[Federal Register Volume 70, Number 58 (Monday, March 28, 2005)]
[Rules and Regulations]
[Pages 15563-15570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6028]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 02-002-2]


Classical Swine Fever Status of Mexican States of Campeche, 
Quintana Roo, Sonora, and Yucatan

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 Campeche, Quintana Roo, Sonora, and Yucatan to the lists of regions 
considered free of classical swine fever (CSF). 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 allows the importation into the United States of pork, pork 
products, live swine, and swine semen from these regions. In addition, 
this rule requires live swine, pork, and pork products imported into 
the United States from the four Mexican States to be certified as 
having originated in one of those States or in another region 
recognized by the Animal and Plant Health Inspection Service as free of 
CSF and as not having been commingled, prior to export to the United 
States, with animals and animal products from regions where CSF exists.

DATES: Effective Date: April 12, 2005.

FOR FURTHER INFORMATION CONTACT: Dr. Hatim Gubara, Staff Veterinarian, 
Regionalization Evaluation Services Staff, National Center for Import 
and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-
1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA) 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 and exportation 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).
    On September 30, 2002, we published in the Federal Register (67 FR 
61293-61300, Docket No. 02-002-1) a proposal to amend the regulations 
in Sec. Sec.  94.9 and 94.10 by adding the Mexican States of Campeche, 
Quintana Roo, Sonora, and Yucatan to the lists of regions considered 
free of classical swine fever (CSF), thus relieving restrictions on 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 paragraph, which, among other things, governs 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. 
Finally, we proposed to remove Sec.  94.21, which contained provisions 
for the importation of pork and pork products from Sonora and Yucatan, 
because our recognition of those two Mexican States as free of CSF 
meant that those provisions would no longer apply.

    Note: Since the proposed rule's publication, Sec. Sec.  94.19 
through 94.25 have been redesignated as Sec. Sec.  94.20 through 
94.26, respectively. Throughout this final rule, we use the current 
section numbers in part 94. Thus, where the proposed rule referred 
to Sec.  94.20, this final rule refers to Sec.  94.21.

    We solicited comments concerning our proposal for 60 days ending 
November 29, 2002. We received one comment by that date. It was from a 
domestic pork producers' association.
    The commenter opposed the proposal, raising a number of issues that 
we will discuss in the paragraphs that follow. Areas of concern 
mentioned by the commenter included APHIS' risk assessment methodology; 
the conditions under which live swine and swine semen would 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 conditions under which pork and pork 
products would be imported into the United States from the four Mexican 
States; the adequacy of controls on the movement of products from CSF-
affected regions into the four Mexican States; the possibility of 
commingling of products originating in the four States with products 
imported into those States from surrounding CSF-affected regions; swine 
identification and traceback in Mexico; and the adequacy of some 
aspects of the veterinary infrastructure in the four Mexican States.
    The commenter noted that for a separate CSF-related rulemaking, 
APHIS conducted a risk analysis that included quantitative risk 
assessments for live swine, swine semen, and pork. (The rulemaking 
cited by the commenter involved the recognition of a region in the 
European Union (EU) consisting of Austria, Belgium, Greece, the 
Netherlands, Portugal, and parts of Germany and Italy as free of CSF; 
that rulemaking was completed with the publication of a final rule in 
the Federal Register (68 FR 16922-16940, Docket No. 98-090-5) on April 
7, 2003.) The commenter stated that risk analyses conducted for our 
September 2002 proposed rule regarding the four Mexican States did not 
include separate assessments for live swine and swine semen, even 
though, in general, there are higher levels of risk associated with 
importing live animals and germ plasm than with importing pork and pork 
products. The commenter requested an explanation of the apparent 
disparity in the risk determination procedures used in the two 
rulemakings.
    In conducting the analyses that provided the basis for our 
September 2002 proposed rule concerning Campeche, Quintana Roo, Sonora, 
and Yucatan, we used our standard approach, which is described in Sec.  
92.2 of the regulations, and we found the risk of CSF transmission to 
the United States via imports from these four Mexican States to be low. 
Historically, we have not conducted separate risk analyses for live 
swine and swine semen in similar rulemakings. Our typical approach when 
evaluating a region for disease-free status has been to conduct 
qualitative analyses. Regions that have met criteria for disease 
freedom, such as the four Mexican States covered by this rulemaking, 
are typically those that have not reported an outbreak of the relevant 
disease in many years, do not allow vaccinations that might mask

[[Page 15564]]

disease, and whose products are considered to present a relatively low 
risk for disease transmission. Regions for which quantitative analyses 
are conducted, on the other hand, are typically those which a 
qualitative evaluation suggests might be associated with a higher level 
of risk due to the presence of such risk factors as recent disease 
outbreaks or a continuing program of vaccination. One such risk factor 
that influenced our approach to the EU risk analysis cited by the 
commenter was the presence of CSF in wild boars in the EU. That risk 
factor was not known to exist in the four Mexican States. The EU rule 
was also much larger in scope than our September 2002 proposed rule, 
involving various countries within the EU and regions within EU 
countries.
    The commenter pointed out that the risk evaluation documentation 
supporting equivalent rulemaking involving Baja California, Baja 
California Sur, Chihuahua, and Sinaloa--a final rule covering the CSF 
status of those four Mexican States was published in the Federal 
Register (68 FR 47835-47842) on August 12, 2003--included probability 
functions for commercial and backyard herds, while the documentation 
for the September 2002 proposed rule did not include these mathematical 
results.
    In the rulemaking involving Baja California, Baja California Sur, 
Chihuahua, and Sinaloa, information that lent itself to the type of 
analysis cited by the commenter was made available to us by the Mexican 
Government. We did not require the Mexican Government to furnish that 
information, however, and do not routinely require such information. 
Generally, our qualitative risk analyses do not include probability 
functions.
    The commenter also suggested that the risk analyses that provided 
the basis for the current rulemaking did not accord with the 
recommendations of the Office International des Epizooties (OIE) for 
conducting such analyses. OIE recommends that an import risk analysis 
contain four components: Release assessment, exposure assessment, 
consequence assessment, and risk estimation. According to the 
commenter, neither our evaluation of the three Yucatan Peninsula States 
nor our evaluation of Sonora contained exposure or consequence 
assessments.
    We believe that the risk analyses that we conducted for the four 
Mexican States did conform to OIE guidelines. The evaluation we 
conducted was a release assessment. The OIE guidelines state that, if 
the release assessment demonstrates no significant risk, the risk 
assessment may conclude at that point. Because we determined the risk 
values for release to be small, we did not conduct exposure or 
consequence assessments.
    Noting the higher risk of disease transmission associated with live 
swine and swine semen relative to that of pork or pork products, the 
commenter requested additional information about the conditions under 
which live swine would be imported into the United States from the four 
Mexican States covered by this rulemaking 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 Campeche, Quintana Roo, Sonora, and Yucatan, 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 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 the four 
Mexican States.
    Live swine may be imported into the United States only in 
accordance with Sec. Sec.  93.500 through 93.521. These sections 
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. As we noted in the 
preamble to our August 2003 final rule covering Baja California, Baja 
California Sur, Chihuahua, and Sinaloa, however, a review of the 
regulations led us to determine that we needed to provide more 
protection against the possible commingling of live swine from certain 
CSF-free regions with swine from other regions before the eligible 
swine are exported to the United States. In that final rule, we added 
to 9 CFR part 94 a new Sec.  94.24 (as noted, that section has since 
been redesignated as Sec.  94.25), which contained a certification 
requirement intended to ensure that live swine, as well as pork and 
pork products, imported from Baja California, Baja California Sur, 
Chihuahua, and Sinaloa originated in one of those States or in another 
region recognized by APHIS as free of CSF and that, prior to export to 
the United States, such animals and animal products have not been 
commingled with animals and animal products from regions where CSF 
exists. The risk factors cited in connection with imports from those 
four CSF-free Mexican States--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 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--also apply to 
Campeche, Quintana Roo, Sonora, and Yucatan. Therefore, in this final 
rule, in addition to adding Campeche, Quintana Roo, Sonora, and Yucatan 
to the lists in Sec. Sec.  94.9 and 94.10 of regions where CSF is not 
known to exist, we are also adding those four Mexican States to the 
list of regions in Sec.  94.25 to which certification requirements 
apply to live swine, pork, and pork products.
    Swine semen may be imported into the United States only in 
accordance with Sec. Sec.  98.30 through 98.36. These sections 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. Paragraph (b) of Sec.  98.31 states that animal semen 
may not be imported into the United States from any region other than 
that in which it was collected. Paragraph (f) of Sec.  98.35 requires 
that 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 make the prospect of 
CSF

[[Page 15565]]

transmission to U.S. swine herds via the importation of swine semen 
from Campeche, Quintana Roo, Sonora, and Yucatan very unlikely. As we 
noted in the preamble to the August 2003 final rule, we did not think 
it necessary to make any changes in the regulations pertaining to 
semen.
    Another concern expressed by the commenter, who raised the same 
issue in connection with the rulemaking covering Baja California, Baja 
California Sur, Chihuahua, and Sinaloa, was that allowing the 
importation of live swine and swine semen from Campeche, Quintana Roo, 
Yucatan, and Sonora 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 to prevent its spread, 
including refusal of entry. Under Sec.  93.507, APHIS may refuse entry 
to swine found upon inspection at the port of entry to have a 
communicable disease or to have been exposed to such a disease within 
60 days of their exportation to the United States. Live swine from 
Mexico are not considered likely to transmit vesicular stomatitis to 
U.S. herds, and we do not require testing of either live swine or other 
species from Mexico for that disease. Blue eye disease does provide 
some 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 
epidemiological 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 due 
to communicable disease conditions in the region of origin, among other 
reasons. Similarly, under Sec.  98.34(a)(3), APHIS may deny import 
permits for animal semen because of communicable disease conditions in 
the region of origin, among other reasons. We intend to rely on our 
authority under 9 CFR parts 93 and 98 to support our decision not to 
issue any permits for the importation of live swine and swine semen 
from any 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 Campeche, Quintana Roo, Sonora, 
and Yucatan differed from the provisions already in place in Sec.  
94.21 for the importation of those commodities from Sonora and Yucatan. 
Among other things, Sec.  94.21 includes requirements that pork or pork 
products from Yucatan and Sonora be derived from swine that were born 
and raised in Sonora or Yucatan and slaughtered in Sonora or Yucatan at 
a federally inspected slaughter plant that is under the direct 
supervision of a full-time salaried veterinarian of the Government of 
Mexico; that, if processed, the pork or pork product was processed in 
either Sonora or Yucatan in a federally inspected processing plant that 
is under the direct supervision of a full-time salaried veterinarian of 
the Government of Mexico; that the pork or pork product has not been in 
contact with pork or pork products from any State in Mexico other than 
Sonora or Yucatan or from any other region not recognized as CSF-free; 
and that the shipment of pork or pork products has not been in any 
State in Mexico other than Sonora or Yucatan or in any other region not 
recognized as CSF-free en route to the United States, unless it has 
been shipped in sealed containers. Since we proposed to remove Sec.  
94.21, the commenter asked why we thought such mitigations were no 
longer needed.
    Risk evaluations carried out during the 1990s led APHIS to conclude 
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. Consequently, 
on January 11, 2000, we published in the Federal Register (65 FR 1529-
1537, Docket No. 97-079-2) the final rule setting out the conditions 
for imports from those two Mexican States. Unlike the current 
rulemaking, however, the January 2000 final rule did not recognize 
Yucatan and Sonora as free of CSF. Generally, import requirements tend 
to be less stringent for disease-free than for disease-affected 
regions, so it was to be expected that the requirements described in 
our September 2002 proposed rule would not be as rigorous as those 
imposed on Sonora and Yucatan in the earlier rulemaking. Our subsequent 
review of the regulations, however, led us to incorporate most of the 
safeguards against the commingling of pork and pork products prior to 
importation into the United States that were contained in Sec.  94.21 
into the certification requirements of Sec.  94.25. Under this final 
rule, imports of pork and pork products from Campeche, Quintana Roo, 
Yucatan, and Sonora will have to meet the certification requirements of 
Sec.  94.25.
    The commenter also requested more information regarding the 
location, disease status, and surveillance of feral swine populations 
in Mexico. Such information would be helpful, according to the 
commenter, in understanding the risk of CSF transmission across the 
feral-domestic swine interface in Mexico.
    Populations of feral swine exist in most Mexican States. There are 
no specific surveillance programs in effect for these populations; 
therefore, no definitive statements can be made about their health 
status. We only view feral swine as a cause for concern if such animals 
are transmitting disease to swine being raised for slaughter. We have 
no evidence to suggest that this is happening or that CSF is 
circulating or has ever circulated in feral swine in Mexico. In 
addition, we do not currently conduct CSF surveillance in feral swine 
within the continental United States, where there is also no evidence 
to suggest that CSF is circulating in feral swine. Therefore, in view 
of our obligation under the World Trade Organization-Sanitary and 
Phytosanitary Measures agreement not to impose discriminatory measures 
on other countries, we do not think it appropriate to require Mexico to 
conduct CSF surveillance in feral swine.
    The commenter noted that the feeding of CSF-infected meat waste to 
swine is known to be one of the principal means of introducing CSF into 
previously free areas and that our supporting documents suggested that 
the majority of waste food feeding occurs in backyard farms. According 
to the commenter, while feeding of waste food from airlines within CSF 
eradication zones is not permitted, feeding of other waste food is 
unregulated. The commenter requested information on what risk 
mitigation strategies were considered in APHIS' risk estimation, given 
the potential for interaction between backyard and feral swine, and the 
possibility of unregulated waste food being fed to backyard swine.
    Safeguards are in place in Mexico to prevent the transmission of 
CSF by means of feeding CSF-infected waste meat to swine. In CSF-free 
Mexican States and States undergoing eradication, the feeding of table 
scraps

[[Page 15566]]

to swine is prohibited, in both commercial and backyard operations. 
Backyard swine are fed on their owners' premises, where wild swine are 
not given access to the food. In the unlikely event that backyard swine 
in a CSF-free zone could have access to table scraps, these scraps 
would include pork from the same free zone or from another zone with 
the same health status, since it is forbidden to introduce raw pork or 
raw pork byproducts from an area in the control or eradication phase 
into a CSF-free zone.
    Noting that producers provide significant funding for animal health 
activities in the four Mexican States, including laboratory facilities 
and functions in some States, the commenter questioned whether APHIS 
could be assured that these responsibilities would be properly carried 
out when producers had significant market downturns that decreased 
their income and their ability to maintain their commitments to disease 
programs.
    As we noted in both the risk analyses for the four Mexican States 
and the proposed rule, for both economic and animal health reasons, the 
swine industry in the Yucatan Peninsula and Sonora is committed to 
producing quality hogs and maintaining CSF-free status. Industry 
leaders have demonstrated awareness of animal disease control measures 
necessary to ensure the maintenance of a healthy and productive animal 
industry. The eradication of CSF from the four Mexican States was 
largely due to the dedication and persistence of the industry and to 
its willingness to work with animal health officials to ensure that the 
disease is not reintroduced.
    The commenter also requested information on the status of a 
national swine identification program in Mexico, on how slaughtered 
swine are traced back to their farms of origin, and on whether 
traceback of live swine or semen importations could be done if needed.
    There is no official national system for the individual 
identification of swine in Mexico, so each farm or State or regional 
swine-producers' union or association establishes its own local 
registration system among its members. An official Mexican standard is 
now being drafted that will make it possible to have a uniform 
identification system, which for swine will entail an individual 
identification in the form of an eartag or tattoo containing 
information about the State of origin and a consecutive number for the 
animal assigned by the Federal Secretariat for Agriculture, Livestock, 
Rural Development, Fisheries and Food Safety (SAGARPA), under the 
control of the State Livestock Promotion and Protection Committees.
    There is an adequate system in place in Mexico to ensure that 
slaughtered swine can be traced back to their premises of origin. The 
federally inspected abattoirs (the Spanish acronym is TIF) have 
government veterinarians who inspect the animals ante and post mortem. 
Each lot of animals is placed in a pen, and each animal is identified 
with the pen number. There is a slaughter schedule that takes the 
animals pen by pen. In the event that any abnormality is detected 
during the inspection, the lot to which the animal belongs can be 
determined from the plant's records, which include information 
concerning the identity of the farm of origin. Municipal abattoirs keep 
logbooks containing information on the animals' origins.
    Mexico is also able to trace back shipments of live swine and swine 
semen to their premises of origin. Shipments of live swine and swine 
semen, whether imported into Mexico from another country or moving 
within Mexico, must be accompanied by animal health certificates. 
According to Article 24 of Mexico's Federal Animal Health Law, the 
animal health certificate must contain, among other things, information 
regarding the place of origin and specific destination of the animals, 
animal products, or other materials in the shipment. This required 
information makes traceback possible when needed.
    Noting that in the site visit report for the Yucatan Peninsula, 
APHIS had recommended that Mexican laboratories obtain a source of CSF-
infected, gamma-irradiated (virus inactivated) tissue for use as a 
positive control for the CSF fluorescent antibody tissue section test, 
the commenter asked whether this recommendation had been followed.
    It was not possible to carry out the recommendation to obtain CSF-
infected, gamma-irradiated tissue because neither of the two national 
reference laboratories has performed this process and it is not 
required for authorizing clinical diagnostic laboratories. The Regional 
Central Laboratory in Merida, Yucatan, is authorized to perform the 
immunoperoxidase, enzyme-linked immunosorbent assay, and 
immunofluorescence test for CSF, however, for which it uses a conjugate 
prepared by PRONABIVE and a monoclonal conjugate prepared by the 
University of Iowa. The laboratory does not use a positive control, 
since the State of Yucatan is a CSF-free zone, and it would be 
hazardous to have virus samples or tissue with virus in such a zone.
    The commenter expressed some concern about a statement in our site 
visit report for the Yucatan Peninsula States that could be interpreted 
as indicating that authorized industry associations could set movement 
control rules.
    The technical guidelines for movements of swine and pork products 
and byproducts nationwide in Mexico are contained in NOM-037-ZOO-1995, 
National Classical Swine Fever Campaign, and compliance is compulsory 
throughout all of Mexico. Under these guidelines, no industry 
association may establish any movement control rules, but such 
associations may be authorized by SAGARPA to issue the animal health 
certificates required for animal movements. For an industry association 
to issue animal health certificates, it must have a veterinarian 
authorized to do so, must be a member of one of Mexico's five national 
certification bodies, and must meet all applicable requirements set 
forth in NOM-037-ZOO-1995.
    The commenter also discussed some narrower issues pertaining to the 
individual States covered by the proposed rule. Areas of concern 
included the veterinary infrastructure of the individual States, the 
disease status of adjacent regions, and movement controls.
    The commenter noted that the documents supporting the current 
rulemaking indicated that, within the Federal component of the Mexican 
animal health infrastructure, 109 veterinarians are currently certified 
to treat CSF and pseudorabies, yet none of them reside in Campeche. The 
commenter expressed the concern that the lack of such certified 
veterinarians in Campeche could cause delays in the diagnosis of these 
diseases.
    We do not believe that the lack of veterinarians residing in 
Campeche would result in delays in diagnosing CSF or pseudorabies in 
that State because State and Federal personnel, working in concert, 
provide adequate coverage. Under the National Epidemiological 
Surveillance System, continuous surveys are conducted of both 
technically advanced and backyard swine production facilities for these 
and other diseases, and followup action is taken where necessary.
    Samples are obtained from both types of facilities by SAGARPA and 
State veterinarians, who are supported by the State Livestock Promotion 
and Protection Committee. In addition, the official animal health 
infrastructure in

[[Page 15567]]

the State encompasses the operations of laboratories, slaughterhouses, 
checkpoints, and quarantine stations, and the control of movements of 
animals and animal products.
    Noting that there were six animal health centers located in the 
State of Campeche but that none was authorized to diagnose CSF, the 
commenter asked whether the State had received expected funding that 
could result in such authorization.
    While the funding has not yet materialized, diagnostic support for 
Campeche is currently available from the Regional Central Laboratory in 
Merida, Yucatan, which is approved to diagnose CSF and provides 
regional service for Yucatan, Campeche, and Quintana Roo. Moreover, 
since Campeche is an area that is free of CSF, the Exotic Animal 
Disease Commission's (EADC's) high-security laboratory in Mexico City 
provides the first level of diagnostic support in suspicious cases, 
while the scheduled annual surveys are channeled to the Regional 
Central Laboratory in Merida. Both laboratories participate in 
diagnosing CSF in the State of Campeche.
    The commenter argued that the CSF status of Campeche's neighboring 
Mexican States, particularly that of Chiapas, should be considered when 
defining the CSF status in regions contiguous to Campeche. The 
commenter noted that the narrow central region of the neighboring 
Mexican State of Tabasco separates Campeche from Chiapas by only 15 
kilometers and that new outbreaks of CSF had been reported in either 
Tabasco or Chiapas every year from 1996 to 2001.
    In fact, although evaluation of adjacent regions is a routine 
component of an APHIS review, APHIS solicited additional information. 
In the year 2001, seven outbreaks of CSF were recorded in Chiapas and 
two in Tabasco. The risks posed by these outbreaks for swine production 
in the State of Campeche are mitigated, however, by the animal movement 
control and inspection activities conducted by SAGARPA, the State 
Government of Campeche, and the State Livestock Promotion and 
Protection Committees. As we noted in the preamble to the September 
2002 proposed rule, animal movement into the Yucatan Peninsula States 
is tightly controlled. A regional quarantine line, known as the 
``Peninsula-Tabasco Quarantine Line,'' has 10 inspection points that 
conduct animal health inspection activities and vehicle disinfection.
    The commenter also requested more recent information with regard to 
the effectiveness of the quarantine line, noting that 2,881 seizures of 
swine were recorded in 1998.
    The Mexican Government has furnished data on the total number of 
seizures of swine, poultry, and bovine products and byproducts, as well 
as products of plant origin, made at this quarantine line for the years 
2001 and 2002. In 2001, there were 408 seizures, and in 2002, 7,488.
    The commmenter also inquired as to whether there was any additional 
evidence of CSF outbreaks in the Pet[aacute]n region of Guatemala, 
which abuts Campeche.
    We have no additional evidence of CSF outbreaks in that region. 
According to information the Mexican Government has received from 
Guatemala, the Pet[aacute]n Region is free of CSF, and Guatemala 
conducts epidemiological surveillance activities in that region in 
order to keep it free. CSF is more commonly reported in the southern 
region of Guatemala, which is not contiguous to Campeche.
    The commenter expressed some of the same concerns about the 
veterinary infrastructure of Quintana Roo as about Campeche, citing the 
absence of veterinarians certified to diagnose CSF and pseudorabies 
residing in the State and the consequent possibility that diagnosis of 
these diseases could be delayed. Since the surveillance activities and 
veterinary infrastructure of Quintana Roo parallel those of Campeche, 
we do not see delayed diagnosis as an issue of particular concern for 
Quintana Roo.
    The commenter requested information on how pork product importation 
is controlled at Puerto Morelos and who is responsible for the 
inspection and verification process. The commenter pointed out that a 
supporting document furnished by the Government of Mexico contained a 
statement that pork and pork products entering Quintana Roo by boat, 
chiefly bound for Cancun, undergo inspection at Puerto Morelos, yet 
there are no international port authorities there because Puerto 
Morelos is not considered to be a commercial port.
    We view the existing controls on the movement of pork and pork 
products into Quintana Roo by boat as adequate to prevent the 
introduction of CSF into the State. Quintana Roo imports pork and pork 
products produced in and shipped from TIF plants in the Mexican States 
of Aguascalientes, Chiapas, Michoacan, Nuevo Leon, Sonora, Tamaulipas, 
Yucatan, and the Federal District. These products are subject to 
regulations set down in Mexican Official Standard NOM-037-ZOO-1995, 
National Campaign against Classical Swine Fever, and in NOM-007-ZOO-
1994, National Campaign against Aujeszky's Disease (i.e., 
pseudorabies). No pork products are received into Quintana Roo from 
abroad, so we do not view the absence of international port authorities 
at Puerto Morelos as problematic.
    The commenter noted that, of the Mexican States from which Quintana 
Roo imports pork products and byproducts, only Sonora and Yucatan are 
recognized in this rulemaking as free of CSF. The commenter requested 
information on how SAGARPA would control movements of products into 
Quintana Roo and what guarantees with regard to compliance with heat 
treatment protocols would be provided to APHIS.
    As we have noted, pork and pork products entering Quintana Roo or 
other CSF-free zones must have been produced in and shipped from TIF 
plants. The Mexican Government regulations are more stringent for 
products produced in TIF plants located in CSF-affected zones than for 
products produced in plants in CSF-free zones. Only cooked or matured 
products are allowed to enter Quintana Roo from non-free zones, and 
these products are subject to various shipping, temperature, and 
recordkeeping requirements. Such products may only be transported in 
sealed vehicles. When the shipments of such pork and pork products 
arrive in the destination State, the Government-or Ministry-authorized 
personnel assigned to the checkpoints at the entrance to the State 
review the animal health certificate, certify that the seal has not 
been removed, and remove the seal and inspect the load to determine 
that it corresponds to what is stated in the animal health certificate.
    In addition to the existing controls placed upon the movement of 
pork and pork products from CSF control or eradication zones into free 
zones, as mentioned earlier, in order to be eligible to enter the 
United States, pork or pork products from Quintana Roo (as well as the 
other three Mexican States in this rule) will have to meet the 
certification requirements of Sec.  94.25. These include requirements 
that the pork or pork products must have been derived from swine born 
and raised in a CSF-free region and slaughtered in such a region at a 
federally inspected slaughter plant; that the pork or pork products 
have never been commingled with pork or pork products that have been in 
a CSF-affected region; and that the pork or pork products have not 
transited through such a region unless moved directly through the 
region to their

[[Page 15568]]

destination in a sealed means of conveyance with the seal intact upon 
arrival at the point of destination. We are confident that these 
certification requirements, as well as the existing Mexican Government 
regulations regarding the movement of pork and pork products into CSF-
free zones, will provide effective protection against commingling of 
products prior to their export from Quintana Roo to the United States.
    The commenter also expressed some concerns about infrastructure and 
product movement issues with regard to Sonora. The commenter asked 
whether the diagnostic laboratories operated by the group of 174 
producers located in the State of Sonora are accredited by the 
Government of Mexico to test for CSF and also inquired about who has 
responsibility for reporting diagnostic activities to the State. The 
commenter also claimed that it is unclear how documents are 
administered in Sonora for inter- and intrastate livestock movements. 
Noting that the document entitled ``Characterization of the State of 
Sonora for International Recognition as a CSF-Free Zone'' indicates 
that health certificates for control of animal movements are issued by 
livestock groups and have the signature of a veterinarian, the 
commenter requested information on where the data regarding these 
movements reside, in case access is needed for disease traceback 
purposes.
    At present there is one laboratory in Sonora that is authorized by 
SAGARPA to conduct CSF diagnostic tests. This laboratory, called the 
``Laboratorio Pecuarius,'' has personnel trained and authorized by 
SAGARPA to perform diagnostic activities according to national and 
international standards. The Laboratorio Pecuarius sends a monthly 
electronic report to the National Epidemiological Surveillance System 
on diagnoses made, including those related to CSF. This report is 
endorsed by the person in charge of the laboratory, who is an 
authorized veterinarian. In addition, the EADC follows up on any 
clinical suspicions of CSF and has diagnostic support from the EADC's 
high-security laboratory, since CSF is classified as an exotic disease 
for Sonora.
    We view Sonora's system of document administration for animal 
movement as adequate to allow traceback when necessary. Various copies 
of the animal health certificate that must accompany animals in transit 
are made and kept. One copy is kept by the user, another by the center 
issuing the certificate, and another by SAGARPA. Access to these 
documents may be obtained in two ways: Centrally, at SAGARPA's offices, 
and at the local level, through the issuing center. In addition, this 
information is processed by each certification body and sent to 
SAGARPA, which is in charge of compiling it and can have access to it 
if required.
    Noting that live swine entering the State of Yucatan are registered 
animals with high genetic value and come overland from Sonora and 
Sinaloa, the commenter requested information on what processes are in 
place to prevent the introduction of communicable diseases of swine 
into the State from infections that may occur as swine shipments move 
through regions of Mexico known to be infected by CSF, pseudorabies, 
and other diseases.
    Effective controls are in place to prevent the infection of swine 
in transit to Yucatan. Swine entering Yucatan from another Mexican 
State must come from a CSF-free State, such as Sonora or Sinaloa, in 
order to be marketed as breeding stock in Yucatan. Such shipments must 
be accompanied by animal health certificates. The vehicles in which the 
swine are carried must be kept sealed from the point of origin to the 
destination. If the vehicles that transported the swine move through a 
CSF-control zone before returning to their place of origin, they must 
be washed and disinfected with an authorized disinfectant. If the swine 
have traveled through States or zones of inferior health status, they 
must be kept in isolation for 20 days at their final destination. 
During this confinement, serological tests for CSF are conducted. Swine 
imported into Yucatan from regions outside Mexico must have originated 
in regions recognized as being CSF-free and must also be isolated upon 
arrival in Yucatan.
    In addition to the controls placed upon swine in transit by the 
Mexican Government, Sec.  94.25 includes, among other things, a 
requirement that live swine intended for export to the United States 
may not have transited a CSF-affected region 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.

Miscellaneous

    As we noted earlier in this document, in our September 2002 
proposed rule, we had proposed to remove references to Campeche, 
Quintana Roo, Sonora, and Yucatan that were contained in Sec.  94.15(b) 
of the regulations because we believed that paragraph, which, among 
other things, governs 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 approved by the Food Safety and Inspection Service of the 
USDA to export products to the United States. 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).
    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 Campeche, Quintana Roo, Sonora, and Yucatan to the 
lists of CSF-free regions and allows pork, pork products, live swine, 
and swine semen to be imported into the United States from those four 
Mexican States under certain conditions. We have determined that 15 
days are needed to ensure that APHIS and Department of Homeland 
Security--Bureau of Customs and Border Protection 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 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    This rule amends the regulations in 9 CFR part 94 by adding the 
Mexican States of Campeche, Quintana Roo, Sonora, and Yucatan to the 
lists of regions in Sec. Sec.  94.9 and 94.10 considered free of CSF 
and to the list of CSF-free regions in Sec.  94.25 from which live 
swine, pork, and pork products intended for export to the United States

[[Page 15569]]

must be certified as having originated in one of those regions or in 
another region recognized by APHIS as free of CSF and as not having 
been commingled, prior to export to the United States, with animals and 
animal products from regions where CSF exists.
    Based on the assumption that Campeche, Quintana Roo, Sonora, and 
Yucatan will not drastically increase their levels of production of 
live swine, swine semen, pork, and pork products over those of the last 
few years, we do not anticipate that U.S. producers of those 
commodities will experience any substantial negative economic effects 
as a result of this rulemaking. This is because the United States is 
expected to import only a small amount of those commodities from the 
four Mexican States.
    This rule is likely to have a minimal effect on U.S. live swine 
markets, both in the short term and in the medium term. As noted 
earlier, we will not begin issuing import permits for live swine or 
swine semen from the four Mexican States until our concerns about blue 
eye disease are allayed. When such imports do commence, we expect that 
their volume will be limited and their economic impact small. Hog 
inventory of the four States covered by this rulemaking amounted to 
about 5 percent of U.S. hog and pig inventory in 2001.\1\ Moreover, the 
four States covered by this rulemaking account for only about 13 
percent of Mexico's live swine production. In 2001, the State of Sonora 
produced 10 percent of Mexico's live swine, Yucatan 2.3 percent, 
Quintana Roo 0.7 percent, and Campeche 0.2 percent. Figures for live 
swine are provided in table 1.
---------------------------------------------------------------------------

    \1\ Agricultural Outlook, Aug. 2002, p.47.

                     Table 1.--Live Hogs in Four Mexican States and Mexico as a Whole, 2001
----------------------------------------------------------------------------------------------------------------
                                                                           Hogs in backyard
                  State                    Hogs in commercial farms           operations             All hogs
----------------------------------------------------------------------------------------------------------------
Campeche................................  6,612 (in 5 farms)........  31,607 (in 137,174 farms).          38,219
Quintana Roo............................  29,179 (in 38 farms)......  137,174 (in 13,450 farms).         166,353
Sonora..................................  2,536,000 (in 174 farms)..  200 (unknown farms).......       2,536,200
Yucatan.................................  500,000 (in 252 farms)....  82,672 (in 8,786 farms)...         582,672
Sum of four States......................  3,071,791.................  251,653...................       3,323,444
Mexico..................................      25,736,000 (pig crop + beginning stocks) in both commercial and
                                                                    backyard operations
----------------------------------------------------------------------------------------------------------------
Source: Risk Assessments of Importing Pork into the United States from the Mexican States of Campeche, Quintana
  Roo, Sonora, and Yucatan; Risk Analysis Systems, PPD, APHIS, USDA.

    This rulemaking is also unlikely to have a significant effect on 
U.S. pork and pork products markets because, as with live swine, the 
United States is unlikely to import large amounts of these commodities 
from Campeche, Quintana Roo, Sonora, and Yucatan. The United States is 
a net exporter of pork, while Mexico, as indicated below in tables 2 
and 3, is a net importer. Between 2000 and 2002, Mexico imported 
between 130,000 and 325,000 metric tons and exported between 35,000 and 
61,000 metric tons.

                                  Table 2.--Mexican Pork Production and Imports
                                                [In metric tons]
----------------------------------------------------------------------------------------------------------------
                                                                                                      2000-2002
                      Calendar year                           2000          2001          2002         average
----------------------------------------------------------------------------------------------------------------
Production..............................................     1,035,000     1,057,000     1,085,000     1,059,000
Imports.................................................       130,000       150,000       325,000       201,667
                                                         ---------------
    Total supply........................................     1,165,000     1,207,000     1,410,000    1,260,667
----------------------------------------------------------------------------------------------------------------
Source: USDA, FAS, GAIN Report  MX4014, Mexico, Livestock and Products, Semiannual Reports 2001 and
  2004.


                                 Table 3.--Mexican Pork Consumption and Exports
                                                [In metric tons]
----------------------------------------------------------------------------------------------------------------
                                                                                                      2000-2002
                      Calendar year                           2000          2001          2002         average
----------------------------------------------------------------------------------------------------------------
Exports.................................................        35,000        40,000        61,000        45,333
Domestic consumption....................................     1,130,000     1,167,000     1,349,000     1,215,333
                                                         ---------------
    Total demand........................................     1,165,000     1,207,000     1,410,000    1,260,667
----------------------------------------------------------------------------------------------------------------
Source: USDA, FAS, GAIN Report  MX4014, Mexico, Livestock and Products, Semiannual Reports 2001 and
  2004.

2Economic Impact on Small Entities

    The Regulatory Flexibility Act requires that agencies consider the 
economic impact of their rules on small entities. The domestic entities 
most likely to be affected by our declaring the Mexican States of 
Campeche, Quintana Roo, Sonora, and Yucatan free of CSF are pork 
producers.
    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 (SBA) 
size criteria.
    We do not expect that U.S. hog producers, U.S. exporters of live 
hogs,

[[Page 15570]]

or U.S. exporters of pork and pork products, small or otherwise, will 
be affected significantly by this final rule. This is because, for the 
reasons discussed above, the amount of live swine, pork, other pork 
products, and swine semen imported into the United States from the 
Mexican States of Sonora, Yucatan, Campeche, and Quintana Roo is likely 
to be small.
    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 no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

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; 7 CFR 2.22, 2.80, and 371.4.


Sec.  94.9  [Amended]

0
2. In Sec.  94.9, paragraph (a) is amended by removing the words 
``Chihuahua, and Sinaloa'' and adding the words ``Campeche, Chihuahua, 
Quintana Roo, Sinaloa, Sonora, and Yucatan'' in their place.


Sec.  94.10  [Amended]

0
3. In Sec.  94.10, paragraph (a) is amended by removing the words 
``Chihuahua, and Sinaloa'' and adding the words ``Campeche, Chihuahua, 
Quintana Roo, Sinaloa, Sonora, and Yucatan'' in their place.


Sec.  94.21  [Removed and Reserved]

0
4. Section 94.21 is removed and reserved.


Sec.  94.25  [Amended]

0
5. In Sec.  94.25, paragraph (a) is amended by removing the words 
``Chihuahua, and Sinaloa'' and adding the words ``Campeche, Chihuahua, 
Quintana Roo, Sinaloa, Sonora, and Yucatan'' in their place.

    Done in Washington, DC, this 22nd day of March 2005.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-6028 Filed 3-25-05; 8:45 am]
BILLING CODE 3410-34-P