[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 http://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 http://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.
---------------------------------------------------------------------------
\1\ To view the rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010.
---------------------------------------------------------------------------
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 http://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 (http://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 http://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 [email protected],
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 http://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 http://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 http://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 http://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 http://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