Exportation and importation of animals and animal products: Recognition of animal disease status of regions in European Union,

[Federal Register: June 25, 1999 (Volume 64, Number 122)]

[Proposed Rules]

[Page 34155-34168]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25jn99-15]

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.

SUMMARY: We are proposing to amend the regulations concerning the importation of animals and animal products to recognize a region in the European Union as a region in which hog cholera is not known to exist, and from which breeding swine, swine semen, and pork and pork products may be imported into the United States under certain conditions. Additionally, we are proposing to recognize Greece as free of foot-and- mouth disease and swine vesicular disease, and to recognize eight Regions in Italy as free of swine vesicular disease. These proposed actions are based on a request from the European Commission's Directorate General for Agriculture and on our analysis of the supporting documentation supplied by the European Commission and individual Member States. These proposed actions would relieve some restrictions on the importation into the United States of certain animals and animal products from those regions. However, because of the status of those regions with respect to other diseases, and, in some cases, because of other factors that could result in an increased risk of introducing animal diseases into the United States, the importation of animals and animal products into the United States from those regions would continue to be subject to certain restrictions. We invite you to comment on this docket. We also invite you to comment on the related risk assessments.

DATES: We will consider all comments that we receive by August 24, 1999.

ADDRESSES: Please send your comment and three copies to: Docket No. 98- 090-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Please state that your comments refer to Docket No. 98-090-1.

You may read any comments that we receive on this docket or its related risk assessments in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Chief Staff Veterinarian, National Center for Import and Export (NCIE), VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8364; or e-mail: gary.s.colgrove@usda.gov.

The full risk assessments associated with this rule can be obtained by calling Dr. Gary Colgrove at (301) 734-8364 or, in the case of the quantitative disease risk assessment, electronically at http://www.aphis.usda.gov/vs/reg-request.html.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (the Department) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. The regulations pertaining to the importation of animals and animal products are set forth in the Code of Federal Regulations (CFR), title 9, chapter I, subchapter D (9 CFR parts 91 through 99).

Until recently, the regulations in parts 91 through 99(referred to below as the regulations) governed the importation of animals and animal products according to the recognized disease status of the exporting country. In general, if a disease occurred anywhere within a country's borders, the entire country was considered to be affected with the disease, and importations of animals and animal products from anywhere in the country were regulated accordingly. However, international trade agreements entered into by the United States-- specifically, the North American Free Trade Agreement and the World Trade Organization Agreement on Sanitary and Phytosanitary Measures-- require APHIS to recognize regions, rather than only countries, and to recognize levels of risk, for the purpose of regulating the importation of animals and animal products into the United States.

Consequently, on October 28, 1997, we published in the Federal Register a final rule (62 FR 56000-56026, Docket No. 94-106-9, effective November 28, 1997) and a policy statement (62 FR 56027-56033, Docket No. 94-106-8) that established procedures for recognizing regions and levels of risk (referred to below as ``regionalization'') for the purpose of regulating the importation of animals and animal products. With the establishment of those procedures, APHIS can now consider requests to allow importations from regions based on levels of risk, as well as to recognize entire countries free of a disease.

In July 1997, APHIS received requests from the European Commission's (EC's) Directorate General for Agriculture to do the following: (1) Recognize certain Member States of the European Union (EU) as free in their entirety of certain specified diseases; and (2) recognize certain regions of EU countries as free of specified diseases, consistent with the disease status of those regions as recognized by the EC.

In response to the first request, and based on our review of supporting documentation accompanying the request, we published a proposed rule in the Federal Register (62 FR 61036-61041, Docket No. 97-086-1) on November 14, 1997, to declare Luxembourg and Portugal free of rinderpest and foot-and-mouth disease (FMD); Greece free of rinderpest; France, Greece, Luxembourg, and Spain free of exotic Newcastle disease; Portugal free of African swine fever; and Belgium, France, and Portugal free of swine vesicular disease (SVD). We solicited comments concerning our proposed rule for 60 days ending January 13, 1998. We received one comment by that date. The comment was from a veterinary association and fully supported the proposed rule. As noted, the proposed rule addressed part of the request submitted by the EC. Following publication of the proposed rule, we continued to review the remainder of the EC's request, including information we received following the initial request. (Our regulations establishing procedures for regionalization became effective after the initial request was received from the EC.) On December 8, 1998, we published a final rule in the Federal Register (63 FR 67573-67575, Docket

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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

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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

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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

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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:

‹bullet› 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.

‹bullet› 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.

‹bullet› 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

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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:

  3. 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.

  4. 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.

  5. 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,

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    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.

  6. 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.

  7. 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.

  8. 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:

    ‹bullet› 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.

    ‹bullet› 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.

    ‹bullet› 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.

    ‹bullet› 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.

    ‹bullet› That if a hog cholera-infected animal is slaughtered, all of the meat from that animal is contaminated with virus. This is a worst case assumption that magnifies the probability of a hog cholera outbreak.

    In addition to these starting assumptions for the risk assessment, we assumed that swine slaughtered to produce pork for export to the United States are slaughtered in compliance with the requirements of the United States Department of Agriculture's Food Safety and Inspection Service. These requirements include ante-mortem and post- mortem inspection. Although the impact of these requirements was not considered in the risk assessment, we believe that the requirements would further reduce the quantity of contaminated pork likely to be exported to the United States.

    The results of the quantitative risk assessment suggest that unmitigated importation of breeding swine into the United States from the region in question would likely result in one or more outbreaks of hog cholera in this country every 33,670 years; the unmitigated importation of swine semen would likely result in one or more outbreaks in this country every 1,842 years; and the unmitigated importation of fresh (chilled or frozen) pork would likely result in one or more outbreaks in this country every 22,676 years. By unmitigated importation, we mean no additional import requirements beyond certification of the origin of the product, the areas it has transited, and the lack of commingling, as well as the biosecurity measures in place in the EU as discussed above and described in EU Council Directives 90/425/EEC, 89/662/EEC, 97/12/EEC, 64/432/EEC, and 91/496/ EEC. Some of these biosecurity measures are set out in our proposed conditions for importation and are described below.

    Results of the Risk Assessments

    The results of both our descriptive and quantitative assessments suggest that the risk of introduction of hog cholera into the United States due to the importation under the conditions described in the preceding paragraph of fresh (chilled or frozen) pork, and breeding swine would be expected to present negligible hog cholera risk levels. Because importation of live swine other than breeding swine would not be cost-effective, we limited our risk assessment to breeding swine. In the future, if we receive requests to import live swine other than breeding swine, we will conduct a separate assessment of the risk of importing those swine. We are proposing additional import requirements for swine semen, over and above those biosecurity measures required by directive in the EU. Our proposed requirements for pork and

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    pork products, breeding swine, and swine semen are discussed below.

    Importation of Pork and Pork Products

    Our conclusion is that, based on the likelihood of importation of the disease agent, the destination of the imported articles and their usage, and disposal of waste, pork and pork products could be imported into the United States from the region in question with negligible risk of introducing hog cholera, provided the pork or pork products meet all other applicable import requirements in the regulations and provided they are accompanied by a certificate of origin certifying the following: (1) That the articles have not been commingled with pork or pork products produced from swine from regions in which hog cholera is known to exist; and (2) that the swine from which the pork or pork products were produced have not lived in a region listed at that time as one in which hog cholera is known to exist and have not transited such a region unless moved directly through such a region in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination.

    Importation of Live Swine and Semen from Swine

    We believe that the risk of the introduction of hog cholera from the importation of live swine and swine semen from the region in question would be negligible if the following risk mitigation measures are taken:

    The swine, which would have to be breeding swine, and swine semen would have to meet all import requirements in the regulations and be accompanied by a certificate of origin certifying that the swine or donor boars have never lived in a region listed at that time as a region in which hog cholera is known to exist, have never transited such a region unless moved directly through such a region in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination, and have never been commingled with swine that have been in a region listed at that time as one in which hog cholera is known to exist.

    Additionally, we are proposing to require that no equipment or materials used in transporting the swine or donor boars under this rule may have previously been used for transporting animals ineligible for export to the United States under the rule, unless they have been cleaned and disinfected following such previous use. This requirement would apply to movement of donor boars from the farm of origin to the semen collection center, and to the movement of other swine from the farm of origin to the point of entry into the United States.

    We would not allow swine semen to be imported into the United States from the region unless the semen comes from a semen collection center approved for export by the veterinary services of the national government of the EU Member State in which the collection center is located. Additionally, we would require that the donor boar be held in isolation for at least 30 days prior to entering the semen collection center, and, no more than 30 days prior to being held in isolation, be tested with negative results with a hog cholera test approved by the International Office of Epizootics. We would also require that the semen shipment not be exported to the United States unless the donor boar is observed by the semen collection center veterinarian while the donor boar is at the collection center, including at least a 40-day holding period at the semen collection center following collection of the semen, and, along with all other swine at the center, exhibits no clinical signs of hog cholera.

    We are proposing to add these requirements to the regulations, even though the current import requirements regarding certain other diseases already require a quarantine period for donor boars in the country of export. In considering the risk of the introduction of hog cholera into the United States through swine semen, we believe it is necessary to assume that quarantine periods do not exist for other diseases, because it is possible that regions currently affected by these other diseases could one day be considered free of them.

    On a practical level, the quarantine requirements we are proposing with regard to swine semen and hog cholera would have minimal current effect on the holding of swine. Currently, quarantine and testing of swine is required for semen imported from regions affected with tuberculosis, brucellosis, and pseudorabies, and each of the diseases is considered to exist in each of the countries included in the region proposed in this document. The current regulations with regard to these diseases require that donor boars be quarantined for a minimum of 60 days before collection of semen for export to the United States (compared to a proposed 30-day minimum quarantine prior to entry into the semen collection center under the hog cholera provisions of this proposal), and that they be tested twice with negative results for tuberculosis, brucellosis, and pseudorabies, as applicable to the region of origin. Tuberculin tests must be conducted with an interval of at least 60 days between tests, and the second test must be conducted no sooner than 30 days following collection of the semen (compared to a minimum holding period of 40 days following collection of semen under the proposed hog cholera regulations).

    The requirements pertaining to pork and pork products and live swine would be added to the regulations in a new Sec. 94.22. The requirements pertaining to swine semen would be added to the regulations in a new Sec. 98.38.

    Movement Restrictions

    We are also proposing to establish a new Sec. 92.3 to provide that whenever the EC establishes a disease quarantine in a region that we have recognized as one in which the disease is not known to exist, the importation of animals and animal products prohibited or restricted movement from the quarantined area in the EU would also be prohibited importation into the United States. We believe this provision, which would be set forth in a new Sec. 92.3, would protect livestock in the United States by establishing a regulatory mechanism that goes into effect as soon as a quarantine is established in the EU and that does not require promulgation of a rule and its publication in the Federal Register each time there is a limited disease outbreak in a free area. The proposed provisions would apply only to those disease outbreaks in the EU for which the region where the outbreak occurs had been recognized by the Department as one in which the disease is not known to exist at the time of the outbreak. We would also add a definition of European Union in Sec. 92.1.

    Miscellaneous

    Additionally, we are proposing to make several nonsubstantive changes to the regulations. In Secs. 94.9 through 94.13, we would combine the references to ``Great Britain'' and ``Northern Ireland'' to read instead ``the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland).'' We are also proposing to change the reference to ``Central American regions'' in Sec. 94.12 to read instead ``Central American countries.'' The word ``countries'' was inadvertently changed to ``regions'' in earlier rulemaking.

    Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed

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    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

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    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

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    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

  9. 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).

  10. 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). * * * * *

  11. 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

  12. 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).

  13. 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. * * * * *

  14. In Sec. 94.9, paragraph (a) would be revised to read as follows:

    Sec. 94.9 Pork and pork products from regions where hog cholera exists.

    (a) Hog cholera is known to exist in all regions of the world except Australia; Canada; Denmark; Fiji; Finland; Iceland; New Zealand; Norway; the Republic of Ireland; Sweden; Trust Territory of the Pacific Islands; the United Kingdom (England, Scotland, Wales, the Isle of Man, and Northern Ireland); and a single region in the European Union consisting of Austria, Belgium, France, Greece, Luxembourg, The Netherlands, Portugal, Spain, the country of Germany except for the Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in the Land of Saxony-Anhalt, and the country of Italy except for the Island of Sardinia and the Regions of Emilia Romagna and Piemonte.\9\

    \9\ See also other provisions of this part, parts 92, 95, and 96 of this chapter, and part 327 of this title for other prohibitions and restrictions on the importation of swine and swine products.

    * * * * *

  15. 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]

  16. 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,''.

  17. 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. * * * * *

  18. 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: * * * * *

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

    Sec. 94.22 Restrictions on the importation of swine, pork, and pork products from parts of the European Union.

    In addition to meeting all other applicable provisions of this part, live swine, pork, and pork products imported from the region of the European Union consisting of Austria, Belgium, France, Greece, Luxembourg, The Netherlands, Portugal, Spain, the country of Germany except for the Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in the Land of Saxony-Anhalt, and the country of Italy except for the Island of Sardinia and the Regions of Emilia Romagna and Piemonte must meet the following conditions:

    (a) Pork and pork products. (1) The pork or pork products must not have been commingled with pork or pork products produced from swine from any region listed at that time in Sec. 94.10(a) as a region in which hog cholera is known to exist;

    (2) The swine from which the pork or pork products were produced must not have lived in a region listed at that time as one in which hog cholera is known to exist, and must not have transited such a region unless moved directly through such a region in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination; and

    (3) The pork and pork products must be accompanied by a certificate issued by an official of the national government for the region of origin who is authorized to issue the foreign meat inspection certificate required by Sec. 327.4 of this title, stating that the provisions of paragraphs (a)(1) and (a)(2) of this section have been met.\17\

    \17\ The certification required may be placed on the foreign meat inspection certificate required by Sec. 327.4 of this title or may be contained in a separate document.

    (b) Live swine. (1) The swine must be breeding swine and must not have lived in a region listed at that time in Sec. 94.10(a) as a region in which hog cholera is known to exist, and must not have transited such a region unless moved directly through such a region in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination;

    (2) The swine must never have been commingled with swine that have been in a region listed at that time as one in which cholera is known to exist;

    (3) No equipment or materials used in transporting the swine may have previously been used for transporting swine that do not meet the requirements of this section, unless the equipment or materials have first been cleaned and disinfected; and

    (4) The swine must be accompanied by a certificate issued by a salaried veterinary officer of the national government of the country of origin, stating that the provisions of paragraphs (b)(1) through (b)(3) of this section have been met.\18\

    \18\ The certification required may be placed on the certificate required by Sec. 93.505(a) of this chapter or may be contained in a separate document.

    (c) The certificates required by paragraphs (a)(3) and (b)(4) of this section must be presented by the importer or his or her agent to the collector of customs at the port of arrival, upon arrival of the swine, pork, or pork products at the port, for the use of the veterinary inspector at the port of entry.

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

  20. 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).

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

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

    In addition to meeting all other applicable provisions of this part, swine semen imported from the region of the European Union consisting of Austria, Belgium, France, Greece, Luxembourg, The Netherlands, Portugal, Spain, the country of Germany except for the Kreis Vechta in the Land of Lower Saxony, the Kreis Warendorf in the Land of Northrhine Westfalia, and the Kreis Altmarkkreis Salzwedel in the Land of Saxony-Anhalt, and the country of Italy except for the Island of Sardinia and the Regions of Emilia Romagna and Piemonte must meet the following conditions:

    (a) The semen must come only from a semen collection center approved for export by the veterinary services of the national government of the country of origin;

    (b) The donor boar must not have lived in a region listed at that time in Sec. 94.10 as one in which hog cholera is known to exist, and must not have transited such a region unless moved directly through such a region in a sealed means of conveyance with the seal determined to be intact upon arrival at the point of destination;

    (c) The donor boar must never have been commingled with swine that have been in a region listed at that time as a region in which hog cholera is known to exist;

    (d) The donor boar must be held in isolation for at least 30 days prior to entering the semen collection center;

    (e) No more than 30 days prior to being held in isolation as required by paragraph (b) of this section, the donor boar must be tested with negative results with a hog cholera test approved by the International Office of Epizootics;

    (f) No equipment or materials used in transporting the donor boar from the farm of origin to the semen collection center may have been used previously

    [[Page 34168]]

    for transporting swine that do not meet the requirements of this section, unless such equipment or materials has first been cleaned and disinfected;

    (g) The donor boar must be observed at the semen collection center by the center veterinarian, and exhibit no clinical signs of hog cholera;

    (h) Before the semen is exported to the United States, the donor boar must be held at the semen collection center for at least 40 days following collection of the semen, and, along with all other swine at the semen collection center, exhibit no clinical signs of hog cholera; and

    (i) The semen must be accompanied to the United States by a certificate issued by a salaried veterinary officer of the national government of the country of origin, stating that the provisions of paragraphs (a) through (h) of this section have been met.\3\

    \3\ The certification required may be placed on the certificate required under Sec. 98.35(c) or may be contained in a separate document.

    Done in Washington, DC, the 21st day of June 1999. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service.

    [FR Doc. 99-16172Filed6-22-99; 4:06 pm]

    BILLING CODE 3410-34-P

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