[Federal Register: November 13, 2003 (Volume 68, Number 219)]
[Proposed Rules]
[Page 64274-64282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no03-6]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[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 regulations@aphis.usda.gov. 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