neutered
animals can transmit brucellosis and therefore no reason to test them.
Since the publication of the proposed rule, Sec. 93.427 has been
amended to change the branding requirements for steers and spayed
heifers imported from Mexico (83 FR 64223-64225, Docket No. APHIS-2016-
0050). We have therefore amended paragraph (a) of that section to be
consistent with the new requirements.
We have made editorial changes to Sec. 93.439 to consolidate the
requirements for testing of sexually intact bovines from both
accredited and non-accredited herds from a Level II region for
tuberculosis because all sexually intact cattle from such regions are
required to be tested at the port regardless of herd status. The
provisions now appear in paragraph (d)(1) of that section.
Similarly, we have made editorial changes to Sec. 93.442 to
consolidate the requirements for the importation of steers and spayed
heifers from all regions with respect to brucellosis. The

[[Page 57950]]

provisions now appear in paragraph (c) of that section.
We have made minor, nonsubstantive changes to Sec. Sec. 93.401(d),
93.438(a), and 93.441(a) to improve the clarity of those paragraphs.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.

Executive Orders 12866, 13563, 13771, and Regulatory Flexibility Act

This final 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. This rule is not subject to the
requirements of Executive Order 13771 because this rule results in no
more than de minimis costs. Details on the estimated costs of this
final rule can be found in the rule's economic analysis.
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 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 website (see footnote 1 in this document for a
link to 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.
This rule amends the regulations governing the importation of
cattle and bison with respect to bovine tuberculosis and brucellosis.
The changes will make these requirements clearer and assure that they
more effectively mitigate the risk of introduction of these diseases
into the United States.
The potential economic effects associated with this rule are not
significant. The requirements for the importation of cattle and bison
from foreign regions will not change significantly as a result of this
rule, and where they do change they will affect very few producers or
importers.
This rule establishes a new system for classifying foreign regions
regarding bovine tuberculosis and brucellosis and establishing the
conditions under which cattle and bison may be imported into the United
States. All foreign regions that currently export cattle to the United
States will 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 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 result of
this rule. There are two specific exceptions to this expectation,
however. These exceptions involve additional testing for sexually
intact cattle from Mexico intended for export to the United States.
Because most bovine exporting regions in Mexico do not have established
brucellosis programs, they will automatically be classified in the
lowest brucellosis category (Level III) and an additional whole herd
brucellosis test will be required for imports of sexually mature and
sexually intact cattle, i.e., breeding cattle, from those regions. In
addition, exporting regions currently Accreditation Preparatory for
tuberculosis will likely be classified as Level IV and an additional
whole herd tuberculosis test will be required for imports of sexually
intact cattle from those regions. This rule also removes the
requirement for a whole herd test and an individual test for sexually
intact cattle from regions classified as Level I.
Some U.S. entities may be indirectly affected by changes in testing
requirements. It is possible that small additional testing costs for
some Mexican breeding cattle may result in an increase in U.S. import
prices. Conversely, small cost savings due to the removal of a whole
herd test requirement for some Mexican heifers may result in a decrease
in U.S. import prices. However, these price impacts if they were to
occur would be extremely minor.
A very small number of sexually intact cattle are imported from
Mexico. In 2018, they numbered 290 head.\5\ Costs of additional whole
herd testing are dependent on the size of the herd from which bovines
destined for export originate. Any imports of sexually intact cattle
from non-accredited herds in Level III regions will be subject to an
additional whole herd brucellosis test in order to export to the United
States and will incur the cost of that testing. Cattle from accredited
herds in Level III regions will not need any herd testing beyond that
required for accreditation, just an individual test at the port. The
majority of those cattle are likely to be of higher genetic quality and
come from accredited herds. Sexually intact cattle imported from Level
IV regions will also be subject to the additional whole herd
tuberculosis test for export to the United States and incur the cost of
that testing. The impact of the changes to testing requirements will be
very limited. Any additional costs will represent a small portion of
the value of the imported bovines. Very few cattle would be affected,
and the per head cost associated with brucellosis and tuberculosis
testing is equivalent to between 0.3 and 0.5 percent of the average per
head value ($1,249) of imported Mexican breeding cattle in 2018.\6\
Even if all imported sexually intact Mexican cattle imported in 2018
had been subject to additional testing, the additional cost would have
been between $1,100 and $1,800 for those 290 head. Whether this
additional testing cost would affect prices paid by U.S. importers
would depend on the competitiveness of the market for Mexican breeding
cattle and responsiveness of U.S. importers of Mexican breeding cattle
to small price changes. We expect any impact would be negligible.
---------------------------------------------------------------------------

\5\ Source: SENASICA, competent veterinary authority of Mexico.
Personal correspondence with APHIS. May 2019.
\6\ Source: U.S. Census Bureau, Economic Indicators Division.
http://usatrade.census.gov.
---------------------------------------------------------------------------

This rule also removes the requirement for a whole herd test and an
individual test for sexually intact cattle from regions classified as
Level I. APHIS intends to recognize the Mexican State of Sonora as
Level I. While about 19 percent of the cattle imported from Sonora are
currently spayed heifers, following the implementation of this rule
they will likely be sexually intact. The only reason to spay heifers
under the current rule is to avoid the cost of testing for brucellosis.
Those Mexican

[[Page 57951]]

producers may save the cost of spaying. The cost associated with
spaying is equivalent to between 1.1 percent and 1.4 percent of the
average per head value ($720) of imported Mexican heifers, excluding
purebred breeding cattle, in 2018.\7\ In total, those Mexican producers
could potentially save a total of about $500,000 to $625,000 in costs
by not spaying those imported heifers. These savings would represent
less than 0.4 percent of the value of all imported Mexican heifers
(about $181 million in 2018), and less than 0.2 percent of the value of
all heifers imported into the United States in 2018 (about $505 million
in 2018).
---------------------------------------------------------------------------

\7\ Source: U.S. Census Bureau, Economic Indicators Division.
http://usatrade.census.gov.
---------------------------------------------------------------------------

As with the breeding cattle, whether this cost savings would affect
prices paid by U.S. importers would depend on the competitiveness of
the market for Mexican heifers and responsiveness of U.S. importers of
Mexican heifers to small price changes. We expect any impact would be
very small.
The effects of this rule on foreign producers of cattle and bison
represent a very small portion of the value of imported Mexican cattle.
The potential additional cost associated with brucellosis and
tuberculosis testing would be equivalent to between 0.3 and 0.5 percent
of the average per head value of imported Mexican breeding cattle. The
potential cost savings from not spaying heifers would be less than 0.4
percent of the value of all imported Mexican heifers. It is possible
that the small additional testing costs may be reflected in an increase
in the price of some imported Mexican breeding cattle, or the small
cost savings from not spaying heifers may be reflected in a decrease in
the price of some imported Mexican heifers. However, given the very
small costs or cost savings relative to the value of the market, these
price impacts if they were to occur will be, at most, extremely minor.
Under these circumstances, the APHIS Administrator certifies that this
rule will not have a significant economic impact on a substantial
number of small entities.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Government. Executive Order 13175 requires Federal agencies to consult
and coordinate with Tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Based on the
foregoing, the USDA's Office of Tribal Relations (OTR) has assessed the
impact of this rule on Indian Tribes and determined that consultation
is not recommended at this time. If consultation is requested, OTR will
work with the APHIS to ensure quality consultation is provided.

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
requirements included in this final rule, which were filed under 0579-
0442, have been submitted for approval to the Office of Management and
Budget (OMB). When OMB notifies us of its decision, if approval is
denied, we will publish a document in the Federal Register providing
notice of what action we plan to take.

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 rule, please contact Mr. Joseph Moxey,
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects in 9 CFR Part 93

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

Accordingly, we are amending 9 CFR part 93 as follows:

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
1. 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
2. Section 93.400 is amended as follows:
0
a. By adding, in alphabetical order, definitions for Accredited herd
for brucellosis, Accredited herd for tuberculosis, and Brucellosis;
0
b. By removing the definition for Brucellosis certified-free province
or territory of Canada;
0
c. By revising the definition for Herd of origin;
0
d. By adding, in alphabetical order, definitions for Import protocol,
Individual test, Non-negative test results, and Notifiable disease;
0
e. By removing the definition for Official tuberculin test;
0
f. By adding, in alphabetical order, definitions for Prevalence, Spayed
heifer, Steer, and Tuberculosis;
0
g. By removing the definitions for Tuberculosis-free herd and Whole
herd test; and
0
h. By adding, in alphabetical order, definitions for 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. A herd of one or more sires and dams and their
offspring from which animals in a consignment presented for export to
the United States originate. The herd of origin may be the birth herd
or the herd where the animal has resided for a minimum 4-month period
immediately prior to movement, unless otherwise specified in an import

[[Page 57952]]

criteria. Additional animals can be moved into a herd of origin during
or after the 4-month qualifying period only if they:
(1) Originate from an accredited herd; or
(2) Originate from a herd of origin that tested negative to a whole
herd test conducted within the last 12 months and the individual
animals being moved into the herd also tested negative to any
additional individual tests for tuberculosis and brucellosis required
by the Administrator.
* * * * *
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 this part 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.
* * * * *
Non-negative test results. Any test results for tuberculosis or
brucellosis within the suspect, reactor, 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.
* * * * *
Prevalence. The number of affected herds occurring during the
period specified in Sec. Sec. 93.437 and 93.440. In some instances,
the Administrator may allow calculation of prevalence based on affected
herd-years to avoid penalizing regions with small herd numbers.
* * * * *
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 sexually intact bovines in a herd of origin
that are 6 months of age or older, and of all sexually intact 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 sexually intact 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
3. 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. A means of
conveyance used to transport an animal to the United States in
accordance with this subpart must be cleaned and disinfected in a
manner specified within an import protocol prior to transport, unless
an exemption has been granted by the Administrator.

Sec. 93.406 [Amended]

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

Sec. 93.408 [Amended]

0
5. In Sec. 93.408, the first sentence is amended by removing the
citation ``Sec. Sec. 93.421 and 93.426'' and adding in its place the
citation ``Sec. 93.421''.

0
6. In each undesignated center heading in subpart D listed in the first
column, redesignate the footnote number in the second column as the
footnote number in the third column:

------------------------------------------------------------------------
Undesignated center heading in subpart D Old footnote New footnote
------------------------------------------------------------------------
Canada.................................. 8 9
Central America and West Indies......... 9 10
Mexico.................................. 10 11
------------------------------------------------------------------------

0
7. Section 93.418 is amended as follows:
0
a. By removing and reserving paragraphs (b) and (c);
0
b. By adding a heading for paragraph (d); and
0
c. 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.
The addition reads as follows:

Sec. 93.418 Cattle and other bovines from Canada.

* * * * *
(d) Conditions for importation. * * *

Sec. 93.423 [Amended]

0
8. 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
9. 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
10. Section 93.427 is amended as follows:
0
a. By revising paragraphs (a) and (c);
0
b. By removing and reserving paragraph (d); and
0
c. In paragraph (e) introductory text, by removing the words
``paragraphs (a) through (d) of''.
The revisions read as follows:

Sec. 93.427 Cattle and other bovines from Mexico.

(a) Cattle and other ruminants from Mexico. Cattle and other
ruminants from

[[Page 57953]]

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,
each steer or spayed heifer imported into the United States from Mexico
shall be identified with a distinct, permanent, and legible ``M'' mark
applied with a freeze brand, hot iron, or other method prior to arrival
at a port of entry, unless the steer or spayed heifer is being
transported in bond for immediate return to Mexico or imported for
slaughter in accordance with Sec. 93.429. The ``M'' mark shall be
between 3 inches (7.5 cm) and 5 inches (12.5 cm) high and wide, and
shall be applied to each animal's right hip, within 4 inches (10 cm) of
the midline of the tailhead (that is, the top of the brand should be
within 4 inches (10 cm) of the midline of the tailhead, and placed
above the hook and pin bones). The brand should also be within 18
inches (45.7 cm) of the anus.
* * * * *
(c) Importation of Holsteins from Mexico. The importation of
Holstein steers, Holstein spayed heifers, Holstein cross steers, and
Holstein cross spayed heifers from Mexico is prohibited.
* * * * *

Sec. 93.432 [Removed and Reserved]

0
11. Section 93.432 is removed and reserved.

0
12. Section 93.437 is added 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.
(f) Listing of regions. Lists of all Level I regions, Level II
regions, Level III regions, Level IV regions, 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
13. Section 93.438 is added to read as follows:

Sec. 93.438 Process for requesting regional classification for
tuberculosis.

(a) Request for regional classification; requirements. A
representative of the national government(s) of any country or
countries who has the authority to make such a request may request that
APHIS classify a region for tuberculosis. 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, Strategy and
Policy Unit, 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 in a timely manner, 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, after reviewing and evaluating the
request for classification, APHIS believes the region can be accurately
classified for tuberculosis, APHIS will publish a notice in the Federal
Register proposing to classify the region according to Sec. 93.437,
and making the information upon which this proposed classification is
based available to the public for review and comment. 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 APHIS website.
(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.

[[Page 57954]]

(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.

(Approved by the Office of Management and Budget under control
number 0579-0442)

0
14. Section 93.439 is added 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 at any time are
prohibited importation into the United States.
(b) Identification of bovines imported for any purpose. Unless
otherwise specified by the Administrator, bovines imported into the
United States for any purpose must be officially identified and
accompanied by a certificate, issued in accordance with Sec.
93.405(a), that lists the official identification of the animals
presented for import.
(c) Importation of bovines from a Level I region. Unless specified
otherwise by the Administrator, bovines may be imported into the United
States from a Level I region for tuberculosis in accordance with
paragraph (b) of 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 part.
---------------------------------------------------------------------------

(d) Importation of bovines from a Level II region. (1) Sexually
intact bovines may be imported into the United States from a Level II
region for tuberculosis for purposes other than immediate slaughter
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.
(2) Steers or spayed heifers may be imported into the United States
from a Level II region for tuberculosis for purposes other than
immediate slaughter in accordance with paragraph (b) of this section.
(e) Importation of bovines from a Level III 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 III region for tuberculosis, provided that:
(i) The bovines are accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines originate directly from a currently accredited herd for
tuberculosis; and
(ii) If sexually intact, 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.
(2) 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) 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
(iii) 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 paragraph (e)(2)(i) of
this section.
(3) 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) The steers or spayed heifers are subjected to an individual
test for tuberculosis 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 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 paragraph
(e)(3)(i) of this section.
(f) Importation of bovines from a Level IV region. (1) 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 accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines originate directly from a currently accredited herd for
tuberculosis and, if steers or spayed heifers, meet the conditions for
importation in paragraph (f)(1)(iii) of this section; and
(ii) If sexually intact, 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
(iii) If steers and spayed heifers, the bovines are subjected to an
individual test for tuberculosis no more than 60 days prior to export
of the bovines to the United States, with negative results.
(2) 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 and no more
than 12 months prior the export of the bovines to the United States,
with negative results each time; and
(ii) 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 accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines meet the requirements in paragraph (f)(2)(i) of this section.
(3) 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

[[Page 57955]]

for tuberculosis on its premises of origin no more than 1 year prior to
the export of the bovines, with negative results; and
(ii) The bovines are subjected to an additional individual test for
tuberculosis no more than 60 days prior to export of the bovines to the
United States, with negative results, except that the individual 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 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. At the discretion
of the Administrator, bovines may be imported into the United States
from a Level V region for tuberculosis for purposes other than
immediate slaughter, provided that:
(1) The bovines are subject to a pre-clearance program administered
by APHIS and detailed in an import protocol published on the APHIS
website; and
(2) 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
(3) 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) and (2) of this
section.

(Approved by the Office of Management and Budget under control
number 0579-0442)

0
15. Section 93.440 is added 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
16. Section 93.441 is added to read as follows:

Sec. 93.441 Process for requesting regional classification for
brucellosis.

(a) Request for regional classification; requirements. A
representative of the national government(s) of any country or
countries who has the authority to make such a request 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, Strategy and Policy
Unit, 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;
(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, after reviewing and evaluating the
request for classification, APHIS believes the region can be accurately
classified for brucellosis, 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

[[Page 57956]]

the Federal Register announcing the revised classification and setting
forth the reasons for this reclassification.

(Approved by the Office of Management and Budget under control
number 0579-0442)

0
17. Section 93.442 is added 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 are prohibited importation into
the United States.
(b) Identification of bovines imported for any purpose. Unless
otherwise specified by the Administrator, bovines imported into the
United States for any purpose must be officially identified and
accompanied by a certificate, issued in accordance with Sec.
93.405(a), that lists the official identification of the animals
presented for import.
(c) Importation of steers and spayed heifers. Unless otherwise
specified by the Administrator, steers and spayed heifers may be
imported into the United States from a region in accordance with
paragraph (b) of this section, without further restrictions under this
part.
(d) Importation of sexually intact bovines from Level I regions.
Unless specified otherwise by the Administrator, sexually intact
bovines may be imported into the United States from a Level I region
for brucellosis in accordance with paragraph (b) of this section.\13\
---------------------------------------------------------------------------

\13\ 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.
---------------------------------------------------------------------------

(e) Importation of sexually intact bovines from a Level II region.
(1) Sexually intact bovines directly from currently accredited herds
for brucellosis. Sexually intact 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 the bovines are accompanied by a
certificate, issued in accordance with Sec. 93.405(a), with an
additional statement that the bovines 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) 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 accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines meet the requirements in paragraph (d)(2)(i) of this section.
(f) Importation of sexually intact bovines from a Level III region.
(1) Sexually intact bovines directly from currently accredited herds
for brucellosis. Sexually intact 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) 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 accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines 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 conducted no
less than 9 months and no more than 15 months apart, 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) 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 accompanied by a certificate, issued in
accordance with Sec. 93.405(a), with an additional statement that the
bovines meet the requirements in paragraph (e)(2)(i) of this section.

(Approved by the Office of Management and Budget under control
number 0579-0442)

Done in Washington, DC, this 14th day of September 2020.
Lorren Walker,
Acting Undersecretary, Marketing and Regulatory Programs.
[FR Doc. 2020-20552 Filed 9-16-20; 8:45 am]
BILLING CODE 3410-34-P