Recognition of Animal Disease Status of Regions in the European Union

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\

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\9\ See also other provisions of this part, parts 92, 95, and 96

of this chapter, and part 327 of this title for other prohibitions

and restrictions on the importation of swine and swine products.

---------------------------------------------------------------------------

* * * * *

7. In Sec. 94.10, paragraph (a) would be amended by revising the

first sentence to read as follows:

Sec. 94.10 Swine from regions where hog cholera exists.

(a) Hog cholera is known to exist in all regions of the world

except Australia; Canada; Denmark; Fiji; Finland; Iceland; New Zealand;

Norway; the Republic of Ireland; Sweden; Trust Territory of the Pacific

Islands; the United Kingdom (England, Scotland, Wales, the Isle of Man,

and Northern Ireland); and a single region in the European Union

consisting of Austria, Belgium, France, Greece, Luxembourg, The

Netherlands, Portugal, Spain, the country of Germany except for the

Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the

Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in

the Land of Saxony-Anhalt, and the country of Italy except for the

Island of Sardinia and the Regions of Emilia Romagna and Piemonte. * *

*

* * * * *

Sec. 94.11 [Amended]

8. In Sec. 94.11, paragraph (a) would be amended by adding the word

``Greece,'' immediately after the word ``Germany,'', by removing the

words ``Great Britain (England, Scotland, Wales, and Isle of Man),''

and ``Northern Ireland,'', and by adding the words ``the United Kingdom

(England, Scotland, Wales, the Isle of Man, and Northern Ireland),''

immediately after the word ``Switzerland,''.

9. In 94.12, paragraph (a) would be revised to read as follows:

Sec. 94.12 Pork and pork products from regions where swine vesicular

disease exists.

(a) Swine vesicular disease is considered to exist in all regions

of the world except Australia; Austria; The Bahamas; Belgium; Bulgaria;

Canada; Central American countries; Chile; Denmark; Dominican Republic;

Fiji; Finland; France; Germany; Greece; Greenland; Haiti; Hungary;

Iceland; Luxembourg; Mexico; The Netherlands; New Zealand; Norway;

Panama; Portugal; Republic of Ireland; Romania; Spain; Sweden;

Switzerland; Trust Territories of the Pacific; the United Kingdom

(England, Scotland, Wales, the Isle of Man, and Northern Ireland);

[[Page 34167]]

Yugoslavia; and the Regions in Italy of Abruzzi, Emilia Romagna,

Friuli, Liguria, Marche, Molise, Piemonte, and Valle d'Aosta.

* * * * *

10. In Sec. 94.13, the introductory text would be revised to read

as follows:

Sec. 94.13 Restrictions on importation of pork or pork products from

specified regions.

Austria; The Bahamas; Belgium; Bulgaria; Chile; Denmark; France;

Germany; Hungary; Luxembourg; The Netherlands; Portugal; Republic of

Ireland; Spain; Switzerland; the United Kingdom (England, Scotland,

Wales, the Isle of Man, and Northern Ireland); Yugoslavia; and the

Regions in Italy of Abruzzi, Emilia Romagna, Friuli, Liguria, Marche,

Molise, Piemonte, and Valle d'Aosta are declared free of swine

vesicular disease in Sec. 94.12(a) of this part. These regions either

supplement their national pork supply by the importation of fresh

(chilled or frozen) pork from regions where swine vesicular disease is

considered to exist; have a common border with such regions; or have

trade practices that are less restrictive than are acceptable to the

United States. Thus, the pork or pork products produced in such regions

may be commingled with fresh (chilled or frozen) meat of animals from a

region where swine vesicular disease is considered to exist, resulting

in an undue risk of swine vesicular disease introduction into the

United States. Therefore, pork or pork products and shipstores,

airplane meals, and baggage containing such pork other than those

articles regulated under part 95 or part 96 of this chapter, produced

in such regions shall not be brought into the United States unless the

following requirements are met in addition to other applicable

requirements of part 327 of this title:

* * * * *

11. A new Sec. 94.22 would be added to read as follows:

Sec. 94.22 Restrictions on the importation of swine, pork, and pork

products from parts of the European Union.

In addition to meeting all other applicable provisions of this

part, live swine, pork, and pork products imported from the region of

the European Union consisting of Austria, Belgium, France, Greece,

Luxembourg, The Netherlands, Portugal, Spain, the country of Germany

except for the Kreis Vechta in the Land of Lower Saxony, the Kreis

Warendorf in the Land of Northrhine Westfalia, and the Kreis

Altmarkkreis Salzwedel in the Land of Saxony-Anhalt, and the country of

Italy except for the Island of Sardinia and the Regions of Emilia

Romagna and Piemonte must meet the following conditions:

(a) Pork and pork products. (1) The pork or pork products must not

have been commingled with pork or pork products produced from swine

from any region listed at that time in Sec. 94.10(a) as a region in

which hog cholera is known to exist;

(2) The swine from which the pork or pork products were produced

must not have lived in a region listed at that time as one in which hog

cholera is known to exist, and must not have transited such a region

unless moved directly through such a region in a sealed means of

conveyance with the seal determined to be intact upon arrival at the

point of destination; and

(3) The pork and pork products must be accompanied by a certificate

issued by an official of the national government for the region of

origin who is authorized to issue the foreign meat inspection

certificate required by Sec. 327.4 of this title, stating that the

provisions of paragraphs (a)(1) and (a)(2) of this section have been

met.\17\

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\17\ The certification required may be placed on the foreign

meat inspection certificate required by Sec. 327.4 of this title or

may be contained in a separate document.

---------------------------------------------------------------------------

(b) Live swine. (1) The swine must be breeding swine and must not

have lived in a region listed at that time in Sec. 94.10(a) as a region

in which hog cholera is known to exist, and must not have transited

such a region unless moved directly through such a region in a sealed

means of conveyance with the seal determined to be intact upon arrival

at the point of destination;

(2) The swine must never have been commingled with swine that have

been in a region listed at that time as one in which cholera is known

to exist;

(3) No equipment or materials used in transporting the swine may

have previously been used for transporting swine that do not meet the

requirements of this section, unless the equipment or materials have

first been cleaned and disinfected; and

(4) The swine must be accompanied by a certificate issued by a

salaried veterinary officer of the national government of the country

of origin, stating that the provisions of paragraphs (b)(1) through

(b)(3) of this section have been met.\18\

---------------------------------------------------------------------------

\18\ The certification required may be placed on the certificate

required by Sec. 93.505(a) of this chapter or may be contained in a

separate document.

---------------------------------------------------------------------------

(c) The certificates required by paragraphs (a)(3) and (b)(4) of

this section must be presented by the importer or his or her agent to

the collector of customs at the port of arrival, upon arrival of the

swine, pork, or pork products at the port, for the use of the

veterinary inspector at the port of entry.

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

12. The authority citation for part 98 would continue to read as

follows:

Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,

111, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7

CFR 2.22, 2.80, and 371.2(d).

13. In part 98, a new Sec. 98.38 would be added to read as follows:

Sec. 98.38 Restrictions on the importation of swine semen from parts

of the European Union.

In addition to meeting all other applicable provisions of this

part, swine semen imported from the region of the European Union

consisting of Austria, Belgium, France, Greece, Luxembourg, The

Netherlands, Portugal, Spain, the country of Germany except for the

Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the

Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in

the Land of Saxony-Anhalt, and the country of Italy except for the

Island of Sardinia and the Regions of Emilia Romagna and Piemonte must

meet the following conditions:

(a) The semen must come only from a semen collection center

approved for export by the veterinary services of the national

government of the country of origin;

(b) The donor boar must not have lived in a region listed at that

time in Sec. 94.10 as one in which hog cholera is known to exist, and

must not have transited such a region unless moved directly through

such a region in a sealed means of conveyance with the seal determined

to be intact upon arrival at the point of destination;

(c) The donor boar must never have been commingled with swine that

have been in a region listed at that time as a region in which hog

cholera is known to exist;

(d) The donor boar must be held in isolation for at least 30 days

prior to entering the semen collection center;

(e) No more than 30 days prior to being held in isolation as

required by paragraph (b) of this section, the donor boar must be

tested with negative results with a hog cholera test approved by the

International Office of Epizootics;

(f) No equipment or materials used in transporting the donor boar

from the farm of origin to the semen collection center may have been

used previously

[[Page 34168]]

for transporting swine that do not meet the requirements of this

section, unless such equipment or materials has first been cleaned and

disinfected;

(g) The donor boar must be observed at the semen collection center

by the center veterinarian, and exhibit no clinical signs of hog

cholera;

(h) Before the semen is exported to the United States, the donor

boar must be held at the semen collection center for at least 40 days

following collection of the semen, and, along with all other swine at

the semen collection center, exhibit no clinical signs of hog cholera;

and

(i) The semen must be accompanied to the United States by a

certificate issued by a salaried veterinary officer of the national

government of the country of origin, stating that the provisions of

paragraphs (a) through (h) of this section have been met.\3\

\3\ The certification required may be placed on the certificate

required under Sec. 98.35(c) or may be contained in a separate

document.

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Done in Washington, DC, the 21st day of June 1999.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-16172 Filed 6-22-99; 4:06 pm]

BILLING CODE 3410-34-P