[Federal Register: May 19, 2006 (Volume 71, Number 97)]
[Rules and Regulations]
[Page 29061-29072]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my06-1]
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[[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.
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\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-entity thresholds.
The SBA defines small hog and pig farms as those earning not more
than $750,000 in annual receipts. National Agricultural Statistics
Service (NASS) data show that the average value of hogs and pigs sold
in 2002 was about $67 per animal. Based on this average price, the
number of hogs and pigs sold annually would need to be fewer than about
11,200 animals for annual receipts to be not more than $750,000. NASS
data are structured to show how many hog and pig farms sold 7,500 or
more animals. NASS data indicate that only about 6 percent of hog and
pig farms sold 7,500 or more animals in 2002. Clearly, most swine
producers are small entities.
Swine product wholesalers are also likely to be mainly small
entities. The SBA small-entity standard for these businesses is not
more than 100 employees. We do not know the size distribution of meat
wholesalers, but the 2002 Economic Census indicates that the average
number of employees per establishment that year was 15.
U.S. imports of swine, swine meat, and swine genetics from the EU-
15 are expected to be timelier because of the rule. To the extent that
the rule results in less delay in imports, any import-related impacts
for U.S. producers and wholesalers will occur more quickly as well. We
cannot predict the number of swine or quantity of swine products that
the rule will affect, but they are unlikely to be significant. Rather,
the major benefit of the rule will be improved trade relations between
the United States and the European Union.
APHIS has not taken steps to minimize significant economic impacts
of the rule on small entities because we do not expect any significant
impacts. An alternative to the proposed 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 products industries. The rule is preferable to
these alternatives in allowing resumption of imports from areas
restored to CSF-free status in a timelier manner, while ensuring that
sanitary safeguards are sufficient.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0265.
[[Page 29070]]
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 734-7477.
List of Subjects
9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and record keeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 98
Animal diseases, Imports.
0
Accordingly, we are amending 9 CFR parts 93, 94, and 98 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
0
1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. In Sec. 93.500, a new definition of European Union-15 (EU-15) is
added, in alphabetical order, to read as follows:
Sec. 93.500 Definitions.
* * * * *
European Union-15 (EU-15). The organization of Member States
consisting of Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Italy, Luxembourg, the Netherlands, Portugal, Republic of
Ireland, Spain, Sweden, and the United Kingdom (England, Scotland,
Wales, the Isle of Man, and Northern Ireland).
* * * * *
0
3. In Sec. 93.505, paragraph (a), the last sentence is removed and
three sentences are added in its place to read as follows:
Sec. 93.505 Certificate for swine.
(a) * * * For domestic swine, the certificate shall also show that
the entire region of origin is free of African swine fever and swine
vesicular disease and that, for 60 days immediately preceding the time
of movement from the premises of origin, no swine erysipelas or swine
plague has existed on such premises or on adjoining premises.
Additionally, except for the region consisting of the EU-15 for the
purposes of classical swine fever, for which additional certification
is required under Sec. 94.25(b)(6), for domestic swine the certificate
shall show that the entire region of origin is free of classical swine
fever.
Note: The EU-15 is considered a single region only for the
purposes of classical swine fever and not for the purposes of any
other swine disease.
* * * * *
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
0
4. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
5. In Sec. 94.0, definitions of European Union-15 (EU-15) and
restricted zone for classical swine fever are added, in alphabetical
order, to read as follows:
Sec. 94.0 Definitions.
* * * * *
European Union-15 (EU-15). The organization of Member States
consisting of Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Italy, Luxembourg, the Netherlands, Portugal, Republic of
Ireland, Spain, Sweden, and the United Kingdom (England, Scotland,
Wales, the Isle of Man, and Northern Ireland).
* * * * *
Restricted zone for classical swine fever. An area, delineated by
the relevant competent veterinary authorities of the region in which
the area is located, that surrounds and includes the location of an
outbreak of classical swine fever in domestic swine or detection of the
disease in wild boar, and from which the movement of domestic swine is
prohibited.
* * * * *
0
6. Section 94.9 is amended as follows:
0
a. Paragraph (a) and footnote 10 are revised to read as set forth
below.
0
b. Paragraphs (b) and (c) are redesignated as paragraphs (c) and (d),
respectively.
0
c. A new paragraph (b) is added to read as set forth below.
0
d. The introductory text of newly designated paragraph (c) is revised
to read as set forth below.
0
e. In newly redesignated paragraph (c)(1)(iii)(C)(2), the words
``paragraph (b)'' are removed each time they occur and the words
``paragraph (c)'' are added in their place.
0
f. In newly redesignated paragraph (c)(2), the words ``paragraph (b)''
are removed and the words ``paragraph (c)'' are added in their place.
0
g. In newly redesignated paragraph (c)(3), the words ``paragraph (b)''
are removed each time they occur and the words ``paragraphs (c)'' are
added in their place.
0
h. In newly redesignated paragraph (d), the words ``paragraph (b)'' are
removed and the words ``paragraph (c)'' are added in their place.
Sec. 94.9 Pork and pork products from regions where classical swine
fever exists.
(a) Classical swine fever is known to exist in all regions of the
world except Australia; Canada; Chile; Fiji; Iceland; the Mexican
States of Baja California, Baja California Sur, Chihuahua, and Sinaloa;
New Zealand; Norway; and Trust Territory of the Pacific Islands.\10\
---------------------------------------------------------------------------
\10\ See also other provisions of this part and parts 93, 95,
and 96 of this chapter, and part 327 of this title, for other
prohibitions and restrictions upon the importation of swine and
swine products.
---------------------------------------------------------------------------
(b) The EU-15 is a single region of low-risk for CSF.
(c) Except as provided in Sec. 94.25 for the EU-15, no fresh pork
or pork product may be imported into the United States from any region
where classical swine fever is known to exist unless it complies with
the following requirements:
* * * * *
0
7. Section 94.10 is revised to read as follows:
Sec. 94.10 Swine from regions where classical swine fever exists.
(a) Classical swine fever is known to exist in all regions of the
world, except Australia; Canada; Chile; Fiji; Iceland; the Mexican
States of Baja California, Baja California Sur, Chihuahua, and Sinaloa;
New Zealand; Norway; and Trust Territory of the Pacific Islands.
(b) The EU-15 is a single region of low-risk for CSF.
(c) Except as provided in Sec. 94.25 for the EU-15, no swine that
are moved
[[Page 29071]]
from or transit any region where classical swine fever is known to
exist may be imported into the United States, except for wild swine
imported into the United States in accordance with paragraph (d) of
this section.
(d) Wild swine may be allowed importation into the United States by
the Administrator upon request in specific cases under Sec. 93.501 or
Sec. 93.504(c) of this chapter.
0
8. Section 94.25 is revised to read as follows:
Sec. 94.25 Restrictions on the importation of pork, pork products,
and swine from the EU-15.
(a) Pork and pork products. In addition to meeting all other
applicable provisions of this part, fresh pork and pork products
imported from the EU-15 must meet the following conditions:
(1) The pork or pork products must not have been derived from swine
that were in any of the following regions or zones, unless the swine
were slaughtered after the periods described:
(i) Any region when the region was classified in Sec. Sec. 94.9(a)
and 94.10(a) as one in which classical swine fever is known to exist,
except for the EU-15;
(ii) A restricted zone in the EU-15 established because of
detection of classical swine fever in domestic swine, 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; or
(iii) A restricted zone in the EU-15 established because of the
detection of classical swine fever 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.
(2) 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 in paragraphs (a)(1)(i) through (a)(1)(iii)
of this section, 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 in paragraphs (a)(1)(i)
through (a)(1)(iii) of this section, unless the swine from which the
pork or pork products were derived were slaughtered after the periods
described.
(3) The swine from which the pork or pork products were derived
must not have transited any region or zone described in paragraphs
(a)(1)(i) through (a)(1)(iii) of this section, 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.
(4) No equipment or materials used in transporting the swine from
which the pork or 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 section,
unless the equipment and materials have first been cleaned and
disinfected.
(5) The pork and pork products 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 inspection
certificate required by Sec. 327.4 of this title, stating that the
applicable provisions of paragraphs (a)(1) through (a)(4) of this
section have been met.\20\
---------------------------------------------------------------------------
\20\ The certification required may be placed on the foreign
meat inspection certificate required by Sec. 327.4 of this title or
may be contained in a separate document.
---------------------------------------------------------------------------
(b) Live swine. In addition to meeting all other applicable
provisions of this title, live swine imported from the EU-15 must meet
the following conditions:
(1) The swine must be breeding swine.
(2) The swine must not have been in any of the following regions or
zones, unless the swine are exported to the United States after the
periods described:
(i) Any region when the region was classified in Sec. Sec. 94.9(a)
and 94.10(a) as one in which classical swine fever is known to exist,
except for the EU-15;
(ii) A restricted zone in the EU-15 established because of the
detection of classical swine fever in domestic swine, 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; or
(iii) A restricted zone in the EU-15 established because of the
detection of classical swine fever 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.
(3) The swine must not have been commingled with other swine that
have at any time been in any of the regions or zones described in
paragraphs (b)(2)(i) through (b)(2)(iii) of this section, unless the
swine are exported after the periods described.
(4) The swine must not have transited any region or zone described
in paragraphs (b)(2)(i) through (b)(2)(iii) of this section, 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;
(5) No equipment or materials used in transporting the swine may
have been used previously for transporting swine that do not meet the
requirements of this section, unless the equipment and materials have
first been cleaned and disinfected.
(6) The swine must be accompanied by a certificate issued by a
salaried veterinary officer of the competent veterinary authority of
the EU-15 Member State, stating that the conditions of paragraphs
(b)(1) through (b)(5) of this section have been met.\21\
---------------------------------------------------------------------------
\21\ The certification required may be placed on the certificate
required by Sec. 93.505(a) of this chapter or may be contained in a
separate document
---------------------------------------------------------------------------
(c) The certificates required by paragraphs (a)(5) and (b)(6) of
this section must be presented by the importer to an authorized
inspector at the port of arrival, upon arrival of the swine, pork, or
pork products at the port.
(Approved by the Office of Management and Budget under control
numbers 0579-0218 and 0579-0265).
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND SEMEN
0
9. The authority citation for part 98 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
10. In Sec. 98.30, definitions of European Union-15 (EU-15) and
restricted zone for classical swine fever are added, in alphabetical
order, to read as follows:
Sec. 98.30 Definitions.
* * * * *
European Union-15 (EU-15). The organization of Member States
consisting of Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Italy, Luxembourg, the
[[Page 29072]]
Netherlands, Portugal, Republic of Ireland, Spain, Sweden, and the
United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern
Ireland).
* * * * *
Restricted zone for classical swine fever. An area, delineated by
the relevant competent veterinary authorities of the region in which
the area is located, that surrounds and includes the location of an
outbreak of classical swine fever in domestic swine or detection of the
disease in wild boar, and from which the movement of domestic swine is
prohibited.
* * * * *
0
11. Section 98.38 is revised to read as follows:
Sec. 98.38 Restrictions on the importation of swine semen from the
EU-15.
In addition to meeting all other applicable provisions of this
part, swine semen imported from the EU-15 must meet the following
conditions, 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:
(a) The semen must come from a semen collection center approved for
export by the competent veterinary authority of the EU-15 Member State.
(b) The semen must not have been collected from a donor boar that
was in any of the following regions or zones, unless the semen was
collected after the periods described:
(1) Any region when the region was classified in Sec. Sec. 94.9(a)
and 94.10(a) of this chapter as one in which classical swine fever is
known to exist, except for the EU-15;
(2) A restricted zone in the EU-15 established because of the
detection of classical swine fever in domestic swine, 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; or
(3) A restricted zone in the EU-15 established because of the
detection of classical swine fever 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 the EU-15 Member
State.
(c) 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 in paragraphs (b)(1) through (b)(3) of this section,
unless the semen was collected after the periods described.
(d) The semen must not have been collected from a donor boar that
transited any region or zone described in paragraphs (b)(1) through
(b)(3) of this section during the periods described, 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;
(e) The donor boar must be held in isolation for at least 30 days
prior to entering the semen collection center.
(f) No more than 30 days prior to being held in isolation as
required by paragraph (e) of this section, the donor boar must be
tested with negative results with a classical swine fever test approved
by the Office International des Epizooties (World Organization for
Animal Health).
(g) No equipment or materials used in transporting the donor boar
from the farm of origin to the semen collection center may have been
used previously for transporting swine that do not meet the
requirements of this section, unless such equipment or materials have
first been cleaned and disinfected.
(h) Except for semen collected from swine in Denmark, Finland, the
Republic of Ireland, Sweden, or the United Kingdom, before the semen is
exported to the United States, 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
classical swine fever.
(i) The semen must be accompanied by a certificate issued by a
salaried veterinary officer of the competent veterinary authority of
the EU-15 Member State, stating that the provisions of paragraphs (a)
through (h) of this section have been met.\3\
---------------------------------------------------------------------------
\3\ The certification required may be placed on the certificate
required under Sec. 98.35(c) or may be contained in a separate
document.
(Approved by the Office of Management and Budget under control
---------------------------------------------------------------------------
numbers 0579-0218 and 0579-0265).
Done in Washington, DC, this 16th day of May 2006.
Jeremy Stump,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 06-4681 Filed 5-18-06; 8:45 am]
BILLING CODE 3410-34-P