[Federal Register: August 12, 2003 (Volume 68, Number 155)]
[Rules and Regulations]
[Page 47835-47842]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au03-1]
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Rules and Regulations
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[[Page 47835]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 01-074-2]
Classical Swine Fever Status of Mexican States of Baja
California, Baja California Sur, Chihuahua, and Sinaloa
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations by adding the Mexican States
of Baja California, Baja California Sur, Chihuahua, and Sinaloa to the
lists of regions considered free of classical swine fever. We have
conducted a series of risk evaluations and have determined that these
four States have met our requirements for being recognized as free of
this disease. This action will allow the importation into the United
States of pork, pork products, live swine, and swine semen from these
regions. We are also adding certification requirements for the
importation of live swine, pork, and pork products from Baja
California, Baja California Sur, Chihuahua, and Sinaloa. The
certification would identify the regions of export and origin as Baja
California, Baja California Sur, Chihuahua, or Sinaloa or some other
region that we recognize as free of classical swine fever and would
also prevent the commingling of animals and products from these States
with animals and products from classical-swine-fever-affected regions
prior to export.
EFFECTIVE DATE: August 27, 2003.
FOR FURTHER INFORMATION CONTACT: Dr. Hatim Gubara, Senior Staff
Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS,
4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture regulates the importation of
animals and animal products into the United States to guard against the
introduction of animal diseases not currently present or prevalent in
this country. The regulations pertaining to the importation of animals
and animal products are set forth in the Code of Federal Regulations
(CFR), title 9, chapter I, subchapter D (9 CFR parts 91 through 99).
Until several years ago, the regulations in parts 91 through 99
(referred to below as the regulations) governed the importation of
animals and animal products according to the recognized disease status
of the exporting country. In general, if a disease occurred anywhere
within a country's borders, the entire country was considered to be
affected with the disease, and importations of animals and animal
products from anywhere in the country were regulated accordingly.
However, international trade agreements entered into by the United
States--specifically, the North American Free Trade Agreement and the
World Trade Organization Agreement on Sanitary and Phytosanitary
Measures--require APHIS to recognize regions, rather than only
countries, for the purpose of regulating the importation of animals and
animal products into the United States.
Consequently, on October 28, 1997, we published in the Federal
Register a final rule (62 FR 56000-56026, Docket No. 94-106-9,
effective November 28, 1997) and a policy statement (62 FR 56027-56033,
Docket No. 94-106-8) that established procedures for recognizing
regions (referred to below as ``regionalization'') for the purpose of
regulating the importation of animals and animal products. With the
establishment of those procedures, APHIS may consider requests to allow
the importation of a particular type of animal or animal product from a
foreign region, as well as requests to recognize all or part of a
country or countries as a region. The regulations define the term
region, in part, as ``any defined geographic land area identifiable by
geological, political, or surveyed boundaries.''
In accordance with these regionalization procedures, on May 13,
2002, we published in the Federal Register (67 FR 31987-31992, Docket
No. 01-074-1) a proposal to amend the regulations in Sec. Sec. 94.9
and 94.10 by adding the Mexican States of Baja California, Baja
California Sur, Chihuahua, and Sinaloa to the lists of regions
considered free of classical swine fever (CSF), thus allowing the
importation into the United States of pork, pork products, live swine,
and swine semen from these regions. We also proposed to remove
references to those four States in Sec. 94.15(b) because we believed
that the provisions of that paragraph, which, among other things,
govern the transiting through the United States of pork and pork
products not otherwise eligible for entry into the United States under
part 94, would no longer apply to those States once they were
recognized as CSF-free.
We solicited comments concerning our proposal for 60 days ending
July 12, 2002. We received six comments by that date. They were from
U.S. and Mexican swine producers, a swine producers' association,
importers, and a representative of the Mexican Government. Five of the
commenters wrote in favor of the proposed rule.
The remaining commenter raised a number of issues, which we will
discuss in the paragraphs that follow. Areas of concern discussed by
the commenter included APHIS' risk assessment methodology; the
conditions under which live swine and swine semen could be imported
from the four Mexican States; the possibility that imports of those two
commodities, in particular, could transmit not only CSF to U.S. herds
but other diseases as well; the adequacy of surveillance programs in
the four Mexican States; and the possibility that Chihuahua might
export to the United States pork and pork products derived from swine
imported into the State from CSF-affected regions.
The commenter cited several concerns regarding the methodology
APHIS used in conducting its risk evaluations of Baja California, Baja
California Sur, Chihuahua, and Sinaloa. Noting that an earlier rule
allowing pork imports from the States of Yucatan and Sonora had been
based on a qualitative ``risk assessment,'' the commenter questioned
[[Page 47836]]
why ``risk evaluations'' of the four Mexican States preceded the
current rulemaking process. The commenter requested explanations of the
differences between the two and of how APHIS decides which type of
analysis to do, and also questioned whether a ``full risk assessment''
had been completed for Baja California, Baja California Sur, Chihuahua,
and Sinaloa. The commenter also pointed out that a proposal to
recognize several European Union (EU) countries, as well as parts of
Italy and Germany, as CSF-free (see 64 FR 34155-34168, Docket No. 98-
090-1, published June 25, 1999) followed an APHIS risk analysis that
included quantitative risk assessments for live swine, semen, and pork.
Because live swine and swine semen imports may pose a greater risk of
CSF transmission than pork imports, the commenter asserted, APHIS
should conduct separate risk assessments for live swine and semen and
then apply appropriate risk-mitigation strategies. Finally, the
commenter also expressed some concern about the age of the data
collected during the site visits APHIS conducted as part of the risk
evaluations of the four Mexican States, pointing out that the most
recent site visit took place in February 1997.
In conducting our risk evaluations of the four Mexican States, we
used our standardized approach, which complies with Sec. 92.2 of the
regulations. It is unclear what the commenter means by a ``full risk
assessment.'' The risk evaluation is equivalent, whether it is called a
risk assessment or a risk evaluation. Historically, we have not
conducted separate risk assessments for live swine and swine semen in
similar rulemakings and have conducted quantitative as well as
qualitative analyses primarily for rules designated as ``significant''
by the Office of Management and Budget. The EU proposal, unlike the one
involving the four Mexican States, was a ``significant'' rule and was
much larger in scope, involving various countries within the EU and
regions within EU countries. For our proposed rule regarding Baja
California, Baja California Sur, Chihuahua, and Sinaloa, we used our
standard risk assessment methods and found the risk of CSF transmission
to the United States via imports from the four Mexican States to be
low. Because there have been no CSF outbreaks in any of the four States
since our February 1997 site visit and APHIS had no information that
risk levels had changed, APHIS did not view additional site visits as
necessary.
The commenter requested additional information about the conditions
under which live swine would be imported, since, heretofore, they have
not been imported into the United States from Mexico, and about the
types, locations, biosecurity policies, etc., of the semen centers that
would have the potential to ship semen for use in U.S. swine herds.
Though this final rule allows imports of live swine and swine semen
from the four Mexican States, we do not intend to issue import permits
for live swine and swine semen from Mexico until we have resolved
several issues related to the presence of blue eye disease in Mexico
(those issues are discussed in greater detail later in this document).
We are confident, however, that once the blue eye disease issue is
settled, the regulations will provide for the safe importation into the
United States of live swine and swine semen from Baja California, Baja
California Sur, Chihuahua, and Sinaloa.
The importation of live swine is subject to the conditions set out
in Sec. Sec. 93.500 to 93.521. These conditions include, among other
things, requirements for import permits, health certification,
inspection and cleaning of conveyances used to transport swine,
inspection of swine at the port of entry, and quarantine methods and
facilities. Section 93.507, which pertains to port-of-entry inspection,
provides that only those swine found to be free of communicable
diseases and not to have been exposed to communicable diseases in the
60 days prior to their importation are eligible for entry. Section
93.510 requires that all imported swine be quarantined for a period of
not less than 15 days, dating from the arrival of the swine at the port
of entry. For the most part, the regulations in part 93 provide
effective prevention against transmission of CSF to the U.S. swine
population by means of imports of live swine. After reviewing our
regulations in light of the issues raised by the commenter, however, we
did determine that we needed to provide more protection against the
possible commingling of live swine from the four CSF-free States with
swine from other regions before the eligible swine are exported to the
United States. This additional protection will take the form of a
certification requirement, which we will discuss later in this
document.
The importation of swine semen is subject to the conditions in
Sec. Sec. 98.30 to 98.36. These conditions include requirements for
the inspection, unloading, cleaning, and disinfection of aircraft,
other means of conveyance, and shipping containers used to move animal
semen into the United States; import permits; and health certificates
and other documents. Part 98 also offers protection against the
commingling of animal semen from disease-free and disease-affected
regions. Section 98.31(b) states that animal semen may not be imported
into the United States from any region other than that in which it was
collected. All shipping containers carrying animal semen for
importation into the United States must be sealed with an official seal
of the national veterinary service of the region of origin. Also, under
part 98, import permits for semen may be denied because of, among other
things, communicable disease conditions in the region of origin or in a
region through which the shipment has been or will be transported.
Taken together, these and other provisions in part 98 will make the
prospect of CSF transmission to U.S. swine herds via the importation of
swine semen from Baja California, Baja California Sur, Chihuahua, and
Sinaloa very unlikely. Our review of part 98 in light of the issues
raised by the commenter led us to conclude that we did not need to make
any changes in the regulations pertaining to semen.
Another concern expressed by the commenter was that allowing the
importation of live swine and swine semen from the four Mexican States
could increase the risk of infection of U.S. swine herds with diseases
such as pseudorabies, vesicular stomatitis, and blue eye disease.
The inspection, permitting, certification, and quarantine
provisions in part 93 allow APHIS to screen imported live swine for
pseudorabies and to take effective measures, which include refusal of
entry, to prevent its spread. APHIS does not regard imports of live
swine from Mexico as a source of risk for transmission of vesicular
stomatitis and does not require testing of other species from Mexico
for that disease. Blue eye disease does provide greater cause for
concern. Although several laboratory tests have been developed for the
detection of that disease, none has been validated or is commercially
available in the United States. Moreover, APHIS does not have current
and complete information on the geographic distribution of blue eye
disease in Mexico. In the absence of specific clinical signs, a
reliable laboratory test, and complete epidemiologic information,
specific mitigation measures for blue eye disease of swine are
difficult to design. Under Sec. 93.504(a)(3), however, APHIS may deny
permits for the importation of live swine and swine specimens if such
imports would pose a disease risk. We intend to rely on this authority
to support our decision to not issue any permits for the importation of
live swine
[[Page 47837]]
and swine semen from the four Mexican States until the issue of blue
eye disease can be addressed more comprehensively. With that goal in
mind, APHIS intends to collect information and conduct an assessment of
the risk of introducing blue eye disease in live swine and swine semen
imported from Mexico.
The commenter also questioned why the import conditions we proposed
to apply to pork and pork products from the four Mexican States
differed from those specified in an earlier final rule pertaining to
imports of pork and pork products from the Mexican States of Sonora and
Yucatan that was published in the Federal Register on January 11, 2000
(65 FR 1529-1537, Docket No. 97-079-2).
Risk evaluations carried out during the 1990s led APHIS to
promulgate the January 2000 final rule referred to by the commenter
after concluding that pork and pork products could safely be imported
into the United States from Yucatan and Sonora under conditions
designed to prevent the commingling of such products prior to
exportation with pork and pork products from surrounding regions with
lower CSF status. Unlike this final rule, however, the January 2000
final rule did not recognize Yucatan and Sonora as free of CSF.
Generally, import requirements tend to be more stringent for disease-
affected regions than for those we recognize as disease-free, so it is
to be expected that the requirements imposed on imports from Yucatan
and Sonora would be more rigorous than those imposed on imports from
Baja California, Baja California Sur, Chihuahua, and Sinaloa. On
September 30, 2002, however, we published in the Federal Register (67
FR 61293-61300, Docket No. 02-002-1) a proposal to add Yucatan and
Sonora, along with the Mexican States of Campeche and Quintana Roo, to
the lists in Sec. Sec. 94.9 and 94.10 of CSF-free regions. Should that
proposed rule be finalized, pork and pork products imported from those
States will be subject to the same requirements as pork and pork
products from Baja California, Baja California Sur, Chihuahua, and
Sinaloa.
The commenter also expressed concerns regarding surveillance
activities in the four Mexican States. The commenter raised questions
regarding the prevention of backyard swine from entering the commercial
slaughtering process, the existence of feral swine populations in the
four States and the prevalence of CSF among those populations, the
States' plans for coping with future CSF outbreaks, the ability of
APHIS to trace infected swine back to particular farms or
slaughterhouses, and the procedures APHIS would use to notify U.S.
importers in the event of an outbreak of CSF in any of the four States.
We believe that if a region from which swine are being imported is
free of CSF, then there is no reason to prevent backyard swine from
that region from being slaughtered and imported. We only view feral
swine as a cause for concern if such animals are transmitting disease
to swine being raised for slaughter. As noted in the risk assessment
documents, in accordance with Mexico's National Eradication Program,
the four Mexican States all have active disease surveillance programs,
strict border controls for animal movement, and emergency response
systems or teams available in the event of CSF outbreaks. The
certificate of origin required under Sec. 93.505 would enable APHIS to
trace infected animals back to specific slaughterhouses or farms. In
the event of an outbreak in any of the four States, APHIS would notify
U.S. importers by imposing an immediate ban and enforcing it by
publishing an interim rule.
The commenter also raised some issues with regard to individual
States. The commenter requested more details regarding the process by
which backyard herds are randomly selected for CSF surveillance in Baja
California. Regarding Baja California Sur, the commenter requested
information on the number of backyard herds tested for CSF and the
sources of the four CSF outbreaks that have occurred in the State since
it was declared free of the disease by Mexico in 1991. With regard to
Sinaloa, the commenter requested information regarding the source of
the 1998 outbreak of CSF in neighboring Durango.
In Baja California, as in the other three Mexican States covered by
this rule, the size of backyard animal samples is established through
the determination of the presence or absence of CSF by the Cannon and
Roe formula (1982), with a confidence interval of 99 percent and an
expected prevalence in backyard premises of 0.15 percent. The number of
municipalities in the State and the number of backyard farms in each
municipality are determined by the Secretariat for Agriculture,
Livestock, Rural Development, Fisheries, and Food Safety (SAGARPA).
Premises are randomly selected for sampling by the assigned
veterinarian according to the number of samples assigned to each
municipality. Based on a swine census conducted in the State in 1998
and 1999, it was determined that samples would be taken from 172 and
241 backyard premises for those years, respectively, and would consist
of 10 percent of the animals randomly selected from the total on each
farm.
A description of the methodology used in sampling backyard herds in
Baja California Sur is provided in the risk evaluation report for that
State. APHIS did not collect data on the sources of the CSF outbreaks
in Baja California Sur because the last of them occurred in 1995, and
the State has remained CSF-free since then.
APHIS did not see a need to collect information on the source of
the 1998 CSF outbreak in Durango because Durango was not among the
Mexican States that were the subject of the proposed rule and we have
not proposed to make any changes to the regulations regarding Durango's
CSF status. Durango, which was declared free of CSF by the Mexican
Government subsequent to the 1998 outbreak and is separated from
Sinaloa by the Sierra Madre Occidental Mountains, is not seen as a
likely source for the introduction of CSF into Sinaloa. In addition,
animals or pork from Durango would be excluded by the certification
requirements in this rule.
Noting the paucity of commercial swine in Chihuahua relative to
backyard swine and the fact that Chihuahua is a net exporter of pork,
the commenter suggested that most of the slaughter volume in the State
must come from swine raised in other regions, possibly including
regions affected with CSF. The commenter requested information on the
origin of the swine that are slaughtered in Chihuahua and on
restrictions on interstate movement of swine into the State.
APHIS has requested data from Chihuahua on the specific origin of
any swine entering the State for slaughter and is awaiting a response.
In any event, APHIS does not consider the importation of pork or pork
products from Chihuahua under the certification requirements of this
final rule to constitute a risk for spreading CSF. Also, as noted in
the risk evaluation document for Chihuahua and in the proposed rule,
some safeguards already exist to prevent Chihuahua from exporting
contaminated pork or pork products to the United States. Movement of
live swine from Mexican States with a lower CSF status into Chihuahua
is prohibited, so even though it does appear that much of the pork
Chihuahua exports comes from imported swine, the swine are likely to
have come from CSF-free regions. Moreover, the swine are slaughtered at
[[Page 47838]]
Tipo Inspecci[oacute]n Federal (TIF) plants that comply with
international sanitary requirements and have official veterinary
sanitary officers and supervision and certification by the countries to
which they export.
Still, APHIS shares the commenter's broader concerns about products
imported into the United States from certain regions designated as free
of CSF. Historically, the CSF-free designation has been justified not
only by the absence of the disease in a particular country but also by
the strong border controls existing at national boundaries. These
border controls were thought to provide effective mitigation against
the risks presented by the possibility of pork, pork products, live
swine, or swine semen being imported into CSF-free countries for
subsequent export to the United States. The advent of regionalization
has allowed APHIS to designate regions within countries, as well as
entire countries, as free of CSF. While regionalization has allowed
APHIS to exercise more flexibility in its regulatory process and has
helped to facilitate trade, it has caused APHIS to reconsider the issue
of border controls in some cases. Border controls between higher- and
lower-risk regions within a country or within a larger community, such
as the EU, may not always be equivalent to border controls between
nations. The possibility that pork or pork products intended for export
to the United States from some CSF-free regions could be derived from
swine that originated in CSF-affected regions or could be commingled
with pork or pork products from affected regions prior to export to the
United States appears to be greater than it did in the past. Such
imports could present a risk of introducing CSF into this country.
Commingling is also a concern with live swine intended for export to
the United States from certain CSF-free regions.
Some sections of the regulations in part 94 do contain provisions
aimed at reducing the potential risks posed by the importation of
animal products from disease-free regions when circumstances exist that
indicate there may be the possibility that those products may be
commingled with animal products from disease-affected regions. For
example, Sec. 94.11 places certain restrictions on meat and other
animal products imported from certain regions that are designated in
Sec. 94.1 as free of rinderpest and foot-and-mouth disease (FMD) but
that (1) supplement their meat supplies by the importation of fresh
meat of ruminants or swine from regions affected by rinderpest or FMD,
(2) share a common land border with such regions, or (3) import
ruminants or swine from such regions under conditions less restrictive
than would be acceptable for importation into the United States.
Section 94.13 has similar provisions for pork and pork products
imported from certain regions that are designated in Sec. 94.12(a) as
being free of swine vesicular disease but that have risk factors like
those of the FMD-free countries listed in Sec. 94.11. The requirements
currently in effect for the importation of pork and pork products from
Yucatan and Sonora in Sec. 94.20 include requirements for
slaughtering, processing, and certification that are intended to
address the risk of commingling.
Notwithstanding the requirements in Sec. 94.20, the regulations in
part 94 lack specific provisions for imports from CSF-free regions that
are analogous to those of Sec. Sec. 94.11 and 94.13. To mitigate the
risks associated with importing live swine, pork, and pork products
from the Mexican States of Baja California, Baja California Sur,
Chihuahua, and Sinaloa--States that are subject to risk factors similar
to those associated with the regions listed in Sec. Sec. 94.11 and
94.13--we are adding a certification requirement to this final rule.
This certification requirement will help to ensure that live swine and
pork and pork products from these four Mexican States will not be
commingled with swine and products from CSF-affected regions in the
region of origin, the region of export, or in transit prior to
exportation, and that pork and pork products derived from swine
originating in affected regions will not be exported to the United
States from the four Mexican States.
Specifically, we are adding a new Sec. 94.24, which specifies the
contents of a certification that will have to accompany live swine,
pork, or pork products imported into the United States from the Mexican
States of Baja California, Baja California Sur, Chihuahua, and Sinaloa.
The new section has three components. The introductory text enumerates
the risk factors that necessitate applying the certification
requirement to the four States. Paragraph (a) specifies the
certification requirements for live swine, and paragraph (b), for pork
and pork products.
Paralleling Sec. Sec. 94.11 and 94.13, the introductory text of
new Sec. 94.24 notes that although Baja California, Baja California
Sur, Chihuahua, and Sinaloa are declared to be free of CSF in
Sec. Sec. 94.9 and 94.10, they supplement their pork supplies with
fresh (chilled or frozen) pork imported from regions designated in
Sec. Sec. 94.9 and 94.10 as being affected by CSF, share a common land
border with such affected regions, or import swine from such 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 these CSF-free regions may
be commingled with live swine, pork, or pork products from regions
where CSF is considered to exist, resulting in a risk of introducing
the disease 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 regulated under 9 CFR part 95
(which regulates, among other things, such swine products as hides and
bristles) or part 96 (which regulates, among other things, swine
casings) must meet the requirements of new Sec. 94.24 in addition to
other applicable requirements in the regulations. For imported live
swine, other applicable requirements include those in Sec. Sec. 93.500
to 93.521, which, as noted earlier, cover, among other things, import
permits, health certification, inspection and cleaning of conveyances
that transport swine, inspection of swine at the port of entry, and
quarantine methods and facilities. Other applicable requirements that
govern the importation of pork and pork products are specified in the
regulations of the Food Safety Inspection Service (FSIS) of the U.S.
Department of Agriculture. Of particular relevance in this case are the
foreign country eligibility requirements for products imported into the
United States in 9 CFR 327.2 and the foreign meat inspection
certificate requirements in Sec. 327.4.
Paragraph (a) of new Sec. 94.24 states that the swine must be
accompanied by a certification issued by a full-time salaried
veterinary officer of the Government of Mexico. 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.
Paragraph (a)(1) specifies that the certification must state that
the swine have not lived in a region designated in Sec. Sec. 94.9 and
94.10 as affected with CSF. This provision, along with the
certification in paragraph (a) that the region of origin and exporting
regions are both CSF-free, will help to ensure that swine exported from
Baja California, Baja California Sur, Chihuahua, and Sinaloa to the
United States will in fact have come from one of those States and will
not have been
[[Page 47839]]
kept on premises in any region where CSF exists.
Paragraph (a)(2) specifies that the certification must state that
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. This provision will help to ensure that the swine will not be
commingled while in Baja California, Baja California Sur, Chihuahua, or
Sinaloa with swine imported into those States from other regions that
may be affected with CSF.
Paragraph (a)(3) specifies that the certification must state that
the swine 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. This provision
will help to ensure that swine intended for export to the United States
from the four Mexican States are not exposed to CSF while in transit
prior to being exported.
Paragraph (a)(4) specifies that the certification must state that
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. This
provision will help ensure that swine from Baja California, Baja
California Sur, Chihuahua, or Sinaloa will not be exposed to CSF as a
result of being transported in a contaminated conveyance.
Paragraph (b) states that pork or pork products intended for export
to the United States must, like live swine, be accompanied by a
certification issued by a full-time salaried veterinary officer of the
Government of Mexico. 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. This
provision will help to ensure that no pork or pork products exported
from the four States to the United States will have originated in or
been in a CSF-affected region.
Paragraph (b)(1) specifies that the certification must state that
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 Government of Mexico 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 FSIS regulations in
9 CFR 327.2. This provision will help ensure that the pork or pork
products will only be derived from swine that are free of CSF and that
slaughtering will take place in establishments and under conditions
that meet FSIS standards.
Paragraph (b)(2) specifies that the certification must state that
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. This provision will help to ensure
that the pork or pork products are not placed at risk of contamination
in their region of origin via contact with pork or pork products that
originated in a CSF-affected region.
Paragraph (b)(3) specifies that the certification must state that
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. This provision will help to ensure that pork or pork
products from the four Mexican States will remain safe from
contamination by being kept in sealed containers while transiting
through CSF-affected regions prior to importation into the United
States.
Finally, paragraph (b)(4) specifies that the certification must
state that if processed, the pork or pork product was processed in a
region designated in Sec. Sec. 94.9 and 94.10 as CSF-free in a
federally inspected processing plant that is under the direct
supervision of a full-time salaried veterinary official of the
Government of Mexico. This provision will help to ensure that
contamination will not occur during processing because the pork or pork
products will be processed under appropriate supervision in
establishments that are eligible to export pork and pork products to
the United States.
Miscellaneous
As we noted earlier in this document, in our May 2002 proposed
rule, we had proposed to remove references to Baja California, Baja
California Sur, Chihuahua, and Sinaloa that were contained in Sec.
94.15(b) of the regulations because we believed that the provisions of
that paragraph, which, among other things, govern the transiting
through the United States of pork and pork products not otherwise
eligible for entry into the United States under part 94, would no
longer apply to those States once we recognized them as CSF-free. Some
of the pork and pork products produced in those States for export,
however, may be produced in plants that are not FSIS-approved. Such
pork and pork products, while ineligible for importation into the
United States under the conditions of this final rule, are allowed to
transit through the United States under current Sec. 94.15(b). In
order to allow such products to continue to transit the United States,
we have decided not to finalize our proposed changes to Sec. 94.15(b).
The May 2002 proposed rule also discussed our intention to
substitute the term ``classical swine fever,'' which has become
standard usage among veterinary practitioners, for ``hog cholera''
wherever the latter term appeared in 9 CFR parts 71, 93, 94, 98, and
130. Because these editorial changes were included in another final
rule pertaining to the CSF status of various regions in the EU,
published in the Federal Register on April 7, 2003 (68 FR 16922-16941,
Docket No. 98-090-5), we will not be finalizing that aspect of the
proposed rule in this final rule.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. This rule adds the
Mexican States of Baja California, Baja California Sur, Chihuahua, and
Sinaloa to the lists of regions considered free of CSF and allows pork,
pork products, live swine, and swine semen to be imported into the
United States from those regions, subject to certain conditions. We
have determined that approximately 2 weeks are needed to ensure that
APHIS personnel at ports of entry receive official notice of this
change in the regulations. Therefore, the Administrator of the Animal
and Plant Health Inspection Service has determined that this rule
should be effective 15 days after publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866
[[Page 47840]]
and, therefore, has not been reviewed by the Office of Management and
Budget.
Based on the assumption that these four States will not drastically
increase their levels of pork production over that of the last few
years, the amount of pork, pork products, live swine, and swine semen
that may potentially be imported into the United States from Baja
California, Baja California Sur, Chihuahua, and Sinaloa is likely to be
negligible. In 2000, the State of Sinaloa produced 1.1 percent of
Mexico's live swine and 1.1 percent of its pork (FAS, USDA, GAIN
Report, 2001), and Chihuahua produced 0.7 percent of Mexico's live
swine and 0.5 percent of Mexico's pork (tables 1 and 2). The States of
Baja California and Baja California Sur, which are not self-sufficient
in pork production, produced smaller percentages. In 2001, these four
States together produced less than 2 percent of Mexico's total number
of live swine (table 1) and slaughtered swine (table 2). Between 1999
and 2001, Mexico exported around 5 percent of its annual production of
pork (table 3), which amounted to 50,667 metric tons on average. Mexico
has not exported any live swine since 1997 (table 4).
Table 1.--Live Swine in Mexican States, 2001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State Swine in commercial farms Swine in backyard operations Total
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Baja California....................... 15,251 (in 10 farms)....................... 6,951 (in 548 farms)................................................ 22,202 (0.09%)
Baja California Sur................... 1,200 (in 2 farms)......................... 20,550 (in unknown number of farms)................................. 21,750 (0.09%)
Chihuahua............................. 2,626 (in 5 farms)......................... 169,183 (in 45,714 farms)........................................... 171,809 (0.67%)
Sinaloa............................... 92,070 (in 25 farms)....................... 192,544 (in 33,475 farms)........................................... 284,614 (1.11%)
Mexico................................ 25,736,000 (swine crop + beginning stocks) in both commercial and backyard operations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Risk Assessments of Importing Pork into the United States From the Mexican States of Baja California, Baja California Sur, Chihuahua, and Sinaloa; Risk Analysis Systems, PPD, APHIS,
USDA.
Table 2.--Number of Swine Slaughtered in Mexican Slaughterhouses
[Percentage of Mexico's Total in Parentheses]
----------------------------------------------------------------------------------------------------------------
State 1999 2000 *
----------------------------------------------------------------------------------------------------------------
Baja California............................................ 16,399 (0.15%) 7,660 (0.13%)
Baja California Sur........................................ 9,044 (0.08%) 4,612 (0.08%)
Chihuahua.................................................. 60,634 (0.55%) 31,117 (0.54%)
Sinaloa.................................................... 132,298 (1.19%) 63,639 (1.11%)
Mexico..................................................... 11,110,978 5,729,229
----------------------------------------------------------------------------------------------------------------
Source: Confederacion Nacional Ganadera with data from SAGARPA. Sum of TIF and municipal slaughterhouses. *As of
June 30, 2000.
Table 3.--Mexican Pork (Metric Tons)
----------------------------------------------------------------------------------------------------------------
Calendar Year 1999 2000 2001
----------------------------------------------------------------------------------------------------------------
Production............................................. 994,000 1,035,000 1,065,000
Imports................................................ 143,000 276,000 300,000
Total supply........................................... 1,137,000 1,311,000 1,365,000
Exports................................................ 33,000 59,000 60,000
Domestic consumption................................... 1,104,000 1,252,000 1,305,000
--------------------
Total demand....................................... 1,137,000 1,311,000 1,365,000
----------------------------------------------------------------------------------------------------------------
Source: USDA, FAS, GAIN Report MX2015, Mexico, Livestock & Products, Semiannual Report 2002; source for
stocks is the FAOSTAT database.
Table 4.--Mexican Exports of Swine, Live Pure-Breeding--010310
----------------------------------------------------------------------------------------------------------------
1995 1996 1997 1998 1999 2000
----------------------------------------------------------------------------------------------------------------
Quantity.......................... 8 29 22 0 0 0
Value............................. $5,000 $439,000 $170,000
----------------------------------------------------------------------------------------------------------------
Source: FAS Global Agricultural Trade System using data from the UN Statistical Office.
Data: Harmonized Tariff Schedule (HS 6 Digit).
The Regulatory Flexibility Act requires that agencies specifically
consider the economic effects of their rules on small entities. The
domestic entities most likely to be affected by our declaring the
Mexican States of Baja California, Baja California Sur, Chihuahua, and
Sinaloa free of CSF are pork producers and importers.
According to the 1997 Agricultural Census, there were about 102,106
hog and pig farms in the United States in that year, of which 93
percent received $750,000 or less in annual revenues. Agricultural
operations with $750,000 or less in annual receipts are considered
small entities, according to the Small Business Administration's size
criteria.
We do not anticipate that any U.S. entities (i.e., importers of
swine and pork and pork products, and swine and pork producers), small
or otherwise, will experience any negative economic effects as a result
of this rule. This is because the amount of pork, pork products, live
swine, and swine semen likely to be imported into the United States
from Chihuahua and Sinaloa is
[[Page 47841]]
negligible. We expect that the amount of these articles likely to be
imported from Baja California and Baja California Sur will either be
less than that from the other two States or none at all.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains an information collection requirement that
was not included in the proposed rule. Specifically, this final rule
requires 50 burden hours for a certification that will have to be
completed by Federal animal health authorities in Mexico to ensure
that, prior to importation into the United States, live swine, pork,
and pork products from Baja California, Baja California Sur, Chihuahua,
and Sinaloa are not commingled with live swine, pork, and pork products
from CSF-affected regions. In accordance with section 3507(j) of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we submitted
this information collection requirement for approval to the Office of
Management and Budget (OMB). OMB has approved the information
collection for a period of 6 months under control number 0579-0230. We
plan, in the near future, to request continuation of that approval for
3 years.
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 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.
0
Accordingly, we are amending 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
0
1. The authority citation for part 94 continues 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]
0
2. In Sec. 94.9, paragraph (a) is amended by adding the words ``the
Mexican States of Baja California, Baja California Sur, Chihuahua, and
Sinaloa;'' after the words ``Isle of Man;''.
Sec. 94.10 [Amended]
0
3. In Sec. 94.10, paragraph (a) is amended by adding the words ``the
Mexican States of Baja California, Baja California Sur, Chihuahua, and
Sinaloa;'' after the words ``Isle of Man;''
0
4. A new Sec. 94.24 is added to read as follows:
Sec. 94.24 Restrictions on the importation of live swine, pork, or
pork products from Baja California, Baja California Sur, Chihuahua, and
Sinaloa.
The Mexican States of Baja California, Baja California Sur,
Chihuahua, and Sinaloa, which are declared to be free of classical
swine fever (CSF) in Sec. Sec. 94.9 and 94.10, supplement their pork
supplies with fresh (chilled or frozen) pork imported from regions
designated in Sec. Sec. 94.9 and 94.10 as being affected by CSF, 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 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 part 95 or part 96 of this chapter, originating in the CSF-free
regions listed in this section shall not be brought into the United
States unless the following requirements are met in addition to other
applicable requirements of parts 93 and 327 of this title:
(a) Live swine. The swine must be accompanied by a certification
issued by a full-time salaried veterinary officer of the Government of
Mexico. 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 classical swine fever 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 classical swine fever.
(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 classical swine fever;
(3) The swine have not transited through a region designated in
Sec. Sec. 94.9 and 94.10 as affected with classical swine fever 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
subchapter.
(b) 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 Government of Mexico. 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 classical swine fever 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 classical swine fever 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 Government of
Mexico 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
[[Page 47842]]
seq.) and the regulations in Sec. 327.2 of this title;
(2) 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 classical swine fever;
(3) The pork or pork products have not transited through a region
designated in Sec. Sec. 94.9 and 94.10 as affected with classical
swine fever 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) If processed, the pork or pork products were processed in a
region designated in Sec. Sec. 94.9 and 94.10 as free of classical
swine fever in a federally inspected processing plant that is under the
direct supervision of a full-time salaried veterinary official of the
Government of Mexico.
(Approved by the Office of Management and Budget under control
number 0579-0230)
Done in Washington, DC, this 7th day of August, 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-20488 Filed 8-11-03; 8:45 am]
BILLING CODE 3410-34-P