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asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Management and Budget (OMB) and
assigned OMB No. 0581–0178
(Vegetable and Specialty Crops.) No
changes in those requirements are
necessary as a result of this action.
Should any changes become necessary,
they would be submitted to OMB for
approval.
This proposed rule would impose no
additional reporting or recordkeeping
requirements on either small or large
California almond handlers. As with all
Federal marketing order programs,
reports and forms are periodically
reviewed to reduce information
requirements and duplication by
industry and public sector agencies.
AMS is committed to complying 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.
USDA has not identified any relevant
Federal rules that duplicate, overlap, or
conflict with this action.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: http://www.ams.usda.gov/
rules-regulations/moa/small-businesses.
Any questions about the compliance
guide should be sent to Antoinette
Carter at the previously-mentioned
address in the FOR FURTHER INFORMATION
CONTACT section.
A 15-day comment period is provided
to allow interested persons to respond
to this proposed rule. Fifteen days is
deemed appropriate because: (1) The
2016–17 crop year begins on August 1,
2016, and the marketing order requires
that the rate of assessment for each crop
year apply to all assessable almonds
handled during such crop year; (2) the
Board needs to have sufficient funds to
pay its expenses which are incurred on
a continuous basis; and (3) handlers are
aware of this action which was
unanimously recommended by the
Board at a public meeting.
List of Subjects in 7 CFR Part 981
Almonds, Marketing agreements,
Nuts, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, 7 CFR part 981 is proposed to
be amended as follows:
PART 981—ALMONDS GROWN IN
CALIFORNIA
1. The authority citation for 7 CFR
part 981 continues to read as follows:
■
Authority: 7 U.S.C. 601–674.
18:16 Jul 15, 2016
Assessment rate.
Jkt 238001
Dated: July 12, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2016–16814 Filed 7–15–16; 8:45 am]
BILLING CODE 3410–02–P
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
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.
SUMMARY:
We will consider all comments
that we receive on or before September
16, 2016.
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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:
ADDRESSES:
For the period August 1, 2016,
through July 31, 2019, the assessment
rate shall be $0.04 per pound for
California almonds. Of the $0.04
assessment rate, 60 percent per
assessable pound is available for
handler credit-back. On and after
August 1, 2019, an assessment rate of
$0.03 per pound is established for
California almonds. Of the $0.03
assessment rate, 60 percent per
assessable pound is available for
handler credit-back.
DATES:
2. Section 981.343 is revised to read
as follows:
■
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§ 981.343
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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
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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Proposed Rules
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.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Summary of the Major Provisions of the
Regulatory Action
We are proposing to remove BSErelated 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 nonbovine 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.
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II. Background
In order to guard against the
introduction and spread of livestock
pests and diseases, APHIS regulates the
importation of animals and animal
products into the United States. The
regulations in 9 CFR parts 92, 93, 94, 95,
96, and 98 (referred to below as the
regulations) govern the importation of
certain animals, meat, other animal
products and byproducts, hay and
straw, embryos, and semen into the
United States in order to prevent the
introduction of various livestock pests
and diseases.
Two of the diseases addressed by the
current regulations regarding sheep and
goats are scrapie and BSE. Scrapie and
BSE belong to the family of diseases
known as TSEs. In addition to scrapie
and BSE, TSEs include, among other
diseases, chronic wasting disease in
deer and elk, and variant CreutzfeldtJakob disease in humans.
The current BSE-related import
regulations restrict the importation of
most live ruminants and ruminantderived products and by-products. The
regulations in § 94.18 provide for the
importation of meat, meat products, and
other edible products derived from
bovines (Bos indicus, Bos taurus and
Bison bison). The current regulations in
§ 93.419 allow only the importation of
sheep and goats for immediate slaughter
or restricted feeding for slaughter from
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
view the rule, go to http://
www.regulations.gov/#!docketDetail;D=APHIS2008-0010.
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we are proposing for other non-bovine
ruminants with respect to TSEs
generally.
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
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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 bovinederived 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 § 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
§ 94.26 provides for the importation of
gelatin derived from horses or swine, or
from sheep and goats that have not been
in a region restricted because of BSE.
Section 94.27 provides for the transit
shipment of meat, meat products, and
other edible products derived from
bovines, ovines, or caprines that are
otherwise prohibited importation into
the United States in accordance with
§ 94.18 through § 94.26. Section 96.2
prohibits the importation of casings,
except stomach casings, from ovines or
caprines that originated in or were
processed in any region listed in
§ 95.4(a)(4), unless certain conditions
are met.
When the BSE regulations were
codified in 1991 (56 FR 19794–19796,
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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
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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
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(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 standardsetting 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
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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.
§ 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, nonclassical 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
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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
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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 noninflammatory 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 TSEaffected 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.
§ 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.
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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 scrapieresistant 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.
§ 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
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paragraph (d) would be redesignated as
paragraph (c).
§ 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 § 93.435.
§ 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
§ 93.419 would be replaced by a
reference to the provisions in § 93.435.
§ 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.
§ 93.428 Sheep and goats and wild
ruminants from Mexico: This section
would be revised to refer to the scrapie
provisions in § 93.435 which would also
apply to sheep and goats from Mexico.
§ 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 § 93.419.
The requirements for importing sheep
and goats for other purposes, currently
contained in § 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 § 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
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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
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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 § 94.24(a).
Currently, non-bovine ruminants
other than sheep and goats from regions
not listed in § 94.24(a) are not subject to
any import restrictions with regard to
BSE. We believe, however, that there is
a certain category of ruminants that
present enough of a potential risk of
spreading TSEs that their importation
should be prohibited unless certain risk
mitigation measures are in place. This
category of ruminants includes certain
ruminants held in zoological facilities
and certain wild ruminants. For the
purposes of discussion, we will refer to
such animals as zoological ruminants to
distinguish them from domesticated
sheep, goats, and bovines.
Scientific literature indicates that at
least certain zoological ruminants are
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
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inoculated with brain tissue
homogenate from the affected nyala, an
affected kudu, and BSE-affected cattle
(Jeffrey, Scott et al. 1992).
The greater kudu, a non-domestic
African antelope, appears to be
particularly susceptible to BSE. Six of
eight kudu that died in a small herd at
the London Zoo from 1989 through 1992
were diagnosed with spongiform
encephalopathy (Kirkwood and
Cunningham 1994). The disease is
presumed to have been introduced to
the kudu herd through feeds containing
ruminant-derived protein around the
time of the BSE epidemic in U.K. cattle.
However, some of the affected kudu
were born after the elimination of the
potentially contaminated feed from the
premises, and one case occurred in a
kudu born at another zoo and
introduced to the affected herd
(Kirkwood, Cunningham et al. 1994).
Because most of the affected kudu did
not consume feed containing ruminantderived protein, it was postulated that
the disease may have spread naturally
in the herd, either by transmission
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 BSErelated encephalopathy between
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members, or from mother to offspring,
within herds of zoological ruminants, as
suspected with the London Zoo kudus,
cannot be ruled out. Although there is
currently no evidence that TSEs exist in
free-living zoological ruminants
(veterinary authorities in southern
African countries conducting passive
surveillance in wildlife have not
encountered any clinical cases or
histopathological lesions compatible
with TSEs (Horn, Bobrow et al.), active
surveillance has not been implemented
in any region of the world for TSEs in
antelope or free-living Caprinae.
Many of the non-domestic ruminants
are endangered species. The scimitarhorned oryx, for example, is listed as
‘‘Extinct in the Wild’’ on the
International Union for Conservation of
Nature Red List (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 BSEaffected region or feeding with BSEcontaminated protein. Even in countries
that have enforced a ban on the feeding
of ruminant protein to domestic
ruminants for an identifiable period of
time, it can be difficult in some cases to
determine when and if a country ceased
feeding ruminant protein to zoo
ruminants.
Because of the potential variety of
practices in the feeding of zoo
ruminants, as well as the potential that
certain zoo ruminants may have
originated in BSE-affected countries, we
believe it is necessary to consider on a
case-by-case basis the potential
spongiform encephalopathy risk of
zoological ruminants. As noted above, a
ruminant may not be imported into the
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United States unless the importer has
first applied for and obtained a permit
from APHIS for such importation. In the
case of zoological ruminants, the
Administrator will consider the disease
risk of each animal and the ability of the
receiving zoo to manage the risks before
deciding whether to issue an import
permit.
Paragraph (a)(3) of § 93.404 currently
provides that an application for a permit
to import ruminants may be denied due
to, among other reasons, the lack of
satisfactory information necessary to
determine that the importation will not
be likely to transmit any communicable
disease to livestock or poultry of the
United States.
Even with zoological ruminants that
would otherwise be denied importation
into the United States, however, we
believe that, in most cases, adequate
mitigation measures with respect to
potential TSE risks can be taken to
allow the animal to be safely imported
into the United States. 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 § 94.24(a). The prohibitions
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apply to zoological ruminants as well as
to domesticated ruminants. However,
the regionally based prohibitions do not
address individual situations where a
ruminant that would otherwise be
denied entry from a region listed in
§ 94.24(a) could be safely entered into
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 § 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 § 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 § 94.24(a). We believe that the
same types of mitigation measures can
be employed to safely import zoological
ruminants from regions listed in
§ 94.24(a).
In this document, therefore, we are
proposing to add a new paragraph (a)(5)
to the import permit provisions in
§ 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
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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/.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
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 §§ 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 § 94.15 to
consolidate the requirements for transit
shipment of all these products into one
section and to eliminate some BSErelated restrictions that are no longer
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warranted. The new requirements
would be similar to those that already
exist in § 94.15. Paragraphs (b) and (c)
of § 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 § 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 § 94.24 restrict the
importation of meat and edible
products, including gelatin, from ovines
and caprines due to BSE, those in
§ 94.25 restrict the importation from
Canada of meat and edible products
from ovines and caprines other than
gelatin, and those in § 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 §§ 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 § 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 nonbovine 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
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proposing to amend § 95.1 by removing
the definitions for positive for a
transmissible spongiform
encephalopathy and suspect for a
transmissible spongiform
encephalopathy because those terms 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 § 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 § 95.5’’ after the
words ‘‘cervids and camelids’’ and
‘‘ovines and caprines,’’ respectively.
These would not be new requirements;
the regulations in § 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
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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 § 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 § 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
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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 § 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 § 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 § 98.2 of the regulations. This
definition is consistent with
international standards.
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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 § 98.5 must include
additional declarations stating that the
embryos or oocytes were collected,
processed, and stored in accordance
with the requirements in § 98.3, and, for
in vivo-derived sheep embryos only,
that the embryo is of either of the
scrapie-resistant genotypes, AARR or
AAQR, based on official testing of the
parents or the embryo. The testing may
be performed at the NVSL or at another
laboratory approved by the
Administrator.
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).
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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 APHISapproved storage facility where they
may be kept and later transferred to
recipient females in a flock that is listed
in the National Scrapie Database. We
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.
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The regulations in § 98.3(h) currently
require that ruminant and swine
embryos have an intact zona pellucida,
which effectively prohibits the
importation of in vitro-derived and
processed embryos except as provided
under § 98.10. We intend to continue to
allow such importations on a case-bycase basis, if the Administrator
determines that any disease risk posed
by the embryos can be adequately
mitigated through pre-entry or postentry 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 § 98.15 set forth the
requirements for ruminant and swine
embryos from regions where foot-andmouth disease or rinderpest exist.
Currently, § 98.15(a)(1) and (2) require
that, for ruminants, no case of BSE
(among other diseases) occurred (1)
during the year before collection in the
embryo collection unit or in any herd in
which the donor dam was present, or (2)
in or within 5 kilometers of the embryo
collection unit, or in any herd in which
the donor dam was present. We are
proposing to remove these requirements
because we believe the proposed
requirements for sheep and goat
embryos in § 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
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BSE since BSE is not circulating in the
sheep and goat populations.
Currently § 98.15(a)(8)(i)(A) requires
that, for ruminants, between the time of
embryo collection and all required
examinations and tests are completed,
no animals in the embryo collection
unit with the donor dam, or in the
donor dam’s herd of origin, exhibited
clinical evidence of BSE (among other
diseases). We 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 § 98.10a will provide
adequate protection against a TSE
introduction through embryo or oocyte
transfer.
Currently, the regulations in § 98.35(e)
require that, for sheep and goat semen
from any part of the world to be
imported into the United States:
• The donor animals must be
permanently identified to enable
traceback to their establishment of
origin;
• They have been kept since birth in
establishments in which no case of
scrapie has been confirmed during their
residency;
• They neither showed clinical signs
of scrapie at the time of semen
collection nor developed scrapie
between the time of semen collection
and the export of semen to the United
States; and
• The dam of the semen donor is not,
or was not, affected with scrapie.
The regulations also require that in
the region where the semen originates,
scrapie is a compulsorily notifiable
disease, an effective surveillance and
monitoring program for scrapie is in
place, affected sheep and goats are
slaughtered and completely destroyed,
and the feeding of meat and bone meal
or greaves derived from ruminants has
been banned and the ban effectively
enforced for the whole region.
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
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with two donor ewes, one scrapie
positive, the other negative (Wang,
Foote et al. 2001). None of the lambs
resulting from embryos of either ewe
developed classical scrapie, nor did the
uninfected ewe that was bred to the
infected ram. The study did not provide
information about the scrapie strain or
the genotypes of the rams, donor ewes,
and recipient ewes.
A more recent study evaluated the
infectivity of semen from infected rams
by injecting it via intracerebral
inoculation into classical scrapiesusceptible transgenic mice
overexpressing the VRQ allele. Semen
from three classical scrapie-positive
VRQ homozygous sheep was injected
into a total of 40 transgenic mice, with
none subsequently developing classical
scrapie. One of the infected sheep was
exhibiting clinical signs of classical
scrapie and the other two were
asymptomatic at the time of collection.
In comparison, the injection of brain
homogenate from 4 scrapie-infected
sheep intracerebrally into 23 transgenic
mice resulted in infection of 100 percent
of the mice (Sarradin, Melo et al. 2008).
Recently, 8 ewes in a historically
scrapie-negative sentinel flock of 24
sheep were discovered to be scrapiepositive 4 months after having been
bred to scrapie-positive rams from an
adjacent highly infected flock. The flock
had also been bred in previous years by
other rams from the infected flock and
had fence line contact with rams from
the infected flock. The ewes had been
bred to these rams in order to increase
the scrapie-susceptibility of the sentinel
flock to the ‘Caine’ strain of scrapie (i.e.,
to increase the proportion of sheep with
at least one valine insertion at codon
136). This strain has a relatively short
incubation period, particularly in sheep
that are homozygous for valine at codon
136. The discovery of the infected ewes
led to an investigation by Rubenstein et
al. (2012) to determine whether it was
possible that scrapie could have been
transmitted to the ewes through
exposure to the semen of infected rams
(Rubenstein, Bulgin et al. 2012).
Using newly developed detection
techniques such as serial protein
misfolding cyclic amplification,
combined with an optical fiber
immunoassay, the investigators detected
prion disease-associated-seeding
activity, which is assumed to imply the
presence of PrPSc in semen samples
from the rams in the affected flock
described above. In addition,
intracerebral inoculation of a newlygenerated sheep scrapie-susceptible
transgenic mouse line with semen from
both infected and uninfected rams from
the flock resulted in the detection of
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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
§ 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.
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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
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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
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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 governmentto-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
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(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
The environmental assessment may
be viewed on the Regulations.gov Web
site or in our reading room. (A link to
Regulations.gov and information on the
location and hours of the reading room
are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) In addition, copies may
be obtained by calling or writing to the
individual listed under FOR FURTHER
INFORMATION CONTACT.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), some of the
reporting and recordkeeping
requirements included in this proposed
rule have been approved under Office of
Management and Budget (OMB) control
numbers 0579–0040 and 0579–0101.
The new reporting and recordkeeping
requirements included in this proposed
rule have been submitted as a new
information collection for approval to
OMB. Please send comments on the
information collection request (ICR) to
OMB’s Office of Information and
Regulatory Affairs via email to oira_
[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
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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.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
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.
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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
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.
2. Section 93.400 is amended as
follows:
■ a. By adding, in alphabetical order,
definitions for ‘‘Certified status’’,
‘‘Classical scrapie’’, and ‘‘Country
mark’’;
■ b. By revising the definitions for
‘‘Designated feedlot’’ and ‘‘Flock’’;
■ c. By adding, in alphabetical order,
definitions for ‘‘Flock of birth’’, ‘‘Flock
of residence’’, ‘‘Goat’’, ‘‘Killed and
completely destroyed’’, ‘‘Non-classical
scrapie’’, and ‘‘Sheep’’;
■ d. By removing the definition of
‘‘Suspect for a transmissible spongiform
encephalopathy’’; and
■ e. By adding, in alphabetical order,
definitions for ‘‘Transmissible
spongiform encephalopathies (TSEs)’’,
and ‘‘TSE-affected sheep or goat’’.
The additions and revisions read as
follows:
■
§ 93.400
Definitions.
*
*
*
*
*
Certified status. A flock that has met
requirements equivalent to the Export
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46631
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
§ 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
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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, noninflammatory neuronal loss, giving a
spongiform appearance to tissues in the
brains and central nervous systems of
affected animals.
TSE-affected sheep or goat. A sheep
or goat suspected or known by the
national veterinary authority of the
region of origin to be infected with a
transmissible spongiform
encephalopathy prior to the disposal of
the animal.
*
*
*
*
*
■ 3. In § 93.401, paragraph (a) is revised
to read as follows:
§ 93.401
General prohibitions; exceptions.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
(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.
*
*
*
*
*
4. Section 93.404 is amended as
follows:
■ a. Paragraphs (a)(2), (a)(3), and (a)(4)
are redesignated as paragraphs (a)(3),
(a)(4), and (a)(7), respectively;
■
3 Importations of certain animals from various
regions are absolutely prohibited under part 94
because of specified diseases.
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b. By adding new paragraph (a)(2) and
paragraphs (a)(5), and (6);
■ 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
■ 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:
■
§ 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
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
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.
*
*
*
*
*
■ 5. Section 93.405 is amended as
follows:
■ a. Paragraph (a)(4) is removed;
■ b. Paragraph (b) is revised;
■ c. Paragraph (c) is removed; and
■ d. Paragraph (d) is redesignated as
paragraph (c) and revised.
The revisions read as follows:
§ 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
§ 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,
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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
§ 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
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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;
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46633
(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.
*
*
*
*
*
§ 93.406
[Amended]
6. Amend § 93.406(b) by removing the
references ‘‘§§ 93.419 and 93.428(b)’’
and adding ‘‘§§ 93.428(b) and 93.435’’ in
their place.
■
§ 93.419
[Removed and Reserved]
7. Section 93.419 is removed and
reserved.
■ 8. In § 93.420, paragraph (a)
introductory text is amended by adding
a sentence after the paragraph heading
to read as follows:
■
§ 93.420 Ruminants from Canada for
immediate slaughter other than sheep and
goats.
(a) * * *. The requirements for the
importation of sheep and goats from
Canada for immediate slaughter are
contained in § 93.435. * * *
*
*
*
*
*
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9. Section 93.424 is amended by
revising paragraph (a) to read as follows:
■
§ 93.424 Import permits and applications
for inspection of ruminants.
(a) For ruminants intended for
importation from Mexico, the importer
shall first apply for and obtain from
APHIS an import permit as provided in
§ 93.404: Provided, that: An import
permit is not required for sheep or goats
imported for immediate slaughter if the
animal is offered for entry at a land
border port designated in § 93.403(c).
*
*
*
*
*
■ 10. Section 93.428 is amended by
revising paragraph (a) to read as follows:
§ 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 § 93.435, and shall
be accompanied by a certificate issued
in accordance with § 93.405 and stating,
if such sheep and goats are shipped by
rail or truck, that such animals were
loaded into cleaned and disinfected cars
or trucks for transportation direct to the
port of entry. Notwithstanding such
certificate, such sheep and goats shall be
detained as provided in § 93.427(a) and
shall be dipped at least once in a
permitted scabies dip under supervision
of an inspector.
*
*
*
*
*
■ 11. Section 93.435 is revised to read
as follows:
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
§ 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
§ 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
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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 § 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
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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 § 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
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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
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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
§ 93.404(a)(5) or (6).
(e) Sheep and goats transiting the
United States. Sheep or goats that meet
the entry requirements for immediate
slaughter in § 93.405 may transit the
United States in accordance with
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46635
§ 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 § 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 diseasefree status in § 92.4 of this subchapter.
APHIS will remove a region from the
list of those it has declared free of
classical scrapie upon determining 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)
§ 93.505
[Amended]
12. Amend § 93.505(a), by removing
the citation ‘‘§ 94.24(b)(6)’’ and
replacing it with the citation
‘‘§ 94.31(b)(6)’’.
■
PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, NEWCASTLE
DISEASE, HIGHLY PATHOGENIC
AVIAN INFLUENZA, AFRICAN SWINE
FEVER, CLASSICAL SWINE FEVER,
SWINE VESICULAR DISEASE, AND
BOVINE SPONGIFORM
ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS
13. The authority citation for part 94
continues to read as follows:
■
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asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
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.
and Transportation of Controlled
Materials and Organisms and Vectors.
To apply for a permit, file a permit
application on VS Form 16–3 (available
■ 14. Section § 94.15 is revised to read
from APHIS, Veterinary Services,
as follows:
National Import Export Services, 4700
River Road Unit 38, Riverdale, MD
§ 94.15 Transit shipment of articles.
20737–1231, or electronically at http://
(a) Any meat or other animal product
www.aphis.usda.gov/animal_health/
or material (excluding materials that are permits/).
required to be consigned to USDA(2) The pork or pork products are
approved establishments for further
packaged at a Tipo Inspeccio´n Federal
processing) that is eligible for entry into plant in Baja California, Baja California
the United States, as provided in this
Sur, Campeche, Chihuahua, Coahuila,
part or in part 95 of this subchapter,
Nuevo Leon, Quintana Roo, Sinaloa,
may transit the United States by air and Sonora, or Yucatan, Mexico, in
ocean ports and overland transportation leakproof containers and sealed with
if the articles are accompanied by the
serially numbered seals of the
required documentation specified in
Government of Mexico, and the
this part and in part 95.
containers remain sealed during the
(b) Any meat or other animal product
entire time they are in transit across
or material that is not eligible for entry
Mexico and the United States.
into the United States, as provided in
(3) The person moving the pork and
this part or in part 95 of this subchapter, pork products through the United States
may transit air and ocean ports only,
notifies, in writing, the authorized
with no overland movement outside the Customs inspector at the United States
airport terminal area or dock area of the port of arrival prior to such transiting.
maritime port, in the United States for
The notification must include the
immediate export if the conditions of
following information regarding the
paragraphs (b)(1) through (4) of this
pork and pork products:
section are met.
(i) Permit number;
(1) The articles must be sealed in
(ii) Times and dates of arrival in the
leakproof containers bearing serial
United States;
numbers during transit. Each container
(iii) Time schedule and route to be
must remain under either Customs seal
followed through the United States; and
(iv) Serial numbers of the seals on the
or Foreign Government seal during the
entire time that it is in the United States. containers.
(4) The pork and pork products must
(2) Before transit, the person moving
transit the United States under Customs
the articles must notify, in writing, the
bond and must be exported from the
authorized Customs inspector at both
the place in the United States where the United States within the time limit
specified on the permit. Any pork or
articles will arrive and the port of
pork products that have not been
export. The notification must include
exported within the time limit specified
the:
on the permit or that have not been
(i) Times and dates of arrival in the
transited in accordance with the permit
United States;
or applicable requirements of this part
(ii) Times and dates of exportation
will be destroyed or otherwise disposed
from the United States;
(iii) Mode of transportation; and
of as the Administrator may direct
(iv) Serial numbers of the sealed
pursuant to the Animal Health
containers.
Protection Act (7 U.S.C. 8301 et seq.).
(d) Poultry carcasses, parts, or
(3) The articles must transit the
products (except eggs and egg products)
United States under Customs bond.
(4) The shipment is exported from the from Baja California, Baja California
United States within 7 days of its entry. Sur, Campeche, Chihuahua, Nuevo
(c) Pork and pork products from Baja
Leon, Quintana Roo, Sinaloa, Sonora,
California, Baja California Sur,
Tamaulipas, or Yucatan, Mexico, that
Campeche, Chihuahua, Coahuila, Nuevo are not eligible for entry into the United
Leon, Quintana Roo, Sinaloa, Sonora,
States in accordance with the
and Yucatan, Mexico, that are not
regulations in this part may transit the
eligible for entry into the United States
United States via land ports for
in accordance with this part may transit immediate export if the following
the United States via land border ports
conditions of paragraphs (d)(1) through
for immediate export if the following
(4) of this section are met:
(1) The person moving the poultry
conditions of paragraphs (c)(1) through
carcasses, parts, or products through the
(4) of this section are met:
United States must obtain a United
(1) The person moving the pork and
States Veterinary Permit for Importation
pork products must obtain a United
States Veterinary Permit for Importation and Transportation of Controlled
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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
Inspeccio´n Federal plant in Baja
California, Baja California Sur,
Campeche, Chihuahua, Nuevo Leon,
Quintana Roo, Sinaloa, Sonora,
Tamaulipas, or Yucatan, Mexico, in
leakproof containers with serially
numbered seals of the Government of
Mexico, and the containers remain
sealed during the entire time they are in
transit through Mexico and the United
States.
(3) The person moving the poultry
carcasses, parts, or products through the
United States must notify, in writing,
the authorized 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 § 94.11(a) and pork and pork
products from regions listed in § 94.13
that do not meet the requirements of
§ 94.11(b) or § 94.13(a) may transit
through the United States for immediate
export, provided the provisions of
paragraph (b) of this section are met,
and provided all other applicable
provisions of this part are met.
(Approved by the Office of Management and
Budget under control numbers 0579–0040
and 0579–0145)
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§ 94.18
[Amended]
15. In paragraph (a), by adding the
word ‘‘and’’ before the citation ‘‘94.23’’
and removing the words ‘‘, and § 94.27’’.
■
§ 94.24
[Removed and Reserved]
16. Section 94.24 is removed and
reserved.
■
§ 94.25
[Removed and reserved]
17. Section 94.25 is removed and
reserved.
■ 18. Section 94.26 is revised to read as
follows:
■
§ 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.
§ 94.27
[Removed and reserved]
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
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.
§ 95.1
[Amended]
21. Section 95.1 is amended by
removing the definitions of ‘‘Positive for
a transmissible spongiform
encephalopathy’’ and ‘‘Suspect for a
transmissible spongiform
encephalopathy’’.
■ 22. Section 95.4 is amended as
follows:
■ a. The section heading is revised;
■ b. Paragraph (a) is revised;
■ c. Paragraph (b)(1) is revised;
■ d. Paragraphs (c)(1)(ii) and (iv) are
revised;
■ 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;
■ f. In newly redesignated paragraph
(c)(3), the first sentence is revised;
■ g. In newly redesignated paragraph
(c)(5), the reference ‘‘(c)(5)’’ is removed
and the reference ‘‘(c)(3)’’ is added in its
place;
■ h. In newly redesignated paragraph
(c)(6), the words ‘‘National Center for
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
■
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Import and Export’’ are removed and the
words ‘‘National Import Export
Services’’ are added in their place;
■ i. Paragraphs (d) and (e) are removed;
■ j. Paragraph (f) and the Note to
paragraph (f) are redesignated as
paragraph (d) and the Note to paragraph
(d), respectively; and
■ k. Paragraph (g) is removed.
The revisions read as follows:
§ 95.4 Restrictions on the importation of
processed animal protein, offal, tankage,
fat, glands, tallow, tallow derivatives, and
serum due to bovine spongiform
encephalopathy.
(a) Except as provided in this section,
or in § 94.15, any of the materials listed
in paragraph (b) in this section derived
from animals, or products containing
such materials, are prohibited
importation into the United States.
(b) * * * (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 § 95.5.
*
*
*
*
*
(iv) Ovines and caprines, and the
material is not ineligible for importation
under the conditions of § 95.5.
*
*
*
*
*
(3) If the facility processes or handles
any processed animal protein,
inspection of the facility for compliance
with the provisions of this section is
conducted at least annually by a
representative of the government agency
responsible for animal health in the
region, unless the region chooses to
have such inspection conducted by
APHIS. * * *
*
*
*
*
*
§ 95.15
[Removed and reserved]
23. Section 95.15 is removed and
reserved.
■
§ 95.40
[Removed and reserved]
24. Section 95.40 is removed and
reserved.
■
PART 96—RESTRICTION OF
IMPORTATIONS OF FOREIGN ANIMAL
CASINGS OFFERED FOR ENTRY INTO
THE UNITED STATES
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.
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§ 96.2
46637
[Amended]
26. Section 96.2 is amended as
follows:
■ a. Paragraph (b)(1) is removed.
■ b. Paragraph (b)(2) is redesignated as
paragraph (b)(1).
■ c. A new paragraph (b)(2) is added
and reserved.
■ 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
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.
28. Section 98.2 is amended by
adding, in alphabetical order,
definitions for ‘‘Oocyte’’ and
‘‘Transmissible spongiform
encephalopathies (TSEs)’’ to read as
follows.
■
§ 98.2
Definitions.
*
*
*
*
*
Oocyte. The first and second
maturation stages of a female
reproductive cell prior to fertilization.
*
*
*
*
*
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, noninflammatory neuronal loss, giving a
spongiform appearance to tissues in the
brains and nervous systems of affected
animals.
*
*
*
*
*
§ 98.3
[Amended]
29. Section 98.3 is amended as
follows:
■ a. In paragraph (d), by adding the
words ‘‘except that, for sheep and goats
only, the donor sire must meet the
scrapie requirements in § 98.35 instead
of the requirements in § 93.435 of this
chapter;’’ after the words ‘‘United
States;’’;
■ b. In paragraph (e), by 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 § 98.10(a) instead of the
requirements in § 93.435 of this
chapter;’’ after the words ‘‘United
States;’’; and
■
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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Proposed Rules
c. In paragraph (f), by removing the
words ‘‘§ 93.404(a)(2) or (3)’’ and adding
the words ‘‘§ 93.404(a)(3) or (4)’’ in their
place.
■ 30. Section 98.4 is amended by adding
paragraph (e) to read as follows:
■
§ 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.
§ 98.5
[Amended]
31. In § 98.5, paragraph (b) is removed
and reserved.
■ 32. Section 98.10a is revised to read
as follows:
■
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
§ 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 §§ 98.3 through 98.8.
In addition to the requirements of
§ 98.5, the health certificate must
indicate that the embryos or oocytes
were collected, processed, and stored in
conformity with the requirements in
§ 98.3(g).
(b) In vivo-derived sheep and goat
embryos or oocytes collected from
donors located in, or originating from,
regions or flocks not recognized by
APHIS as free of classical scrapie, may
be imported in accordance with §§ 98.3
through 98.8 and the following
conditions:
(1) The embryos or oocytes must be
accompanied by a health certificate
meeting the requirements listed in
§ 98.5, and with the following
additional certifications:
(i) The embryos or oocytes were
collected, processed and stored in
conformity with the requirements in
§ 98.3(g).
(ii) For in vivo-derived sheep embryos
only: The embryo is of the genotype
AAQR or AARR based on official testing
of the parents or the embryo.
(iii) Certificates for sheep embryos
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:
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(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
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Fmt 4702
Sfmt 4702
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 § 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 § 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)
■ 33. Section 98.13 is amended by
adding paragraph (c) to read as follows:
§ 98.13
Import permit.
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(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.
*
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*
*
*
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18JYP1
Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Proposed Rules
§ 98.15
[Amended]
§ 98.30
Definitions.
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*
Establishment. The premises in which
animals are kept.
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■ 36. Section 98.35 is amended as
follows:
■ 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;
■ b. Newly redesignated (e)(1)(iii) is
revised;
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
*
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17:46 Jul 15, 2016
c. New paragraph (e)(1)(iv) is added;
d. Paragraph (e)(3) is revised; and
■ e. Paragraphs (e)(4) and (5) are added.
The revisions and additions read as
follows:
■
34. Section 98.15 is amended as
follows:
■ a. In paragraph (a), introductory text,
by removing the words ‘‘follows, except
that, with regard to bovine spongiform
encephalopathy, the following does not
apply to bovines, cervids, or camelids’’
and adding the word ‘‘follows:’’ in their
place.
■ b. In paragraph (a)(1)(i), by removing
the words ‘‘Bovine spongiform
encephalopathy, contagious’’ and
adding the word ‘‘Contagious’’ in their
place.
■ c. In paragraph (a)(2)(i), by removing
the words ‘‘Bovine spongiform
encephalopathy, contagious’’ and
adding the word ‘‘Contagious’’ in their
place.
■ d. In paragraph (a)(7)(i)(A), by
removing the words ‘‘Bovine
spongiform encephalopathy,
brucellosis’’ and adding the word
‘‘Brucellosis’’ in their place.
■ e. In paragraph (a)(8)(i)(A), by
removing the words ‘‘Bovine
spongiform encephalopathy,
brucellosis’’ and adding the word
‘‘Brucellosis’’ in their place.
■ 35. Section 98.30 is amended by
adding, in alphabetical order, a
definition for ‘‘Establishment’’ to read as
follows.
■
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■
§ 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.
*
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*
(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
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Fmt 4702
Sfmt 9990
46639
notification to the responsible APHIS
Veterinary Services Service Center.
(4) The importer, the owner of a
recipient flock or herd to which delivery
of the semen is made, or the owner of
an APHIS-approved semen storage
facility must maintain records of the
disposition (including destruction) of
imported or stored semen for 5 years
after the semen is transferred or
destroyed. These records must be made
available during normal business hours
to APHIS representatives on request for
review and copying.
(5) The owner of all sheep or goats
resulting from semen imported under
this section shall:
(i) Identify them at birth with a
permanent official identification
number consistent with the provisions
of § 79.2 of this chapter; such
identification may not be removed
except at slaughter and must be
replaced if lost;
(ii) Maintain a record linking the
official identification number to the
imported semen, including a record of
the replacement of lost tags;
(iii) Maintain records of any sale or
disposition of such animals, including
the date of sale or disposition, the name
and address of the buyer, and the
animal’s official identification number;
and
(iv) Keep the required records for a
period of 5 years after the sale or death
of the animal. APHIS may view and
copy these records during normal
business hours.
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*
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
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18JYP1
| File Type | application/pdf |
| File Modified | 2016-07-16 |
| File Created | 2016-07-16 |