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



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 Rules and Regulations
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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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

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