[Federal Register Volume 68, Number 200 (Thursday, October 16, 2003)]
[Rules and Regulations]
[Pages 59527-59531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26042]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 00-080-3]


Change in Disease Status of East Anglia With Regard to Classical 
Swine Fever

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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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; (301) 734-4356.

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 Sec. Sec.  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,

[[Page 59528]]

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 
Sec.  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

[[Page 59529]]

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 Sec.  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 Sec.  
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 Sec. Sec.  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

[[Page 59530]]

Kingdom excluding East Anglia for the 2-year period 2001-2002.\1\
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    \1\ All import statistics are from the World Trade Atlas, based 
on U.S. Census Bureau data.
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    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\
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    \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.
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    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.
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    \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.
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    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\
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    \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.
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    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

[[Page 59531]]

and poultry products, Reporting and recordkeeping requirements.

0
Accordingly, we are amending 9 CFR part 94 as follows:

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

0
1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.


Sec.  94.9  [Amended]

0
2. In Sec.  94.9, paragraph (a) is amended by removing the words 
``,except for East Anglia (Essex, Norfolk, and Suffolk counties)''.


Sec.  94.10  [Amended]

0
3. In Sec.  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.
[FR Doc. 03-26042 Filed 10-15-03; 8:45 am]
BILLING CODE 3410-34-P