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Proposed Rule

Change in Disease Status of the Republic of Korea With Regard to Foot-and-Mouth Disease and Rinderpest

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AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations to add the Republic of Korea to the list of regions that are considered free of rinderpest and foot-and-mouth disease (FMD). We are taking this action because we have conducted an evaluation and determined that the Republic of Korea is free of rinderpest and FMD. We are also proposing to add the Republic of Korea to the list of regions that are subject to certain import restrictions on meat and meat products because of their proximity to or trading relationships with rinderpest- or FMD-affected countries. These actions would update the disease status of the Republic of Korea with regard to rinderpest and FMD while continuing to protect the United States from an introduction of those diseases by providing additional requirements for meat and other animal products imported into the United States from the Republic of Korea.

DATES:

We will consider all comments that we receive on or before May 29, 2009.

ADDRESSES:

You may submit comments by either of the following methods:

Reading Room: You may read any comments that we receive on this docket 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.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

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FOR FURTHER INFORMATION CONTACT:

Dr. Julia Punderson, Senior Staff Veterinarian, Regionalization Evaluation Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.

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SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various communicable diseases, including rinderpest, foot-and-mouth disease (FMD), African swine fever, classical swine fever, and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations lists regions of the world that are declared free of rinderpest or free of both rinderpest and FMD. Rinderpest or FMD is considered to exist in all other parts of the world not listed. Section 94.11 of the regulations lists regions of the world that have been determined to be free of rinderpest and FMD, but are subject to certain restrictions because of their proximity to or trading relationships with rinderpest or FMD-affected regions.

On April 18, 2000, we published in the Federal Register an interim rule (65 FR 20713-20714, Docket No. 00-033-1) amending the regulations to remove the Republic of Korea (South Korea) from the list in § 94.1 of regions declared free of FMD and rinderpest because of a confirmed FMD diagnosis. That rule was effective retroactively to March 20, 2000, which was the date when FMD was initially detected. The rule also removed the Republic of Korea from the list of countries listed in § 94.11 that are declared to be free of these diseases, but that are subject to certain restrictions because of their proximity to or trading relationships with rinderpest or FMD-affected regions. As a result of the interim rule, the importation into the United States of any ruminant, or any fresh (chilled or frozen) meat of any ruminant that left the Republic of Korea on or after March 20, 2000, was prohibited or restricted.

The last FMD outbreaks in the Republic of Korea in 2000 and 2002 were limited in scope and rapidly controlled; no subsequent outbreaks have occurred since 2002. As for rinderpest, the Republic of Korea has not had an outbreak of the disease since 1931. In 2007, the Government of the Republic of Korea submitted information to APHIS to support an official request for recognition of its FMD-free status. In response, APHIS conducted a site visit to the Republic of Korea in March 2008 to substantiate information provided with the request and obtain evidence firsthand. We conducted a disease risk evaluation [1] and concluded the Republic of Korea is free of FMD. We also concluded that the surveillance, prevention, and control measures implemented by the Republic of Korea are sufficient to minimize the likelihood of introducing FMD or rinderpest into the United States via imports of susceptible species or products from such species.

In light of our conclusions, we propose to add the Republic of Korea to the list in § 94.1 of regions that have been declared free of FMD and rinderpest. We also propose to add the Republic of Korea to the list in § 94.11 of regions that are declared to be free of these diseases, but that are subject to certain restrictions because of their proximity to or trading relationships Start Printed Page 14094with rinderpest or FMD-affected regions.

Risk Evaluation

Drawing on data submitted by the Government of the Republic of Korea and on observations from our site visit to the country, we have evaluated the animal health status of the Republic of Korea relative to FMD and rinderpest. Our evaluation was conducted according to the 11 factors identified in § 92.2, “Application for recognition of the animal health status of a region,” which are used to determine the level of risk associated with importing animals or animal products into the United States from a given region. A summary evaluation of each factor is discussed below.

Veterinary Authority and Infrastructure

All regulations related to the control of FMD in the Republic of Korea are based on that country's Act on the Prevention of Contagious Animal Diseases. These regulations address disease control and preventive measures, including notification of suspicious cases, stamping-out, movement controls, disinfection, vaccination, surveillance, importation quarantine, disposal, and compensation. Governmental veterinary services responsible for implementing these measures consist of the Animal Health Division of the Republic of Korea Ministry for Food, Agriculture, Forestry and Fisheries (MiFAFF), National Veterinary Research and Quarantine Service (NVRQS), and Provincial Veterinary Services. NVRQS is an executive agency within MiFAFF tasked with the prevention and control of major animal diseases. NVRQS responsibilities include quarantine inspection of animals and animal products, livestock product safety, veterinary research, and epidemiological surveillance.

Each of the Republic of Korea's nine provinces and seven metropolitan cities has its own animal health laboratory and veterinary service responsible for the prevention and control of major animal diseases within their region. They are also the primary diagnostic laboratories for animal diseases.

Animal health officials in the Republic of Korea have the legal authority to enforce all pertinent regulations pertaining to FMD and maintain the necessary veterinary infrastructure to carry out effective FMD surveillance and control activities. Governmental veterinary authorities, industry and trade organizations, and non-profit groups work together closely and effectively to monitor livestock health. These efforts minimize the risk of FMD and rinderpest to livestock in the United States via importation of ruminants and ruminant products from the Republic of Korea.

Disease Status in the Region

The Republic of Korea was free of FMD from 1934 until March 2000, when the disease was detected on a small dairy farm in Kyonggi Province. Control measures on the affected farm began immediately. Extensive disease surveillance was undertaken and by mid-April the full extent of the outbreak was confirmed on 11 additional farms. Two of these farms were also in Kyonggi Province, eight were in Chungnam Province, and one was in Chungbuk Province, 140 km southwest of the first infected farm.

Protection zones with a radius of 10 km were set up around each infected farm. Within these zones, animal movements were restricted and livestock markets and artificial insemination were suspended. In addition, a 20-km surveillance zone was set up around the infected farms. In both protection and surveillance zones, veterinary authorities immediately implemented testing, vaccination, and surveillance. Epidemiologically linked farms outside the zones were also investigated and tested. All animals found to be infected were cattle, with no evidence of infection in pigs. Although the last infected herd was identified in April 2000, testing for FMD continued through July. In all, a total of 17,831 animals on 4,782 farms were tested during the outbreak. Both cattle and swine were vaccinated and all vaccinated animals were permanently marked and subject to additional testing and clinical examination.

In May 2002, Korean veterinary authorities again confirmed the presence of FMD, this time on pig farms in Kyonggi and Chungbuk Provinces. Governmental veterinary authorities immediately implemented emergency animal disease control and eradication measures. FMD was found on 16 farms in May and June 2002. Two of these farms had mixed populations of animals, but infection could only be demonstrated in the swine. Control zones were immediately established around the infected farms, and an immediate stamping-out policy was implemented with movement controls, quarantine, and culling of affected animals. The last control zone was lifted in August 2002.

In June 2002, the Republic of Korea invited an International Epidemiology Assessment Team consisting of members from Australia, New Zealand, and the United States to assess its FMD control measures. The team determined that stamping-out and movement restrictions were effective in containing the spread of disease, as was the use of pen-side diagnostic tests for rapid detection of infected animals. They concluded that the capability for early diagnosis together with prompt stamping-out of infected farms significantly limited the number of FMD cases. No evidence exists of any species infected with FMD in the Republic of Korea.

Disease Status of Adjacent Regions and Separation Measures

The Republic of Korea shares its northern border with the Democratic People's Republic of Korea (North Korea). The two countries are separated by the 2.5 mile wide fenced and patrolled demilitarized zone (DMZ) that runs the full length of the border, making intentional or inadvertent entry of animals from North Korea unlikely. FMD must be considered to be endemic in North Korea, which has sporadically reported outbreaks to the World Organization for Animal Health (OIE) as recently as 2007. No commerce in livestock takes place by land between the Republic of Korea and North Korea.

Other close neighbors of the Republic of Korea are China and Japan. The Republic of Korea is separated from these countries by the Yellow Sea and the Sea of Japan. The last reported outbreak of FMD in Japan occurred in March and April 2000. China has reported FMD outbreaks to OIE on a nearly annual basis, but no evidence exists that FMD has been transported into the Republic of Korea from China or other surrounding regions since increased biosecurity and other disease control measures were instituted after the 2000 and 2002 outbreaks.

Disease Control Programs

The Republic of Korea does not currently maintain an active disease control program as there is no evidence of FMD in the country and no outbreaks have occurred since 2002. However, the Republic of Korea has in place a comprehensive surveillance system with both active (seroepidemiologic) and passive (clinical) components. In addition to surveillance, the Korean Government has instituted animal movement controls, border inspection, disinfection, and emergency plans to prevent the incursion of FMD into the country.

To promote reporting of possible disease outbreaks, the Republic of Korea has developed an indemnification Start Printed Page 14095program encouraging farmers to report suspect cases and to deter movement of sick animals to slaughter or auction. The Republic of Korea also provides temporary subsistence funding as needed, and livestock cooperatives provide low interest loans and assistance with feed and management. An emergency hotline is available to encourage reporting of suspicious cases, as is a quarantine hotline to receive emergency reports from ports of entry. The Republic of Korea imposes sanctions to discourage delays in reporting suspect cases and provides rewards for third-person reporting of suspect cases as an incentive for early disease identification.

The Republic of Korea also levies penalties for cases of negligence related to disease reporting. Penalties include imprisonment for veterinarians or farmers failing to report sick or dead animals, importation of prohibited items, or failure to submit goods to quarantine inspection. Livestock owners or transporters who violate rules related to disease reporting and prevention face imprisonment or fines. Fines can also be levied on any person who refuses, obstructs, or evades an epidemiological investigation, violates animal import requirements, or evades quarantine inspections of mailed goods.

As part of its FMD disease prevention efforts, the Republic of Korea has also incorporated provisions governing garbage control and swill feeding. By law, swill or garbage is prohibited for use in animal feed. Because of the predominance of small farms, the Republic of Korea's training, education, and outreach efforts to increase awareness have targeted small-scale farmers. Disease education programs are organized through various agricultural cooperatives that provide contact and information for all farmers.

The Republic of Korea has an effective system for detecting and investigating suspect FMD cases. Frequent monitoring of animal premises and movements permits effective surveillance and virus detection in various FMD-susceptible species, and incentive programs encourage reporting of suspected cases. These efforts effectively minimize the risk of exposing livestock in the United States to FMD through importation of Korean cattle, beef, and related products.

Vaccination Status of the Region

Vaccination for FMD has not been practiced in the Republic of Korea since August 2000. During the 2002 FMD outbreak, which affected primarily swine, NVRQS decided not to vaccinate. The International Epidemiology Assessment Team reviewed this decision and concluded that, under the circumstances of the outbreak, vaccination would not have been advantageous. The time required to achieve immunity with vaccination in pigs takes several weeks and it was considered that many farms would already have been infected when the disease was first recognized; a program of emergency vaccination would have masked the presence of the virus and delayed eradication efforts.

The Republic of Korea's current policy of not vaccinating for FMD is scientifically sound and can help speed the identification of clinical signs if an FMD outbreak occurs again. The Republic of Korea has strong disincentives for non-reporting of suspected cases, maintains a generous indemnity program, and enforces supporting animal health regulations, making it likely that clinical signs of FMD would be reported promptly.

The Republic of Korea does not produce FMD vaccines but actively maintains a vaccine reserve, with plans for implementing emergency vaccinations if needed.

Animal Movement Controls and Biosecurity

Border controls are administered by the NVRQS and Customs, Immigration and Quarantine. Livestock and livestock products may enter the country legally at officially designated airports and maritime ports where they are inspected by animal quarantine officers. Importation of cloven-hoofed live animals, their meat, meat products, or milk from countries or via areas affected with FMD is prohibited. Importation of live cloven-hoofed animals from FMD-free countries requires prior notification and submission of a health certificate, and all are inspected and quarantined for a minimum of 15 days in the quarantine facilities of the NVRQS. Importation of genetic material requires certification from the exporting country that the material originated from countries without FMD or rinderpest and that these diseases have not been reported in the exporting country. Other movement requirements include the treatment of international garbage prior to incineration by a licensed company and the treatment of imported hay for feed or bedding.

Inspection of non-commercial items is focused on passengers, cargo, and mail arriving from regions or countries considered to be high-risk. Detector dogs are used to inspect cargo and mail at major international ports; confiscated items are bagged, disinfected, and incinerated. At ports of entry, disinfecting foot mats are placed at passenger disembarkation gates, and electronic message boards and posters with information on FMD in several languages are set up at passenger gates and at customs.

Movement of animals within the Republic of Korea primarily takes place through local livestock cooperatives. The Agricultural Cooperatives Act calls for these cooperatives to work closely with local veterinary authorities to monitor movements of animals and products. A national animal identification database, piloted by the national veterinary authorities, focuses on improved recordkeeping for small farms and will address movement control of animals from these farms. Farmers are required to keep track of all transactions of livestock sales and purchases, certificates of testing, and vaccination history for program diseases prior to movement. Movement certificates are required for all trade and are issued by the provincial veterinary services.

Livestock Demographics and Marketing Practices

The Republic of Korea produces less than 50 percent of the beef it consumes; in 2006, total beef consumption was 331,000 tons, of which 179,000 tons were imported. The country's cattle population is approximately 2.6 million. Low-density cattle production is predominant in the Republic of Korea, with more than 80 percent of farmers owning fewer than 10 animals. Other farmed FMD-susceptible species are found in very small numbers.

Beef cattle raised in the Republic of Korea consist primarily of traditional Korean native cattle, or Hanwoo, with a current national herd of around 2 million head. The most likely product to be exported to the United States would be specialized product, specifically the Hanwoo beef produced from Korean native cattle. Biosecurity measures and controls at Korean beef production facilities are effective in preventing FMD outbreaks, and commercial cattle operations do not constitute a significant risk for introducing FMD into the United States.

Disease Surveillance Capability

The Republic of Korea conducts extensive active and passive disease surveillance of livestock. Active surveillance incorporates statistical and purposive (targeted) sampling; passive surveillance includes reporting and followup of suspect cases. Intensive followup of suspicious samples is conducted in conjunction with Start Printed Page 14096confirmatory testing, quarantine, and other necessary controls.

Following the 2000 FMD outbreak, the Republic of Korea expanded its active surveillance program. As part of this effort, clinical surveillance teams were organized to make periodic farm visits and examine all livestock on the premises. The Republic of Korea also conducts serological surveillance, which includes collecting statistically selected samples as well as samples from targeted populations. The active surveillance system also involves slaughterhouse and breeding farm surveillance and the use of a pen-side test for rapid detection of FMD-infected animals during an outbreak. Passive surveillance is done for all clinical suspects reported by farmers, veterinarians, or other animal health officials. All reports are investigated by the provincial veterinary services, and samples are collected for any suspicious cases.

Diagnostic Laboratory Capability

The Republic of Korea maintains a central national laboratory and laboratories in each province as part of the National FMD surveillance program. The Republic of Korea has the diagnostic capabilities to adequately test samples for the presence of the FMD virus with adequate quality control activities, laboratory equipment, and sufficient staffing.

Emergency Response Capability

The Republic of Korea has emergency response plans in place for controlling FMD should an outbreak of the disease occur. FMD emergency control guidelines describe standard operating procedures to be used during an FMD emergency. Contingency exercises are held annually to evaluate staff performance and update procedures as needed. In the event of an FMD outbreak, several governmental agencies are tasked with implementing a coordinated emergency response that includes epidemiological investigations, vaccine distribution, disinfection, movement restrictions, stamping-out operations, and public awareness and guidance.

The above findings are detailed in the evaluation document that may be obtained by contacting the person listed under FOR FURTHER INFORMATION CONTACT. The document may also be viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov). It explains the factors that have led us to conclude that the Republic of Korea is free of rinderpest and FMD. It also establishes that the Republic of Korea has adequate veterinary infrastructures in place to prevent, control, and manage FMD and rinderpest outbreaks. Therefore, we are proposing to recognize the Republic of Korea as free of rinderpest and FMD and add the country to the list in § 94.1(a)(2) of regions that are considered free of rinderpest and FMD.

This proposed action would also relieve certain restrictions due to FMD and rinderpest on the importation into the United States of certain live animals and animal products from the Republic of Korea. However, because the Republic of Korea imports meat from regions that APHIS does not consider to be FMD free and from regions where FMD status has not been reviewed, the importation of meat and other products from ruminants into the United States from the Republic of Korea would continue to be subject to certain restrictions. For this reason, we are proposing to add the Republic of Korea to the list in § 94.11(a) of regions declared free of rinderpest and FMD but that are subject to special restrictions on the importation of their meat and other animal products into the United States. The regions listed in § 94.11(a) are subject to these special restrictions because they: (1) Supplement their national meat supply by importing fresh (chilled or frozen) meat of ruminants or swine from regions that are designated in § 94.1(a) as 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.

Under § 94.11, meat and other animal products of ruminants and swine, including ship stores, airplane meals, and baggage containing these meat or animal products, may not be imported into the United States except in accordance with § 94.11 and the applicable requirements of the USDA's Food Safety and Inspection Service at 9 CFR chapter III.

Section 94.11 generally requires that the meat and other animal products of ruminants and swine be: (1) 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) accompanied by an additional certificate, issued by a full-time salaried veterinary official of the national government of 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, transported through, or that have otherwise been in a region where rinderpest or FMD exists.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA) requires the agency to prepare and make available for public comment an initial regulatory flexibility analysis that will describe the impact of the proposed rule on small entities. In lieu of preparing a regulatory flexibility analysis, section 605 of the RFA allows an agency to certify that the proposed rulemaking will not have a significant economic impact on a substantial number of small entities. The following is a factual basis for certification of this rule.

The proposed rule would amend the regulations to add the Republic of Korea to the list of regions considered to be free of rinderpest and FMD. The proposed action, which was requested by the Republic of Korea, follows a risk assessment conducted by APHIS concluding that the Republic of Korea is free of both diseases and has the veterinary infrastructure in place to detect and effectively eradicate the diseases if necessary. The effect of the rule would be to remove certain rinderpest and FMD-related prohibitions and restrictions on the importation into the United States of ruminants, or fresh (chilled or frozen) meat or other products of ruminants, from the Republic of Korea. APHIS imposes such restrictions because an FMD or rinderpest outbreak in the United States has the potential for severe economic consequences. Even though imports of swine and swine products would be allowed under APHIS' regulations related to FMD and rinderpest, those commodities would not be eligible for import from the Republic of Korea, due to USDA regulations designed to prevent the introduction of diseases other than FMD and rinderpest.[2]

We do not anticipate that changing the FMD and rinderpest status of the Republic of Korea would have a significant economic impact on a Start Printed Page 14097substantial number of U.S. entities, large or small, because the volume of currently prohibited/restricted animals and animal products imported into the United States from the Republic of Korea is likely to be very small relative to overall U.S. supply of those commodities (production and net imports from all foreign sources). There are several reasons for this. First, the volume of U.S. imports from the Republic of Korea prior to March 20, 2000, when that country was considered to be free of FMD and rinderpest, was negligible.[3] During the 3-year period from 1997 to 1999, the United States did not import any reportable amounts of ruminants or fresh (chilled or frozen) meat or other products of ruminants from the Republic of Korea, other than 1.3 metric tons of dairy products in 1998.

Second, the Republic of Korea produces less beef, milk, and pork than it consumes, and is therefore a net importer of these commodities. Given this fact, there would not be a significant volume of exports of those commodities to the United States.

Finally, APHIS' staff expects that Hanwoo beef, a premium-priced specialty meat produced from Korean native cattle, is likely to be the Republic of Korea's primary export to the United States if the proposed rule becomes effective. Because of its premium price, the market for Hanwoo beef would be limited; it is likely to be sold to a niche market, such as Korean restaurants in the United States.

Importers, brokers, and others that would import Hanwoo beef, and restaurants that would serve that product, are the U.S. entities most likely to be affected by the rule. They stand to benefit from the increased business activity. The number of these entities is unknown but it is likely to be very small, given the expected limited market for Hanwoo beef in the United States. The size of these entities is also unknown, although it is reasonable to assume that, as with U.S. businesses in general, most are small under the standards of the U.S. Small Business Administration. The proposed action should have no noticeable effect on U.S. beef producers, given the expected limited demand for Hanwoo beef.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

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.

Paperwork Reduction Act

This proposed rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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List of Subjects in 9 CFR Part 94

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Accordingly, we propose to amend 9 CFR part 94 as follows:

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PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

1. The authority citation for part 94 continues to read as follows:

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Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

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[Amended]

2. In § 94.1, paragraph (a)(2) is amended by adding the words “Republic of Korea,” after the word “Japan,”.

[Amended]

3. In § 94.11, paragraph (a) is amended by adding the words “Republic of Korea,” after the word “Japan,”.

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Done in Washington, DC, this 25th day of March 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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Footnotes

1.  APHIS Evaluation of the Status of the Republic of Korea Regarding Foot-and-Mouth Disease and Rinderpest. Riverdale, MD: USDA, APHIS, Veterinary Services, October 2008.

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2.  APHIS' risk evaluation states that the animal health status of swine for diseases other than FMD has not been evaluated. In the absence of a favorable evaluation, live swine and swine-derived products will not be eligible to be imported from the Republic of Korea, even with the proposed changes in effect.

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3.  Effective March 20, 2000, APHIS removed the Republic of Korea from the list of regions considered to be free of both rinderpest and FMD.

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[FR Doc. E9-7013 Filed 3-27-09; 8:45 am]

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