[Federal Register Volume 64, Number 122 (Friday, June 25, 1999)]
[Proposed Rules]
[Pages 34155-34168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16172]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 92, 94 and 98
[Docket No. 98-090-1]
RIN 0579-AB03
Recognition of Animal Disease Status of Regions in the European
Union
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations concerning the
importation of animals and animal products to recognize a region in the
European Union as a region in which hog cholera is not known to exist,
and from which breeding swine, swine semen, and pork and pork products
may be imported into the United States under certain conditions.
Additionally, we are proposing to recognize Greece as free of foot-and-
mouth disease and swine vesicular disease, and to recognize eight
Regions in Italy as free of swine vesicular disease. These proposed
actions are based on a request from the European Commission's
Directorate General for Agriculture and on our analysis of the
supporting documentation supplied by the European Commission and
individual Member States. These proposed actions would relieve some
restrictions on the importation into the United States of certain
animals and animal products from those regions. However, because of the
status of those regions with respect to other diseases, and, in some
cases, because of other factors that could result in an increased risk
of introducing animal diseases into the United States, the importation
of animals and animal products into the United States from those
regions would continue to be subject to certain restrictions. We invite
you to comment on this docket. We also invite you to comment on the
related risk assessments.
DATES: We will consider all comments that we receive by August 24,
1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 98-
090-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road Unit 118, Riverdale, MD 20737-1238.
Please state that your comments refer to Docket No. 98-090-1.
You may read any comments that we receive on this docket or its
related risk assessments in our reading room. The reading room is
located in room 1141 of the USDA South Building, 14th Street and
Independence Avenue, SW., Washington, DC. Normal reading room hours are
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 690-2817 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Chief Staff
Veterinarian, National Center for Import and Export (NCIE), VS, APHIS,
4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8364; or
e-mail: gary.s.colgrove@usda.gov.
The full risk assessments associated with this rule can be obtained
by calling Dr. Gary Colgrove at (301) 734-8364 or, in the case of the
quantitative disease risk assessment, electronically at
http://www.aphis.usda.gov/vs/reg-request.html.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture (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 pertaining to the
importation of animals and animal products are set forth in the Code of
Federal Regulations (CFR), title 9, chapter I, subchapter D (9 CFR
parts 91 through 99).
Until recently, the regulations in parts 91 through 99 (referred to
below as the regulations) governed the importation of animals and
animal products according to the recognized disease status of the
exporting country. In general, if a disease occurred anywhere within a
country's borders, the entire country was considered to be affected
with the disease, and importations of animals and animal products from
anywhere in the country were regulated accordingly. However,
international trade agreements entered into by the United States--
specifically, the North American Free Trade Agreement and the World
Trade Organization Agreement on Sanitary and Phytosanitary Measures--
require APHIS to recognize regions, rather than only countries, and to
recognize levels of risk, for the purpose of regulating the importation
of animals and animal products into the United States.
Consequently, on October 28, 1997, we published in the Federal
Register a final rule (62 FR 56000-56026, Docket No. 94-106-9,
effective November 28, 1997) and a policy statement (62 FR 56027-56033,
Docket No. 94-106-8) that established procedures for recognizing
regions and levels of risk (referred to below as ``regionalization'')
for the purpose of regulating the importation of animals and animal
products. With the establishment of those procedures, APHIS can now
consider requests to allow importations from regions based on levels of
risk, as well as to recognize entire countries free of a disease.
In July 1997, APHIS received requests from the European
Commission's (EC's) Directorate General for Agriculture to do the
following: (1) Recognize certain Member States of the European Union
(EU) as free in their entirety of certain specified diseases; and (2)
recognize certain regions of EU countries as free of specified
diseases, consistent with the disease status of those regions as
recognized by the EC.
In response to the first request, and based on our review of
supporting documentation accompanying the request, we published a
proposed rule in the Federal Register (62 FR 61036-61041, Docket No.
97-086-1) on November 14, 1997, to declare Luxembourg and Portugal free
of rinderpest and foot-and-mouth disease (FMD); Greece free of
rinderpest; France, Greece, Luxembourg, and Spain free of exotic
Newcastle disease; Portugal free of African swine fever; and Belgium,
France, and Portugal free of swine vesicular disease (SVD). We
solicited comments concerning our proposed rule for 60 days ending
January 13, 1998. We received one comment by that date. The comment was
from a veterinary association and fully supported the proposed rule. As
noted, the proposed rule addressed part of the request submitted by the
EC. Following publication of the proposed rule, we continued to review
the remainder of the EC's request, including information we received
following the initial request. (Our regulations establishing procedures
for regionalization became effective after the initial request was
received from the EC.) On December 8, 1998, we published a final rule
in the Federal Register (63 FR 67573-67575, Docket
[[Page 34156]]
No. 97-086-2), which made final the provisions we had proposed in
November 1997. Our determinations regarding the EC's request with
regard to hog cholera in the EU, FMD and SVD in Greece, and SVD in
Italy are set forth in this document.
Summary of Proposed Changes
In this document, we are proposing to add Greece to the list of
regions recognized as free of FMD. We are also proposing to add Greece
to the list of FMD-free regions whose exports of ruminant and swine
meat and products to the United States are subject to certain
restrictions to ensure a negligible risk of introducing FMD into this
country.
We are also proposing to add Greece and eight Regions in northern
Italy (listed below) to the list of regions recognized as free of SVD,
and to the list of SVD-free regions whose exports of pork and pork
products to the United States are subject to certain restrictions to
ensure a negligible risk of introducing SVD into this country. The
following Regions in northern Italy would be added to these lists:
Abruzzi, Emilia Romagna, Friuli, Liguria, Marche, Molise, Piemonte, and
Valle d'Aosta.
Additionally, with the exception of specified regions in Germany
and Italy, we are proposing to recognize Austria, Belgium, France,
Germany, Greece, Italy, Luxembourg, The Netherlands, Portugal, and
Spain as a region in which hog cholera is not known to exist, and from
which breeding swine, swine semen, and pork and pork products may be
imported into the United States under certain conditions (discussed
below). The regions that would be excepted from this recognition and
that would continue to be considered regions in which hog cholera is
known to exist are the following: In Germany, the Kreis Vechta in the
Land of Lower Saxony, the Kreis Warendorf in the Land of Northrhine
Westfalia, and the Kreis Altmarkkreis Salzwedel in the Land of Saxony-
Anhalt; and in Italy, the Island of Sardinia and the Regions of Emilia
Romagna and Piemonte.
We discuss each of the proposed changes at greater length below.
Greece Free of FMD and SVD; Certain Regions in Italy Free of SVD
We are proposing to recognize Greece as free of both FMD and SVD,
and to recognize eight Regions of Italy as free of SVD. Regulations
concerning FMD and SVD are as follows.
FMD: In Sec. 94.1 of the regulations, paragraph (a)(1) provides
that rinderpest or FMD exists in all regions of the world except those
listed in Sec. 94.1(a)(2), which have been declared to be free of those
diseases. The regulations in Sec. 94.1(b) prohibit, with specified
exceptions, the importation into the United States of any ruminant or
swine, or any fresh (chilled or frozen) meat of any ruminant or swine,
that is from any region where rinderpest or FMD exists, or that has
entered a port in, or otherwise transited, a region where rinderpest or
FMD exists. Furthermore, the regulations in Sec. 94.2 restrict the
importation of fresh (chilled or frozen) products other than meat, and
milk and milk products, of ruminants or swine that originate in or
transit a region where rinderpest or FMD exists. Additionally, the
importation of organs, glands, extracts, and secretions of ruminants or
swine originating in a region where rinderpest or FMD exists is
restricted under the regulations in Sec. 94.3, and the importation of
cured or cooked meat from a region where rinderpest or FMD exists is
restricted under the regulations in Sec. 94.4. Finally, the regulations
in part 98 restrict the importation of ruminant and swine embryos and
animal semen from a region where rinderpest or FMD exists.
SVD: In Sec. 94.12 of the regulations, paragraph (a) provides that
SVD is considered to exist in all regions of the world except those
listed in Sec. 94.12(a), which have been declared to be free of SVD.
Paragraph (b) of Sec. 94.12 provides that no pork or pork products may
be imported into the United States from a region where SVD exists
unless the pork or pork product meets specified conditions and is not
otherwise prohibited importation into the United States by the
regulations.
Proposed Recognition of Greece as Free of FMD and SVD
As indicated above, Sec. 94.1 (a)(1) and (a)(2) categorize
countries or other regions regarding their freedom from both rinderpest
and FMD. Regions that are recognized as free of only one of the
diseases are subject to the same restrictions as those in which both
diseases exist. In our December 8, 1998, final rule, we recognized
Greece as free of rinderpest. In this document, based on the
information submitted to us by the EC's Directorate General for
Agriculture, we are proposing to recognize Greece as free of FMD.
Additionally, based on the information submitted, we are proposing to
recognize Greece as free of SVD. Because a number of the criteria we
examined with regard to Greece were common to our review concerning
both FMD and SVD, we have combined the discussion of the two diseases.
Based on the information submitted to us, we have concluded the
following:
Veterinary infrastructure: The veterinary services authorities in
Greece have the legal authority, organization, and infrastructure to
control and eradicate FMD and SVD. The official veterinary force
includes approximately 810 veterinarians located at the country's
Veterinary Service headquarters and in the field, 70 laboratory
veterinarians, and 190 lay assistants organized under the national
Veterinary Service. The field force is distributed among 51 Local
Disease Control Centers, each of which reports to the National Disease
Control Center in Athens. In the event of an animal disease emergency,
the national Veterinary Service has the authority to call on police and
local authorities to provide support in depopulating infected premises,
disposing of animal carcasses, controlling and restricting animal
movements, and closing markets and abattoirs.
Disease History and Surveillance
FMD: The last outbreak of FMD in Greece was diagnosed in 1996 and
was confined to the Prefecture of Evros. Surveillance for FMD is
primarily passive at present, but active surveillance was carried out
during and after the 1996 outbreak.
SVD: The last case of SVD in Greece was diagnosed in 1979.
Surveillance for SVD is passive. Any suspected case of vesicular
disease in swine is first investigated to determine if it is FMD. If
FMD is ruled out, SVD is included in the differential diagnosis.
Diagnostic capabilities: Greece has diagnostic capabilities for
both SVD and FMD. Diagnoses are carried out in accordance with the
recommendations of the EC's Standing Veterinary Committee, which
reflect international standards established by the Office International
des Epizooties (OIE).
Vaccination: No vaccination is practiced in Greece for either FMD
or SVD. Vaccination for FMD has been prohibited since 1991 and no
vaccination for SVD has ever been practiced.
Adjacent regions: Greece is bordered by Albania, Macedonia,
Bulgaria, and Turkey, none of which are recognized by the Department as
being free of FMD or SVD.
Border controls: Although parts of its borders are mountainous,
Greece is not separated from regions of higher risk by a uniform
physical barrier. However, because of active FMD infection in Turkey,
which is bordered by the Prefecture of Evros, Greece has implemented
requirements in that
[[Page 34157]]
Prefecture for inspection of animals, along with serological testing of
animals moved out of the Prefecture for fattening or breeding.
Under EC requirements, swine are not permitted into Greece from
regions where SVD exists without first testing negative for SVD.
Movement across borders: The movement of animals and animal
products into Greece from regions of higher disease risk is strictly
controlled. The primary outbreaks of FMD that occurred during 1996 were
associated with the illegal movement of immigrants into Greece from
Turkey. Greece has subsequently tightened security and increased the
presence of police and armed forces along the border. The border
patrols are assisted by dogs. In addition, the movement controls that
have been implemented in Evros create, in effect, a buffer that further
mitigates the risk of FMD spreading into other Greek territories should
the disease be reintroduced into Evros.
Demographics: According to a 1997 census, the ruminant and swine
populations of Greece were as follows: 541,700 head of cattle,
9,244,000 sheep, 5,668,000 goats, and 904,000 pigs. Most production
units in Greece can be characterized as small holdings, and there is no
known feature of livestock production (e.g., extreme density of
livestock) that increases the risk of disease spread.
Detection and eradication of disease: Both FMD and SVD are
compulsorily notifiable diseases in Greece. The State Veterinary
Service of Greece has the authority, diagnostic capability, and
experience to rapidly detect, contain, and eradicate any incursion of
FMD and SVD that might occur.
The findings described above are set forth in greater detail in a
descriptive risk evaluation that we prepared. The risk evaluation may
be obtained by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
In addition to proposing to include Greece in the lists in
Secs. 94.1(a)(2) and 94.12(a) of regions declared free of both
rinderpest and FMD, and of SVD, respectively, we are also proposing to
add Greece to two other lists: The list in Sec. 94.11(a) of regions
declared free of rinderpest and FMD whose exports of meat and other
animal products to the United States are nevertheless subject to
certain restrictions, and to the list in Sec. 94.13 of regions declared
free of SVD whose exports of pork and pork products are also subject to
restrictions.
Meat and other animal products from regions listed in Sec. 94.11(a)
are subject to those restrictions because the regions: (1) Supplement
their national meat supply by importing fresh (chilled or frozen) meat
of ruminants or swine from regions where rinderpest or FMD exists; (2)
have a common land border with regions where rinderpest or FMD exists;
or (3) import ruminants or swine from regions where rinderpest or FMD
exists under conditions less restrictive than would be acceptable for
importation into the United States.
The regions listed in Sec. 94.13 have risk conditions regarding SVD
that are similar to those in Sec. 94.11(a) regarding rinderpest and
FMD.
Because Greece meets each of the criteria described above that
constitutes additional risk for FMD and SVD, we are proposing to
include Greece in the lists of regions in Secs. 94.11(a) and 94.13.
Section 94.11 applies to meat and other animal products of
ruminants and swine and to ship stores, airplane meals, and baggage
containing these meat or animal products. Section 94.11 generally
requires that meat and other animal products of ruminants and swine:
(1) Be prepared in an inspected establishment that is eligible to have
its products imported into the United States under the Federal Meat
Inspection Act; and (2) be accompanied by an additional certificate,
issued by a full-time salaried veterinary official of the national
government that is responsible for the health of the animals within the
exporting region, assuring that the meat or other animal products have
not been commingled with or exposed to meat or other animal products
originating in, imported from, or transported through a region where
rinderpest or FMD exists. Section 94.11 also requires that these
articles meet applicable requirements of the U.S. Department of
Agriculture's Food Safety and Inspection Service (FSIS) at 9 CFR
chapter III.
The requirements in Sec. 94.13, concerning SVD, are generally the
same as those in Sec. 94.11, which addresses risks associated with
rinderpest and FMD. Proposed Recognition of Regions in Italy as Free of
SVD
We are also proposing to recognize eight Regions in Italy as free
of SVD. An Italian ``Region'' is the largest administrative unit within
the country. The Regions that we would recognize as SVD-free are:
Abruzzi, Emilia Romagna, Friuli, Liguria, Marche, Molise, Piemonte, and
Valle d'Aosta. Based on the information submitted to us, we have
concluded the following:
Veterinary infrastructure: The National Veterinary Services of
Italy is well-organized and adequately staffed. Animal health programs
are organized under the Italian Ministry of Health. Field services are
delivered through 21 Regions, each with a regional veterinary chief.
There are approximately 220 health units, each headed by a veterinary
chief having responsibility for animal health and welfare and public
health. The chief of each local unit reports to the regional chief on
animal health matters in general, and reports directly to the Ministry
of Health in Rome on matters relating to trade in the EU. Approximately
5,000 veterinarians are employed in an official capacity at either the
Federal, Regional, or local level.
Disease history and surveillance: The SVD virus is not known to
exist in any of the eight Regions. The last cases of SVD that occurred
in any of these Regions were in 1996 in Abruzzi and Molise. In the
other Regions, the last cases occurred in 1995 or earlier. An active
surveillance program for SVD is conducted in each of the eight Regions,
as well as in the rest of Italy. Each of the eight Regions has achieved
SVD-accredited status in Italy through an established testing and
accreditation program.
Diagnostic capabilities: Animal health laboratory services are
provided by 10 Regional laboratories and a National Institute in Rome.
Each laboratory has a specialized area of competence. The laboratory in
Brescia is the national reference laboratory for vesicular diseases.
All suspected cases of vesicular disease are forwarded to the Brescia
laboratory, which has full competency in conducting serological and
virological procedures for SVD. Diagnoses are carried out in accordance
with the recommendations of the EC's Standing Veterinary Committee,
which reflect international standards established by the OIE.
Vaccination: No vaccination for SVD is carried out in any of the
eight Regions or anywhere else in Italy.
Adjacent regions: The Regions under consideration lie in the north
of Italy, extending southward into the west-central portion of the
country bordering the Adriatic Sea. To the north, several of the
Regions are bordered by France, Switzerland, Austria, and/or
Yugoslavia. Switzerland, Austria, and Yugoslavia are recognized by the
Department as free of SVD. In our December 8, 1998, final rule
(discussed above), we recognized France as free of SVD. The Regions of
Friuli and Emilia Romagna are bordered by Regions (Lombardia, Trentino
Alto Adige and/or Veneto) within Italy that have experienced limited
outbreaks of SVD in 1998. The Regions of Emilia Romagna, Marche,
Abruzzi, and Molise are bordered by Regions that experienced
[[Page 34158]]
outbreaks in 1997. As noted above, all Regions in Italy conduct active
surveillance for SVD.
Border controls: The Regions of Italy are administrative units
that, in association with Federal authorities, have local
responsibility to control animal diseases. The eight Regions in
question are delineated, in some areas, by physical features that
present a barrier to the movement of animals. In general, however, the
introduction of SVD into these Regions is prevented more by the control
measures implemented in affected areas than by physical separation of
Regions.
Movement across borders: In accordance with the Italian SVD
accreditation program, swine can enter an accredited Region only if
they originate from accredited premises. In the broader sense, the
eight Regions rely on control measures imposed within Regions of higher
risk to prevent SVD from entering free areas. Regionalization of
affected areas in the EU, including Italy, is based on strict controls
being exercised over the movement of animals and animal products within
the region where an outbreak occurs. A 3-kilometer protection zone,
surrounded by a 7-kilometer surveillance zone, is established around
the affected premises or area. All movement of swine and swine products
is prohibited from the protection and surveillance zones. The infected
herd(s) and all contact herds are depopulated and the carcasses are
either rendered or buried. Movement controls are lifted only after
clinical examinations and serology indicate the swine remaining in the
area are free of SVD.
If it is evident that the disease is not under control in an
affected region, the EC's Standing Veterinary Committee may require
that control measures be extended to include a buffer zone outside the
surveillance zone. In addition, Member States are free to impose
additional controls, above and beyond those prescribed by the EC, on
affected regions within their territory.
Demographics: Swine raising within the eight Regions is typified by
small holdings in which the swine are raised for the owner's
consumption. Although commercial operations exist, these are not, in
general, regions of high swine density.
Disease detection and surveillance: SVD is a compulsorily
notifiable disease in Italy. The Italian Veterinary Services has the
diagnostic capability, authority, and experience to rapidly detect,
contain, and eradicate any incursion of SVD into these Regions that
might occur.
The findings described above are set forth in greater detail in a
descriptive risk evaluation that we prepared. The risk evaluation may
be obtained by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
Although we are adding the Italian Regions of Abruzzi, Emilia
Romagna, Friuli, Liguria, Marche, Molise, Piemonte, and Valle d'Aosta
to the list of regions in Sec. 94.12(a) in which SVD is considered not
to exist, we are also proposing to add each of the eight Regions to the
list in Sec. 94.13 of regions declared free of SVD that are subject to
special restrictions on the exportation of meat and other animal
products to the United States.
As noted above in our discussion regarding Greece's freedom from
SVD, pork and pork products from regions listed in Sec. 94.13 are
subject to restrictions because the regions: (1) Supplement their
national pork supply by importing fresh (chilled or frozen) pork from
regions where SVD is considered to exist; or (2) have a common land
border with regions designated as regions in which SVD is considered to
exist; or (3) have certain import requirements that are less
restrictive than are acceptable to the United States.
We are proposing to include in the list in Sec. 94.13 the eight
Regions in question because they each meet criteria 1 and 3, and all,
except for Valle D'Aosta meet criterion 2 (assuming that Piemonte is
recognized as free of SVD as provided in this proposed rule).
Request for Regionalization with Regard to Hog Cholera
In its July 1997 request to the Department, the EC's Directorate
General for Agriculture requested that APHIS both recognize certain EU
countries as free of specified diseases, and recognize as free from
disease (where freedom is not currently recognized) ``all regions of
the Community which are not subject to restrictions either in
accordance with the provisions of relevant Directives or with decisions
taken as safeguard measures * * *''
As discussed above, we have evaluated and are proposing regulatory
changes to the disease status of Greece with regard to FMD and SVD, and
to the status of eight Regions in Italy with regard to SVD. One of the
other diseases specifically addressed by the EC in its request was
classical swine fever (referred to in the current regulations and in
this proposed rule as hog cholera).
Consistent with procedures for requesting regionalization that were
established in our October 28, 1997, final rule, the request from the
EC's Directorate General for Agriculture was that APHIS consider the
hog cholera status of one region of the EC consisting of multiple
member States. (Under the definitions in Sec. 92.1, a region can be ``a
group of national entities (countries) combined into a single area.'')
Certain countries or states in the EU are already listed in the
regulations at Sec. 94.10 as individual regions in which hog cholera is
not known to exist. These countries or states are: Denmark; Finland;
Great Britain; Northern Ireland; The Republic of Ireland; and Sweden.
The application for regionalization from the EC's Directorate General
for Agriculture does not address these Member States of the EU and we
are proposing no change to their hog cholera status.
The EC's Directorate General for Agriculture stated that its
application with regard to hog cholera was on behalf of the following
Member States: Austria, Belgium, France, Germany, Greece, Italy,
Luxembourg, The Netherlands, Portugal, and Spain. In its letter of
request for regionalization, the EC's Directorate General of
Agriculture referred to a veterinary equivalency agreement under
discussion between the EC and the United States. The request for
regionalization stated that ``[a]n objective of the equivalency
agreement is that products which are free to circulate within the
territory of one of the Parties to the agreement may be exported to the
other Party. On this basis, therefore, animals and products which are
derived from the free area of a Member State which is affected by one
of these diseases should be eligible for export to the USA.''
The EC requested that we consider all of the EU free of hog cholera
except for those regions for which the EC had restrictions in place
because of outbreaks of hog cholera. At the time of the request, there
were areas under such EC restrictions in Belgium, Germany, Italy, The
Netherlands, and Spain.
We reviewed all of the information submitted to us by the EC's
Directorate General for Agriculture. Following our receipt of the
initial request, we requested and received additional information from
the EC and from individual Member States. In addition, in December
1997, we conducted a site visit to and met with veterinary officials in
Belgium, Germany, Spain, and The Netherlands--four of the five EC
Member States that had experienced outbreaks of hog cholera in 1997.
The purpose of the site visit was to gather additional information
necessary for APHIS to reach a decision on the EC's
[[Page 34159]]
request. (A report on the site visit can be obtained from the person
listed under FOR FURTHER INFORMATION CONTACT. Additional information on
the fifth affected Member State, Italy, was provided by EC officials
during meetings with APHIS representatives. During the period we were
collecting and reviewing information, the areas subject to EC
restrictions changed due to eradication efforts in the affected
countries, and, in some cases, additional outbreaks. As of the
publication date of this proposal, at least 6 months (the OIE standard
for qualifying for freedom from hog cholera) have elapsed since the
most recent outbreaks in Belgium (July 1997), The Netherlands (March
1998), and Spain (July 1998).
Based on the information available to us, we believe that, with the
exception of specified regions in Germany and Italy, a region
consisting of Austria, Belgium, France, Germany, Greece, Italy,
Luxembourg, The Netherlands, Portugal, and Spain can be recognized as a
region in which hog cholera is not known to exist. Therefore, we are
proposing to amend the regulations at Secs. 94.9(a) and 94.10(a) to
reflect that recognition.
We are proposing to make this change based on the following
conclusions-- (Please note: Because the request from the EC was for the
recognition of one region consisting of multiple countries, where
appropriate, we have evaluated the following factors for the region as
a whole):
Authority, organization, and veterinary infrastructure: Control is
shared between the national services of the individual Member States
and the EC. In terms of exports to the United States, the Member States
are responsible for control of the production circumstances and
requirements, including inspections required by statute, and for
issuing health certification attesting to standards and requirements.
The EC is responsible for overall coordination of the shared control of
animal health, inspections and audits of inspection systems, and the
legislative action necessary to ensure uniform application of standards
and requirements within the single European Market.
Disease status: The most recent hog cholera outbreaks in the
countries addressed in the EC's request occurred as follows: Austria,
1996 (in wild boars); Belgium, 1997; France, 1993; Germany, November
1998; Greece, 1985; Italy, March 1999; Luxembourg, 1987; The
Netherlands, March 1998; Portugal, 1985; and Spain, July 1998.
Adjacent regions: Outbreaks of hog cholera occur sporadically in
the neighboring border countries of Albania, the Czech Republic,
Slovenia, Poland, and Slovakia. Although there have been no outbreaks
in the Czech Republic since early 1995, serological tests still show
positive results in wild boar.
Extent of an active disease control program: All measures for the
control of hog cholera are harmonized within the EU. The EC imposes
animal quarantine measures and movement controls for livestock. It also
prohibits the importation of swine from any region within the EU or
country outside of the EU in which hog cholera is known to exist,
unless animals imported from outside the EU are accompanied by a
declaration that the animals tested negative for hog cholera. The EC
has a ``stamping out'' policy for hog cholera. Eradication is carried
out by compulsory slaughter and destruction, by burning, burial, or
rendering of all susceptible species on the affected premises and any
adjacent premises where animals may have been exposed to hog cholera.
Contaminated material is also destroyed.
If an outbreak of hog cholera occurs, a quarantine is placed on the
affected premises. Additionally, a protection zone with a radius of at
least 3 kilometers and a surveillance zone with a radius of at least 10
kilometers is placed around the affected premises. An immediate stop on
movement from the zone is placed on all premises within the protection
zone and the surveillance zone for at least 30 days and 15 days,
respectively, after depopulation and cleaning and disinfection of the
affected premises.
Measures taken within the protection zone, in addition to
depopulation of affected premises, include: Serological testing and
clinical examination of all remaining swine herds; a ban on
transporting swine into or out of the zone; and a movement ban for
swine within the zone for the first 21 days after establishment of the
protection zone. The veterinary services of the national government of
the EU Member State in which the zone is located may grant permission
for swine movement for immediate slaughter, immediate destruction of
swine, and diagnostic killing. Also, swine markets, auctions, and like
events are prohibited.
Measures taken within the surveillance zone include: The
serological testing and clinical examination of all swine herds, and a
movement ban for all swine within the zone for 7 days following
establishment of the zone. The veterinary services of the national
government of the EU Member State in which the zone is located may
grant permission for swine movement for immediate slaughter, immediate
destruction of pigs, and diagnostic killing.
Vaccination: Member States in the EU are prohibited from using hog
cholera vaccine and use, instead, purely sanitary measures. All Member
States had discontinued vaccination by January 1990.
Movement of animals and animal products: Veterinary checks are
conducted at the point of origin and point of destination for swine
movements within the EU. With regard to hog cholera within the EU,
swine may move to other Member States from regions considered free of
hog cholera, and the importation of swine from third countries
(countries outside the EU) is allowed with certain conditions if the
animals are accompanied by a declaration that the countries are free of
hog cholera, or the animals tested negative for hog cholera. Details on
movement controls are described in EU Council Directives 90/425/EEC,
89/662/EEC, 97/12/EEC, 64/432/EEC, 91/496/EEC, 90/675/EEC, and others.
Historically, the spread of the hog cholera virus among EU Member
States has reflected the complex marketing practices within the EU:
Swine born in one Member State are commonly fattened or
slaughtered in another. For example, in 1995, approximately 3.8 million
piglets moved from one Member State to another for fattening.
Approximately 3.9 million finished pigs moved from one Member State to
another for slaughter.
Animals moving from one Member State to another are not
inspected at the border. Border controls were abolished with the
formation of the Internal Market and were replaced with a system of
veterinary checks at the points of origin and destination described in
EU Council Directives 90/425/EEC, 89/662/EEC, 97/12/EEC, 64/432/EEC,
91/496/EEC, 90/675/EEC, and others.
Document checks, identity checks, and sanitary inspections
may be conducted at the farm of destination.
Livestock are individually tagged prior to movement so that
tracebacks to the farm of origin can be done.
There is essentially no control over passenger baggage moving
within the EU, although spot checks may be conducted on the baggage of
passengers arriving from third countries.
Livestock demographics and marketing practices: The EU has a total
of 1,272,631 hog farms. Of those, 845,559 are fattening farms.
Disease surveillance: OIE List A diseases of swine (and other
species) are compulsorily notifiable in the EU. (List A diseases are
those that have the
[[Page 34160]]
potential for very serious and rapid spread, irrespective of national
borders, that are of serious socio-economic or public health
consequence, and that are of major importance in the international
trade of animals and animal products.) Suspicion of such diseases must
be reported to the veterinary services of the national government of
the EU Member State in question, which must ensure official
investigation by an official veterinarian. Veterinary laboratories are
available to all Member States to investigate outbreaks of any animal
disease. All the laboratories are qualified to recognize and diagnose
List A diseases. Laboratory tests for hog cholera are run on all sick
swine if hog cholera or another notifiable disease of swine is
suspected.
Tests are required for wild boar that are shot or found dead.
Diagnostic laboratories: National reference laboratories are
responsible for coordinating the standards and diagnostic methods in
other national laboratories in the Member State concerned. Liaison
among the national reference laboratories is the responsibility of the
Institute for Virology of the Veterinary College, Hanover, Germany,
which is the Community Reference Laboratory for hog cholera.
Regions Where Hog Cholera Is Known to Exist
As noted above, the request from the EC's Directorate General for
Agriculture that swine and swine products be eligible for import to the
United States from most of the EU excluded certain specified areas. We
concur that certain areas in the EU must continue to be considered as
those in which hog cholera is known to exist.
In delineating such regions, we began with those identified as such
by the EC. However, we had to take into account continued outbreaks in
certain areas of the EU, and the fact that the EC released certain
areas from restrictions prior to the completion of a 6-month waiting
period. (According to OIE standards, areas can be recognized as free of
hog cholera 6 months after the last case of the disease when ``stamping
out'' is practiced.) Therefore, we used the following criteria in
identifying those regions where hog cholera is known to exist: (1) The
region experienced one or more outbreaks of hog cholera in domestic
swine within the past 6 months; or (2) evidence exists that hog cholera
exists in wild swine in the region and that the wild swine have been a
source of infection in domestic swine.
In establishing geographic boundaries for the regions, we used the
boundaries of the smallest administrative jurisdiction that has
effective oversight of normal animal movements into, out of, and within
that jurisdiction, and that, in association with national authorities
if necessary, has the responsibility for controlling animal disease
locally. In Germany, this administrative unit is a Kreis; in Italy, it
is a Region. Veterinary infrastructures exist within the units we chose
and are capable of controlling the movement of swine and pork products
in the event of an outbreak of hog cholera.
Based on the above criteria, we are proposing to continue to
consider the following regions of the EU as regions in which hog
cholera is known to exist:
1. In Germany, the Kreis Vechta in the Land of Lower Saxony, the
Kreis Warendorf in the Land of Northrhine Westfalia, and the Kreis
Altmarkkreis Salzwedel in the Land of Saxony-Anhalt.
2. In Italy, the Island of Sardinia and the Regions of Emilia
Romagna and Piemonte.
Because imports of swine, swine semen, and pork and pork products
into the United States from the regions in Germany and Italy described
above would pose such a high risk of introducing hog cholera into the
United States, such imports would continue to be subject to the current
mitigation measures in parts 94 and 98 of the regulations. As such,
imports of live swine or swine semen would continue to be prohibited
from those regions, as would pork or pork products that have not been
treated in accordance with part 94.
Importation Conditions Based on Risk Factors
Although we are proposing to recognize a region consisting of
Austria, Belgium, France, Greece, Luxembourg, The Netherlands,
Portugal, Spain, and most of Germany and Italy as one in which hog
cholera is not known to exist, it should be noted that such a
designation does not presume negligible risk. A country or other region
may, at a given moment, be one in which a disease does not exist, but
if the probability of disease reintroduction is high, the risk of
disease in animals and products exported from that country or other
region cannot automatically be classified as acceptable. Therefore,
import restrictions may have to imposed before exports from that
country or region will be allowed into the United States.
In responding to the application for regionalization submitted by
the EC's Directorate General for Agriculture, we assessed the disease
risk under current EU regulations of the importation of live breeding
swine, swine semen, and pork and pork products into the United States
from the region described above. In conducting our assessment, we
evaluated the risk by means of both a descriptive (formerly referred to
as ``qualitative'') and quantitative approach. Each of these
assessments is discussed below. (The full risk assessments are
available from the person listed under FOR FURTHER INFORMATION CONTACT,
or, in the case of the quantitative disease risk assessment,
electronically at http://www.aphis.usda.gov/vs/reg-request.html).
Descriptive Risk Assessment
In preparing the descriptive assessment, we considered the
information described above, and particularly the following facts:
1. The EU system of internal controls on the movement of animals
and animal products includes veterinary checks at the points of origin
and points of destination (EU Council Directives 90/425/EEC, 89/662/
EEC, 97/12/EEC, 64/432/EEC, 91/496/EEC, 90/675/EEC, and others). This
system replaced the prior system of veterinary checks at the borders of
individual Member States. A ``stamping out'' policy is in effect for
hog cholera. In the case of outbreaks, protection zones with a radius
of at least 3 kilometers and surveillance zones with a radius of at
least 10 kilometers are established to prevent the disease from
spreading to other areas. Immediate ``stop movements'' are placed on
all premises within the two zones for at least 30 and 15 days,
respectively, after depopulation and cleaning and disinfection of an
affected premises. In practice, the size and duration of these zones
frequently exceed these minimum requirements. The EU practices
extensive tracing and preventive slaughter in the event of an outbreak.
2. The EU is known to have endemic hog cholera in wild boar
populations in northern Germany, and perhaps also in some alpine areas
in Austria, France, and Italy. We have not included some of these
endemic areas as high-risk areas in this proposed rule, because there
have been no recent hog cholera outbreaks in domestic swine in these
areas.
3. Outbreaks of hog cholera in domestic swine have occurred in the
EU every year for the past 6 years. In 1993, outbreaks occurred in
Belgium, France, Germany, and Italy. In 1994, outbreaks occurred in
Austria, Belgium, Germany,
[[Page 34161]]
and Italy. In 1995 and 1996, outbreaks occurred in Austria, Germany,
and Italy. In 1997, outbreaks occurred in Belgium, Germany, Italy,
Spain, and The Netherlands. In 1998, outbreaks occurred in Germany,
Italy, Spain, and the Netherlands. In 1999, an outbreak occurred in
Italy. Some of these outbreaks have been epidemiologically related to
disease in wild boar populations. Secondary and tertiary spread is
known to have occurred.
4. In 1997, an estimated 103 of 611 outbreaks in the EU occurred
outside any zones that were under restrictions because of hog cholera.
Of these 103, only one was a swine semen collection center approved for
export, and only one was a breeding operation that engaged in export
sales. The remainder were fattening farms, mixed operations, or feeder
pig operations. No other export-oriented swine semen collection center
or breeding operation outside of restricted zones became infected in
1998. Epidemiological evidence suggests the disease was present in
various regions for 7 days to nearly 8 weeks before it was detected and
the region was placed under restrictions.
5. Outbreaks of hog cholera occur sporadically in countries
adjacent to the EU. Adjacent countries known to have had outbreaks of
hog cholera in the past several years include Albania, the Czech
Republic, Slovenia, Poland, Bulgaria, and Slovakia. Many of these
countries have wild boar populations that commingle with wild boar
populations in the EU.
6. APHIS's data indicate that an average of approximately 1,500
breeding swine and 700-1,800 doses of semen were imported into the
United States each year from 1994 to 1997 from the EU Member States
recognized as free from hog cholera.
Quantitative Risk Assessment
In addition to the descriptive assessment of risk described above,
we conducted a quantitative assessment of the probability of the
introduction of hog cholera into the United States from the region in
question. While we based our proposed consideration of the hog cholera
status of the region in question on the descriptive assessment, the
quantitative assessment enabled us to assess the likelihood of the
introduction of hog cholera from the region into the United States
under certain conditions, and to determine what, if any, mitigating
measures we considered necessary to reduce any risk to a negligible
level.
In conducting our quantitative assessment, we made some starting
point assumptions. These assumptions are listed below and are described
in more detail in ``Biological Risk Analysis: Risk Assessment and Risk
Management Options for Imports of Swine and Swine Products from the
European Union, USDA Animal and Plant Health Inspection Service, June
2, 1999.'' (Please note: The Quantitative Risk Assessment methodology
is under independent review. We welcome comments on the methodology
applied to import questions.)
In general, we made the following starting point assumptions:
That the region of export adheres to the current APHIS
regulations that require that veterinary authorities of the exporting
country provide certification of the origin of an animal or animal
product to be exported and ensure that the animal or animal product has
not been exposed to a contagious disease during shipment from the point
of origin to the point of embarkation, and, additionally, that OIE
export guidelines are applied to movement of animals and animal
products within the EU.
That 1996 and 1997 outbreaks of hog cholera in the
Netherlands should be used as a ``worst case'' scenario of an
undetected outbreak of hog cholera occurring outside of an established
protection or surveillance zone.
That the following routine procedures for swine semen
currently in place in the EU are adhered to. Specifically, the EU
regulations require that animals must have been accompanied to a semen
collection center by a veterinary certificate of origin, that they have
not been given the opportunity to commingle with swine from hog
cholera-affected areas, and that the semen originate from a collection
center approved for export by the veterinary services of the national
government of the EU Member State in which the collection center is
located. In addition, donor boars are held in isolation for at least 30
days prior to entering the semen collection center, and test results
for hog cholera using a test approved by the OIE and performed during
that 30-day period must be negative.
That all swine slaughtered to produce pork for export to
the United States from the EU are handled in compliance with EU
regulations for the control and eradication of hog cholera, and that
pork for export to the United States is produced using the EU's
standard operating procedures for pork production.
That if a hog cholera-infected animal is slaughtered, all
of the meat from that animal is contaminated with virus. This is a
worst case assumption that magnifies the probability of a hog cholera
outbreak.
In addition to these starting assumptions for the risk assessment,
we assumed that swine slaughtered to produce pork for export to the
United States are slaughtered in compliance with the requirements of
the United States Department of Agriculture's Food Safety and
Inspection Service. These requirements include ante-mortem and post-
mortem inspection. Although the impact of these requirements was not
considered in the risk assessment, we believe that the requirements
would further reduce the quantity of contaminated pork likely to be
exported to the United States.
The results of the quantitative risk assessment suggest that
unmitigated importation of breeding swine into the United States from
the region in question would likely result in one or more outbreaks of
hog cholera in this country every 33,670 years; the unmitigated
importation of swine semen would likely result in one or more outbreaks
in this country every 1,842 years; and the unmitigated importation of
fresh (chilled or frozen) pork would likely result in one or more
outbreaks in this country every 22,676 years. By unmitigated
importation, we mean no additional import requirements beyond
certification of the origin of the product, the areas it has transited,
and the lack of commingling, as well as the biosecurity measures in
place in the EU as discussed above and described in EU Council
Directives 90/425/EEC, 89/662/EEC, 97/12/EEC, 64/432/EEC, and 91/496/
EEC. Some of these biosecurity measures are set out in our proposed
conditions for importation and are described below.
Results of the Risk Assessments
The results of both our descriptive and quantitative assessments
suggest that the risk of introduction of hog cholera into the United
States due to the importation under the conditions described in the
preceding paragraph of fresh (chilled or frozen) pork, and breeding
swine would be expected to present negligible hog cholera risk levels.
Because importation of live swine other than breeding swine would not
be cost-effective, we limited our risk assessment to breeding swine. In
the future, if we receive requests to import live swine other than
breeding swine, we will conduct a separate assessment of the risk of
importing those swine. We are proposing additional import requirements
for swine semen, over and above those biosecurity measures required by
directive in the EU. Our proposed requirements for pork and
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pork products, breeding swine, and swine semen are discussed below.
Importation of Pork and Pork Products
Our conclusion is that, based on the likelihood of importation of
the disease agent, the destination of the imported articles and their
usage, and disposal of waste, pork and pork products could be imported
into the United States from the region in question with negligible risk
of introducing hog cholera, provided the pork or pork products meet all
other applicable import requirements in the regulations and provided
they are accompanied by a certificate of origin certifying the
following: (1) That the articles have not been commingled with pork or
pork products produced from swine from regions in which hog cholera is
known to exist; and (2) that the swine from which the pork or pork
products were produced have not lived in a region listed at that time
as one in which hog cholera is known to exist and have not transited
such a region unless moved directly through such a region in a sealed
means of conveyance with the seal determined to be intact upon arrival
at the point of destination.
Importation of Live Swine and Semen from Swine
We believe that the risk of the introduction of hog cholera from
the importation of live swine and swine semen from the region in
question would be negligible if the following risk mitigation measures
are taken:
The swine, which would have to be breeding swine, and swine semen
would have to meet all import requirements in the regulations and be
accompanied by a certificate of origin certifying that the swine or
donor boars have never lived in a region listed at that time as a
region in which hog cholera is known to exist, have never transited
such a region unless moved directly through such a region in a sealed
means of conveyance with the seal determined to be intact upon arrival
at the point of destination, and have never been commingled with swine
that have been in a region listed at that time as one in which hog
cholera is known to exist.
Additionally, we are proposing to require that no equipment or
materials used in transporting the swine or donor boars under this rule
may have previously been used for transporting animals ineligible for
export to the United States under the rule, unless they have been
cleaned and disinfected following such previous use. This requirement
would apply to movement of donor boars from the farm of origin to the
semen collection center, and to the movement of other swine from the
farm of origin to the point of entry into the United States.
We would not allow swine semen to be imported into the United
States from the region unless the semen comes from a semen collection
center approved for export by the veterinary services of the national
government of the EU Member State in which the collection center is
located. Additionally, we would require that the donor boar be held in
isolation for at least 30 days prior to entering the semen collection
center, and, no more than 30 days prior to being held in isolation, be
tested with negative results with a hog cholera test approved by the
International Office of Epizootics. We would also require that the
semen shipment not be exported to the United States unless the donor
boar is observed by the semen collection center veterinarian while the
donor boar is at the collection center, including at least a 40-day
holding period at the semen collection center following collection of
the semen, and, along with all other swine at the center, exhibits no
clinical signs of hog cholera.
We are proposing to add these requirements to the regulations, even
though the current import requirements regarding certain other diseases
already require a quarantine period for donor boars in the country of
export. In considering the risk of the introduction of hog cholera into
the United States through swine semen, we believe it is necessary to
assume that quarantine periods do not exist for other diseases, because
it is possible that regions currently affected by these other diseases
could one day be considered free of them.
On a practical level, the quarantine requirements we are proposing
with regard to swine semen and hog cholera would have minimal current
effect on the holding of swine. Currently, quarantine and testing of
swine is required for semen imported from regions affected with
tuberculosis, brucellosis, and pseudorabies, and each of the diseases
is considered to exist in each of the countries included in the region
proposed in this document. The current regulations with regard to these
diseases require that donor boars be quarantined for a minimum of 60
days before collection of semen for export to the United States
(compared to a proposed 30-day minimum quarantine prior to entry into
the semen collection center under the hog cholera provisions of this
proposal), and that they be tested twice with negative results for
tuberculosis, brucellosis, and pseudorabies, as applicable to the
region of origin. Tuberculin tests must be conducted with an interval
of at least 60 days between tests, and the second test must be
conducted no sooner than 30 days following collection of the semen
(compared to a minimum holding period of 40 days following collection
of semen under the proposed hog cholera regulations).
The requirements pertaining to pork and pork products and live
swine would be added to the regulations in a new Sec. 94.22. The
requirements pertaining to swine semen would be added to the
regulations in a new Sec. 98.38.
Movement Restrictions
We are also proposing to establish a new Sec. 92.3 to provide that
whenever the EC establishes a disease quarantine in a region that we
have recognized as one in which the disease is not known to exist, the
importation of animals and animal products prohibited or restricted
movement from the quarantined area in the EU would also be prohibited
importation into the United States. We believe this provision, which
would be set forth in a new Sec. 92.3, would protect livestock in the
United States by establishing a regulatory mechanism that goes into
effect as soon as a quarantine is established in the EU and that does
not require promulgation of a rule and its publication in the Federal
Register each time there is a limited disease outbreak in a free area.
The proposed provisions would apply only to those disease outbreaks in
the EU for which the region where the outbreak occurs had been
recognized by the Department as one in which the disease is not known
to exist at the time of the outbreak. We would also add a definition of
European Union in Sec. 92.1.
Miscellaneous
Additionally, we are proposing to make several nonsubstantive
changes to the regulations. In Secs. 94.9 through 94.13, we would
combine the references to ``Great Britain'' and ``Northern Ireland'' to
read instead ``the United Kingdom (England, Scotland, Wales, the Isle
of Man, and Northern Ireland).'' We are also proposing to change the
reference to ``Central American regions'' in Sec. 94.12 to read instead
``Central American countries.'' The word ``countries'' was
inadvertently changed to ``regions'' in earlier rulemaking.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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
[[Page 34163]]
by the Office of Management and Budget.
The Secretary of Agriculture is authorized to promulgate
regulations to prevent the introduction or dissemination of any
contagious, infectious, or communicable disease of animals from a
foreign country into the United States. This proposed rule would
recognize certain regions in the EU as those in which hog cholera is
not known to exist, and from which breeding swine, swine semen, and
pork and pork products may be imported into the United States under
certain conditions. Additionally, we are proposing to recognize Greece
as free of FMD and SVD, and to recognize eight Regions in Italy as free
of SVD. These proposed actions are based on a request from the EC's
Directorate General for Agriculture and on our review of the supporting
documentation supplied by the EC and individual Member States. These
proposed actions would relieve some restrictions on the importation
into the United States of certain animals and animal products from
those regions.
In considering this proposed rulemaking, we considered three
options. The first, which we could have applied to all the diseases
addressed by this proposed rule, was to retain the current regulations
and make no changes. We did not consider this an acceptable option
because it was not warranted by the disease status of the regions in
question and such inaction would have been contrary to U.S. obligations
under international trade agreements. A second option, specific to hog
cholera, was to allow free movement of swine, swine semen, and pork
from the region we are proposing to recognize as one in which hog
cholera does not exist. Based on our risk assessments, however, we
concluded that adopting that option would lead to an unacceptable risk
of introducing hog cholera into the United States. Therefore, we chose
to propose the provisions of this proposed rule, based on the
information discussed in this document.
Below is a summary of the economic analysis for the changes in the
import regulations proposed in this document. The economic analysis
provides a cost-benefit analysis as required by E.O. 12866 and the
analysis of impacts on small entities as required by the Regulatory
Flexibility Act. A copy of the full economic analysis is available for
review at the location listed in the ADDRESSES section at the beginning
of this document
We do not have enough data for a comprehensive analysis of the
economic impact of this proposed rule on small entities. Therefore, in
accordance with 5 U.S.C. 603, we have performed an Initial Regulatory
Flexibility Analysis for this proposed rule. We are inviting comments
about this proposed rule as it relates to small entities. In
particular, we are interested in determining the number and kind of
small entities that may incur benefits or costs from implementation of
this proposed rule and the economic impact of those benefits or costs.
Recognition of Certain EU Regions as Those in Which Hog Cholera
Does Not Exist
The analyses with regard to hog cholera examine the economic impact
of the potential importation of fresh (chilled or frozen) pork,
breeding swine and swine semen from regions in the EU that would be
recognized by this proposed rule as those in which hog cholera does not
exist. This proposed rule is in response to a request received in July
1997 from the European Commission's Directorate General for Agriculture
to do the following: (1) Recognize certain EU Member States as free in
their entirety of certain specified diseases; and (2) recognize certain
regions of EU Member States as free of specified diseases, consistent
with the disease status of those regions as recognized by the European
Union.
This proposed rule is in accordance with the policy of
``regionalization,'' whereby import requirements are tailored to
regions determined by science-based risk factors, rather than being
restricted to political boundaries.
Only certain regions in Germany and Italy would not be recognized
by this proposed rule as those in which hog cholera is not known to
exist. Five EU Member States that are already recognized in the current
regulations as those in which hog cholera is not known to exist are
excluded from this analysis, because the regulations governing hog
cholera do not currently restrict their pork, live swine, and swine
semen exports to the United States.
Potential exports to the United States from the 10 EU Member States
of concern (Austria, Belgium, France, Germany, Greece, Italy,
Luxembourg, the Netherlands, Portugal, and Spain) constitute the trade
volumes used in the analysis, assuming no risk of disease introduction.
For pork, the quantities are based on the proportion of Denmark's
global pork exports that are imported into the United States. It is
assumed that a similar percentage of the global pork exports of each of
the Member States of concern could be exported to the United States.
The total quantity of pork assumed is about 137,800 metric tons. For
breeding swine and swine semen imports, quantities that might be
imported are based on historical data and prior U.S. demand for EU
swine genetic stock.
It should be noted that present high levels of U.S. pork production
and depressed pork prices imply that imports resulting from this
regulatory change are likely to be minimal. The import quantities used
in the analysis allow assessment of potential impacts if market
conditions were to change in favor of U.S. imports of EU swine and
swine products. Estimated effects on producers and consumers reflect
the expected effects of these imports assuming no disease risks. Net
trade benefits are then compared to the likelihood that hog cholera
would be introduced into the United States and the projected costs that
would arise from such introduction.
Although we expect that the proposed impact from the regulatory
changes would be minimal, we used a net trade benefit model to evaluate
what would happen should trade occur. The economic model used to
evaluate pork imports is a net trade welfare model. Benefits to the
United States of pork imports from the EU Member States of concern are
calculated as the net change in consumer surplus and producer surplus.
Assuming an import volume of 138,000 metric tons of pork, the annual
net trade benefit is estimated to be about $5.5 million (1997 dollars).
Based on pork data for the period 1993-97, the welfare changes in
consumer surplus and producer surplus would represent about a 0.9
percent decrease in U.S. pork production, a 0.8 percent increase in
pork consumption, and a 1.0 percent decline in the farmgate price of
pork.
The annual value of breeding boar imports is assumed to be zero for
the minimum and most likely import volume, and $0.9 million for the
maximum import volume. For breeding gilt imports, it is assumed that
the annual values are zero for the minimum and most likely import
volume, and $1.2 million for the maximum import volume. The reason
breeding swine are unlikely to be imported is because of the minimal
marginal benefits that would be gained, given the genetic
characteristics of many EU swine breeds already incorporated by U.S.
breeders. Based on historical data, the annual value of swine semen
imports is assumed to be zero, $46,000, and $102,000 for the minimum,
most likely, and maximum import volumes, respectively.
The import quantities used to estimate trade impacts are also used
to examine the consequences and
[[Page 34164]]
likelihoods of hog cholera introduction due to the effects of this
proposed rule. Four biological consequence scenarios (low, moderate,
high, and very high) are considered for each commodity group (pork,
live swine, and swine semen). The consequence scenarios are weighted
separately for each commodity group, based on their assumed likelihoods
of occurrence. The low and moderate scenarios are considered most
likely for pork, due to the expectation that any initial exposure that
might occur would be in a small to medium-sized waste feeding operation
in a low-density area. Waste feeding is generally considered the most
likely means by which a foreign animal disease such as hog cholera
could be introduced into the United States via contaminated pork.
However, if hog cholera were introduced through breeding swine or swine
semen, the first herds affected would most likely be large commercial
herds. We invite public comment on the assumed weighting factors for
pork, breeding swine, and swine semen. (The quantitative disease risk
assessment associated with this rule can be obtained by calling Dr.
Gary Colgrove at (301) 734-8364, or electronically at http://
www.aphis.usda.gov/vs/reg-request.html.)
Under conservative assumptions, net consequences of any hog cholera
introduction under the four biological consequence scenarios are
estimated to range from $24 million (1997 dollars) to $355 million for
pork, and from $91 million to $958 million for live swine and swine
semen.
Despite the serious consequences that could result from a hog
cholera outbreak, extremely small likelihoods of hog cholera
introduction when risk mitigation measures are taken make overall
disease risks insignificant. For pork, assuming no risk mitigation
measures other than certification of origin and handling, and the
mitigating measures already in place in the EU, the expected frequency
of hog cholera introduction was found to be only one or more outbreaks
in 22,676 years. For breeding swine, the likelihood of hog cholera
introduction, assuming no additional mitigation measures, was estimated
to be one or more outbreaks in 33,670 years. Certification of origin
and handling is universally accepted in international animal and animal
product trade agreements as integral to disease prevention, and is
therefore included in the starting analysis.
Swine semen imports would satisfy acceptable levels of risk if they
were conducted in accordance with EU provisions for semen collection,
with the additional mitigating measure of a 40-day hold on donor boars
prior to shipment of the semen to the United States. Again, for this
determination of risk, we are assuming that no other regulations are in
place that require a holding period after semen collection. This 40-day
holding period would allow for observation of the donor animals and
other animals in the semen collection center for potential clinical
signs of hog cholera. We determined that the most likely expected
frequency of simulation distributions of hog cholera introduction
without application of the 40-day holding period would be one or more
outbreaks in 1,842 years, compared to a most likely expected frequency
of one or more outbreaks in 257.7 million years with the 40-day hold.
In our economic analysis, we compared potential trade benefits and
disease costs. We expect that pork, breeding swine, and swine semen
imports from the region in question would be unlikely to be
significantly affected by these proposed regulatory changes, given
current hog and pork market conditions. Nevertheless, for purposes of
the comparison, we assumed that a certain level of trade in these
commodities would occur. We conducted simulations assuming imports of
137,779 metric tons of pork, 800 doses of swine semen, and 1,592
breeding swine, based on historical volumes of imports from countries
in the EU in which hog cholera is not known to exist. For each
commodity, the simulations generated probability distributions of the
annual net benefits of trade minus the product of the annual likelihood
of hog cholera introduction and the discounted net economic
consequences of hog cholera introduction. The most likely value of the
distribution, given the assumed import levels, is $3.4 million for pork
imports and $1.22 million for breeding swine imports. For swine semen,
the most likely value of the distribution is negative $19,074 without
the 40-day hold, and positive $28,714 when the 40-day hold mitigation
is included. We emphasize again, however, that we do not expect
significant levels of imports as a result of these proposed regulatory
changes, but the simulation results are presented to provide some
insight into the potential impact of the proposed regulatory changes
should market conditions change in the future.
Regarding effects of the proposed rule on small entities, more than
88 percent of all U.S. hog farms meet the Small Business Administration
size criterion for small entities of annual revenues of less than
$500,000. It is unlikely that any producers, large or small, would be
significantly affected. Pork, breeding swine, and swine semen imports
from the region in question would be unlikely to be significantly
affected by this proposed regulatory change, given current market
conditions.
Even if EU pork exports to the United States were to eventually
grow to levels that have been assumed in the trade analysis, potential
economic effects on small producers would amount to less than 1 percent
of average revenues. Therefore, we do not believe this proposed rule
would have a significant economic impact on small entities, even if the
U.S. pork market were more attractive for EU exports.
Recognition of Greece as Free of FMD and SVD
We are also proposing to recognize Greece as free of FMD and SVD.
In the absence of any other restrictions due to other diseases of
concern, recognizing Greece as free of FMD and SVD would eliminate
certain restrictions on the importation of ruminants, swine, and their
products into the United States from that country.
Historically, Greece's exports of hoofed farm animals, meat and
meat products, and milk have been very small compared to the amounts
and values of these commodities traded by the United States. The
average annual value of hoofed farm animals exported by Greece during
the period from 1994-1997 was only 0.05 percent of the average value of
these animals imported by the United States over the same period.
Comparable percentages for meat and meat products and for milk were 0.5
percent and 1.9 percent, respectively. In other words, in the unlikely
event that all of Greece's exports of these commodities were diverted
to the United States, they would comprise only extremely small portions
of U.S. imports.
Entities potentially directly affected by this proposed rule--
assuming no other overriding disease restrictions--are brokers, agents,
and others in the United States who would be directly involved in the
importation and sale of hoofed farm animals, meat and meat products,
and milk from Greece. In theory, U.S. producers of these commodities
could be indirectly affected if imports were substantial enough to
influence prices. As indicated above, this possibility is extremely
remote.
The number and sizes of entities that might be directly involved in
the importation and sale of hoofed farm animals, meat and meat
products, and milk from Greece is not known. Nevertheless, it is
reasonable to assume that most of these entities would be
[[Page 34165]]
small, based on criteria established by the Small Business
Administration.
To the extent that the proposed rule would reduce restrictions on
imports from Greece of hoofed farm animals, meat and meat products, and
milk, it could have a positive economic effect on U.S. importers.
However, imports are likely to be of extremely small amounts compared
to U.S. trade overall, and the economic impact on U.S. entities, large
and small, is expected to be negligible. Likewise, indirect economic
impacts on U.S. producers are expected to be insignificant.
Recognition of Regions in Italy as Free of SVD
We are also proposing to recognize eight Regions in northern Italy
as free of SVD. Due to the unavailability of trade statistics for the
eight Regions in question, we based our analysis on swine and pork
trade for Italy as a whole.
Italy's breeding swine imports far outweigh its exports. The
average annual value of such exports during the period 1994-97 was only
$4,000, compared to annual imports valued at over $2 million. In
contrast, the United States is a net exporter of breeding swine, with
the average value of exports, $6.5 million, six times the average value
of imports, $1.1 million. For other swine, Italy, again, is a net
importer, with imports valued at an annual average of about $135
million, compared to exports valued at less than $2 million. The United
States is also a net importer of other swine, with average annual
imports of $204 million and exports of $4 million.
Italy is a net importer of pork, with average annual imports of
over $1.5 billion, compared to exports of $55 million. The United
States is a net exporter of pork, with average annual exports of over
$770 million, compared to imports of $466 million. In only one category
of pork, ``hams, shoulders with bone,'' is Italy a net exporter. Its
annual exports in that category have averaged about $30 million,
compared to imports of about $6 million. The United States is also a
net exporter of hams, although its trade is more balanced; the average
annual value of such exports from 1994-97 was about $6 million,
compared to imports valued at about $4 million.
Italy's trade in edible swine offal was fairly balanced during the
period 1994-97, with imports slightly outweighing exports. In 1997,
however, exports surged to become 40 percent greater than imports. The
United States is a strong net exporter of edible swine offal, with
exports averaging $94 million annually over the 4-year period, compared
to an annual average for imports of $7 million.
Overall, then, Italy's imports of swine and pork outweigh its
exports, while the opposite is true for the United States (except in
the case of live swine other than breeding swine, a U.S. import market
dominated by Canada). The notable exception to this pattern for Italy
is the category ``hams, shoulders with bones,'' for which Italy has a
sizable export industry. It is not known what percentage of these
commodities are produced in the eight Regions of Italy addressed by
this proposed rule. Clearly, trade consequences for the United States
would be smaller than those indicated by Italy's national statistics,
and, thus it is assumed to be insignificant. U.S. imports of ``hams,
shoulders with bone'' originating in the eight Regions would compete as
much with imports of these products from other countries as they would
with those produced in the United States.
Small entities that could be directly affected by the proposed rule
change would be buyers and wholesalers of swine and pork products. Pork
and swine imports from the eight Regions of Italy would likely be very
minor, and economic impacts on U.S. entities, large and small, would be
insignificant. Current low pork prices in the United States make it all
the more probable that pork imports from the eight Regions in Italy, if
they were to occur, would be extremely limited.
This proposed rule contains information collection and
recordkeeping requirements. These requirements are described in the
section of this document entitled ``Paperwork Reduction Act.''
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
National Environmental Policy Act
We are preparing an environmental assessment in accordance with:
(1) The National Environmental Policy Act of 1969, as amended (NEPA)
(42 U.S.C. 4321 et seq.), (2) regulations of the Council on
Environmental Quality for implementing the procedural provisions of
NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR
part 372). When the environmental assessment is completed, we will
inform the public through a notice in the Federal Register that it is
available.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 98-090-1.
Please send a copy of your comments to: (1) Docket No. 98-090-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,
OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW.,
Washington, DC 20250. A comment to OMB is best assured of having its
full effect if OMB receives it within 30 days of publication of this
proposed rule.
Under this proposed rule, importers of breeding swine, pork and
pork products, and swine semen from the region in the EU that we would
recognize as one in which hog cholera is not known to exist would be
required to include origin and movement certification with the imported
commodity. Additionally, importers of breeding swine or swine semen
would have to include the results of tests conducted on the imported
swine or donor boars.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. We need this outside input to help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected;
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic,
[[Page 34166]]
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission
responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 1 hour per response.
Respondents: Importers of swine, swine semen, and pork and pork
products.
Estimated annual number of respondents: 30.
Estimated annual number of responses per respondent: 10.
Estimated annual number of responses: 300.
Estimate total annual burden on respondents: 300 hours.
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue SW., Washington, DC 20250.
List of Subjects
9 CFR Part 92
Animal diseases, Imports.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 98
Animal diseases, Imports.
Accordingly, we are proposing to amend 9 CFR parts 92, 94, and 98,
as follows:
PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR
REQUESTING RECOGNITION OF REGIONS
1. The authority citation for part 92 would continue to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105,
111, 114a, 134a, 134b, 134c, 134d, 134f, 135, 136, and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 92.1, a definition of European Union would be added, in
alphabetical order, to read as follows:
Sec. 92.1 Definitions.
* * * * *
European Union. 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).
* * * * *
3. A new Sec. 92.3 would be added to read as follows:
Sec. 92.3 Movement restrictions.
Whenever the European Commission (EC) establishes a quarantine in
the European Union in a region the Animal and Plant Health Inspection
Service recognizes as one in which the disease is not known to exist
and the EC imposes prohibitions or other restrictions on the movement
of animals or animal products from the quarantined area in the European
Union, such animals and animal products are prohibited importation into
the United States.
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY; PROHIBITED AND
RESTRICTED IMPORTATIONS
4. The authority citation for part 94 would continue to read as
follows:
Authority: 7 U.S.C. 147a, 150ee, 161, 162, and 450; 19 U.S.C.
1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136, and 136a; 31
U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and
371.2(d).
5. In Sec. 94.1, paragraph (a)(2) would be amended by adding the
word ``Greece,'' immediately after the words ``Isle of Man),'' and
paragraph (a)(3) would be revised to read as follows:
Sec. 94.1 Regions where rinderpest or foot-and-mouth disease exists;
importations prohibited.
(a) * * *
(3) The following regions are declared to be free of rinderpest but
not foot-and-mouth disease: None.
* * * * *
6. In Sec. 94.9, paragraph (a) would be revised to read as follows:
Sec. 94.9 Pork and pork products from regions where hog cholera
exists.
(a) Hog cholera is known to exist in all regions of the world
except Australia; Canada; Denmark; Fiji; Finland; Iceland; New Zealand;
Norway; the Republic of Ireland; Sweden; Trust Territory of the Pacific
Islands; the United Kingdom (England, Scotland, Wales, the Isle of Man,
and Northern Ireland); and a single region in the European Union
consisting of Austria, Belgium, France, Greece, Luxembourg, The
Netherlands, Portugal, Spain, the country of Germany except for the
Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the
Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in
the Land of Saxony-Anhalt, and the country of Italy except for the
Island of Sardinia and the Regions of Emilia Romagna and Piemonte.\9\
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\9\ See also other provisions of this part, parts 92, 95, and 96
of this chapter, and part 327 of this title for other prohibitions
and restrictions on the importation of swine and swine products.
---------------------------------------------------------------------------
* * * * *
7. In Sec. 94.10, paragraph (a) would be amended by revising the
first sentence to read as follows:
Sec. 94.10 Swine from regions where hog cholera exists.
(a) Hog cholera is known to exist in all regions of the world
except Australia; Canada; Denmark; Fiji; Finland; Iceland; New Zealand;
Norway; the Republic of Ireland; Sweden; Trust Territory of the Pacific
Islands; the United Kingdom (England, Scotland, Wales, the Isle of Man,
and Northern Ireland); and a single region in the European Union
consisting of Austria, Belgium, France, Greece, Luxembourg, The
Netherlands, Portugal, Spain, the country of Germany except for the
Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the
Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in
the Land of Saxony-Anhalt, and the country of Italy except for the
Island of Sardinia and the Regions of Emilia Romagna and Piemonte. * *
*
* * * * *
Sec. 94.11 [Amended]
8. In Sec. 94.11, paragraph (a) would be amended by adding the word
``Greece,'' immediately after the word ``Germany,'', by removing the
words ``Great Britain (England, Scotland, Wales, and Isle of Man),''
and ``Northern Ireland,'', and by adding the words ``the United Kingdom
(England, Scotland, Wales, the Isle of Man, and Northern Ireland),''
immediately after the word ``Switzerland,''.
9. In 94.12, paragraph (a) would be revised to read as follows:
Sec. 94.12 Pork and pork products from regions where swine vesicular
disease exists.
(a) Swine vesicular disease is considered to exist in all regions
of the world except Australia; Austria; The Bahamas; Belgium; Bulgaria;
Canada; Central American countries; Chile; Denmark; Dominican Republic;
Fiji; Finland; France; Germany; Greece; Greenland; Haiti; Hungary;
Iceland; Luxembourg; Mexico; The Netherlands; New Zealand; Norway;
Panama; Portugal; Republic of Ireland; Romania; Spain; Sweden;
Switzerland; Trust Territories of the Pacific; the United Kingdom
(England, Scotland, Wales, the Isle of Man, and Northern Ireland);
[[Page 34167]]
Yugoslavia; and the Regions in Italy of Abruzzi, Emilia Romagna,
Friuli, Liguria, Marche, Molise, Piemonte, and Valle d'Aosta.
* * * * *
10. In Sec. 94.13, the introductory text would be revised to read
as follows:
Sec. 94.13 Restrictions on importation of pork or pork products from
specified regions.
Austria; The Bahamas; Belgium; Bulgaria; Chile; Denmark; France;
Germany; Hungary; Luxembourg; The Netherlands; Portugal; Republic of
Ireland; Spain; Switzerland; the United Kingdom (England, Scotland,
Wales, the Isle of Man, and Northern Ireland); Yugoslavia; and the
Regions in Italy of Abruzzi, Emilia Romagna, Friuli, Liguria, Marche,
Molise, Piemonte, and Valle d'Aosta are declared free of swine
vesicular disease in Sec. 94.12(a) of this part. These regions either
supplement their national pork supply by the importation of fresh
(chilled or frozen) pork from regions where swine vesicular disease is
considered to exist; have a common border with such regions; or have
trade practices that are less restrictive than are acceptable to the
United States. Thus, the pork or pork products produced in such regions
may be commingled with fresh (chilled or frozen) meat of animals from a
region where swine vesicular disease is considered to exist, resulting
in an undue risk of swine vesicular disease introduction into the
United States. Therefore, pork or pork products and shipstores,
airplane meals, and baggage containing such pork other than those
articles regulated under part 95 or part 96 of this chapter, produced
in such regions shall not be brought into the United States unless the
following requirements are met in addition to other applicable
requirements of part 327 of this title:
* * * * *
11. A new Sec. 94.22 would be added to read as follows:
Sec. 94.22 Restrictions on the importation of swine, pork, and pork
products from parts of the European Union.
In addition to meeting all other applicable provisions of this
part, live swine, pork, and pork products imported from the region of
the European Union consisting of Austria, Belgium, France, Greece,
Luxembourg, The Netherlands, Portugal, Spain, the country of Germany
except for the Kreis Vechta in the Land of Lower Saxony, the Kreis
Warendorf in the Land of Northrhine Westfalia, and the Kreis
Altmarkkreis Salzwedel in the Land of Saxony-Anhalt, and the country of
Italy except for the Island of Sardinia and the Regions of Emilia
Romagna and Piemonte must meet the following conditions:
(a) Pork and pork products. (1) The pork or pork products must not
have been commingled with pork or pork products produced from swine
from any region listed at that time in Sec. 94.10(a) as a region in
which hog cholera is known to exist;
(2) The swine from which the pork or pork products were produced
must not have lived in a region listed at that time as one in which hog
cholera is known to exist, and must not have transited such a region
unless moved directly through such a region in a sealed means of
conveyance with the seal determined to be intact upon arrival at the
point of destination; and
(3) The pork and pork products must be accompanied by a certificate
issued by an official of the national government for the region of
origin who is authorized to issue the foreign meat inspection
certificate required by Sec. 327.4 of this title, stating that the
provisions of paragraphs (a)(1) and (a)(2) of this section have been
met.\17\
---------------------------------------------------------------------------
\17\ 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. (1) The swine must be breeding swine and must not
have lived in a region listed at that time in Sec. 94.10(a) as a region
in which hog cholera is known to exist, and must not have transited
such a region unless moved directly through such a region in a sealed
means of conveyance with the seal determined to be intact upon arrival
at the point of destination;
(2) The swine must never have been commingled with swine that have
been in a region listed at that time as one in which cholera is known
to exist;
(3) No equipment or materials used in transporting the swine may
have previously been used for transporting swine that do not meet the
requirements of this section, unless the equipment or materials have
first been cleaned and disinfected; and
(4) The swine must be accompanied by a certificate issued by a
salaried veterinary officer of the national government of the country
of origin, stating that the provisions of paragraphs (b)(1) through
(b)(3) of this section have been met.\18\
---------------------------------------------------------------------------
\18\ 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)(3) and (b)(4) of
this section must be presented by the importer or his or her agent to
the collector of customs at the port of arrival, upon arrival of the
swine, pork, or pork products at the port, for the use of the
veterinary inspector at the port of entry.
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
12. The authority citation for part 98 would continue to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,
111, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.2(d).
13. In part 98, a new Sec. 98.38 would be added to read as follows:
Sec. 98.38 Restrictions on the importation of swine semen from parts
of the European Union.
In addition to meeting all other applicable provisions of this
part, swine semen imported from the region of the European Union
consisting of Austria, Belgium, France, Greece, Luxembourg, The
Netherlands, Portugal, Spain, the country of Germany except for the
Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the
Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in
the Land of Saxony-Anhalt, and the country of Italy except for the
Island of Sardinia and the Regions of Emilia Romagna and Piemonte must
meet the following conditions:
(a) The semen must come only from a semen collection center
approved for export by the veterinary services of the national
government of the country of origin;
(b) The donor boar must not have lived in a region listed at that
time in Sec. 94.10 as one in which hog cholera is known to exist, and
must not have transited such a region unless moved directly through
such a region in a sealed means of conveyance with the seal determined
to be intact upon arrival at the point of destination;
(c) The donor boar must never have been commingled with swine that
have been in a region listed at that time as a region in which hog
cholera is known to exist;
(d) The donor boar must be held in isolation for at least 30 days
prior to entering the semen collection center;
(e) No more than 30 days prior to being held in isolation as
required by paragraph (b) of this section, the donor boar must be
tested with negative results with a hog cholera test approved by the
International Office of Epizootics;
(f) 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
[[Page 34168]]
for transporting swine that do not meet the requirements of this
section, unless such equipment or materials has first been cleaned and
disinfected;
(g) The donor boar must be observed at the semen collection center
by the center veterinarian, and exhibit no clinical signs of hog
cholera;
(h) Before the semen is exported to the United States, the donor
boar must be held at the semen collection center for at least 40 days
following collection of the semen, and, along with all other swine at
the semen collection center, exhibit no clinical signs of hog cholera;
and
(i) The semen must be accompanied to the United States by a
certificate issued by a salaried veterinary officer of the national
government of the country of origin, 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.
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Done in Washington, DC, the 21st day of June 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-16172 Filed 6-22-99; 4:06 pm]
BILLING CODE 3410-34-P
