[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.

[[Page 57948]]

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