Federal Register, Volume 77 Issue 242 (Monday, December 17, 2012)

[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Rules and Regulations]
[Pages 74555-74559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30259]

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Rules and Regulations
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 /
Rules and Regulations

[[Page 74555]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 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: Final rule.

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SUMMARY: APHIS is amending the regulations governing the importation of
certain animal embryos and animal semen by removing one of the
conditions for the importation of swine semen from the APHIS-defined
European CSF region, a region of Europe that we recognize as a single
low-risk region for classical swine fever. We have determined that the
40-day holding period for swine semen and donor boars after the
collection of swine semen is unnecessary. We are also announcing the
addition of Estonia, Hungary, Slovakia, and Slovenia to the APHIS-
defined European CSF region, the addition of Estonia, Slovakia, and
Slovenia to the list of regions APHIS considers free of swine vesicular
disease (SVD), and the addition of Slovakia and Slovenia to the list of
regions APHIS considers free of foot-and-mouth disease (FMD) and
rinderpest. These actions will 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: Effective Date: January 16, 2013.

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) 855-7731.

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 94.0, 94.9, and 94.10 of the regulations provide for the
listing of regions of the world that APHIS considers free of, or low-
risk for, CSF. The APHIS-defined European CSF region, consisting of
countries of Europe 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.
Section 94.12 of the regulations provides for the listing of
regions that are declared free of SVD, and Sec. 94.13 of the
regulations provides for the listing of 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 provides for the listing of regions
of the world that are declared free of rinderpest or free of both
rinderpest and FMD. Section 94.11 of the regulations provides for the
listing of 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 February 11, 2011, we published in the Federal Register a
proposed rule \1\ (76 FR 7721-7731, Docket No. APHIS-2008-0043) to add
Estonia, Hungary, Slovakia, and Slovenia to the APHIS-defined EU CSF
region. (NOTE: In a final rule published on November 10, 2011 [76 FR
70037-70040, Docket No. APHIS-2009-0093], APHIS changed the term
``APHIS-defined EU CSF region'' to ``APHIS-defined European CSF
region.'') We also proposed to add Estonia, Slovakia, and Slovenia to
the list of regions we consider free of SVD and to add Slovakia and
Slovenia to the list of regions considered free of FMD and rinderpest.
Finally, we proposed to amend Sec. 98.38 to remove the 40-day post-
collection holding period for swine semen and donor boars prior to
export of swine semen from the APHIS-defined EU CSF region to the
United States. Except for semen collected from swine in Denmark,
Finland, the Republic of Ireland, Sweden, or the United Kingdom, we
required 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 that the donor
boars, along with all other swine at the semen collection center,
exhibit no clinical signs of CSF.
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\1\ To view the proposed rule, supporting documents, or the
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0043.
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We solicited comments concerning the proposed rule for 60 days
ending April 12, 2011, and received three comments by that date. They
were from an organization representing the pork industry within the
United States and two private citizens. These comments are discussed
below by topic.

[[Page 74556]]

Comments Regarding Evaluations of Animal Disease Status in Support of
the Proposed Rule

In order for APHIS to evaluate the CSF, SVD, FMD, and/or rinderpest
status of their respective countries, the Governments of Estonia,
Hungary, Slovakia, and Slovenia provided us with information regarding
the authority, organization, and infrastructure of the official
veterinary services in their countries; the status of their countries
and adjacent regions with regard to the disease(s) under evaluation;
the degree to which their countries are separated from regions of
higher risk; and livestock demographics and marketing practices. They
also provided information regarding vaccination against the disease(s)
of interest; the extent of active disease control programs for the
diseases; movement controls and biosecurity for movement from higher
risk regions; disease surveillance; diagnostic laboratory capabilities;
and emergency response capacity.
Based on this information, a site visit to each country, and other
publicly available information, APHIS prepared 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 conclusions in these
evaluations led us to issue the proposed rule.
One commenter stated that, since the evaluations were finalized,
FMD has been detected in Bulgaria. The commenter stated that European
Commission \2\ (EC) regulations regarding FMD are adequate to monitor,
detect, control, and eradicate the disease in Member States, but also
suggested that the introduction of FMD into Bulgaria was due to that
country's failure to adhere to EC regulations regarding passive
surveillance and disease reporting. The commenter suggested that this
failure may be indicative of the potential for similar failures in
passive surveillance and disease reporting in Estonia, Hungary,
Slovakia, and Slovenia. Accordingly, the commenter requested that we
not finalize the proposed rule until the EC finishes its review of the
outbreaks in Bulgaria and implements corrective actions to make certain
that all EU Member States are conducting adequate passive surveillance
for FMD, and until we prepare new evaluations to take those additional
measures into consideration insofar as they pertain to Estonia,
Hungary, Slovakia, and Slovenia.
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\2\ The European Commission 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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Because Bulgaria is an EU Member State, and thus eligible for
intra-Community trade, APHIS concurs with the commenter that the
outbreaks of FMD in Bulgaria are an issue of concern, and accordingly
has been monitoring the disease situation in that country. The EC has
provided APHIS officials stationed within the EU with regular updates
regarding the outbreaks, and has posted updated outbreak information
for the general public at the Web site for its Standing Committee on
the Food Chain and Animal Health.
To summarize, on January 4, 2011, FMD was detected in a single wild
boar in Bulgaria. Since then, there have been multiple outbreaks,
primarily along the border between Bulgaria and Turkey. In response to
the outbreaks, Bulgarian officials implemented measures to delineate
the scope of the outbreaks and to control and eradicate the disease in
domestic livestock within the country.
To date, we have no evidence that domestic ruminant populations in
other Member States should be considered exposed to or potentially
affected with FMD. Indeed, the EC recently reduced the restricted area
of Bulgaria that is covered by EC measures designed to prevent the
spread of FMD. Furthermore, as the commenter conceded, current EC
regulations, if adhered to, are sufficient to detect, control, and
eradicate FMD whenever it occurs within a Member State.
Based on the information provided to us by Estonia, Hungary,
Slovakia, and Slovenia, as corroborated by our site visits to the
countries, we believe the countries have implemented the relevant EC
legislation regarding surveillance for CSF, SVD, FMD and/or rinderpest,
and that producers in these countries can recognize clinical signs of
the diseases and report any such potentially affected animals in a
timely manner. Therefore, we are not granting the commenter's request.
We will, however, continue to closely monitor the current FMD situation
in Bulgaria.
The same commenter asserted that our conclusion--that live swine,
swine semen, pork, and pork products may safely be imported into the
United States from Estonia, Hungary, Slovakia, and Slovenia, subject to
the restrictions of the regulations--was based on the absence of FMD
within the EU. Accordingly, the commenter requested that we not
finalize the proposed rule until we prepare new assessments that take
into consideration the presence of FMD in Bulgaria. Similarly, another
commenter asked what information had been taken into consideration in
reaching our conclusions.
As noted above, our conclusions were based on an evaluation of the
information supplied by Estonia, Hungary, Slovakia, and Slovenia
regarding the authority, organization, and infrastructure of the
veterinary services in their countries; the status of their countries
and adjacent regions with regard to the disease(s) under evaluation;
the degree to which their countries are separated from regions of
higher risk; livestock demographics and marketing practices;
vaccination against the disease(s) of interest; the extent of active
disease control programs for the diseases; movement controls and
biosecurity for movement from higher risk regions; disease
surveillance; diagnostic laboratory capabilities; and emergency
response capacity. Cumulatively, this information demonstrated the
countries' compliance with existing EC regulations, which mitigate the
likelihood that CSF, SVD, FMD, and/or rinderpest will be introduced
into the domestic swine populations within the countries, and led to
our conclusion that, by applying the restrictions of the regulations,
swine, swine semen, pork, and pork products may safely be imported from
Estonia, Hungary, Slovakia, or Slovenia into the United States.
In addition, we note that Estonia and Hungary have been listed
under Sec. 94.11 since 2002 and 1994, respectively, as regions that
are free of FMD but subject to certain restrictions because of their
trading relationships with FMD-affected countries.
A commenter pointed out that, in our evaluation of Slovakia with
regard to CSF, SVD, FMD, and rinderpest, we noted that Slovakian
veterinary inspectors are not stationed at every border crossing into
the country to inspect passenger baggage. The commenter also pointed
out that, at those crossings where inspectors are stationed, there are
certain hours throughout the day when the crossings are unattended by
the inspectors. The commenter suggested that Slovakia needed to
position inspectors at all ports of entry and needed to expand
inspection coverage beyond normal working hours. Additionally, the
commenter pointed out that, in the evaluation of Hungary with regard to
CSF, we noted that posters alerting travelers to prohibitions on the
importation of certain animal products in personal baggage were not
displayed at several of the border inspection posts

[[Page 74557]]

(BIPs) in the country. As a result, the commenter questioned our basis
for concluding that the risk posed by the importation of contaminated
animal products in passenger baggage is sufficiently mitigated at ports
of entry into these two countries and stated that we had not provided
sufficient evidence to support this conclusion.
Slovakia has stationed inspectors at the busiest border crossings
during those hours of the day when the most travelers enter the country
through these border crossings. Slovakia's actions are consistent with
EC regulation (EC) 206/2009, which allows a country to utilize a risk-
based approach to establishing controls at ports of entry to minimize
the likelihood that animal products imported into the country in
personal baggage will serve as fomites for diseases affecting
livestock.\3\ Our determination that the risk posed by the importation
of contaminated animal products in passenger baggage is sufficiently
mitigated at ports of entry into Slovakia was based on this
consistency, on the physical and technological infrastructure of the
BIPs, on the apparent volume of passenger baggage entering through
these BIPs at the time of our site visit, on the number of inspectors
employed at the BIPs and the training afforded to these inspectors, and
on the auditing and monitoring of inspections conducted by the State
Veterinary and Food Administration of the Slovak Republic, the
veterinary authority for Slovakia.
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\3\ Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:077:0001:0019:EN:pdf. Accessed on May 6,
2011.
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Requiring Slovakia to station inspectors at all ports of entry and
beyond normal business hours would be significantly more stringent than
EC standards, and is not necessary to reach a determination that the
risk that contaminated products will enter the country in passenger
baggage has been sufficiently mitigated.
We agree with the commenter that posters alerting travelers to
prohibitions and restrictions on the importation of animal products in
personal baggage help to reduce the risk that contaminated products may
enter Hungary in such baggage, and should be fully incorporated into
their controls at all ports of entry into the country. However, the
presence or absence of such posters was not our sole consideration in
determining whether Hungary has sufficiently mitigated the risk that
contaminated products will enter Hungary in passenger baggage. As we
did for Slovakia, we evaluated the physical and technological
infrastructure of the BIPs, the number of inspectors stationed at BIPs
and other border crossings, the degree to which these inspectors have
been trained to inspect personal baggage, the volume of passenger
baggage entering the country, the number of random and targeted luggage
searches, and the reporting and monitoring requirements governing these
inspections that have been imposed by the veterinary authority for
Hungary. Collectively, the results of these evaluations led us to
conclude that the risk that contaminated products will enter Hungary in
passenger baggage is sufficiently mitigated.
The same commenter pointed out that, in our evaluation of Slovakia,
we noted that the majority of swine holdings in the country are small,
and that biosecurity on those farms is somewhat lacking in comparison
to biosecurity standards at larger, commercially maintained premises
within the country. The commenter further pointed out that we conceded
that these swine have more of a risk of exposure to CSF, SVD, FMD, and
rinderpest, and that the primary mitigation we cited was the lack of
movement of swine from these facilities or the movement only for custom
slaughter. The commenter suggested that access to a lucrative market
such as the United States could change these production practices, and
increase the likelihood that such producers will instead choose to
export their swine. The commenter suggested that this, in turn, could
increase the risk that swine or pork products contaminated with CSF,
SVD, FMD, or rinderpest virus could be imported to the United States
from Slovakia. Accordingly, the commenter requested that we prepare a
new evaluation that takes this possible change in marketing practices
into consideration.
We do not consider a new evaluation to be necessary. Such producers
have had access to foreign markets within the EU and throughout the
world for an extended period of time, and have not changed their
marketing practices. Moreover, even if these marketing practices were
to change in the manner suggested by the commenter, all such animals
and animal products would still be subject to EC regulations and U.S.
import requirements, which we consider to be effective in mitigating
the risk of importation of affected swine and/or contaminated products
into the United States.

Comment Regarding the Removal of the 40-Day Post-Collection Holding
Period for Swine Semen Imported From the APHIS-Defined EU CSF Region

As noted above, we proposed to remove one of the conditions for the
importation of swine semen from the APHIS-defined EU CSF region, which
required, with limited exceptions, 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 that the donor boars, along with all other swine at the
semen collection center, exhibit no clinical signs of CSF. We proposed
to remove this requirement on the grounds that, since we established
the requirement, the EC has modified its regulations to strengthen
controls for CSF introduction or dissemination via infected germplasm,
and we have strengthened our own regulations governing the importation
of swine semen from a CSF-affected region. We also noted that the
majority of swine semen used for artificial insemination is less than 5
days old and the current prohibition, therefore, was burdensome to
exporters and inhibited trade.
One commenter stated that, in the event of an outbreak of CSF, it
often takes several days to conduct an epidemiological investigation.
The commenter stated that, if we were to remove the requirement, there
is a possibility that swine semen contaminated with CSF virus could be
imported into the United States and used to inseminate domestic sows
before the scope of the outbreak is delineated and a prohibition on the
importation of swine semen from the affected country into the United
States is put in place. The commenter asked that APHIS provide to the
U.S. pork industry a detailed response plan for exposure of U.S. swine
to fresh semen that is epidemiologically linked to a CSF case in the
exporting country.
Current EU regulations specify conditions for approval and
supervision of artificial insemination centers, pre-admission
quarantine and testing of boars, serologic testing for CSF, clinical
observation of donor boars, and movement controls and epidemiologic
investigation procedures in the event that an outbreak of CSF is
suspected. The movement controls include restrictions on the movement
of swine semen, and epidemiologic investigations may include
inspections of swine semen collection facilities. Because of these
interlocking safeguards and our own regulations and policies, we
consider the possibility that CSF

[[Page 74558]]

virus-contaminated germplasm will be exported to the United States from
a country within the APHIS-defined European CSF region to be remote,
even with the removal of the 40-day holding period.
In the unlikely event that the scenario proposed by the commenter
comes to pass, we would take actions consistent with the outbreak of
any foreign animal disease within the United States. In collaboration
with State animal health officials and other emergency response
partners, we would determine the scope of the outbreak, identify
potentially affected animals, place the appropriate restrictions or
prohibitions on the movement of those animals, implement the mitigation
measures necessary to prevent further disease spread, and conduct
cleaning and disinfection of affected premises and articles.

Lists of Regions Removed From the CFR

When we published the proposed rule for this action in February
2011, the countries included in the APHIS-defined EU CSF region (now
APHIS-defined European CSF region), and foreign regions considered free
of or affected with various animal diseases and pests, including CSF,
SVD, rinderpest, and FMD, were listed in our animal and animal product
import regulations in 9 CFR parts 92, 93, 94, 96, and 98. In a final
rule \4\ published in the Federal Register on January 10, 2012 (77 FR
1388-1396, Docket No. APHIS-2009-0035), we removed lists of regions
classified with respect to certain animal diseases and pests from those
regulations. The lists are now posted on APHIS' Web site, rather than
published in the Code of Federal Regulations.
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\4\ See http://www.regulations.gov/#!docketDetail;D=APHIS-2009-
0035.
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Accordingly, the proposed addition of Estonia, Hungary, Slovakia,
and Slovenia to the APHIS-defined European CSF region, the proposed
additions of Estonia, Slovakia, and Slovenia to the list of regions
APHIS considers free of SVD, and the proposed addition of Slovakia and
Slovenia to the list of regions APHIS considers free of FMD and
rinderpest do not need to be finalized through rulemaking. Instead,
this preamble provides notice that we are amending the lists on APHIS'
Web site (http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml). Copies of the lists are also be available via
postal mail, fax, or email upon request to the Sanitary Trade Issues
Team, National Center for Import and Export, Veterinary Services,
Animal and Plant Health Inspection Service, 4700 River Road Unit 38,
Riverdale, Maryland 20737.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes described above.

Executive Order 12866 and the Regulatory Flexibility Act

This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic
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 will experience
only a minimal loss of welfare as a result of this action. The analysis
provides a basis for the APHIS Administrator's determination that this
action will not have a significant economic impact on a substantial
number of small entities. Copies of the full analysis are available on
the Regulations.gov Web site (see footnote 1), or by contacting the
person listed under FOR FURTHER INFORMATION CONTACT.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.

National Environmental Policy Act

Environmental assessments and findings of no significant impact
have been prepared for this final rule. The environmental assessments
provide a basis for the conclusion that the importation of swine, swine
semen, pork, and pork products from Estonia, Hungary, Slovakia, and
Slovenia under the conditions specified in the rule will not have a
significant impact on the quality of the human environment. Based on
the findings of no significant impact, the Administrator of the Animal
and Plant Health Inspection Service has determined that environmental
impact statements need not be prepared.
The environmental assessments and findings of no significant impact
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 and findings of no significant impact
may be viewed on the Regulations.gov Web site.\5\ Copies of the
environmental assessments and findings of no significant impact are
also available for public inspection at USDA, Room 1141, South
Building, 14th Street and Independence Avenue SW., Washington, DC,
between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
Persons wishing to inspect copies are requested to call ahead on (202)
799-7039 to facilitate entry into the reading room. In addition, copies
may be obtained by writing to the individual listed under FOR FURTHER
INFORMATION CONTACT.
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\5\ Go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2008-0043. The environmental assessments and findings of no
significant impact will appear in the resulting list of documents.
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Paperwork Reduction Act

This final 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 in 9 CFR Part 98

Animal diseases, Imports.

Accordingly, we are amending 9 CFR part 98 as follows:

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

0
1. 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.

Sec. 98.38 [Amended]

0
2. Section 98.38 is amended as follows:
0
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''.
0
b. By removing paragraph (h).
0
c. By redesignating paragraph (i) as paragraph (h).

[[Page 74559]]

0
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 11th day of December 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-30259 Filed 12-14-12; 8:45 am]
BILLING CODE 3410-34-P