[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Rules and Regulations]
[Pages 68834-68864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26302]



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Vol. 86

Friday,

No. 230

December 3, 2021

Part III





Department of Agriculture





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 Animal and Plant Health Inspection Service





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9 CFR Parts 92, 93, 94, et al.





Importation of Sheep, Goats, and Certain Other Ruminants; Final Rule

  Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / 
Rules and Regulations  

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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

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

ACTION: Final rule.

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SUMMARY: 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 non-bovine 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.

DATES: Effective January 3, 2022.

FOR FURTHER INFORMATION CONTACT: 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:

I. Executive Summary

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 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 non-bovine 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.
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    \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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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 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 Creutzfeldt-Jakob disease in humans.
    The current BSE-related import regulations restrict the importation 
of most live ruminants and ruminant-derived products and byproducts. 
The exceptions are cervids and camelids, and their products, which are 
not subject to BSE-related restrictions. The regulations in Sec.  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 Sec.  93.419 allow only the 
importation of sheep and goats for immediate slaughter or restricted 
feeding for slaughter from

[[Page 68835]]

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 BSE-related 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 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.
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    \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.
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    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\
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    \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.
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    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.
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    \5\ See footnote 1.
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    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 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 Sec.  94.24(a). Section 93.405 
contains BSE-specific 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 Sec.  
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 Sec. Sec.  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 Sec.  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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Sec.  93.400, Definitions

    We proposed to revise definitions for designated feedlot and flock. 
We proposed to change the definition of designated feedlot to reference 
scrapie-related restrictions rather than BSE-related 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 TSE-affected 
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.

Sec.  93.401, General Prohibitions; Exceptions

    As noted above, Sec.  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 non-bovine ruminants that have been in regions listed in 
Sec.  94.24(a). (Section 94.24(a) currently contains a list of regions 
in which BSE is known to exist, 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 Sec.  
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 Sec.  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 Sec.  93.401 and discuss 
them below.

Sec.  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 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.

Sec.  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.

Sec.  93.406, Diagnostic Tests

    We proposed a minor harmonizing change to this section due to our 
proposed removal of Sec.  93.419, which we discuss immediately below. 
We received no comments on this change and will not discuss it further 
in this document.

Sec.  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 Sec.  93.435. We 
received no comments on this change and will not discuss it further in 
this document.

Sec.  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 Sec.  93.419. We proposed to 
update the reference because we proposed to move these provisions to 
Sec.  93.435. We received no comments on this change and will not 
discuss it further in this document.

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Sec.  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.

Sec.  93.428, Sheep and Goats and Wild Ruminants From Mexico

    We proposed to revise this section to refer to the scrapie 
provisions in Sec.  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.

Sec.  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 Sec.  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 Sec.  93.435. 
Because we proposed to remove the general prohibition on importing 
small ruminants from BSE-affected regions in Sec.  93.401, we proposed 
to make the requirements here in general consistent with international 
standards by limiting imports for these purposes to animals from 
classical scrapie-free countries or flocks, except as permitted by the 
Administrator under paragraph (a)(5) of Sec.  93.404. This change was 
intended to work in tandem with the proposed revision to Sec.  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 Sec. Sec.  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 Sec.  94.15 to consolidate the requirements 
for transit shipment of all these products into one section and to 
eliminate some BSE-related restrictions that are no longer warranted. 
The new requirements that we proposed are similar to those that already 
exist in Sec.  94.15.
    We proposed that the specific requirements for meat, meat products, 
and other edible products derived from bovines, ovines, or caprines in 
Sec.  94.27 would be removed because they are no longer warranted. We 
also proposed that Sec.  95.15 would be removed. Finally, we proposed 
to remove references in parts 94 and 95 to Sec. Sec.  94.27 and 95.15.
    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, Sec.  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 Sec.  
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 Sec. Sec.  94.24 and 94.25. We also proposed 
to amend Sec.  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 Sec.  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

[[Page 68838]]

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 Sec.  95.9. 
We received no comments on these changes and will not be discussing 
them further in this document.
    In paragraph (c) of Sec.  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 Sec.  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 Sec.  95.5 have always applied to products derived from 
all ruminant species, due to concerns about commingling or cross-
contamination. 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 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 Sec.  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 Sec.  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 Sec.  96.2 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The regulations in Sec.  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 Sec.  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

[[Page 68839]]

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 Sec.  
98.5 must include additional declarations stating that the embryos or 
oocytes were collected, processed, and stored in accordance with the 
requirements in Sec.  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 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 
first-generation 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 APHIS-approved 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/contact-us.
    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 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 Sec.  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 Sec.  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 pre-entry 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 Sec.  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 Sec.  98.15 set forth the requirements for 
ruminant and swine embryos from regions where foot-and-mouth disease 
exists. Currently, Sec.  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 Sec.  98.10a 
will provide

[[Page 68840]]

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 Sec.  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 Sec.  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 Sec.  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.
    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 scrapie-susceptible 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 scrapie-positive 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 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 newly-generated 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 Sec.  
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

[[Page 68841]]

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 Sec.  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 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, 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.
---------------------------------------------------------------------------

    \7\ See https://www.regulations.gov/document/APHIS-2009-0095-0005.
---------------------------------------------------------------------------

    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 Sec.  93.417, paragraph (a) specifies that for ruminants 
imported from Canada, the importer must apply for and obtain an import 
permit as provided in Sec.  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 Sec.  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 Sec.  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

[[Page 68842]]

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 Sec.  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 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 Sec.  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 
Sec.  93.435(b) to remove this restriction.
    One commenter stated that while the proposed Sec.  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 Sec.  93.435(f), we set out the process by which we 
would recognize regions as free of classical scrapie. One 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 
Sec.  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

[[Page 68843]]

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.
---------------------------------------------------------------------------

    \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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    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. 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 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 low-risk 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 Sec.  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 case-by-case basis at 
the discretion of the Administrator.
    One commenter noted that in Sec.  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/

[[Page 68844]]

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 Sec.  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 Sec.  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 
Sec.  93.405 and paragraph (d) of Sec.  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 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 Sec.  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 Sec.  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 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.
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    \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.
---------------------------------------------------------------------------

    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 Sec.  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

[[Page 68845]]

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 ruminant-derived protein, 
it was postulated that the disease may have spread naturally in the 
herd, either by transmission 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 BSE-related 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 
scimitar-horned 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.
    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 BSE-affected 
region or feeding with BSE-contaminated 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 Sec.  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 Sec.  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 Sec.  94.24(a) could be safely entered 
into

[[Page 68846]]

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 Sec.  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/animal-and-animal-product-import-information/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, 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 post-export 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 with the animals themselves, including for 
imports of wild and free-ranging species, such as bighorn sheep.
    One commenter stated that non-bovine 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 Sec.  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 Sec.  
98.35(e) accordingly.
    One commenter stated that there should be no restrictions 
pertaining to scrapie for ovine in vivo-derived

[[Page 68847]]

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 vivo-derived 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 Sec.  
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 Sec.  98.10a(b)(1)(ii) appear to 
allow this possibility. The commenter asked for clarification about 
what would be required under Sec.  98.10a(c), which provides that any 
additional certifications or testing requirements will be specified on 
the import permit.
    The commenter's understanding of Sec.  98.10a(b)(1)(ii) is correct. 
We note that the requirements for additional certification and testing 
in Sec.  98.10a(c) are the same as those in Sec.  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 
Sec.  98.10a(a) requires that the holding has a certified status 
equating to `negligible risk' under EU TSE legislation. However, Sec.  
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 Sec.  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 full-range 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 BSE-related restrictions from 
cervids in a final rule published in the Federal Register on December 
4, 2013 (78 FR 72980-73008, Docket No. APHIS-2008-0010).\10\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 Sec. Sec.  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 Sec.  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

[[Page 68848]]

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 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\
---------------------------------------------------------------------------

    \11\ USDA, National Agricultural Statistics Service (NASS), 
Sheep and Goats; Commodity Trade, United Nations Trade Data Base 
(HTS-0104): https://comtrade.un.org.
---------------------------------------------------------------------------

    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 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 high-risk 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

[[Page 68849]]

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.

Overview of the Action and Affected Entities

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.
    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,      January 1,      January 1,      January 1,      January 1,
              U.S. goat inventory by class                     2017            2018            2019            2020            2021        5-yr average
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Goat and kids.......................................           1,706           1,675           1,646           2,655           2,582           2,053
    Market..............................................             409             400             409             478             465             432
    Breeding............................................           1,305           1,275           1,270           2,177           2,117           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            2017            2018            2019            2020        5-yr average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Canada..................................................          21,223           8,829           7,338          13,341          10,102          12,167
World...................................................          21,223           8,829           7,338          13,341          10,102          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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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 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).

[[Page 68850]]



                                   Table 4--U.S. Lamb, Mutton, and Goat Production, Imports, Exports, and Consumption
                                                                       [2016-2020]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               U.S.                                                                            U.S.
                          Year                              production     U.S. imports    U.S. imports    U.S. exports    U.S. exports     consumption
                                                               (MT)            (MT)          ($1,000)          (MT)          ($1,000)          (MT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016....................................................          78,729         103,893        $785,801           3,381         $17,222         179,241
2017....................................................          74,491         122,078         978,335           3,849          20,377         192,720
2018....................................................          79,926         124,874       1,032,717           3,867          19,732         200,933
2019....................................................          77,316         127,150       1,149,380           4,104          19,448         200,362
2020....................................................          72,596         132,966       1,010,793           9,625          16,644         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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Average (2016-
                         Country                               2016            2017            2018            2019            2020            2020)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Australia...............................................          80,949          92,514          97,448         101,031         107,516          95,892
New Zealand.............................................          22,222          28,034          26,011          24,465          23,380          24,822
Rest of the World.......................................             723           1,530           1,415           1,654           2,070           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/). https://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 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/#ui-id-2).

                     Table 6--Member Countries Recognized as Having a Negligible BSE Risk *
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Argentina                             Hungary                               Panama
Australia                             Iceland                               Paraguay
Austria                               India                                 Peru
Belgium                               Ireland                               Poland
Bolivia                               Israel                                Portugal \7\
Brazil                                Italy                                 Romania
Bulgaria                              Japan                                 Serbia \8\
Canada                                Korea (Rep. of)                       Singapore
Chile                                 Latvia                                Slovakia
Colombia                              Liechtenstein                         Slovenia
Costa Rica                            Lithuania                             Spain \9\
Croatia                               Luxembourg                            Sweden
Cyprus                                Malta                                 Switzerland
Czech Republic                        Mexico                                The Netherlands
Denmark                               Namibia                               United States of America
Estonia                               New Zealand                           Uruguay
Finland \10\                          Nicaragua                             ....................................
Germany                               Norway                                ....................................
----------------------------------------------------------------------------------------------------------------
* In accordance with Chapter 11.4 of the Terrestrial Code OIE (September 2021) https://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/.
\7\ Includes Azores and Madeira.

[[Page 68851]]

 
\8\ Includes Excluding Kosovo administered under the United Nations.
\9\ Includes Balearic Islands and Canary Islands.
\10\ Includes Asland Island.


                   Table 7--OIE-Member Countries Recognized as Having a Controlled BSE Risk **
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Chinese Taipei.                       France.                               Ireland.
Ecuador.                              Greece.                               ....................................
----------------------------------------------------------------------------------------------------------------
** 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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)        Meat of sheep and goat
                                                 --------------------------------          (metric tons)
                      Year                                                       -------------------------------
                                                      Export          Import          Export          Import
----------------------------------------------------------------------------------------------------------------
2016............................................       2,650,680             133          16,462         161,418
2017............................................       2,496,323             714          29,873         140,283
2018............................................       2,432,082             953          25,408         141,472
2019............................................       3,117,174           1,065          33,261         112,070
    Average.....................................       2,674,065             716          26,251         138,811
----------------------------------------------------------------------------------------------------------------
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

[[Page 68852]]

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    Number of live
        Non-EU countries          sheep (HS:0204) in    sheep and goats
                                      metric tons         (HS: 0104)
------------------------------------------------------------------------
Argentina.......................               1,060                   0
Australia.......................              14,205                   6
Brazil..........................                   0                   0
Canada..........................                   4                   0
Chile...........................               1,834                   0
Colombia........................                   0                   0
Costa Rica......................                   0                   0
Japan...........................                   0                   0
Iceland.........................               1,571                   0
India...........................                   0                   0
Israel..........................                   0                   0
Mexico..........................                   0                   0
Namibia.........................                   0                   0
New Zealand.....................             116,661                  12
Nicaragua.......................                   0                   0
Norway..........................                 222                   3
Panama..........................                   0                   0
Paraguay........................                   0                   0
Peru............................                   0                   0
Rep. of Korea...................                   0                   0
Singapore.......................                   6                   0
Switzerland.....................                   3                  40
Taiwan..........................                   0                   0
Uruguay.........................                 702                   0
USA.............................                   0                   0
                                 ---------------------------------------
    TOTAL.......................             136,262                  58
Australia & New Zealand.........             130,866                  18
                                 ---------------------------------------
    All (except Australia & New                5,396                  40
     Zealand)...................
------------------------------------------------------------------------
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.

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 recent estimated elasticities for sheep and goat meat that are 
available in the literature.
---------------------------------------------------------------------------

    \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 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).
---------------------------------------------------------------------------

    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 medium-level 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.

[[Page 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                   1,582              3,165              4,747
 year, metric tons.....................................
Change in U.S. consumption, metric tons................              1,143              2,287              3,430
Change in U.S. production,* metric tons................               -439               -878             -1,317
Percentage change in U.S. price........................              -0.77              -1.53              -2.30
Change in consumer welfare (U.S. dollars)..............        $11,824,458        $23,725,979        $35,689,520
Change in producer welfare (U.S. dollars)..............       ($4,344,373)       ($8,664,768)      ($12,955,727)
Annual net welfare gain (U.S. dollars).................         $7,480,086        $15,061,211        $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\........  $8.66 million.
Decrease in welfare incurred by small          $6.07 million.
 entities \2\.
Average decrease per animal, small entities    $2.17.
 \3\.
Average decrease per small entity \4\........  $67.15.
Average decrease as a percentage of average    1.3%.
 sales by small entities \5\.
------------------------------------------------------------------------
\1\ From table 10.
\2\ Change 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.

Costs of Preventing Fence-Line Contact

    There are currently no APHIS-approved 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]
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                             Item                                    Amount        Cost per unit     (dollars,
                                                                                     (dollars)       rounded)
----------------------------------------------------------------------------------------------------------------
Wood posts (8-inch diameter).................................                  6           30.20             181
Wood posts (4-inch diameter..................................                  4            9.70              39
Steel posts (6.5 ft.)........................................                 52            5.40             281
Insulators...................................................                285            0.38             108
Springs......................................................                  5            7.60              38
Strainers....................................................                  5            3.80              19
High tensile wire............................................          6,600 ft.            0.03             178
Energizer....................................................                 25            1.19              30
Cut-out switch...............................................                  1            8.10               8
Ground/lightening rods.......................................                  4           17.30              69

[[Page 68854]]

 
Labor and equipment..........................................           18 hours           17.50             315
                                                              --------------------------------------------------
    Total....................................................  .................  ..............           1,266
        Cost per foot........................................  .................  ..............            0.96
----------------------------------------------------------------------------------------------------------------
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 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 notice-based 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 
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

[[Page 68855]]

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.

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.

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-to-government 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 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

[[Page 68856]]

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 E-Government 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.

List of Subjects

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

    Imports, Livestock, Reporting and recordkeeping requirements.

9 CFR Part 98

    Animal diseases, Imports.

    Accordingly, we are amending 9 CFR parts 92, 93, 94, 95, 96, and 98 
as follows:

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS AND COMPARTMENTS

0
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.


0
2. Section 92.2 is amended by revising the OMB statement at the end of 
the section to read as follows:


Sec.  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

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

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


0
4. Section 93.400 is amended as follows:
0
a. By adding, in alphabetical order, definitions for Certified status, 
Classical scrapie, and Country mark;
0
b. By revising the definitions for Designated feedlot and Flock;
0
c. By adding, in alphabetical order, definitions for Flock of birth, 
Flock of residence, Goat, Killed and completely destroyed, Non-
classical scrapie, and Sheep;
0
d. By removing the definition of Suspect for a transmissible spongiform 
encephalopathy; and
0
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:


Sec.  93.400  Definitions.

* * * * *
    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 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 Sec.  
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.
* * * * *

[[Page 68857]]

    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, non-
inflammatory 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.
* * * * *

0
5. Section 93.401 is amended by revising paragraph (a) and adding a 
heading for paragraph (b) to read as follows:


Sec.  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. * * *
* * * * *

0
6. Section 93.404 is amended as follows:
0
a. Paragraphs (a)(2), (3), and (4) are redesignated as paragraphs 
(a)(3), (4), and (7), respectively;
0
b. By adding new paragraph (a)(2) and paragraphs (a)(5) and (6);
0
c. In newly redesignated paragraph (a)(7)(v), by removing ``paragraph 
(a)(4)(iv)'' and adding ``paragraph (a)(7)(iv)'' in its place;
0
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
0
e. By revising the OMB statement at the end of the section.
    The additions and revision read as follows:


Sec.  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 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)


0
7. Section 93.405 is amended as follows:
0
a. By adding a heading for paragraph (a) and removing paragraph (a)(4);
0
b. By revising paragraph (b);
0
c. By removing paragraph (c);
0
d. By redesignating paragraph (d) as paragraph (c);
0
e. By revising newly redesignated paragraph (c); and
0
f. By revising the OMB statement at the end of the section.
    The addition and revisions read as follows:


Sec.  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

[[Page 68858]]

individual sheep or goat identification applied to the animals; and, 
when required by Sec.  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 Sec.  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 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 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)


[[Page 68859]]




Sec.  93.406  [Amended]

0
8. Section 93.406(b) is amended by removing the references ``Sec. Sec.  
93.419 and 93.428(b)'' and adding ``Sec. Sec.  93.428(b) and 93.435'' 
in their place.


Sec.  93.419  [Removed and Reserved]

0
9. Section 93.419 is removed and reserved.

0
10. Section 93.420 is amended in paragraph (a) introductory text by 
adding a sentence after the paragraph heading to read as follows:


Sec.  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 Sec.  93.435. * * 
*
* * * * *

0
11. Section 93.424 is amended by revising paragraph (a) to read as 
follows:


Sec.  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 Sec.  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 Sec.  
93.403(c).
* * * * *

0
12. Section 93.428 is amended by revising paragraph (a) and the OMB 
statement at the end of the section to read as follows:


Sec.  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 Sec.  93.435, and shall 
be accompanied by a certificate issued in accordance with Sec.  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 
Sec.  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)


0
13. Section 93.435 is revised to read as follows:


Sec.  93.435  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 Sec.  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-and-animal-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-animal-product-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 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 Sec.  93.403(b) or as 
provided for in Sec.  93.403(f) and be inspected at the port of entry 
and otherwise handled in accordance with Sec.  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 Sec.  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

[[Page 68860]]

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 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
    (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 Sec.  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 Sec.  
93.405 may transit the United States in accordance with Sec.  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 Sec.  
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 Sec.  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

[[Page 68861]]

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.

(Approved by the Office of Management and Budget under control 
numbers 0579-0040, 0579-0101, and 0579-0453)


Sec.  93.505  [Amended]

0
14. Section 93.505(a) is amended by removing the citation ``Sec.  
94.24(b)(6)'' and adding the citation ``Sec.  94.31(b)(6)'' in its 
place.

PART 94--FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY 
PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE 
FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM 
ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

0
15. The authority citation for part 94 continues to read as follows:

    Authority:  7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

0
16. Section 94.15 is revised to read as follows:


Sec.  94.15  Transit shipment of articles.

    (a) Any meat or other animal product or material (excluding 
materials that are required to be consigned to USDA-approved 
establishments for further processing) eligible for entry into the 
United States, as provided in this part or in part 95 of this 
subchapter, may transit the United States by air and ocean ports and 
overland transportation if the articles are accompanied by the required 
documentation specified in this part and in part 95.
    (b) Any meat or other animal product or material not eligible for 
entry into the United States, as provided in this part or in part 95 of 
this subchapter, may transit air and ocean ports only, with no overland 
movement outside the airport terminal area or dock area of the maritime 
port, in the United States for immediate export if the conditions of 
paragraphs (b)(1) through (4) of this section are met.
    (1) The articles must be sealed in leakproof containers bearing 
serial numbers during transit. Each container must remain under either 
Customs seal or foreign government seal during the entire time that it 
is in the United States.
    (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;
    (iii) Mode of transportation; and
    (iv) Serial numbers of the sealed containers.
    (3) The articles must transit the United States under Customs bond.
    (4) The shipment is exported from the United States within 7 days 
of its entry.
    (c) Pork and pork products from Baja California, Baja California 
Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, 
Sonora, and Yucatan, Mexico, that are not eligible for entry into the 
United States in accordance with this part may transit the United 
States via land border ports for immediate export if the following 
conditions of paragraphs (c)(1) through (4) of this section are met:
    (1) The person moving the pork and pork products 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 pork or pork products are packaged at a Tipo 
Inspecci[oacute]n Federal plant in Baja California, Baja California 
Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, 
Sonora, or Yucatan, Mexico, in leakproof containers and sealed with 
serially numbered seals of the Government of Mexico, and the containers 
remain sealed during the entire time they are in transit across Mexico 
and the United States.
    (3) The person moving the pork and pork products through the United 
States notifies, in writing, the authorized Customs inspector at the 
United States port of arrival prior to such transiting. The 
notification must include the following information regarding the pork 
and pork products:
    (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
    (iv) Serial numbers of the seals on the containers.
    (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 Inspecci[oacute]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

[[Page 68862]]

    (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 Sec.  94.11(a) and pork and pork products from regions listed 
in Sec.  94.13 that do not meet the requirements of Sec.  94.11(b) or 
Sec.  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)


Sec.  94.18  [Amended]

0
17. Section 94.18 is amended in paragraph (a) by adding the word 
``and'' before the citation ``94.23'' and removing ``, and 94.27''.


Sec.  94.24  [Removed and Reserved]

0
18. Section 94.24 is removed and reserved.


Sec.  94.25  [Removed and Reserved]

0
19. Section 94.25 is removed and reserved.

0
20. Section 94.26 is revised to read as follows:


Sec.  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)


Sec.  94.27  [Removed and Reserved]

0
21. Section 94.27 is removed and reserved.

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), 
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

0
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.


Sec.  95.1   [Amended]

0
23. Section 95.1 is amended by removing the definitions of Positive for 
a transmissible spongiform encephalopathy and Suspect for a 
transmissible spongiform encephalopathy.

0
24. Section 95.4 is amended as follows:
0
a. By revising the section heading and paragraphs (a), (b) introductory 
text, (b)(1), and (c)(1)(ii) and (iv);
0
b. By removing paragraphs (c)(2) and (3) and redesignating paragraphs 
(c)(4) through (8) as (c)(2) through (6), respectively;
0
c. In newly redesignated paragraph (c)(3), by revising the first 
sentence;
0
d. In newly redesignated paragraph (c)(5), by removing the reference 
``(c)(5)'' and adding the reference ``(3)'' in its place;
0
e. By removing paragraphs (d) and (e);
0
f. By redesignating paragraph (f) and the Note to paragraph (f) as 
paragraph (d) and Note 1 to paragraph (d), respectively; and
0
g. By removing paragraph (g).
    The revisions read as follows:


Sec.  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 Sec.  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 Sec.  95.5;
* * * * *
    (iv) Ovines or caprines, and the material is not ineligible for 
importation under the conditions of Sec.  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. * 
* *
* * * * *


Sec.  95.15  [Removed and Reserved]

0
25. Section 95.15 is removed and reserved.


Sec.  95.40  [Removed and Reserved]

0
26. Section 95.40 is removed and reserved.

PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS 
OFFERED FOR ENTRY INTO THE UNITED STATES

0
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.


Sec.  96.2  [Amended]

0
28. Section 96.2 is amended as follows:
0
a. By removing paragraph (b)(1) and redesignating paragraph (b)(2) as 
paragraph (b)(1);
0
b. By adding a new reserved paragraph (b)(2); and
0
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

0
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.


0
30. Section 98.2 is amended by adding, in alphabetical order, 
definitions for Oocyte and Transmissible spongiform encephalopathies 
(TSEs) to read as follows:


Sec.  98.2  Definitions.

* * * * *
    Oocyte. The first and second maturation stages of a female 
reproductive cell prior to fertilization.
* * * * *

[[Page 68863]]

    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.
* * * * *


Sec.  98.3   [Amended]

0
31. Section 98.3 is amended as follows:
0
a. In paragraph (d), by adding the words ``except that, for sheep and 
goats only, the donor sire must meet the scrapie requirements in Sec.  
98.35 instead of the requirements in Sec.  93.435 of this chapter;'' 
after the words ``United States;'';
0
b. In paragraph (e), by:
0
i. Removing the ``part 92'' and adding the citation ``part 93'' in its 
place; and
0
ii. Adding the words ``except that, for sheep and goats only, the donor 
dam must meet the requirements for embryo donors in Sec.  98.10(a) 
instead of the requirements in Sec.  93.435 of this chapter;'' after 
the words ``United States;''; and
0
c. In paragraph (f), by removing ``Sec.  93.404(a)(2) or (3)'' and 
adding ``Sec.  93.404(a)(3) or (4)'' in its place.

0
32. Section 98.4 is amended by redesignating paragraph (d) as paragraph 
(e) and adding a new paragraph (d) to read as follows:


Sec.  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.
* * * * *


Sec.  98.5  [Amended]

0
33. Section 98.5 is amended as follows:
0
a. By removing and reserving paragraph (b); and
0
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.

0
34. Section 98.10a is revised to read as follows:


Sec.  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 Sec. Sec.  98.3 through 98.8. In 
addition to the requirements of Sec.  98.5, the health certificate must 
indicate that the embryos or oocytes were collected, processed, and 
stored in conformity with the requirements in Sec.  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 Sec. Sec.  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 Sec.  98.5, and with the 
following additional certifications:
    (i) The embryos or oocytes were collected, processed and stored in 
conformity with the requirements in Sec.  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
    (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 
Sec.  98.10.

[[Page 68864]]

    (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 Sec.  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).

0
35. Section 98.13 is amended by adding paragraph (c) to read as 
follows:


Sec.  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.
* * * * *


Sec.  98.15  [Amended]

0
36. Section 98.15 is amended as follows:
0
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;
0
b. In paragraph (a)(1)(i), by removing the words ``Bovine spongiform 
encephalopathy, contagious'' and adding the word ``Contagious'' in 
their place;
0
c. In paragraph (a)(2)(i), by removing the words ``Bovine spongiform 
encephalopathy, contagious'' and adding the word ``Contagious'' in 
their place;
0
d. In paragraph (a)(7)(i)(A), by removing the words ``Bovine spongiform 
encephalopathy, brucellosis'' and adding the word ``Brucellosis'' in 
their place; and
0
e. In paragraph (a)(8)(i)(A), by removing the words ``Bovine spongiform 
encephalopathy, brucellosis'' and adding the word ``Brucellosis'' in 
their place.

0
37. Section 98.30 is amended by adding, in alphabetical order, a 
definition for Establishment to read as follows:


Sec.  98.30  Definitions.

* * * * *
    Establishment. The premises in which animals are kept.
* * * * *

0
38. Section 98.35 is amended as follows:
0
a. By revising paragraph (e) introductory text;
0
b. By removing paragraph (e)(1)(ii) and redesignating paragraphs 
(e)(1)(iii) and (iv) as paragraphs (e)(1)(ii) and (iii), respectively;
0
c. By revising newly redesignated (e)(1)(iii);
0
d. By adding new paragraph (e)(1)(iv);
0
e. By removing ``; and'' at the end of paragraph (e)(2)(iv) and adding 
a period in its place;
0
f. By revising paragraph (e)(3);
0
g. By adding paragraphs (e)(4) and (5); and
0
h. By revising the OMB statement at the end of the section.
    The revisions and additions read as follows:


Sec.  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 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 Sec.  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