05-6028. 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.

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; [phone].

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 §§ 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 § 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 § 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, §§ 94.19 through 94.25 have been redesignated as §§ 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 § 94.20, this final rule refers to § 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 § 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 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 §§ 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 § 94.24 (as noted, that section has since been redesignated as § 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 §§ 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 §§ 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 § 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 §§ 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 § 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 § 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 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 § 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 § 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 § 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 § 94.21 for the importation of those commodities from Sonora and Yucatan. Among other things, § 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 § 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 § 94.21 into the certification requirements of § 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 § 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 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 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 Petán 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 Petán 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 § 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 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, § 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 § 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 § 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 § 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 §§ 94.9 and 94.10 considered free of CSF and to the list of CSF-free regions in § 94.25 from which live swine, pork, and pork products intended for export to the United States 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.

Table 1.—Live Hogs in Four Mexican States and Mexico as a Whole, 2001

State	Hogs in commercial farms	Hogs in backyard 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]

Calendar year	2000	2001	2002	2000-2002 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]

Calendar year	2000	2001	2002	2000-2002 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.

2

Economic 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, 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

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

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.

§ 94.9

[Amended]

2. In § 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.

§ 94.10

[Amended]

3. In § 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.

§ 94.21

[Removed and Reserved]

4. Section 94.21 is removed and reserved.

§ 94.25

[Amended]

5. In § 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.

Footnotes

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