Importation of Sheep, Goats, and Certain Other Ruminants, 46619-46639 [2016-16816]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Proposed Rules]
[Pages 46619-46639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16816]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 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, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations that govern the 
importation of animals and animal products to revise the 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 proposing to remove BSE-
related import restrictions on sheep and goats and most of their 
products, and to add import restrictions related to transmissible 
spongiform encephalopathies for certain wild, zoological, or other non-
bovine ruminant species. The conditions we are proposing for the 
importation of specified commodities are based on internationally 
accepted scientific literature and will in general align our 
regulations with guidelines set out in the World Organization for 
Animal Health's Terrestrial Animal Health Code.

DATES: We will consider all comments that we receive on or before 
September 16, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0095.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2009-0095, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2009-
0095 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: For information concerning live 
animals, contact Dr. Oriana Beemer, Veterinary Medical Officer, Animal 
Permitting and Negotiating Services, National Import Export Services, 
VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231; (301) 
851-3300.
    For information regarding ruminant products and for other 
information regarding this proposed rule, contact Dr. Christopher 
Robinson, Director, Animal Products Permitting and Negotiation 
Services, National Import Export Services, VS, APHIS, 4700 River Road, 
Unit 38, Riverdale, MD 20737-1231; (301) 851-3300.

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 that are considered a risk 
for BSE. The current regulations allow the importation of non-pregnant 
slaughter or feeder sheep that are under 12 months old from Canada, 
certain products from sheep and goats, and sheep and goat semen. The 
conditions we are proposing for the importation of sheep and goats and 
their products are based on internationally accepted scientific 
literature and are consistent with World Organization for Animal Health 
(OIE) guidelines. We are proposing these amendments after conducting a 
thorough review of relevant scientific literature and a comprehensive 
evaluation of the issues

[[Page 46620]]

and concluding that the proposed changes to the regulations will 
continue to guard against the introduction of transmissible spongiform 
encephalopathies (TSEs) such as BSE and scrapie into the United States, 
while allowing the importation of additional animals and animal 
products into this country.

Legal Authority for the Regulatory Action

    Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et 
seq.), the Secretary of Agriculture has the authority to issue orders 
and promulgate regulations to prevent the introduction into the United 
States and the dissemination within the United States of any pest or 
disease of livestock. The Animal and Plant Health Inspection Service 
(APHIS) of the U.S. Department of Agriculture (USDA or Department) 
administers regulations in 9 CFR 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 proposing to remove BSE-related import restrictions on sheep 
and goats and the products derived from them. We are also proposing to 
add 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 proposed rule's impact would stem from its effect on U.S. 
imports of the affected commodities. Assuming an increase in imports of 
1,966 metric tons (MT) in a net trade welfare model, we project a 
decrease in wholesale prices of a little more than 1 percent and a fall 
in domestic production of 615 MT. We estimate consumption would 
increase by 1,351 MT. As a result, producer welfare would decline by 
about $6.3 million and consumer welfare would increase by about $14.4 
million, yielding an annual net welfare benefit of about $8.1 million. 
USDA does not have an estimate of the costs or benefits of the change 
in import restrictions for certain wild, zoological, or other non-
bovine ruminant species, and we request comment on such an estimate.

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 by-products. 
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 Canada, provided 
that the sheep and goats are under 12 months of age and are not 
pregnant.
    In a final rule published on December 4, 2013 (78 FR 72979-73008, 
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.\1\ 
However, that rule did not address BSE-related restrictions on 
domesticated sheep and goats or other non-bovine ruminant species. We 
believe that further refinement of the regulations is in order given 
the latest scientific information regarding BSE and scrapie. In this 
proposed rule, therefore, we are proposing 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 first 
discuss the changes we are proposing regarding BSE and sheep and goats, 
then the changes we are proposing regarding scrapie. Lastly, we address 
the changes we are proposing for other non-bovine ruminants with 
respect to TSEs generally.
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    \1\ To view the rule, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010.
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    In addition to these changes, we are also proposing to establish 
provisions that would allow the importation, in specific cases, of 
other ruminants that would not otherwise be eligible for importation 
due to TSEs, if the Administrator determines that the disease risk 
posed by the animals can be adequately mitigated through pre-entry and 
post-entry mitigation measures. Conversely, we are proposing that 
certain ruminants whose importation is not currently restricted due to 
TSEs would, in specific cases, be subject to specified pre-entry and 
post-entry requirements, if the Administrator determines that the 
measures are necessary to guard against the transmission of TSEs to 
livestock in the United States. These provisions are discussed in more 
detail in this document under the heading ``Zoological Ruminants.''

Nature of BSE

    As noted, BSE belongs to the family of diseases known as TSEs. All 
TSEs affect the central nervous systems of the infected animals. 
However, the distribution of infectivity in the body of the animal and 
mode of transmission differ according to the species and the TSE agent.
    The agent that causes BSE has yet to be fully characterized. The 
theory that is most accepted in the international scientific community 
is that the agent is an abnormal form of a normal protein known as 
cellular prion protein. The BSE agent does not evoke a traditional 
immune response or inflammatory reaction in host animals. BSE is 
confirmed by post-mortem examination of an animal's brain tissue, which 
may include detection of the abnormal form of the prion protein in the 
brain tissues. The pathogenic form of the protein is both less soluble 
and more resistant to degradation than the normal form. The BSE agent 
is resistant to heat and to normal sterilization processes.
    BSE is not a contagious disease, and therefore is not spread 
through casual contact between animals. Scientists believe that the 
primary route of transmission is through ingestion of feed that has 
been contaminated with a sufficient amount of tissue from an infected 
animal. This route of transmission can be prevented by excluding 
potentially contaminated materials from ruminant feed.

Current Regulations Regarding BSE

    The protective measures APHIS has taken against BSE have evolved 
over the

[[Page 46621]]

years, as scientific understanding of the disease has increased. From 
1997 until 2005, the only two categories of regions listed in the CFR 
with regard to BSE were regions in which BSE was known to exist, and 
those regions that presented an undue risk of introducing BSE into the 
United States because their import requirements were less restrictive 
than those that would be acceptable for import into the United States 
and/or because the regions had inadequate surveillance. In a January 
2005 final rule (70 FR 460-553, Docket No. 03-080-3), APHIS amended its 
regulations to recognize a category of regions that present a minimal 
risk of introducing BSE into the United States, even though BSE may 
have been diagnosed in the region. The December 4, 2013, final rule 
amended the BSE regulations to change the categories of regions in 
which BSE is known to exist. Formerly, we had used the following 
classifications: Regions of undue risk for BSE and BSE minimal-risk 
regions. In the final rule, we adopted the system used by the OIE of 
classifying areas as being either of negligible risk, controlled risk, 
or undetermined risk for BSE. Whether live bovines and bovine-derived 
products are eligible for importation into the United States, and under 
what conditions, is in many cases determined by the BSE category of the 
region from which the animal or product originates.
    The prohibitions on the importation of animals, meat, and other 
animal products into the United States 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 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.  
94.18 through Sec.  94.26. 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), unless certain conditions are met.
    When the BSE regulations were codified in 1991 (56 FR 19794-19796, 
Docket No. 90-252), they applied to all ruminants. Over the past two 
decades, however, extensive research has been conducted regarding BSE. 
Based on the information now 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. Therefore, we are proposing to amend the BSE 
regulations to remove the current prohibitions and restrictions 
regarding such commodities, except as noted. We discuss below the 
scientific literature regarding BSE and sheep and goats and the 
rationale for our proposed changes to the regulations.
    Experiments dating back to the 1990s 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, 
information on BSE transmission in sheep and goats that were not 
experimentally inoculated or exposed to experimentally inoculated sheep 
or goats is extremely limited. There have been only two retroactively 
diagnosed cases of naturally occurring BSE in goats. In these two cases 
there was no evidence of lateral spread.
    In 2005, BSE in a goat was confirmed at the Community Reference 
Laboratory in Weybridge, United Kingdom. The goat was slaughtered in 
2002 in France and was tested as part of a slaughter surveillance 
program. An epidemiologic investigation conducted at the time of the 
initial TSE diagnosis did not detect any additional cases in the herd. 
The goat and its entire herd were destroyed at the time the initial 
test results were received, and no additional TSE cases were detected. 
It is not known how the goat acquired BSE; however, because the goat 
was born prior to the enactment of a ruminant-to-ruminant feed ban, it 
is possible that consumption of infected ruminant protein was the route 
of inoculation (Eloit, Adjou et al. 2005; ProMED 2005).
    A second naturally occurring case of BSE in a goat was confirmed in 
2011 in the United Kingdom (U.K.) in a goat born in 1990 and evaluated 
as part of a retrospective study. This goat was also born prior to the 
enactment of strict BSE control measures in feed (Spiropoulos, Lockey, 
et al. 2011). There have been no other naturally occurring cases of BSE 
reported in sheep or goats. Based on the absence of detection of BSE in 
sheep and goats born after the effective implementation of feed bans, 
APHIS believes it is unlikely that BSE is being laterally transmitted 
within domestic sheep or goat populations.
    Because of concerns that BSE may be present in sheep and goats, 
some countries have embarked on testing programs to detect BSE in these 
animals. Due to the clinical similarities between BSE and scrapie, 
surveillance programs for BSE in sheep and goats often target animals 
that have tested positive to TSE screening tests (sometimes using 
archived samples of animals that were presumed to have had scrapie) in 
order to increase the likelihood of finding a BSE-positive animal. 
Because the United Kingdom was the epicenter of the bovine BSE 
epizootic in the 1990s, most experts believe that if BSE were to exist 
within domestic sheep or goat populations, it would most likely occur 
and be detectable in the United Kingdom. To date, studies conducted in 
the United Kingdom have not detected any cases of BSE in domestic sheep 
(Gravenor, Ryder et al. 2003; Stack, Jeffrey et al. 2006) and only one 
case in a goat (Spiropoulos, Lockey, et al. 2011), despite the testing 
of thousands of animals, and have concluded that BSE does not appear to 
be amplifying through lateral transmission in these populations.
    Additional estimates show that if BSE were present in U.K. domestic 
sheep populations, it would exist at an extremely low level. Two recent 
studies evaluated the potential prevalence of BSE in the domestic sheep 
population of the United Kingdom. In order to maximize efficiency, both 
studies used historical samples in which a TSE, presumably scrapie, had 
been detected. Additional testing was performed on these samples to 
determine if BSE, rather than scrapie, was responsible for the initial 
positive results. Neither study identified any cases of BSE, but both 
were able to determine that the highest likely prevalence of BSE in the 
U.K. sheep population was extremely low (Gravenor, Ryder et al. 2003; 
Stack, Jeffrey et al. 2006).
    Since 2005, the European Commission has required that each index 
case of a TSE in a flock receive additional testing to determine if BSE 
is the diagnosis. Estimates of the likely prevalence of BSE in sheep 
have been made based on data collected during 2005 and 2006. With over 
1.5 million sheep tested, it was calculated with 95 percent confidence 
that there were at most 0.3-0.5 cases (depending on the model used) of 
BSE per 10,000 healthy slaughter sheep in the European Union (EU) 
countries at highest risk for BSE

[[Page 46622]]

(United Kingdom, Ireland, France, and Portugal) (EFSA 2007). No cases 
of BSE in sheep have been reported since this study was published, so 
we would expect the risk to be lower if the calculation was repeated to 
include data from subsequent years.
    Based on the evidence discussed above, 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. 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. For these reasons, we would continue to restrict the 
importation of these commodities.
    The changes we are proposing with regard to sheep and goats and BSE 
are consistent with the approach taken by the OIE. The OIE, of which 
the United States is a Member country, is the internationally 
recognized standard-setting body that develops science-based 
recommendations for the safe trade of animals and animal products. The 
World Trade Organization has recognized the OIE as the international 
forum for setting animal health standards, reporting global animal 
disease events, and presenting guidelines and recommendations on 
sanitary measures relating to animal health.
    The OIE facilitates intergovernmental cooperation to prevent the 
spread of contagious diseases in animals by sharing scientific research 
among its members. The major functions of the OIE are to collect and 
disseminate information on the distribution and occurrence of animal 
diseases and to ensure that science-based standards govern 
international trade in animals and animal products. The OIE carries out 
its function through the development and revision of international 
standards for diagnostic tests, vaccines, and the safe international 
trade of animals and animal products.
    The OIE develops risk-based standards, which are published in the 
OIE Terrestrial Animal Health Code (Code). As an OIE Member country, 
the United States reviews and, where appropriate, comments on all draft 
OIE chapters and revisions. As part of the U.S. consideration of OIE 
drafts, APHIS distributes these drafts to the U.S. livestock and 
aquaculture industries, veterinary experts in various U.S. academic 
institutions, and other interested persons for review and comment.
    In addition, each year, prior to formulating its comments for the 
OIE annual meeting, APHIS makes available on its Web site those 
potential changes to the Code that the OIE has submitted to Member 
countries for comment, and accepts information and recommendations from 
the public regarding those proposed changes. Through its OIE Reference 
Laboratories and Collaborating Centers, APHIS also provides OIE Member 
countries with technical assistance and expert advice on disease 
surveillance and control and risk analysis, as well as diagnostic 
assistance, evaluation, and consultation.
    Over the years, the OIE Member countries, including the United 
States, have agreed to amend the OIE guidelines for BSE based on 
increased scientific evidence regarding the disease. Current OIE 
recommendations regarding BSE in ruminants do not include any BSE-
related measures for sheep and goats other than the general 
requirements applied to all ruminant meat and bone meal (processed 
animal proteins).

Importation of Live Ruminants

    In this proposed rule, we would amend the regulations to remove 
most of the current BSE provisions regarding sheep and goats. Below, we 
identify specific sections and paragraphs in the regulations from which 
regulatory text relating to BSE and sheep and goats would be removed or 
revised.
    Sec.  93.400 Definitions: We would remove the definition of suspect 
for a transmissible spongiform encephalopathy because this term would 
no longer appear in the regulations. We would also revise the 
definitions for designated feedlot and flock. The definition of 
designated feedlot is being changed to reference scrapie-related 
restrictions rather than BSE-related restrictions. The current 
definition of flock is being expanded to include goats as well as 
sheep. We would add definitions for certified status, classical 
scrapie, country mark, flock of birth, flock of residence, goat, killed 
and completely destroyed, non-classical scrapie, sheep, transmissible 
spongiform encephalopathies (TSEs), and TSE-affected sheep or goat, 
since these terms are currently not defined.
    Specifically, we propose 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.'' In the U.S. Scrapie Flock Certification Program, 
Export Certified flocks receive a high level of monitoring, including 
annual inspections and inspection of all cull animals, and are subject 
to official identification and recordkeeping requirements, among other 
things. Export Certified flocks in the United States are considered 
scrapie free. These requirements are consistent with OIE 
recommendations in Article 14.8.5 of the OIE Terrestrial Health Code.
    We would define classical scrapie as ``any form of scrapie that the 
Administrator has determined poses a significant risk of natural 
transmission'' and non-classical scrapie as ``any form of scrapie that 
the Administrator has determined poses a low risk of natural 
transmission.'' We are proposing these definitions to distinguish 
between strains of the disease that pose a significant risk of natural 
transmission and thus present a significant livestock disease risk, and 
those strains that pose a low risk of natural transmission and do not 
present a significant livestock disease risk.
    We would define country mark as ``a permanent mark approved by the 
Administrator for identifying a sheep or goat to its country of 
origin.'' We are proposing this definition to distinguish this mark 
from other forms of identification, such as eartags or backtags, that 
might be used on an animal. We are proposing 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 would define flock of birth as ``the flock into which a sheep or 
goat is born'' and flock of residence as ``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.'' We are proposing to add these two 
definitions to clarify to which flocks certain requirements pertain.
    We would define goat as ``any animal of the genus Capra'' and sheep 
as ``any

[[Page 46623]]

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 are proposing to define killed and completely destroyed as 
``killed, or maintained under quarantine in a manner that will prevent 
disease spread until the animal is no longer living; and the remains 
have been disposed of in a way that prevents disease spread'' to 
clarify that sheep and goats known to be affected by TSEs are not to 
enter slaughter channels.
    We are proposing to define transmissible spongiform 
encephalopathies (TSEs) as ``A family of progressive and generally 
fatal neurodegenerative disorders thought to be caused by abnormal 
proteins, called prions, that typically produce 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.'' The Administrator 
may make a determination that a disease meeting these general criteria 
is not a TSE of whose introduction or dissemination would cause adverse 
animal health or disease concerns and that animals affected by it would 
not be subject to the regulations if the disease presents a low risk of 
transmission.
    We are proposing to define TSE-affected sheep or goat as ``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'' in order to 
clarify to which animals the provisions would apply.
    Sec.  93.404 Import Permits for Ruminants: We are proposing to add 
a new paragraph (a)(2) to this section to specify additional 
information that an importer would have to submit with the application 
for an import permit for sheep and goats. Specifically, we would 
require that, for sheep and goats imported for immediate slaughter or 
restricted feeding for slaughter, the slaughter establishment to which 
the animals will be imported, or the designated feedlot in which the 
animals will be maintained until moved to slaughter be specified. 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 will also clarify that these animals are in, and 
are not to be removed from, slaughter channels.
    For sheep and goats imported for purposes other than immediate 
slaughter or restricted feeding for slaughter, we would require that 
the importer provide 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. 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 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 are also proposing to add a new paragraph (a)(5) to this section 
to address mitigation measures to allow the importation of zoological 
ruminants. This change is discussed below under the heading 
``Zoological Ruminants.''
    Last, we would 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 
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.
    Current paragraphs (a)(2), (a)(3),and (a)(4) would be redesignated 
as paragraphs (a)(3), (a)(4) and (a)(7), respectively.
    Sec.  93.405 Health Certificate for Ruminants: Paragraph (a)(4) 
describes the information that must be included on a health certificate 
accompanying sheep or goats from Canada. We are proposing to remove 
this paragraph because paragraph (b), which contains additional 
requirements for health certificates for goats, would be revised to 
incorporate requirements for health certificates for sheep. These 
additional requirements would include some of the information currently 
required under paragraph (a)(4), because that information is relevant 
to animal diseases other than BSE. Paragraph (c), which currently 
contains additional requirements for health certificates for sheep, 
would be removed, and paragraph (d) would be redesignated as paragraph 
(c).
    Sec.  93.419 Sheep and goats from Canada: This section would be 
removed and reserved. Provisions for the importation of sheep and goats 
from Canada would be moved to Sec.  93.435.
    Sec.  93.420 Ruminants from Canada for immediate slaughter other 
than sheep and goats: The reference in paragraph (a) to the provisions 
regarding sheep and goats for immediate slaughter in Sec.  93.419 would 
be replaced by a reference to the provisions in Sec.  93.435.
    Sec.  93.424 Import permits and applications for inspection of 
ruminants (from Mexico): Paragraphs (a)(1) and (2) would be removed, 
and paragraph (a) would be revised 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 U.S./Mexico border. 
Currently the regulations 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 are proposing to 
remove this exemption because we need the information from the import 
permit to conduct a traceback investigation in the event of a disease 
outbreak.
    Sec.  93.428 Sheep and goats and wild ruminants from Mexico: This 
section would be revised to refer to the scrapie provisions in Sec.  
93.435 which would also apply to sheep and goats from Mexico.
    Sec.  93.435 Sheep and goats: This section would be revised to 
contain provisions for importing sheep and goats from anywhere in the 
world. The provisions for sheep and goats imported for immediate 
slaughter and restricted feeding for slaughter would be similar to the 
existing requirements for sheep and goats imported for those purposes 
from Canada, currently contained in Sec.  93.419. The requirements for 
importing sheep and goats for other purposes, currently contained in 
Sec.  93.435, would be updated to make them 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 would allow for the importation of animals that are very low risk 
due to their genotype or other factors. We would also 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

[[Page 46624]]

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 proposed action would allow more timely changes to the list 
than if we had to do it through rulemaking, as we do now. APHIS 
considers a disease to exist in a region when we receive reports of an 
outbreak of the disease in the region from veterinary officials of the 
national government of the region and/or the OIE, or from another 
source that the Administrator determines to be reliable, e.g., APHIS 
inspectors based in foreign countries.
    As it is now, when APHIS determines that a disease is present in a 
region and presents a potential threat to animal health in the United 
States, we would take immediate action to restrict imports from that 
region. We would no longer need to follow that action with an interim 
rule in the Federal Register to change text in the regulations. 
Instead, we would immediately list the region on the APHIS Web site and 
announce the listing through a notice, rather than a rule, in the 
Federal Register. The notice would provide an opportunity for public 
comment.
    We would add a region to a list of regions we recognize as free of 
classical scrapie only after completing an evaluation and making it 
available for public comment. We would do this through a notice in the 
Federal Register. Following the close of the comment period, we would 
publish another notice responding to comments and announcing APHIS' 
decision. The criteria we are proposing for evaluating a region's 
classical scrapie disease status would be consistent with current 
scientific understanding, international standards, and 9 CFR part 92, 
``Importation of Animals and Animal Products: Procedures for Requesting 
Recognition of Regions.'' Additional details about the factors APHIS 
reviews to determine a region's status may be found on the APHIS Web 
site at https://www.aphis.usda.gov/import_export/animals/reg_request.shtml.

Zoological Ruminants

    Section 93.404 of the regulations contains provisions regarding 
permits for the importation of ruminants into the United States. With 
several exceptions, ruminants are not eligible for importation if the 
importer has not first applied for and obtained an import permit from 
APHIS. Part 93 subpart D contains a number of provisions that 
specifically prohibit or restrict the importation of ruminants into the 
United States with regard to specified diseases, or that set forth risk 
mitigation measures that must be taken or agreed to before an import 
permit will be issued. Among the specific prohibitions and restrictions 
in current part 93 subpart D are those, discussed above, that prohibit 
the importation of live non-bovine ruminants from regions listed in 
Sec.  94.24(a).
    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 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).
    Information about the infectivity of tissues from TSE-affected 
zoological ruminants is limited to studies of tissue from four London 
Zoo kudus with spongiform encephalopathy. Fifteen of 32 kudu tissue 
homogenates transmitted BSE to mice. Of these, fresh central nervous, 
lymphoreticular, and distal ileum tissue indicated moderate or high 
levels of spongiform encephalopathy infectivity. Traces of infectivity 
were demonstrated in kudu spleen, lung, skin, conjunctiva, and salivary 
gland (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

[[Page 46625]]

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. Although the precise measures APHIS considers necessary could 
vary on a case-by-case basis, such measures could include the 
following:
     That the animal be held at approved permanent post-entry 
quarantine facilities;
     That any movement of the animal out of or among such 
facilities occur only in accordance with a compliance agreement between 
APHIS and the owners of approved facilities; and
     That, upon the death of the animal, the APHIS Service 
Center Director be notified, and the carcass be tested for TSEs and be 
completely destroyed in a manner acceptable to the Administrator.
    Any conditions for the importation of a zoological ruminant would 
be spelled out in the import permit for that animal. Any such 
conditions could also be applied to any progeny of the animal, as well 
to as any ruminants housed with either the animal or its progeny. In 
the event that the conditions of importation of a zoological ruminant 
were applied to its progeny or contact animals, the Administrator could 
require that a zoo enter into a cooperative, compliance, or other 
agreement that sets out specific requirements for releasing the progeny 
or contact animals based on postmortem testing of the imported animal 
with negative results.

Ruminants From Regions Where BSE Exists

    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 the United States, provided certain risk mitigation measures are 
taken.
    Section 93.401 of the regulations contains general prohibitions on 
the importation of ruminants. We would amend paragraph (a) of this 
section by revising the second sentence to remove the reference to 
Sec.  94.24(a). That section contains a list of regions in which BSE is 
known to exist, but is no longer needed since we have changed the way 
we recognize regions for BSE risk. We are proposing to amend the second 
sentence 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.
    In the preceding section of this document, we discussed the type of 
mitigation measures that could be used to adequately mitigate TSE risk 
from zoo ruminants from regions other than those listed in Sec.  
94.24(a). We believe that the same types of mitigation measures can be 
employed to safely import zoological ruminants from regions listed in 
Sec.  94.24(a).
    In this document, therefore, we are proposing to add a new 
paragraph (a)(5) to the import permit provisions in Sec.  93.404 to 
address such situations. The new paragraph would provide 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

[[Page 46626]]

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 would also provide that importers seeking a permit pursuant to 
the paragraph must send their request by postal mail to the 
Administrator, c/o National Import Export Services, 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 Web site at https://www.aphis.usda.gov/animal_health/permits/.

Sheep and Goat Products

    The regulations in 9 CFR 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 are 
also proposing to amend part 94, part 95, and part 96 of the 
regulations to remove the current BSE provisions regarding sheep and 
goats. In the following sections, we identify those CFR sections and 
paragraphs from which regulatory text relating to BSE and sheep and 
goats would be removed.

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 are proposing 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 would be similar to those that 
already exist in Sec.  94.15. Paragraphs (b) and (c) of Sec.  94.15 
would be redesignated as (c) and (d), respectively. 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. Section 95.15 would also be 
removed.

Restrictions on the Importation of Meat and Edible Products Due to BSE

    The regulations in Sec.  94.24 restrict the importation of meat and 
edible products, including gelatin, from ovines and caprines due to 
BSE, those in Sec.  94.25 restrict the importation from Canada of meat 
and edible products from ovines and caprines other than gelatin, and 
those in Sec.  94.26 apply to gelatin derived from horses or swine or 
from ovines or caprines that have not been in a region restricted 
because of BSE. While there is no BSE risk associated with gelatin or 
meat and other edible products derived from sheep and goats, these 
restrictions also function as protection against the introduction of 
other TSEs, such as scrapie.
    We are proposing to remove Sec. Sec.  94.24 and 94.25. This will 
remove both the prohibition on the importation of meat and other edible 
products ovines and caprines from regions in which BSE is known to 
exist, and the requirement that meat and edible products from sheep and 
goats from Canada, other than gelatin, be derived only from animals 
less than 12 months of age. These restrictions were related to concerns 
about BSE risk and are no longer warranted since there is no scientific 
evidence that BSE is circulating in sheep or goats.
    We are proposing 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.

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. We are proposing 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 no longer appear in the regulations.
    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 are proposing to amend this section first by revising the section 
heading to remove the exception for certain tallow derivatives. We 
would also revise paragraph (b)(1) to remove the exception for tallow 
derivatives from that paragraph. We are 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.
    Paragraph (a) contains a list of regions in which BSE is known to 
exist. We would revise the paragraph to remove this list, which is no 
longer needed since we have changed the way we recognize regions for 
BSE risk.
    In paragraph (c), we would remove the reference to paragraph (a)(4) 
from paragraph (c)(1)(iv), and remove paragraphs (c)(2) and (c)(3). 
These revisions would remove BSE-related restrictions from these 
products when derived from sheep and goats. We would also amend 
paragraphs (c)(1)(ii) and (iv) to add the words ``and the material is 
not ineligible for importation under the conditions of Sec.  95.5'' 
after the words ``cervids and camelids'' and ``ovines and caprines,'' 
respectively. These would not be new requirements; 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. Paragraphs (c)(4) through (c)(8) would be 
redesignated as paragraphs (c)(2) through (c)(6), respectively.
    In newly redesignated paragraph (c)(3), we would amend 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

[[Page 46627]]

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 would 
continue to require inspections for facilities that process or handle 
processed animal proteins.
    Paragraphs (d) and (e) contain restrictions on serum, serum 
albumin, serocolostrum, amniotic liquids or extracts, and placental 
liquids derived from ovines and caprines due to BSE. We are proposing 
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.
    Paragraph (g) contains restrictions on offal derived from ovines 
and caprines. These restrictions are no longer warranted and paragraph 
(g) would be removed.
    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 are proposing to remove Sec.  95.40.

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 would 
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 would also redesignate paragraph (b)(2) as 
(b)(1).

Sheep and Goat Germ Plasm

    The regulations in 9 CFR part 98 govern the importation into the 
United States of germ plasm (embryos and semen), including germ plasm 
from sheep and goats. Subpart A sets forth requirements for ruminant 
and swine embryos from regions free of rinderpest and foot-and-mouth 
disease (FMD), and for embryos of horses and asses. Subpart B sets 
forth requirements for ruminant and swine embryos from regions where 
rinderpest and FMD exist. Subpart C sets forth the requirements for the 
importation of animal semen from species regulated by APHIS.
    Currently, the regulations in Sec.  98.10a provide that embryos 
from sheep in regions other than Australia, Canada, and New Zealand may 
be imported only if the embryos are transferred to females in a flock 
that participates in the Voluntary Scrapie Flock Certification Program 
(9 CFR part 54, subpart B) and qualifies as a ``Certified'' flock, or:
     The embryos are transferred to females in a flock that 
participates in the Voluntary Scrapie Flock Certification Program and 
the flock owner has agreed, in writing, to maintain the flock, and all 
first generation (F1) progeny resulting from the embryos in accordance 
with all requirements of the Voluntary Scrapie Flock Certification 
Program; and
     The importer provides the Voluntary Scrapie Flock 
Certification Program identification number as part of the application 
for an import permit; and
     The embryos are the progeny of a dam and sire that are 
part of flocks in the region of origin that participate in a program 
that has been determined by the Administrator to be equivalent to the 
Voluntary Scrapie Flock Certification Program, and those flocks have 
been determined to be at a level equivalent to ``Certified.''
    In addition, the flock to which the embryos are transferred must 
also be monitored for scrapie until the flock, and all first generation 
progeny resulting from the embryos qualifies as a ``Certified'' flock.
    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 are proposing to add provisions for 
goat embryos and both sheep and goat oocytes to the regulations in 
Sec.  98.10a. Specifically, we would revise the section heading to read 
``Sheep and goat embryos and oocytes.'' We would also add a definition 
of oocyte to read ``the first and second maturation stages of a female 
reproductive cell prior to fertilization'' to Sec.  98.2 of the 
regulations. This definition is consistent with international 
standards.
    We are proposing to allow the importation of in vivo-derived sheep 
and goat 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.
    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 are 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 are also proposing 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).

[[Page 46628]]

Enrollment in this program requires an annual inspection with inventory 
reconciliation and submission of tissues from certain animals for 
scrapie testing. We are making this change because the scientific 
literature demonstrates that embryos are low risk for scrapie 
transmission. APHIS has determined that requiring all F1 offspring to 
be maintained in an SFCP flock is unnecessary as well as overly 
burdensome on importers.
    Instead, we would 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 would also 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) National Import Export Services (NIES) Service 
Center. To be listed in the National Scrapie Database, a flock owner 
must contact the local VS Surveillance, Preparedness and Response 
(SPRS) field office 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 SPRS field 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 NIES Service Center or SPRS field office, contact 
the State or Territory Point of Contact (POC). A list of POCs can be 
found on the APHIS Web site at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/contact-us.
    Finally, we would 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.
    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 processed embryos 
except as provided under Sec.  98.10. We intend 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.
    The regulations in 98.13 provide requirements for import permits 
for ruminant and swine embryos from regions where rinderpest or FMD 
exist. We are proposing 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 are proposing this 
change to ensure that the permit requirements for sheep and goat 
embryos and oocytes from regions where rinderpest or FMD exist are 
consistent with the requirements for sheep and goat embryos and oocytes 
from regions that are free of those diseases.
    The regulations in Sec.  98.15 set forth the requirements for 
ruminant and swine embryos from regions where foot-and-mouth disease or 
rinderpest exist. 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 are proposing to remove these requirements 
because we believe the proposed requirements for sheep and goat embryos 
in Sec.  98.10a will provide adequate protection against a TSE 
introduction via embryo or oocyte transfer.
    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 are proposing to amend this requirement by removing 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.
    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 are proposing 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.
    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 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

[[Page 46629]]

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).
    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 have determined that the 
previous restrictions in our regulations are no longer consistent with 
APHIS' assessment of the scrapie transmission risks associated with 
sheep or goat semen, or with international standards. We are therefore 
proposing to amend Sec.  98.35 to remove paragraph (e)(1)(ii) 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 redesignate paragraphs (e)(1)(iii) and (e)(1)(iv) 
as (e)(1)(ii) and (e)(1)(iii), respectively. We would also amend newly 
redesignated paragraph (e)(1)(iii) 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 will add a new paragraph (e)(1)(iv) to 
allow APHIS to establish testing requirements for semen and/or semen 
donors.
    We are also proposing 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 
are proposing to add new paragraphs (e)(4) and (5) to describe 
recordkeeping requirements for APHIS-approved semen storage facilities, 
including a requirement that 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.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis are available by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT or 
on the Regulations.gov Web site (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    This analysis examines impacts on U.S. entities of a rule that 
would remove BSE restrictions on the importation of live sheep and 
goats and most of their products. The rule also would align our scrapie 
regulations generally with OIE guidelines and establish a notice-based 
approach for recognizing regions as free of scrapie. We are also 
proposing to 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 proposed rule's impact would stem from its effect on U.S. 
imports of the affected commodities. Consumer welfare gains from the 
potential increase in imports are expected to exceed producer welfare 
losses. While the rule could affect U.S. imports of a wide

[[Page 46630]]

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 animals received by zoos, but APHIS 
does not have information that would allow us to evaluate such impacts. 
Estimated net benefits of the rule are demonstrated in terms of 
increased imports of lamb, mutton, and goat meat.
    U.S. imports of sheep and goat meat come almost entirely from 
Australia and New Zealand, 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 imports are expected to be 
small in comparison to an already large import base. We model three 
levels of additional sheep and goat meat imports into the United 
States: 983 MT, 1,966 MT, and 3,932 MT. These quantities are equal to 
approximately 5, 10, and 20 percent of the sum of (i) average EU sheep 
and goat meat exports to non-EU markets, 2010-2014, excluding Australia 
and New Zealand and (ii) average sheep and goat meat exports to EU 
countries by 21 other countries, 2010-2014. The largest assumed 
quantity is equivalent to less than 3 percent of average annual U.S. 
sheep and goat meat consumption during this same period.
    The medium level of assumed additional imports, 1,966 MT, would 
cause a decrease in wholesale prices of a little more than 1 percent 
and a fall in domestic production of 615 MT. Consumption would increase 
by 1,351255 MT. Producer welfare would decline by about $6.3 million 
and consumer welfare would increase by about $14.4 million, yielding an 
annual net welfare benefit of about $8.1 million. 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 
imports from existing sources, the price and welfare effects would be 
smaller than indicated; we note that over one half of the current U.S. 
market is imported.
    The majority of establishments that may be affected by the proposed 
rule are small, and the economic impacts are likely to be small as 
well. If an additional 1,966 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 $48, or the 
equivalent of about 1 percent of average annual sales by small 
entities. We welcome public comment that would allow us to better 
understand likely economic effects of the rule.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this proposed 
rule will be preempted; (2) no retroactive effect will be given to this 
proposed rule; and (3) administrative proceedings will not be required 
before parties may file suit in court challenging this proposed rule.

Executive Order 13175

    This proposed 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.
    The Animal and Plant Health Inspection Service has assessed the 
impact of this rule on Indian tribes and determined that this rule does 
not, to our knowledge, have tribal implications that require tribal 
consultation under E.O. 13175. If a Tribe requests consultation, the 
Animal and Plant Health Inspection Service will work with the Office of 
Tribal Relations to ensure meaningful consultation is provided where 
changes, additions and modifications identified herein are not 
expressly mandated by Congress.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with changes 
to the import regulations pertaining to sheep, goats, and certain other 
non-bovine ruminants, and products derived from sheep and goats, we 
have prepared an environmental assessment. The environmental assessment 
was prepared in accordance with: (1) The National Environmental Policy 
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    The environmental assessment may be viewed on the Regulations.gov 
Web site or in our reading room. (A link to Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

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 this proposed rule have been 
approved under Office of Management and Budget (OMB) control numbers 
0579-0040 and 0579-0101. The new reporting and recordkeeping 
requirements included in this proposed rule have been submitted as a 
new information collection for approval to OMB. Please send comments on 
the information collection request (ICR) to OMB's Office of Information 
and Regulatory Affairs via email to oira_submissions@omb.eop.gov, 
Attention: Desk Officer for APHIS, Washington, DC 20503. Please state 
that your comments refer to Docket No. APHIS-2009-0095. Please send a 
copy of your comments to USDA using one of the methods described under 
ADDRESSES at the beginning of this document, preferably the use of the 
Federal eRulemaking Portal.
    APHIS uses a variety of information collection procedures and forms 
to gather data in its effort to prevent the introduction or spread of 
disease. Information collected via these procedures and forms 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.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's

[[Page 46631]]

functions, including whether the information will have practical 
utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.531 hours per response.
    Respondents: State representatives; Foreign governments/veterinary 
officials; accredited veterinarians; importers and owners of sheep, 
goats, and certain other small ruminants; slaughter plant personnel; 
and feedlot personnel.
    Estimated annual number of respondents: 7,423.
    Estimated annual number of responses per respondent: 8.73.
    Estimated annual number of responses: 64,771.
    Estimated total annual burden on respondents: 34,408 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this new information collection are located at https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0095 and can be 
obtained from Ms. Kimberly Hardy, APHIS' Information Collection 
Coordinator, at (301) 851-2727.
    USDA will respond to any ICR-related comments in the final rule. 
All comments will also become a matter of public record.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
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. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects

9 CFR Part 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 proposing to amend 9 CFR parts 93, 94, 95, 96, 
and 98 as follows:

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, 
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR 
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

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

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

0
2. Section 93.400 is amended as follows:
0
a. By adding, in alphabetical order, definitions for ``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 that has been designated by the 
Administrator as one that is eligible to receive sheep and goats from 
regions that are 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 premises, 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 that will prevent disease spread until the 
animal is no longer living; and the remains have been

[[Page 46632]]

disposed of in a way that prevents disease spread.
* * * * *
    Non-classical scrapie. Any form of scrapie that the Administrator 
has determined poses a low risk of natural transmission.
* * * * *
    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, that typically produce 
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
3. In Sec.  93.401, paragraph (a) is revised to read as follows:


Sec.  93.401  General prohibitions; exceptions.

    (a) 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.

* * * * *
0
4. Section 93.404 is amended as follows:
0
a. Paragraphs (a)(2), (a)(3), and (a)(4) are redesignated as paragraphs 
(a)(3), (a)(4), and (a)(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), the reference to 
``paragraph (a)(4)(iv)'' is removed and a reference to ``paragraph 
(a)(7)(iv)'' is added in its place; and
0
d. In newly redesignated paragraph (a)(7)(vi), the references to 
``paragraph (a)(4)(iv)(A)'' and ``paragraph (a)(4)(iv)(B)'' are removed 
and references to ``paragraph (a)(7)(iv)(A)'' and ``paragraph 
(a)(7)(iv)(B)'', respectively, are added in their place.
    The additions 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 that has been 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 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. 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 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. Importers 
seeking a permit pursuant to this paragraph must send their request to 
the Administrator, c/o National Import Export Services, VS, APHIS, 4700 
River Road Unit 39, Riverdale, MD 20737-1231, or via the APHIS Web site 
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 that are determined to be AA at codon 136 
and either RR, HR, KR or QR at codon 171 and for female sheep that are 
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 for import other than the requirement 
that they originate in a flock or region that is 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.
* * * * *
0
5. Section 93.405 is amended as follows:
0
a. Paragraph (a)(4) is removed;
0
b. Paragraph (b) is revised;
0
c. Paragraph (c) is removed; and
0
d. Paragraph (d) is redesignated as paragraph (c) and revised.
    The revisions read as follows:


Sec.  93.405  Health certificate for ruminants.

* * * * *
    (b) Sheep and goats. (1) 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 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,

[[Page 46633]]

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) 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:
    (i) That the sheep or goats originated from a region recognized as 
free of classical scrapie by APHIS; or that the animals have reached 
and maintained certified status in a scrapie flock certification 
program approved by APHIS;
    (ii) That 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) That 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) That none of the female sheep or goats is carrying an 
implanted embryo from a lower health status flock; or that any 
implanted embryo met the requirements for import into the United States 
when implanted and documentation as required in part 98 of this 
subchapter is attached;
    (v) That 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) That 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) 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) 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 is recognized as free of classical scrapie by APHIS; 
or
    (ii) The region 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;
    (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 is recognized as free of classical scrapie by APHIS; 
or
    (ii) The region 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;
    (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) That 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) That 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) 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.
* * * * *


Sec.  93.406  [Amended]

0
6. Amend Sec.  93.406(b) 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
7. Section 93.419 is removed and reserved.
0
8. In Sec.  93.420, paragraph (a) introductory text is amended 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. * * 
*
* * * * *

[[Page 46634]]

0
9. 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
10. Section 93.428 is amended by revising paragraph (a) to read as 
follows:


Sec.  93.428  Sheep and goats and wild ruminants from Mexico.

    (a) Sheep and goats 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.
* * * * *
0
11. 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 unique 
identification numbers using official identification devices, or by 
other means that have been approved by the Administrator, and which 
will allow the animals that are 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 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 may be found on the APHIS Web site at [ADDRESS TO BE 
ADDED IN FINAL RULE].
    (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 that has been approved by the Administrator for 
this use. A list of the acceptable country marks may be found on the 
APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE]
    (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 which include 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 imported for immediate slaughter must 
be imported only through a port of entry allowed in Sec.  93.403, in a 
means of conveyance sealed in the country of origin with seals of the 
national government, and must be moved directly as a group from the 
port of entry to a recognized slaughtering establishment for slaughter 
as a group; and
    (2) The sheep and goats shall be inspected by the port veterinarian 
or other designated APHIS representative at the port of entry to 
determine that the animals are free from evidence of communicable 
disease and are considered fit for further travel; and
    (3) The seals on the means of conveyance must be broken only at the 
port of entry by the APHIS port veterinarian or at the recognized 
slaughtering establishment by an authorized USDA representative. If the 
seals are broken by the APHIS port veterinarian at the port of entry, 
the means of conveyance must be resealed with seals of the U.S. 
Government before being moved to the recognized slaughtering 
establishment; and
    (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 that 
are have been determined to be free of classical scrapie by APHIS, or 
that have scrapie awareness, surveillance, and control programs that 
have been 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 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

[[Page 46635]]

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 the 
purpose and will be linked 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 
that they have the required country mark, or 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;
    (iii) Will maintain records of the acquisition and disposition of 
all imported sheep and goats entering the feed lot, 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) 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;
    (ix) 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
    (x) Agrees to maintain sexually intact animals of different genders 
over 5 months of age in separate enclosures.
    (xi) 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) 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 in a scrapie 
flock certification program recognized by APHIS as acceptable for this 
purpose, 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 Web site 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, National Import 
Export Services, Veterinary Services, Animal and Plant Health 
Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 
20737.
    (2) APHIS will add a region to this list only after it conducts an 
evaluation of the region in accordance with Sec.  92.2 of this 
subchapter and finds that classical scrapie is not likely to be present 
in its sheep or goat populations. In the case of a region formerly on 
this list that is 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 that classical 
scrapie exists there based on reports APHIS receives 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 and 0579-0101)


Sec.  93.505  [Amended]

0
12. Amend Sec.  93.505(a), by removing the citation ``Sec.  
94.24(b)(6)'' and replacing it with the citation ``Sec.  94.31(b)(6)''.

PART 94--RINDERPEST, 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
13. The authority citation for part 94 continues to read as follows:


[[Page 46636]]


    Authority: 7 U.S.C. 450, 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
14. Section Sec.  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) that is 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 that is 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, National Import Export Services, 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, National 
Import Export Services, 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 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
    (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 and 0579-0145)

[[Page 46637]]

Sec.  94.18  [Amended]

0
15. In paragraph (a), by adding the word ``and'' before the citation 
``94.23'' and removing the words ``, and Sec.  94.27''.


Sec.  94.24  [Removed and Reserved]

0
16. Section 94.24 is removed and reserved.


Sec.  94.25  [Removed and reserved]

0
17. Section 94.25 is removed and reserved.
0
18. 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.


Sec.  94.27  [Removed and reserved]

0
19. 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
20. 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
21. Section 95.1 is amended by removing the definitions of ``Positive 
for a transmissible spongiform encephalopathy'' and ``Suspect for a 
transmissible spongiform encephalopathy''.
0
22. Section 95.4 is amended as follows:
0
a. The section heading is revised;
0
b. Paragraph (a) is revised;
0
c. Paragraph (b)(1) is revised;
0
d. Paragraphs (c)(1)(ii) and (iv) are revised;
0
e. Paragraphs (c)(2) and (c)(3) are removed, and paragraphs (c)(4) 
through (c)(8) are redesignated as paragraphs (c)(2) through (c)(6), 
respectively;
0
f. In newly redesignated paragraph (c)(3), the first sentence is 
revised;
0
g. In newly redesignated paragraph (c)(5), the reference ``(c)(5)'' is 
removed and the reference ``(c)(3)'' is added in its place;
0
h. In newly redesignated paragraph (c)(6), the words ``National Center 
for Import and Export'' are removed and the words ``National Import 
Export Services'' are added in their place;
0
i. Paragraphs (d) and (e) are removed;
0
j. Paragraph (f) and the Note to paragraph (f) are redesignated as 
paragraph (d) and the Note to paragraph (d), respectively; and
0
k. Paragraph (g) is removed.
    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) * * * (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 and camelids, and the material is not ineligible for 
importation under the conditions of Sec.  95.5.
* * * * *
    (iv) Ovines and 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
23. Section 95.15 is removed and reserved.


Sec.  95.40  [Removed and reserved]

0
24. Section 95.40 is removed and reserved.

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

0
25. 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
26. Section 96.2 is amended as follows:
0
a. Paragraph (b)(1) is removed.
0
b. Paragraph (b)(2) is redesignated as paragraph (b)(1).
0
c. A new paragraph (b)(2) is added and reserved.
0
d. In paragraph (c)(3), by removing the words ``paragraphs (b)(2)(i) 
through (b)(3)(iv)'' and replacing them with the words ``paragraph 
(b)(1).''

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

0
27. 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
28. 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.
* * * * *
    Transmissible spongiform encephalopathies (TSEs). A family of 
progressive and generally fatal neurodegenerative disorders thought to 
be caused by abnormal proteins, called prions, that typically produce 
characteristic microscopic changes, including, but not limited to, non-
inflammatory neuronal loss, giving a spongiform appearance to tissues 
in the brains and nervous systems of affected animals.
* * * * *


Sec.  98.3  [Amended]

0
29. 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 removing the citation ``part 92'' and adding 
the citation ``part 93'' in its place, and by 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

[[Page 46638]]

0
c. In paragraph (f), by removing the words ``Sec.  93.404(a)(2) or 
(3)'' and adding the words ``Sec.  93.404(a)(3) or (4)'' in their 
place.
0
30. Section 98.4 is amended by adding paragraph (e) to read as follows:


Sec.  98.4  Import permit.

* * * * *
    (e) 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
31. In Sec.  98.5, paragraph (b) is removed and reserved.
0
32. 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 which are from a flock or herd that has 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 that are not of the genotype 
AAQR or AARR, and for all goat embryos, must contain these additional 
certifications:
    (A) In the country or zone:
    (1) TSEs of sheep and goats are compulsorily notifiable;
    (2) A scrapie awareness, surveillance, monitoring, and control 
system is in place;
    (3) TSE-affected sheep and goats are killed and completely 
destroyed;
    (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 in which 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.
    (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 
in which the recipients reside is listed in the National Scrapie 
Database; except that 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 that is 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 that are 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 to which 
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) In vitro-derived or manipulated sheep or goat embryos and 
oocytes. As provided in Sec.  98.10, 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.
    (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 and 0579-0101)
0
33. 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.
* * * * *

[[Page 46639]]

Sec.  98.15  [Amended]

0
34. 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.
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
35. 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
36. Section 98.35 is amended as follows:
0
a. Paragraph (e)(1)(ii) is removed and paragraphs (e)(1)(iii) and 
(e)(1)(iv) are redesignated as paragraphs (e)(1)(ii) and (e)(1)(iii), 
respectively;
0
b. Newly redesignated (e)(1)(iii) is revised;
0
c. New paragraph (e)(1)(iv) is added;
0
d. Paragraph (e)(3) is revised; and
0
e. Paragraphs (e)(4) and (5) are added.
    The revisions and additions read as follows:


Sec.  98.35  Declaration, health certificate, and other documents for 
animal semen.

* * * * *
    (e) * * *
    (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 that is 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 that is 
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.
* * * * *

    Done in Washington, DC, this 12th day of July 2016.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2016-16816 Filed 7-15-16; 8:45 am]
BILLING CODE 3410-34-P