Importation of Swine and Swine Products From the European Union, 29061-29072 [06-4681]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 71, Number 97 (Friday, May 19, 2006)]
[Rules and Regulations]
[Pages 29061-29072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4681]



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Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Rules and 
Regulations

[[Page 29061]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 98

[Docket No. 02-046-2]
RIN 0579-AB79


Importation of Swine and Swine Products From the European Union

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations governing the importation of 
animals and animal products into the United States to apply a uniform 
set of importation requirements related to classical swine fever (CSF) 
to a region consisting of all of the 15 Member States of the European 
Union (EU) that comprised the EU as of April 30, 2004 (the EU-15) and 
prohibit for a specified period of time the importation of live swine 
and swine products from any area in the EU-15 that is identified by the 
veterinary authorities of the region as a restricted zone. We have 
determined these changes are necessary to help prevent the introduction 
of CSF into the United States while increasing our responsiveness to 
changes in the CSF situation in the EU.

DATES: Effective Date: June 19, 2006.

FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff 
Veterinarian, Regionalization and Evaluation Services, National Center 
for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, 
MD 20737-1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA or the Department) 
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), rinderpest, foot-and-mouth 
disease, bovine spongiform encephalopathy, swine vesicular disease, and 
African swine fever.
    Sections 94.9 and 94.10 of the regulations state that CSF is known 
to exist in all regions of the world, except for those regions listed 
in Sec. Sec.  94.9(a) and 94.10(a). The importation of live swine and 
swine products from regions not recognized as free of CSF is restricted 
or prohibited. In addition, with regard to CSF, the regulations 
restrict the importation of live swine and swine products from a region 
consisting of certain European Union (EU) Member States and portions of 
Member States, even though that region is listed as being free of the 
disease. The restrictions on imports from that EU region were 
established in a final rule published in the Federal Register on April 
7, 2003 (68 FR 16922-16941, Docket No. 98-090-5).
    In that final rule, we established certain mitigation measures for 
the importation of live swine, pork and pork products, and swine semen 
from the region. Although there were no CSF outbreaks in EU domestic 
swine within the defined region at the time, the risk analyses that we 
conducted in conjunction with that rulemaking assumed that, because CSF 
was endemic in wild boar in several parts of the EU, it was likely CSF 
would continue to occur in domestic swine in the region. Further, the 
risk analyses considered the open borders among EU Member States. To 
address these situations, the final rule required that commodities from 
the region of the EU that was considered to be unaffected with CSF be 
segregated from those from CSF-affected regions of the EU and other 
CSF-affected regions, and that measures be taken to ensure that donor 
boars providing semen for export to the United States are truly free of 
CSF.
    On April 8, 2005, we published in the Federal Register (70 FR 
17928-17940, Docket No. 02-046-1) a proposal to amend the regulations 
governing the importation of animals and animal products into the 
United States to recognize a region consisting of the 15 Member States 
of the EU that comprised the EU as of April 30, 2004 (the EU-15) as a 
single region of low risk for CSF. The EU-15 consists of those Member 
States that we had recognized as a single region regarding CSF in our 
2003 final rule, plus additional Member States. We proposed to apply a 
uniform set of importation requirements related to CSF to the EU-15 and 
to prohibit for a specified period of time the importation of live 
swine and swine products from any area in the EU-15 that is identified 
by the veterinary authorities of the region as a restricted zone.
    We solicited comments concerning our proposal for 60 days ending 
June 7, 2005. We received 10 comments by that date. They were from an 
importer of swine semen, a swine producer and pork processor, a 
representative of the National Pork Producers Council, a representative 
of the National Pork Board, representatives of State governments, a 
representative of the European Commission (EC), and other members of 
the public.
    Two commenters opposed the proposal in general. One commenter 
expressed general support for the importation of swine and swine 
products, as long as appropriate testing, quarantine, and certification 
are carried out. Several commenters agreed with the concept of allowing 
movement of live swine from a restricted zone, or products derived from 
such swine, after an appropriate period of time, but either expressed 
concerns regarding certain provisions of the proposal or recommended 
specific changes. One commenter expressed general support for 
regulating the importation or exportation of animals. Another commenter 
opposed the importation of all swine and swine products from the EU. 
The specific issues raised by the commenters are discussed below by 
topic.

Forty-Day Holding Period Before the Shipment of Swine Semen to the 
United States

    In Sec.  98.38 of the proposed rule, we set out conditions for 
exporting swine

[[Page 29062]]

semen to the United States from the EU-15. One of those conditions (set 
out in Sec.  98.30(f) of the proposal) was that, before swine semen may 
be exported to the United States from the EU-15, the donor boar must be 
held at the semen collection center and observed by the center 
veterinarian 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. This requirement, which we proposed to apply 
to importations of swine semen from anywhere in the EU-15, is already 
in place in the current regulations in Sec.  98.38(h), but only with 
regard to the importation of swine semen from those Member States of 
the EU-15 that we recognized as a single region for CSF in our April 
2003 final rule. The import restrictions established in that final 
rule, including the restrictions on swine semen, did not apply to those 
five Member States that APHIS had recognized as free of CSF before the 
April 2003 final rule (Denmark, Finland, the Republic of Ireland, 
Sweden, and the United Kingdom).
    Our April 2005 proposal extended those restrictions on the 
importation of swine semen to the entire EU-15, including Denmark, 
Finland, the Republic of Ireland, Sweden, and the United Kingdom. We 
explained that we believed such an extension of the restrictions was 
necessary because, as part of the EU, those five Member States trade 
with the rest of the EU under what is essentially an open-border 
trading policy and, therefore, the CSF risk from those five Member 
States must be considered the same as from the region we recognized in 
our April 2003 final rule.
    Several commenters addressed the provisions in the proposed rule 
regarding the importation of swine semen. Of these, one commenter 
supported the proposed restrictions. The other commenters objected to 
those restrictions.
    The commenter who supported the proposed provisions stated that it 
was his understanding that the requirement for a 40-day holding period 
in Sec.  98.38(h) was established because swine do not develop a rapid 
or predictable antibody response to the CSF virus, at least with 
currently available diagnostic tests. According to the commenter, the 
40-day holding period provides a reasonable buffer that facilitates the 
detection of CSF exposure, even in poor-responding animals.
    Three commenters expressed concern with the proposed 40-day holding 
period for semen, stating that the 40-day holding period would render 
fresh boar semen worthless, because there are no extenders available 
that will preserve sperm cells for more than 7 to 10 days. The 
commenters stated that freezing of the semen is not a feasible 
alternative because the fertility of frozen boar semen is vastly 
inferior to that of fresh semen.
    One commenter stated that the 40-day holding period is unnecessary 
because, according to the commenter, donor boars must already be held 
in a separate facility for 6 months before the semen is collected for 
export and no swine may be added to the donor boar population for 60 
days before the semen is collected. The commenter did not specify the 
source of the requirements described. The commenter stated that, 
because of these requirements, it would be more logical to require that 
the donor boar be tested with negative results for CSF in the mini-stud 
(an area where a group of boars from the larger group of boars at the 
semen collection center are held for semen collection) than to require 
the 40-day post-collection holding period.
    The same commenter stated that another option would be to exclude 
the importation of swine semen from Denmark from the 40-day holding 
requirement. The commenter stated that the proposed rule did not take 
into account the safeguards already in place for the importation of 
Danish fresh boar semen. Additionally, said the commenter, the proposed 
rule did not recognize the ``extraordinary measures'' that Denmark 
employs to keep the country free of CSF and other diseases of economic 
importance, such as government-operated truck disinfection facilities 
at the border with Germany.
    One commenter stated that a requirement for a 40-day holding period 
following collection of swine semen is disproportionate to the risk of 
the transmission of CSF through semen, and that the routine use of a 
combination of antibiotics, as required under the EC Directive 90/429/
EEC, should be sufficient to deal with any risk that might be present.
    APHIS response. As we stated above, the current requirement for a 
40-day, post-collection holding period for swine semen, set forth in 
Sec.  98.38, was established by a final rule APHIS published in April 
2003, and currently applies to the importation of swine semen from some 
Member States of the EU-15, but not all. The 40-day hold on semen was 
based on risk analyses we conducted in support of the April 2003 final 
rule.\1\ These risk analyses indicated that, without mitigation, the 
importation of swine semen from the EU region recognized by the final 
rule would present a relatively high risk of introducing CSF into the 
United States. The 40-day hold was determined to be an effective 
mitigation measure and is consistent with the internationally 
recognized recommendations of the World Organization for Animal Health 
(OIE) for semen exported from countries that are free of CSF in 
domestic swine but that have CSF infection in wild boar populations 
(Article 2.6.7.13, 2004 OIE International Animal Health Code). With 
regard to the commenter who stated that donor boars must already be 
held in a separate facility for 6 months before the semen is collected 
for export, APHIS regulations do not include that requirement.
---------------------------------------------------------------------------

    \1\ Biological Risk Analysis: Risk assessment and management 
options for imports of swine and swine products from the European 
Union--June 2, 1999; and Risk Analysis for Importation of 
Classifical Swine Fever Virus in Swine and Swine Products from the 
European Union--December 2000.
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    We continue to consider it necessary to mitigate the CSF risk from 
the importation of swine semen from the EU. However, in light of the 
comments we received on our proposed rule suggesting the possibility of 
alternative methods of risk mitigation that would be less economically 
disruptive than a 40-day hold, we are not, at this time, making final 
the requirement for a 40-day hold with regard to those five EU Member 
States that we had previously individually recognized as free of CSF 
(Denmark, Finland, the Republic of Ireland, Sweden, and the United 
Kingdom). Instead, we will give the issue of a 40-day hold further 
consideration based on the information available to us, including the 
information received in comments in response to our April 2005 proposed 
rule. After we consider all the information available to us, we will 
publish a document in the Federal Register discussing our conclusions. 
If we consider it warranted to formally assess the effectiveness of 
alternative mitigation measures, we will make such an assessment 
available to the public for comment.

Request That the Final Rule Apply to More Than the EU-15

    Two commenters stated that the provisions of the proposed rule 
should not be limited to the EU-15, but should also be applied to the 
10 Member States that became part of the EU after April 30, 2004 (the 
EU-10). Both commenters stated that every EU Member State is required 
to adhere to the same EC regulations, directives, and decisions, 
including a comprehensive monitoring

[[Page 29063]]

and control system for the containment and eradication of CSF outbreaks 
wherever they may occur across the EU. Therefore, stated the 
commenters, the same APHIS rationale that supports application of the 
proposed rule to the EU-15 equally supports its application to the EU-
10. One of the commenters stated that this conclusion is further 
supported by the fact that, with limited exceptions, animals and animal 
products can move freely within the EU-25. One of the commenters stated 
that the rule should also apply to all future EU Member States. Another 
commenter asked how the proposed rule will be extended to address the 
inclusion of additional countries with varying degrees of veterinary 
equivalency as they join the EU.
    One commenter stated that, at a minimum, Poland should be added to 
the Member States covered by the proposed rule. The commenter also 
requested that APHIS identify (1) any statutory requirement that a risk 
assessment of Poland's (or any other country's) animal disease status 
be completed before determining its animal health status and (2) any 
statutory or regulatory impediment to using the EU accession process, 
and the materials used for that, as a basis for modifying Poland's 
animal disease status, without conducting a separate risk assessment.
    APHIS response. It would not be appropriate to include EU Member 
States other than the EU-15 in this final rule without first providing 
the public with full notice and opportunity to comment under the 
Administrative Procedure Act. In addition, APHIS regulations at 9 CFR 
92.2 specify that the public have access to the information upon which 
a risk analysis is based and the methodology used in the risk analysis 
during the comment period of a proposed rule. In developing our April 
2005 proposal to recognize the EU-15 as a single region with regard to 
CSF, we considered three analyses of risk and provided for notice and 
comment regarding those analyses.\2\ Because this criterion has not yet 
been met for Member States beyond the EU-15, we cannot, at this time, 
include such Member States in the region recognized by this final rule.
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    \2\ Biological Risk Analysis: Risk assessment and management 
options for imports of swine and swine products from the European 
Union--June 2, 1999; Risk Analysis for Importation of Classical 
Swine Fever Virus in Swine and Swine Products from the European 
Union--December 2000; and APHIS Supplememntal Risk Analysis for 
Importation of the Classical Swine Fever Virus in Swine and Swine 
Products from France and Spain--November 2003.
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    APHIS intends to evaluate each of the EU-10 Member States regarding 
CSF. As part of these evaluations, APHIS conducted site visits to 
Hungary, Lithuania, Poland, and Slovakia in 2004 and to the Czech 
Republic, Latvia, Estonia, and Slovenia in 2005. The risk analysis for 
each new Member State will progress independently as the necessary 
information becomes available to APHIS. We will use these risk analyses 
as tools to identify what risk mitigation measures, if any, would be 
necessary to protect U.S. livestock if swine and swine products were to 
be imported from the countries evaluated.
    If, in the future, there appear to be acceptable alternatives to 
the procedures currently specified under Sec.  92.2 of the regulations, 
we will consider such alternatives. We will provide the public with an 
opportunity to comment on such alternatives--and will take such 
comments into consideration--before making any changes to the 
regulations.
    With regard to the comment that specifically addressed imports from 
Poland, we are currently in the process of preparing a proposed rule 
that would make our analysis regarding such imports available to the 
public. Although there is no statutory requirement that APHIS complete 
a separate risk assessment before determining a country's animal health 
status, we consider such an assessment to be an integral component of 
the Agency's decision-making process.

Concerns That the Proposed Rule Would Severely Restrict Exports From 
the EU-15

    In our proposed rule, Sec.  94.24(b) contained requirements 
governing the importation of live swine from the EU-15. (Please note: 
The provisions we are making final that were included in Sec.  94.24 of 
the proposed rule appear in this final rule in Sec.  94.25. An APHIS 
final rule regarding bovine spongiform encephalopathy published on 
January 4, 2005 (70 FR 460-553, Docket No. 03-080-3) redesignated Sec.  
94.24 as Sec.  94.25.) Among the conditions in proposed Sec.  94.24(b) 
was the requirement that the swine have not lived in:
     A restricted zone in the EU-15, established because of a 
CSF outbreak in domestic swine, during the 6 months following 
depopulation of the swine in the restricted zone and the cleaning and 
disinfection of the last infected premises in the zone;
     A restricted zone established because of the detection of 
CSF in wild boar, until the designation of the zone as a restricted 
zone is removed by the competent veterinary authority of an EU-15 
Member State; or
     Any other region classified in Sec. Sec.  94.9(a) and 
94.10(a) as a region in which CSF is known to exist.
    Additionally, Sec.  94.24(b)(2) of the proposed rule required that 
the swine must not have transited any of the areas described above 
unless they were moved through the zone or region in a sealed means of 
conveyance with the seal determined to be intact upon arrival at the 
point of destination. Further, the swine must never have been 
commingled with swine that were in such a zone or region.
    The provisions of proposed Sec.  94.24(a) applied the same 
restrictions described above to swine from which pork or products 
intended for export to the United States were derived.
    One commenter stated that, because the Member States of the EU-10 
are considered by APHIS to comprise a region in which CSF is known to 
exist, the proposed rule would prohibit the exportation to the United 
States of swine or swine products from the EU-15 if the swine have 
lived in or transited (except for direct transit under the conditions 
described below under the heading ``Request for Clarification of Extent 
of Restrictions on Swine and Swine Products'') any part of the EU-10 or 
have been commingled with swine from any part of the EU-10. The 
commenter stated that, considering the nature of the internal EU 
market, which encompasses all 25 EU Member States, such a provision 
would severely restrict export from the EU-15 to the United States and 
is a further reason why the rule should be expanded, in line with 
Article 15 of the Veterinary [Equivalence] Agreement, to include all 
Member States of the EU-25. (The stated objective of the Veterinary 
Equivalence Agreement is to facilitate trade in live animals and animal 
products between the EU and the United States by establishing a 
mechanism for the recognition of equivalence of sanitary measures, 
consistent with the protection of public and animal health, and improve 
communication and cooperation on sanitary issues.)
    APHIS response. We recognize that, under this rule, swine and swine 
products from the EU-15 will be prohibited importation into the United 
States if the swine involved have been in other EU Member States or 
have been commingled with swine from other Member States. However, as 
discussed above, it would not be in accordance with the regulations in 
Sec.  92.2 and with the Administrative Procedure Act to include EU 
Member States other than the EU-15 in this final rule without first 
providing the public with full notice of

[[Page 29064]]

and opportunity to comment on such inclusion.

Request for Clarification of Extent of Restrictions on Swine and Swine 
Products

    One commenter requested clarification of whether a pig that was in 
a restricted zone while it was a restricted zone would be permanently 
banned from importation into the United States, or be banned only 
during the time that the area is considered a restricted zone. The 
commenter stated that the latter should be the case. The commenter said 
the same question applies to pork and pork products from swine that 
were in a restricted zone at the time it was a restricted zone.
    It was not our intention to permanently prohibit the importation of 
swine, or swine products or semen derived from swine, that have been in 
an area during the time it was a restricted zone, and we explain below, 
under the heading, ``Scope of Restrictions on the Importation of Swine 
and Swine Products from the EU-15,'' the wording we are using in this 
final rule to make that clear.
    Before we explain that, however, we wish to (1) explain a wording 
change we are making in this final rule to be more precise about the 
nature of CSF contamination, and (2) clarify a statement we made in the 
proposed rule regarding the depopulation of swine following an outbreak 
of CSF.
    1. ``Infected'' and ``affected.'' In Sec. Sec.  94.24(a)(1)(ii)(A) 
and 98.38(b)(2)(i) of our proposal we referred to cleaning and 
disinfection of infected premises in a restricted region or zone. 
Properly speaking, the description ``infected'' should be used to apply 
to the animals contaminated with the disease agent, and the premises 
where the animals are located should be referred to as being 
``affected.'' We are using that terminology in this final rule.
    2. Depopulation of swine after a CSF outbreak. As noted above, we 
proposed to require that live swine not have been in a restricted zone 
in the EU-15, established because of a CSF outbreak in domestic swine, 
during the 6 months following depopulation of the swine in the 
restricted zone and the cleaning and disinfection of the last infected 
premises in the zone. This same condition was included in the proposed 
rule with regard to swine from which pork and pork products intended 
for export to the United States from the EU-15 were derived, and with 
regard to donor boars from which semen intended for export to the 
United States from the EU-15 was collected.
    We did not intend to imply that all swine in a restricted zone 
would need to be depopulated before we would accept swine and swine 
products from that area. Consistent with international standards and 
with standard practice in the United States when a limited outbreak of 
a disease of concern occurs, only those swine on the affected premises 
would need to be depopulated. The boundaries of a restricted area are 
drawn to encompass more than just the affected premises, in order to 
temporarily restrict the movement of animals from other than the 
affected premises that may pose an increased risk of being infected 
with the disease due to proximity to the infected animals or other 
factors. Therefore, in this final rule, we are making it clear that we 
intend that only the swine on the affected premises in the restricted 
zone must have been depopulated.

Scope of Restrictions on the Importation of Swine and Swine Products 
From the EU-15

    As noted above, it was not our intention to permanently prohibit 
the importation of swine, or swine products or semen derived from 
swine, that have been in an area during the time it was a restricted 
zone. Once sufficient time has elapsed to ensure that swine from the 
formerly restricted zone are not infected with CSF, they, and products 
and semen derived from such swine, may be imported into the United 
States. This is consistent with the intention stated in our December 
2000 risk analysis to accept exports of swine, swine products, and 
semen only from regions that have not experienced a CSF outbreak within 
the previous 6 months.\3\
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    \3\ Risk Analysis for Importation of Classical Swine Fever Virus 
in Swine and Swine Products from the European Union--December 2000.
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    In this final rule, we are being more specific in Sec. Sec.  
94.25(a), 94.25(b), and 98.38(b) to make clearer the conditions under 
which swine and swine products are eligible for importation into the 
United States from the EU-15 with regard to CSF. In this final rule, we 
are setting forth the following:
    1. Pork and pork products. Among the provisions included in Sec.  
94.25(a) of this final rule, we are providing that the pork and pork 
products must not have been derived from swine that were in any of the 
following regions or zones at any time during the following periods, 
unless the swine were slaughtered after the periods described:
     Any region when the region was classified in Sec. Sec.  
94.9(a) and 94.10(a) as one in which CSF is known to exist, except for 
the EU-15;
     A restricted zone in the EU-15 established because of 
detection of CSF in domestic swine, from the time of the detection 
until the designation of the zone as a restricted zone is removed by 
the competent veterinary authority of an EU-15 Member State or until 6 
months following depopulation of the swine on affected premises in the 
restricted zone and the cleaning and disinfection of the last affected 
premises in the zone, whichever is later; or
     A restricted zone in the EU-15 established because of the 
detection of CSF in wild boar, from the time of detection until the 
designation of the zone as a restricted zone is removed by the 
competent veterinary authority of an EU-15 Member State.
    For the period described above following the detection of CSF in 
domestic swine, we provide that the period during which exports to the 
United States are prohibited could be longer than 6 months if the EU-15 
has not yet removed its designation of the area as a restricted zone by 
that time. We expect that this situation, if it arises at all, will 
occur infrequently. However, we consider it prudent to provide for any 
such situations where the EU has reason to believe the designation of 
an area as a restricted zone should be extended.
    Additionally, we are providing in Sec.  94.25(a)(2) that the pork 
and pork products must not have been commingled with pork or pork 
products derived from other swine that were in any of the regions or 
zones described above, unless the other swine were slaughtered after 
the periods described. Additionally, the pork and pork products must 
not have been derived from swine that were commingled with other swine 
that were in any of the regions or zones described above, unless the 
swine from which the pork and pork products were derived were 
slaughtered after the periods described.
    In Sec.  94.25(a)(3), we are providing that the swine from which 
the pork and pork products were derived must not have transited any 
region or zone described above, unless the swine were moved directly 
through the region or zone in a sealed means of conveyance with the 
seal determined to be intact upon arrival at the point of destination, 
or unless the swine were slaughtered after the periods described.
    2. Live swine. Among the provisions included in Sec.  94.25(b) of 
this final rule, we are providing that live swine imported from the EU-
15 must not have been in any regions or zones described above, unless 
the swine are exported after the periods described.

[[Page 29065]]

    Additionally, we are providing in Sec.  94.25(b)(3) that the swine 
must not have been commingled with other swine that have at any time 
been in any of the regions or zones described above, unless the swine 
are exported after the periods described. We are also providing that 
the swine must not have transited any region or zone described above, 
unless the swine were moved directly through the region or zone in a 
sealed means of conveyance with the seal determined to be intact upon 
arrival at the point of destination, or unless the swine are exported 
after the periods described.
    3. Swine semen. Among the provisions included in Sec.  98.38 of 
this final rule, we are providing that swine semen imported from the 
EU-15 must not have been collected from a donor boar that was in any of 
the regions or zones described above, unless the semen was collected 
after the periods described.
    We are providing in Sec.  98.38(c) that the semen must not have 
been collected from a donor boar that was commingled with swine that at 
any time were in any of the regions or zones described above, unless 
the semen was collected after the periods described.
    Additionally, we are providing in Sec.  98.38(d) that the semen 
must not have been collected from a donor boar that transited any 
region or zone described above, unless the donor boar was moved 
directly through the region or zone in a sealed means of conveyance 
with the seal determined to be intact upon arrival at the point of 
destination, or unless the semen was collected after the periods 
described.

Concerns With EU Removal of Movement Restrictions in Less Than 6 Months

    Several commenters expressed concern that, even though the proposed 
rule would not allow the importation into the United States of swine 
and swine products from a restricted zone until 6 months after the 
depopulation of swine in the zone and the cleaning and disinfection of 
the last infected premises in the zone, the EU allows free movement of 
animals and products from such a zone after only 20 or 30 days. One 
commenter stated that the shorter EU ``release period'' would require 
the United States to track any swine or swine products moving from a 
restricted zone to some other area of the EU before the 6 months are 
up, in order to ensure that the swine or swine products are not 
exported to the United States.
    APHIS Response. We are making no changes based on these comments. 
The commenter is correct that EC regulations would allow movement of 
animals and products from CSF restricted zones before a 6-month period 
expired. However, the proposed rule anticipated the potential for this 
``shorter EU `release period.' '' As we stated in the proposed rule, 
swine and swine products would not be allowed importation from the EU-
15 unless they are accompanied by certification by an official of the 
competent veterinary authority of the EU-15 Member State that the 
conditions of this rule have been met. In considering the CSF risk in 
the EU-15, we evaluated the ability of officials in that region to 
ensure that prohibitions on the importation into the United States of 
swine and swine products from the restricted zones would be effectively 
enforced.
    The commenters are correct that, because of the potential 
difference between the restrictions of the EC and those of this rule 
with regard to when restrictions are removed, it will be necessary to 
track the movement of any swine that are moved from a restricted area 
before 6 months have elapsed. However, such tracking will be the 
responsibility of EU veterinary officials.

How APHIS' Proposed Restrictions Compare to International Standards

    One commenter stated that the provision that would prohibit the 
importation of live swine and pork and pork products from restricted 
zones for 6 months after depopulation of swine in the restricted zone 
and the cleaning and disinfection of the last infected premises in the 
zone is more stringent than the standards contained in Article 2.6.7.6 
of the Terrestrial Animal Health Code of the World Organization for 
Animal Health (OIE Code). The commenter stated that Article 2.6.7.6 of 
the OIE Code provides that if a CSF outbreak occurs in an establishment 
in a country or zone free of CSF in domestic and wild swine or free of 
CSF in domestic pigs only, the status of the country or zone may, under 
certain measures, be restored 30 days after completion of a policy for 
``stamping out'' the disease.
    APHIS response. We are making no changes based on this comment. 
Current EU regulations allow CSF restrictions in protection zones to be 
removed no earlier than 30 days after completion of preliminary 
cleaning and disinfection measures on the infected holding (no earlier 
than 20 days in surveillance zones). Measures are lifted only after 
clinical examinations and serology indicate that the pigs remaining in 
the zones are free of CSF. Presumably, after restrictions are released, 
swine from the area could be moved throughout the EU.
    Based on observations and assumptions that we discussed in two risk 
analyses used to support our April 2005 proposed rule, we proposed to 
recognize the EU-15 as a region of low risk for CSF rather than as a 
CSF-free region.\4\ As discussed in our proposed rule, we are concerned 
that a 30-day period following a CSF outbreak in the EU-15 is 
insufficient to ensure that the area where an outbreak occurred is no 
longer affected by the disease.
---------------------------------------------------------------------------

    \4\ See footnote 1 above.
---------------------------------------------------------------------------

    We consider a 6-month waiting period to be appropriate for several 
reasons. First, as described in our risk analyses, we are concerned by 
the recurrence of CSF in several areas of the EU shortly after EC 
restrictions were removed from those areas and the movement of swine 
commenced. For example, in December 2001 a CSF outbreak was confirmed 
in Osoma, Spain, 22 days after release of EC movement restrictions (83 
days after depopulation of the last previous outbreak in Spain). A CSF 
outbreak in August 2002 in Luxembourg was epidemiologically linked to 
an outbreak that occurred in June 2002. The August 2002 outbreak 
occurred 27 days after release of EC movement restrictions (56 days 
after depopulation of the affected pigs involved in the June outbreak). 
During the 1997-1998 CSF epidemic, the EC usually maintained movement 
restrictions for more than 30 days, but disease spread was nonetheless 
extensive. These observations and the EC actions suggest that 30 days 
may be an insufficient duration for restrictions.
    Our proposed 6-month period for restrictions was based on the 
relevant OIE standard (OIE Code, 2004) at the time our risk 
documentation was developed. The 6-month waiting period was the OIE 
standard for a country or zone free of CSF in domestic pigs but with 
infection in the wild pig population. In that standard, OIE recommended 
that, where a stamping out policy without vaccination has been 
implemented for CSF control, recognition of freedom from CSF may be 
acquired 6 months after the last outbreak in domestic pigs. The 
commenter is correct that the OIE standard has been recently revised 
(OIE Code 2005) and currently recommends release of restrictions 30 
days after completion of the appropriate stamping out activities. 
However, that change was made after development of our proposed rule, 
which did not invite public comment regarding the change in the OIE 
recommendations.
    Despite the change in the OIE recommendations, we continue to be 
concerned that restrictions for only 30 days may not be sufficient, for 
the reasons discussed above. However, we

[[Page 29066]]

welcome any relevant scientific information regarding this issue and, 
if we consider it warranted after review of the information, could 
consider alternatives to a 6-month restriction period in future 
rulemaking.

Concerns That the Rule as Proposed Would Eliminate APHIS Site Visits to 
the EU-15

    Several commenters expressed concern that implementation of the 
proposed rule would eliminate APHIS site visits to the EU-15 for the 
purpose of evaluating compliance with procedures deemed critical for 
the protection of the U.S. swine industry. One commenter recommended 
that USDA officials be required to make onsite evaluations in the EU-15 
before importations of swine and swine products are allowed to resume 
from a restricted zone. Another commenter stated that the rule should 
not prohibit such onsite evaluations. A third commenter requested 
further clarification of the reasons for eliminating site visits to the 
EU, and stated that site visits are an important component of the risk 
assessment process. That commenter stated that a site visit that APHIS 
conducted in response to a regionalization request from Mexico allowed 
U.S. officials to become aware of the occurrence of porcine ``blue eye 
disease'' that may have gone unnoticed had such a visit not been 
conducted.
    APHIS response. We are making no changes based on these comments. 
We agree that site visits are valuable tools in evaluating and 
verifying animal disease conditions, especially in countries where 
there has been limited history of animal and animal product trade with 
the United States. As we stated in our proposed rule, APHIS reserves 
the right to make site visits and review documentation related to the 
outbreak and eradication activities. Additionally, Sec.  92.2(g) of the 
current regulations, regarding application for recognition of the 
animal health status of a region, provides that, if a region is granted 
animal health status in accordance with the regulations, that region 
may be required to submit additional information pertaining to animal 
health status or allow APHIS to conduct additional information 
collection activities in order for that region to maintain its status. 
Such additional information collection activities could include a site 
visit if deemed necessary by APHIS.
    APHIS considers its knowledge of the CSF conditions and the 
effectiveness of CSF control measures in the EU-15 to be extensive. 
Although our risk analyses assumed there will be future CSF outbreaks 
in domestic swine within the EU-15, they concluded that the EU is 
capable of detecting, controlling, and eradicating CSF in its domestic 
swine if an outbreak occurs. Because we expect future CSF outbreaks to 
occur in what we are considering a low-risk region for CSF, and expect 
that such outbreaks will be quickly and effectively controlled, we do 
not anticipate a need to make routine site visits to the region. 
However, this rule does not prohibit APHIS from taking such action if 
conditions warrant.

Concern That Assessment of Disease Status Will Become Less Transparent

    One commenter stated that, although the current process for 
assessing and changing the CSF-status of countries or other regions in 
the EU is laborious, it is also highly transparent.
    APHIS response. We do not consider that a significant level of 
transparency will be lost by the new approach, whereas the amount of 
labor and time required to re-initiate trade will be significantly 
reduced. With respect to transparency, OIE reports of CSF outbreaks in 
the region will continue to be available to interested parties. 
Procedurally, this rulemaking explains clearly how APHIS will respond 
to those reports. As discussed above, APHIS has gained confidence in 
control of CSF by the EC through extensive evaluations of the EU-15 
region and the history of trade of swine and swine products between the 
EU-15 and the United States. We consider the process established in 
this rule to be warranted and advantageous, allowing APHIS to respond 
more quickly to changes in CSF conditions within a recognized low-risk 
region while maintaining the Agency's sanitary standards.

Concerns Regarding Efficacy of EU CSF Control Measures and Risk Levels

    One commenter stated that, to date, control measures in EU Member 
States have not been effective in preventing the introduction of CSF 
into domestic swine herds in the EU.
    APHIS response. As previously stated, the risk analyses we 
conducted with regard to the imports of swine and swine products from 
the EU-15 demonstrate that the risk of exporting CSF from the EU-15 and 
having it enter and become established in the United States is low, 
even assuming continuing outbreaks in the region. Among the factors we 
consider in conducting a risk analysis is whether a region seeking to 
export commodities to the United States has a veterinary infrastructure 
capable of detecting, controlling, and eradicating the disease 
efficiently in the case of an outbreak. We have determined that the EC 
veterinary infrastructure possesses such capabilities.

Request for Additional Surveillance

    One commenter expressed concern that, although the proposed rule 
would result in all of the EU-15 Member States being considered as 
having the same level of risk for CSF exposure because of freedom of 
trade within the EU, it would appear that different levels of risk 
exist throughout the EU and that certain areas should be required to 
undergo significant additional surveillance to ensure detection of CSF 
exposure.
    APHIS response. We are making no changes to the final rule based on 
this comment. The final rule anticipates that additional surveillance 
is necessary for areas within the EU-15 where the CSF virus has been 
detected either in domestic swine or wild boar. The APHIS evaluation 
has shown that surveillance plans are implemented at a Member State or 
regional level. The EC reviews and approves individual surveillance 
plans. The continuing appropriateness of the plans to a given situation 
or local risk spectrum is assessed during inspections by the EC's Food 
and Veterinary Office. In addition, APHIS reviews surveillance programs 
during its initial onsite evaluations and also reviews the adequacy of 
detection methods by laboratories throughout the region. Finally, APHIS 
considers the surveillance approaches described in individual 
contingency plans, detection capabilities, and movement restrictions 
and control measures implemented at the EU level under EC regulation 
[Council Directive 2001/89/EC] to be adequate for detection, control, 
and eradication of CSF in domestic swine.

Request That the Rule Apply to Diseases in Addition to CSF

    One commenter requested that the proposed rule be extended to apply 
to all animal diseases and not be confined to CSF. The commenter stated 
that if APHIS will accept the decisions of the EU with regard to CSF, 
then APHIS should also accept the decisions of the EU with regard to 
other animal diseases. Another commenter stated that the proposed rule 
would not fulfill U.S. obligations under the Veterinary [Equivalence] 
Agreement, which the commenter stated would entail regionalization of 
the EU not just for CSF, but for all major animal diseases.
    APHIS response. We are making no changes based on these comments. 
The regionalization approach and import conditions established by this 
final rule

[[Page 29067]]

are based on the CSF-specific conditions that exist in the EU-15 and 
the CSF control measures applied in that region. These conditions and 
measures are discussed in the document ``APHIS Risk Considerations on 
Importation of Classical Swine Fever (CSF) Virus in Breeding Swine, 
Swine Semen, and Fresh Pork from a European Union Region of Fifteen 
Member States,'' which was released for public review and comment when 
our proposed rule was published in April 2005. The conditions and 
control measures for other major animal diseases were not addressed in 
that document. However, we are considering establishing the same or 
similar regionalization approaches with regard to other major animal 
diseases. We would make any such proposed expanded application of this 
approach available for public comment, along with any supporting 
evaluations.

Smallest Administrative Unit To Be Considered for Regionalization in 
Italy

    One commenter stated that, although the proposal identified the 
``Region'' as the smallest administrative unit in Italy that APHIS will 
consider for regionalization, in its ``Notice of Availability of Draft 
Document Concerning the Identification of the EU Administrative 
Units,'' APHIS announced that the Aziende Sanitarie Locali will be the 
smallest administrative unit in Italy considered for regionalization.
    APHIS response. At the time the proposed rule was published in 
April 2005, the ``Region'' was recognized by APHIS as the smallest 
administrative unit for the purpose of regionalizing Italy in the event 
of future animal disease outbreaks. However, after the proposed rule 
was published, we reevaluated the issue of the appropriate smallest 
administrative unit for regionalization in Italy and identified the 
Aziende Sanitarie Locali as that administrative unit. On April 21, 
2005, we gave notice in the Federal Register (70 FR 20733-20734, Docket 
No. 04-081-1) of the availability of a draft document listing what 
APHIS considered the smallest appropriate administrative units for 
regionalization in Italy and in other EU Member States. On July 29, 
2005, we published a notice in the Federal Register (70 FR 43838-43839, 
Docket No. 04-081-2) advising the public that we were making the draft 
document final with minor changes. Therefore, APHIS considers the 
Aziende Sanitarie Locali to be the smallest appropriate administrative 
unit in Italy for purposes of regionalization.

Request for Clarification of the Likely Source of CSF Diagnosed in 
France

    One commenter noted that the proposed rule stated that infected 
wild boar are the suspected source of virus linked to an April 2002 CSF 
outbreak in France. The commenter expressed concern that this statement 
erroneously suggests that the outbreak was linked to infection in wild 
boars in France. The commenter stated that epidemiological 
investigations in fact suggested that the introduction of CSF occurred 
when a farmer from Germany visited the holding in France where the CSF 
was detected.
    APHIS response. We agree that the language in the proposed rule may 
have erroneously given the impression that the 2002 outbreak in 
Chemery-les-Deux in France was linked to CSF-infected wild boar 
populations in that country. The commenter correctly points out that 
the epidemiology investigation for that outbreak, as described in the 
``APHIS Risk Analysis for Importation of the Classical Swine Fever 
Virus in Swine and Swine Products from France and Spain--November 
2003,'' reported that French authorities hypothesized that the outbreak 
was the result of secondary spread of infection from a CSF outbreak in 
a domestic swine herd in Germany. It should be noted that this 
clarification does not alter APHIS' conclusion that EU control measures 
for CSF in wild boar are a critical component of the overall EU 
controls for CSF. The risk analyses conducted by APHIS' assessment 
demonstrated that infected wild boar continue to be a potential source 
of infection in domestic swine. However, the risk of the spread of CSF 
infection originating in wild boar is mitigated by the EC regulations 
that place movement restrictions on domestic swine from infected wild 
boar areas.

Certification Clarifications

    In Sec.  94.25(b)(6) of this rule, we provide that live swine 
exported from the EU-15 must be accompanied to the United States by a 
certificate issued by a salaried veterinary officer of the competent 
veterinary authority of the EU-15 Member State. This requirement was 
included in our proposed rule. For pork and pork products, Sec.  
94.25(a)(5) provides that pork and pork products imported from the EU-
15 must be accompanied by a certificate issued by an official of the 
competent veterinary authority of the EU-15 Member State who is 
authorized to issue the foreign meat certificate required by 9 CFR 
327.4 This requirement was likewise included in our proposed rule. 
However, in Sec.  98.38(g) of the proposed rule with regard to the 
importation of swine semen from the EU-15, we stated only that the 
semen must be accompanied to the United States by a certificate issued 
by a salaried veterinary officer of the EU-15 Member State, and did not 
indicate that the veterinary officer must be employed by the competent 
veterinary authority of that State. To clarify our intent and to be 
consistent with the other provisions in this final rule, we are 
providing in Sec.  98.38(i) that the individual issuing the certificate 
with regard to swine semen must be a salaried veterinary officer of the 
competent veterinary authority of the EU-15 Member State.
    Section 93.505 of the current regulations requires that, except for 
swine from Canada, all swine intended for importation into the United 
States be accompanied by official certification regarding the health 
status of the swine and the disease status of the region of origin. 
Paragraph (a) of Sec.  93.505 requires that the certificate 
accompanying the swine show that the entire region of origin of the 
swine is free of CSF and other specified diseases of swine. In 
accordance with our proposed action to allow the importation of 
breeding swine from the EU-15, we proposed to change the language in 
Sec.  93.505 to clarify that certification that the entire region is 
free of CSF does not apply to the EU-15. The wording we used in 
proposed Sec.  93.505 was as follows: ``* * * except for the region 
consisting of the EU-15 for the purposes of classical swine fever, for 
which alternative certification is required under Sec.  94.24(b)(4), 
for domestic swine the certificate shall show that the entire region of 
origin is free of classical swine fever.''
    Our use of the term ``alternative certification'' was intended to 
apply only to the certification requirement in Sec.  93.505(a) 
regarding CSF. We did not intend to imply that there were alternative 
certification requirements regarding diseases other than CSF for swine 
imported from the EU-15. For diseases other than CSF, the certification 
requirements in Sec.  93.505 will continue to apply to imports from the 
individual EU Member States. To make clear our intention, in this final 
rule we are replacing the term ``alternative certification'' with the 
term ``additional certification.'' Additionally, we are adding a note 
to Sec.  93.505(a) to make clear that we consider the EU-15 to be a 
single region of origin only with regard to CSF and not with regard to 
any other diseases of swine.

[[Page 29068]]

Equipment and Materials Used To Transport Swine

    The conditions in Sec.  94.25 regarding the importation of live 
swine from the EU-15 include the requirement that no equipment or 
materials used to transport the swine may have been used previously for 
transporting swine that do not meet the requirements of the final rule, 
unless such equipment and material have first been cleaned and 
disinfected. A similar requirement is included in Sec.  98.38 regarding 
donor boars from which swine semen intended for export is collected. 
These requirements are necessary to guard against contamination of the 
animals with the CSF disease agent.
    Although the same risk mitigation measure is necessary for swine 
from which pork and pork products intended for importation from the EU-
15 are derived, our proposed rule did not explicitly include that 
requirement for such swine. To make clear our intent, we are providing 
in Sec.  94.25(a)(4) that no equipment or materials used in 
transporting the swine from which the pork and pork products were 
derived from the farm of origin to the slaughtering establishment may 
have been used previously for transporting swine that do not meet the 
requirements of this final rule, unless such equipment and materials 
have first been cleaned and disinfected.

Other Nonsubstantive Changes

    In this final rule, we have made certain nonsubstantive changes, 
such as redesignations of paragraphs and corresponding changes to 
paragraph references, to accommodate the changes discussed above.

Conclusion

    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 discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be significant for the purposes of Executive 
Order 12866 and, therefore, has been reviewed by the Office of 
Management and Budget.
    Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the 
Secretary of Agriculture is authorized to promulgate regulations to 
prevent the introduction into the United States or dissemination of any 
pest or disease of livestock. APHIS decides whether animals and animal 
products may be exported from foreign regions to the United States 
based on disease risk assessments.
    In this rule we are amending the regulations in 9 CFR part 94 to 
(1) apply a uniform set of importation requirements related to CSF to a 
region consisting of the EU-15, and (2) prohibit for a specified period 
of time the importation of live swine and swine products from any area 
in the EU-15 that is identified by the veterinary authorities of the 
region as a restricted zone.
    The purpose of this rule is to enable APHIS to respond more readily 
to changes in CSF status within the EU, while maintaining the Agency's 
sanitary safeguards. The rule will change the requirements by which 
imports of swine, swine meat, and swine genetics are allowed to resume 
following restoration of CSF-free status for areas within the EU-15 
that have been quarantined because of this disease.
    Separate rulemaking each time an area within the EU-15 experiences 
a CSF outbreak and each time CSF-free status is restored will no longer 
be required. Rather, APHIS will recognize EU quarantine decisions and 
require the EU to certify that the conditions set forth in this rule 
are met. As an additional safeguard, imports of swine, swine meat, and 
swine genetics by the United States from areas in which CSF had been 
detected in domestic swine will be restricted from the time of 
detection until the designation of the zone as a restricted zone is 
removed by the competent veterinary authority of an EU-15 Member State 
or until 6 months following depopulation of the swine on affected 
premises in the restricted zone and the cleaning and disinfection of 
the last affected premises in the zone, whichever is later.
    This action is being taken based on APHIS' analysis of the risks of 
CSF introduction from the EU. CSF is a highly contagious and fatal 
disease of swine. It was eradicated from the United States in 1976 
after a 16-year effort, at a cost to USDA and individual States of 
about $140 million ($479 million in 2005 dollars). The potential for 
reintroduction of CSF into the United States remains a major concern, 
not only because of production losses and eradication costs, but also 
because of the adverse effects reintroduction would have on U.S. swine 
and pork exports.
    In this analysis, expected benefits and costs of the rule are 
examined in accordance with Executive Order 12866. Impacts for small 
entities are also considered, as required by the Regulatory Flexibility 
Act.
    An alternative to the rule would be to not change the regulations, 
that is, to continue to initiate rulemaking whenever the CSF status of 
an area within the EU-15 changes. Continuing with the current 
procedures would not achieve the objective of improving the Agency's 
responsiveness to CSF status changes. A second alternative would be to 
not include in the rule the 6-month period of import restriction 
following restoration of an area's CSF-free status when CSF had been 
detected in domestic swine. This alternative would forfeit the 
additional sanitary assurance that the 6-month period will provide to 
the U.S. swine and swine product industries that the reestablished 
imports are CSF-free. The rule is preferable to these alternatives in 
allowing timelier resumption of imports from areas restored to CSF-free 
status, while ensuring that sanitary safeguards are adequate.

Effects of the Rule

    Simplification of the process by which an area in the EU-15 region 
that has been quarantined for CSF reacquires CSF-free status will allow 
for timelier resumption of U.S. imports of swine, swine meat, and swine 
genetics from the area. In addition, the rule will result in more 
efficient use of APHIS resources. These areas of impact are discussed 
below.
    More Timely Reestablishment of CSF-Free Status. With this rule, 
reestablishment of CSF-free status for an area that has been under 
quarantine is expected to require less time than currently, 
notwithstanding the 6-month restriction on importation of swine and 
swine products from the area following depopulation of the swine on 
affected premises in the quarantined zone and completion of cleaning 
and disinfection measures, if domestic swine were infected. More timely 
recognition of an area's CSF-free status will allow imports of swine, 
swine meat, and swine genetics from the area to resume sooner than at 
present.
    The economic effect will depend on the time saved, and the 
additional swine, swine meat, and swine genetics that will be imported 
because of more timely reinstatement of an area's CSF-free status. We 
cannot predict the number of swine or quantity of swine products 
imported that the rule will affect, but they are unlikely to be 
significant. Less than 6 percent of domestically available swine (U.S. 
production plus imports minus exports) and less than 3 percent of 
domestically available pork are imported. Most swine imports come from 
one country, Canada, and most swine product imports come from two, 
Canada and Denmark.

[[Page 29069]]

    Impacts of the rule for the U.S. swine and swine product industries 
will be minor. However, we expect the rule to lead more generally to 
improved trade relations between the United States and the EU. One or 
more of the areas within the EU-15 region not yet recognized by the 
United States as free of CSF--i.e., Luxembourg and parts of Germany and 
Italy--may be among the first to benefit from this rule.
    More Efficient Use of APHIS Resources. A second area of impact will 
be the effect of the rule on APHIS operations. The rule will result in 
fewer site visits, risk assessments, Federal Register publications, and 
other rulemaking tasks currently required for reinstating an area's 
CSF-free status. Resources that are devoted to these tasks will become 
available for other uses.
    Gains to the Agency from the reallocation of resources are not 
readily quantified. They will be realized in terms of the additional 
time APHIS staff have for other tasks, and will depend on the frequency 
with which CSF quarantines and CSF-free status reinstatements take 
place within the EU-15 region.
    Swine Semen Import Requirements. In April 2003, APHIS published a 
final rule that recognized--with the exception of specified regions in 
Germany and Italy--the countries of Austria, Belgium, Germany, Greece, 
Italy, the Netherlands, and Portugal as a single region in which CSF is 
not known to exist, but from which the importation of live swine and 
swine products into the United States is restricted because of CSF 
infection in wild boar populations. Among the restrictions applied to 
importations from that region are certain requirements regarding swine 
semen. One requirement is that, before swine semen is exported to the 
United States, the donor boar be held at the semen collection center 
and observed by the center veterinarian 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. The 40-day hold is 
considered an effective mitigation measure and is consistent with OIE 
recommendations for semen exported from countries that are free of CSF 
in domestic swine but that have CSF infection in wild boar populations.
    Before publication of the April 2003 final rule, five EU Member 
States--Denmark, Finland, the Republic of Ireland, Sweden, and the 
United Kingdom--were considered CSF-free. In our April 8, 2005 proposed 
rule, we proposed to begin applying the 40-day hold requirement to 
these five EU countries.
    Some of the comments we received in response to our proposed rule 
addressed the issue of the 40-day hold on semen. We discussed these 
comments, above, under the heading ``Forty-Day Holding Period Before 
the Shipment of Swine Semen to the United States.'' As we stated, 
above, we continue to consider it necessary to mitigate the CSF risk 
from the importation of swine semen from the EU. However, in light of 
the comments received on the proposed rule suggesting the possibility 
of alternative methods of risk mitigation that would be less 
economically disruptive than a 40-day hold, we are not, at this time, 
making final the requirement for a 40-day hold with regard to those 
five EU Member States that we had previously individually recognized as 
free of CSF (Denmark, Finland, the Republic of Ireland, Sweden, and the 
United Kingdom). Instead, we will give the issue of a 40-day hold 
further consideration based on the information available to us. After 
we consider all the information available to us, we will publish a 
document in the Federal Register discussing our conclusions.
    In the economic analysis we conducted for the proposed rule, we 
raised the question of possible effects of the 40-day hold on the five 
EU Member States that APHIS had recognized as free of CSF before the 
April 2003 final rule. However, because this final rule will not change 
swine semen import requirements for those five Member States, we are 
not addressing in this analysis potential effects on those five Member 
States of a 40-day hold requirement.

Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires 
agencies to evaluate the potential effects of their proposed and final 
rules on small businesses, small organizations, and small governmental 
jurisdictions.
    U.S. entities that could be affected by the rule are swine 
producers and swine product wholesalers. The size of entities that may 
be affected by the rule is unknown. However, it is reasonable to assume 
that most fall below the U.S. Small Business Administration's (SBA) 
small-