Classical Swine Fever Status of Chile

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending the regulations for importing animals and animal products by adding Chile to the list of regions we recognize as free of classical swine fever (CSF). We are taking this action at the request of the Government of Chile and after conducting a risk evaluation that indicates that Chile is free of this disease. We are also adding Chile to a list of CSF-free 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, and amending those requirements to accommodate the addition of Chile to the list. These actions relieve restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Chile while continuing to protect against the introduction of this disease into the United States.

EFFECTIVE DATE:

July 28, 2004.

FOR FURTHER INFORMATION CONTACT:

Dr. Charisse Cleare, Senior 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 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 (FMD), African swine fever (ASF), 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.

On November 13, 2003, we published in the Federal Register (68 FR 64274-64282, Docket No. 03-009-1) a proposal to amend the regulations by adding Chile to the list of regions we recognize as free of CSF. We also proposed to add Chile to a list of CSF-free 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, and to amend those requirements to accommodate the addition of Chile to the list. In addition, we proposed to amend those certification requirements to require, for pork and pork products from a region listed in § 94.24, an additional statement that the swine from which the pork and pork products were derived have not lived in a region affected with CSF.

We solicited comments concerning our proposal for 60 days ending January 12, 2004. We received three comments by that date. They were from an importer and from associations of pork producers. Two of the commenters supported the proposed rule. The third commenter asked for additional information regarding several issues in the proposed rule. These issues are discussed below by topic.

The commenter requested additional information about the ongoing surveillance that Chile's Agricultural and Livestock Service (Servicio Agricola y Ganadero, SAG) conducts for CSF in Chilean commercial swine. The commenter stated that data referred to in material supporting Chile's request to be considered free of CSF are several years old and appear to be “point-in-time” samples related to managing and eliminating the last outbreaks of CSF in Chile in 1995 and 1996. The commenter asked whether there is a plan for federally funded, routine, ongoing surveillance for commercial and noncommercial populations of swine in Chile. The commenter also wanted to know whether both swine held on breeding farms and swine intended for slaughter were being sampled as part of the testing and what specific level of detection the current testing supports.

As stated in the evaluation that we conducted regarding the CSF status of Chile, SAG tested swine on 321 family farms, located in all 13 regions of Chile, for CSF in 2000 and 2001. The number of samples totaled 1,705. In addition, the evaluation referred to serological data for 2002 that SAG provided. Those data included samples taken at both commercial premises and backyard (family) premises that possessed or raised swine. These data reflected testing performed from January to December 2002. We based our determination that Chile is free of CSF on these data, not the data from the earlier testing conducted after the last outbreaks of CSF in Chile to which the commenter refers.

Chile does have a plan for federally funded, routine, ongoing surveillance for CSF in both commercial and noncommercial populations of swine. Both swine held on breeding farms and swine held on commercial properties that send swine for slaughter at export facilities are tested using an enzyme-linked immunosorbent assay for CSF under the surveillance plan.

As to the specific level of detection, the sampling design for 2002 was based on two sets of high-risk herds. In the first set, the sampling design for herds that were considered high risk due to their proximity to certain areas (airports, seaports, land borders, garbage dumps, or owners with a history of feeding waste to pigs) was intended to detect a 20 percent within-herd prevalence. In the second set, the sampling design for herds considered high risk due to a history of past positive serology was intended to detect a 1 percent within-herd prevalence level.

The commenter also asked whether there is a plan for federally funded, routine, ongoing surveillance for wild boars in Chile, stating that it did not appear that a surveillance program had been developed or conducted for CSF or other communicable diseases of swine in the wild boar population. The commenter stated that the wild boar population should be thoroughly assessed for possible infection by CSF and other communicable diseases of swine before the Animal and Plant Health Inspection Service (APHIS) declares Chile free of CSF.

As of December 2002, SAG had not performed surveillance for CSF in the free-range wild boar population. However, SAG performed surveillance for CSF at wild boar operations in Chile, based on the rationale that animals at these operations originated as wild animals and have been in captivity for several generations.

APHIS has no evidence that suggests that CSF is present in or has ever been present in feral swine in Chile. We consider this situation to be analogous to conditions in the United States. There is no evidence to suggest that CSF is present in feral swine within the continental United States. Therefore, APHIS does not conduct surveillance for CSF in feral swine within the continental United States at this time. Under the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures and the principle of national treatment in the WTO General Agreement on Tariffs and Trade, APHIS must establish requirements for the importation of animals and animal products that are no more restrictive than the requirements APHIS imposes on the interstate movement of animals and animal products. Given these circumstances, APHIS does not believe it would be appropriate to require Chile to conduct CSF surveillance in its wild boar population. We are making no changes to the proposed rule in response to this comment.

Given the situation discussed above, the commenter requested assurance that wild boar in Chile pose a negligible, minimal risk of transmitting diseases to commercial swine. The commenter cited recent experiences in European countries as indicating that the two populations may be linked with respect to CSF transmission.

As we discussed in the proposed rule, several circumstances mitigate the risk of disease transmission, if any disease were to be present, from wild boar to commercial swine in Chile. There are few commercial swine operations in those regions of Chile where there are concentrated populations of wild boar; rather, family farms are usually prevalent in such regions. Even if CSF or another communicable disease of swine were present in the wild boar population, it is unlikely that such a disease would be transmitted from wild boar to commercial swine facilities because of the biosecurity measures in place at those facilities. In addition, the mountainous habitat of the wild boars and the areas of Chile devoted to domestic swine production are separated by forests, which the wild boar do not enter because there is no food for them in the forests.

In the proposed rule, we stated that the official diagnostic laboratory of SAG in Santiago does not isolate the causative agent for CSF because the biosecurity level of the laboratory is not sufficient to allow use of live CSF virus, which is necessary to confirm a diagnosis of CSF. This means that Chile must use a laboratory in Spain to confirm a diagnosis of CSF. We explained further that the biosecurity controls Chile imposes when a suspected case of CSF is discovered would be effective at containing the spread of a possible CSF infection even without an immediate confirmation of a CSF diagnosis. The commenter agreed with APHIS on this point, but requested that we discuss whether confirmatory testing for FMD and ASF could be accomplished within Chile. If confirmatory testing for these diseases could not be accomplished within Chile, the commenter asserted, the importation of live swine, pork, and pork products from Chile would pose a risk to the health of U.S. swine.

We consider Chile to be free of both FMD and ASF. In making the determination that these diseases do not exist in Chile, we considered Chile's diagnostic capabilities for these diseases, in the same way that we considered Chile's diagnostic capability for CSF in the proposed rule. When we determined that Chile was free from FMD and ASF, we evaluated Chile's diagnostic capabilities for these diseases and determined that they were satisfactory. If we were to determine that Chile's diagnostic capabilities for either of these diseases were inadequate at some point in the future, we would undertake separate rulemaking to amend § 94.1 (which lists regions free of FMD and rinderpest) or § 94.8 (which lists regions where ASF exists) accordingly. We are making no changes to the proposed rule in response to this comment.

The commenter noted that the United States is free of blue-eye disease (BED), and that BED appears to be a disease concern elsewhere. Given that live swine from Chile would be allowed to be imported into the United States if Chile was declared free of CSF, the commenter was concerned about the BED status of Chilean swine.

At this time, APHIS has no evidence that BED is present in Chile. If the commenter has such evidence, we would be willing to consider it. The proposed rule was prompted by a request from Chile to evaluate its CSF status; the risk evaluation and proposed rule addressed the risk of a possible CSF introduction into the United States via swine, pork, or pork products imported from Chile. If it becomes necessary to restrict imports of Chilean swine, pork, or pork products due to BED, we will undertake separate rulemaking to restrict their importation or, in the case of live swine, use our authority under § 93.504(a)(3) to deny the swine a permit for importation into the United States due to communicable disease conditions in Chile.

The commenter asked that APHIS clarify the circumstances that prompt us to conduct a qualitative risk assessment rather than a quantitative risk assessment. The commenter stated that semi-quantitative or quantitative analyses allow for a more standardized risk evaluation and allow stakeholders to more easily compare risks and determine what level of risk APHIS considers acceptable. The commenter also questioned the value of qualitative risk assessments, stating that such assessments rely too heavily on the information gathered by a small site visit team, despite the obvious skills of the site team members.

APHIS' decision on whether to conduct a qualitative or quantitative risk assessment when evaluating the disease status of a region is dependent primarily on two factors. One of these is the disease conditions in the region that has requested to be evaluated regarding its disease status. Regions that request to be declared free of a disease typically have not reported an outbreak of the relevant disease in many years and do not allow vaccination, which might mask disease. Such regions may be considered to pose a relatively low risk for disease presence. For such regions, APHIS has historically conducted qualitative analyses when evaluating their disease status. Chile's last outbreak of CSF occurred in 1996, and Chile no longer vaccinates swine for CSF; these considerations indicated to us that a qualitative risk assessment was appropriate.

The second factor is whether or not we perceive that there may be underlying risk in the region. Regions for which quantitative analyses are conducted are typically those for which a qualitative evaluation has suggested that the region poses a higher level of risk than that described above. Risks of trade in commodities from the higher-risk regions often lend themselves to evaluation by a quantitative risk analysis model. However, no evidence gathered during the qualitative risk assessment for Chile indicated that such underlying risks exist in Chile for CSF. Based on these considerations, we conducted a qualitative risk assessment to evaluate whether Chile is free from CSF.

APHIS is preparing a description of its regionalization process, which will be posted on the Veterinary Services Web site when it is finalized. An announcement of its availability will be published in the Federal Register in the near future. Among other things, the description will outline the way in which APHIS conducts and applies risk analyses to assist with the decisionmaking process for regionalization.

We are, however, making minor editorial changes to the regulatory text to improve clarity.

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 above.

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 Chile to the lists of regions considered free of CSF and allows pork, pork products, live swine, and swine semen to be imported into the United States from Chile, subject to certain conditions. We have determined that approximately 2 weeks 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.

Under the regulations in 9 CFR part 94, the importation into the United States of live swine, pork, pork products, and swine semen that originates in or transits any region where CSF exists is generally prohibited, except for certain pork products processed in accordance with the regulations. Furthermore, even if a region is considered free of CSF, the importation of pork and pork products from that region may be restricted, depending on the region's proximity to or trading relationships with regions where CSF exists. CSF is a transmissible animal disease with potentially serious consequences for international trade of animals and animal products.

The Agriculture and Livestock Service of the Government of Chile asked APHIS to evaluate Chile's CSF status. APHIS conducted a site visit in Chile and, using data from this site visit and data supplied by the Government of Chile, performed a subsequent risk evaluation that indicated that Chile is free of CSF. This final rule, therefore, recognizes Chile as free of CSF. However, since Chile shares borders with regions that the United States does not recognize as free of CSF, imports live swine from a region that the United States does not recognize as free of CSF, and imports certain products from regions affected with CSF under conditions that are less restrictive than those in our regulations in 9 CFR part 94, we are also adding certification requirements for live swine, pork, and pork products imported into the United States from Chile to ensure their freedom from CSF.

In 1997, Chile had 105,665 swine farms on which 1.7 million swine were raised. There were 289 commercial premises, which represented 69 percent of Chile's hog facilities. In the United States in 2000, on the other hand, there were 98,460 swine producers raising about 59,407,000 swine valued at $4.26 billion. Chile has never exported live swine to the United States. In 1998, the United States imported from Chile 18 metric tons of frozen swine edible offal (Harmonized Tariff Schedule [HS] code number 020649). No other pork meat or any other pork product has been imported by the United States from Chile since then (table 1).

Frozen and dried pork accounts for 87 percent of all Chilean exports of pork and pork products; the remaining 13 percent consists of either fresh or chilled pork. In 2000, Chile exported 33,900 metric tons of pork. Of this, 30.1 metric tons was cooked pork, which was exported either frozen or dried (table 2). That same year, the United States imported 368,700 metric tons of pork, more than 10 times the total of Chile's pork exports.

On average, between 1998 and 2001, Chile's global exports of live swine amounted to approximately 0.3 percent of the volume of U.S. imports of live swine (tables 3 and 4). Specifically, Chile's global exports of live swine were 0.28 percent of the volume of U.S. imports of live swine in 1998, 0.33 percent in 1999, 0.39 percent in 2000, and 0.32 percent in 2001. Between 1998 and 2001, the volume of Chile's exports of pork and pork products to the world was, on average, equivalent to 9 percent of the volume of U.S. imports of pork and pork products.

Economic Effects on Small Entities

The Regulatory Flexibility Act requires that agencies consider the economic effects of their rules on small entities. Domestic swine producers and processors of pork and pork products, as well as brokers, agents and others in the United States who would become involved in any future importation and sale of swine, pork, and pork products from Chile, are most likely to be directly affected by this change to Chile's CSF status. The number and size of the entities that may become involved in any future importation and sale of swine (or products) from Chile is unknown. However, it is reasonable to assume that most will be small, based on the Small Business Administration's standards, since most businesses are classified as small under those standards.

From an economic standpoint, this change in Chile's CSF status should have little or no effect on domestic entities in the United States. This is because exports from Chile in quantities sufficient to have a significant effect on the U.S. market are unlikely. We do not anticipate that any U.S. entities, small or otherwise, will experience any significant economic effects as a result of this action.

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

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0235.

Government Paperwork Elimination Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 9 CFR Part 94

• Animal diseases
• Imports
• Livestock
• Meat and meat products
• Milk
• Poultry and poultry products
• Reporting and recordkeeping requirements

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.

2. In § 94.9, paragraph (a) is amended by adding the word “Chile;” after the word “Canada;”.

3. In § 94.10, paragraph (a) is amended by adding the word “Chile;” after the word “Canada;”.

4. Section 94.24 is revised to read as follows.