[Federal Register Volume 68, Number 219 (Thursday, November 13, 2003)]
[Proposed Rules]
[Pages 64274-64282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28389]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 219 / Thursday, November 13, 2003 / 
Proposed Rules  

[[Page 64274]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 03-009-1]


Classical Swine Fever Status of Chile

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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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 [email protected]. 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 (202) 690-2817 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; (301) 734-4356.

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

[[Page 64275]]

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 
Investigaci[oacute]n en Sanidad Animal--Instituto Nacional de 
Investigaci[oacute]n y Tecnologia Agrar[iacute]a 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

[[Page 64276]]

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 Sec.  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 Sec.  
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, Sec.  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 Sec. Sec.  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:
    [sbull] The pork or pork products were derived from swine that were 
born and raised in a region designated in Sec. Sec.  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

[[Page 64277]]

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;
    [sbull] The pork or pork products were derived from swine that have 
not lived in a region that is designated in Sec.  94.9 or Sec.  94.10 
as affected with CSF;
    [sbull] The pork or pork products have never been commingled with 
pork or pork products that have been in a region that is designated in 
Sec. Sec.  94.9 and 94.10 as affected with CSF;
    [sbull] The pork or pork products have not transited a region 
designated in Sec. Sec.  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
    [sbull] If processed, the pork or pork product was processed in a 
region designated in Sec. Sec.  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:
    [sbull] The swine have not lived in a region designated in 
Sec. Sec.  94.9 and 94.10 as affected with CSF;
    [sbull] The swine have never been commingled with swine that have 
been in a region designated in Sec. Sec.  94.9 and 94.10 as affected 
with CSF; and
    [sbull] The swine have not transited a region designated in 
Sec. Sec.  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

[[Page 64278]]

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 Sec. Sec.  94.9 and 94.10 of regions where 
CSF is not known to exist. We are also proposing to revise Sec.  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 Sec.  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 Sec.  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

[[Page 64279]]

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).
---------------------------------------------------------------------------

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

    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
----------------------------------------------------------------------------------------------------------------
                                                                    Import volume by year (in metric tons)
   Commodity (by HS 6-digit        Origin of U.S. imports    ---------------------------------------------------
           category)                                              1998         1999         2000         2001
----------------------------------------------------------------------------------------------------------------
Swine carcasses, fresh or       World.......................       10,555       11,206        4,542        1,676
 chilled (HS 020311).
Swine carcasses, frozen (HS     World.......................           68           46           70           39
 020321).
Swine hams, fresh or chilled    World.......................       48,976       61,099       76,469       75,482
 (HS 020312).
Swine hams, with bone in (HS    World.......................       10,023        7,977        5,533        4,470
 020322).
Swine edible offal, fresh or    World.......................       10,065        9,499       15,557       20,904
 chilled (HS 020630).
Swine edible offal, except for  World (except Chile)........        4,281        4,437        4,138        4,092
 liver, frozen (HS 020649).
                                Chile.......................    18 (0.4%)            0            0            0
Swine livers, frozen (HS        World.......................          248           98           29          264
 020641).
Swine hams/shoulders, salted,   World.......................          818        1,555        1,659        1,280
 dried (HS 021011).
Swine bellies, salted and       World.......................       10,073       16,673       21,720       19,836
 dried, bacon (HS 021012).
Swine meat, except ham,         World.......................        3,768        3,440        4,725        6,709
 salted, dried, smoked (HS
 021019).
Swine fresh cuts (NES) (HS      World.......................       87,434      116,325      148,401      163,131
 020319).
Swine frozen cuts (NES) (HS     World.......................       60,137       69,625       85,900       80,175
 020329).
                                                             --------------
    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
------------------------------------------------------------------------
                                Export volume by year (in metric tons)
  Commodity (by HS 6-digit   -------------------------------------------
          category)              1998       1999       2000       2001
------------------------------------------------------------------------
Swine carcasses, fresh or         4,741        645         21        455
 chilled (HS 020311)........
Swine carcasses, frozen (HS         108         80          6        164
 020321)....................
Swine hams, fresh or chilled          0        146        790        797
 (HS 020312)................
Swine hams, with bone in (HS        661        201        456      5,357
 020322)....................
Swine edible offal, fresh or          3          5        104        103
 chilled (HS 020630)........
Swine edible offal, except        4,888      5,331      5,677      7,261
 for liver, frozen (HS
 020649)....................
Swine livers, frozen (HS            248         98         29        264
 020641)....................
Swine bellies, salted &              11          3          2          2
 dried, bacon (HS 021012)...
Swine fresh cuts (NES) (HS            0        865      2,638      2,448
 020319)....................
Swine frozen cuts (NES) (HS       7,857      5,587      9,070     17,049
 020329)....................
                             ------------
    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.


[[Page 64280]]


                                                          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

[[Page 64281]]

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 
(301) 734-7477.

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 (301) 734-7477.

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.


Sec.  94.9  [Amended]

    2. In Sec.  94.9, paragraph (a) would be amended by adding the word 
``Chile;'' after the word ``Canada;''.


Sec.  94.10  [Amended]

    3. In Sec.  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.


Sec.  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 Sec. Sec.  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 
Sec. Sec.  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 Sec. Sec.  
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 Sec. Sec.  94.9 and 94.10 as affected 
with CSF;
    (3) The swine have not transited a region designated in Sec. Sec.  
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 Sec.  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 Sec. Sec.  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 Sec. Sec.  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 Sec.  327.2 of this title;
    (2) The pork or pork products were derived from swine that have not 
lived in a region designated in Sec. Sec.  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 
Sec. Sec.  94.9 and 94.10 as affected with CSF;
    (4) The pork or pork products have not transited through a region 
designated in Sec. Sec.  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 Sec. Sec.  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

[[Page 64282]]

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.
[FR Doc. 03-28389 Filed 11-12-03; 8:45 am]
BILLING CODE 3410-34-P