E7-1530. Classical Swine Fever Status of the Mexican State of Nayarit

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of classical swine fever (CSF). We are proposing this action at the request of the Mexican Government and the State of Nayarit, and after conducting a risk evaluation that indicates that Nayarit is free of this disease. We are also proposing to add Nayarit to the list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. These actions would relieve certain CSF-related restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Nayarit while continuing to protect against the introduction of this disease into the United States.

DATES:

We will consider all comments that we receive on or before April 2, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0104 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0104, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0104.

Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Chip Wells, Senior Staff Veterinarian, Regionalization Evaluation Services-Import, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; [phone].

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation into the United States of specified animals and animal products in order to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease, African swine fever, classical swine fever (CSF), and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.9 of the regulations restricts the importation into the United States of pork and pork products from regions where CSF is known to exist. Section 94.10 of the regulations prohibits, with certain exceptions, the importation of swine that originate in or are shipped from or transit any region in which CSF is known to exist. Sections 94.9 and 94.10 provide that CSF exists in all regions of the world except for certain regions listed in those sections.

The Government of Mexico and the Mexican State of Nayarit requested that the Animal and Plant Health Inspection Service (APHIS) evaluate the animal disease status of the State of Nayarit with respect to CSF and provided information in support of that request in accordance with 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.” Using information submitted to us by the Federal Government of Mexico and State Government of Nayarit, as well as information gathered during a site visit by APHIS staff to Nayarit, we have reviewed and analyzed the animal health status of Nayarit with respect to CSF. Our determinations concerning this request, based on the information submitted to us and the information we gathered, are set forth below.

Risk Analysis

APHIS conducted a risk analysis to examine the risk of introducing CSF ^[1] from the importation of swine and swine products from Nayarit, Mexico. These findings are described in further detail in an April 2006 risk analysis that may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) We summarize our findings for each of the 11 factors in 9 CFR 92.2 below and summarize our risk considerations of these findings following our discussions of the factors.

Authority, Organization, and Veterinary Infrastructure

Nayarit has the legal authority to enforce Federal and State CSF regulations and the necessary veterinary infrastructure to carry out CSF surveillance and control activities. One of the strengths observed by the joint APHIS/Canadian Food Inspection Agency (CFIA) site-visit team was the apparent good communication and cooperation existing among the Mexican Federal, State, and municipal government officials, the Animal Agriculture Promotion and Protection Committee (CFPP) representatives, and swine producers. APHIS could not identify any risk issues associated with this factor that would pose an unacceptable risk to the United States if trade with Nayarit in swine, pork, and pork products were to occur.

Disease Status

The State of Nayarit has not reported a clinical case of CSF since 1989 and was declared free of CSF by the Government of Mexico in May 1999. This 15-year time period exceeds that recommended by the World Organization for Animal Health for the disease-free period required for CSF disease freedom recognition. Wild boar are not known to exist in Nayarit, and therefore, are not considered by APHIS to be a risk for introduction or spread of CSF virus in the State. APHIS also concluded that the CSF surveillance program, which is discussed in more detail in the risk analysis, would likely detect a change in the disease status of Nayarit (i.e. introduction of CSF). APHIS could not identify any risks associated with this factor that would pose any unacceptable risk to the United States if trade with Nayarit in swine, pork, and pork products were to occur.

Disease Status of Adjacent Regions

Nayarit shares borders with the States of Durango, Jalisco, Sinaloa, and Zacatecas. Sinaloa and Durango were declared to be CSF-free by the Mexican Government in 1993 and 1999, respectively. Zacatecas and Jalisco were declared to be in the eradication phase by the Mexican Government in 2004. On July 18, 2006 (after the risk analysis for this proposal was drafted), the Government of Mexico declared the States of Jalisco and Zacatecas to be CSF-free. Although APHIS considers Sinaloa to be CSF-free, APHIS has not evaluated Durango, Zacatecas, or Jalisco, and therefore currently considers them to be CSF-affected.

The existence of common land borders with CSF-affected regions does present a risk for reintroducing CSF into Nayarit. However, movement controls and certification requirements regarding region of origin and commingling concerns are designed to mitigate this risk. Because Nayarit has common land borders with CSF-affected regions, we would add the State to the list in § 94.25 of regions considered free of CSF, but to which additional CSF-related certification requirements apply. The specific requirements are explained later in this document under the heading “Certification Requirements.”

Extent of Active Disease Control Program

CSF is considered exotic to Nayarit; therefore, it does not have an active disease control program. However, the Mexican Government has an ongoing active CSF disease control program which includes surveillance, movement control, and emergency response provisions for the CSF-free States such as Nayarit. The APHIS site visit team concluded that Nayarit is in compliance with provisions of the program and has maintained its CSF-free designation since 1999.

Vaccination

Vaccination for CSF ceased in Nayarit in March 1996, just before its status changed from control to eradication phase. Since that date, CSF vaccination has been prohibited in Nayarit.

Separation From Adjacent Regions of Higher Risk

The State of Nayarit is located along the Pacific coastline of central Mexico. Nayarit borders the States of Sinaloa and Durango on the north, Zacatecas to the east, and Jalisco on the east and south. Natural barriers to disease transmission include the Pacific Ocean to the west and the Sierra Madre Occidental Mountains to the east.

Surface transport into and out of Nayarit primarily move along a north-south corridor from Sinaloa in the north and Jalisco in the south. There are no major seaports on the Nayarit coast and commercial air traffic is light, limited to regional passenger service and private aircraft.

APHIS has determined that the natural barriers of the mountains and ocean, and the few highways into Nayarit, limit the movement of swine and products into the State, thus reducing the risk of CSF introduction.

Movement Controls

The movement controls established by the Mexican National CSF Campaign and implemented and enforced by the Nayarit officials limit the illegal movement of swine or pork products from CSF affected zones. The system of inspection posts in Nayarit was cited by the APHIS site visit team as a strong point in the State's CSF control program. The system of inspection posts ensures reasonable enforcement of these provisions, significantly limiting the risk of CSF introduction into Nayarit. These findings are described in further detail in the risk analysis.

Livestock Demographics and Marketing Practices

Nayarit is not a major swine production area. In 2004, there were 34 commercial swine farms in Nayarit, with a population of 30,634 animals. Only 2 farms had over 4,000 hogs. Another 18,650 hogs are reared in backyards, intended for personal consumption by their owners. The slaughtering and processing of swine in Nayarit is currently handled by State-inspected municipal plants, since there are no federally inspected (in Spanish, Tipo Inspección Federal, or TIF) plants handling swine in Nayarit; slaughter and processing through a TIF plant would be necessary for pork to be exported to the United States as well as to CSF-free States in Mexico.

Currently, Nayarit consumes more pork than it produces and does not have the infrastructure, such as TIF plants, necessary to meet the export requirements of § 94.25 for exportation of pork or pork products to the United States. This dynamic limits the legal movement of swine and pork from Nayarit to the United States. Should producers in Nayarit develop a desire to export, they would need to identify an appropriate TIF plant outside of the State or request that a plant within the State be certified as a TIF plant in accordance with the regulatory requirements of the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS).

Disease Surveillance

An active CSF surveillance program is conducted in Nayarit in accordance with the National CSF Campaign. Nayarit conducts an annual serological sampling survey in commercial and backyard swine herds. APHIS concludes that the surveillance program is sufficient to detect the presence of CSF virus if it were to be introduced into Nayarit.

Diagnostic Laboratory Capabilities

The State of Nayarit does not have a diagnostic laboratory accredited for CSF diagnosis. All samples deemed suspicious for CSF are sent to the National Veterinary Services Diagnostic Laboratory (CENASA), located in the State of Mexico. This laboratory has been previously evaluated in other risk analyses and was not reevaluated during the site visit to Nayarit. Based on these prior assessments, APHIS has confidence that CENASA would be able to detect CSF in samples submitted for serological testing.

Considering the relatively small swine population in Nayarit, this arrangement is satisfactory for CSF diagnosis and surveillance needs. However, if the swine population in the State increases significantly, this factor may need to be reassessed.

Emergency Response Capacity

Mexico has an established national system for surveillance and reporting of exotic animal diseases operated by their Ministry of Agriculture, Livestock Production, Rural Development, Fishery, and Food (SAGARPA) in collaboration with the Mexico-United States Commission for the Prevention of Foot and Mouth Disease and Other Exotic Animal Diseases. As a disease-free State, CSF virus is considered to be exotic in Nayarit.

Whenever CSF is suspected, SAGARPA must immediately be notified and a precautionary quarantine is implemented in the focal and perifocal area to include the affected, exposed, and at-risk premises. If CSF is confirmed by CENASA, then the quarantine becomes definitive. Movement controls are implemented, sick animals are killed, dead animals are sanitarily disposed of, and an epidemiological investigation ensues.

A close association and cooperation was observed between the Mexican Federal, State, and municipal government officials, the CFPP staff, and swine producers. This cooperation was especially effective in the operation of Nayarit's existing animal health checkpoints. Although no CSF suspect cases have been reported in Nayarit in recent years, these officials demonstrated knowledge of processes required under the National CSF Emergency Plan. These observations give APHIS confidence that an effective veterinary infrastructure exists in Nayarit capable of responding to a CSF outbreak. APHIS was unable to identify specific limitations in this system that would pose a risk to the United States.

These findings are described in further detail in a qualitative evaluation that may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT and may be viewed on the Internet at http://www.regulations.gov. (Instructions for accessing Regulations.gov are provided under the heading ADDRESSES at the beginning of this proposed rule.) The evaluation documents the factors that have led us to conclude that Nayarit is free of CSF. Therefore, we are proposing to recognize the Mexican State of Nayarit as free of CSF and to add it to the lists in §§ 94.9 and 94.10 of regions where CSF is not known to exist.

Certification Requirements

As previously noted, we are proposing to amend § 94.25 by adding the State of Nayarit to the list of regions in § 94.25, which, among other things, applies restrictions on the importation of live swine, pork, or pork products from certain regions that are listed as free of CSF in §§ 94.9(a) and 94.10(a).

A CSF-free region may be added to the list in § 94.25(a) when it supplements its pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplements its pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of 9 CFR part 94, or has a common land border with a CSF-affected region, or imports live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. As previously noted, Nayarit shares land borders with Durango, Zacatecas, and Jalisco, which are States we have not evaluated for CSF and thus are considered by APHIS to be CSF-affected. Thus, even though we are proposing to declare Nayarit free of CSF, there is a risk that live swine, pork, or pork products originating in Nayarit may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States.

Adding Nayarit to the list of regions in § 94.25(a) would mean that live swine, pork, or pork products and shipstores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under parts 95 or 96 of this chapter, may not be imported into the United States unless the requirements described below were met. For all swine, pork, and pork products, each shipment would have to be accompanied by a certification issued by a full-time salaried veterinary officer of the Government of Mexico that would have to be presented to an authorized inspector at the port of arrival in the United States. Pursuant to § 94.25(b), the certification for live swine would have to state that:

• The swine have not lived in any region where CSF is considered to exist;
• The swine have not been in contact with swine that have been in a region where CSF is considered to exist;
• The swine have not transited through a region where CSF is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
• The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of 9 CFR 93.502.

Pursuant to § 94.25(c), the certification accompanying pork or pork products would have to state that:

• The pork or pork products are derived from swine that were born and raised in a CSF-free region and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the FSIS regulations in 9 CFR 327.2;
• The pork or pork products were derived from swine that have not lived in any region where CSF is considered to exist;
• The pork or pork products have never been commingled with pork or pork products from any region where CSF is considered to exist;
• The pork or pork products have not transited through a region where CSF is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and
• If processed, the pork or pork products were processed in a CSF-free region in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico.

As mentioned above, the State of Nayarit currently does not have any federally inspected (TIF) slaughtering or processing plants. Accordingly, no pork or pork products could be exported from Nayarit until this and all other requirements of § 94.25 have been met.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This proposed rule would amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of CSF. We are proposing this action at the request of the Mexican Government and the State of Nayarit and after conducting a risk evaluation that indicates that Nayarit is free of this disease. We are also proposing to add Nayarit to a list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. These actions would relieve certain CSF-related restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Nayarit while continuing to protect against the introduction of this disease into the United States.

This proposed rule is likely to have a minimal effect on U.S. live swine markets, both in the short term and in the medium term. Hog inventory of the State covered by this rulemaking amounted to about four-tenths of 1 percent of U.S. hog and pig inventory in 2004.^[2] In 2004, there were 34 commercial swine farms in Nayarit with a population of 30,634 hogs and pigs. Another 18,650 hogs and pigs were reared in backyards, intended for consumption by the owners (table 1). Nayarit has never exported swine to the United States. This State—as is the case with Mexico as a whole—is a net importer of swine (table 2).

In 2004, the State of Nayarit produced around 4,000 metric tons of pork, an amount equal to 0.35 percent of Mexico's production of pork (table 3). Slaughter/processing plants handling swine in Nayarit are not TIF establishments. Only TIF plants are allowed to ship pork and pork products abroad or to CSF-free States in Mexico.

Table 1.—Live Hogs in Nayarit, 2000-2004, and Mexico as a Whole, 2004

Nayarit	Hogs in commercial farms	Hogs in backyard operations	All hogs
2000	10,809	30,006	40,815
2001	36,799	29,587	66,386
2002	34,279	30,890	65,169
2003	36,665	25,010	61,675
2004	30,634	18,650	49,284
Mexico (2004)	26,208,000 (pig crop + beginning stocks) in both commercial and backyard operations.
Source: SAGARPA; APHIS Risk Analysis on Importation of Classical Swine Fever (CSF) Virus from Nayarit, Mexico; Regional Evaluation Services, National Center for Import and Export, VS, APHIS, USDA; and Regionalization Evaluation Services (http://www.aphis.usda.gov/​vs/​ncie/​reg-request.html), April 2006.

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 Nayarit. The United States is a net exporter of pork, while Mexico, as indicated below in tables 2 and 3, is a net importer. In 2004, Mexico exported 36,000 metric tons of pork, averaging only around 3.2 percent of total Mexican pork production.

Table 2.—U.S. and Mexican Trade With the World of Live Swine and Pork, 2004

Commodity	Exports	Imports	Net trade with the world
Live swine (head):
Mexican swine	0	189,867	189,867 (net imports) *.
U.S. swine	174,010	8,505,518	8,331,508 (net imports).
Pork (metric tons):
Mexican pork	36,476	86,102	49,626 (net imports).
U.S. pork	747,357	469,442	277,916 (net exports).
*Net Imports = Imports minus exports; Net Exports = Exports minus imports
Source: USDA, FAS, UN Trade Statistics, 6-digit data.

Table 3.—Swine Production (Head) and Pork Production (Metric Tons) in United States and Mexico, 2004

United States		Mexico		Nayarit, MX
Swine	Pork	Swine	Pork	Swine	Pork
60,000,000	9,302,759	15,350,000	1,150,000	49,000	4,080
Source: USDA, FAS, GAIN Report # MX6010, Mexico, Livestock and Products, Semiannual Report 2006.

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 proposal to declare the Mexican State of Nayarit free of CSF are pork producers.

According to the 2002 Agricultural Census, there were about 66,036 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, would be affected significantly by this proposed rule. This is because, for the reasons discussed above, the amount of live swine, pork, and other pork products imported into the United States from the Mexican State of Nayarit is likely to be small.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with our proposal to list the Mexican State of Nayarit as free of CSF, we have prepared an environmental assessment. The environmental assessment was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

This proposed 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 propose to amend

PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

1. The authority citation for part 94 would continue to read as follows:

Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, 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) would be amended by adding the word “Nayarit,” after the word “Chihuahua,”.

§ 94.10

[Amended]

3. In § 94.10, paragraph (a) would be amended by adding the word “Nayarit,” after the word “Chihuahua,”.

§ 94.25

[Amended]

4. In § 94.25, paragraph (a) would be amended by adding the word “Nayarit,” after the word “Chihuahua,”.

Done in Washington, DC this 25th day of January 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  APHIS considers all of Mexico to be affected by blue-eye disease of pigs, a disease which is not known to exist in the United States. APHIS has not evaluated Mexico, including the State of Nayarit, for blue-eye disease. As a result, APHIS denies permits for the importation of live swine and swine semen from all of Mexico, including Nayarit (9 CFR 93.504(a)(3)). CSF is the disease hazard evaluated in the risk analysis, which does not address blue-eye disease.

2.  APHIS Risk Analysis on Importation of Classical Swine Fever (CSF) Virus from Nayarit, Mexico; Regional Evaluation Services, National Center for Import and Export, VS, APHIS, USDA; and USDA, FAS, GAIN Report # MX6010, Mexico, Livestock and Products, Semiannual Report 2006.