[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: [email protected].
    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

[[Page 34162]]

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\
---------------------------------------------------------------------------

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

    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