03-26042. Change in Disease Status of East Anglia With Regard to Classical Swine Fever

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending the regulations governing the importation of certain animals, meat, and other animal products by restoring East Anglia, a region of England that includes the counties of Essex, Norfolk, and Suffolk, to the list of regions considered free of classical swine fever. This final rule follows an interim rule that removed East Anglia from that list due to the detection of classical swine fever in that region. Based on the results of an evaluation of the current classical swine fever situation in East Anglia, we have determined that East Anglia can be restored to the list of regions considered to be free of classical swine fever. This rule relieves certain classical swine fever-related prohibitions and restrictions on the importation of swine and swine products into the United States from East Anglia.

EFFECTIVE DATE:

October 16, 2003.

FOR FURTHER INFORMATION CONTACT:

Dr. Charisse Cleare, Senior Staff Veterinarian, 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 of certain animals and animal products into the United States 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. The regulations in §§ 94.9(a) and 94.10(a) provide that CSF exists in all regions of the world except for certain regions listed in those sections.

In an interim rule effective August 4, 2000, and published in the Federal Register on September 20, 2000 (65 FR 56774-56775, Docket No. 00-080-1), we amended the regulations by removing East Anglia (a region of England that includes Essex, Norfolk, and Suffolk counties) from the lists of regions considered to be free of CSF (which, at the time, we referred to as hog cholera). That action was necessary because CSF had been confirmed in East Anglia. The effect of the interim rule was to restrict the importation of pork and pork products and to prohibit the importation of swine into the United States from East Anglia.

Although we removed East Anglia from the list of regions considered to be free of CSF, we recognized that Great Britain's Ministry of Agriculture, Fisheries and Food (now part of the Department for Environment, Food, and Rural Affairs) immediately responded to the detection of CSF by initiating measures to eradicate the disease. In addition, disease spread was contained within East Anglia. Therefore, we limited the effect of our interim rule to East Anglia. We also stated that we intended to reassess the situation in the region at a future date in the context of Office International des Epizooties (OIE) standards, and that as part of that reassessment process, we would consider all comments received regarding the interim rule.

Additionally, we stated in the interim rule that the future reassessment would enable us to determine whether it was necessary to continue to prohibit the importation of swine and to restrict the importation of pork and pork products from East Anglia, or whether we could restore East Anglia to the list of regions in which CSF is not known to exist.

We solicited comments concerning the interim rule for 60 days ending November 20, 2000. We received one comment by that date, from a national pork industry association. This comment is addressed below.

On March 13, 2003, we published a notice in the Federal Register (68 FR 11998-11999, Docket No. 00-080-2) in which we advised the public of the availability of an evaluation that we had prepared concerning the CSF status of East Anglia. The evaluation, entitled “APHIS Evaluation of the Classical Swine Fever Status of East Anglia (counties of Norfolk, Suffolk, and Essex) November 2002,” assessed the CSF status of East Anglia and the related disease risks associated with importing animals and animal products into the United States from East Anglia.

We solicited comments concerning the evaluation for 60 days ending May 12, 2003, and received one comment by that date. The comment, which was submitted by a national pork industry association, was a resubmission of the comment sent by that organization in response to the September 2000 interim rule. The comment is discussed below.

De Facto Regionalization

Comment: The Animal and Plant Health Inspection Service (APHIS) should have followed its regulations in 9 CFR part 92 in the initial rulemaking to remove East Anglia from the list of regions recognized as free of CSF. In that rulemaking, APHIS established East Anglia, England, as a region affected with CSF, and continued to recognize the rest of Great Britain as free of that disease. There are several specific procedures set forth in part 92 that APHIS should be following. These are: (1) That APHIS will make information submitted in support of a request for regionalization available to the public prior to rulemaking; (2) that APHIS will publish a proposed rule for public comment; and (3) that during the comment period, the public will have access to the information upon which APHIS based its risk analysis, as well as to the methodology used to conduct the analysis.

Response: The regulations in 9 CFR part 92, “Importation of Animals and Animal Products; Procedures for Requesting Recognition of Regions,” were published in October 1997 in conjunction with APHIS' policy on regionalization (see Docket No. 94-106-8, 62 FR 56027-56033, October 28, 1997). The regulations set out the process by which a foreign government may apply to have all or part of a country recognized as a region or for approval to export animals or animal products to the United States under conditions based on the risk associated with animals or animal products from that region. Our intention was for these regulations to tell veterinary officials of foreign governments that have different risk levels within the country or extending across national boundaries and that wish to begin exporting animals or animal products to the United States how to request an initial evaluation of animal disease status or conditions for import of commodities. We did not intend for these regulations to apply in circumstances where an outbreak of a disease in a region previously recognized as disease-free, or an increased incidence of disease in a foreign region makes it necessary for the United States to take interim measures to protect its livestock from the foreign animal disease. In these cases, APHIS must take immediate action to prohibit or restrict imports from the region that now presents a disease concern, and the scope of that action may be limited to the portion of the region that presents the disease risk. Such action may include publishing an interim rule to provide an appropriate basis for enforcing prohibitions or restrictions that may initially be announced administratively. In these circumstances, APHIS has a responsibility to take whatever measures appear necessary to prevent the introduction of disease. We believe that publishing a proposed rule for comment would be contrary to the public interest because doing so would delay our taking protective actions. We also believe that making the information upon which we base our decisions for establishing a region via an interim rule available to the public for comment prior to publishing the interim rule would also be contrary to the public interest for the same reason. In the case of East Anglia, we felt that risk considerations justified our regionalization approach. However, we understand the commenter's concerns, and we have taken actions to address them. One of the actions we took in this case was the preparation of a risk assessment on the disease status of East Anglia, which we made available to the public for comment prior to this final rule.

We took action at a regional level in the case of East Anglia because we believed that the disease situation warranted it. We already had extensive information about the region, including information on the authority, organization, and infrastructure of the veterinary services organization of the region; the extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity for such movements; livestock demographics and marketing practices in the region; the type and extent of disease surveillance conducted in the region; diagnostic laboratory capabilities in the region; and the region's policies and infrastructure for animal disease control, i.e., the region's emergency response capacity. This information provided the basis for our previous recognition of the region as free of the disease. Our obligations under international trade agreements compel us to take no more restrictive actions than necessary to prevent the introduction of disease. Unless we determine that this information is no longer reliable, it should provide a rational basis for believing that the region can effectively control an outbreak within a smaller region.

Unjustified Emergency Action

Comment: While the CSF outbreak in East Anglia presented an emergency situation justifying the issuance of an interim rule in order to protect against the introduction of CSF into the United States, the specific action APHIS took was not justified. The emergency situation only justified an interim rule removing all of Great Britain from the list of CSF-free regions, and any action with respect to regionalizing East Anglia should have been handled according to the procedures in § 92.2.

Response: As explained previously, we believe that it was appropriate to limit the scope of our action to the specific region of East Anglia, given the specific disease situation and the extensive information we already possessed about East Anglia and Great Britain as a whole. Given these factors, we are confident that we had sufficient justification for taking action with respect to East Anglia on an emergency basis to protect against the introduction of CSF into the United States. We believe that any action to remove all of Great Britain from the list of CSF-free regions would have been unnecessary and unjustified.

Veterinary Equivalency Agreement

Comment: The Veterinary Equivalency Agreement (VEA) signed by the United States and the European Union (EU), which includes provisions concerning the recognition of regionalization decisions taken by the parties with respect to certain diseases, does not supercede or change U.S. statutory or regulatory law regarding regionalization. Thus, APHIS should have followed its procedures in part 92 in regionalizing East Anglia for CSF.

Response: The action that we took regarding East Anglia was not related to the VEA. As noted elsewhere in this document, we believe our action was consistent with our regulations and statutory authority, neither of which was affected by the VEA.

Inconsistency With Other Regionalization Requests

Comment: APHIS has received requests from the EU to recognize certain regions in the EU as free of specified animal diseases, but has not yet made any decisions or changes to the regulations based on these requests. How was APHIS able to reach a decision about the disease-free status of Great Britain with the exception of East Anglia while the other regionalization requests it had received from the EU have been under consideration since June 1999?

Response: The request that we received from the EU related to a much larger region that was not already recognized as free of CSF. In addition, that request related to establishing a single region composed of multiple countries, some of which continue to experience outbreaks of CSF. Immediate action at a regional level was not necessary in the case of the EU as it was for East Anglia. The amount of time necessary to reach a decision in these two situations is not comparable because the two situations are not comparable.

One factor that influenced the comparative speed of the evaluation of Great Britain in comparison with the evaluation of other EU regions was that Great Britain was already recognized individually as disease-free. In comparison, other EU regions under consideration were not previously recognized as disease-free, and several of these regions continue to experience periodic outbreaks of CSF. In addition, our long-standing trade relationship with Great Britain provided us with the information necessary to reach a decision about the disease status of the entire country. This particular outbreak was a temporary emergency situation that was ultimately limited to 16 sites in a particular region of the country and was contained and eradicated quickly.

Future Procedures

Comment: Veterinary infrastructure and animal health authorities of the United Kingdom are highly professional and extremely conscientious, and APHIS confidence in them is well-founded. APHIS was also correct in its decision to take action in order to protect against the introduction of CSF into the United States. However, it is possible that APHIS might take similar action in the future (i.e., prohibit or restrict the movement of animals and animal products from particular regions within a disease-free country rather than from the entire country) with countries whose veterinary infrastructures are not as adequate as that of the United Kingdom. Thus, APHIS should clarify the regionalization procedures it intends to follow in the future. Further, in the interim rule, APHIS stated that it intended to reassess the disease situation in East Anglia in accordance with the standards of the OIE to determine whether it is necessary to continue to prohibit or restrict the importation of animals and animal products from that region. This statement suggests that APHIS intends at some future time to declare these regions free of the specified disease without following the process set forth in § 92.2. Finally, does APHIS' stated intent to reassess the situation in accordance with the standards of the OIE mean that APHIS plans to wait until East Anglia had completed the 6-month disease-free waiting period prescribed by the OIE before it considered the region disease-free?

Response: We wish to note that we have developed a uniform set of procedures to be followed when a region that we recognize as free of disease experiences an outbreak of that disease. These procedures, which are described in a proposed rule published in the Federal Register on June 24, 2003 (68 FR 37426-37429, Docket No. 02-001-1), include steps we would take to prevent the introduction of disease from that region or from a portion of that region and steps we would take to further assess the region's animal health status. These procedures include the release of a risk assessment for public comment prior to final rulemaking.

We will continue to implement our thorough and rigorous risk assessment process and will continue to require information about the authority, organization, and infrastructure of the veterinary services organization of each region; the extent to which movements of animals and animal products are controlled from regions of higher risk, and the level of biosecurity for such movements; livestock demographics and marketing practices in each region; diagnostic laboratory capabilities in each region; and each region's policies and infrastructure for animal disease control, i.e., the region's emergency response capacity.

We will continue to take immediate action to protect U.S. livestock by prohibiting or restricting imports of animals and animal products from regions that experience outbreaks of specified animal diseases.

We will continue to reassess the disease status of each region in the context of the standards of the OIE and additional relevant information, and will continue to consider all public comments we receive regarding any action that we take. Although we do take international standards such as those of the OIE into consideration, we conduct independent risk assessments using our own stringent criteria. We do not base our decisions about the disease-free status of regions or countries on the decisions of the OIE.

The commenter is correct that our stated intent to reassess situations such as the one in East Anglia in accordance with the standards of the OIE means that we intend to declare regions free of specified diseases without following the process set forth in § 92.2. Rather, we will follow the process described in the previous paragraphs. As stated previously, part 92 was not specifically intended to apply to the type of situation dealt with in the interim rule that removed East Anglia from the list of CSF-free regions. An interim rule of that type is intended to be just that, an “interim” or “temporary” measure which provides the immediate protection necessary for animal health purposes. Interim rules of this type give APHIS an opportunity to evaluate the effectiveness of emergency response measures taken in the subject region to deal with the outbreak and to determine whether the outbreak is indeed a temporary situation or indicates a fundamental change in the region's disease status. If a region takes immediate and effective steps to control and eradicate the disease, as East Anglia did, we believe it is appropriate for the region to be returned to its previous disease-free status.

Therefore, for the reasons given in this document, and based on our evaluation, we are amending §§ 94.9 and 94.10 in this final rule to add East Anglia to the list of regions considered free of CSF.

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. Immediate implementation of this rule is warranted to relieve certain CSF-related prohibitions and restrictions on the importation of swine and other products of swine into the United States from East Anglia that are no longer necessary. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

This 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.

We are amending the regulations governing the importation of certain animals, meat, and other animal products by restoring East Anglia, a region of England that includes the counties of Essex, Norfolk, and Suffolk, to the list of regions considered free of CSF. This final rule follows an interim rule that removed East Anglia from that list due to the detection of CSF in that region. Based on the results of an evaluation of the current CSF situation in East Anglia, we have determined that East Anglia can be restored to the list of regions considered to be free of CSF. This rule relieves certain CSF-related prohibitions and restrictions on the importation of swine and other products of swine into the United States from East Anglia.

The economic effects of this rule on U.S. entities will depend upon the number of swine and the quantity of pork products that will be exported to the United States from East Anglia, and the significance of these exports with respect to overall U.S. swine and pork product imports. Swine and pork producers and pork product wholesalers are the entities we expect will be affected by this rule.

We do not have specific information on the level of swine or pork products imported from East Anglia before that region was removed from the list of regions considered free of CSF in August 2000. However, an indication of the level of imports from East Anglia that may result once the region is again considered CSF-free can be acquired by comparing imports of swine and pork products from the United Kingdom prior to and during the period of East Anglia's restriction. Average annual imports from the United Kingdom including East Anglia for the 3-year period 1997-1999 are compared to average annual imports from the United Kingdom excluding East Anglia for the 2-year period 2001-2002.^[1]

Live swine have been prohibited entry into the United States from East Anglia since August 2000. During 1997-1999, the number of swine imported from the United Kingdom averaged 249 per year, and represented about 0.01 percent of average U.S. imports of 3.8 million swine per year. The average annual value of swine imported from the United Kingdom was about $123,000, or about 0.05 percent of the average annual value of all swine imports ($265 million). The average price of swine imported from the United Kingdom during the period 1997-1999 was much higher than the average price of all swine imports ($567 per animal compared to $72 per animal), reflecting their value as breeding stock rather than slaughter stock.^[2]

During 2001-2002, there were no swine imports from the United Kingdom. If all swine imported from the United Kingdom during 1997-1999 came, in fact, from East Anglia, then a similar number, if not more, can be expected to be imported once East Anglia is again considered CSF-free. Total annual imports from all sources in 2001-2002 increased to over 5.5 million swine. While the effect of renewed swine imports from East Anglia will be small in terms of its percentage share of swine imported by the United States, the high average price during 1997-1999 suggests that future imports may again help serve breeding demands of U.S. swine operations.

A similar comparison of pork product imports from the United Kingdom over the two time periods can be used in considering the impact of renewed importation of these commodities from East Anglia. During 1997-1999, the quantity of pork products imported from the United Kingdom averaged about 3.5 million kilograms per year, and represented about 1.55 percent of average U.S. imports of 225 million kilograms per year. Their average annual value was about $13 million, or about 2.76 percent of the average annual value of all product imports of $476 million.

During 2001-2002, there was a significant decline in the quantity of pork products imported from the United Kingdom, to about 509,400 kilograms per year, while total U.S. pork imports increased to 346 million kilograms per year. The United Kingdom's share of total imports fell to 0.15 percent, one-tenth of its share during 1997-1999. The average annual value was about $1.8 million, or about 0.24 percent of the average annual value of all pork product imports of $745 million (again, one-tenth of the United Kingdom's share during 1997-1999). The dramatic increase in annual pork product imports by the United States from the period 1997-1999 to the period 2001-2002—from 225 million kilograms to 346 million kilograms—contributed to the large percentage decline in imports from the United Kingdom.

If the decline in pork product imports from the United Kingdom was caused by the restrictions placed upon imports from East Anglia, then removal of those restrictions can be expected to result in a percentage share of U.S. imports for the United Kingdom similar to that acquired during 1997-1999, about 1.6 percent of total pork product imports by quantity and 2.8 percent by value. Based on the average annual level of total pork product imports during 2001-2002, these percentages represent about 5.4 million kilograms, valued at about $21 million.

Imports of swine and pork products from the United Kingdom are likely to expand once East Anglia is again considered CSF-free. The expansion could be noteworthy for the United Kingdom if exports to the United States return to the levels seen during 1997-1999: Breeding swine exports in the hundreds of animals per year where currently there are none, and an increase in pork product exports by a factor of 10. The economic effects will not be significant for U.S. entities. As a percentage of overall U.S. imports, the United Kingdom's supply of swine and pork products during 1997-1999 was small. Similar export levels can be expected to result from this rule.

Swine and pork producers and pork product wholesalers are the U.S. entities that may be affected by this rule. The Small Business Administration (SBA) has established size standards for determining which entities can be considered small, using the North American Industrial Classification System (NAICS). The SBA defines small hog and pig farms (NAICS 112210, “Hog and pig farming”) as those earning not more than $750,000 in annual receipts. National Agricultural Statistics Service data on hog farm inventories include farm size categories, among others, with minimums of 2,000 and 5,000 head. Only those swine operations with inventories well in excess of 3,000 animals would likely earn more than $750,000 in annual sales.^[3] Over 95 percent of U.S. swine operations hold inventories of fewer than 2,000 head. Thus, most swine and pork producers can be considered small entities based on SBA standards.

In the same way, pork product wholesalers are also primarily small entities. The SBA defines pork product wholesalers (NAICS 424420, “Packaged frozen food merchant wholesalers,” and NAICS 424470, “Meat and meat product merchant wholesalers”) as small if they employ 100 or fewer employees. Information on the size distribution of meat wholesalers is not available, but the 1997 Economic Census indicates that the average number of employees per establishment that year was 14.^[4]

Although the industries that may be affected by this final rule are largely composed of small entities, the economic effects of the rule will not be significant. While imports of swine and pork products from the United Kingdom are expected to increase as a result of this rule, their market shares of overall U.S. imports are expected to remain 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 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

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; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and 371.4.

§ 94.9

[Amended]

2. In § 94.9, paragraph (a) is amended by removing the words “,except for East Anglia (Essex, Norfolk, and Suffolk counties)”.

§ 94.10

[Amended]

3. In § 94.10, paragraph (a) is amended by removing the words “,except for East Anglia (Essex Norfolk, and Suffolk counties)”.

Done in Washington, DC, this 9th day of October 2003.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  All import statistics are from the World Trade Atlas, based on U.S. Census Bureau data.

2.  U.S. Census Bureau statistics indicate that 93 purebred breeding swine were imported from the United Kingdom in 1999, but that none were imported in 1997 or 1998. However, the average price paid for swine imported from the United Kingdom during the period 1997-1999 clearly suggests that animals classified as non-purebred breeding swine were imported for breeding purposes.

3.  Assuming about a 6-month production cycle, one inventory unit would roughly represent two annual sale units. An average price of $102 per head (230 pounds selling weight, at $44.30 per cwt, the average of hog prices in 2001), implies a gross revenue of $204 per head of inventory, yielding $750,000/$204 per head=3,676 head.

4.  As reported in the 1997 Economic Census of the U.S. Census Bureau, there were 3,557 meat and meat product wholesale establishments that had a total of 50,256 paid employees.