[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]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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.

* * * * *
    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).
* * * * *


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.

* * * * *
    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).
* * * * *


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