Federal Register, Volume 76 Issue 29 (Friday, February 11, 2011)

[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Proposed Rules]
[Pages 7721-7731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3112]

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Proposed Rules
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 /
Proposed Rules

[[Page 7721]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 98

[Docket No. APHIS-2008-0043]
RIN 0579-AD20

Importation of Live Swine, Swine Semen, Pork, and Pork Products;
Estonia, Hungary, Slovakia, and Slovenia

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations governing the
importation of animals and animal products to add Estonia, Hungary,
Slovakia, and Slovenia to the region of the European Union that we
recognize as a low-risk region for classical swine fever (CSF). Swine,
swine semen, pork, and pork products may be imported into the United
States from this region under certain conditions. We are proposing to
remove one of these conditions, a 40-day holding period for swine semen
and donor boars after the collection of swine semen, based on our
determination that it is unnecessary. We are also proposing to add
Estonia, Slovakia, and Slovenia to the list of regions we consider free
of swine vesicular disease (SVD) and to add Slovakia and Slovenia to
the list of regions considered free of foot-and-mouth disease (FMD) and
rinderpest. These proposed actions would relieve some restrictions on
the importation into the United States of certain animals and animal
products from those regions, while continuing to protect against the
introduction of CSF, SVD, FMD, and rinderpest into the United States.

DATES: We will consider all comments that we receive on or before April
12, 2011.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0043 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2008-0043, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0043.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Donald Link, Import Risk Analyst,
Regionalization Evaluation Services, National Center for Import and
Export, VS, APHIS, 920 Main Campus Drive Suite 200, Raleigh, NC 27606;
(919) 855-7730.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture (USDA) regulates the
importation of animals and animal products into the United States to
guard against the introduction of animal diseases not currently present
or prevalent in this country. The regulations in 9 CFR part 94
(referred to below as the regulations) prohibit or restrict the
importation of specified animals and animal products to prevent the
introduction into the United States of various animal diseases,
including classical swine fever (CSF), foot-and-mouth disease (FMD),
swine vesicular disease (SVD), and rinderpest. These are dangerous and
communicable diseases of ruminants and swine.
The regulations in 9 CFR part 98 govern the importation of animal
germplasm to prevent the introduction of contagious diseases of
livestock and poultry into the United States. Subparts A and B of part
98 apply to animal embryos, and subpart C (Sec. Sec. 98.30 through
98.38) applies to animal semen.
Sections 94.9 and 94.10 of the regulations list regions of the
world that are declared free of, or low-risk for, CSF. The APHIS-
defined EU CSF region, consisting of the 19 Member States of the EU
that we currently recognize as a single region with regard to CSF, is
currently the only region we consider low-risk for CSF. Sections 94.24
and 98.38 specify restrictions necessary to mitigate the risk of
introducing CSF into the United States via pork, pork products, live
swine, and swine semen from that region. We will discuss the
restrictions on swine semen, found in Sec. 98.38, at greater length
later in this document.
Section 94.12 of the regulations lists regions that are declared
free of SVD, and Sec. 94.13 of the regulations lists regions that have
been determined to be free of SVD, but that are subject to certain
restrictions because of their proximity to, or trading relationships
with, SVD-affected regions.
Section 94.1 of the regulations lists regions of the world that are
declared free of rinderpest or free of both rinderpest and FMD. Section
94.11 of the regulations lists regions that have been determined to be
free of rinderpest and FMD, but that are subject to certain
restrictions because of their proximity to or trading relationships
with rinderpest- or FMD-affected regions.
On May 1, 2004, Estonia, Hungary, Slovakia, and Slovenia became
Member States of the EU. As part of the accession process, these new EU
Member States adopted the legislation of the European Commission (EC)
\1\ regarding animal health, welfare, and identification, including
legislation pertaining to CSF, FMD, and SVD. This legislation became
the basis for new standard operating procedures for domestic animal
health matters in Estonia, Hungary, Slovakia, and Slovenia by the time
of their accession. Estonia, Hungary, Slovakia, and Slovenia also
adopted the harmonizing

[[Page 7722]]

EC legislation regarding sanitary measures applicable to import and
trade in live animals and animal products.
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\1\ The EC is the EU institution responsible for representing
the EU as a whole. It proposes legislation, policies, and programs
of action and implements decisions of the EU Parliament and Council.
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Prior to joining the EU in 2004, the Government of Slovakia
requested APHIS to evaluate its animal health status with respect to
CSF in 1997, to SVD in 2001, and to FMD and rinderpest in 2002.
Likewise, the Government of Hungary requested that APHIS evaluate its
animal health status with respect to CSF in 2001. After joining the EU,
the Government of Estonia made a similar request with respect to CSF
and SVD in 2005, and, that same year, the Government of Slovenia made a
request for APHIS to evaluate its animal health status with respect to
CSF, SVD, FMD, and rinderpest. APHIS had previously listed Estonia as
free of FMD and rinderpest in a final rule published in the Federal
Register on May 30, 2002 (67 FR 37663-37664, Docket No. 01-041-2), and
had listed Hungary as free of FMD and rinderpest in a final rule
published in the Federal Register on June 1, 1994 (59 FR 28216-28218,
Docket No. 93-172-2), and SVD in a final rule published in the Federal
Register on August 2, 1973 (38 FR 20610-20611).

Summary of Proposed Changes

In this document, we are proposing to add Estonia, Hungary,
Slovakia, and Slovenia to the APHIS-defined EU CSF region. We are also
proposing to remove one of the conditions pertaining to the importation
of swine semen from that region. With the exception of semen collected
from swine in Denmark, Finland, the Republic of Ireland, Sweden, or the
United Kingdom, we require that, before swine semen may be exported to
the United States, the semen and donor boars be held at the semen
collection center for at least 40 days following collection of the
semen, and, along with all other swine at the semen collection center,
exhibit no clinical signs of CSF. For reasons discussed later in this
document, we have determined that this requirement is unnecessary.
We are also proposing to add Estonia, Slovakia, and Slovenia to the
list of regions recognized as free of SVD, and to the list of SVD-free
regions whose exports of pork and pork products to the United States
are subject to certain restrictions to prevent the introduction of SVD
into this country.
Additionally, we are proposing to add Slovakia and Slovenia to the
list of regions recognized as free of FMD and rinderpest. We are also
proposing to add Slovakia and Slovenia to the list of FMD and
rinderpest-free regions whose exports of ruminant and swine meat and
products to the United States are subject to certain restrictions to
prevent the introduction of FMD and rinderpest into this country.
As part of our evaluation of their disease status, APHIS identified
the smallest administrative units (AUs) within each of these EU Member
States that we would consider designating as regions in the event of
future animal disease outbreaks. See the discussion of these AUs under
the section titled ``Administrative Units.''

The Low-Risk CSF Region in the EU; History

Before discussing our assessments of the animal health status of
Estonia, Hungary, Slovakia, and Slovenia with regard to CSF and other
diseases, and our determination that Estonia, Hungary, Slovakia, and
Slovenia can be added to the APHIS-defined EU CSF region, we consider
it helpful to explain how the region came about and how countries were
added to that region. Later in this document, we will discuss under
what conditions swine semen may currently be imported into the United
States from that region, in order to provide context for the provision
that we are proposing to remove from those requirements.
Traditionally, we have recognized countries either as affected with
CSF or free of CSF. Pork and pork products from a country affected with
CSF could be imported into the United States only after meeting
rigorous processing and certification requirements; live swine, with a
few, limited exceptions, could not be imported into the United States
from such countries. Conversely, swine, pork, pork products, and semen
from countries that we considered free of CSF could be imported into
the United States under certain conditions.
In 1999, we prepared a risk analysis, titled ``Biological Risk
Analysis: Risk assessment and management options for imports of swine
and swine products from the European Union--June 2, 1999,'' in response
to a request from the EC that we recognize a region of 10 EU Member
States as free of CSF. That analysis, along with another, supplemental
risk analysis, ``Risk Analysis for Importation of Classical Swine Fever
Virus in Swine and Swine Products from the European Union--December
2000,'' took into consideration the CSF history of the 10 Member States
in the EC's request, the CSF history of countries adjacent to this
region, the veterinary infrastructure and policies of the region, and
the historical volumes of imports into the United States of breeding
swine, swine semen, pork, and pork products from the region. Moreover,
the analyses also took into consideration the open borders among Member
States of the EU, and the possibility of commingling of pork products
from a CSF-free region and a CSF-affected region prior to their
importation into the United States.
The analyses concluded that, because of this open-border policy,
and because CSF was endemic in wild boar in several parts of the EU, it
was likely that limited outbreaks of CSF would continue to occur in
domestic swine in the region.
Based on the analyses, we decided that the unrestricted importation
of swine, swine semen, pork, and pork products from the region could
present a risk of introducing CSF into the United States. However, we
also decided that this risk was low, and that the application of
certain risk mitigation measures on the importation of these products
would further reduce the risk of introduction of CSF into the United
States. Therefore, we initiated a rulemaking that we finalized on April
7, 2003 (68 FR 16922-16941, Docket No. 98-090-5), to recognize a single
region of 10 Member States or parts of Member States of the EU that we
determined to present a low risk of introducing CSF into the United
States.
In that rule, we mentioned that we considered the control
mechanisms for CSF employed by the EU to be sufficient to mitigate any
risk that continuing outbreaks of CSF in the EU could pose to swine,
swine semen, pork, or pork products destined for export to the United
States. We outlined these EU-imposed mitigation measures, which
included measures to prevent widespread exposure and establishment of
the disease; specific mitigation measures, such as wildlife
surveillance and epidemiological investigations; and contingency plans
establishing proactive approaches to CSF control. In sum, we stated
that we considered the EU as a whole to be homogeneous with regard to
CSF risk, regardless of individual outbreaks within Member States.
Accordingly, in a rulemaking that we finalized on May 19, 2006 (71
FR 29061-29072, Docket No. 02-046-2), we recognized the EU-15.\2\ We
considered the EU-15 to be those 15 Member States comprising the EU as
of April 20, 2004: Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Italy, Luxembourg, the Netherlands, Portugal, Republic of
Ireland, Spain, Sweden, and the United Kingdom (England, Scotland,

[[Page 7723]]

Wales, the Isle of Man, and Northern Ireland).
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\2\ To view this rule, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2005-0028.
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Second, in recognition of the presence of CSF within the EU, and
the possibility of future outbreaks of the disease, we also recognized
``restricted zones,'' or quarantined areas for CSF within the Member
States of the EU-15. We defined a restricted zone in the regulations as
``An area, delineated by the relevant competent veterinary authorities
of the region in which the area is located, that surrounds and includes
the location of an outbreak of CSF in domestic swine or detection of
the disease in wild boar, and from which the movement of domestic swine
is prohibited.'' We stated that, once a restricted zone was
established, a prohibition on the importation of swine and swine
products from that region into the United States would be immediate,
with no action required by APHIS.
Finally, on November 28, 2007, we issued a final rule (72 FR 67227-
67233, Docket No. APHIS-2006-0106) \3\ that amended the regulations to
add the Czech Republic, Latvia, Lithuania, and Poland to the low-risk
region for CSF. The rule also removed the term ``EU-15'' and added
``APHIS-defined EU CSF region'' in its place, since the addition of
these countries had rendered the former term obsolete.
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\3\ To view this rule, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0106.
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We will now discuss the analyses that have led us to propose to
include Estonia, Hungary, Slovakia, and Slovenia in the EU CSF region,
to conclude that Estonia, Slovakia, and Slovenia are free of SVD, and
to conclude that Slovakia and Slovenia are free of FMD and rinderpest.

APHIS Evaluations Regarding the CSF and SVD Status of Estonia, the CSF
Status of Hungary, and the CSF, SVD, FMD, and Rinderpest Statuses of
Slovakia and Slovenia

APHIS has conducted an evaluation regarding the CSF and SVD status
of Estonia; an evaluation regarding the CSF status of Hungary; an
evaluation regarding the CSF, SVD, FMD, and rinderpest status of
Slovakia; and an evaluation regarding the CSF, SVD, FMD, and rinderpest
status of Slovenia. The evaluations regarding Estonia and Slovakia were
finalized in January 2011, the evaluation regarding Hungary in May
2009, and the evaluation regarding Slovenia in October 2007. Each
evaluation may be viewed on the Regulations.gov Web site (see ADDRESSES
above for instructions for accessing Regulations.gov). In the following
paragraphs, we summarize our findings for each of the 11 factors set
out in our procedures for requesting recognition of regions in 9 CFR
92.2 and summarize our risk considerations of these findings following
our discussion of the factors.

Authority, Organization, and Veterinary Infrastructure

As stated above, Estonia, Hungary, Slovakia, and Slovenia have
adopted the legislation of the EC regarding animal health, welfare, and
identification, as well as sanitary measures applicable to import and
trade in live animals and animal products. At the time of accession,
Commission Decisions and Regulations concerning CSF, SVD, and FMD
became directly applicable in the new EU Member States, whereas Council
Directives were implemented in national legislation. Our evaluations
document that Estonia, Hungary, Slovakia, and Slovenia have, in fact,
implemented these directives; this documentation was corroborated by
site visits.
APHIS concludes that the official veterinary services of Estonia,
Hungary, Slovakia, and Slovenia have sufficient legal authority,
personnel, and financial resources to carry out animal health
activities quickly and efficiently. The official offices are well-
organized, with clear lines of command and reporting, as well as
sufficient autonomy at the local level to carry out the tasks assigned.
Internal and external auditing practices are adequate to monitor for
compliance with the provisions of the pertinent animal health
legislation.

Disease History

CSF: The most recent outbreak of CSF in domestic swine in Estonia
occurred in 1994. In Hungary, the most recent outbreak of CSF in
domestic swine occurred in 1993. In Slovakia, the last outbreak of CSF
in domestic swine occurred in 2008. In Slovenia, the last outbreak in
domestic swine occurred in 1996.
In both Hungary and Slovakia, CSF is endemic within the wild boar
population. We discuss this at greater length later in this document.
SVD: SVD has never been reported to have occurred in either Estonia
or Slovenia. In 1972, there were 16 cases of SVD reported in Slovakia;
in each case, the swine had been imported into the country.
FMD: FMD was last reported in Slovenia in 1968, and in Slovakia in
1973.
Rinderpest: Rinderpest was last reported in Slovakia in 1881, and
in Slovenia in 1883; the countries are recognized by the World
Organization for Animal Health (OIE) as being free of the disease.

Disease Status of Adjacent Regions

CSF: Estonia is bordered by Latvia to the south and Russia to the
east. APHIS considers Latvia to be a low-risk region for CSF. APHIS has
not evaluated Russia for its CSF status. However, Russia has
experienced multiple outbreaks of CSF in domestic swine since 1996, and
had its most recent outbreak in 2010. It is worth noting, in this
regard, that APHIS considers any country that we have not evaluated for
CSF as having a status equivalent to that of a CSF-affected country.
The risk analysis for Estonia considers the occurrence of CSF in
Russia to be a potential risk factor for the introduction of CSF into
that country. However, no region in Russia that borders Estonia has
reported a CSF outbreak since 2000, and adequate control measures
appear to be in place to prevent the possible spread of the disease to
Estonia. Therefore, the analysis concludes that the Russian regions
adjacent to Estonia do not appear to pose a high risk as potential
sources of CSF introduction.
Hungary shares borders with seven countries. Of these, four are EU
Member States: Austria, Slovakia, Romania, and Slovenia. The remaining
three--Croatia, Serbia and Montenegro, and Ukraine--are EC-designated
``third countries,'' i.e., countries that are approved by the EC to
export certain live animals and animal products to EU Member States
because they meet certain animal health standards that are at least
equivalent to those required of EU Member States. None of these three
countries, however, is approved to export live swine, swine semen,
pork, or pork products to the EU at this time.
APHIS considers Austria to be a low-risk region for CSF. CSF has
been enzootic, or persistently present, within Romania for the last few
years, although it currently appears to be under control. Hungary
continues to implement enhanced checks for forbidden pork products from
Romania in passenger baggage at and near the Hungary/Romania border.
The CSF disease histories of Slovakia and Slovenia are discussed
earlier in this document.
APHIS has not evaluated Croatia, Serbia and Montenegro, or Ukraine
for their CSF status. Between July 2006 and April 2008, Croatia
reported a series of outbreaks in its domestic swine population--129
occurrences in total, over 11 counties--with several occurring between
20 and 50 kilometers (approximately 12.4 to 31 miles) from

[[Page 7724]]

the Hungarian border. In addition, according to the OIE, Serbia and
Montenegro was known to have had widespread CSF in its domestic swine
population as recently as 2005. Subsequently, Serbia and Montenegro
implemented vaccination in the domestic swine population in order to
control the outbreak. No evidence exists, however, to suggest that CSF
has been eradicated in the country; in fact, there was a limited
outbreak in domestic swine as recently as 2010. Finally, Ukraine
reported its last CSF outbreak in 2001. In response to the outbreak,
Ukraine undertook several disease control measures, including a
quarantine of the area, depopulation of weak or sick animals, and
vaccination of all domestic swine within a 3 kilometer (approximately
1.86 mile) radius.
Because five of the seven countries adjacent to Hungary have had
recent CSF outbreaks, the risk analysis for that country considers
these countries to be potential sources of infection of CSF. The
analysis notes that Hungary has surveillance measures in place to
detect CSF in its wild boar population and, because of the harmonized
control measures that Hungary adopted at the time of its accession into
the EU, the analysis considers the risk of CSF in its wild boar to be
sufficiently mitigated.
Slovakia is bordered by Austria to the west, the Czech Republic to
the northwest, Poland to the northeast, Ukraine to the east, and
Hungary to the south. APHIS considers Austria, the Czech Republic, and
Poland to be low-risk regions for CSF.
The analysis concludes that CSF could be introduced into domestic
swine in Slovakia from a neighboring country, but that EC control
measures serve to limit this risk, and that, accordingly, the risk is
less immediate than that posed by native infected boar.
Slovenia is bordered by Austria to the north, Italy to the west,
Hungary to the upper northeast, and Croatia to the south and lower
northeast. APHIS considers Austria and Italy to be low risk regions for
CSF. Croatia has experienced recent outbreaks of CSF.\4\ The CSF
disease history of Hungary is discussed earlier in this document.
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\4\ An evaluation of the disease status of Croatia with regard
to CSF has been initiated.
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The risk analysis considers the occurrence of CSF in Croatia to
present a potential risk factor for the introduction of CSF into
Slovenia. However, APHIS recognizes that Slovenia, in response to
outbreaks within Croatia, strengthened its CSF surveillance along the
Croatian border, and considers this a reasonable risk mitigation.
SVD: With regard to the SVD status of countries bordering Estonia,
neither Latvia nor Russia has ever reported an outbreak of SVD. With
regard to the status of those countries bordering Slovakia and
Slovenia, APHIS considers Austria, the Czech Republic, Hungary, and
Poland to be free of SVD. APHIS considers certain regions of Italy to
be affected with SVD, and has not evaluated either Croatia or Ukraine
for their SVD status. The risk analyses conclude that the regions
adjacent to Estonia, Slovakia, and Slovenia appear to pose a low risk
as potential sources of SVD introduction into these three countries.
FMD: With regard to the FMD status of countries bordering Slovakia
and Slovenia, APHIS considers Austria, the Czech Republic, Hungary,
Italy, and Poland to be free of FMD, but has not evaluated Croatia or
Ukraine for their FMD status. The risk analysis concludes that the risk
of introduction of FMD into Slovakia or Slovenia from neighboring
countries is low, and mitigated by movement controls and border
veterinary inspection.
Rinderpest: APHIS considers Austria, the Czech Republic, Hungary,
Italy and Poland to be free of rinderpest, but has not evaluated
Croatia or the Ukraine for their rinderpest status.

Degree of Separation From Adjacent Regions

Estonia is separated from most nearby regions by large bodies of
water. It is bordered to the southwest by the Gulf of Riga, to the west
by the Baltic Sea, to the north by the Gulf of Finland, and to the east
by Lake Peipus, Lake Pskov, and the Narva River. Estonia shares land
borders with only two countries: Latvia to the south, and Russia to the
east. As mentioned above, APHIS considers Latvia to be a low risk for
CSF, and Latvia has never reported an occurrence of SVD. There have
been multiple outbreaks of CSF in Russia in recent years; however,
there has not been an outbreak in the two administrative regions that
border Estonia since 2000. Thus, land regions immediately adjacent to
Estonia do not appear to pose a high risk for CSF and SVD.
There are few natural barriers to animal or human movement along
the majority of Hungary's borders. The most significant natural barrier
is the Danube River, which constitutes a portion of the border with
Slovakia. Nonetheless, the analysis considers the risk of introduction
of CSF into Hungary to be partially mitigated by border veterinary
inspection and ongoing disease surveillance efforts, which are
concentrated on border counties.
There are few natural barriers to the introduction of CSF, FMD,
SVD, or rinderpest via animal or human movement along the border
between Slovakia and neighboring countries. As noted above, the Danube
River forms part of the border between Slovakia and Hungary; it also
runs along a portion of the Austro-Slovakian border. The Carpathian
Mountains lie to the north, but are not high enough to substantially
limit animal movement. Animals in neighboring countries that could
serve as reservoirs for CSF, SVD, FMD, and rinderpest--deer, chamois,
bison, and wild boar--tend to be nonmigratory, and all bordering
countries except Ukraine are considered by APHIS to be free of FMD,
SVD, and rinderpest. Accordingly, the analysis concludes that CSF, SVD,
FMD, or rinderpest could be introduced into Slovakia through animal
movement, but that the risk of such introduction is very low with
regard to FMD, SVD, or rinderpest. There is a slightly greater risk of
CSF introduction into Slovakia, since wild boars are the primary
reservoir of the disease and may enter Slovakia from neighboring
countries. Nonetheless, the risk of CSF introduction is still low,
based on the risk-mitigation measures Slovakia has in place, including
wildlife surveillance.
Slovenia is bordered by the countries of Austria, Italy, Hungary,
and Croatia. The Adriatic Sea is on its southwestern border. The Julian
Alps provide a natural barrier between Slovenia and Austria, and
substantially limit animal movement at their highest points. The Alps
also separate Slovenia from Italy, but are more passable along this
border, particularly since their incline drops as they approach the
Adriatic Sea. Slovenia is separated from Croatia and Hungary by a State
border alone. Effective movement controls, border veterinary
inspection, and enhanced disease surveillance in border regions
mitigate the risk of introduction of disease from these two countries.

Extent of an Active Disease Control Program

Due to the absence of CSF and SVD outbreaks in recent years, there
are no CSF and SVD control programs currently active in Estonia.
In response to the detection of CSF in wild boar along the border
with Slovakia, Hungary has exercised disease control measures within
the infected area. As pertains to the wild boar population, Hungary has
implemented hunting restrictions and mandatory veterinary inspections
for any boar shot

[[Page 7725]]

or found dead within an affected county. As pertains to the domestic
swine population, Hungary has implemented a census of all swine on
premises within the quarantined area, standard procedures for cleaning
and disinfection, and enhanced reporting requirements for swine
exhibiting clinical signs of CSF infection.
Shortly before Slovakia's accession to the EU, the EC recognized
that CSF was endemic in the wild boar population in a certain area of
the country, and thus designated the area a restricted area.
Accordingly, the EC imposed movement restrictions on swine and swine
products from the area, and required Slovakia to undertake an
eradication-based CSF vaccination program for wild boar within the
area. Slovakia does not have active disease control programs for SVD,
FMD, or rinderpest, as none of these diseases have been reported in the
country in many years.
Control measures for CSF in Slovenia include active systematic
monitoring, veterinary inspection, movement certificates, field
investigations, and laboratory investigations. Due to the prolonged
absence of SVD, FMD, and rinderpest in Slovenia, Slovenia does not have
aggressive active disease surveillance programs for these diseases, but
maintains interlocking safeguards in order to prevent, detect, and
suppress them. These safeguards include veterinary certificates,
standard procedures for cleaning and disinfection, training of
veterinarians, veterinary technicians, and animal owners, indemnity and
compensation for diseased animals, and incentives for compliance with
animal health regulations.

Vaccination

General preventive vaccination against CSF and SVD is prohibited in
Estonia; emergency vaccinations for CSF are permitted only under
exceptional circumstances to prevent the spread of the disease in the
event of an outbreak, and only if sanctioned by the EC.
Routine vaccination for CSF has been prohibited within Hungary
since 1974. As noted above, the current outbreak of CSF in the wild
boar population within the country is being managed through hunting
restrictions, population control, and surveillance efforts.
Routine vaccination of domestic swine against CSF and SVD is
currently prohibited in Slovakia, as is vaccination of any animal for
FMD, although FMD vaccinations may be implemented in the event of an
outbreak. As noted above, however, there is CSF vaccination of wild
boar in the EC-designated restricted area within the country. Moreover,
since the last vaccination of domestic swine for CSF occurred in 2000,
there is some potential of detecting vaccine titers during CSF
slaughter surveillance. Finally, FMD vaccinations may be implemented in
the event of an outbreak.
The last vaccination against CSF occurred in Slovenia in 2000;
however, Slovenia has the authority to implement emergency vaccinations
in the event of a CSF outbreak. SVD vaccination is prohibited. FMD
vaccinations, although currently prohibited, may be implemented in the
event of an outbreak.

Movement Control From Higher Risk Regions

Some forms of CSF, SVD, and FMD are difficult to detect in live
animals or in post-mortem examinations without laboratory testing, and,
in some instances, detection may be delayed due to deficiencies in
active surveillance or diagnostic testing capabilities. Any such delay
in detection of an outbreak could increase the risk that infected
animals or animal products are exported to the United States.
Consequently, the risk analyses analyze potential pathways for disease
introduction into Estonia, Hungary, Slovakia, and Slovenia, such as
importation and intra-Community trade in live animals and animal
products, vehicular and human traffic, and commodities for human
consumption.
Import Controls: Importations must occur at specified road, rail,
air, and/or sea ports through a border inspection post (BIP) approved
by the EC; inspections and veterinary checks occur at such BIPs. The EC
conducts a rigorous inspection of each BIP prior to approval and
carries out regular audits to monitor the efficacy of sanitary
controls. APHIS considers EC-approved BIPs to be capable of performing
appropriate inspections and veterinary checks on animals and animal
products; this was corroborated by several site visits to Slovakian and
Hungarian BIPs in November 2004 and by visits to two BIPs in Estonia in
November 2005. Although the site visit to Slovenia did not include a
visit to a BIP, Slovenia provided APHIS with information certifying
that each Slovenian BIP is approved by the EC.
Swine, ruminants, and derived products such as meat, meat products,
and genetic material are harmonized commodities under EC legislation,
which means that the restrictions on imports from non-EU countries are
generally standardized across all EU Member States. Binding EC
legislation lists the non-EU countries, and establishments within those
countries, that are approved for export of certain commodities to the
EU. Slaughterhouses, cutting plants, semen collection centers, and
other exporting establishments are subject to inspection prior to
approval. Veterinary certificates required for export to the EU outline
comprehensive animal health and testing requirements and must be
endorsed by an official veterinarian of the exporting country.
At the time the analyses were conducted, four non-EU countries were
authorized to export both live swine and fresh pork products to EU
Member Countries: Chile, New Zealand, Norway, and Switzerland. Three
additional countries (Australia, Canada, and the United States) were
authorized to export fresh pork products alone, and one (Iceland) was
authorized to export live swine, but not pork products. The United
States is free of SVD, CSF, and FMD. APHIS recognizes all seven other
countries to be free of SVD (although some are subject to the
restrictions specified in Sec. 94.13), and all but Switzerland to be
free of CSF.\5\ APHIS also considers these countries to be free of FMD,
although some are subject to the restrictions specified in Sec. 94.11.
---------------------------------------------------------------------------

\5\ An evaluation of the disease status of Switzerland with
regard to CSF has been initiated.
---------------------------------------------------------------------------

However, although the importation of swine and pork products into
Estonia, Hungary, Slovakia, and Slovenia is currently limited to these
eight countries, and although the import practices of Estonia, Hungary,
Slovakia, and Slovenia have proven generally effective with regard to
CSF, SVD, or FMD, EC legislation allows EU Member States to import
fresh pork and pork products derived from swine from several regions
that APHIS has not evaluated and therefore regards as having the same
status as regions affected with these diseases. Moreover, EU Member
States may also import bovine embryos and meat and meat products from
both domestic and wild ruminants from regions that APHIS considers
affected with FMD.
Veterinary inspectors at the entry BIPs check that the
documentation accompanying commodities is in order, including
appropriate health certificates and other movement control documents,
and that the shipment is properly identified and the identification
matches the documentation. Veterinary inspectors also conduct physical
examinations of incoming shipments in accordance with EC legislation.
However, because CSF, SVD, and FMD testing is generally not required at
the BIPs, the mandated inspections would

[[Page 7726]]

not usually detect subclinical infection. The causal agents of CSF,
SVD, and FMD could also remain viable through carcass maturation,
transport, and storage, and could be present in genetic material.
Accordingly, the risk evaluations determined that there is some
risk of CSF, SVD, and/or FMD introduction into Estonia, Hungary,
Slovakia, and Slovenia through the importation of commodities from non-
EU Member States. However, the evaluations also found that this risk is
substantially mitigated by EC certification requirements for meat, meat
products, and genetic material, such as veterinary inspection of live
animals prior to shipment, restrictions on the sources (countries,
regions, premises, or production facilities) from which trade is
permitted, certification of disease status by an official veterinarian,
veterinary inspection at BIPs, and requirements for processing meant to
inactivate viral disease agents.
Trade Controls: As EU Member States, Estonia, Hungary, Slovakia,
and Slovenia may engage in intra-Community trade with other Member
States as governed by EC legislation that was transposed into national
legislation prior to accession. Live animals and animal products must
originate from a holding center or organization (e.g., market or
assembly center) that is under State veterinary control, i.e., that has
regular veterinary checks. The animals must be appropriately
identified, must be accompanied by an appropriate health certificate
signed by an official veterinarian of the country of origin, and must
be segregated according to destination, if destined for shipment to
multiple locations. Intra-Community trade in swine and swine products,
including semen and embryos, from CSF- or SVD-affected regions of EU
Member States is prohibited, and States with such regions must adhere
to animal health control measures meant to control the spread of these
diseases in order to engage in trade with other Member States. Because
FMD is not known to be present in the EU, there are no current trade
restrictions based on FMD; however, EC legislation authorizes the
imposition of such restrictions in the event of an outbreak.
Establishments such as slaughterhouses, processing plants, milk
processing plants, and semen collection centers must be approved by the
Member State in which they reside according to criteria similar to
those for exporting establishments in non-EU countries. The EC and
official veterinary services of the Member State conduct periodic
audits to monitor compliance with approval criteria and certification
requirements.
The risk analyses conclude that there is some risk of CSF, SVD and/
or FMD and rinderpest being introduced into Estonia, Hungary, Slovakia,
and Slovenia from other EU Member States, but this risk is low, based
on the absence of FMD in the EU and the mitigation measures for CSF and
SVD imposed through EC and transposed national legislation.
Veterinary Control of Passenger Traffic: Estonia shares a land
border with only one non-EU country, Russia. Customs officials, rather
than veterinary officers, control the majority of border crossings.
Cars and buses are subject to inspections and random luggage checks;
not all buses or pieces of luggage, therefore, are inspected. Cleaning
and disinfection procedures are enforced for all transport vehicles
carrying live animals; disinfection barriers also exist for vehicles
and pedestrians at each BIP and point of entry.
Informational posters are hung at border crossing points, press
releases are distributed, and information is disseminated to customs
officers and customs clients to publicize regulations regarding
prohibitions and restrictions on personal imports of meat. During
visits by APHIS to two Estonian BIPs in 2005, APHIS found that
prohibited food items were not often found in the luggage of
individuals entering Estonia. However, at one of these BIPs, there was
a high volume of road traffic from Estonia into Russia due to the
comparatively low price of basic commodities in Russia.
In Hungary, BIP veterinary staff, employed by the county
Agricultural Offices but under the direct supervisory and
administrative responsibility of the central Ministry of Agriculture
and Rural Development office in Budapest, oversee the operations of
each BIP. These inspectors conduct searches, may seize prohibited
goods, segregate live animals through a separate point of entry, and
enforce cleaning and disinfection procedures.
There is, however, significant movement of passengers who do not
pass through these BIPs from countries that are not part of the EU. The
Hungarian Frontier Guard, which controls the frontier borders of
Hungary, conducts random checks and other control activities at these
points of entry in conjunction with customs officials. During our site
visits, both the Frontier Guards and customs officials appeared
familiar with EU requirements and prohibitions regarding importation of
meat and dairy products transported in personal consignments.
In addition, while informational posters informing travelers of
prohibitions on the importation of certain meat and dairy products were
reported to be present at BIPs and other border crossings at the time
of accession, APHIS found no such posters during our site visit.
The State Veterinary and Food Administration controls all border
crossing points in Slovakia, including all BIPs. There are, however,
several crossings for passenger traffic that do not have official
veterinary inspection. All individuals attempting to enter the country
with agricultural products are redirected to a BIP with veterinary
inspection. Customs officials visually check all passenger luggage at
BIPs on the Ukrainian border, and selected passenger luggage at
Slovakia's airport BIP. Moreover, during our site visit, APHIS noticed
wall notices informing travelers of prohibitions on the importation of
certain meat and dairy products were present in many, but not all,
BIPs.
The Veterinary Administration of the Republic of Slovenia (VARS)
includes both an Internal Veterinary Inspection Sector (10 regional
offices and 2 branch offices) and the Border Veterinary Inspection
Service (BVIS). The annual disease control program issued by VARS
outlines the frequency and location of inspections for the Regional
Offices to undertake within Slovenia itself. The BVIS has
administrative and supervisory responsibility for the 6 BIPs in
Slovenia. BVIS veterinary inspectors are present at the BIPs during
working hours, but do not conduct inspections outside normal working
hours without prior notice.
Slovenian road border crossings are also staffed by customs
officials from the Customs Administration of the Republic of Slovenia
(CARS). Customs officials conduct searches of personal luggage at
border crossings for prohibited meat and dairy products. The customs
officials are not themselves veterinarians, but work in close
coordination with the veterinary inspectors of VARS: VARS inspectors
conduct their training and meet with them monthly to discuss areas for
improvement. CARS produces posters, brochures, and Web site information
to promote awareness of prohibitions on the importation of meat and
other animal products.
Accordingly, the analyses conclude that there is a risk of
introduction of CSF, FMD, SVD, or rinderpest into Slovakia or Slovenia,
CSF or SVD into Estonia, and CSF into Hungary via passenger traffic,
but that this risk is significantly mitigated by the control

[[Page 7727]]

measures in place at points of entry to the countries.

Livestock Demographics

As stated above, Estonia, Hungary, Slovakia, and Slovenia adopted
EC legislation with regard to animal identification at the time of
their accession. Each country has in place herd registration and animal
identification requirements for ruminants and swine that include
movement tracking through a centralized database or register. Health
certificates and/or movement authorization certificates are required
for all internal movements of ruminants and swine. We will discuss
livestock demographics for swine first, then discuss demographics for
ruminants, as warranted.
Between 2002 and 2004, the total number of swine holdings in
Estonia was approximately 3,835. However, 30 large-scale confinement
facilities, each with holdings of at least 2,000 swine, account for the
majority of all swine production in the country. Outdoor production
facilities are rare, although some small backyard farms do keep swine
outdoors in the summer months.
In 2007, the domestic swine population in Hungary was 3.3 million.
Approximately 70 percent of all pigs slaughtered in any given year, as
well as the majority of pigs destined for commercial export, originate
from large-scale facilities of more than 100 pigs. However, it was once
common for Hungarians to raise swine for personal consumption, and,
although such small-scale farms have declined greatly in number in
recent years, they still are more numerous than the large-scale
facilities within the country.
In 2006, there were 921,723 pigs on 6,806 holdings in Slovakia. The
majority of holdings have between 1 and 450 pigs, although there are
several large commercial confinement facilities of 7,000 to 10,000 pigs
in the eastern and southwestern parts of the country.
In Slovenia, there were approximately 26,000 swine holdings and
608,000 pigs in 2004. Eight large-scale confinement facilities, each
with between 500 and 5,700 sows, account for half of commercial pig
production.
In all four countries, there is some overlap between the
distribution of swine holdings and areas of concentration of wild
boars; however, the majority of swine in Estonia, Hungary, and Slovenia
are housed in confinement facilities, with minimal to no outdoor
access, and are moved only for slaughter or export. This is not the
case with Slovakia, where small to medium holdings constitute the
majority of the industry; however, many of these facilities either do
not move swine or move them only for custom slaughter for personal
consumption.
As part of our evaluations, APHIS conducted site visits of
production facilities in Hungary and Slovakia and a rendering plant in
Estonia, and determined that they adhered to State-mandated biosecurity
measures that are adequate to prevent wild animal incursions into the
facilities and the spread of communicable swine diseases by other
routes. The risk analyses for Estonia, Hungary, and Slovenia therefore
conclude that the prevalence of large commercial confinement facilities
in these countries, the distribution of the wild boar population in
each country in relation to these facilities, mandatory animal
identification requirements, movement controls, and other biosecurity
measures adequately mitigate the export risk to the United States. The
risk analysis for Slovakia finds that the risk posed by the prevalence
of smaller, outdoor production facilities is often mitigated by the
lack of movement of swine from the facilities, or their movement only
for custom slaughter.
In 2006, there were 524,247 cattle on 19,904 holdings, 326,322
sheep on 4,949 holdings, and 5,507 goats on 918 holdings in Slovakia.
Ruminant holdings tend to be constructed in a manner that allows the
animals space to graze, and rely on biosecurity measures, such as
perimeter fencing and cleaning and disinfection techniques, that
minimize but do not prevent contact with wildlife or disease
introduction. That said, Slovakia has in place movement restrictions,
isolation parameters, and assembly center requirements that APHIS
considers sufficient to mitigate the risk that meat derived from FMD-
infected ruminants could be exported to the United States.
Cattle are distributed throughout Slovenia, primarily on small- to
medium-sized family farms. Family farms frequently maintain cattle for
dairy production or breeding. There are large commercial breeding
operations (of approximately 600 head apiece) in Slovenia, but most
large commercial operations specialize in fattening and meat
production. The majority of cattle or products from cattle that are
exported from Slovenia originate from cattle held on large-scale
commercial operations.
In 2006, there were 144,000 sheep and goats in Slovenia, on 8,600
sheep and goat holdings. As for cattle and swine, Slovenia has in place
mandatory animal identification and registration for sheep and goats,
which facilitates traceability. In addition, APHIS' regulations
governing bovine spongiform encephalopathy currently prohibit the
importation of ruminant-derived products from Slovenia. These
safeguards address the risk of FMD being introduced into the United
States through the importation of ruminant-derived products from
Slovenia.

Disease Surveillance

CSF: Estonia, Hungary, Slovakia, and Slovenia all have national
surveillance programs in place for CSF in domestic swine and wild boar.
Active surveillance is primarily based on serology for antibodies to
the CSF virus, as is common throughout the world. Since antibodies
usually occur late in CSF infection, serological surveillance would
likely miss an early infection (e.g., in the first 21 days). In each
country, training, the distribution of informational literature, and
national surveillance exercises aid in passive surveillance for CSF by
developing and maintaining the ability to quickly detect this disease.
APHIS considers passive surveillance to be sufficient to detect overt
clinical signs of CSF, but detection may be delayed in the case of
moderate- or low-virulence strains.
SVD: Estonia conducts serological surveillance for SVD in domestic
swine. Slovakia does not conduct active surveillance for SVD, but
instead relies on passive surveillance similar to that employed to
detect CSF. Due to the absence of SVD in the country, Slovenia relies
primarily on passive surveillance strategies. Consequently, detection
of SVD in Slovakia or Slovenia may be delayed in some instances based
on the absence of overt clinical signs.
FMD: Slovakia and Slovenia conduct passive surveillance for FMD. As
noted above, passive surveillance may delay the detection of the
disease in some instances based on the absence of clinical signs of
infection.

Diagnostic Capabilities

Estonia, Hungary, Slovakia, and Slovenia have established
accredited national reference laboratories (NRLs) for animal diseases,
including CSF, SVD, and FMD. In Slovenia, the National Veterinary
Institute (NVI) at the University of Ljubljana is the NRL for a number
of diseases, although there are nine regional laboratories that perform
initial diagnostic and screening tests. Overall, the laboratories are
well organized and equipped, with experienced scientific and technical
staff. Standard operating procedures and quality control measures are
in place throughout.
CSF: In each country, the NRL provides a range of tests for the

[[Page 7728]]

diagnosis and confirmation of CSF. Testing includes the virus isolation
and antigen enzyme-linked immunosorbent assay (ELISA) tests, as well as
the nested polymerase chain reaction, immunofluorescence, and
immunoperoxidase methods.
During APHIS' site visit to the NRL in Hungary, we had some
concerns regarding the lack of sensitivity of one of the assays
employed, a fluorescent antibody test for wild boars. In response,
Hungary implemented more sensitive assays that are consistent with OIE
specifications. Moreover, APHIS notes that Slovenia's NVI Biohazard
Level 3 containment center is not yet completed. Because the NVI cannot
handle live CSF virus until this is constructed, it cannot perform all
CSF diagnostic tests, and thus it has not yet been accredited by VARS
and the EU. (Similar restrictions apply to FMD testing.) Finally, the
NRLs of both Estonia and Slovenia rely in certain instances on
corroborative testing that takes place outside of each country.
We do not believe that any of these issues decisively compromises
the ability of Estonia, Hungary, or Slovenia to detect CSF in samples
from domestic swine and wild boars in a timely manner; we have
determined that, in each instance, other factors mitigate the risk
associated with the issue of concern; and we have therefore concluded
that the laboratory systems of Estonia, Hungary, Slovakia, and
Slovenia, on the whole, have adequate diagnostic capabilities for CSF.
SVD: The NRL of Estonia currently conducts both serological and
nucleic acid testing for SVD. Slovakia does not employ active
surveillance for SVD, hence there is no required testing for the
disease. However, the NRL of Slovakia does provide a partial range of
diagnostic tests for the detection of SVD, as such testing is
requested. The NRL of Slovenia has historically conducted limited ELISA
testing for SVD: In 2004, there were 30 samples tested, each of which
tested negative for SVD, while there were no samples tested in either
2005 or 2006. A monitoring program was designed for 2008. The NRL can,
however, process up to 500 samples by ELISA each day.
FMD: The NRLs of Slovakia and Slovenia are capable of performing
ELISA tests for FMD antigens. However, because the NRL of Slovakia
cannot perform virus isolation tests, confirmatory testing is currently
conducted in Riems, Germany. Similarly, because the NRL of Slovenia
lacked accreditation for handling live FMD virus at the time of our
analysis, samples were being sent instead to Pirbright, United Kingdom,
for virological testing. Should either of these procedures continue,
they could result in a slight delay in confirming an outbreak in the
two countries.

Emergency Response Capacity

Estonia, Hungary, Slovakia, and Slovenia all have contingency plans
in place and supporting legislation to control and eradicate CSF
outbreaks in domestic swine. In addition, Estonia has in place a
contingency plan to control and eradicate SVD; Slovakia, SVD and FMD;
and Slovenia, FMD. These contingency plans conform closely to the
provisions of EC legislation. The EC has a stamping out policy with
regard to CSF, SVD, and FMD. Eradication is carried out by compulsory
depopulation of all animals on the affected premises with burial or
incineration of the carcasses, as well as certain cleaning and
disinfection protocols. All live animals, animal products, and genetic
material moved from affected premises during the time between disease
introduction and detection of the outbreak must be destroyed.
Additionally, surveillance zones of at least a 10-kilometer radius from
the affected premises are established, and the movement of live
animals, animal products, and genetic material is suspended until the
restrictions are lifted.
While Slovenia currently has no contingency plan for the control
and eradication of SVD, the disease has never been reported to have
occurred in that country. Furthermore, APHIS recognizes Slovenia's
thorough contingency plans for CSF and FMD. In particular, the FMD
contingency plan encourages the detection and reporting of vesicular
diseases that could lead to an SVD diagnosis.

Release Assessment Conclusions

APHIS found no evidence to suggest CSF or SVD exists within
Estonia. Moreover, we determined that there are measures or factors in
place which mitigate the pathways through which these diseases could be
introduced into Estonia: Migration of wild boar, trade of swine and
swine products, vehicle and human traffic, and importation of swine
products for personal consumption. APHIS concludes that the risk of
introduction of these diseases into Estonia is therefore low. Moreover,
APHIS concludes that the risk of introduction of CSF or SVD into the
United States from products imported from Estonia is mitigated by
additional import restrictions already specified in the regulations.
APHIS found that CSF exists in the wild boar population living
within Hungary, as evidenced by a 2009 outbreak of CSF in wild boar.
Moreover, APHIS has determined that, even if CSF were eradicated in
wild boar within the country, there is a risk of reintroduction of the
disease because the wild boar populations in neighboring countries are
known to be affected with CSF. However, as noted earlier, APHIS does
not consider the presence of CSF in wild boar within a country grounds
for precluding that region's inclusion in the APHIS-defined EU CSF low-
risk region. Moreover, APHIS has determined that swine operations
within Hungary, especially larger commercial ones, adhere to
biosecurity measures intended to preclude the introduction of CSF into
their holdings.
Upon being added to the EU CSF region, Hungary would be subject to
the requirement, under the existing regulations in Sec. 94.24, that
its veterinary authorities certify that live swine and swine products
exported to the United States did not originate from the restricted
zone in Hungary and have never been commingled with swine or swine
products from that area. We consider this requirement, in conjunction
with the risk mitigation measures imposed by Hungary and the EC,
sufficient to mitigate the CSF risk associated with the importation of
pork and pork products from Hungary.
APHIS found that CSF exists within Slovakia in wild boar in the EC-
designated eradication zone. While surveillance and vaccination within
this area have reduced the incidence of CSF in recent years, there is a
clear risk of disease introduction to domestic swine via contact with
such boars, although the risk of exposure to infected boars is
substantially mitigated by commercial production and biosecurity
practices on swine confinement operations. Exposure to wild boar is
more likely on small farms without such measures; however, such farms
often raise pigs only for personal consumption.
Upon being added to the EU CSF region, Slovakia would be subject to
the requirement, under the existing regulations in Sec. 94.24, that
its veterinary authorities certify that live swine and swine products
imported into the United States did not originate from the CSF-
restricted zone in Slovakia, and have never been commingled with swine
or swine products from that area. We consider this requirement, in
conjunction with the risk mitigation measures imposed by Slovakia and
the EC, sufficient to mitigate the CSF risk associated with the
importation of pork and pork products from Slovakia.

[[Page 7729]]

APHIS has no evidence that SVD, FMD, or rinderpest currently exists
in Slovakia. The most likely sources of introduction of these two
diseases into Slovakia are migration of wild boar or smuggled
agricultural products. Slovakia has adequate mitigation measures in
place to detect the smuggling of agricultural products. It is possible
that infected wild boar could enter Slovakia and come in contact with
domestic swine; this risk is somewhat mitigated, but not altogether
removed, by the biosecurity measures of commercial confinement
facilities within Slovakia. However, the introduction of SVD, FMD, or
rinderpest into the domestic herd in Slovakia would only pose a risk of
disease introduction into the United States if diseased swine or animal
products derived from diseased swine were not detected prior to export.
APHIS regards the risk of this occurring to be low.
APHIS found no evidence to suggest that CSF, SVD, FMD, or
rinderpest exists in Slovenia. The most likely source of introduction
of CSF, SVD or FMD into Slovenia is wild boar from neighboring
countries affected with the diseases. However, the introduction of
these diseases into Slovenia's domestic herd would only pose a risk of
disease introduction into the United States if diseased swine or animal
products derived from diseased swine were not detected prior to export.
APHIS regards the risk of this occurring to be low. Furthermore, should
these diseases be introduced, APHIS has evaluated EC control measures
and found them efficacious in detecting and controlling outbreaks of
CSF, SVD, and FMD in domestic livestock.
As a result of our analyses, we have concluded that the risk
profiles for Estonia, Hungary, Slovakia, and Slovenia are equivalent in
CSF risk to the APHIS-defined EU CSF region. The region is defined in
Sec. Sec. 93.500, 94.0, and 98.30, and is recognized as a single
region of low-risk for CSF in Sec. Sec. 94.9 and 94.10. The region is
subject to the import restrictions specified in Sec. 94.24 for live
swine, pork, and pork products, and Sec. 98.38 for swine semen.
Therefore, we are proposing to amend the definition of the APHIS-
defined EU CSF region Sec. Sec. 93.500, 94.0, and 98.30 in order to
include Estonia, Hungary, Slovakia, and Slovenia in the region, and,
accordingly, to allow the importation of live swine, swine semen, pork,
and pork products into the United States from these four countries
under the restrictions listed in the regulations.
We are proposing to recognize Estonia, Slovakia, and Slovenia as
free of SVD, and Slovakia and Slovenia as free of FMD and rinderpest.
In addition to proposing to include Estonia, Slovakia, and Slovenia in
the list in Sec. 94.12(a) of regions declared free of SVD, and
Slovakia and Slovenia to the list in Sec. 94.1(a)(2) of regions
declared free of both rinderpest and FMD, we are also proposing to add
Estonia, Slovakia, and Slovenia to the list in Sec. 94.13 of regions
declared free of SVD whose exports of pork and pork products are also
subject to restrictions and to add Slovakia and Slovenia to the list in
Sec. 94.11(a) of regions declared free of rinderpest and FMD whose
exports of meat and other animal products to the United States are
nevertheless subject to certain restrictions.

Risk Mitigation Measures for the Importation of Swine Semen From the
APHIS-Defined EU CSF Region and the 40-Day Post-Collection Holding
Period

Currently, the requirements for the importation of swine semen from
the APHIS-defined EU CSF region, which are found in paragraphs (a)
through (i) of Sec. 98.38, provide, among other things, that semen
must come from an approved semen collection center, that it must come
from a donor boar that has never been in or transited a region where
CSF is known to exist or a restricted zone for CSF, that it must come
from a donor boar that has never commingled with swine that have been
in such regions or zones, that the donor boar must be held in isolation
for 30 days prior to semen collection, and that the boar must be tested
for CSF prior to being held in isolation with negative results. In
addition, paragraph (h) of the section currently requires that, except
for semen collected from swine in Denmark, Finland, Sweden, the
Republic of Ireland, and the United Kingdom, before the semen is
exported to the United States, the donor boar must be held at the semen
collection center for at least 40 days following collection of the
semen, and, along with all other swine at the semen collection center,
exhibit no clinical signs of CSF.
After reviewing relevant information, we are proposing to remove
paragraph (h) from the regulations.
Three considerations, which are documented in a risk assessment
titled ``APHIS Risk Considerations on the Necessity of the 40-Day Post-
Collection Holding Period for Swine Semen Imported from the European
Union'' (June 2008) that accompanies this proposed rule, led us to this
conclusion. First, in recognizing the APHIS-defined EU CSF region, we
decided that EC quarantine regulations with respect to areas affected
by CSF would form the basis for the additional restrictions or
mitigation measures that we would impose upon imports of swine and
swine products from that region. We will only impose additional
restrictions in circumstances where we have determined that, in the
absence of such restrictions, EC regulations would prove insufficient
to adequately mitigate the risk of CSF being introduced into the United
States by such animals and animal products. In other words, the
restrictions that our regulations impose upon the EU CSF region are
dependent on the restrictions in the EC regulations themselves; as the
latter become more or less restrictive, our regulations should change
accordingly.
Since we recognized the EU CSF region, significant changes have
been made to the EC regulations to strengthen its controls for CSF
introduction or dissemination via infected swine germplasm. These
include additional controls on the intra-community trade of swine
semen, the immediate halt of the movement of swine semen from
collection centers within all restricted zones established during an
outbreak of CSF, and additional testing requirements for all animals in
swine semen centers prior to releasing an area from restrictions
following an outbreak.
Second, since we conducted the 1999 risk analysis that suggested
the need for the 40-day holding period, we have strengthened our
regulations governing the importation of swine semen from a CSF-
affected area within the EU CSF region and added additional mitigation
measures for products imported from that region. For example, we have
since added a 6-month restriction on the importation into the United
States of swine and swine products from a restricted zone within the EU
CSF region following an outbreak.
Finally, at the time we put the 40-day holding period in place, we
believed that it would not be overly burdensome for exporters of swine
semen or otherwise inhibit trade. However, we have since learned that
artificial insemination of sows relies overwhelmingly on fresh boar
semen or semen that has been chilled for no more than 5 days; indeed,
such semen accounts for approximately 99 percent of all artificial
insemination worldwide. Methods, such as freezing, exist to preserve
swine semen for longer periods of time; however, swine semen is
extremely sensitive to freezing and thawing, losing both potency and
fertility in the process. Given the other increased restrictions on the
importation of swine semen from the EU CSF region, continuing to
require the 40-day hold, and thus to interfere with trade in swine
semen, no longer appears

[[Page 7730]]

necessary. Accordingly, we are proposing to remove Sec. 98.38(h),
which requires the 40-day hold, from the regulations.

Administrative Units

On October 28, 1997, we published in the Federal Register a final
rule (62 FR 56000-56026, Docket No. 94-106-9) and a policy statement
(62 FR 56027-56033, Docket No. 941068) that established procedures for
recognizing regions and levels of risk for the purpose of regulating
the importation of animals and animal products. With the establishment
of those procedures, APHIS can consider requests to allow importations
from regions based on levels of risk, as well as to recognize entire
countries as free of a disease. In subsequent rules, we identified the
smallest administrative jurisdictions, referred to as administrative
units (AUs), in the APHIS-defined EU CSF region that we would use to
regionalize those Member States in the event of future animal disease
outbreaks. As discussed in those documents, we believe that each of
those jurisdictions is the smallest that can be demonstrated to have
oversight of normal animal movements into, out of, and within that
Member State, and that, in association with national authorities, if
necessary, has effective control over animal movements and animal
diseases locally.
We have identified the following AUs for each country addressed in
this proposal: For both Estonia and Hungary, the AU would be the
county; for Slovakia, the district; and for Slovenia, the region.
We have also reevaluated the AUs that we currently recognize for
other countries in the EU to determine whether any modifications to
these recognitions were necessary. Prior to July 29, 2005, the AU for
Italy was the region. In a notice that we published in the Federal
Register (70 FR 43838-43839, Docket No. 04-081-2) on that date, we
advised the public that, among other things, we considered the aziende
sanitarie locali (local health unit), a smaller administrative unit,
the AU for Italy. Since that time, we have determined that this unit
does not have sufficient control over local animal movements to fulfill
the criteria established for an AU. Therefore, we intend to once again
identify the region as the AU for Italy. We invite comments on that
determination.
Accordingly, these AUs would be used to regionalize those Member
States in the event of future animal disease outbreaks.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866, and has therefore not been
reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
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).
The analysis identifies hog and pig producers as the small entities
most likely to be affected by this action and considers the effects on
domestic prices associated with increased imports of swine, swine
semen, pork, and pork products. Based on the information presented in
the analysis, we expect that domestic pork producers would experience
only a minimal loss in welfare as a result of this action. The analysis
provides a basis for the APHIS Administrator's determination that this
action would not have a significant economic impact on a substantial
number of small entities.

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 rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
proposed addition of Estonia, Hungary, Slovakia, and Slovenia to the
list of EU countries considered to be a low risk CSF, Estonia,
Slovakia, and Slovenia to the list of regions recognized as free of
SVD, but that are subject to certain import restrictions, and Slovakia
and Slovenia to the list of regions recognized as free of FMD and
rinderpest, but that are subject to certain import restrictions, we
have prepared environmental assessments for each country.
The environmental assessments were prepared in accordance with: (1)
The National Environmental Policy Act of 1969 (NEPA), as amended (42
U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental
Quality for implementing the procedural provisions of NEPA (40 CFR
parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part
1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
The environmental assessments may be viewed on the Regulations.gov
Web site or in our reading room. We invite the public to comment on
those environmental assessments. Comments on the environmental
assessments may be submitted using the same process as comments on the
proposed rule. Instructions for accessing Regulations.gov and for
submitting comments 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

This proposed rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).

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 98

Animal diseases, Imports.

Accordingly, we propose to amend 9 CFR parts 93, 94, 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. In Sec. 93.500, the definition of APHIS-defined EU CSF region
is revised to read as follows:

[[Page 7731]]

Sec. 93.500 Definitions.

* * * * *
APHIS-defined EU CSF region. The European Union Member States of
Austria, Belgium, the Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg,
the Netherlands, Poland, Portugal, Republic of Ireland, Slovakia,
Slovenia, Spain, Sweden, and the United Kingdom (England, Scotland,
Wales, the Isle of Man, and Northern Ireland).
* * * * *

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS

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

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.

4. In Sec. 94.0, the definition of APHIS-defined EU CSF region is
revised to read as follows:

Sec. 94.0 Definitions.

Sec. 94.1 [Amended]

5. In Sec. 94.1, paragraph (a)(2) is amended by adding the words
``Slovakia, Slovenia,'' immediately after the word ``Portugal,''.

Sec. 94.11 [Amended]

6. In Sec. 94.11, paragraph (a) is amended by adding the words
``Slovakia, Slovenia,'' immediately after the word ``Portugal,''.
7. In Sec. 94.12, paragraph (a) is revised to read as follows:

Sec. 94.12 Pork and pork products from regions where swine vesicular
disease exists.

(a) Swine vesicular disease is considered to exist in all regions
of the world except Australia, Austria, the Bahamas, Belgium, Bulgaria,
Canada, Central American countries, Chile, the Czech Republic, Denmark,
Dominican Republic, Estonia, Fiji, Finland, France, Germany, Greece,
Greenland, Haiti, Hungary, Iceland, Latvia, Lithuania, Luxembourg,
Mexico, the Netherlands, New Zealand, Norway, Panama, Poland, Portugal,
Republic of Ireland, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Trust Territories of the Pacific, the United Kingdom
(England, Scotland, Wales, the Isle of Man, and Northern Ireland),
Yugoslavia, and the Regions in Italy of Friuli, Liguria, Marche, and
Valle d'Aosta.
* * * * *
8. In Sec. 94.13 introductory text, the first sentence is revised
to read as follows:

Sec. 94.13 Restrictions on importation of pork or pork products from
specified regions.

Austria, the Bahamas, Belgium, Bulgaria, Chile, the Czech Republic,
Denmark, Estonia, France, Germany, Hungary, Latvia, Lithuania,
Luxembourg, the Netherlands, Poland, Portugal, Republic of Ireland,
Slovakia, Slovenia, Spain, Switzerland, the United Kingdom (England,
Scotland, Wales, the Isle of Man, and Northern Ireland), Yugoslavia,
and the Regions in Italy of Friuli, Liguria, Marche, and Valle d'Aosta
are declared free of swine vesicular disease in Sec. 94.12(a). * * *
* * * * *

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

9. 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.

10. In Sec. 98.30, the definition of APHIS-defined EU CSF region
is revised to read as follows:

Sec. 98.30 Definitions.

Sec. 98.38 [Amended]

11. Section 98.38 is amended as follows:
a. In the introductory text, by removing the words ``, except as
noted in paragraph (h) of this section with regard to swine semen
imported from Denmark, Finland, the Republic of Ireland, Sweden, or the
United Kingdom''.
b. By removing paragraph (h).
c. By redesignating paragraph (i) as paragraph (h).
d. In newly redesignated paragraph (h), by removing the words
``through (h)'' and adding the words ``through (g)'' in their place.

Done in Washington, DC, this 7th day of February 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-3112 Filed 2-10-11; 8:45 am]
BILLING CODE 3410-34-P