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Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 92, 93, 94, 95, 96, and 98
[Docket No. APHIS–2009–0095]
RIN 0579–AD10
Importation of Sheep, Goats, and
Certain Other Ruminants
Animal and Plant Health
Inspection Service, Department of
Agriculture (USDA).
ACTION: Final rule.
AGENCY:
We are amending the
regulations governing the importation of
animals and animal products to revise
conditions for the importation of live
sheep, goats, and certain other nonbovine ruminants, and products derived
from sheep and goats, with regard to
transmissible spongiform
encephalopathies such as bovine
spongiform encephalopathy (BSE) and
scrapie. We are removing BSE-related
import restrictions on sheep and goats
and most of their products, and adding
import restrictions related to
transmissible spongiform
encephalopathies for certain wild,
zoological, or other non-bovine
ruminant species. The conditions we are
adopting for the importation of specified
commodities are based on
internationally accepted scientific
literature and will generally align our
regulations with guidelines established
in the World Organization for Animal
Health’s Terrestrial Animal Health
Code.
SUMMARY:
DATES:
Effective January 3, 2022.
Dr.
Alexandra MacKenzie, Veterinary
Medical Officer, Strategy & Policy, VS,
APHIS, 4700 River Road, Unit 39,
Riverdale, MD 20737–1231; (301) 851–
3300, option 2.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Executive Summary
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Need for the Regulatory Action
The current bovine spongiform
encephalopathy (BSE)-related import
regulations prohibit the importation of
most live sheep and goats, and most
sheep and goat products, from countries
considered a risk for BSE. The current
regulations allow only the importation
of non-pregnant slaughter or feeder
sheep under 12 months old from
Canada, certain products from sheep
and goats, and sheep and goat semen.
We are amending the regulations to
remove BSE-related import restrictions
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on sheep and goats and most of their
products because they are no longer
warranted, and to add import
restrictions related to transmissible
spongiform encephalopathies (TSEs) for
certain wild, zoological, or other nonbovine ruminant species because those
animals pose a risk of introducing or
spreading BSE or other TSEs.
The conditions we are adopting for
the importation of sheep and goats and
their products are based on
internationally accepted scientific
literature and are generally consistent
with World Organization for Animal
Health (OIE) guidelines. We are taking
this action after conducting a thorough
review of relevant scientific literature
and a comprehensive evaluation of the
issues 1 and concluding that the changes
to the regulations will continue to guard
against the introduction of transmissible
spongiform encephalopathies such as
BSE and scrapie into the United States,
while allowing the importation of
additional animals and animal products
into this country.
Legal Authority for the Regulatory
Action
Under the Animal Health Protection
Act (AHPA, 7 U.S.C. 8301 et seq.), the
Secretary of Agriculture has the
authority to issue orders and promulgate
regulations to prevent the introduction
into the United States and the
dissemination within the United States
of any pest or disease of livestock. The
Animal and Plant Health Inspection
Service (APHIS) of the U.S. Department
of Agriculture (USDA or Department)
administers regulations in title 9,
chapter I, subchapter D that govern the
exportation and importation of animals
(including poultry) and animal
products.
Summary of the Major Provisions of the
Regulatory Action
We are removing BSE-related import
restrictions on sheep and goats and the
products derived from them. We are
also adding import restrictions related
to TSEs for certain wild, zoological, or
other non-bovine ruminant species. The
existing BSE-related import restrictions
also function as protection against the
introduction of other TSEs, such as
scrapie. While the BSE-related
restrictions are no longer warranted for
non-bovine ruminant products, it is
necessary for us to add appropriate
1 To view the supporting scientific
documentation, other supporting documents, the
proposed rule, and the comments we received, go
to https://www.regulations.gov and enter APHIS–
2009–0095 in the Search field. In the supporting
scientific documentation, the list of scientific
literature referenced begins on page 17.
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safeguards against the introduction of
other TSEs for non-bovine ruminants.
Costs and Benefits
This final rule’s impact would stem
from its effect on U.S. imports of the
affected commodities. Assuming an
increase in imports of 3,165 metric tons
(MT) in a net trade welfare model, we
project 1.5 percent decrease in
wholesale prices and a fall in domestic
production of 878 MT. We estimate
consumption would increase by 2,287
MT. As a result, producer welfare
decline by about $8.7 million and U.S.
consumer welfare would increase by
about $23.7 million, yielding an annual
net welfare benefit of about $15.1
million.
The rule has the potential to expand
the U.S. export market, to the extent that
it influences changes in our trading
partners’ import policies. Because
predicting if and when other countries
will make changes to their trade policies
is highly speculative, our analysis
assumes no trade policy changes by
foreign countries as a result of the rule
and therefore no impact on U.S. exports.
II. Background
In order to guard against the
introduction and spread of livestock
pests and diseases, APHIS regulates the
importation of animals and animal
products into the United States. The
regulations in 9 CFR parts 92, 93, 94, 95,
96, and 98 (referred to below as the
regulations) govern the importation of
certain animals, meat, other animal
products and byproducts, hay and
straw, embryos, and semen into the
United States in order to prevent the
introduction of various livestock pests
and diseases.
Two of the diseases addressed by the
current regulations regarding sheep and
goats are scrapie and BSE. Scrapie and
BSE belong to the family of diseases
known as TSEs. In addition to scrapie
and BSE, TSEs include, among other
diseases, chronic wasting disease in
deer and elk, and variant CreutzfeldtJakob disease in humans.
The current BSE-related import
regulations restrict the importation of
most live ruminants and ruminantderived products and byproducts. The
exceptions are cervids and camelids,
and their products, which are not
subject to BSE-related restrictions. The
regulations in § 94.18 provide for the
importation of meat, meat products, and
other edible products derived from
bovines (Bos indicus, Bos taurus, and
Bison bison). The current regulations in
§ 93.419 allow only the importation of
sheep and goats for immediate slaughter
or restricted feeding for slaughter from
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Canada, provided that the sheep and
goats are under 12 months of age and
are not pregnant.
APHIS has had import restrictions
related to BSE since 1991 for live
ruminants and most ruminant products.
In a final rule published in the Federal
Register on December 4, 2013 (78 FR
72980–73008, Docket No. APHIS–2008–
0010), we amended the BSE-related
import requirements for B. indicus, B.
taurus, B. bison, and removed the BSErelated import restrictions on camelids
and cervids from any region. However,
that rule did not address BSE-related
restrictions on domesticated sheep and
goats. We therefore believe that further
refinement of the regulations is in order
given the latest scientific information
regarding BSE transmission in sheep
and goats.
Scientific Basis
The protective measures APHIS has
taken against BSE have evolved over the
years, as scientific understanding of the
disease has changed. When the BSE
regulations were codified on April 30,
1991 (56 FR 19794–19796, Docket No.
90–252), they applied to all ruminants.
Over the past three decades, however,
extensive research has been conducted
regarding BSE transmissibility for
various ruminant species. Based on the
information available, it does not appear
to be necessary to continue to prohibit
or restrict the importation of sheep and
goats and their products with regard to
BSE, except in certain limited
situations.
This scientific information is as
follows: Experiments dating back to
shortly after the issuance of the
regulations have demonstrated the
ability of BSE to be transmitted to
domestic sheep and goats via oral
challenge and other routes of
inoculation, and, in one study, for
inoculated sheep to transmit BSE
laterally (Foster, Hope et al. 1993;
Foster, Parnham et al. 2001; Foster,
Parnham et al. 2001; Jeffrey, Ryder et al.
2001; Bellworthy, Hawkins et al. 2005;
Andreoletti, Morel et al. 2006;
Bellworthy, Dexter et al. 2008; Konold,
Bone et al. 2008). However, naturally
occurring BSE has not been identified in
sheep, and has only been documented
in two goats, as a result of retrospective
surveillance studies. Both goats were
born prior to our initiation of extended
ruminant feed bans, and ongoing
surveillance has not shown evidence
that BSE is circulating within domestic
sheep and goat populations. Therefore,
the science suggests that import
restrictions for sheep and goats based on
BSE, other than general prohibition on
processed ruminant proteins and
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products containing them for use as
ruminant feed, are not warranted to
address BSE risk.2 (We discuss the
scientific background for removing or
revising particular restrictions below in
the context of specific changes to the
regulations.) APHIS has continued to
monitor the scientific literature
regarding BSE transmissibility in sheep
and goats under conditions other than
experimental inoculation and no
contravening literature has been
published. Additionally, no evidence
has emerged to indicate that BSE is
circulating in domesticated sheep and
goats.
Based on the evidence cited above,
which was described at greater length in
the proposed rule and the supporting
scientific documentation that
accompanied it, we believe it is not
warranted to continue to prohibit or
restrict trade of live sheep and goats and
the products of sheep and goats due to
BSE, other than processed animal
protein.3 Conversely, small ruminants
can transmit another TSE, scrapie, and
scrapie-specific restrictions are
warranted.4
Therefore, on July 18, 2016, we
published in the Federal Register (81
FR 46619–46639, Docket No. APHIS–
2009–0095) a proposal 5 to amend the
regulations regarding BSE and scrapie as
they apply to the importation of sheep
and goats and products derived from
sheep and goats, as well as to other
ruminant species that are not bovines,
cervids, and camelids. We proposed to
remove BSE-specific prohibitions and
restrictions, and, in their place,
establish a framework for evaluating
foreign regions and, as warranted,
foreign flocks for scrapie status.
We solicited comments concerning
our proposal for 60 days ending
September 16, 2016. We received 53
comments by that date. They were from
sheep and goat producers, importers,
private citizens, and representatives of
State and foreign governments. Most of
2 A fuller discussion of the scientific information
in support of the proposed rule is found in the
supporting scientific documentation that
accompanied that rule. See footnote 1.
3 We continue to consider processed animal
protein-containing materials derived from sheep
and goats to be a BSE risk due to the possibility that
such material has been commingled with bovine
materials, and because one significant use of these
materials is in animal feed, the consumption of
which can result in BSE transmission. For these
reasons, we continue to restrict the importation of
these commodities.
4 An extensive discussion of the transmissibility
of scrapie is found in our prior proposed and final
rules to revise our domestic scrapie regulations, and
their supporting documents. To view these
documents, go to https://www.regulations.gov/
docket/APHIS-2007-0127.
5 See footnote 1.
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the commenters were generally
supportive of the proposed rule, but
some asked questions or expressed
concerns about some of the provisions.
We describe the changes we proposed
below, and whether we received any
comments regarding them. We then
discuss the comments that we did
receive, by topic.
Before going through the changes that
we proposed, however, we believe that
it is important to note that the primary
regulations that we proposed revisions
to were those governing the importation
of animals, meat, and other animal
products into the United States, which
are set forth in 9 CFR parts 93, 94, 95,
and 96.
Section 93.401 prohibits the
importation of any non-bovine ruminant
that has been in a region listed in
§ 94.24(a). Section 93.405 contains BSEspecific requirements for health
certificates for sheep and goats intended
for importation. Section 94.24 restricts
the importation of meat and edible
products from ovines and caprines due
to BSE. Section 94.25 restricts the
importation from Canada of meat and
edible products other than gelatin from
sheep and goats, and § 94.26 provides
for the importation of gelatin derived
from horses or swine, or from sheep and
goats that have not been in a region
restricted because of BSE. Section 94.27
provides for the transit shipment of
meat, meat products, and other edible
products derived from bovines, ovines,
or caprines that are otherwise
prohibited importation into the United
States in accordance with §§ 94.18
through 94.26. Section 95.4 contains
restrictions on the importation of
processed animal protein, offal, tankage,
fat, glands, certain tallow other than
tallow derivatives, and serum due to
bovine spongiform encephalopathy.
Section 96.2 prohibits the importation
of casings, except stomach casings, from
ovines or caprines that originated in or
were processed in any region listed in
§ 95.4(a)(4) as having BSE, unless
certain conditions are met.
While these regulatory provisions,
which contain BSE-specific restrictions
and prohibitions on the importation of
small ruminants and their products,
were those primarily addressed by the
proposed rule, the changes that we
proposed to these sections necessitated
proposing a number of smaller,
harmonizing changes throughout the
regulations. Therefore, for the sake of
completeness, we now discuss all of the
changes that we proposed. We present
these sequentially, except when the
various provisions work in consort and
a thematic discussion is therefore
warranted.
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§ 93.400, Definitions
We proposed to revise definitions for
designated feedlot and flock. We
proposed to change the definition of
designated feedlot to reference scrapierelated restrictions rather than BSErelated restrictions. We proposed to
expand the definition of flock to include
goats as well as sheep. We also
proposed to remove the definition of
suspect for a transmissible spongiform
encephalopathy because that term
would no longer appear in the
regulations. We received no comments
on these changes and they will not be
discussed further in this document.
We also proposed to add definitions
for terms that are currently not defined
in the regulations. Specifically, we
proposed to define certified status,
classical scrapie, flock of birth, flock of
residence, killed and completely
destroyed, non-classical scrapie,
transmissible spongiform
encephalopathies (TSEs), and TSEaffected sheep or goat. We received no
comments on these changes and they
will not be discussed further in this
document.
We proposed to define country mark
to distinguish this mark from other
forms of identification, such as eartags
or backtags, that might be used on an
animal. We also proposed to require the
use of country marks for sheep and
goats because this permanent
identification allows APHIS to trace an
animal back to the country of origin in
the event that the animal shows
symptoms of a TSE. We received no
comments on the definition itself, but
did receive comments on the proposed
use of country marks for imported sheep
and goats. The comments are discussed
below.
We proposed to define goat as ‘‘any
animal of the genus Capra’’ and sheep
as ‘‘any animal of the genus Ovis’’ to
clarify that the requirements for sheep
and goats apply not only to
domesticated sheep and goats, but also
to wild animals of those genera which
are also susceptible to scrapie. We
received comments on these definitions
and discuss them below.
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§ 93.401, General Prohibitions;
Exceptions
As noted above, § 93.401 of the
regulations contains general
prohibitions on the importation of
ruminants. We proposed to amend this
section by revising the second sentence,
which prohibits the importation of nonbovine ruminants that have been in
regions listed in § 94.24(a). (Section
94.24(a) currently contains a list of
regions in which BSE is known to exist,
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but is being removed because this
blanket prohibition was no longer
needed since we were proposing to
allow the importation of small
ruminants from BSE-affected regions of
the world.) We also proposed to amend
the second sentence of § 93.401 to read
‘‘Notwithstanding any other provision
of this subpart, the importation of any
ruminant that is not a bovine, camelid,
cervid, sheep, or goat is prohibited.’’
This change would remove BSE
restrictions on the importation of many
non-bovine ruminants, but would
continue to protect against the
introduction of TSEs into the United
States.
Currently § 93.401(a) also provides
that the Administrator may, upon
request in specific cases, allow
ruminants or products to be brought
into or through the United States under
such conditions as he or she may
prescribe, when he or she determines in
the specific case that such action will
not endanger the livestock or poultry of
the United States. Providing for the
importation of specific animals in
individual cases has great value for
conservation efforts. In order to
maintain genetic diversity in species
with very small populations, animals
must be moved between zoological
collections, both domestically and
internationally.
We received comments on these
changes to § 93.401 and discuss them
below.
it, are discussed at greater length below
under the heading ‘‘Zoological
Ruminants.’’ We received comments on
this change and will discuss them
below.
Last, we proposed to provide for
permits to be issued by the
Administrator for sheep of certain
classical scrapie-resistant genotypes, as
determined by testing at the National
Veterinary Services Laboratories (NVSL)
or another laboratory approved by the
Administrator. This would reduce
import restrictions on animals found to
be genetically resistant to scrapie. We
received several questions about this
provision. We respond to them below.
§ 93.404, Import Permits for Ruminants
We proposed to specify additional
information that an importer would
have to submit with the application for
an import permit for sheep and goats for
immediate slaughter or restricted
feeding for slaughter. We need this
information to validate that the animals
are slaughtered and to rapidly locate the
animals should the country of origin
report a disease outbreak. It also is
needed to clarify that these animals are
in, and are not to be removed from,
slaughter channels. We also proposed to
require additional information for sheep
and goats imported for purposes other
than immediate slaughter or restricted
feeding for slaughter. We need this
information to ensure that a continuous
previous health history is available for
animals that may be considered for
importation into the United States. We
received some questions about these
requirements. We respond to them
below.
We also proposed to add a new
paragraph to this section to address
mitigation measures to allow the
importation of zoological ruminants.
This change, and the scientific basis for
We proposed a minor harmonizing
change to this section due to our
proposed removal of § 93.419, which we
discuss immediately below. We
received no comments on this change
and will not discuss it further in this
document.
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§ 93.405, Health Certificate for
Ruminants
We proposed to revise the
requirements for health certificates for
sheep and goats to remove BSE-specific
requirements. The requirements that we
proposed included some information
that was previously required; however,
that information is relevant to animal
diseases other than BSE and could not
be removed. We also proposed to
remove certain additional requirements
for health certificates for sheep. We
received no comments on these changes
and will not discuss them further in this
document.
§ 93.406, Diagnostic Tests
§ 93.419, Sheep and Goats From Canada
We proposed to remove and reserve
this section, and move provisions for
the importation of sheep and goats from
Canada to § 93.435. We received no
comments on this change and will not
discuss it further in this document.
§ 93.420, Ruminants From Canada for
Immediate Slaughter Other Than Sheep
and Goats
Paragraph (a) of this section referred
to the provisions regarding sheep and
goats for immediate slaughter in
§ 93.419. We proposed to update the
reference because we proposed to move
these provisions to § 93.435. We
received no comments on this change
and will not discuss it further in this
document.
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§ 93.424, Import Permits and
Applications for Inspection of
Ruminants (From Mexico)
The regulations in this section
provide that wethers (castrated male
sheep or goats) do not need to be
accompanied by an import permit if
they enter the United States from
Mexico through land border ports, even
if they are not being imported for
immediate slaughter. We proposed to
revise the requirements in this section
to state that sheep and goats for
immediate slaughter do not need to be
accompanied by an import permit if
entering the United States through a
port on the United States/Mexico
border. We proposed to remove this
exemption for small ruminants not
intended for immediate slaughter
because we need the information from
the import permit to conduct a
traceback investigation in the event of a
disease outbreak. We received no
comments on these proposed changes
and will not discuss them further in this
document.
§ 93.428, Sheep and Goats and Wild
Ruminants From Mexico
We proposed to revise this section to
refer to the scrapie provisions in
§ 93.435, which would apply to sheep
and goats from anywhere in the world,
including Mexico. We received no
comments on this change and will not
discuss it further in this document.
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§ 93.435, Sheep and Goats
We proposed to revise this section to
contain provisions for importing sheep
and goats from anywhere in the world.
We proposed provisions for sheep and
goats imported for immediate slaughter
or restricted feeding for slaughter, and
provisions for other intended purposes.
The provisions for sheep and goats
imported for immediate slaughter and
restricted feeding for slaughter that we
proposed are similar to the requirements
for sheep and goats imported for those
purposes from Canada, which had been
contained in § 93.419. In other words,
we proposed to make the provisions,
which had been Canada-specific,
broadly applicable to ruminants from
anywhere in the world.
We also proposed to update the
requirements for importing sheep and
goats for other purposes, which had
been contained in § 93.435. Because we
proposed to remove the general
prohibition on importing small
ruminants from BSE-affected regions in
§ 93.401, we proposed to make the
requirements here in general consistent
with international standards by limiting
imports for these purposes to animals
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from classical scrapie-free countries or
flocks, except as permitted by the
Administrator under paragraph (a)(5) of
§ 93.404. This change was intended to
work in tandem with the proposed
revision to § 93.401 to allow for the
importation of animals that are very low
risk for scrapie due to their genotype or
other factors, in the absence of a general
BSE-specific prohibition. We received
some comments on these changes and
discuss them below.
We also proposed to revise this
section to establish a notice-based
approach for recognizing regions as free
of classical scrapie. The regulations
would provide the web address and a
contact for requesting copies of the list
of classical scrapie-free regions by mail,
fax, or email. The regulations also
would explain APHIS’ process for
adding or removing a region to or from
the list. This approach is similar to the
method we use to recognize disease
status for other diseases. It would also
allow more timely changes to the list
than if we had to do it through
rulemaking, as we do now. We received
several comments on the
implementation of this approach and
discuss them below.
Transit Shipment of Articles
The regulations in §§ 94.15, 94.27,
and 95.15 currently provide
requirements for the transit shipment of
animal products and materials. Section
94.15 provides general requirements for
the movement and handling of animal
products and materials through the
United States for immediate export.
Section 94.27 provides requirements for
transit shipment of meat, meat products,
and other edible products derived from
bovines, ovines, or caprines through air
or ocean ports or by overland transport.
Section 95.15 provides requirements for
transit shipment of animal byproducts
through air or ocean ports or by
overland transport.
We proposed to revise § 94.15 to
consolidate the requirements for transit
shipment of all these products into one
section and to eliminate some BSErelated restrictions that are no longer
warranted. The new requirements that
we proposed are similar to those that
already exist in § 94.15.
We proposed that the specific
requirements for meat, meat products,
and other edible products derived from
bovines, ovines, or caprines in § 94.27
would be removed because they are no
longer warranted. We also proposed that
§ 95.15 would be removed. Finally, we
proposed to remove references in parts
94 and 95 to §§ 94.27 and 95.15.
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We received no comments on these
changes and will not discuss them
further in this document.
Sheep and Goat Products
The regulations in parts 94, 95, and 96
prohibit or restrict the importation of
certain animals and animal products,
byproducts, and foreign animal casings
into the United States to prevent the
introduction of communicable diseases
of livestock and poultry. We proposed
to amend parts 94, 95, and 96 of the
regulations to remove the current BSE
provisions regarding sheep and goats. In
the following sections, we identify those
sections and paragraphs from which
regulatory text relating to BSE and
sheep and goats would be removed.
As we mentioned previously in this
document, § 94.24 restricts the
importation of meat and edible products
from ovines and caprines due to BSE.
Section 94.25 restricts the importation
from Canada of meat and edible
products other than gelatin from sheep
and goats, and § 94.26 provides for the
importation of gelatin derived from
horses or swine, or from sheep and goats
that have not been in a region restricted
because of BSE.
We proposed to remove §§ 94.24 and
94.25. We also proposed to amend
§ 94.26 by removing the references to
ovines and caprines that have not been
in a region restricted because of BSE
from the section heading and the
regulatory text. In place of those
references we would add a reference to
non-bovine ruminants. Gelatin derived
from non-bovine ruminants, like gelatin
derived from horses and swine, does not
present a risk for BSE since there is no
scientific evidence that BSE is
circulating in sheep or goats.
We received no comments on these
changes and will not be discussing them
further in this document.
Restrictions on Importation of
Byproducts Derived From Ruminants
Due to BSE
Part 95 of the regulations prohibits or
restricts the importation of products
other than meat and other edible
products to prevent the introduction of
certain animal diseases.
Section 95.1 contains definitions of
terms used in the part. We proposed to
amend § 95.1 by removing the
definitions for positive for a
transmissible spongiform
encephalopathy and suspect for a
transmissible spongiform
encephalopathy because those terms
would no longer appear in the
regulations. We received no comments
on these changes and will not be
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discussing them further in this
document.
Section 95.4 contains restrictions on
the importation of processed animal
protein, offal, tankage, fat, glands,
certain tallow other than tallow
derivatives, and serum due to bovine
spongiform encephalopathy. We
proposed amending this section first by
revising the section heading to remove
the exception for certain tallow
derivatives. We are also revising
paragraph (b)(1) to remove the exception
for tallow derivatives from that
paragraph. We proposed making these
changes in order to be consistent with
our requirements for bovine-derived
tallow derivatives, which are subject to
restrictions set out in § 95.9. We
received no comments on these changes
and will not be discussing them further
in this document.
In paragraph (c) of § 95.4, we
proposed to remove the reference to
paragraph (a)(4) from paragraph
(c)(1)(iv), and to remove paragraphs
(c)(2) and (3) entirely. These revisions
would collectively remove BSE-related
restrictions from these products when
derived from sheep and goats.
We also proposed to amend
paragraphs (c)(1)(ii) and (iv) to clarify
that the material that is imported must
not be ineligible for importation under
the conditions of § 95.5 of the
regulations. Section 95.5 contains our
restrictions on the importation of
processed animal protein to address
possible BSE risk; as we mentioned
previously in this document,
consumption of processed animal
protein is a viable pathway for the
transmission of BSE.
This was a clarification rather than a
new requirement; the regulations in
§ 95.5 have always applied to products
derived from all ruminant species, due
to concerns about commingling or crosscontamination. However, this change
would clarify that the restrictions in that
section continue to apply to products
derived from cervids, camelids, ovines,
and caprines. We also proposed to
redesignate paragraphs (c)(4) through (8)
as paragraphs (c)(2) through (6),
respectively. We received no comments
on these changes and will not be
discussing them further in this
document.
In newly redesignated paragraph
(c)(3), we proposed amending the first
sentence to remove the requirement that
facilities that process or handle any
material derived from mammals be
inspected at least annually for
compliance with the provisions of this
section, either by a representative of the
government agency responsible for
animal health in the region, or by
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APHIS. Instead, we would require only
facilities that process or handle
processed animal protein be inspected
at least annually. The rendering process
used to make processed animal protein
creates a material that cannot be
differentiated by species without a
polymerase chain reaction test, and
much rendering is performed involving
multiple species. As a result, there is a
risk of cross-contamination with
processed animal protein that does not
exist with the other products. For this
reason, we continue to require
inspections for facilities that process or
handle processed animal proteins.
We received no comments on this
change and will not be discussing it
further in this document.
Paragraphs (d) and (e) in § 95.4
contain restrictions on serum, serum
albumin, serocolostrum, amniotic
liquids or extracts, and placental liquids
derived from ovines and caprines due to
BSE. We proposed to remove both of
these paragraphs because BSE-related
restrictions on these products are no
longer warranted. These products
present a risk of introducing other
diseases, however, and would continue
to be prohibited importation into the
United States, except for scientific,
educational, or research purposes if the
Administrator determines that the
importation can be made under
conditions that will prevent the
introduction of animal diseases into the
United States.
We received no comments on these
changes and will not be discussing them
further in this document.
Paragraph (g) contains restrictions on
offal derived from ovines and caprines.
These restrictions are no longer
warranted and paragraph (g) would be
removed. We received no comments on
this change and will not be discussing
it further in this document.
Section 95.40 contains additional
certification requirements for certain
materials derived from sheep and goats,
including processed animal protein,
tankage, offal, glands and unprocessed
fat tissue, and derivatives of those
products. These additional certification
requirements were established due to
BSE concerns and are no longer
warranted; therefore, we proposed to
remove § 95.40. We received no
comments on this change and will not
be discussing it further in this
document.
Restrictions on the Importation of
Foreign Animal Casings
Part 96 of the current regulations
includes provisions regarding the
importation of animal casings into the
United States. The regulations in § 96.2
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prohibit the importation of ruminant
casings into the United States to prevent
the introduction of BSE. We proposed to
remove the restrictions on casings
derived from sheep and goats by
removing paragraph (b)(1), which
pertains to casings derived from sheep
slaughtered in Canada.
We received no comments on this
change and will not be discussing it
further in this document.
Sheep and Goat Germplasm
The regulations in part 98 govern the
importation into the United States of
germplasm (embryos and semen),
including germplasm from sheep and
goats.
Subpart A sets forth requirements for
ruminant and swine embryos from
regions free of foot-and-mouth disease
(FMD), and for embryos of horses and
asses.6 Subpart B sets forth
requirements for ruminant and swine
embryos from regions where FMD
exists. Subpart C sets forth the
requirements for the importation of
animal semen from species regulated by
APHIS.
The regulations in § 98.10a require
that embryos from sheep in regions
other than Australia, Canada, and New
Zealand may be imported only under
certain conditions that serve to protect
against the introduction of TSEs into the
United States. Because sheep and goat
embryos and oocytes present similar
disease risks, those risks can be
addressed by the same mitigations, and
also because we anticipate that use of
oocytes will increase as reproductive
technology continues to improve, we
proposed to add provisions for goat
embryos and both sheep and goat
oocytes to the regulations in § 98.10a.
Specifically, we proposed to revise the
section heading to read ‘‘Sheep and goat
embryos and oocytes.’’ We also
proposed to add a definition of oocyte
consistent with international standards.
We received no comments on these
changes and will not be discussing them
further in this document; however, we
did receive other comments on the
requirements for imported embryos and
oocytes and discuss them below.
We proposed to allow the importation
of in vivo-derived sheep and goat
6 At the time the 2016 proposed rule was
published, these regulations also governed the
importation of ruminant and swine embryos from
regions where rinderpest exists. Since then,
rinderpest was removed from the regulations in a
final rule published on April 11, 2018 (83 FR
15491–15495) because the disease has been
eradicated worldwide. Therefore, we will not be
referring to rinderpest in this document. To view
the rule removing rinderpest from the regulations,
go to https://www.regulations.gov/document/
APHIS-2017-0070-0001.
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embryos and oocytes with the
requirement that, if these embryos and
oocytes are collected from donors in, or
originating from, regions not free of
classical scrapie, the health certificate
required under § 98.5 must include
additional declarations stating that the
embryos or oocytes were collected,
processed, and stored in accordance
with the requirements in § 98.3, and, for
in vivo-derived sheep embryos only,
that the embryo is of either of the
scrapie-resistant genotypes, AARR or
AAQR, based on official testing of the
parents or the embryo. The testing may
be performed at the NVSL or at another
laboratory approved by the
Administrator. We received some
comments on these changes and will
discuss them below.
We proposed that the certificate that
would accompany sheep embryos that
are not of either of these genotypes,
sheep embryos that are in vitro-derived
or processed, and all goat embryos,
would also have to include statements
that in the region where the embryos
originate:
• TSEs of sheep and goats are
compulsorily notifiable;
• A classical scrapie awareness,
surveillance, monitoring, and control
system is in place;
• TSE-affected sheep and goats are
killed and completely destroyed; and
• The feeding of meat-and-bone meal
of ruminant origin has been banned and
effectively enforced in the whole
country.
The certificate would also have to
state that the donor animals:
• Have been kept since birth in flocks
in which no case of classical scrapie had
been confirmed during their residency;
• Are permanently identified to
enable traceback to their flock of birth
or herd of origin, and the identification
is recorded on the certificate
accompanying the embryos and linked
to the embryo container identification;
• Showed no clinical sign of classical
scrapie at the time of embryo or oocyte
collection; and
• Have not tested positive for, and are
not suspect for, a transmissible
spongiform encephalopathy.
We proposed adding these
certification requirements for embryo
genotypes that are not scrapie resistant,
but which originate from regions not
considered by APHIS as free of classical
scrapie, to ensure that mitigations are in
place to detect classical scrapie if it is
present in sheep or goat populations.
We received comments on these
changes and will discuss them below.
We also proposed to remove the
existing requirement that sheep embryos
from regions other than Australia, New
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Zealand, or Canada be transferred only
to flocks in the Voluntary Scrapie Flock
Certification program (SFCP).
Enrollment in this program requires an
annual inspection with inventory
reconciliation and submission of tissues
from certain animals for scrapie testing.
We proposed making this change
because the scientific literature
demonstrates that embryos are low risk
for scrapie transmission. APHIS has
determined that requiring all firstgeneration offspring to be maintained in
an SFCP flock is unnecessary as well as
overly burdensome on importers.
Instead, we proposed to require that
sheep and goat embryos or oocytes from
regions that are not free of classical
scrapie be imported only for transfer to
females in flocks listed in the National
Scrapie Database, or to an APHISapproved storage facility where they
may be kept and later transferred to
recipient females in a flock that is listed
in the National Scrapie Database. We
also proposed to allow imported
embryos or oocytes that are not
otherwise restricted by the conditions of
an import permit to be transferred from
a listed flock to any other listed flock
with written notification to the
responsible APHIS Veterinary Services
(VS) Service Center. To be listed in the
National Scrapie Database, a flock
owner must contact the local VS Field
Operations (FiOps) office for the
receiving State or a cooperating State
Veterinarian’s office and request to be
listed; and provide the location of the
flock and the owner’s contact
information. The VS FiOps office or
State Veterinarian’s Office will enter the
information in the database, and will
issue the flock identification and the
premises identification number that are
required to be submitted on the permit
application. To find the nearest VS
FiOps office, contact the State or
Territory Point of Contact (POC). A list
of POCs can be found on the APHIS
website at https://www.aphis.usda.gov/
aphis/ourfocus/animalhealth/contactus.
We received no comments on these
changes and will not be discussing them
further in this document.
Finally, we proposed to require the
importer, owner of a recipient flock, or
the owner of an APHIS-approved
embryo or oocyte storage facility to
maintain records of the disposition
(including destruction) of imported or
stored embryos or oocytes for 5 years
after the embryo or oocyte is transferred
or destroyed. These records would have
to be made available during normal
business hours to APHIS representatives
on request for review and copying. This
recordkeeping requirement is consistent
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with the recordkeeping requirements for
imported semen that already exist, and
would allow us to conduct traceback
investigations in the event of a disease
introduction. We received no comments
on this change and will not be
discussing it further in this document.
The regulations in § 98.3(h) currently
require that ruminant and swine
embryos have an intact zona pellucida,
which effectively prohibits the
importation of in vitro-derived and
micromanipulated embryos except as
provided under § 98.10. We stated that
we intended to continue to allow such
importations on a case-by-case basis, if
the Administrator determines that any
disease risk posed by the embryos can
be adequately mitigated through preentry or post-entry mitigation measures,
or through combinations of such
measures.
We received no comments on this
explanation of the interaction between
the two sections and will not be
discussing it further in this document.
The regulations in § 98.13 provide
requirements for import permits for
ruminant and swine embryos from
regions where FMD exists. We proposed
to add a new paragraph (c) to this
section specifying that applications for
a permit to import sheep and goat
embryos and oocytes must include the
flock identification number of the
receiving flock and the premises or
location identification number assigned
in the APHIS National Scrapie Database;
or, in the case of embryos or oocytes
moving to a storage facility, the
premises or location identification
number must be included. We proposed
this change to ensure that the permit
requirements for sheep and goat
embryos and oocytes from regions
where FMD exists are consistent with
the requirements for sheep and goat
embryos and oocytes from regions that
are free of the disease. We received no
comments on this change and will not
be discussing it further in this
document.
The regulations in § 98.15 set forth the
requirements for ruminant and swine
embryos from regions where foot-andmouth disease exists. Currently,
§ 98.15(a)(1) and (2) require that, for
ruminants, no case of BSE (among other
diseases) occurred (1) during the year
before collection in the embryo
collection unit or in any herd in which
the donor dam was present, or (2) in or
within 5 kilometers of the embryo
collection unit, or in any herd in which
the donor dam was present. We
proposed to remove these requirements
because we believe the proposed
requirements for sheep and goat
embryos in § 98.10a will provide
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adequate protection against a TSE
introduction via embryo or oocyte
transfer. We received no comments on
this provision and will not be
discussing it further in this document.
Section 98.15(a)(7)(i)(A) currently
requires that, for ruminants, not less
than 30 days, nor more than 120 days
after embryo collection, the donor dam
must be examined and found free of
BSE (among other diseases). We
proposed to remove the requirement
that sheep and goats be found free of
clinical signs of BSE because sheep and
goat embryos do not present a risk for
transmitting BSE since BSE is not
circulating in the sheep and goat
populations. We received no comments
on this provision and will not be
discussing it further in this document.
Currently § 98.15(a)(8)(i)(A) requires
that, for ruminants, between the time of
embryo collection and all required
examinations and tests are completed,
no animals in the embryo collection
unit with the donor dam, or in the
donor dam’s herd of origin, exhibited
clinical evidence of BSE (among other
diseases). We proposed to remove BSE
from the list of diseases in this
paragraph because we believe the
proposed requirements for sheep and
goat embryos in § 98.10a will provide
adequate protection against a TSE
introduction through embryo or oocyte
transfer. We received no comments on
this provision and will not be
discussing it further in this document.
Currently, the regulations in § 98.35(e)
require that, for sheep and goat semen
from any part of the world to be
imported into the United States:
• The donor animals must be
permanently identified to enable
traceback to their establishment of
origin;
• They have been kept since birth in
establishments in which no case of
scrapie has been confirmed during their
residency;
• They neither showed clinical signs
of scrapie at the time of semen
collection nor developed scrapie
between the time of semen collection
and the export of semen to the United
States; and
• The dam of the semen donor is not,
or was not, affected with scrapie.
The regulations also require that in
the region where the semen originates,
scrapie is a compulsorily notifiable
disease, an effective surveillance and
monitoring program for scrapie is in
place, affected sheep and goats are
slaughtered and completely destroyed,
and the feeding of meat and bone meal
or greaves derived from ruminants has
been banned and the ban effectively
enforced for the whole region.
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At the time the regulations were
established, they were consistent with
the then-current scientific
understanding of scrapie and existing
international standards. However,
advances in scientific understanding of
the disease now allow us to relieve
some restrictions on the importation of
sheep and goat semen. Epidemiological
evidence from natural cases in the field
suggests that classical scrapie is
unlikely to be transmitted via semen
(Wrathall 1997). In addition, studies to
date have failed to detect PrPSc proteins
in components of semen (Gatti, Meyer et
al. 2002).
As part of a study to investigate
transmission of classical scrapie through
embryo transfer, Wang, et al., used a
classical scrapie-positive ram to mate
with two donor ewes, one scrapie
positive, the other negative (Wang,
Foote et al. 2001). None of the lambs
resulting from embryos of either ewe
developed classical scrapie, nor did the
uninfected ewe that was bred to the
infected ram. The study did not provide
information about the scrapie strain or
the genotypes of the rams, donor ewes,
and recipient ewes.
A more recent study evaluated the
infectivity of semen from infected rams
by injecting it via intracerebral
inoculation into classical scrapiesusceptible transgenic mice
overexpressing the VRQ allele. Semen
from three classical scrapie-positive
VRQ homozygous sheep was injected
into a total of 40 transgenic mice, with
none subsequently developing classical
scrapie. One of the infected sheep was
exhibiting clinical signs of classical
scrapie and the other two were
asymptomatic at the time of collection.
In comparison, the injection of brain
homogenate from 4 scrapie-infected
sheep intracerebrally into 23 transgenic
mice resulted in infection of 100 percent
of the mice (Sarradin, Melo et al. 2008).
More recently, 8 ewes in a historically
scrapie-negative sentinel flock of 24
sheep were discovered to be scrapiepositive 4 months after having been
bred to scrapie-positive rams from an
adjacent highly infected flock. The flock
had also been bred in previous years by
other rams from the infected flock and
had fence line contact with rams from
the infected flock. The ewes had been
bred to these rams in order to increase
the scrapie-susceptibility of the sentinel
flock to the ‘Caine’ strain of scrapie (i.e.,
to increase the proportion of sheep with
at least one valine insertion at codon
136). This strain has a relatively short
incubation period, particularly in sheep
that are homozygous for valine at codon
136. The discovery of the infected ewes
led to an investigation by Rubenstein et
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al. (2012) to determine whether it was
possible that scrapie could have been
transmitted to the ewes through
exposure to the semen of infected rams
(Rubenstein, Bulgin et al. 2012).
Using newly developed detection
techniques such as serial protein
misfolding cyclic amplification,
combined with an optical fiber
immunoassay, the investigators detected
prion disease-associated-seeding
activity, which is assumed to imply the
presence of PrPSc in semen samples
from the rams in the affected flock
described above. In addition,
intracerebral inoculation of a newlygenerated sheep scrapie-susceptible
transgenic mouse line with semen from
both infected and uninfected rams from
the flock resulted in the detection of
PrPSc in all of the mice inoculated with
semen from scrapie-positive rams, but
in none of the mice inoculated with
semen from scrapie-negative rams.
These experiments suggest that semen
from scrapie-infected rams could harbor
infectious PrPSc; however, additional
studies are necessary to determine
whether the level of infectivity in semen
is sufficient to transmit scrapie laterally
to ewes or to embryos resulting from the
use of scrapie-infected semen donors.
To date, there has been no direct
evidence to support the transmission of
TSE infectivity through semen of sheep
and goats to other sheep or goats;
however, the studies conducted have
been somewhat limited.
Based on the findings of these studies,
we proposed to amend § 98.35 to
eliminate the requirement that donor
animals have been kept since birth in
establishments in which no case of
scrapie has been confirmed during their
residency, and to redesignate the
subsequent paragraphs. We also
proposed to require that the donor
animals were not, and are not, restricted
in the country of origin or destroyed due
to exposure to a TSE, and proposed to
add a new paragraph to allow APHIS to
establish testing requirements for semen
and/or semen donors. We received no
comments on these changes and will not
be discussing them further in this
document.
We also proposed to revise paragraph
(e)(3) to include semen from all
countries, and to allow semen to be
imported to an APHIS-approved semen
storage facility prior to being transferred
to females in a flock listed in the
National Scrapie Database. This change
will provide an additional option for
producers and importers. Further, we
proposed to add new paragraphs to
describe recordkeeping requirements for
APHIS-approved semen storage
facilities, including a requirement that
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progeny of imported semen be officially
identified and records maintained of
their disposition in order to allow these
animals to be traced if a need arises. We
received no comments on these
provisions and will not be discussing
them further in this document.
We now discuss the comments that
we did receive, by topic.
Importation of Live Ruminants
We proposed to amend § 93.404 to
specify additional information that an
importer would have to submit with the
application for an import permit for
sheep and goats. For sheep and goats
imported for purposes other than
immediate slaughter or restricted
feeding for slaughter, we proposed to
require that, if the sheep and goats
originate in regions not free of classical
scrapie, the importer would have to
provide documentation showing that
the animals have reached and
maintained certified status in a scrapie
flock certification program that has been
evaluated and approved by the
Administrator. The documentation
would have to specify the address, or
other means of identification, of the
premises and flock of birth, and any
other flocks in which the animal has
resided. We also proposed to add a new
paragraph (a)(6) which would provide
for permits to be issued by the
Administrator for sheep of certain
classical scrapie-resistant genotypes, as
determined by testing at the NVSL or
another laboratory approved by the
Administrator.
One commenter stated that sheep
entering the United States from other
countries should be held to the same set
of rules and regulations as flocks at the
Export Certified level in the U.S. SFCP
(described in the regulations in 9 CFR
part 54) in the United States. The
commenter also stated that sheep
should not be allowed to enter the
country based solely on codon test
results.
We agree with the commenter that the
same level of risk mitigation should be
required for imported sheep and goats
as required by the Export Category of
the U.S. SFCP. However, we disagree
that genotype should not be used to
mitigate risk associated with imported
sheep. As we explained in the
supporting scientific documentation
that accompanied the proposed rule,
resistance to classical scrapie is
consistently associated with the
presence of alanine (A) at codon 136,
arginine (R) at codon 154, and R at
codon 171. Sheep homozygous for this
combination appear almost completely
resistant to classical scrapie under
natural conditions. Female sheep with
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RR at codon 171, or male sheep either
with RR at codon 171 or with AA at
codon 136 and QR at codon 171, are no
more likely to transmit classical scrapie
than sheep meeting the requirements of
the Export Category of the U.S. SFCP.
We proposed to remove BSE-related
restrictions from goats as well as sheep.
Four commenters stated that there is
neither sufficient published literature
nor large enough surveillance sampling
to draw the conclusion that there is no
BSE risk in goats. The commenters
stated that surveillance for goats needs
to be expanded in the national scrapie
eradication program and APHIS should
recommend that trading partners
expand their TSE surveillance for goats
so good decisions may be made
regarding safe trade. The commenters
further stated that APHIS should
publish another proposed rule regarding
goats specifically when APHIS is able to
demonstrate and cite evidence
documenting BSE restrictions on goats
should be removed.
As we explained in the supporting
scientific documentation accompanying
the proposed rule, naturally occurring
BSE has only been documented in two
goats, as a result of retrospective
surveillance studies. Both goats were
born prior to the initiation of extended
ruminant feed bans, and ongoing
surveillance has not shown evidence of
BSE circulating within domestic sheep
and goat populations. Experience
internationally in countries with BSE
has demonstrated that feed bans are
effective control measures and the
incidence of BSE worldwide continues
to decline because of these measures.
Furthermore, we will require that any
goat imported into the United States
either comes from a region recognized
by APHIS as free of classical scrapie or
has reached and maintained certified
status in a SFCP determined by APHIS
to provide equivalent risk reduction as
the USDA APHIS Export Category of the
SFCP. The requirements for APHIS to
determine classical scrapie-free status
and for equivalent status for scrapie
flock certification programs in an
exporting region are set out in the
APHIS guidance document
accompanying the proposed rule,7 and
includes the flock meeting the
requirements equivalent to the Export
Certified status of the U.S. SFCP while
participating in a program under the
supervision of the national veterinary
authority of the region of origin. This
equivalency must be determined by
APHIS evaluation. We also require that
the feeding of meat and bone meal,
7 See https://www.regulations.gov/document/
APHIS-2009-0095-0005.
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greaves, or similar materials of ruminant
origin to sheep and goats is banned and
has been effectively enforced in the
region for at least 7 years.
As discussed previously in this
document, we proposed a requirement
for additional information that an
importer would have to submit with the
application for an import permit for
sheep and goats. One commenter stated
the proposed rule seemed to require an
import permit, but currently, all other
livestock exports from Canada to the
United States are completed with only
an export certificate or a less complex
requirement, if the animals are entering
the United States via a land port. The
commenter asked for Canada and the
United States to enter into a bilateral
agreement to remove the requirement
for an import permit for live sheep and
goats and replace it with an export
certification.
In § 93.417, paragraph (a) specifies
that for ruminants imported from
Canada, the importer must apply for and
obtain an import permit as provided in
§ 93.404. An exception to the permit
requirement is provided for certain
ruminants, including wethers and sheep
or goats imported for immediate
slaughter, if those ruminants are offered
for entry at a land border port, and
provided certain other conditions are
met. We did not propose to amend this
section. A permit ensures collection of
the additional information needed to
determine the initial eligibility of
animals for importation.
One commenter stated that it appears
in cases of export of small ruminants for
any purpose other than slaughter or
feeding for slaughter, the export
certificate required in § 93.405(b) will
require an extensive amount of
information including transport route,
port of entry, and, most notably, all
premises on which the animal has
resided throughout its life. The
commenter asked us to explain the need
for this documentation.
The documentation is needed to
ensure animals have been kept in
holdings complying with § 93.405(b)
and (c), equivalent to the Export
Category of the U.S. Scrapie Flock
Certification Program. This certification
requirement is incorporated to address
the potential risks of other premises
where the donor animals resided which
were not of equivalent status.
We proposed to define country mark
as ‘‘a permanent mark approved by the
Administrator for identifying a sheep or
goat to its country of origin.’’ We
proposed this definition to distinguish
this mark from other forms of
identification, such as eartags or
backtags, that might be used on an
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animal. We also proposed to require the
use of country marks for sheep and
goats imported for purposes other than
immediate slaughter or restricted
feeding for slaughter because these other
purposes are not terminal, and this
permanent identification allows APHIS
to trace an animal back to the country
of origin in the event that the animal
shows symptoms of a TSE.
One commenter stated that the
proposed changes do not address the
requirement for animal branding. The
commenter claimed that current
requirements for cattle branding are not
enforced consistently at different border
ports, creating trade barriers and
expressed concern that branding
requirements for sheep and goats
exported for feeding prior to slaughter
may present similar trade barriers. The
same commenter and four other
commenters also noted the proposed
rule required a permanent country mark
for all imported live sheep and goats.
The commenters stated branding is not
common practice in the sheep and goat
industries and has been raised as a
significant issue for the humane
treatment of these animals. The
commenters asked APHIS to provide an
alternative option to branding, where
possible.
APHIS notes that we proposed in
§ 93.435(a)(3) to require imported sheep
and goats to be permanently identified
with a country mark using a means and
in a location on the animal approved by
the Administrator, but we did not
specify any particular method of
identification. We may approve
methods other than hot iron branding to
permanently identify animals; however,
no consistently effective alternative
methods exist currently. The revisions
that we proposed were simply to allow
for their development, should it occur.
This requirement is similar to the
requirements for bovines from Canada,
which must be permanently identified
with a brand, ear tattoo, or other means
deemed acceptable by the
Administrator. This permanent
identification allows APHIS to trace an
animal back to the country of origin in
the event the animal shows symptoms
of a TSE. Because many forms of eartags
are not tamper-evident and may be lost
or removed and reused, we generally do
not consider eartags a permanent form
of identification. We are not aware of
these requirements resulting in barriers
to trade.
We proposed to require that health
certificates for imported sheep and goats
include the official individual sheep or
goat identification applied to the
animals. One commenter asked what
would be required as official
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identification, particularly for goats. The
commenter noted that in Canada, all
sheep are currently required to be
tagged with an official Canadian
government radio frequency
identification (RFID) device when they
leave the farm of origin, but goats are
not required to be tagged. However, for
the voluntary scrapie flock certification
program, animals must only carry two
unique forms of identification while on
farm, but neither of those identification
methods is required to be the Canadian
official RFID. The commenter asked if
APHIS would recognize this as
acceptable identification.
APHIS will require official Canadian
RFID eartags for goats and sheep
imported from Canada and this will be
specified in guidance published on
APHIS’ website. Sheep and goats
imported for purposes other than
immediate slaughter will also require a
permanent mark unless maintained as a
segregated group in a designated feedlot.
One commenter noted that under
proposed § 93.435(b), officials of the
country of origin would be required to
seal conveyances at the point of
departure for animals going directly to
slaughter or feeding for slaughter. The
commenter asked why this is different
from the requirements for cattle, where
seals are placed at the port of entry by
U.S. inspection staff.
The commenter is correct in
identifying a discrepancy between the
treatment of cattle going directly to
slaughter or restricted feeding for
slaughter and our proposed
requirements for sheep and goats going
directly to slaughter or restricted
feeding for slaughter. This was an
oversight in the proposed rule and there
is no technical basis for such a
discrepancy. The requirement that
conveyances carrying sheep and goats
for immediate slaughter be sealed at the
point of departure is a BSE-related
restriction and is no longer warranted.
We have amended § 93.435(b) to remove
this restriction.
One commenter stated that while the
proposed § 93.435(e) addresses
provisions for transit through the United
States, it does not seem to address the
possibility of a rest stop should the
duration of travel be excessive.
Under the 28-Hour Law (49 U.S.C.
80502), rest stops are required for
animals being transported in the United
States. Section 93.401(b) of the
regulations sets out the conditions
under which rest stops for ruminants
may occur. We did not propose any
changes to those provisions.
In proposed § 93.435(f), we set out the
process by which we would recognize
regions as free of classical scrapie. One
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commenter asked what criteria would
be used to determine whether a region
is free of classical scrapie and if those
criteria were consistent with World
Organization for Animal Health (OIE)
guidelines. The commenter noted three
European Union (EU) Member States
have met EU criteria to be considered
negligible risk for classical scrapie, and
asked whether, given the EU criteria
were the same as the OIE, EU Member
States could be recognized (or receive
an expedited review) as free of classical
scrapie by the United States.
The criteria for classical scrapie-free
country status were described in the
guidance document published with the
proposed rule. The criteria are
consistent with OIE guidelines and
include the existence of a system of
effective official veterinary control and
oversight within the region for at least
7 years, a program of targeted
surveillance and monitoring for
classical scrapie in place for at least 10
years, and a ban on feeding to sheep and
goats of meat and bone meal, greaves, or
similar materials of ruminant origin that
has been effectively enforced in the
region for at least 7 years, among other
requirements. EU Member States will be
reviewed in accordance with § 92.2 of
the regulations using the criteria in the
guidance document in the order in
which complete submissions are
received.
One commenter asked why, for
imports based on the scrapie status of
the flock of origin, the certification
program of the country must be
approved by APHIS. The commenter
asked APHIS to consider, as
recommended by OIE, including in its
import health certificate requirements
criteria that are equivalent to the OIE’s
criteria for ‘‘scrapie free establishments’’
and accept imports based on the
certification that these criteria have
been met.
We cannot accept imports solely on
certification that OIE requirements have
been met. The United States needs to
ensure that proper oversights by the
competent authority exist in the region
of origin and that the program has been
effectively implemented. Further,
because the OIE guidelines do not
specify a minimum number of animals
that must be tested before a flock is
certified, we believe that testing levels
specified by OIE may not be sufficient
to detect scrapie in a flock before it is
certified as free.
One commenter asked whether APHIS
could approve the EU scrapie status
flock certification program as a whole,
instead of requesting applications from
each Member State. The commenter
stated that the EU flock certification
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program respects harmonized rules, laid
down in Annex VIII to Regulation (EC)
No 999/2001,8 which follow OIE criteria
for establishments free from scrapie, and
require the Member State to maintain
lists of holdings with negligible risk of
classical scrapie based on those criteria.
The commenter also stated that EU
holdings listed as having a negligible
risk of classical scrapie would be
considered equivalent to ‘Export
Certified Flocks’ in the United States
and also meet the recommendations at
Article 14.8.5 of the OIE Code. The
commenter stated that, once APHIS
considers and confirms this to be the
case, documentation detailing all the
holdings of residence or provenance
since birth of sheep and goats intended
for export to the United States should
not be necessary or required.
We will review the EU scrapie status
flock certification program when the
first EU Member State applies. If the
implementation by that Member State of
the EU scrapie flock certification
program requirements are determined to
be equivalent to the United States’
program requirements, subsequent
Member State certification program
reviews may be limited to an evaluation
of the Member State’s implementation
of the EU scrapie status flock
certification program and may take into
consideration the prior APHIS
determination of the EU scrapie flock
certification program. We will not
prejudge the results of any EU Member
State’s program evaluation in this final
rule.
In the proposed rule, we proposed to
define certified status as a flock that has
met the requirements equivalent to the
Export Certified status of the U.S.
Scrapie Flock Certification Program
while participating in a program under
the supervision of the national
veterinary authority of the region of
origin as determined by an evaluation
conducted by APHIS of the program.
One commenter asked if the program
in Canada, which is administered by
Scrapie Canada but is overseen by the
Canadian Food Inspection Agency
(CFIA), and for which all inspections
are performed by federally accredited
veterinarians, would meet the
requirements. The commenter noted
that in the U.S. SFCP, Export Certified
flocks receive a high level of
monitoring, including annual
inspections and inspection of all cull
animals. The commenter stated that in
Canada, cull animals are not inspected
although records of sales are reviewed.
8 The EU regulations can be viewed online at
https://eur-lex.europa.eu/legal-content/EN/TXT/
HTML/?uri=CELEX:32001R0999&from=EN.
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On-farm adult mortalities are tested for
scrapie by accredited laboratories. The
commenter asked if this level of
surveillance would be acceptable.
Countries should request evaluation
of their certification program to have it
officially recognized by APHIS as
equivalent. We will not prejudge the
results of any country’s program
evaluation in this final rule.
We proposed to allow sheep and goats
for breeding to be imported in two ways.
One way is for the animal to originate
in a region recognized by APHIS as free
of classical scrapie. The other is for the
animal to reach and maintain certified
status in a scrapie flock certification
program determined to provide the
same risk reduction as the Export
Category of the U.S. SFCP. One
commenter stated that Canada’s
voluntary scrapie free flock certification
program has been designed based on
OIE guidelines, with some exceptions
based on equivalent risk outcomes.
Canada’s program differs in allowing
flocks or herds to achieve certified
status after 5 years of monitoring,
whereas the OIE guidelines and the U.S.
program require 7 years of monitoring.
The commenter stated that the rule only
considers a country’s flock certification
program guidelines and does not
consider the impact of a country’s
national scrapie prevalence, or the
presence of a national scrapie
eradication program. The commenter
stated that the very low national
prevalence for scrapie and the CFIA’s
ongoing and robust national scrapie
eradication program, in combination
with strict flock certification program
requirements, provide the confidence
needed to certify flocks or herds as
negligible risk after 5 years on the
program.
Countries should request evaluation
of their certification program to have it
officially recognized by APHIS as
equivalent. In recognizing equivalence,
we will consider the possibilities that
countries could apply additional or
different mitigations to provide
equivalent risk status as the U.S.
program. We will not prejudge the
results of any country’s program
evaluation in this final rule.
We proposed to allow for permits to
be issued by the Administrator for sheep
of certain classical scrapie-resistant
genotypes, as determined by testing at
the NVSL or another laboratory
approved by the Administrator. One
commenter expressed confusion about
what will be expected for sheep tested
for genetic markers of scrapie resistance.
The commenter noted that the proposed
rule states such sheep must meet all
requirements for import other than the
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requirement that they originate in a
flock or region free of classical scrapie.
The commenter asked if this means
sheep confirmed to carry the specified
genes for scrapie resistance will not be
required to be from a flock that is
certified under the CFIA’s Voluntary
Scrapie Flock Certification Program
(VSFCP). The commenter asked if this
would apply uniformly to both males
and females. The commenter also asked
if importation of these genetically lowrisk sheep would be at the discretion of
the Administrator, i.e. on a case-by-case
basis.
The provisions for the importation of
genetically resistant sheep are in
§ 93.404(a)(6). Sheep permitted entry
under these provisions are not required
to come from a flock certified under a
scrapie free certification program.
However, as we explained in the
proposed rule, only females that are
genotype AARR, or males that are
genotype AARR or AAQR, may be
imported under this provision on a caseby-case basis at the discretion of the
Administrator.
One commenter noted that in
§ 93.404(a)(6), we proposed to require
that genetic testing be completed at the
National Veterinary Services
Laboratories or another laboratory
approved by the Administrator. The
commenter asked whether we would
require these tests to be completed at a
laboratory in the United States. The
commenter also asked if a laboratory
recognized by the CFIA for the VSFCP
in Canada would be recognized, and if
we would make a list of acceptable
laboratories available.
APHIS will consider approval of
foreign laboratories with the required
expertise and where there are
appropriate quality assurance
procedures in place. In general, APHIS
will consider approving laboratories
that are approved by the competent
veterinary authority of the national
government of the exporting region,
provided that region has a scientifically
sound approval and oversight process in
place for laboratories. Review of the
degree of laboratory oversight in the
country will occur in our overall
evaluation of the country’s scrapie
program. If we approve foreign
laboratories, this will be detailed in the
import protocols designed for the
importation of sheep/goats for specific
countries/regions and the negotiated
export health certificates. APHIS will
need the approved laboratory results
before import permit issuance, and the
information will accompany export
health certificates.
One commenter stated that the EU
recognizes sheep with genotype ARR/
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ARR as genetically resistant. The
commenter asked APHIS to take this
into consideration for all sheep, not just
those for research and diagnostics, when
a permit is requested.
As we explained in the proposed rule,
only females with genotype AARR or
males with genotype AARR or AAQR
may be imported under this provision.
The reason for this restriction is that the
OIE does not recognize the ARR/ARR
genotype as genetically resistant to
scrapie. Permits will still be required for
animals with known genotypes which
may be allowed if they meet other
import requirements. The genotyping
requirements are not specific to sheep
for research/diagnostics.
We proposed to amend
§ 93.405(b)(2)(i) to require that the
health certificate accompanying
imported sheep and goats state that the
sheep or goats originated from a region
recognized as free of classical scrapie by
APHIS, or that the animals had reached
and maintained certified status in a
scrapie flock certification program
approved by APHIS. One commenter
suggested that we amend this
requirement to read ‘‘or the animals
have reached and maintained certified
status in a scrapie flock certification
program approved by APHIS or
equivalent status.’’ The same
commenter also suggested amending
§ 93.435(d) in a similar fashion. The
commenter stated these changes would
accommodate holdings in the EU
designated as negligible risk for classical
scrapie.
Our intent is to recognize equivalent
status in an equivalent program
regardless of the name given to the
status or to the program. For clarity, we
will revise both paragraphs, paragraph
(b)(2)(i) of § 93.405 and paragraph (d) of
§ 93.435, to read ‘‘certified status or
equivalent status in a scrapie flock
certification program approved by
APHIS.’’
We proposed that sheep and goats
entering ‘‘terminal feedlots’’ be required
to be permanently identified. One
commenter stated that while there is no
scrapie transmission risk associated
with lambs being fed for slaughter, on
occasion ewe lambs do move out of
feedlots and enter breeding flocks. The
commenter stated that this poses an
enforcement problem and an
unnecessary risk since records and
inspection are the only practical tools
for assuring all animals in a terminal
feedlot are either processed or
terminated and are properly disposed
of. The commenter stated that APHIS
should require all imported sexually
intact sheep and goats be permanently
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identified in a tamper-proof manner
regardless of their age or intended use.
Since all imported animals require
official identification, we presume the
commenter is referring to the country
marks exemption for animals kept
segregated in feedlots as provided in
§ 93.435(a)(3). While there are
circumstances where the Administrator
may determine that a country mark is
required for animals imported to
terminal feedlots, we disagree that there
is significant risk associated with
animals properly handled within these
terminal feedlots under APHIS oversight
and restrictions that would necessitate
all such animals having country marks
as well as official identification.
One commenter recommended that
APHIS place additional requirements on
designated feedlots receiving imported
animals from regions not free of
classical scrapie for restricted feeding
and eventual slaughter to include that
there be no fence-line contact with other
sheep or goats. The commenter stated
that this could be accomplished by
requiring at least a 30-foot fence
separation or a solid-wall perimeter
designed to prevent fluid transfer
between animals in the designated
feedlot and sheep or goats outside the
feedlot. The commenter also stated that
APHIS should also inspect and approve
the designated feedlot’s biosecurity
provisions and practices to minimize
the risk of TSE transmission between
animals in and outside the designated
feedlot.
We agree with the commenter. A
designated feedlot may be a specified
area within a larger facility that contains
animals intended for subsequent
movement from the facility.
Additionally, scrapie may be spread
through contact with bodily fluids such
as nasal mucus, urine, saliva, and feces
and therefore fence-line contact between
imported animals in designated feedlots
and other sheep or goats that could
subsequently move from the facility
could pose a risk of scrapie
transmission. We have amended
§ 93.435 to include a new paragraph
(c)(11)(viii) requiring the operator of the
feedlot to prevent fence-line contact by
a method acceptable to the
Administrator. We will work with
individual operators to determine the
best means of preventing such contact
in their feedlots.
One commenter asked that, in
addition to recognizing the negligible
risk that genotype AARR females pose
in transmitting scrapie, APHIS also
allow the import of genotype AAQR
females under the same conditions. The
commenter cited the limited risk
genotype AAQR females pose, given the
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additional requirement that these
animals must come from a flock known
to be free of classical scrapie.
APHIS disagrees. In general, a
glutamine (Q) at codon 171 of the PrP
allele is associated with susceptibility to
scrapie. AAQR scrapie-positive animals
occur with some frequency.9 AARR
sheep imported under this provision of
the proposed rule do not have to
originate in scrapie-free flocks, only in
flocks having no known risk for scrapie.
One commenter noted that for
ruminant species that are not bovines,
cervids, sheep, goats or camelids, the
rule indicates a case-by-case approach
will be used to mitigate TSE risk for
zoological or wild ruminants considered
for import. The commenter stated this
approach works well in these unique
situations but may be too burdensome
for certain farmed alternative livestock
(e.g., water buffalo and yaks) posing an
extremely low risk based on both
reported susceptibility to TSEs and
known feeding practices.
Farmed alternative bovid livestock
(domestic water buffalo, Bubalus
bubalis or domestic yak, Bos grunniens)
that are not sheep or goats are
recognized as very low risk for BSE, but
unknown risk for other TSEs. An
unknown risk should not be presumed
to be a negligible risk, particularly when
the diseases in question are
degenerative and fatal. Accordingly,
these species may be evaluated under a
similar process as zoological ruminants
on a case-by-case basis, or through
protocols with detailed mitigations for
import of these domestic bovid species.
Zoological Ruminants
Currently, non-bovine ruminants
other than sheep and goats from regions
not listed in § 94.24(a) are not subject to
any import restrictions with regard to
BSE. We believe, however, that there is
a certain category of ruminants that
present enough of a potential risk of
spreading TSEs that their importation
should be prohibited unless certain risk
mitigation measures are in place. This
category of ruminants includes certain
ruminants held in zoological facilities
and certain wild ruminants. For the
purposes of discussion, we will refer to
such animals as zoological ruminants to
distinguish them from domesticated
sheep, goats, and bovines.
Scientific literature indicates that at
least certain zoological ruminants are
9 The genetics of scrapie resistance were
discussed extensively in a rulemaking that
amended the domestic scrapie regulations in 2019.
To view the proposed and final rules, supporting
materials, and comments we received, go to https://
www.regulations.gov and enter APHIS–2007–0127
in the Search field.
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susceptible to TSEs caused by the BSE
agent. In association with the BSE
epidemic in domestic cattle in Europe,
TSEs have been diagnosed in several
species of zoo animals, all from the
families Bovidae and Felidae. Sixteen
cases of TSEs have been recorded from
antelope in U.K. zoos including one
nyala (Tragelaphus angasi), six eland
(Taurotragus oryx), six greater kudu
(Tragelaphus strepsiceros), one gemsbok
(Oryx gazelle), one Arabian oryx (Oryx
leucoryx), and one scimitar-horned oryx
(Oryx dammah) (Travis and Miller
2003). The first recorded case was a
nyala euthanized at a wildlife park in
England in 1986, the same year that the
first BSE cases in cattle were recognized
(Wells, Scott et al. 1987; Jeffrey and
Wells 1988). Reported cases of TSEs in
zoo bovids peaked around 1991, and no
additional cases in zoo antelope have
been reported since 1996 (Kirkwood
2000).
Several lines of evidence support the
hypothesis that at least some, if not all,
of the spongiform encephalopathy cases
diagnosed in zoo bovids were caused by
the BSE agent. First, the cases in zoos
coincide geographically and temporally
with the BSE epidemic in Great Britain.
Second, epidemiologic investigations
indicated that all affected animals, or
the herds into which they were born or
moved, could have been exposed to
feeds containing ruminant- derived
protein or other potentially
contaminated material (Kirkwood and
Cunningham 1994). Finally, comparable
patterns of incubation periods and
pathologic effects were seen in mice
inoculated with brain tissue
homogenate from the affected nyala, an
affected kudu, and BSE-affected cattle
(Jeffrey, Scott et al. 1992).
The greater kudu, a non-domestic
African antelope, appears to be
particularly susceptible to BSE. Six of
eight kudu that died in a small herd at
the London Zoo from 1989 through 1992
were diagnosed with spongiform
encephalopathy (Kirkwood and
Cunningham 1994). The disease is
presumed to have been introduced to
the kudu herd through feeds containing
ruminant-derived protein around the
time of the BSE epidemic in U.K cattle.
However, some of the affected kudu
were born after the elimination of the
potentially contaminated feed from the
premises, and one case occurred in a
kudu born at another zoo and
introduced to the affected herd
(Kirkwood, Cunningham et al. 1994).
Because most of the affected kudu did
not consume feed containing ruminantderived protein, it was postulated that
the disease may have spread naturally
in the herd, either by transmission
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between individuals or through
contamination of the environment
(Kirkwood, Cunningham et al. 1993).
The epidemiology of the TSE cases in
kudu contrasts with BSE in cattle in
several respects. The attack rate in the
London Zoo kudu herd is notably higher
than the attack rate seen in BSE affected
cattle herds. The pattern of disease in
antelope also differs from cattle affected
with BSE, characterized by a younger
average age of onset and a shortened
clinical course (Kirkwood and
Cunningham 1999). Additionally,
infectivity in greater kudu with TSE is
distributed in a wider range of tissues
than in cattle with BSE (Cunningham,
Kirkwood et al. 2004).
A wide range of species in zoological
collections were probably exposed to
BSE-contaminated feed; new cases in
other captive zoological species may
emerge, or it is possible that some
species may carry and transmit the
disease without showing clinical signs.
The possibility of transmission of BSErelated encephalopathy between
members, or from mother to offspring,
within herds of zoological ruminants, as
suspected with the London Zoo kudus,
cannot be ruled out. Although there is
currently no evidence that TSEs exist in
free-living zoological ruminants
(veterinary authorities in southern
African countries conducting passive
surveillance in wildlife have not
encountered any clinical cases or
histopathological lesions compatible
with TSEs (Horn, Bobrow et al.), active
surveillance has not been implemented
in any region of the world for TSEs in
antelope or free-living Caprinae.
Many of the non-domestic ruminants
are endangered species. The scimitarhorned oryx, for example, is listed as
‘‘Extinct in the Wild’’ on the
International Union for Conservation of
Nature Red List (https://
www.iucnredlist.org/), and 13 species of
the Caprinae subfamily are listed as
threatened on the Red List. In order to
maintain genetic diversity in these very
small populations, animals must be
moved between zoological collections,
both domestically and internationally
(Shackleton 1997). Movement of
animals may also be a goal of
conservation programs seeking to
reintroduce captive-bred endangered
species into the wild. Both types of
movement carry the risk of inadvertent
introduction of infectious diseases that
may have serious consequences for
conservation efforts. The management of
animal genetic resources must include a
consideration of the potential risk of
importing undetected prion diseases
with rare breeding stock.
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Although each of the cases to date of
ruminant TSEs possibly connected to
BSE in zoo animals was diagnosed in a
region known to be affected with BSE,
we believe that even zoological
ruminants in regions not categorized as
BSE-affected or as posing undue risk of
BSE could be at risk for BSE-related
TSEs, due to possible origin in a BSEaffected region or feeding with BSEcontaminated protein. Even in countries
that have enforced a ban on the feeding
of ruminant protein to domestic
ruminants for an identifiable period of
time, it can be difficult in some cases to
determine when and if a country ceased
feeding ruminant protein to zoo
ruminants.
Because of the potential variety of
practices in the feeding of zoo
ruminants, as well as the potential that
certain zoo ruminants may have
originated in BSE-affected countries, we
believe it is necessary to consider on a
case-by-case basis the potential
spongiform encephalopathy risk of
zoological ruminants. As noted above, a
ruminant may not be imported into the
United States unless the importer has
first applied for and obtained a permit
from APHIS for such importation. In the
case of zoological ruminants, the
Administrator will consider the disease
risk of each animal and the ability of the
receiving zoo to manage the risks before
deciding whether to issue an import
permit.
Paragraph (a)(3) of § 93.404 currently
provides that an application for a permit
to import ruminants may be denied due
to, among other reasons, the lack of
satisfactory information necessary to
determine that the importation will not
be likely to transmit any communicable
disease to livestock or poultry of the
United States.
Even with zoological ruminants that
would otherwise be denied importation
into the United States, however, we
believe that, in most cases, adequate
mitigation measures with respect to
potential TSE risks can be taken to
allow the animal to be safely imported
into the United States. The precise
measures APHIS considers necessary
could vary on a case-by-case basis.
As noted above, the current
regulations contain broad prohibitions
and restrictions regarding the
importation of non-bovine ruminants
other than sheep and goats from regions
listed in § 94.24(a). The prohibitions
apply to zoological ruminants as well as
to domesticated ruminants. However,
the regionally-based prohibitions do not
address individual situations where a
ruminant that would otherwise be
denied entry from a region listed in
§ 94.24(a) could be safely entered into
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the United States, provided certain risk
mitigation measures are taken.
Therefore, we proposed to add a new
paragraph (a)(5) to the import permit
provisions in § 93.404 to address such
situations. The new paragraph provides
that, in specific cases, a permit may be
issued for ruminants that would
otherwise be prohibited importation due
to TSEs pursuant to part 93, subpart D,
if the Administrator determines that the
disease risk posed by the animals can be
adequately mitigated through pre-entry
or post-entry mitigation measures, or
through combinations of such measures.
Such measures would be specified in
the permit. If it is determined prior to
or after importation that any pre-entry
or post-entry requirements were not
met, or that the ruminants are affected
with or have been exposed to TSEs, the
ruminants, their progeny, and any other
ruminants that have been housed with
or exposed to the ruminants will be
disposed of or otherwise handled as
directed by the Administrator.
We also proposed to require that
importers seeking a permit pursuant to
the paragraph must send their request
by postal mail to the Administrator, c/o
Strategy and Policy, VS, APHIS, 4700
River Road Unit 39, Riverdale, MD
20737–1231, or make their request
online via APHIS’ electronic permitting
system, by email or by fax. Information
about using these methods to request a
permit can be found on the APHIS
website at https://www.aphis.usda.gov/
aphis/ourfocus/animalhealth/animaland-animal-product-importinformation/animal-health-permits.
Several commenters raised concerns
about the conditions for importation of
zoological ruminants.
Four commenters stated that for true
(traditional) zoo animals, the originally
imported animals should stay in zoo
confinement—that is, essentially
quarantined—for life and only their
progeny could move, provided there
was the observed and/or tested absence
of TSEs in the imported animals and the
progeny.
APHIS generally agrees with the
commenters, and it is our intent that the
animals would remain under quarantine
within a zoo for life. If an animal had
to be transferred between zoos, the
receiving zoo would need APHIS
approval as a quarantine facility and
would need to operate under a
compliance agreement with APHIS. As
we explained in the proposed rule,
importation of zoological ruminants will
be considered on a case-by-case basis.
This includes a compliance agreement
between APHIS and the zoo regarding
how the animal will be maintained,
including with cohorts and offspring,
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APHIS approval of any post-importation
movement of the animal, proper
notification upon death of the animal,
post-mortem examination, and proper
carcass disposal.
The same commenters stated, with
regard to importing any zoological or
wild animals into the United States
other than to traditional zoos, that
APHIS should consider this only after a
whole country or region risk assessment
has been done with a finding of
negligible risk for TSEs and a proposal
for public notice and comment be
published.
We do not consider that a TSE risk
assessment of the country or region of
origin is warranted. As we explained
above, the pathology and spread of TSEs
associated with zoological ruminants
vary from the pathologies of BSE in
cattle and scrapie in domesticated sheep
and goats, and there is not yet any
evidence for TSEs in free-living
zoological ruminants. The evaluations
will be case-specific, and will focus on
the TSE risk associated with each
specific importation. We will evaluate
herd and individual health histories for
the animals, necropsy records
maintained by the zoos and in large
databases maintained by zoo
organizations (such as the International
Species Information System) and the
ability of the zoo to quarantine the
animals. We would have to reach a
determination that it is possible to
mitigate any TSE risk through postexport quarantine and movement
regulation.
We proposed to define goat as ‘‘any
animal of the genus Capra’’ and sheep
as ‘‘any animal of the genus Ovis.’’ One
commenter stated that classifying all
species in the genus Ovis as sheep and
all species in the genus Capra as goats
for the purposes of importation and
with regards to TSE requirements is
overly cautious and puts unwarranted
restrictions on wild members of the
genera. The commenter stated that
bighorn sheep (O. canadensis) from
wild populations present a limited risk
for the introduction of TSEs. The
mitigation measures provided as
examples would be impossible to apply
to a free-ranging population. The
commenter recommended factors such
as the history of exposure to domestic
sheep as well as other criteria be
considered in the evaluation of requests
for importation of bighorn sheep by
wildlife management agencies.
The rule provides the flexibility
necessary to assess each importation in
light of the science known at the time,
the risk factors associated with the area
from which the animals are to be
imported, and the risk factors associated
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with the animals themselves, including
for imports of wild and free-ranging
species, such as bighorn sheep.
One commenter stated that nonbovine ruminants, other than domestic
sheep and goats, should be subject to
import restrictions and concurred with
APHIS that at least some animals in this
category present enough of a potential
risk of spreading TSEs that their
importation should be prohibited,
unless certain risk mitigation measures
are in place. The commenter stated it is
inappropriate to propose regulatory
changes for zoological and wild
ruminants in this rulemaking and that
APHIS should withdraw the sections
dealing with these animals and propose
them in a separate rulemaking, if
warranted.
APHIS disagrees that making changes
to the regulations governing the
importation of zoological and wild
ruminants is inappropriate in this
rulemaking. As we explained in the
proposed rule, APHIS will consider the
potential TSE risk for each proposed
importation on a case-by-case basis and
may deny entry if the risk presented is
too great.
Sheep and Goat Germplasm
One commenter stated that sheep
with genotype AARR are considered
genetically resistant and the EU accepts
semen of such sheep. Under EU
regulations, if the donor is not
genetically resistant, then the donor
must belong to a holding listed as
presenting at least a controlled risk of
classical scrapie. The commenter asked
that APHIS take this into consideration
when a permit is requested.
We agree that semen from genotype
AARR rams is genetically resistant to
scrapie and should be accepted with
minimal additional requirements; we
have amended § 98.35(e) accordingly.
Five commenters stated that the risk
of scrapie transmission via semen or
embryos is very low and the genetic
profile of rams for scrapie resistance
may be even more important than
country status. The commenters
therefore asked APHIS to grant permit
exemptions for semen collected from
rams testing AARR and AAQR. The
commenters stated that this change
would result in the sheep semen import
requirements being generally equivalent
to the embryo importation requirements.
APHIS agrees with the commenters
concerning the low risk of scrapie
transmission from AARR and AAQR
semen donors and we have amended
§ 98.35(e) accordingly.
One commenter stated that there
should be no restrictions pertaining to
scrapie for ovine in vivo-derived
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embryos to be consistent with Article
4.7.14 of the OIE Code.
APHIS disagrees. As we explained in
the supporting scientific documentation
accompanying the proposed rule,
although the scientific literature has
supported classifying embryos collected
in accordance with International
Embryo Transfer Society guidelines as
low risk with respect to scrapie
transmission, the limited number of
animals studied, and the lack of
diversity of scrapie strains evaluated,
make it appropriate to apply additional
mitigations in order to reduce the
likelihood embryos selected for export
will be infected. These concerns also
extend to the use of in vivo-derived
sheep embryos, which the OIE classifies
as unrestricted. Therefore, APHIS will
also apply the OIE criteria for in vivoderived goat embryos to in vivo-derived
sheep embryos unless the embryo is of
genotype AA at codon 136 and either
RR or QR at codon 171. APHIS may also
require additional testing for sheep and
goat-derived oocytes and embryos (and
their donor animals) originating from
countries or regions not considered
scrapie-free by APHIS.
One commenter noted that the
proposed rule mentioned possible
additional certification or testing
requirements as established by APHIS
for semen and embryos. The commenter
stated that if this is to allow for
flexibility as science progresses, they
supported the provisions, but they
would also appreciate further details
and clarification if APHIS intends to
add further certification and testing
requirements immediately.
The commenter’s interpretation is
correct. The provisions in § 98.10a(c) are
intended to address any new
developments in scrapie testing, our
understanding of embryo risk, or
unforeseen situations. We have no plans
to implement additional certification or
testing requirements for semen and
embryos at this time.
One commenter stated that in the EU,
ARR/ARR homozygote or ARR
heterozygote embryos are considered
genetically resistant and may be traded
regardless of the scrapie status of the
donor flock. The commenter noted that
the provisions in § 98.10a(b)(1)(ii)
appear to allow this possibility. The
commenter asked for clarification about
what would be required under
§ 98.10a(c), which provides that any
additional certifications or testing
requirements will be specified on the
import permit.
The commenter’s understanding of
§ 98.10a(b)(1)(ii) is correct. We note that
the requirements for additional
certification and testing in § 98.10a(c)
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are the same as those in § 98.35; that is,
these requirements are the same for both
semen and embryos. APHIS notes most
conditions are waived for genetically
resistant embryos, but the statement that
the donors were not affected by, or
exposed to, a TSE is required for all
embryos, even those that are genetically
resistant.
One commenter stated that if embryos
are not genetically resistant, then the EU
requires that the donors belong to a
holding designated as at least
‘‘controlled risk’’ for classical scrapie.
The commenter noted § 98.10a(a)
requires that the holding has a certified
status equating to ‘negligible risk’ under
EU TSE legislation. However,
§ 98.10a(b)(1)(iii) provides another
option provided the country
requirements and donor requirements
can be met. The commenter asked for
clarification that this arrangement
would be considered acceptable by
APHIS.
The commenter is correct; the
provisions in § 98.10a(b)(1)(iii) allow for
the importation of genetically
susceptible embryos with additional
certifications.
Issues Outside the Scope of the Rule
Two commenters were opposed to the
importation of live animals because of
concerns about humane treatment of the
animals.
The humane treatment of regulated
animals is outside the scope of this
rulemaking.
One commenter stated that APHIS
should also harmonize its other import
regulations, especially those for FMD,
with OIE standards to remove
impediments to trade.
Amending our other import
regulations, including those governing
imports from regions where FMD exists,
is outside the scope of this rulemaking.
One commenter asked for
requirements for importation of cervids
in regard to the presence or absence of
TSEs to be included in the rules. The
commenter noted that chronic wasting
disease has been detected in moose and
reindeer in Norway, a country that has
conducted a low level of surveillance
for a number of years. The commenter
further stated that it is clear that the fullrange of susceptible species has not yet
been identified for this disease, in spite
of more than 20 years of research.
Amending our import regulations
regarding cervids is outside the scope of
this rulemaking. We removed BSErelated restrictions from cervids in a
final rule published in the Federal
Register on December 4, 2013 (78 FR
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72980–73008, Docket No. APHIS–2008–
0010).10
Five commenters noted that we did
not propose to prohibit the feeding of
sheep and goat milk or milk products to
ruminants in the United States. The
commenters stated that this is a mistake
because of the risk of scrapie
transmission through these products.
The commenters also stated that the
importation of sheep and goat milk or
milk products into the United States
from scrapie-infected countries for
sheep and/or goat feeding should be
prohibited as recommended by the OIE
and supported by the scientific
literature. The same five commenters
stated that the importation and feeding
of blood and blood products from sheep
and goats to sheep and goats from
countries not free of scrapie and not at
least negligible risk for BSE is a risk and
should not be allowed. This is because
blood and blood products are not
covered under the U.S. Food and Drug
Administration’s (FDA) ruminant feed
rule and therefore not covered under the
processed animal protein restrictions as
discussed in the proposed rule.
Provisions governing the importation
of most milk and milk products are
contained in §§ 94.2 and 94.16 of the
regulations. We note that animal feed is
within the purview of the FDA and that
prohibiting the use of any products in
animal feed is outside the scope of
APHIS’ regulatory authority.
Miscellaneous
In part 92, we are revising the Office
of Management and Budget statement at
the end of § 92.2 to add reference to the
paperwork burden requirements
associated with this final rule, which
were filed under 0579–0453.
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 Order 12866 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. Pursuant to
the Congressional Review Act (5 U.S.C.
801 et seq.), the Office of Information
and Regulatory Affairs designated this
rule as a not a ‘major rule’, as defined
by 5 U.S.C. 804(2).
We have prepared an economic
analysis for this rule. The economic
10 To view the rule, the supporting documents,
and the comments we received, go to https://
www.regulations.gov and enter APHIS–2008–0010
in the Search field.
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analysis provides a cost-benefit analysis,
as required by Executive Order 12866,
which directs 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). The economic
analysis also provides a final regulatory
flexibility analysis that examines the
potential economic effects of this rule
on small entities, as required by the
Regulatory Flexibility Act.
This analysis examines impacts on
U.S. entities of a rule that will remove
BSE restrictions on the importation of
live sheep and goats and most of their
products. We are amending the import
regulations for certain wild, zoological,
or other non-bovine ruminant species by
adding safeguards related to
transmissible spongiform
encephalopathies. The rule aligns our
scrapie regulations in general with OIE
guidelines and establish a notice-based
approach for recognizing regions as free
of scrapie. This action is part of a
continuing program to allow the
importation of agricultural products that
APHIS has determined are without
significant risk of introducing exotic
animal diseases.
This rule’s impact will stem from its
effect on U.S. imports of the affected
commodities. Consumer welfare gains
from the increase in imports are
expected to exceed producer welfare
losses. While the rule will affect U.S.
imports of a wide range of commodities,
we focus our attention on the
production and trade of live sheep and
goats and their meat. This rule may
affect imports of other ruminants such
as non-bovine ruminant species
received by zoos, but APHIS does not
have information that would allow us to
evaluate such impacts. Estimated net
benefits of the rule are quantified in
terms of increased imports of sheep
meat and goat meat.
Over the past 5 years, 2016–2020,
annual live sheep and goat imports
averaged about 12,167 head, valued at a
little over $800,000, and all of which
came from Canada (see table 2). We do
not anticipate a significant increase
because of this rule in the number of
sheep and goats imported.
U.S. imports of sheep and goat meat
come almost entirely from Australia and
New Zealand (see table 5), with chilled
or frozen lamb the main product. To
evaluate potential effects of the rule, we
estimate impacts for U.S. production,
consumption, and prices of sheep and
goat meat imports using a net trade
welfare model. The increase in import
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quantities attributable to this rule is
expected to be small in comparison to
existing imports. We model three levels
of additional sheep and goat meat
imports: 1,582 metric tons (MT), 3,165
MT, and 4,747 MT. These quantities are
equal to approximately 5, 10, and 15
percent of the sum of (i) average EU–27
sheep and goat meat exports to non EU–
27 markets, 2016–2019 (i.e., 26,251 MT,
see table 8), and (ii) average sheep and
goat meat exports to EU–27 countries by
other eligible countries, 2016–2019,
excluding Australia and New Zealand
(see table 9) of 5,396 MT. In sum, this
is the EU–27’s external volume of trade
of the above-mentioned commodities.
The largest assumed quantity (i.e., 4,747
MT) is equivalent to less than 2 percent
of average annual U.S. sheep and goat
meat consumption (i.e., 193,839 MT)
during this same time period (see table
4).
The medium level of assumed
additional imports, 3,165 MT, would
cause a decrease in wholesale prices of
less than 1.5 percent and a fall in
domestic production of 878 MT,
whereas U.S. consumption would
increase by 2,287 MT. U.S. producer
welfare would decline by about $8.7
million and U.S. consumer welfare
would increase by about $23.7 million,
yielding an annual net welfare benefit of
about $15.1 million (see table 10).
Similarly, the other two assumed import
levels yield positive net benefits. To the
extent that sheep and goat meat
imported as a result of this rule may
displace U.S. imports from existing
sources, the price and welfare effects
would be smaller than indicated; we
note that over one-half of the U.S.
market for sheep and goat meat is
imported.11
The majority of establishments that
may be affected by the rule are small
entities, and economic impacts are
likely to be small as well. If an
additional 3,165 MT of sheep and goat
meat were to be imported by the United
States because of this rule, the annual
decrease in producer welfare per small
entity would be about $67, or the
equivalent of about 1 percent of average
annual sales by small entities.
Introduction
This economic analysis examines
impacts on U.S. entities for a rule that
will change BSE and scrapie import and
transit restrictions for sheep, goats, and
non-bovine wild ruminants, their
embryos, semen, and products. The rule
11 USDA, National Agricultural Statistics Service
(NASS), Sheep and Goats; Commodity Trade,
United Nations Trade Data Base (HTS–0104):
https://comtrade.un.org.
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will amend most of the BSE restrictions
on the importation of live sheep and
goats and their products; align our
scrapie regulations in general with OIE
guidelines and establish a notice-based
approach for recognizing regions as free
of scrapie; and amend the BSE and
scrapie regulations as they apply to
other ruminant species that are not
bovines, cervids, camelids, sheep or
goats. The rule is part of a continuing
program to allow the importation of
agricultural products that APHIS has
determined are without significant risk
of introducing exotic animal diseases
into the United States.
This document provides a benefit-cost
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
potential net economic benefits.
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This document also
examines the potential economic effects
of the rule on small entities, as required
by the Regulatory Flexibility Act, and
possible cost savings.
When the BSE regulations were
codified in 1991, they applied to all
ruminants. Over the past two decades,
however, extensive research on BSE has
been conducted. Based on the
information now available, it is not
warranted to continue to prohibit or
restrict the importation of sheep and
goats and their products with regard to
BSE, other than processed animal
protein.
The revisions for scrapie will set
restrictions for live animal importation
that are generally consistent with those
recommended by the OIE. For embryos
of sheep and goats, APHIS will require
the donor to be eligible for importation,
genetically resistant, or tested and found
negative for scrapie, and the sire to not
be a suspect, scrapie-positive, or highrisk animal. The revisions will also
allow importation of most sheep- and
goat-derived material in imported feed
or feed ingredients from countries that
are scrapie-free.
This rule’s expected impact stems
from its potential effect on U.S. imports
of the affected commodities. We begin
the analysis with an overview of
production and trade in sheep and goats
and their meat by the United States and
other countries. While the rule will
allow imports of sheep and goats and
their products without regard to a
country’s BSE status, we restrict the
analysis to countries of negligible or
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Overview of the Action and Affected
Entities
controlled BSE risk. Regions of
unknown risk for BSE are likely as well
to be of unknown risk for scrapie.
Scenarios are modeled to evaluate the
significance of potential changes in
sheep and goat meat imports.
This rule may affect imports of other
ruminants such as animals received by
zoos, but APHIS does not have
information that would allow us to
evaluate such impacts. Potential net
benefits of the rule are quantified in
terms of increased availability of sheep
and goat meat to U.S. consumers at
competitive prices.
U.S. Production and Trade of Sheep,
Goats, and Their Products
The United States is not a major
producer of sheep, and the sector has
been in long-term decline for decades.
The Nation’s sheep inventory fell by 7
percent between 2010 and 2019 (from
5.62 million to 5.23 million head).
Over half of the U.S. produced sheep
are raised primarily in western,
southwestern and midwestern States,
such as: California, Idaho, Montana,
Wyoming, Texas, and South Dakota; and
in the east, mainly in Vermont.
68849
The U.S. meat goat industry is small,
with the national inventory averaging,
between 2016 and 2020, at 2.1 million
head. The number of goats raised for
meat production increased between
2016 and 2020 on average by about 13
percent. On average between 2016 and
2020 the U.S. goat inventory was around
2.1 million animals.
Goats are raised in many States, with
major holdings in 10 States: Alabama,
California, Georgia, Kentucky, Missouri,
North Carolina, Oklahoma, South
Dakota, Tennessee, and Texas, which
account for 70 percent of the total.
TABLE 1—U.S. INVENTORY (IN 1,000 HEAD) OF LIVE GOATS BY CLASS
January 1,
2017
U.S. goat inventory by class
All Goat and kids .....................................
Market ...............................................
Breeding ............................................
1,706
409
1,305
January 1,
2018
January 1,
2019
1,675
400
1,275
January 1,
2020
1,646
409
1,270
2,655
478
2,177
January 1,
2021
5-yr average
2,582
465
2,117
2,053
432
1,629
Source: USDA, NASS, Sheep and Goats (February 2021).
Between 2016 and 2020, Canada was
the only foreign supplier of sheep and
goats into the United States. Over these
5 years, the annual average U.S. imports
of sheep and goats was 12,167 animals,
valued on average at $801,383 (tables 2
and 3). In 2016, there was a notable
increase in the number of imported
sheep and goats. However, after that
year, their numbers decreased
substantially.
TABLE 2—U.S. NUMBER (HEAD) OF IMPORTED LIVE SHEEP (HS 010410) AND GOATS (HS 010420) BY COUNTRY
Country
2016
Canada .....................................................
World ........................................................
2017
21,223
21,223
2018
8,829
8,829
2019
7,338
7,338
2020
13,341
13,341
5-yr average
10,102
10,102
12,167
12,167
Source: Commodity Trade, United Nations Trade Data Base (HTS–0104) (https://comtrade.un.org)/.
TABLE 3—U.S. VALUE (US $) OF IMPORTS OF LIVE SHEEP (HS 010410) AND GOATS (010420) BY COUNTRY
Country
2016
2017
2018
2019
2020
5-yr average
Canada .....................................................
1,641,000
497,437
402,884
817,565
648,029
801,383
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Source: Commodity Trade, United Nations Trade Data Base (HTS–0104) (https://comtrade.un.org/).
In order for sheep and goats to be
eligible to be imported into the United
States, they have to be from scrapie-free
flocks. Under the rule, sheep and goats
from flocks having certified status
(meeting requirements equivalent to the
Export Certified status of the U.S.
Scrapie Flock Certification Program)
would be eligible for U.S. importation.
Only two countries are recognized by
the United States as being wholly free
of scrapie: Australia and New Zealand.
With this rule, we do not anticipate a
significant increase in the number of
sheep and goats imported. The fact that
Australia and New Zealand have ceased
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exporting sheep and goats to the United
States in recent years supports this
expectation. A major reason is the cost
of transporting live animals.
Over the 5-year period, 2016–2020,
the year average value of sheep and
goats imported by the United States was
around $801,000, as shown in table 3,
was small in comparison to the value of
$548 million per year in imported lamb,
mutton, and goat meat. The quantity of
U.S. imported lamb, mutton and goat
meat supplies was over one-half of the
U.S. consumption for these meats. Over
the 2016–2020 period, lamb, mutton,
and goat meat consumption grew from
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around 179,000 MT to over 195,000 MT,
a 9 percent increase (table 4).
The amount of U.S. exports of lamb
and mutton during this period when
compared to U.S. imports of the same
product accounts for only 5 percent. In
terms of value, the difference is even
greater since U.S. imports of lamb and
goat meat consist of higher quality lamb
cuts such as legs and loins, whereas it
exports primarily lower quality cuts.
Over one-half of U.S. lamb, mutton, and
goat meat exports, 2016–2020, were to
Mexico (40 percent), the Netherlands
(10 percent), and Canada (7 percent).
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TABLE 4—U.S. LAMB, MUTTON, AND GOAT PRODUCTION, IMPORTS, EXPORTS, AND CONSUMPTION
[2016–2020]
U.S.
production
(MT)
Year
2016
2017
2018
2019
2020
U.S. imports
(MT)
U.S. imports
($1,000)
U.S. exports
(MT)
U.S. exports
($1,000)
U.S.
consumption
(MT)
.........................................................
.........................................................
.........................................................
.........................................................
.........................................................
78,729
74,491
79,926
77,316
72,596
103,893
122,078
124,874
127,150
132,966
$785,801
978,335
1,032,717
1,149,380
1,010,793
3,381
3,849
3,867
4,104
9,625
$17,222
20,377
19,732
19,448
16,644
179,241
192,720
200,933
200,362
195,937
Average .............................................
76,595
122,192
991,405
4,965
19,448
193,839
Source: UN Commercial Trade Data (https://comtrade.un.org), USDA/ERS/Red Meat Production, and Consumption Statistics by meat categories, 2019; https://www.ers.usda.gov/data-products/ Lamb, Mutton and Goat Meat Domestic Historical and Recent data, 2020.
Roughly 99 percent of U.S. imports of
sheep and goat meat have been supplied
by Australia (i.e., 77 percent) and New
Zealand (i.e., 22 percent) during 2016
and 2020 (table 5).
TABLE 5—U.S. IMPORTS OF LAMB, MUTTON, AND GOAT MEAT BY COUNTRY OF ORIGIN IN MT
2014–2018
Country
2016
2017
2018
2019
2020
Average
(2016–2020)
Australia ...................................................
New Zealand ............................................
Rest of the World .....................................
80,949
22,222
723
92,514
28,034
1,530
97,448
26,011
1,415
101,031
24,465
1,654
107,516
23,380
2,070
95,892
24,822
1,478
TOTAL ..............................................
103,894
122,078
124,874
127,150
132,966
122,192
Source: USDA/Foreign Agricultural Service (FAS), United Nations Commercial Trade Data (https://comtrade.UN.ORG/).
www.ers.usda.gov/data-products/ Lamb, Mutton, and Goat Meat Domestic Historical and Recent data, 2020.
The increasing U.S. demand for meats
of goat as well as lamb is reflected in the
increasing import levels. The volume of
imported meats of goat, lamb, and
mutton between 2016 and 2020
increased by 28 percent from 103,894 to
132,966 metric tons.
Production and Trade by Countries of
Negligible-Risk or Controlled-Risk for
BSE
This section presents information on
sheep and goat inventories; lamb,
mutton, and goat meat production; and
trade of these animals and products by
countries listed by OIE as having
negligible- or controlled-risk for BSE.
Tables 6 and 7 show the countries
https://
classified, as of September 2021, as
having negligible BSE risk or controlled
BSE risk. The lists include Australia,
New Zealand, and Canada, the principal
sources of U.S. imports of these
commodities. Also included are EU–27
members and other countries that are
potential sources of additional imports.
(Source: https://www.oie.int/en/disease/
bovine-spongiform-encephalopathy/#uiid-2).
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TABLE 6—MEMBER COUNTRIES RECOGNIZED AS HAVING A NEGLIGIBLE BSE RISK *
Argentina
Australia
Austria
Belgium
Bolivia
Brazil
Bulgaria
Canada
Chile
Colombia
Costa Rica
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland 10
Germany
Hungary
Iceland
India
Ireland
Israel
Italy
Japan
Korea (Rep. of)
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Mexico
Namibia
New Zealand
Nicaragua
Norway
Panama
Paraguay
Peru
Poland
Portugal 7
Romania
Serbia 8
Singapore
Slovakia
Slovenia
Spain 9
Sweden
Switzerland
The Netherlands
United States of America
Uruguay
* In accordance with Chapter 11.4 of the Terrestrial Code OIE (September 2021) https://www.oie.int/animal-health-in-the-world/official-diseasestatus/bse/list-of-bse-risk-status/.
7 Includes Azores and Madeira.
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8 Includes
9 Includes
68851
Excluding Kosovo administered under the United Nations.
Balearic Islands and Canary Islands.
Asland Island.
10 Includes
TABLE 7—OIE-MEMBER COUNTRIES RECOGNIZED AS HAVING A CONTROLLED BSE RISK **
Chinese Taipei.
Ecuador.
France.
Greece.
Ireland.
** In accordance with Chapter 11.4 of the Terrestrial Code of OIE (September 2021).
China (with the exclusion of Hong
Kong and Macau) as of November 2013
is recognized as a country having one
zone with negligible BSE risk. United
Kingdom as of September 2016 is
recognized as a country with two
negligible BSE risk zones: England and
Wales, and Scotland, according to
Chapter 11.4 of the Terrestrial Code. For
this analysis, we categorize potential
sources into two groups: Countries that
belong to the EU and all others. Trade
information for the two groups of
countries is presented in tables 8 and 9.
The EU–27 had on average between
2016 and 2020 annual inventories of 90
million sheep and 13 million goats.12
Five countries (France, Greece, Italy,
Romania, and Spain) accounted for 85
percent of the goat inventory and 80
percent of the sheep inventory.13
Combined sheep and goat meat
production in the EU–27 averaged about
926,000 MT during the same period.
As can be seen in table 8, between
2016 and 2019, live sheep and goats
imported by EU–27 countries averaged
around 716 animals. Almost all of these
imports were sourced within the EU–27.
Four countries (Italy, France, Greece,
and Spain) accounted for over 70
percent of imports. Exports of live sheep
and goats totaled over 2.67 million
head. Three EU–27 countries (Romania,
Spain, and France) accounted for 75
percent of the EU–27’s sheep and goat
exports.
TABLE 8—EXTERNAL TRADE FLOWS OF LIVE SHEEP AND GOATS (HS: 0104) AND THEIR MEAT (HS: 0204) BETWEEN THE
EU–27 GROUP COUNTRIES WITH NEGLIGIBLE-BSE RISK OR CONTROLLED-BSE RISK AND THE NON EU–27 GROUP
COUNTRIES
Sheep and goats
(numbers)
Year
Export
2016 .................................................................................................................
2017 .................................................................................................................
2018 .................................................................................................................
2019 .................................................................................................................
Average ....................................................................................................
Meat of sheep and goat
(metric tons)
Import
2,650,680
2,496,323
2,432,082
3,117,174
2,674,065
133
714
953
1,065
716
Export
16,462
29,873
25,408
33,261
26,251
Import
161,418
140,283
141,472
112,070
138,811
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Data Source: https://comtrade.un.org/.
Table 8 shows that EU–27 countries
as a group were net importers of sheep
meat and goat meat with annual imports
averaging between 2016 and 2020
around 139,000 MT, compared to their
annual exports of 26.3 thousand metric
tons. The yearly average number of EU–
27 exports of live sheep and goats
between 2016 and 2020 was
approximately 2.7 million. EU–27
countries are net exporters of these
animals, even though exporting live
animals costs more than exporting their
animal products (i.e., due to higher
transportation costs which include the
cost of veterinarians accompanying
animals in long distances to ensure their
good health.)
New Zealand is the largest exporter of
sheep and goats to the EU–27 countries
followed by Australia and the South
American countries of Chile and
Argentina. Other non EU–27 countries
that supply this group are Canada,
Norway, Iceland, Switzerland, and
Singapore (table 9).
New Zealand and Australia with
about 90 percent of sheep and goat meat
exports in their group are the dominant
exporters. Excluding these two
countries, because they are already the
principal U.S. suppliers, the remaining
countries in this group exported on
average between 2016 and 2020
annually about 5,396 MT of goat and
sheep meat and 58 live animals.
Excluding Australia and New Zealand
(i.e., 96 percent of this group’s exports
to EU–27), seven other countries (i.e.,
Argentina, Canada, Chile, Iceland,
Norway, Singapore, and Uruguay)
supplied the EU–27 group with less
than 4 percent (or 5,640 MT) of sheep
and goat meat on average between 2014
and 2018.
Several of the non-EU group countries
are not free of FMD. For live sheep and
goats and their products to be eligible to
be imported by the United States, they
have to come from regions that are free
of this disease. The rule would revise
import restrictions related to BSE and
scrapie only; other animal health
restrictions would still apply, so
imports from those non-EU group
countries with FMD would still be
prohibited and are not considered in
this analysis.
Altogether, the North and South
American countries of Canada,
Argentina, Uruguay, Chile; the Asian
country of Singapore; and the European
countries of Norway, Switzerland, and
Iceland exported to the EU–27 an
annual average of 5,396 MT of sheep
and goat meat between 2016 and 2020.
We combine this quantity of sheep and
goat meat with the average amount
12 European Commission Agriculture and Rural
Development, EU agriculture- statistical & economic
information. Sheep meat & goat meat. https://
ec.europa.eu/agriculture/statistics/agricultural/
20162011/pdf/d17-0-417_en.pdf
13 Although Romania is the fourth largest
producer of sheep & goats in the EU & about 88
percent of its exports goes to EU countries, it is not
classified as negligible- or controlled-risk for BSE
by the OIE.
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Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Rules and Regulations
shipped by EU–27 countries to non EU–
27 markets, 26,251 MT (table 8) and
from table 9 the amount of sheep meat
countries that are allowed to ship to
EU–27 (i.e., 5,396 MT), to arrive at a
base value for examining possible
impacts of the rule for U.S. entities
(26,251 + 5,396 = 31,647 MT).
Particularly in the case of Argentina,
Canada, Chile, and Uruguay, lower
transportation costs could provide an
incentive for exporters to divert a share
of their sheep and goat meat EU–27
shipments to the United States.
TABLE 9—EXPORTS OF LIVE SHEEP AND GOATS (NUMBER) AND THEIR MEAT (METRIC TONS) BY NON-EU COUNTRIES
WITH NEGLIGIBLE- OR CONTROLLED-BSE RISK
[2016–2019 annual averages to EU–27 group]
Meat of goats and
sheep (HS:0204) in
metric tons
Non-EU countries
Number of live
sheep and goats
(HS: 0104)
Argentina ..................................................................................................................................................
Australia ...................................................................................................................................................
Brazil ........................................................................................................................................................
Canada ....................................................................................................................................................
Chile .........................................................................................................................................................
Colombia ..................................................................................................................................................
Costa Rica ...............................................................................................................................................
Japan .......................................................................................................................................................
Iceland .....................................................................................................................................................
India .........................................................................................................................................................
Israel ........................................................................................................................................................
Mexico ......................................................................................................................................................
Namibia ....................................................................................................................................................
New Zealand ............................................................................................................................................
Nicaragua .................................................................................................................................................
Norway .....................................................................................................................................................
Panama ....................................................................................................................................................
Paraguay ..................................................................................................................................................
Peru .........................................................................................................................................................
Rep. of Korea ..........................................................................................................................................
Singapore .................................................................................................................................................
Switzerland ..............................................................................................................................................
Taiwan .....................................................................................................................................................
Uruguay ...................................................................................................................................................
USA ..........................................................................................................................................................
1,060
14,205
0
4
1,834
0
0
0
1,571
0
0
0
0
116,661
0
222
0
0
0
0
6
3
0
702
0
0
6
0
0
0
0
0
0
0
0
0
0
0
12
0
3
0
0
0
0
0
40
0
0
0
TOTAL ..............................................................................................................................................
Australia & New Zealand .........................................................................................................................
136,262
130,866
58
18
All (except Australia & New Zealand) ..............................................................................................
5,396
40
Source: United Nations (https://www.trademap.org/) Department of Economic and Social Affairs, Statistics Division, Trade Statistics (HS2007
commodity codes) October 2020. HS:0204 & HS:0104.
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Expected Benefits and Costs of the Rule
To evaluate potential effects of the
rule, we estimated impacts for U.S.
production, consumption, and prices of
sheep and goat meat imports from EU
and non-EU sources, as described. We
use a net trade 14 welfare model, and
data from the USDA Foreign
Agricultural Service’s Global
Agricultural Trade System (GATS),
Food and Agriculture Organization of
the United Nations’ FAO Stat, and the
United Nations Commercial Trade
Statistics (https://comtrade.un.org). The
demand and supply elasticities used are
–0.77 (Sande and Houston 2007) and
0.80 respectively (Sullivan, Wainio, and
Roningen 1989). These are still the most
14 In this case ‘‘net trade’’ welfare model refers to
the way we model the importing country (i.e., USA)
as a net trader (i.e., either a net exporter when
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recent estimated elasticities for sheep
and goat meat that are available in the
literature.
We modeled three levels of additional
sheep meat imports by the United
States: 1,582 MT, 3,165 MT, and 4,747
MT. These quantities are equal to
approximately 5, 10, and 15 percent of
the sum of (i) average EU–27 sheep and
goat meat exports to non EU–27
markets, 2016–2019 (i.e., 26,251 MT, see
table 8), and (ii) average sheep and goat
meat exports to EU–27 countries by
other eligible countries, 2016–2019,
excluding Australia and New Zealand
(see table 9) of 5,396 MT. In sum, this
is the EU–27’s external volume of trade
of the above-mentioned commodities.
The largest assumed quantity (i.e., 4,747
MT) is equivalent to less than 2 percent
of average annual U.S. sheep and goat
meat consumption (i.e., 193,839 MT)
during this same time period (see table
4).
Table 10 presents the changes that
would result from the assumed
increased imports. For the mediumlevel increase, 3,939 MT, the wholesale
price would decline by approximately
1.53 percent and domestic production
would fall by 878 MT. U.S.
consumption would increase by 2,287
MT. Producer welfare would decline by
about $8.67 million and consumer
welfare would increase by about $23.7
million, yielding an annual net welfare
gain of about $15.1 million.
exports are greater than imports or net importer)—
whatever is the specific case of the commodity in
question (i.e., goats and sheep and their meat in this
case).
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68853
TABLE 10—ESTIMATED IMPACTS OF SHEEP MEAT IMPORTS AS A RESULT OF THE FINAL RULE, FOR THREE ASSUMED
LEVELS OF IMPORTATION
Assumed additional sheep and goat meat imports per year, metric tons ................
Change in U.S. consumption, metric tons .................................................................
Change in U.S. production,* metric tons ...................................................................
Percentage change in U.S. price ..............................................................................
Change in consumer welfare (U.S. dollars) ..............................................................
Change in producer welfare (U.S. dollars) ................................................................
Annual net welfare gain (U.S. dollars) ......................................................................
1,582
1,143
¥439
¥0.77
$11,824,458
($4,344,373)
$7,480,086
3,165
2,287
¥878
¥1.53
$23,725,979
($8,664,768)
$15,061,211
4,747
3,430
¥1,317
¥2.30
$35,689,520
($12,955,727)
$22,733,799
Note: The baseline data used are 5-year annual averages for production, consumption, price, exports and imports, as reported in the last row
of table 3. The demand and supply elasticities used are ¥0.70 and 0.80, respectively. * U.S. production data is for sheep meat only, goat meat
data is unavailable.
For each of the three assumed levels
of sheep and goat meat imports,
consumer welfare gains would outweigh
producer welfare losses. The majority of
establishments that may be affected by
the final rule are small entities, and
economic impacts are likely to be small
as well. If an additional 3,165 MT of
sheep and goat meat were to be
imported by the United States because
of this rule, the annual decrease in
producer welfare per small entity would
be about $67.15, or the equivalent of
about 1.3 percent of average annual
sales by small entities (table 11).
As another aspect of the rule, U.S.
sheep and goat producers may benefit
from resulting genetic improvements
through increased imports of sheep and
goat germplasm (breeding animals,
embryos, and semen). These imports
may yield advantageous genetic
characteristics such as heavier bone and
greater muscle expression, higher
productivity and product quality,
disease resistance, reproductive
efficiency and greater feed efficiency.
However, additional germplasm imports
also are not expected to be significant.
TABLE 11—ECONOMIC IMPACT FOR U.S. SMALL ENTITIES OF ADDITIONAL ANNUAL SHEEP AND GOAT MEAT IMPORTS OF
3,165 METRIC TONS
Total decline in producer welfare 1 ...................................................................................................................................................
Decrease in welfare incurred by small entities 2 ..............................................................................................................................
Average decrease per animal, small entities 3 .................................................................................................................................
Average decrease per small entity 4 .................................................................................................................................................
Average decrease as a percentage of average sales by small entities 5 ........................................................................................
$8.66 million.
$6.07 million.
$2.17.
$67.15.
1.3%.
1 From
table 10.
in producer welfare multiplied by 70 percent, the percentage of total sales by sheep and lamb producers with annual revenues of not
more than $750,000, that is, small entities. We assume that the change in producer welfare would be proportional to sales share.
3 Decrease in producer welfare for small entities divided by 2.8 million, the number of sheep and lamb sold by small entities.
4 Average decrease per animal multiplied by 31, the average of the number of sheep and lambs and goats sold per small entity.
5 Average decrease per small entity divided by $5,000, the average annual revenue per small entity.
2 Change
Costs of Preventing Fence-Line Contact
There are currently no APHISapproved feedlots in the United States
for imported sheep and goats. This rule
will require that the operator of an
approved feedlot prevent fence-line
contact between other sheep or goats
being fed for purposes other than direct
movement to slaughter or that are
outside the feedlot and sheep and goats
imported for restricted feeding and
eventual slaughter from regions not free
of classical scrapie by a method
acceptable to the APHIS Administrator.
The Agency will work with individual
operators to determine the best means of
preventing such contact in their
feedlots. As a commenter on the
proposed rule noted, one way of
preventing fence-line contact would be
to use double fencing to create a
separation between paddocks.
One recommended type of fencing for
sheep and goats is a perimeter of woven
wire and high-tensile electrified fence.
As shown in table 12, one estimate
places the initial cost for this type of
fencing at about $1.00 per foot, for a
quarter-mile (1,320 feet) straight
perimeter permanent fence (Iowa State
University, 2012). Average annual
maintenance costs would be about 5
percent of construction costs and the
estimated useful life would be 25 years.
TABLE 12—CONSTRUCTION COSTS FOR HIGH-TENSILE ELECTRIFIED WIRE FENCE
[Based on a 1,320 ft. fence]
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Item
Wood posts (8-inch diameter) ...............................................................................................
Wood posts (4-inch diameter ................................................................................................
Steel posts (6.5 ft.) ................................................................................................................
Insulators ...............................................................................................................................
Springs ...................................................................................................................................
Strainers .................................................................................................................................
High tensile wire ....................................................................................................................
Energizer ................................................................................................................................
Cut-out switch ........................................................................................................................
Ground/lightening rods ..........................................................................................................
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Cost per unit
(dollars)
Amount
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4
52
285
5
5
6,600 ft.
25
1
4
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30.20
9.70
5.40
0.38
7.60
3.80
0.03
1.19
8.10
17.30
Total cost (dollars, rounded)
181
39
281
108
38
19
178
30
8
69
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TABLE 12—CONSTRUCTION COSTS FOR HIGH-TENSILE ELECTRIFIED WIRE FENCE—Continued
[Based on a 1,320 ft. fence]
Item
Cost per unit
(dollars)
Amount
Total cost (dollars, rounded)
Labor and equipment .............................................................................................................
18 hours
17.50
315
Total ................................................................................................................................
Cost per foot ............................................................................................................
..............................
..............................
........................
........................
1,266
0.96
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Source: Iowa State University, 2012. Estimated Costs for Livestock Fencing. Extension and Outreach, Ag Decision Maker, File B1–75. Gates
are not included in the estimate. Values converted from 2011 to 2016 dollars using gross domestic product (GDP) deflator.
Another estimate of fencing costs
provided by a representative of the
National Lamb Feeders Association
(NLFA) is $4.00 per linear foot, with the
size of an average square pen 150 feet
on each side. The NLFA representative
anticipates that there could be as many
as 20 feedlots that will apply for import
approval. He also noted that existing
feedlots with multiple pens already
have no need for double fencing on one
side between them because of the ‘‘bunk
line’’ feeding, where pens are separated
by space to allow the bunk to be easily
filled. Most feedlots have back-to-back
pens in a row and would only need to
double-fence a pen along sides not
separated by a bunk line from another
pen.
The cost of double fencing for a
feedlot operator will depend on the
number, size, and configuration of
existing pens, and the distance between
the existing pen and the added fencing.
Industry sources suggest two likely
courses of action by feedlots that decide
to apply for import approval: Use an
existing pen for which double fencing
would need to be constructed on three
side (the fourth side would have a bunk
line with another pen); or construct a
new pen near an existing pen, and add
the double fencing on three sides. In the
first instance, the length of additional
fencing, assuming a pen with a side of
150 feet and a 20-foot distance between
the two fences, would be 450 feet (the
three sides), plus 120 feet (two lengths
of 20 feet at each of the two rear corners
and a 20-foot length at each corner on
the bunk-line side), for a total of 570
feet. In the second instance, there would
be the new pen, 600 feet, plus the 570
feet for the second fence, as described,
for a total of 1,170 feet.
Based on unit costs of between $1.00
and $4.00 per linear foot, and assuming
that the length of fencing that would be
required ranges between 570 and 1,170
feet, averaging 870 feet, we estimate that
the cost per feedlot may average
between $870 and $3,480. Assuming
that 20 feedlots apply for import
approval, the total cost for the industry
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may range between $17,400 and
$69,600.
Alternatives to the Rule
An alternative to this rule would be
to remove BSE-related restrictions on
the importation of small ruminants, but
not establish a notice-based approach
for recognizing regions as free of
scrapie. Under this alternative, APHIS
would evaluate regions in accordance
with part 92 for scrapie and other TSE
status, and then initiate rulemaking in
order to authorize importation of This
alternative was rejected because it
would mean forgoing recognized trade
advantages of timelier notice-based
actions in comparison to rule
promulgation. Based on APHIS
experience in an analogous subject area,
the authorization of fruit and vegetable
imports, rulemaking takes, in general,
18 months to 2 years, whereas noticebased authorizations generally average
6–12 months. This longer time frame
also delays the time it takes for
consumers to experience the welfare
benefits associated with increased
imports.
Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act
requires agencies to evaluate the
potential effects of their proposed and
final rules on small businesses, small
organizations, and small governmental
jurisdictions. This final regulatory
flexibility analysis describes expected
impacts of this rule on small entities, as
required by section 604 of the Act.
Need for and Objectives of the Rule
The objective of the rule is to change
BSE and scrapie import and transit
restrictions for live sheep, goats, and
wild ruminants, their embryos, semen,
and products and byproducts, in
recognition of actual risks posed by
these diseases. The rule would remove
BSE restrictions on the importation of
live sheep and goats and most products
of sheep and goats. It would amend the
import regulations for certain wild,
zoological, or other non-bovine
ruminant species by adding restrictions
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related to transmissible spongiform
encephalopathies. It would also
establish a notice-based approach for
recognizing regions as free of scrapie.
The legal basis for this rule is the
Animal Health Protection Act (7 U.S.C.
8301 et seq.), by which the Secretary of
Agriculture may restrict the importation
of any animal or article if the Secretary
determines that the prohibition is
necessary to prevent the introduction
into or dissemination within the United
States of any pest or disease of livestock.
Significant Issues Raised by Public
Comment in Response to the Initial
Regulatory Flexibility Analysis
There were no significant issues
raised by public comment in response to
the initial regulatory flexibility analysis.
Comments Filed by the Office of
Advocacy of the U.S. Small Business
Administration in Response to the
Proposed Rule
There were no comments filed by the
Office of Advocacy of the U.S. Small
Business Administration in response to
the Initial Regulatory Flexibility
Analysis.
Potentially Affected Small Entities
The Small Business Administration
(SBA) has established guidelines for
determining which firms are considered
small under the Regulatory Flexibility
Act. This rule could affect 88,338
establishments categorized within the
following industries and corresponding
North American Industry Classification
System codes: Animal (except poultry)
slaughtering (NAICS 311611), meat
processing (NAICS 311612), meat and
meat product merchant wholesalers
(NAICS 424470), sheep farming (NAICS
112410), and goat farming (NAICS
112420).
Under SBA standards, animal
slaughtering and meat processing
establishments with no more than 1,000
employees and meat and meat product
wholesalers with no more than 150
employees are considered small.
According to the 2012 Economic
Census, there were 1,603 animal
slaughtering establishments, of which
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95 percent were considered small.
Establishments with fewer than 20
employees accounted for over 81
percent of establishments, but their
share of total sales was only 2.8 percent.
In 2012, of the 1,381 U.S. companies
that processed and sold meat, about 97
percent were small entities. Of the 2,295
establishments that were wholesaling
meat and meat products that year, 96
percent were small. Thus, animal
slaughterers, meat processors, and
wholesalers that could be affected by
the rule are predominantly small by
SBA standards.
Sheep farming (NAICS 112410) and
goat farming (NAICS 112420)
establishments are classified as small if
their annual receipts are not more than
$750,000. According to the 2012 Census
of Agriculture (most recent data on farm
sizes), there were 88,338 farms that sold
about 3.8 million lamb and sheep in the
United States. Of these, 88,206 farms
(99.9 percent) had combined sales of
about 2.8 million head (about 70 percent
of all lamb and sheep sold) and are
considered small, with average sales of
about 31 head and average annual
receipts of about $5,000 in 2012. The
remaining 0.1 percent of the farms sold
a total of about 1 million lamb and
sheep, and the farms had an average
annual income from the sale of sheep
and lamb of about $1.48 million.
In 2012, there were 63,844 farms that
sold about 1.3 million goats for meat.
The number of goats sold per farm in
2012 was about 20 head, compared to
average lamb and sheep sales (all farms)
of 43 head. We use the per farm
statistics for lamb and sheep production
in the following estimation of impacts
for small entities, since the 2012 Census
of Agriculture does not provide detailed
size standards for goat farming. As
shown in table 11, we can expect the
impact for U.S. small-entity producers
to be small. When we assume that an
additional 3,165 MT of sheep and goat
meat would be imported by the United
States because of this rule, the annual
decrease in producer welfare per small
entity is estimated to be about $67.15 or
the equivalent of about 1.3 percent of
average annual sales by small entities.
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Projected Reporting, Recordkeeping,
and Other Compliance Requirements
Reporting and recordkeeping
requirements associated with the final
rule are discussed in the rule under the
heading ‘‘Paperwork Reduction Act.’’
Under that heading, APHIS estimates
that it will take 0.531 hours per
response to comply with the paperwork
and recordkeeping requirements of this
rule.
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Steps Taken by APHIS To Minimize
Significant Economic Impacts on Small
Entities
We had no initial information that
would suggest significant impacts on
small entities, and did not receive
additional information concerning
affected entities during the public
comment period on the proposed rule
that would alter this assessment. In the
absence of apparent significant
economic impacts, we have not
identified steps that would minimize
such impacts.
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
Governments.’’ 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.
APHIS is aware of growing interest
among Tribal nations in rules that could
result in price fluctuations, particularly
after recent supply chain disruptions.
APHIS invited general Tribal
consultation during the proposed
rulemaking process with no Tribal
response. Recent evaluation for Tribal
implications, however, indicate the
potential for increased market variations
in sheep, goat, and other ruminants
warranting Tribal engagement.
APHIS collaborated with the USDA
Office of Tribal Relations (OTR) to
provide for a meaningful government-togovernment consultation on these
implications. This opportunity for
consultation occurred on November 1,
2021, with 13 Tribal nations in
attendance. The Tribes present did not
express questions or concerns about the
rule or its supporting documents.
APHIS is committed to full compliance
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with Executive Order 13175 throughout
the implementation of this rule.
Paperwork Reduction Act
In accordance with Section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), some of the
reporting and recordkeeping
requirements included in the proposed
rule and this final rule were previously
approved under Office of Management
and Budget (OMB) control numbers
0579–0040 and 0579–0101. The
remaining reporting and recordkeeping
requirements that were solely associated
with the proposed rule to this final rule
were submitted to OMB as a new
information collection assigned OMB
comment-filed number 0579–0453. The
proposed rule allowed for public
comment on the reporting and
recordkeeping requirements. However,
APHIS did not receive comments
concerning the calculations for the
information collection activities, their
instruments (such as the import permits
or health certificates), or reported
burden.
Since publication of the proposed
rule, the information collection
procedures and forms are unchanged,
except for the removal of one activity
and adjustments in the estimates for
seven activities. Information collected
in accordance with the regulations of
this final rule includes, but is not
limited to, the names of the exporter
and importer of the animal
commodities; the origins of the animals
or animal products to be imported; the
health status of the animals or the
processing methods used to produce
animal products to be imported; the
destination of delivery in the United
States; and whether the animals or
animal products were temporarily
offloaded in another country during
transit to the United States. APHIS
removed the activity related to reporting
of animals, poultry, or eggs offered for
importation (VS Form 17–30) because
this information is reported in another
information collection. APHIS reduced
the burden estimates for three activities
because the number of respondents was
overestimated and increased the burden
estimates for four activities to account
for rounding errors. Lastly, APHIS
decreased the estimated number of
respondents by 67 which in turn
resulted in 906 fewer responses and 439
fewer burden hours. However, the
public reporting burden estimated hours
per response remains at 0.531 hours
with 9 responses per respondent.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
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compliance with the E-Government 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. However, less than 1 percent
of the information required to be
collected under this final rule can be
processed electronically, either by
downloading a fillable PDF file,
emailing a document, or for respondents
with accounts, using APHIS’ electronic
information systems such as ePermits,
Veterinary Services Process
Streamlining, or Automated Commercial
Environment to process and submit
information. The remainder of the
collection activities cannot be processed
electronically because there are
instruments (such as permanent country
marks, seals, or the VS 1–27, Permit for
Movement of Restricted Animals) that
must typically accompany the animals
during transit. For assistance with EGovernment Act compliance related to
this final rule, please contact Mr. Joseph
Moxey, APHIS’ Paperwork Reduction
Act Coordinator, at (301) 851–2483, or
the Veterinary Services contact listed
above under FOR FURTHER INFORMATION
CONTACT.
9 CFR Part 92
Animal diseases, Imports, Livestock,
Quarantine.
9 CFR Part 93
Animal diseases, Imports, Livestock,
Poultry and poultry products,
Quarantine, Reporting and
recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock,
Meat and meat products, Milk, Poultry
and poultry products, Reporting and
recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports,
Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.
9 CFR Part 96
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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.
2. Section 92.2 is amended by revising
the OMB statement at the end of the
section to read as follows:
■
§ 92.2 Application for recognition of the
animal health status of a region or a
compartment.
*
*
*
*
*
(Approved by the Office of Management
and Budget under control numbers
0579–0040 and 0579–0453)
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
3. The authority citation for part 93
continues to read as follows:
■
Definitions.
*
9 CFR Part 98
Animal diseases, Imports.
Accordingly, we are amending 9 CFR
parts 92, 93, 94, 95, 96, and 98 as
follows:
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4. Section 93.400 is amended as
follows:
■ a. By adding, in alphabetical order,
definitions for Certified status, Classical
scrapie, and Country mark;
■ b. By revising the definitions for
Designated feedlot and Flock;
■ c. By adding, in alphabetical order,
definitions for Flock of birth, Flock of
residence, Goat, Killed and completely
destroyed, Non-classical scrapie, and
Sheep;
■ d. By removing the definition of
Suspect for a transmissible spongiform
encephalopathy; and
■ e. By adding, in alphabetical order,
definitions for Transmissible
spongiform encephalopathies (TSEs)
and TSE-affected sheep or goat.
The additions and revisions read as
follows:
■
§ 93.400
Imports, Livestock, Reporting and
recordkeeping requirements.
19:36 Dec 02, 2021
1. The authority citation for part 92
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.
List of Subjects
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PART 92—IMPORTATION OF ANIMALS
AND ANIMAL PRODUCTS:
PROCEDURES FOR REQUESTING
RECOGNITION OF REGIONS AND
COMPARTMENTS
*
*
*
*
Certified status. A flock that has met
requirements equivalent to the Export
Certified status of the U.S. Scrapie Flock
Certification Program while
participating in a program under the
supervision of the national veterinary
authority of the region of origin, as
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determined by an evaluation conducted
by APHIS of the program.
*
*
*
*
*
Classical scrapie. Any form of scrapie
that the Administrator has determined
poses a significant risk of natural
transmission.
*
*
*
*
*
Country mark. A permanent mark
approved by the Administrator for
identifying a sheep or goat to its country
of origin.
*
*
*
*
*
Designated feedlot. A feedlot
designated by the Administrator as one
eligible to receive sheep and goats from
regions not free of classical scrapie, and
whose owner or legally responsible
representative has signed an agreement
as specified in § 93.435(c)(11) and is in
full compliance with all the provisions
of the agreement.
*
*
*
*
*
Flock. Any group of one or more
sheep or goats maintained on a single
premise, or on more than one premises
under the same ownership and between
which unrestricted movement is
allowed; or two or more groups of sheep
or goats under common ownership or
supervision on two or more premises
that are geographically separated, but
among which there is an interchange or
movement of animals.
Flock of birth. The flock into which a
sheep or goat is born.
Flock of residence. The flock:
(1) Within which an individual sheep
or goat was born, raised, and resided
until exported to the United States; or
(2) In which the sheep or goat resided
for breeding purposes for 60 days or
more until exported to the United
States; or
(3) In which sheep and goats for
export were assembled for export to the
United States and maintained for at
least 60 days immediately prior to
export, without any addition of animals
or contact with animals other than
through birth, on a single premises, or
on more than one premises under the
same ownership and between which
unrestricted movement occurred.
Goat. Any animal of the genus Capra.
*
*
*
*
*
Killed and completely destroyed.
Killed, or maintained under quarantine
in a manner preventing disease spread
until the animal is no longer living; and
the remains have been disposed of in a
manner preventing disease spread.
*
*
*
*
*
Non-classical scrapie. Any form of
scrapie the Administrator has
determined poses a low risk of natural
transmission.
*
*
*
*
*
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Sheep. Any animal of the genus Ovis.
*
*
*
*
Transmissible spongiform
encephalopathies (TSEs). A family of
progressive and generally fatal
neurodegenerative disorders thought to
be caused by abnormal proteins, called
prions, typically producing
characteristic microscopic changes,
including, but not limited to, noninflammatory neuronal loss, giving a
spongiform appearance to tissues in the
brains and central nervous systems of
affected animals.
TSE-affected sheep or goat. A sheep
or goat suspected or known by the
national veterinary authority of the
region of origin to be infected with a
transmissible spongiform
encephalopathy prior to the disposal of
the animal.
*
*
*
*
*
■ 5. Section 93.401 is amended by
revising paragraph (a) and adding a
heading for paragraph (b) to read as
follows:
*
§ 93.401
General prohibitions; exceptions.
(a) General provisions. No ruminant
or product subject to the provisions of
this part shall be brought into the
United States except in accordance with
the regulations in this part and part 94
of this subchapter; 3 nor shall any such
ruminant or product be handled or
moved after physical entry into the
United States before final release from
quarantine or any other form of
governmental detention except in
compliance with such regulations.
Notwithstanding any other provision of
this subpart, the importation of any
ruminant that is not a bovine, camelid,
cervid, sheep, or goat is prohibited.
Provided, however, the Administrator
may upon request in specific cases
permit ruminants or products of such to
be brought into or through the United
States under such conditions as he or
she may prescribe, when he or she
determines in the specific case that such
action will not endanger the livestock of
the United States.
3 Importations of certain animals from
various regions are absolutely prohibited
under part 94 because of specified diseases.
(b) Ruminants in transit. * * *
*
*
*
*
■ 6. Section 93.404 is amended as
follows:
■ a. Paragraphs (a)(2), (3), and (4) are
redesignated as paragraphs (a)(3), (4),
and (7), respectively;
■ b. By adding new paragraph (a)(2) and
paragraphs (a)(5) and (6);
■ c. In newly redesignated paragraph
(a)(7)(v), by removing ‘‘paragraph
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*
VerDate Sep<11>2014
19:36 Dec 02, 2021
Jkt 256001
(a)(4)(iv)’’ and adding ‘‘paragraph
(a)(7)(iv)’’ in its place;
■ d. In newly redesignated paragraph
(a)(7)(vi), by removing ‘‘paragraph
(a)(4)(iv)(A)’’ and ‘‘paragraph
(a)(4)(iv)(B)’’ and adding ‘‘paragraph
(a)(7)(iv)(A)’’ and ‘‘paragraph
(a)(7)(iv)(B)’’, respectively, in their
place; and
■ e. By revising the OMB statement at
the end of the section.
The additions and revision read as
follows:
§ 93.404 Import permits for ruminants and
for ruminant test specimens for diagnostic
purposes; and reservation fees for space at
quarantine facilities maintained by APHIS.
(a) * * *
(2) In addition to the requirements in
paragraph (a)(1) of this section, the
importer must submit the following
information along with the application
for an import permit:
(i) For sheep or goats imported for
immediate slaughter, or for restricted
feeding for slaughter:
(A) The slaughter establishment to
which the animals will be imported; or
(B) The designated feedlot in which
sheep and goats imported for restricted
feeding for slaughter will be maintained
until moved to slaughter.
(ii) For sheep and goats imported for
purposes other than immediate
slaughter or restricted feeding for
slaughter:
(A) The flock identification number, if
imported to a flock, and the premises or
location identification number, of the
flock or other premises to which the
animals are imported as listed in the
Scrapie National Database.
(B) For sheep and goats from regions
not free from classical scrapie, the
importer must provide documentation
that the animal has reached and
maintained certified status in a scrapie
flock certification program determined
by the Administrator to provide
equivalent risk reduction as the Export
Category of the U.S. Scrapie Flock
Certification Program. The
documentation must specify the
address, or other means of
identification, of the premises and flock
of birth, and any other flock(s) in which
the animals have resided.
*
*
*
*
*
(5) In specific cases, a permit may be
issued for ruminants that would
otherwise be prohibited importation due
to TSEs pursuant to this subpart, if the
Administrator determines the disease
risk posed by the animals can be
adequately mitigated through pre-entry
or post-entry mitigation measures, or
through combinations of such measures.
These measures will be specified in the
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permit. If it is determined prior to or
after importation that any pre-entry or
post-entry requirements were not met,
or the ruminants are affected with or
have been exposed to TSEs, the
ruminants, their progeny, and any other
ruminants that have been housed with
or exposed to the ruminants will be
disposed of or otherwise handled as
directed by the Administrator. Importers
seeking a permit pursuant to this
paragraph (a)(5) must send their request
to the Administrator, c/o Strategy and
Policy, VS, APHIS, 4700 River Road
Unit 39, Riverdale, MD 20737–1231, or
via the APHIS website at https://
www.aphis.usda.gov/import_export/
animals/live_animals.shtml.
(6) The Administrator may issue
permits under paragraph (a)(5) of this
section for male sheep determined to be
AA at codon 136 and either RR, HR, KR,
or QR at codon 171 and for female sheep
determined to be AA at codon 136 and
RR at codon 171 by the National
Veterinary Services Laboratories or
another laboratory approved by the
Administrator. Such sheep must meet
all requirements in this part for import
other than the requirement that they
originate in a flock or region free of
classical scrapie. The permit will
provide for post entry confirmation of
the animal’s scrapie susceptibility
genotype and/or genetic testing for
identity.
*
*
*
*
*
(Approved by the Office of Management and
Budget under control numbers 0579–0040,
0579–0224, and 0579–0453)
7. Section 93.405 is amended as
follows:
■ a. By adding a heading for paragraph
(a) and removing paragraph (a)(4);
■ b. By revising paragraph (b);
■ c. By removing paragraph (c);
■ d. By redesignating paragraph (d) as
paragraph (c);
■ e. By revising newly redesignated
paragraph (c); and
■ f. By revising the OMB statement at
the end of the section.
The addition and revisions read as
follows:
■
§ 93.405
Health certificate for ruminants.
(a) Issuance and required information.
* * *
*
*
*
*
*
(b) Sheep and goats—(1) Information
required. In addition to the statements
required by paragraph (a) of this section,
the certificate accompanying sheep or
goats from any part of the world must
also include the name and address of
the importer; the number or quantity of
sheep or goats to be imported; the
purpose of the importation; the official
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individual sheep or goat identification
applied to the animals; and, when
required by § 93.435, the permanent
country mark and other identification
present on the animal, including
registration number, if any; a
description of each sheep or goat linked
to the official identification number,
including age, sex, breed, color, and
markings, if any; the flock of residence;
the address (including street, city, State,
and ZIP Code) of the destination where
the sheep or goats are to be physically
located after importation, including the
premises or location identification
number assigned in the APHIS National
Scrapie Database and when applicable
the flock identification number; the
name and address of the exporter; the
port of embarkation in the region of
export; the mode of transportation, route
of travel and port of entry in the United
States; and, for sheep or goats imported
for purposes other than immediate
slaughter or restricted feeding for
slaughter, the certificate must specify
the region of origin and, for regions not
free of scrapie, the address or other
identification of the premises and flock
of birth, and any other flock in which
the animals have resided.
(2) Additional statements. The
certificate accompanying sheep or goats
from any part of the world, except as
provided in paragraph (b)(4) of this
section for sheep or goats imported for
immediate slaughter, and in paragraph
(b)(5) of this section for sheep or goats
for restricted feeding for slaughter, must
also state that:
(i) The sheep or goats originated from
a region recognized as free of classical
scrapie by APHIS; or the animals have
reached and maintained certified status
or equivalent status in a scrapie flock
certification program or equivalent
program approved by APHIS;
(ii) The sheep or goats have not
commingled with sheep or goats of a
lower health status, or resided on the
premises of a flock or herd of lower
health status, after leaving the flock of
residence and prior to arrival in the
United States;
(iii) Any enclosure, container or
conveyance in which the sheep or goats
had been placed during the export
process, and which had previously held
sheep or goats, was cleaned and
disinfected in accordance with
§ 54.7(e)(2) of this chapter prior to being
used for the sheep or goats;
(iv) None of the female sheep or goats
is carrying an implanted embryo from a
lower health status flock; or that any
implanted embryo meets the
requirements for import into the United
States when implanted, and
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19:36 Dec 02, 2021
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documentation as required in part 98 of
this subchapter is attached;
(v) The veterinarian issuing the
certificate has inspected the sheep or
goats, and their flock(s) of residence,
within 30 days of consignment for
import to the United States, and found
the animals and the flock(s) of residence
to be free of any evidence of infectious
or contagious disease;
(vi) As far as it is possible for the
veterinarian who inspects the animals to
determine, none of the sheep or goats in
the flock(s) of residence has been
exposed to any infectious or contagious
disease during the 60 days immediately
preceding shipment to the United
States; and
(vii) The animals’ movement is not
restricted within the country of origin
due to animal health reasons.
(3) Test results. The certificate
accompanying sheep or goats from any
part of the world, except as provided in
paragraph (b)(4) of this section for sheep
or goats imported for immediate
slaughter, or in paragraph (b)(5) of this
section for sheep or goats for restricted
feeding for slaughter, must also include:
(i) The results of any testing required
in the import permit; and
(ii) Any other information required in
the import permit.
(4) Sheep or goats imported for
immediate slaughter. For sheep or goats
imported for immediate slaughter, in
addition to the statements required
under paragraph (a) of this section, the
certificate must include statements that:
(i) The region where the sheep or
goats originated is recognized as free of
classical scrapie by APHIS; or
(ii) The region where the sheep or
goats originated has not been recognized
as free of classical scrapie by APHIS but
the following criteria have been met:
(A) TSEs in sheep and goats are
compulsorily notifiable to the national
veterinary authority of the region;
(B) An effective classical scrapie
awareness, surveillance, monitoring,
and control system is in place;
(C) TSE-affected sheep and goats are
killed and completely destroyed;
(D) The sheep and goats selected for
export showed no clinical sign of
scrapie on the day of shipment and are
fit for travel;
(E) The sheep and goats have not
tested positive for, and are not suspect
for, a transmissible spongiform
encephalopathy; and
(F) The animals’ movement is not
restricted within the country of origin
due to animal health reasons.
(5) Sheep or goats for restricted
feeding for slaughter. For sheep or goats
imported for restricted feeding for
slaughter, in addition to the statements
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required under paragraph (a) of this
section, the certificate must include
statements that:
(i) The region where the sheep or
goats originated is recognized as free of
classical scrapie by APHIS; or
(ii) The region where the sheep or
goats originated has not been recognized
as free of classical scrapie by APHIS but
the following criteria have been met:
(A) TSEs in sheep and goats are
compulsorily notifiable to the national
veterinary authority of the region;
(B) An effective classical scrapie
awareness, surveillance, monitoring and
control system is in place;
(C) TSE-affected sheep and goats are
killed and completely destroyed;
(D) The sheep or goats showed no
clinical sign of scrapie or any other
infectious disease on the day of
shipment and are fit for travel;
(E) The sheep or goats have not tested
positive for, and are not suspect for, a
transmissible spongiform
encephalopathy;
(F) The animals’ movement is not
restricted within the country of origin
due to animal health concerns;
(G) Female sheep and goats are not
known to be pregnant, are not visibly
pregnant, and female animals have not
been exposed:
(1) To a sexually intact male at over
5 months of age; or
(2) To a sexually intact male within 5
months of shipment;
(H) The veterinarian issuing the
certificate has inspected the sheep or
goats for export, and their flock(s) of
residence, within 30 days of
consignment for shipment to the United
States, and found the animals and the
flock(s) of residence to be free of any
evidence of infectious or contagious
disease; and
(I) As far as it is possible for the
veterinarian who inspects the animals to
determine, none of the sheep or goats
has been exposed to any infectious or
contagious disease during the 60 days
immediately preceding shipment to the
United States.
(c) Refusal of entry. If ruminants are
unaccompanied by the certificate as
required by paragraphs (a) and (b) of
this section, or if such ruminants are
found upon inspection at the port of
entry to be affected with a
communicable disease or to have been
exposed thereto, they shall be refused
entry and shall be handled or
quarantined, or otherwise disposed of as
the Administrator may direct.
(Approved by the Office of Management and
Budget under control numbers 0579–0040,
0579–0165, 0579–0234, 0579–0393, and
0579–0453)
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§ 93.406
[Amended]
§ 93.435
8. Section 93.406(b) is amended by
removing the references ‘‘§§ 93.419 and
93.428(b)’’ and adding ‘‘§§ 93.428(b) and
93.435’’ in their place.
■
§ 93.419
[Removed and Reserved]
9. Section 93.419 is removed and
reserved.
■
10. Section 93.420 is amended in
paragraph (a) introductory text by
adding a sentence after the paragraph
heading to read as follows:
■
§ 93.420 Ruminants from Canada for
immediate slaughter other than sheep and
goats.
(a) * * * The requirements for the
importation of sheep and goats from
Canada for immediate slaughter are
contained in § 93.435. * * *
*
*
*
*
*
11. Section 93.424 is amended by
revising paragraph (a) to read as follows:
■
§ 93.424 Import permits and applications
for inspection of ruminants.
(a) For ruminants intended for
importation from Mexico, the importer
shall first apply for and obtain from
APHIS an import permit as provided in
§ 93.404: Provided, that: An import
permit is not required for sheep or goats
imported for immediate slaughter if the
animal is offered for entry at a land
border port designated in § 93.403(c).
*
*
*
*
*
12. Section 93.428 is amended by
revising paragraph (a) and the OMB
statement at the end of the section to
read as follows:
■
jspears on DSK121TN23PROD with RULES3
§ 93.428 Sheep and goats and native wild
ruminants from Mexico.
(a) Sheep, goats, and native wild
ruminants intended for import from
Mexico must be imported in accordance
with § 93.435, and shall be accompanied
by a certificate issued in accordance
with § 93.405 and stating, if such sheep
and goats are shipped by rail or truck,
that such animals were loaded into
cleaned and disinfected cars or trucks
for transportation direct to the port of
entry. Notwithstanding such certificate,
such sheep and goats shall be detained
as provided in § 93.427(a) and shall be
dipped at least once in a permitted
scabies dip under supervision of an
inspector.
*
*
*
*
*
(Approved by the Office of Management and
Budget under control numbers 0579–0040
and 0579–0453)
13. Section 93.435 is revised to read
as follows:
■
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Sheep and goats.
(a) General provisions. (1) Sheep and
goats imported from anywhere in the
world shall be accompanied by a
certificate issued in accordance with
§ 93.405. If the sheep or goats are not
accompanied by the certificate, or if
they are found upon inspection at the
port of entry to be affected with or
exposed to a communicable disease,
they shall be refused entry and shall be
handled or quarantined, or otherwise
disposed of, as the Administrator may
direct.
(2) All imported sheep and goats must
be officially identified at the time of
presentation for entry into the United
States with official identification
devices or methods and which will
allow the animals not imported for
immediate slaughter or for feeding for
slaughter to be traced at any time to the
farm or premises of birth, and for
animals imported for immediate
slaughter or for feeding for slaughter to
the flock of residence. Official
identification devices may not be
removed or altered at any time after
entry into the United States, except by
an authorized USDA representative at
the time of slaughter. A list of the
acceptable types of official
identification devices or methods may
be found on the APHIS website at
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/animal-andanimal-product-import-information/
imports/live-animal-imports.
(3) All imported sheep and goats other
than for immediate slaughter or as
provided in paragraph (c) of this section
for restricted feeding for slaughter must
be identified at the time of presentation
for entry into the United States with a
country mark using a means and in a
location on the animal approved by the
Administrator for this use. A list of the
acceptable country marks may be found
on the APHIS website at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/animal-and-animalproduct-import-information/imports/
live-animal-imports.
(4) Except as provided in paragraph
(b) of this section for sheep or goats
imported for immediate slaughter, and
in paragraph (c) of this section for sheep
or goats for restricted feeding for
slaughter, the importer shall maintain
records of the sale, death or other
disposition of all imported animals
including the official identification
number(s) and country marks on the
animals at the time of import; a record
of the replacement of any lost
identification devices linking the new
official identification number to the lost
device number; the date and manner of
disposition; and the name and address
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68859
of the new owner. Such records must be
maintained for a period of 5 years after
the sale or death of the animal. The
records must be available for APHIS to
view and copy during normal business
hours.
(b) Sheep and goats imported for
immediate slaughter from anywhere in
the world. (1) Sheep and goats for
immediate slaughter may only be
imported into the United States from
countries or regions determined to be
free of classical scrapie by APHIS, or
that have scrapie awareness,
surveillance, and control programs
evaluated and determined by APHIS to
be effective.
(2) Sheep and goats imported for
immediate slaughter must be imported
only through a port of entry listed in
§ 93.403(b) or as provided for in
§ 93.403(f) and be inspected at the port
of entry and otherwise handled in
accordance with § 93.408.
(3) The ruminants must be moved
directly from the port of entry to a
recognized slaughtering establishment
in conveyances that are sealed with
seals of the U.S. Government at the port
of entry. The seals may be broken only
at the recognized slaughtering
establishment by an authorized USDA
representative.
(4) The shipment must be
accompanied from the port of entry to
the recognized slaughtering
establishment by APHIS Form VS 17–
33.
(c) Sheep and goats imported for
restricted feeding for slaughter. (1)
Sheep and goats for restricted feeding
for slaughter purposes may only be
imported into the United States from
countries or regions determined to be
free of classical scrapie by APHIS, or
that have scrapie awareness,
surveillance, and control programs
evaluated and determined by APHIS to
be effective.
(2) The sheep and goats must be
imported only through a port of entry
allowed in § 93.403 in a means of
conveyance sealed in the region of
origin with seals of the national
government of the region of origin. The
seals may be broken either by an APHIS
representative at the port of entry, or at
the designated feedlot by an authorized
APHIS representative. If the seals are
broken by an APHIS representative, the
means of conveyance must be resealed
with seals of the U.S. Government
before being moved to the designated
feedlot; and
(3) The sheep and goats shall be
inspected by the port veterinarian or
other designated representative at the
port of entry to determine that the
animals are free from evidence of
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communicable disease and are
considered fit for further travel; and
(4) The sheep and goats must be
moved directly as a group from the port
of entry to a designated feedlot; and
(5) The sheep and goats may not be
commingled with any sheep or goats
that are not being moved directly to
slaughter from the designated feedlot;
and
(6) The sheep and goats may be
moved from the port of entry only to a
feedlot designated in accordance with
paragraph (c)(11) of this section and
must be accompanied from the port of
entry to the designated feedlot by
APHIS Form VS 17–130 or other
movement documentation stipulated in
the import permit; and
(7) Upon arrival at the designated
feedlot, the official identification for
each animal must be reconciled by an
APHIS veterinarian, or other official
designated by APHIS, with the
accompanying documentation; and
(8) The sheep and goats must remain
at the designated feedlot until
transported to a recognized slaughtering
establishment. The sheep and goats
must be moved directly to the
recognized slaughtering establishment
in a means of conveyance sealed by an
accredited veterinarian, a State
representative, or an APHIS
representative with seals of the U.S.
Government. The seals must be broken
at the recognized slaughtering
establishment only by an authorized
USDA representative; and
(9) The sheep and goats must be
accompanied to the recognized
slaughtering establishments by APHIS
Form VS 1–27 or other documentation
stipulated in the import permits; and
(10) The sheep and goats must be
slaughtered within 12 months of
importation.
(11) To be eligible as a designated
feedlot to receive sheep and goats
imported for feeding, a feedlot must be
approved by APHIS. To be approved by
APHIS, the feedlot operator or his or her
agent must enter into a compliance
agreement with the Administrator. The
compliance agreement must provide
that the operator:
(i) Will monitor all imported feeder
animals to ensure that they have the
required official identification at the
time of arrival to the feedlot; and will
not remove official identification from
animals unless medically necessary, in
which case new official identification
will be applied and cross referenced in
the records. Any lost official
identification will be replaced with
eartags provided by APHIS for purposes
of this paragraph (c)(11)(i) and will be
linked as the new official identification
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with the lost identification. If more than
one animal loses their official
identification at the same time, the new
official identification will be linked
with all possible original identification
numbers;
(ii) Will monitor all incoming
imported feeder animals to ensure they
have the required country mark, or will
maintain all imported animals in
separate pens from U.S. origin animals,
and all sheep and goats that enter the
feedlot are moved only for slaughter;
(iii) Will maintain records of the
acquisition and disposition of all
imported sheep and goats entering the
feedlot, including the official
identification number and all other
identifying information, the age of each
animal, the date each animal was
acquired and the date each animal was
shipped to slaughter, and the name and
location of the plant where each animal
was slaughtered. For imported animals
that die in the feedlot, the feedlot will
remove the official identification device
if affixed to the animal, or will record
any other official identification on the
animal and place the official
identification device or record of official
identification in a file with a record of
the disposition of the carcass;
(iv) Will maintain copies of the
APHIS Forms VS 17–130 and VS 1–27
or other movement documentation
deemed acceptable by the Administrator
that have been issued for incoming
animals and for animals moved to
slaughter and that list the official
identification of each animal;
(v) Will allow State and Federal
animal health officials access to inspect
its premises and animals and to review
inventory records and other required
files upon request;
(vi) Will keep required records for at
least 5 years;
(vii) Will designate either the entire
feedlot or pens within the feedlot as
terminal for sheep and goats to be
moved only directly to slaughter;
(viii) Will prevent fence-line contact
with sheep or goats outside the
designated feedlot;
(ix) Agrees that if inventory cannot be
reconciled or if animals are not moved
to slaughter as required, the approval of
the feedlot to receive additional animals
will be immediately withdrawn and any
imported animals remaining in the
feedlot will be disposed of as directed
by the Administrator;
(x) Agrees that if an imported animal
gives birth in the feedlot, the offspring
will be humanely euthanized and the
birth tissues and soiled bedding
disposed of in a sanitary landfill or by
another means approved by the
Administrator; and
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(xi) Agrees to maintain sexually intact
animals of different genders over 5
months of age in separate enclosures.
(xii) For a feedlot to be approved to
receive sheep or goats imported for
feeding under this section, but which do
not have a country mark, the
compliance agreement must also
provide that the feedlot will maintain
all imported animals in separate pens
from U.S. origin animals and that all
sheep and goats that enter the feedlot
are moved only for slaughter.
(d) Other importations. Sheep or goats
imported other than as provided in
paragraph (b) of this section for
immediate slaughter or as provided in
paragraph (c) of this section for sheep
and goats imported for restricted feeding
for slaughter must originate from a
region recognized as free of classical
scrapie by APHIS or from a flock that
has certified status or equivalent status
in a scrapie flock certification program
or equivalent program approved by
APHIS, or as provided in § 93.404(a)(5)
or (6).
(e) Sheep and goats transiting the
United States. Sheep or goats that meet
the entry requirements for immediate
slaughter in § 93.405 may transit the
United States in accordance with
§ 93.401 regardless of their intended use
in the receiving country.
(f) Classical scrapie status of foreign
regions. APHIS considers classical
scrapie to exist in all regions of the
world except those declared free of this
disease by APHIS.
(1) A list of regions that APHIS has
declared free of classical scrapie is
maintained on the APHIS website at
https://www.aphis.usda.gov/import_
export/animals/animal_disease_
status.shtml. Copies of the list are also
available via postal mail, fax, or email
upon request to Regionalization
Evaluation Services, Strategy and
Policy, Veterinary Services, Animal and
Plant Health Inspection Service, 4700
River Road Unit 38, Riverdale,
Maryland 20737.
(2) APHIS will add a region to the list
in paragraph (f)(1) only after conducting
an evaluation of the region in
accordance with § 92.2 of this
subchapter and finding classical scrapie
is not likely to be present in its sheep
or goat populations. In the case of a
formerly listed region removed due to
an outbreak, the region may be returned
to the list in accordance with the
procedures for reestablishment of a
region’s disease-free status in § 92.4 of
this subchapter. APHIS will remove a
region from the list of those it has
declared free of classical scrapie upon
determining classical scrapie exists
there based on reports APHIS receives
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(2) Before transit, the person moving
the articles must notify, in writing, the
authorized Customs inspector at both
the place in the United States where the
articles will arrive and the port of
export. The notification must include
the:
(i) Times and dates of arrival in the
United States;
(ii) Times and dates of exportation
from the United States;
(Approved by the Office of Management and
(iii) Mode of transportation; and
Budget under control numbers 0579–0040,
(iv) Serial numbers of the sealed
0579–0101, and 0579–0453)
containers.
§ 93.505 [Amended]
(3) The articles must transit the
United States under Customs bond.
■ 14. Section 93.505(a) is amended by
(4) The shipment is exported from the
removing the citation ‘‘§ 94.24(b)(6)’’
United States within 7 days of its entry.
and adding the citation ‘‘§ 94.31(b)(6)’’
(c) Pork and pork products from Baja
in its place.
California, Baja California Sur,
Campeche, Chihuahua, Coahuila, Nuevo
PART 94—FOOT–AND–MOUTH
Leon, Quintana Roo, Sinaloa, Sonora,
DISEASE, NEWCASTLE DISEASE,
and Yucatan, Mexico, that are not
HIGHLY PATHOGENIC AVIAN
eligible for entry into the United States
INFLUENZA, AFRICAN SWINE FEVER,
in accordance with this part may transit
CLASSICAL SWINE FEVER, SWINE
the United States via land border ports
VESICULAR DISEASE, AND BOVINE
for immediate export if the following
SPONGIFORM ENCEPHALOPATHY:
conditions of paragraphs (c)(1) through
PROHIBITED AND RESTRICTED
(4) of this section are met:
IMPORTATIONS
(1) The person moving the pork and
■ 15. The authority citation for part 94
pork products must obtain a United
continues to read as follows:
States Veterinary Permit for Importation
and Transportation of Controlled
Authority: 7 U.S.C. 1633, 7701–7772,
Materials and Organisms and Vectors.
7781–7786, and 8301–8317; 21 U.S.C. 136
and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,
To apply for a permit, file a permit
and 371.4.
application on VS Form 16–3 (available
from APHIS, Veterinary Services,
■ 16. Section 94.15 is revised to read as
Strategy and Policy, 4700 River Road
follows:
Unit 38, Riverdale, MD 20737–1231, or
§ 94.15 Transit shipment of articles.
electronically at https://
(a) Any meat or other animal product
www.aphis.usda.gov/animal_health/
or material (excluding materials that are permits/).
required to be consigned to USDA(2) The pork or pork products are
approved establishments for further
packaged at a Tipo Inspeccio´n Federal
processing) eligible for entry into the
plant in Baja California, Baja California
United States, as provided in this part
Sur, Campeche, Chihuahua, Coahuila,
or in part 95 of this subchapter, may
Nuevo Leon, Quintana Roo, Sinaloa,
transit the United States by air and
Sonora, or Yucatan, Mexico, in
ocean ports and overland transportation leakproof containers and sealed with
if the articles are accompanied by the
serially numbered seals of the
required documentation specified in
Government of Mexico, and the
this part and in part 95.
containers remain sealed during the
(b) Any meat or other animal product
entire time they are in transit across
or material not eligible for entry into the Mexico and the United States.
United States, as provided in this part
(3) The person moving the pork and
or in part 95 of this subchapter, may
pork products through the United States
transit air and ocean ports only, with no notifies, in writing, the authorized
overland movement outside the airport
Customs inspector at the United States
terminal area or dock area of the
port of arrival prior to such transiting.
maritime port, in the United States for
The notification must include the
immediate export if the conditions of
following information regarding the
paragraphs (b)(1) through (4) of this
pork and pork products:
section are met.
(i) Permit number;
(1) The articles must be sealed in
(ii) Times and dates of arrival in the
leakproof containers bearing serial
United States;
numbers during transit. Each container
(iii) Time schedule and route to be
must remain under either Customs seal
followed through the United States; and
(iv) Serial numbers of the seals on the
or foreign government seal during the
entire time that it is in the United States. containers.
jspears on DSK121TN23PROD with RULES3
of outbreaks of the disease in sheep or
goats from veterinary officials of the
exporting country, from the World
Organization for Animal Health (OIE),
from other sources the Administrator
determines to be reliable, or upon
determining that the region’s animal
health infrastructure, regulations, or
policy no longer qualifies the region for
such status.
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68861
(4) The pork and pork products must
transit the United States under Customs
bond and must be exported from the
United States within the time limit
specified on the permit. Any pork or
pork products that have not been
exported within the time limit specified
on the permit or that have not been
transited in accordance with the permit
or applicable requirements of this part
will be destroyed or otherwise disposed
of as the Administrator may direct
pursuant to the Animal Health
Protection Act (7 U.S.C. 8301 et seq.).
(d) Poultry carcasses, parts, or
products (except eggs and egg products)
from Baja California, Baja California
Sur, Campeche, Chihuahua, Nuevo
Leon, Quintana Roo, Sinaloa, Sonora,
Tamaulipas, or Yucatan, Mexico, that
are not eligible for entry into the United
States in accordance with the
regulations in this part may transit the
United States via land ports for
immediate export if the following
conditions of paragraphs (d)(1) through
(4) of this section are met:
(1) The person moving the poultry
carcasses, parts, or products through the
United States must obtain a United
States Veterinary Permit for Importation
and Transportation of Controlled
Materials and Organisms and Vectors.
To apply for a permit, file a permit
application on VS Form 16–3 (available
from APHIS, Veterinary Services,
Strategy and Policy, 4700 River Road
Unit 38, Riverdale, MD 20737–1231, or
electronically at https://
www.aphis.usda.gov/animal_health/
permits/).
(2) The poultry carcasses, parts, or
products are packaged at a Tipo
Inspeccio´n Federal plant in Baja
California, Baja California Sur,
Campeche, Chihuahua, Nuevo Leon,
Quintana Roo, Sinaloa, Sonora,
Tamaulipas, or Yucatan, Mexico, in
leakproof containers with serially
numbered seals of the Government of
Mexico, and the containers remain
sealed during the entire time they are in
transit through Mexico and the United
States.
(3) The person moving the poultry
carcasses, parts, or products through the
United States must notify, in writing,
the authorized U.S. Customs and Border
Protection (CBP) inspector at the United
States port of arrival prior to such
transiting. The notification must include
the following information regarding the
poultry to transit the United States:
(i) Permit number;
(ii) Times and dates of arrival in the
United States;
(iii) Time schedule and route to be
followed through the United States; and
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(iv) Serial numbers of the seals on the
containers.
(4) The poultry carcasses, parts, or
products must transit the United States
under U.S. Customs bond and must be
exported from the United States within
the time limit specified on the permit.
Any poultry carcasses, parts, or
products that have not been exported
within the time limit specified on the
permit or that have not transited in
accordance with the permit or
applicable requirements of this part will
be destroyed or otherwise disposed of as
the Administrator may direct pursuant
to the Animal Health Protection Act (7
U.S.C. 8301 et seq.).
(e) Meat and other products of
ruminants or swine from regions listed
in § 94.11(a) and pork and pork
products from regions listed in § 94.13
that do not meet the requirements of
§ 94.11(b) or § 94.13(a) may transit
through the United States for immediate
export, provided the provisions of
paragraph (b) of this section are met,
and provided all other applicable
provisions of this part are met.
(Approved by the Office of Management and
Budget under control numbers 0579–0040,
0579–0145, and 0579–0453)
§ 94.18
[Amended]
17. Section 94.18 is amended in
paragraph (a) by adding the word ‘‘and’’
before the citation ‘‘94.23’’ and
removing ‘‘, and 94.27’’.
■
§ 94.24
[Removed and Reserved]
18. Section 94.24 is removed and
reserved.
■
§ 94.25
[Removed and Reserved]
19. Section 94.25 is removed and
reserved.
■
20. Section 94.26 is revised to read as
follows:
■
jspears on DSK121TN23PROD with RULES3
§ 94.26 Gelatin derived from horses,
swine, or non-bovine ruminants.
Gelatin derived from horses, swine, or
non-bovine ruminants must be
accompanied at the time of importation
into the United States by an official
certificate issued by a veterinarian
employed by the national government of
the region of origin. The official
certificate must state the species of
animal from which the gelatin is
derived.
(Approved by the Office of Management and
Budget under control number 0579–0453)
§ 94.27
[Removed and Reserved]
21. Section 94.27 is removed and
reserved.
■
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PART 95—SANITARY CONTROL OF
ANIMAL BYPRODUCTS (EXCEPT
CASINGS), AND HAY AND STRAW,
OFFERED FOR ENTRY INTO THE
UNITED STATES
22. The authority citation for part 95
continues to read as follows:
■
Authority: 7 U.S.C. 8301–8317; 21 U.S.C.
136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22,
2.80, and 371.4.
§ 95.1
[Amended]
23. Section 95.1 is amended by
removing the definitions of Positive for
a transmissible spongiform
encephalopathy and Suspect for a
transmissible spongiform
encephalopathy.
■ 24. Section 95.4 is amended as
follows:
■ a. By revising the section heading and
paragraphs (a), (b) introductory text,
(b)(1), and (c)(1)(ii) and (iv);
■ b. By removing paragraphs (c)(2) and
(3) and redesignating paragraphs (c)(4)
through (8) as (c)(2) through (6),
respectively;
■ c. In newly redesignated paragraph
(c)(3), by revising the first sentence;
■ d. In newly redesignated paragraph
(c)(5), by removing the reference ‘‘(c)(5)’’
and adding the reference ‘‘(3)’’ in its
place;
■ e. By removing paragraphs (d) and (e);
■ f. By redesignating paragraph (f) and
the Note to paragraph (f) as paragraph
(d) and Note 1 to paragraph (d),
respectively; and
■ g. By removing paragraph (g).
The revisions read as follows:
■
§ 95.4 Restrictions on the importation of
processed animal protein, offal, tankage,
fat, glands, tallow, tallow derivatives, and
serum due to bovine spongiform
encephalopathy.
(a) Except as provided in this section,
or in § 94.15, any of the materials listed
in paragraph (b) in this section derived
from animals, or products containing
such materials, are prohibited
importation into the United States.
(b) The restricted materials are as
follows:
(1) Processed animal protein, tankage,
offal, tallow, and tallow derivatives,
unless in the opinion of the
Administrator, the tallow cannot be
used in feed;
*
*
*
*
*
(c) * * *
(1) * * *
(ii) Cervids or camelids, and the
material is not ineligible for importation
under the conditions of § 95.5;
*
*
*
*
*
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(iv) Ovines or caprines, and the
material is not ineligible for importation
under the conditions of § 95.5.
*
*
*
*
*
(3) If the facility processes or handles
any processed animal protein,
inspection of the facility for compliance
with the provisions of this section is
conducted at least annually by a
representative of the government agency
responsible for animal health in the
region, unless the region chooses to
have such inspection conducted by
APHIS. * * *
*
*
*
*
*
§ 95.15
[Removed and Reserved]
25. Section 95.15 is removed and
reserved.
■
§ 95.40
[Removed and Reserved]
26. Section 95.40 is removed and
reserved.
■
PART 96—RESTRICTION OF
IMPORTATIONS OF FOREIGN ANIMAL
CASINGS OFFERED FOR ENTRY INTO
THE UNITED STATES
27. The authority citation for part 96
continues to read as follows:
■
Authority: 7 U.S.C. 8301–8317; 21 U.S.C.
136 and 136a; 7 CFR 2.22, 2.80, and 371.4.
§ 96.2
[Amended]
28. Section 96.2 is amended as
follows:
■ a. By removing paragraph (b)(1) and
redesignating paragraph (b)(2) as
paragraph (b)(1);
■ b. By adding a new reserved
paragraph (b)(2); and
■ c. In paragraph (c)(3), by removing the
words ‘‘paragraphs (b)(2)(i) through
(b)(3)(iv)’’ and adding the words
‘‘paragraph (b)(1)’’ in their place.
■
PART 98—IMPORTATION OF CERTAIN
ANIMAL EMBRYOS AND ANIMAL
SEMEN
29. The authority citation for part 98
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.
30. Section 98.2 is amended by
adding, in alphabetical order,
definitions for Oocyte and
Transmissible spongiform
encephalopathies (TSEs) to read as
follows:
■
§ 98.2
Definitions.
*
*
*
*
*
Oocyte. The first and second
maturation stages of a female
reproductive cell prior to fertilization.
*
*
*
*
*
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Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Rules and Regulations
Transmissible spongiform
encephalopathies (TSEs). A family of
progressive and generally fatal
neurodegenerative disorders thought to
be caused by abnormal proteins, called
prions, typically producing
characteristic microscopic changes,
including, but not limited to,
noninflammatory neuronal loss, giving a
spongiform appearance to tissues in the
brains and nervous systems of affected
animals.
*
*
*
*
*
§ 98.3
[Amended]
31. Section 98.3 is amended as
follows:
■ a. In paragraph (d), by adding the
words ‘‘except that, for sheep and goats
only, the donor sire must meet the
scrapie requirements in § 98.35 instead
of the requirements in § 93.435 of this
chapter;’’ after the words ‘‘United
States;’’;
■ b. In paragraph (e), by:
■ i. Removing the ‘‘part 92’’ and adding
the citation ‘‘part 93’’ in its place; and
■ ii. Adding the words ‘‘except that, for
sheep and goats only, the donor dam
must meet the requirements for embryo
donors in § 98.10(a) instead of the
requirements in § 93.435 of this
chapter;’’ after the words ‘‘United
States;’’; and
■ c. In paragraph (f), by removing
‘‘§ 93.404(a)(2) or (3)’’ and adding
‘‘§ 93.404(a)(3) or (4)’’ in its place.
■ 32. Section 98.4 is amended by
redesignating paragraph (d) as
paragraph (e) and adding a new
paragraph (d) to read as follows:
■
§ 98.4
Import permit.
*
*
*
*
*
(d) Applications for a permit to
import sheep and goat embryos and
oocytes must include the flock
identification number of the receiving
flock and the premises or location
identification number assigned in the
APHIS National Scrapie Database; or, in
the case of embryos or oocytes moving
to a storage facility, the premises or
location identification number must be
included.
*
*
*
*
*
§ 98.5
[Amended]
33. Section 98.5 is amended as
follows:
■ a. By removing and reserving
paragraph (b); and
■ b. In the OMB statement at the end of
the section, by removing ‘‘number
0579–0040’’ and adding ‘‘numbers
0579–0040 and 0579–0453’’ in its place.
■ 34. Section 98.10a is revised to read
as follows:
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§ 98.10a Sheep and goat embryos and
oocytes.
(a) Sheep and goat embryos or oocytes
collected from donors located in, or
originating from, regions recognized by
APHIS as free of classical scrapie, or
from a flock or herd having certified
status in a scrapie flock certification
program recognized by APHIS as
acceptable, may be imported in
accordance with §§ 98.3 through 98.8. In
addition to the requirements of § 98.5,
the health certificate must indicate that
the embryos or oocytes were collected,
processed, and stored in conformity
with the requirements in § 98.3(g).
(b) In vivo-derived sheep and goat
embryos or oocytes collected from
donors located in, or originating from,
regions or flocks not recognized by
APHIS as free of classical scrapie, may
be imported in accordance with §§ 98.3
through 98.8 and the following
conditions:
(1) The embryos or oocytes must be
accompanied by a health certificate
meeting the requirements listed in
§ 98.5, and with the following
additional certifications:
(i) The embryos or oocytes were
collected, processed and stored in
conformity with the requirements in
§ 98.3(g).
(ii) For in vivo-derived sheep embryos
only: The embryo is of the genotype
AAQR or AARR based on official testing
of the parents or the embryo.
(iii) Certificates for sheep embryos not
of the genotype AAQR or AARR, and for
all goat embryos, must contain the
following additional certifications:
(A) In the country or zone:
(1) TSEs of sheep and goats are
compulsorily notifiable to the national
veterinary authority of the region;
(2) A scrapie awareness, surveillance,
monitoring, and control system is in
place;
(3) TSE-affected sheep and goats are
killed and completely destroyed; and
(4) The feeding to sheep and goats of
meat-and-bone meal of ruminant origin
has been banned and the ban is
effectively enforced in the whole
country.
(B) The donor animals:
(1) Have been kept since birth in
flocks or herds where no case of scrapie
had been confirmed during their
residency; and
(2) Are permanently identified to
enable a traceback to their flock or herd
of origin, and this identification is
recorded on the certificate
accompanying the embryo(s) and linked
to the embryo container identification;
and
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68863
(3) Showed no clinical sign of scrapie
at the time of embryo/oocyte collection;
and
(4) Have not tested positive for, and
are not suspect for, a transmissible
spongiform encephalopathy; and
(5) Are not under movement
restrictions within the country or region
of origin as a result of exposure to a
transmissible spongiform
encephalopathy.
(2) [Reserved]
(c) Any additional certifications or
testing requirements established by
APHIS, based on genetic susceptibility
of the embryo or embryo parents, and/
or on scrapie testing of the embryo
donor, will be listed in the APHIS
import permit. Such certifications or
required test results must also be
recorded on the health certificate
accompanying the embryo(s).
(d) Sheep and goat embryos or oocytes
may only be imported for transfer to
recipient females in the United States if
the flock or herd where the recipients
reside is listed in the National Scrapie
Database; except APHIS may permit
importation of sheep and goat embryos
or oocytes to an APHIS-approved
storage facility where they may be kept
until later transferred to recipient
females in a flock or herd in the United
States listed in the APHIS National
Scrapie Database, and under such
conditions as the Administrator deems
necessary to trace the movement of the
imported embryos or oocytes. Imported
sheep or goat embryos or oocytes not
otherwise restricted by the conditions of
an import permit may be transferred
from a listed flock or herd to any other
listed flock or herd, or from an embryo
storage facility to a listed flock or herd,
with written notification to the
responsible APHIS Veterinary Services
Service Center.
(e) The importer, the owner of a
recipient flock or herd where delivery of
the embryos or oocytes is made, or the
owner of an APHIS-approved embryo or
oocyte storage facility must maintain
records of the disposition (including
destruction) of imported or stored
embryos or oocytes for 5 years after the
embryo or oocyte is transferred or
destroyed. These records must be made
available during normal business hours
to APHIS representatives on request for
review and copying.
(f) For in vitro-derived and
manipulated sheep or goat embryos and
oocytes, APHIS will make a case-by-case
determination or establish conditions in
an import permit that includes any
additional mitigations deemed
necessary to prevent the introduction of
disease as provided in § 98.10.
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(g) The owner of all sheep or goats
resulting from embryos or oocytes
imported under this section shall:
(1) Identify them at birth with a
permanent official identification
number consistent with the provisions
of § 79.2 of this chapter; such
identification may not be removed
except at slaughter and must be
replaced if lost;
(2) Maintain a record linking the
official identification number to the
imported embryo or oocyte including a
record of the replacement of lost tags;
(3) Maintain records of any sale or
disposition of such animals, including
the date of sale or disposition, the name
and address of the buyer, and the
animal’s official identification number;
and
(4) Keep the required records for a
period of 5 years after the sale or death
of the animal. APHIS may view and
copy these records during normal
business hours.
(Approved by the Office of Management and
Budget under control numbers 0579–0040,
0579–0101, and 0579–0453).
35. Section 98.13 is amended by
adding paragraph (c) to read as follows:
■
§ 98.13
Import permit.
*
*
*
*
*
(c) Applications for a permit to import
sheep and goat embryos and oocytes
must include the flock identification
number of the receiving flock and the
premises or location identification
number assigned in the APHIS National
Scrapie Database; or, in the case of
embryos or oocytes moving to a storage
facility, the premises or location
identification number must be included.
*
*
*
*
*
§ 98.15
[Amended]
36. Section 98.15 is amended as
follows:
■ a. In paragraph (a) introductory text,
by removing the words ‘‘follows, except
that, with regard to bovine spongiform
encephalopathy, the following does not
apply to bovines, cervids, or camelids.’’
and adding the word ‘‘follows:’’ in their
place;
■ b. In paragraph (a)(1)(i), by removing
the words ‘‘Bovine spongiform
encephalopathy, contagious’’ and
adding the word ‘‘Contagious’’ in their
place;
■ c. In paragraph (a)(2)(i), by removing
the words ‘‘Bovine spongiform
encephalopathy, contagious’’ and
adding the word ‘‘Contagious’’ in their
place;
■ d. In paragraph (a)(7)(i)(A), by
removing the words ‘‘Bovine
spongiform encephalopathy,
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brucellosis’’ and adding the word
‘‘Brucellosis’’ in their place; and
■ e. In paragraph (a)(8)(i)(A), by
removing the words ‘‘Bovine
spongiform encephalopathy,
brucellosis’’ and adding the word
‘‘Brucellosis’’ in their place.
■ 37. Section 98.30 is amended by
adding, in alphabetical order, a
definition for Establishment to read as
follows:
§ 98.30
Definitions.
*
*
*
*
*
Establishment. The premises in which
animals are kept.
*
*
*
*
*
■ 38. Section 98.35 is amended as
follows:
■ a. By revising paragraph (e)
introductory text;
■ b. By removing paragraph (e)(1)(ii)
and redesignating paragraphs (e)(1)(iii)
and (iv) as paragraphs (e)(1)(ii) and (iii),
respectively;
■ c. By revising newly redesignated
(e)(1)(iii);
■ d. By adding new paragraph (e)(1)(iv);
■ e. By removing ‘‘; and’’ at the end of
paragraph (e)(2)(iv) and adding a period
in its place;
■ f. By revising paragraph (e)(3);
■ g. By adding paragraphs (e)(4) and (5);
and
■ h. By revising the OMB statement at
the end of the section.
The revisions and additions read as
follows:
§ 98.35 Declaration, health certificate, and
other documents for animal semen.
*
*
*
*
*
(e) The certificates accompanying
sheep semen collected from rams that
are not of the genotypes AARR or
AAQR, and for all goat semen shall, in
addition to the statements required by
paragraph (d) of this section, state that:
(1) * * *
(iii) The donor animal is not, nor was
not, restricted in the country of origin,
or destroyed, due to exposure to a TSE.
(iv) Any additional certifications or
testing requirements established by
APHIS, based on genetic susceptibility
of the semen donor, and/or on scrapie
testing of the donor or semen, will be
listed in the APHIS import permit. Such
certifications or required test results
must also be recorded on the health
certificate accompanying the semen.
*
*
*
*
*
(3) Sheep and goat semen may only be
imported for transfer to recipient
females in the United States if the flock
or herd in which recipients reside is
listed in the National Scrapie Database;
except that APHIS may permit
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importation of sheep and goat semen to
an APHIS-approved storage facility
where they may be kept until later
transferred to recipient females in a
flock or herd in the United States listed
in the APHIS National Scrapie Database,
and under such conditions as the
Administrator deems necessary to trace
the movement of the imported semen.
Imported sheep or goat semen not
otherwise restricted by the conditions of
an import permit may be transferred
from a listed flock or herd to any other
listed flock or herd or from an approved
semen storage facility to a listed flock or
herd or another approved semen storage
facility with written notification to the
responsible APHIS Veterinary Services
Service Center.
(4) The importer, the owner of a
recipient flock or herd to which delivery
of the semen is made, or the owner of
an APHIS-approved semen storage
facility must maintain records of the
disposition (including destruction) of
imported or stored semen for 5 years
after the semen is transferred or
destroyed. These records must be made
available during normal business hours
to APHIS representatives on request for
review and copying.
(5) The owner of all sheep or goats
resulting from semen imported under
this section shall:
(i) Identify them at birth with a
permanent official identification
number consistent with the provisions
of § 79.2 of this chapter; such
identification may not be removed
except at slaughter and must be
replaced if lost;
(ii) Maintain a record linking the
official identification number to the
imported semen, including a record of
the replacement of lost tags;
(iii) Maintain records of any sale or
disposition of such animals, including
the date of sale or disposition, the name
and address of the buyer, and the
animal’s official identification number;
and
(iv) Keep the required records for a
period of 5 years after the sale or death
of the animal. APHIS may view and
copy these records during normal
business hours.
*
*
*
*
*
(Approved by the Office of Management and
Budget under control numbers 0579–0040
and 0579–0453)
Done in Washington, DC, this 30th day of
November 2021.
Jennifer Moffitt,
Undersecretary, Marketing and Regulatory
Programs.
[FR Doc. 2021–26302 Filed 12–2–21; 8:45 am]
BILLING CODE 3410–34–P
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| File Type | application/pdf |
| File Modified | 2021-12-03 |
| File Created | 2021-12-03 |