03-28389. Classical Swine Fever Status of Chile

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations for importing animals and animal products by adding Chile to the list of regions we recognize as free of classical swine fever (CSF). We are proposing this action at the request of the Government of Chile and after conducting a risk evaluation that indicates that Chile is free of this disease. We are also proposing to add Chile to a list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF, and to amend those requirements to accommodate the addition of Chile to the list. These actions would relieve restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Chile while continuing to protect against the introduction of this disease into the United States.

DATES:

We will consider all comments that we receive on or before January 12, 2004.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 03-009-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 03-009-1. If you use e-mail, address your comment to [e-mail]. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 03-009-1” on the subject line.

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 [phone] before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Charisse Cleare, Senior Staff Veterinarian, Regionalization Evaluation Services Staff, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; [phone].

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation into the United States of specified animals and animal products in order to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease, African swine fever, classical swine fever (CSF), and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.9 of the regulations restricts the importation into the United States of pork and pork products from regions where CSF is known to exist. Section 94.10 of the regulations prohibits, with certain exceptions, the importation of swine that originate in or are shipped from or transit any region in which CSF is known to exist. Sections 94.9 and 94.10 provide that CSF exists in all regions of the world except for certain regions listed in those sections.

The Government of Chile requested that the Animal and Plant Health Inspection Service (APHIS) evaluate Chile's animal disease status with respect to CSF and provided information in support of that request in accordance with 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.” Using information submitted to us by the Government of Chile, as well as information gathered during a site visit by APHIS staff to Chile in 2002, we have reviewed and analyzed the animal health status of Chile with respect to CSF. Based on the information submitted to us and the information we gathered, we have concluded the following:

Risk Evaluation

Veterinary Infrastructure

Animal disease control and eradication programs in Chile operate under the authority of the Agricultural and Livestock Service (Servicio Agricola y Ganadero, SAG). SAG is organized into three levels: A central branch in Santiago, the capital of Chile; the regional organization, distributed across each of Chile's 13 regions; and an operative level within each region.

Animal health activities in Chile are conducted under the authority of the Animal Sanitation Law (DFLRRA No. 16, 1963). This law provides adequate authority for import controls, movement controls within Chile, animal quarantine, requiring reporting of animal diseases, disease control measures, seizure and depopulation, cleaning and disinfection, Chilean Federal government access to animals and premises, and enforcement of Chilean Federal laws and regulations.

Within SAG, the Livestock Protection Department (Departamento de Proteccion Pecuaria, DPP) manages animal health programs, including border port control, animal health laboratories, and animal quarantine centers. The DPP director serves as the chief veterinary officer of SAG.

Chile is divided from north to south into 13 regions identified as Regions I to XII and the Metropolitan Region (Region RM), which is located between Regions V and VI and includes Santiago. Regional directors are responsible for delivery of SAG programs within their regions. Each regional livestock veterinarian-in-charge reports to the Ministry of Agriculture's regional director and to the DPP headquarters. Animal health functions performed at the regional level include animal health support to slaughter plants and facilities that store meat for export; management of the Program for Certification of Herds under Official Control (Planteles Bajo Control Oficial, PABCO); surveillance for swine, poultry, and ruminant diseases; disease eradication; and international port activity. Regions are subdivided into sections, of which there are a total of 62.

PABCO is a voluntary program managed by the Livestock Projects Sub-Department of DPP. However, only animals and animal products from livestock production facilities that operate under PABCO and comply with program standards are certified for export and interregional trade. The program is supervised by regional and section veterinary medical officers (VMOs) and is carried out by accredited veterinarians on the farms. The accredited veterinarians maintain records on animal production and health for each farm.

Slaughterhouses and processing plants used before export must also be approved and must operate under animal and public health inspection programs for diseases and residue monitoring. Sanitary controls (ante- and post-mortem) in slaughterhouses are directly supervised by the Ministry of Health. DPP section personnel working alongside Ministry of Health veterinarians manage quality controls for animal health and public health. Ministry of Health personnel are required to report any suspicious case of disease to the SAG section VMO, who must investigate within 24 hours of such a report.

Our evaluation indicated that animal health officials in Chile have the legal authority to enforce their Federal regulations regarding CSF and that the necessary veterinary infrastructure is in place to carry out CSF surveillance and control activities.

Disease History and Surveillance

The two most recent diagnoses of CSF in Chile occurred in May 1995 and July 1996. One of the premises that was affected in the May 1995 outbreak was the only premises found to be affected in the July 1996 outbreak. In the outbreaks, the affected premises were family farm operations that raised swine for self-consumption. All of the premises were located more than 1,000 kilometers from commercial swine production areas.

In 1995, SAG instituted sanitary controls to address the outbreak, including quarantine of the premises, slaughter of affected swine, ring vaccination of the remainder of each herd, and surveillance of the premises until November 1995. In response to the 1996 outbreak, SAG instituted quarantine and depopulation of all the swine, disinfection, and surveillance of the premises until December 1996.

In 1998, Chile conducted an enzyme-linked immunosorbent assay (ELISA) survey of 2,551 Chilean fattener swine for CSF and obtained negative results. The swine surveyed represented 7 of the 13 regions. The statistical plan considered a prevalence of 0.5 percent with a confidence level of 99 percent. From 2000 to 2001, ELISA testing was performed on swine from 321 family farms and from all 13 regions. The number of samples totaled 1,705. There was one positive result from an aged sow with no CSF clinical symptoms. The sow was from a previously affected area in Region II. This positive result was due to previous vaccination, as discussed below. For 2002, surveillance was performed using ELISA and immunofluorescence methods of detection. Tests were ordered due to monitoring activities and disease surveillance. All results were negative. Chile has also performed CSF surveillance at slaughterhouses nationwide.

CSF has never been detected in wild boar in Chile. Although the country does not have a surveillance program for wild boar, Chile has identified breeding operations whose swine originated from wild boar. Such operations are under official monitoring and control by the Department of Natural Resources (not SAG). Chile is conducting surveillance at these facilities because the animals were originally wild, even though they may have been in captivity for several generations.

By December 2002, SAG had tested 127 blood samples that were collected from 10 breeding operations with swine that originated from wild boar. Samples representing a 25 percent sampling (10 of 40 herds) were tested for CSF using ELISA and yielded negative results. However, as of December 2002, sampling had not been performed on free-ranging wild boar. SAG is designing a study to survey domestic swine that are located closest to the foothills of the areas where the wild boars reside.

There are few commercial swine operations in those regions of Chile where concentrations of wild boars are present; rather, family farms are usually prevalent in such regions. There is no evidence of CSF in the wild boar population and no evidence that domestic swine have contracted CSF from wild boars. Even if CSF was present in the wild boar population, it is unlikely that CSF would be transmitted from wild boar to commercial swine facilities because of the biosecurity measures in place at those facilities. In addition, the mountainous habitat of the wild boars and the areas of Chile devoted to domestic swine production are separated by forests, which the wild boars do not enter because there is no food for them in the forests.

Diagnostic Capabilities

The official diagnostic laboratory of SAG in Santiago does not isolate the causative agent for CSF because the biosecurity level of the laboratory is not sufficient to allow use of live CSF virus, which is necessary to confirm a diagnosis of CSF. Chile uses the Centro de Investigación en Sanidad Animal—Instituto Nacional de Investigación y Tecnologia Agraría y Alimentaria (Animal Health Research Center—National Institute for Food and Agriculture Technology and Research), which is located in Spain, as its reference laboratory when the presence of CSF virus must be confirmed. The turnaround time for results to be reported from Spain is 2 weeks.

In addition, SAG's official diagnostic laboratory accumulates samples to be tested for CSF with ELISA until it has 100 samples—enough to run an entire ELISA plate. As a result, the laboratory does not perform this test on samples as soon as they arrive.

APHIS does not consider the limitations of the laboratory a major risk factor because control procedures that would halt the spread of a possible CSF outbreak are in place. Chile has a document entitled “Contingency Manual for Classical Swine Fever” that prescribes response procedures when CSF is detected. In the event of a suspect CSF case, the official veterinarian of SAG would place the premises and animals under a prediagnostic quarantine until diagnostic results from SAG's official diagnostic laboratory are received. During the prediagnostic quarantine, necropsies would be performed and blood and organ samples would be taken for testing. SAG officials stated that its VMOs can make a preliminary diagnosis of CSF based on clinical evidence within 24 hours and that SAG has the legal authority to impose a quarantine based on this diagnosis, which provides sufficient precautions to contain the spread of CSF if it is present. The prediagnostic quarantine can prohibit the movement of susceptible animals from the premises to other farms, fairs, or slaughterhouses, except those with a high biosecurity level. If there are no clinical signs of disease in other animals that have been placed under prediagnostic quarantine, those animals are moved to a municipal slaughterhouse, not an export slaughterhouse. These slaughterhouses have adequate veterinary inspection and biosecurity procedures.

The prediagnostic quarantine remains in place until the results of the preliminary diagnostic tests from SAG's official diagnostic laboratory are available. Chile indicates that the most probable time to detect clinical signs compatible with CSF, deliver samples to the domestic diagnostic laboratory, and confirm the clinical diagnosis with the preliminary tests would be 5 days, although this process could be accomplished in as little as 3 days. Samples are delivered to the laboratory on the same day they are collected from all areas of Chile. Trading partners would be alerted immediately after confirmation of CSF by SAG.

Vaccination Status

Vaccination for CSF has been prohibited in Chile since October 6, 1997. On certain farms, there are still some vaccinated sows that show positive antibody titers and false-positive results during surveillance activities.

Disease Status of Adjacent Regions

APHIS considers Peru, Bolivia, and Argentina to be affected with CSF. Peru had outbreaks of CSF in 2002, and continued to have outbreaks in 2003. The last CSF outbreaks in Argentina and Bolivia occurred in 1999; no subsequent cases of CSF had been identified in Argentina or Bolivia by the Office International des Epizooties (OIE) as of August 2003.

Degree of Separation From Adjacent Regions

Chile is separated from Peru by an area of desert and from Bolivia and Argentina by the Andes Mountains. On the west, Chile is bounded by the Pacific Ocean.

Movement Controls and Biological Security

Import Controls

Chile allows the importation of processed meat products, including raw processed or fresh raw delicatessen products, raw matured or acidified processed products, and long cure/maturation products. Long cure/maturation products are defined by SAG as hams that undergo salt curing and maturation for at least 8 months. Chile also imports processed cooked meat products and cooked sausages. The countries from which these products are exported to Chile must be officially pronounced free of African swine fever (ASF), bovine fever, CSF, foot-and-mouth disease (FMD), swine vesicular disease (SVD), and Teschen's disease by the OIE, as stated in SAG's resolution regarding the importation of these products. Countries that are not recognized as free of the listed diseases as a whole but that contain regions recognized by Chile as free of the listed diseases may only export products of long cure/maturation and processed cooked meat or cooked sausages. For these countries, the animals from which the meat products are derived must come from regions free of the diseases, as evaluated and recognized by SAG. In addition, the abattoir and processing plants in which the swine from which these products are derived are slaughtered and processed must be located in regions free of these diseases. Countries that cannot fulfill the listed requirements may only export processed cooked meat or cooked sausages to Chile. All of the above products must be accompanied by an official health certificate issued by the animal health protection organization of the government of the country of origin.

As noted, long cure/maturation products must undergo salt curing and maturation for at least 8 months to be eligible for importation into Chile. These products include Serrano ham, Spanish-style ham, Iberian ham, Parma ham, and others. Also, as noted above, these products may be imported into Chile from regions recognized by Chile as free of the listed diseases, even if the country in which the disease-free region is located is not recognized as disease-free as a whole by Chile, if the requirements previously stated are met.

However, Chile's requirement for the length of curing and maturation is not as long as APHIS” for some of these products. At this time, APHIS considers Spain and certain regions in Italy to be affected with CSF. As a result, Iberian and Italian hams from affected regions must meet the requirements in § 94.17 to be eligible for importation into the United States. Section 94.17 requires, among other things, that Italian-type hams intended for export to the United States from CSF-affected regions be placed in a chamber for curing for a minimum of 314 days—substantially longer than Chile's 8-month requirement for Italian and Iberian hams. Iberian hams intended for export to the United States from CSF-affected regions must, under § 94.17, undergo a 365-day minimum curing process. The curing periods required by APHIS to prevent the introduction of CSF into the United States by long cure/maturation products from regions considered by the United States to be affected with CSF are thus longer than those required by Chile for the importation into Chile of such products from regions in a country considered by Chile to be affected with CSF. If Chile were to import long cure/maturation products from regions considered by the United States to be affected with CSF and then export those products to the United States, there would be a risk that CSF could be introduced into the United States via those products.

In addition to the requirements for long cure/maturation products, Chile has cooking requirements for processed cooked meat and cooked sausages intended for importation into Chile from regions recognized by Chile as free of the listed diseases if the country in which the disease-free region is located is not recognized as disease-free as a whole by Chile. The required cooking temperature is 68 oC for 30 minutes. With regard to the importation of these products into the United States, however, § 94.9 prescribes that pork and pork products from regions where CSF exists may be imported into the United States only if all bones were completely removed prior to cooking and the pork or pork product was heated by some method other than a flash-heating method to an internal temperature of 69 oC throughout. Thus, if Chile were to import processed cooked meat and cooked sausages from regions the United States considers to be affected with CSF and then export those products to the United States, there would be a risk that CSF could be introduced into the United States via those products.

Accordingly, we are proposing to require that Chilean pork and pork products imported into the United States be accompanied by certification regarding their origin. The certification would have to identify the exporting region and the region of origin of the pork or pork products as a region designated in §§ 94.9 and 94.10 as free of CSF at the time the pork or pork products were in the region. The certification would also have to state that:

• The pork or pork products were derived from swine that were born and raised in a region designated in §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations of the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service in 9 CFR 327.2;
• The pork or pork products were derived from swine that have not lived in a region that is designated in § 94.9 or § 94.10 as affected with CSF;
• The pork or pork products have never been commingled with pork or pork products that have been in a region that is designated in §§ 94.9 and 94.10 as affected with CSF;
• The pork or pork products have not transited a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
• If processed, the pork or pork product was processed in a region designated in §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region.

Chile imports live swine primarily for use as breeding animals. Reports provided by the Government of Chile showed that live swine were imported in 1998 from France; in 1999 from Belgium and the United States; in 2000 from Canada, France, and the United States; and in 2001 until November 2002 from Canada. The number of shipments per year has ranged from 12 to 177.

Swine for importation into Chile must originate from regions pronounced free of ASF, bovine fever, CSF, SVD, Teschen's disease, and vesicular stomatitis by the OIE and must also be recognized by Chile as free of these diseases, as stated in SAG's resolution regarding the importation of live swine for reproduction. The region of origin must also be pronounced free of FMD without vaccination by OIE, as stated in SAG's resolution, and also be recognized as such by Chile. The farm of origin must, among other things, be free of brucellosis, tuberculosis, transmissible gastroenteritis, corona respiratory virus, swine epidemic diarrhea, and pseudorabies without vaccination. In addition, the animals must be accompanied by an official health certificate. Similar controls exist for the importation of porcine semen.

Live swine imported into Chile enter privately owned quarantine facilities. When operating, these facilities are under the supervision of the SAG section VMO. Private quarantine facilities must be authorized by SAG prior to use and must be inspected prior to each use. Site visit team members confirmed that the facilities consistently employ effective biological safeguards.

However, Chile has imported live swine from France. At this time, France is not recognized by the United States as CSF-free. Accordingly, we are proposing that swine exported from Chile must be accompanied by the following certification regarding the origin of the swine:

• The swine have not lived in a region designated in §§ 94.9 and 94.10 as affected with CSF;
• The swine have never been commingled with swine that have been in a region designated in §§ 94.9 and 94.10 as affected with CSF; and
• The swine have not transited a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination.

Export Controls

All physical inspection of meat destined for export from Chile takes place at export slaughter facilities. A public health veterinarian and a SAG veterinarian are present. The SAG veterinarian watches the meat being loaded and crated for export. Official SAG seals are placed on the crates by the SAG veterinarian. Shipments are also accompanied by sanitary health certificates. As noted earlier, export slaughter facilities only accept swine from farms participating in the PABCO program. Family farm swine are taken to municipal slaughter facilities or are slaughtered at the farm. Meat from swine slaughtered at these municipal facilities is for national consumption and not for export.

Swine for export are inspected by the SAG section VMO at the farm of origin when they are loaded on the truck. They cannot be inspected at the airport because there is not a containment area.

Movement Across Borders

There are 76 border control points in Chile: 13 airports, 24 seaports, and 39 land crossings.

Since 2001, all live swine imported into Chile have entered through the Santiago airport. Other commercial animal or animal product shipments entering the Santiago airport include semen, horses, vaccines, embryos, chicks, and fertile eggs. Almost no meat arrives through the Santiago airport.

Passengers arriving on commercial flights are asked to declare whether they are carrying plant or animal products. Amnesty bins are available throughout the airport to allow passengers to dispose of prohibited materials before they enter Customs. When fresh fruit or meat that is not processed according to specifications is discovered in the baggage of passengers arriving from areas that SAG considers to be high risk, the fruit or meat is confiscated and destroyed. SAG has two beagles in Santiago that are used to inspect baggage from high-risk commercial flights. At the time of the site visit, Santiago was the only international airport in Chile that used the beagles.

In addition to using beagles, passenger luggage from high-risk flights entering the Santiago airport is x-rayed before leaving the airport, using x-ray machines specifically designed to detect organic material. Passenger luggage is opened for inspection if agricultural products are suspected to be present. Not every airport has x-ray machines; at other airports, physical inspections of high-risk luggage are performed instead. (SAG considers fruits from Bolivia, Colombia, and Peru and fresh or inadequately processed meat from Argentina, Bolivia, the European Union, and Peru to be high-risk commodities.)

Food waste containing animal products from commercial flights is collected and heat treated until any CSF virus that might be present would be destroyed. This function is carried out by commercial enterprises. In Santiago, SAG representatives meet private planes and perform inspections.

Passenger traffic also arrives in Chile on cruise ships. Passengers are advised not to disembark with agricultural products. SAG operates a quarantine area near the ships to process disembarking passengers and inspect their luggage. Fruit or meat products that are confiscated are destroyed by SAG. Food wastes are prohibited from being offloaded from the ship and must be disposed of in the sea at least 12 miles from shore. Ships carrying fresh fruit are prohibited from discharging garbage at port.

At land border crossings, every car, bus, and truck is stopped. All cars are searched thoroughly by checking the passenger compartment, the trunk, under the seats, and the glove compartment. All luggage is opened and inspected by Customs and SAG personnel. All fruits, vegetables, meat, and honey found in cars and buses are confiscated and destroyed. Animals (e.g., birds) without the appropriate supporting paperwork may also be confiscated. Inspection personnel reside on-site at the inspection stations.

Empty live-haul trucks, which are used to carry livestock, are allowed to move from Argentina and other potentially CSF-affected regions into Chile without thorough cleaning and disinfection. Chile indicated that, in Region V (the region with the largest volume of traffic crossing the Argentine border), any empty vehicle that enters Chile and was used to transport cargo must be cleaned and washed. SAG inspectors verify the condition of the vehicle by visual inspection. If the cleanliness of the vehicle is not satisfactory to the inspectors, the vehicle is turned back. Similar controls are also applied at other land border crossings.

This practice concerns us in view of the role of contaminated live-haul trucks in the serious CSF outbreaks that occurred in the Netherlands in 1997-1998. This severe outbreak was initiated by an empty contaminated live-haul truck that transited from a CSF-affected area in Germany. In fact, the truck had been cleaned and disinfected, but the procedure was not adequate. Without adequate cleaning and disinfection, trucks could introduce CSF from affected regions.

Therefore, to address the risk presented by empty live-haul trucks that enter Chile from Argentina and other potentially CSF-affected regions without thorough cleaning and disinfection, we are proposing that any live swine exported to the United States from Chile would have to be accompanied by certification that the conveyance or materials used to transport the swine, if previously used for transporting swine, had first been cleaned and disinfected in accordance with 9 CFR 93.502. This certification requirement would be in addition to the certifications regarding the origin of live swine discussed previously under the heading “Import Controls.”

Cargo from outside Chile is allowed to transit Chile to seaports such as Valparaiso or San Antonio for shipment to other countries. Currently, however, in-transit cargo must comply with all Chilean regulations, even if the ultimate destination is a different country. The team was informed that this policy may change in the future to accommodate in-transit shipping to the port of Valparaiso. This would require the use of in-bond sanitary and phytosanitary safeguarding procedures.

Livestock Demographics and Marketing Practices

In 1997, Chile had more than 1.7 million swine held by 105,665 swine producers. There were 289 commercial premises, which held 69 percent of all swine in Chile. Commercial swine populations are concentrated in Regions RM and VI. Family farm areas are mostly located in Regions VIII, IX, and X. At the time of the site visit, there were 100 commercial swine operations in Chile, many with multiple premises. Agrosuper is one of the largest commercial operations. While Agrosuper imports its own swine, most facilities purchase any imported swine they use from the Pig Improvement Company (PIC) in Chile. PIC has purchased swine from Belgium, France, and the United States. The number of small family farms has dramatically decreased in the last 5 years, due mostly to companies purchasing the land to plant fruit trees. Another factor in this decline is a law requiring that all swine be slaughtered at a slaughterhouse, rather than on the premises. The owners would have to pay for transportation to the slaughterhouse and for the slaughter of the swine. In addition, swine producers on family farms can no longer simply collect food waste to feed to the swine; processed feed or other feed must be purchased instead, increasing the cost of maintaining the swine.

There are currently no detailed data on the distribution of the population of wild boar known as javelins (Sus scropha). These animals moved into Chile sometime between 1975 and 1978 over the mountains from Argentina. They are mainly located in the southern part of the country, high in the mountains. Their range and the domestic swine production areas are separated by forests. The wild boar normally do not enter these forests because their food is not located there. There are no hunting restrictions for wild boars, and Chileans in the south hunt and eat them. As noted earlier, it is unknown whether the wild boar population is infected with CSF.

Because all swine operations that wish to participate in the interregional and international export markets must operate under the PABCO quality assurance program, the level of compliance with the national government's efforts to maintain Chile's CSF-free status is high.

Detection and Eradication of Disease

CSF has been effectively controlled in and eradicated from Chile in the past and is not known to exist in Chile at this time. The Government of Chile maintains a surveillance system capable of detecting CSF should the disease be reintroduced to the country. The Government of Chile has laws, policies, and infrastructure to detect, respond to, and eliminate any occurrence of CSF.

These findings are described in further detail in a qualitative evaluation that may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT. The evaluation may also be viewed on the Internet at http://www.aphis.usda.gov/​vs/​ncie/​reg-request.html by following the link for “Information previously submitted by Regions requesting export approval and their supporting documentation” and then clicking on the triangle beside “Chile/Swine/Classical Swine Fever” and selecting “Response by APHIS.” The evaluation documents the factors that have led us to conclude that Chile is free of CSF.

Therefore, we are proposing to recognize Chile as free of CSF and to add it to the lists in §§ 94.9 and 94.10 of regions where CSF is not known to exist. We are also proposing to revise § 94.24, which currently contains additional CSF-related certification requirements for four Mexican States that we consider to be free of CSF. Because the proposed certification requirements for Chile described previously in this document are essentially the same as the certification requirements for the four Mexican States presently named in § 94.24, apart from specific references to the national government of the region in question, we are proposing to add a list of regions to which the certification requirements in § 94.24 apply and to amend the certification requirements so that they refer generically to the national government of the region of export of the swine, pork, or pork products.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

Under the regulations in 9 CFR part 94, the importation into the United States of live swine, pork, pork products, and swine semen that originates in or transits any region where CSF exists is generally prohibited, except for certain pork products processed in accordance with the regulations. Furthermore, even if a region is considered free of CSF, the importation of pork and pork products from that region may be restricted, depending on the region's proximity to or trading relationships with countries or regions where CSF exists. CSF is a transmissible animal disease with potentially serious consequences for international trade of animals and animal products.

The Agriculture and Livestock Service of the Government of Chile has asked APHIS to evaluate Chile's CSF status. APHIS conducted a site visit in Chile and, using data from this site visit and data supplied by the Government of Chile, performed a subsequent risk evaluation that indicated that Chile is free of CSF. This proposed rule, therefore, would recognize Chile as free of CSF. However, since Chile shares borders with countries that the United States does not recognize as free of CSF, imports live swine from a country that the United States does not recognize as free of CSF, and imports certain products from countries affected with CSF under conditions that are less restrictive than those in our regulations in 9 CFR part 94, we are also proposing to add certification requirements for live swine, pork, and pork products imported into the United States from Chile to ensure their freedom from CSF.

As described above, in 1997, Chile had 105,665 swine farms on which 1.7 million swine were raised. There were 289 commercial premises, which represented 69 percent of Chile's hog facilities.^[1] In the United States in 2000, on the other hand, there were 98,460 swine producers raising about 59,407,000 swine valued at $4.26 billion.^[2] Chile has never exported live swine to the United States. In 1998, the United States imported from Chile 18 metric tons of frozen swine edible offal (Harmonized Tariff Schedule [HS] code number 020649). No other pork meat or any other pork product has been imported by the United States from Chile since then (table 1).

Frozen and dried pork accounts for 87 percent of all Chilean exports of pork and pork products; the remaining 13 percent consists of either fresh or chilled pork. In 2000, Chile exported 33,900 metric tons of pork. Of this, 30.1 metric tons was cooked pork, which was exported either frozen or dried (table 2). That same year, the United States imported 368,700 metric tons of pork, more than 10 times the total of Chile's pork exports.

On average, between 1998 and 2001, Chile's global exports of live swine amounted to approximately 0.3 percent of the volume of U.S. imports of live swine (tables 3 and 4). Specifically, Chile's global exports of live swine were 0.28 percent of the volume of U.S. imports of live swine in 1998, 0.33 percent in 1999, 0.39 percent in 2000, and 0.32 percent in 2001. Between 1998 and 2001, Chile's exports of pork and pork products to the world was, on average, equivalent to 9 percent of U.S. imports of pork and pork products.

Table 1.—U.S. Imports of Pork and Pork Products

Commodity (by HS 6-digit category)	Origin of U.S. imports	Import volume by year (in metric tons)
		1998	1999	2000	2001
Swine carcasses, fresh or chilled (HS 020311)	World	10,555	11,206	4,542	1,676
Swine carcasses, frozen (HS 020321)	World	68	46	70	39
Swine hams, fresh or chilled (HS 020312)	World	48,976	61,099	76,469	75,482
Swine hams, with bone in (HS 020322)	World	10,023	7,977	5,533	4,470
Swine edible offal, fresh or chilled (HS 020630)	World	10,065	9,499	15,557	20,904
Swine edible offal, except for liver, frozen (HS 020649)	World (except Chile)	4,281	4,437	4,138	4,092
	Chile	18 (0.4%)	0	0	0
Swine livers, frozen (HS 020641)	World	248	98	29	264
Swine hams/shoulders, salted, dried (HS 021011)	World	818	1,555	1,659	1,280
Swine bellies, salted and dried, bacon (HS 021012)	World	10,073	16,673	21,720	19,836
Swine meat, except ham, salted, dried, smoked (HS 021019)	World	3,768	3,440	4,725	6,709
Swine fresh cuts (NES) (HS 020319)	World	87,434	116,325	148,401	163,131
Swine frozen cuts (NES) (HS 020329)	World	60,137	69,625	85,900	80,175
Total quantity		246,464	301,980	368,743	378,058
Source: USDA/Foreign Agricultural Service (FAS) Global Agricultural Trade System using data from the United Nations (UN) Statistical Office.
NES = not elsewhere specified.

Table 2.—Chilean Exports of Pork and Pork Products

Commodity (by HS 6-digit category)	Export volume by year (in metric tons)
	1998	1999	2000	2001
Swine carcasses, fresh or chilled (HS 020311)	4,741	645	21	455
Swine carcasses, frozen (HS 020321)	108	80	6	164
Swine hams, fresh or chilled (HS 020312)	0	146	790	797
Swine hams, with bone in (HS 020322)	661	201	456	5,357
Swine edible offal, fresh or chilled (HS 020630)	3	5	104	103
Swine edible offal, except for liver, frozen (HS 020649)	4,888	5,331	5,677	7,261
Swine livers, frozen (HS 020641)	248	98	29	264
Swine bellies, salted & dried, bacon (HS 021012)	11	3	2	2
Swine fresh cuts (NES) (HS 020319)	0	865	2,638	2,448
Swine frozen cuts (NES) (HS 020329)	7,857	5,587	9,070	17,049
Total quantity	18,517	12,961	18,793	33,900
Source: FAS Global Agricultural Trade System using data from the UN Statistical Office.
NES = not elsewhere specified.

Table 3.—U.S. Imports of Live Swine

Swine (by HS 6-digit category)		1998	1999	2000	2001
Pure-bred (HS-010310) 1	Quantity (swine)	415	594	4,585	22,178
	Value	$70,000	$182,000	$1,117,000	$5,080,000
Non-pure-bred category A (HS-010391) 2	Quantity (metric tons)	20,383	29,978	2,336,048	42,276
	Value	$38,993,000	$51,200,000	$72,285,000	$103,168,000
Non-pure-bred category B (HS-010392) 3	Quantity (metric tons)	318,246	259,024	2,016,931	280,621
	Value	$249,787,000	$175,100,000	$217,977,000	$249,754,000
Total value		$288,850,000	$226,482,000	$291,379,000	$358,002,000
1 Imported from Canada, Denmark, and United Kingdom.
2 Imported from Canada, Denmark, and Australia.
3 Imported from Canada, Denmark, Norway, Australia, and United Kingdom.
Source: FAS Global Agricultural Trade System using data from the UN Statistical Office.

Table 4.—Chilean Exports of Live Swine

Swine (by HS 6-digit category)		1998	1999	2000	2001
Pure-bred (HS-010310)	Quantity (metric tons)	95	unknown	unknown	unknown
	Value	$759,000	$688,000	$1,126,000	$1,132,000
Non-pure-bred category A (HS-010391)	Quantity (metric tons)	0	unknown	0	0
	Value	0	$25,000	0	0
Non-pure-bred category B (HS-010392)	Quantity (metric tons)	30	unknown	0	0
	Value	$44,000	$45,000	0	0
Total value		$803,000	$758,000	$1,126,000	$1,132,000
Source: FAS Global Agricultural Trade System using data from the UN Statistical Office.

Economic Effects on Small Entities

The Regulatory Flexibility Act requires that agencies consider the economic effects of their rules on small entities. Domestic swine producers and processors of pork and pork products, as well as brokers, agents and others in the United States who would become involved in any future importation and sale of swine, pork, and pork products from Chile, are most likely to be directly affected by the proposed change to Chile's CSF status. The number and size of the entities that might become involved in any future importation and sale of swine (or products) from Chile is unknown. However, it is reasonable to assume that most would be small, based on the Small Business Administration's standards, since most businesses are classified as small under those standards.

From an economic standpoint, the proposed change in Chile's CSF status should have little or no effect on domestic entities in the United States. This is because exports from Chile in quantities sufficient to have a significant effect on the U.S. market are unlikely. We do not anticipate that any U.S. entities, small or otherwise, will experience any significant economic effects as a result of this action.

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

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. 03-009-1. Please send a copy of your comments to: (1) Docket No. 03-009-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 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.

This proposed rule would recognize Chile as free of CSF and add certification requirements for live swine, pork, and pork products imported into the United States from Chile to ensure their freedom from CSF.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will 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; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Full-time, salaried veterinary officers, employed by the Government of Chile, who will be completing the certificates necessary to export swine, pork, and pork products to the United States.

Estimated annual number of respondents: 5.

Estimated annual number of responses per respondent: 5.

Estimated annual number of responses: 25.

Estimated total annual burden on respondents: 25 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at [phone].

Government Paperwork Elimination Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS” Information Collection Coordinator, at [phone].

List of Subjects in 9 CFR Part 94

• Animal diseases
• Imports
• Livestock
• Meat and meat products
• Milk
• Poultry and poultry products
• Reporting and recordkeeping requirements

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

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 would continue to read as follows:

Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.4.

§ 94.9

[Amended]

2. In § 94.9, paragraph (a) would be amended by adding the word “Chile;” after the word “Canada;”.

§ 94.10

[Amended]

3. In § 94.10, paragraph (a) would be amended by adding the word “Chile;” after the word “Canada;”.

4. Section 94.24 would be revised to read as follows.

§ 94.24

Restrictions on the importation of live swine, pork, or pork products from certain regions free of classical swine fever.

The regions listed in paragraph (a) of this section are recognized as free of classical swine fever (CSF) in §§ 94.9(a) and 94.10(a) but supplement their pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, supplement their pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of this part, share a common land border with CSF-affected regions, or import live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. Thus, there exists a possibility that live swine, pork, or pork products from the CSF-free regions listed in paragraph (a) of this section may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States. Therefore, live swine, pork, or pork products and shipstores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under parts 95 or 96 of this chapter, may not be imported into the United States from a region listed in paragraph (a) of this section unless the requirements in this section, in addition to other applicable requirements of part 93 of this chapter and part 327 of this title, are met.

(a) Regions subject to the requirements of this section: Chile and the Mexican States of Baja California, Baja California Sur, Chihuahua, and Sinaloa.

(b) Live swine. The swine must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the swine in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin as a region designated in §§ 94.9 and 94.10 as free of CSF at the time the swine were in the region and must state that:

(1) The swine have not lived in a region designated in §§ 94.9 and 94.10 as affected with CSF.

(2) The swine have never been commingled with swine that have been in a region that is designated in §§ 94.9 and 94.10 as affected with CSF;

(3) The swine have not transited a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(4) The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of § 93.502 of this chapter.

(c) Pork or pork products. The pork or pork products must be accompanied by a certification issued by a full-time salaried veterinary officer of the national government of the region of export. Upon arrival of the pork or pork products in the United States, the certification must be presented to an authorized inspector at the port of arrival. The certification must identify both the exporting region and the region of origin of the pork or pork products as a region designated in §§ 94.9 and 94.10 as free of CSF at the time the pork or pork products were in the region and must state that:

(1) The pork or pork products were derived from swine that were born and raised in a region designated in §§ 94.9 and 94.10 as free of CSF and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in § 327.2 of this title;

(2) The pork or pork products were derived from swine that have not lived in a region designated in §§ 94.9 and 94.10 as affected with CSF;

(3) The pork or pork products have never been commingled with pork or pork products that have been in a region that is designated in §§ 94.9 and 94.10 as affected with CSF;

(4) The pork or pork products have not transited through a region designated in §§ 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and

(5) If processed, the pork or pork products were processed in a region designated in §§ 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the national government of that region. (Approved by the Office of Management and Budget under control number 0579-0230)

Done in Washington, DC, this 6th day of November 2003.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  APHIS, Veterinary Services/Trade in Animals and Animal Products Branch.

2.  USDA, “Agricultural Statistics 2000,” page VII-18. Washington, DC, National Agricultural Statistics Service, 2000.