[Federal Register Volume 68, Number 155 (Tuesday, August 12, 2003)]
[Rules and Regulations]
[Pages 47835-47842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20488]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 68, No. 155 / Tuesday, August 12, 2003 / 
Rules and Regulations  

[[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.

-----------------------------------------------------------------------

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