[Federal Register Volume 68, Number 66 (Monday, April 7, 2003)]
[Rules and Regulations]
[Pages 16922-16941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8314]



[[Page 16921]]

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Part IV





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 71, 92, et al.



Recognition of Animal Disease Status of Regions in the European Union; 
Final Rule

  Federal Register / Vol. 68, No. 66 / Monday, April 7, 2003 / Rules 
and Regulations  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 71, 92, 93, 94, 98, and 130

[Docket No. 98-090-5]
RIN 0579-AB03


Recognition of Animal Disease Status of Regions in the European 
Union

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations concerning the importation of 
animals and animal products to recognize a region in the European Union 
as a region in which hog cholera (classical swine fever) is not known 
to exist, and from which breeding swine, swine semen, and pork and pork 
products may be imported into the United States under certain 
conditions, in the absence of restrictions associated with other 
foreign animal diseases of swine. Additionally, we are recognizing 
Greece and four Regions in Italy as free of swine vesicular disease. 
These actions are based on a request from the European Commission's 
(EC's) Directorate General for Agriculture and on our analysis of the 
supporting documentation supplied by the EC and individual Member 
States. These actions will relieve some restrictions on the importation 
into the United States of certain animals and animal products from 
those regions. However, because of the status of those regions with 
respect to other diseases, and, in some cases, because of other factors 
that could otherwise result in a risk of introducing animal diseases 
into the United States, the importation of animals and animal products 
into the United States from those regions will continue to be subject 
to certain restrictions.

EFFECTIVE DATE: April 7, 2003.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Director, Sanitary 
Trade Issues Team, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 734-4356. The full risk analysis and economic 
analysis associated with this rule may be obtained electronically at 
http://www.aphis.usda.gov/vs/ncie/reg-request.html, or by contacting 
the person listed under this heading.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA or the Department) 
regulates the importation of animals and animal products into the 
United States to guard against the introduction of animal diseases not 
currently present or prevalent in this country. The regulations 
pertaining to the importation of animals and animal products are set 
forth in the Code of Federal Regulations (CFR), title 9, chapter I, 
subchapter D (9 CFR parts 91 through 99).
    On June 25, 1999, we published in the Federal Register (64 FR 
34155-34168, Docket No. 98-090-1) a proposal to amend the regulations 
by recognizing--with the exception of specified regions in Germany and 
Italy--the countries of Austria, Belgium, France, Germany, Greece, 
Italy, Luxembourg, the Netherlands, Portugal, and Spain as a region in 
which hog cholera (classical swine fever (CSF)) is not known to exist, 
and from which breeding swine, swine semen, and pork and pork products 
may be imported into the United States under certain conditions. The 
regions in Germany and Italy that were not included in that region are 
the following: In Germany, the Kreis Vechta in the Land of Lower 
Saxony, the Kreis Warendorf in the Land of Northrhine Westfalia, and 
the Kreis Altmarkkreis Salzwedel in the Land of Saxony-Anhalt; and in 
Italy, the Island of Sardinia (referred to in this document as the 
Region of Sardegna), and the Regions of Emilia-Romagna and Piemonte.
    Additionally, we proposed to add Greece to the list of regions 
recognized as free of foot-and-mouth disease (FMD). We also proposed to 
add Greece to the list of FMD-free regions whose exports of ruminant 
and swine meat and products to the United States are subject to certain 
restrictions to guard against introducing FMD into this country. These 
restrictions were proposed because Greece imports fresh meat of 
ruminants or swine from regions where FMD exists; has a common border 
with regions where FMD exists; and imports ruminants or swine from 
regions where FMD exists under conditions less restrictive than would 
be acceptable for importation into the United States.
    Finally, we proposed to add Greece and eight Regions in northern 
Italy (listed below) to the list of regions recognized as free of swine 
vesicular disease (SVD). Additionally, we proposed to add Greece and 
the eight Regions in Italy to the list of SVD-free regions whose 
exports of pork and pork products to the United States are subject to 
certain restrictions to guard against introducing SVD into this 
country. These restrictions were proposed because of the same 
situations with regard to SVD that were described in the preceding 
paragraph regarding FMD and Greece. We proposed to add the following 
Regions in northern Italy to these lists: Abruzzi, Emilia-Romagna, 
Friuli-Venezia Giulia (referred to in the proposed rule as Friuli), 
Liguria, Marche, Molise, Piemonte, and Valle d'Aosta.
    Before developing our proposed rule, we conducted an analysis to 
determine the likelihood of introducing CSF from the European Union 
(EU) and to determine what, if any, mitigation measures we considered 
necessary. We assessed the likelihood of introducing CSF through the 
importation of live breeding swine, swine semen, and pork and pork 
products, and submitted the risk analysis for peer review.
    We solicited comments concerning our proposal, including the risk 
analysis, for 60 days ending August 24, 1999. We received five comments 
by that date. They were from a domestic industry organization, a 
veterinary association, the EC, and other members of the public.
    One of the comments expressed concerns with several aspects of our 
risk analysis. Based on that comment, and as recommended by the 
Department's Office of Risk Assessment and Cost Benefit Analysis based 
in part on peer review comments, we revised the initial risk analysis 
and included a supplement that presented in more detail specific 
information about CSF outbreaks in the EU.
    On May 3, 2002, we published in the Federal Register a notice (67 
FR 22388-22389, Docket No. 98-090-2) that the revised risk analysis was 
available for public review and we requested comments on the revised 
document. The comment period was initially scheduled to end July 2, 
2002, but on July 5, 2002, in response to a request by a commenter, we 
published a notice in the Federal Register (67 FR 44798-44799, Docket 
No. 98-090-3) that reopened and extended the comment period until July 
17, 2002. We received 21 comments by that date. They were from domestic 
and foreign industry organizations, individual businesses, a U.S. State 
Port Authority, the EC, a member State of the EU, and other members of 
the public.
    We carefully considered all comments we received on our June 1999 
proposal and our May 2002 notice of availability of the revised risk 
analysis. For the reasons given in the proposed rule and in this 
document, we are adopting our June 1999 proposed rule as a final rule, 
with the changes discussed below. (It should be noted that even though 
this

[[Page 16923]]

final rule removes some importation restrictions on animals and 
products from certain foreign regions with regard to CSF and SVD, the 
importation of swine and swine products from the EU may continue to be 
prohibited or restricted due to the presence in the EU of other 
diseases affecting swine, such as brucellosis, pseudorabies, and 
tuberculosis.)
    We will first discuss the issues raised by commenters in response 
to our June 1999 proposed rule, then we will discuss the issues raised 
in response to our revised risk analysis.

Comments on the June 1999 Proposed Rule

    Of the five comments we received in response to our June 1999 
proposed rule, three supported the proposal as written. Of the other 
two comments, one generally supported the proposal, but recommended 
certain changes. The other expressed concerns with a number of 
provisions of the proposal and its supporting documentation. We discuss 
below the issues raised by the commenters.

SVD in Italy

    As discussed above, in our June 1999 proposed rule, we proposed to 
list eight Regions in Italy as those in which SVD is not known to 
exist. (In Italy, a ``Region'' is a type of political jurisdiction.) 
Those eight Regions were Abruzzi, Emilia-Romagna, Friuli-Venezia 
Giulia, Liguria, Marche, Molise, Piemonte, and Valle d'Aosta. One 
commenter requested that we also recognize the following nine Regions 
as those in which SVD does not exist: Lombardia, Trentino-Alto Adige, 
Veneto, Toscana, Umbria, Lazio, Basilicata, Puglia, and Sardegna. We 
have carefully evaluated the information contained in the comment, and 
believe that it would be appropriate to allow members of the public to 
comment on the change requested by the commenter. Therefore, we are not 
making any changes in this final rule in response to this comment, but 
we intend to initiate a separate notice and comment rulemaking 
regarding those additional Regions.
    Further, because SVD was diagnosed in the Regions of Abruzzi, 
Emilia Romagna, Molise, and Piemonte in 2002, we are not including 
those Regions in this final rule as regions in which SVD does not 
exist. However, we are developing an updated evaluation of the SVD 
situation in those Regions. We will publish a notice in the Federal 
Register when the updated evaluation is ready for public review and 
will accept comment on the evaluation for a specified period of time. 
Following review of any comments we receive, we will determine whether 
it is appropriate to consider those Regions as regions in which SVD 
does not exist. If such a determination is made, we will publish a 
final rule to that effect in the Federal Register.

FMD in Greece

    We proposed in our June 1999 proposal to recognize Greece as a 
region in which FMD does not exist. Following publication of that 
proposal, FMD was diagnosed in the summer of 2000 in cattle in several 
prefectures in Greece. However, since September 2000, there have been 
no incidences of FMD in that country. Therefore, on March 21, 2002, we 
published a proposal in the Federal Register (67 FR 13105-13108, Docket 
No. 01-059-1) to recognize Greece free of FMD. We solicited comments 
concerning our proposal for 60 days ending March 20, 2002, and received 
no comments. Following the comment period, we published a final rule in 
the Federal Register (67 FR 44524-44526, Docket No. 01-059-2) in which 
we adopted the proposed rule as a final rule without change.

Change in Terminology

    Our regulations in 9 CFR chapter I use the term ``hog cholera.'' 
When we published our June 1999 proposed rule, consistent with the 
existing regulations, we used the term ``hog cholera.'' However, it is 
standard practice among veterinary practitioners in the international 
community to refer to hog cholera as ``classical swine fever'' or 
``CSF.'' Therefore, in the remainder of this final rule, including the 
regulatory text at the end of this document, we use the term 
``classical swine fever'' (or ``CSF'') rather than ``hog cholera.'' 
Additionally, for the sake of consistency throughout our regulations in 
9 CFR chapter I, we are removing the term ``hog cholera'' wherever it 
appears in the existing regulations (i.e., parts 71, 93, 94, 98, and 
130) and adding in its place the term ``classical swine fever.''

Administrative Units Considered

    As noted above, in Italy, the smallest administrative jurisdiction 
we considered for purposes of regionalization was the ``Region.'' In 
Germany, we used the ``kreis.'' One commenter said that it was not 
clear from the proposal why APHIS concluded that the Italian Region and 
the German kreis should be considered for regionalization purposes. The 
commenter stated that the proposal did not include information relating 
to unique characteristics of the regions and physical boundaries that 
may or may not be present. Another commenter agreed with our use of the 
kreis in Germany for CSF regionalization purposes but recommended that, 
in Italy, we use instead the ``Unita Sanitarie Locali.''
    As discussed in our proposed rule, we chose to use the Italian 
``Region'' and German ``kreis'' for purposes of regionalization because 
we considered them to be the smallest administrative jurisdictions in 
those countries that have effective oversight of normal animal 
movements into, out of, and within those jurisdictions, and that, in 
association with national authorities if necessary, have the 
responsibility for controlling animal disease locally. The commenter 
who suggested we use the Unita Sanitarie Locali as the smallest 
administrative jurisdiction in Italy did not offer any information as 
to how the Unita Sanitarie Locali meets those criteria. Therefore, we 
are not making any changes based on the comments received, but we 
welcome further information on this issue.

Information on Outbreaks

    One commenter stated that the proposed rule did not include 
information relating to specific outbreaks in the regions addressed by 
the proposed rule, and that it would have been instructive for APHIS to 
have included in the proposed rule a map indicating where the CSF 
outbreaks occurred in relation to the proposed regionalization, along 
with a list of reasons for the outbreaks (e.g., wild boar exposure, 
feeding of uncooked garbage, transport into the area, or unknown 
origin).
    We agree that the type of information referred to by the commenter 
is important in assessing the CSF risk presented by imports from 
particular regions, and we considered those factors in our risk 
analysis. At the time we published the proposed rule, some of the 
information was available on the APHIS Internet website, which was 
referenced in the proposed rule. The supplement to our initial risk 
analysis illustrates in more detail the type of information referred to 
by the commenter.

Concern With Regionalization

    One commenter on our June 1999 proposal expressed concern that, 
following publication of the proposed rule, an outbreak of CSF occurred 
in the Kreis Uckermark in the Land of Brandenburg in Germany, which was 
included in the proposal as an area in which CSF is not known to exist. 
The commenter stated further that, even

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though the prevalence of CSF in wild boars in Brandenburg had been 
determined to be under 1 percent, that apparently was enough to lead to 
infection of the domestic population. The commenter concluded that 
there is insufficient control of the potential sources of the 
introduction of CSF into herds in Germany to allow that country to be 
regionalized.
    When we developed the risk analysis on which we based our proposed 
rule, we included among our assumptions the probability that CSF 
outbreaks would continue to occur in the EU, just as we must assume 
there is some chance of an outbreak of a particular disease in any 
country we currently consider free of that disease. Starting from the 
assumption that future outbreaks of CSF would occur, we evaluated the 
risk of disease spread based on the length of time between the 
occurrence of CSF infections and the time that control efforts, such as 
implementation of new restriction zones, took effect. We concluded that 
breeding swine, swine semen, and pork and pork products could be 
imported with extremely low risk from the region we were proposing to 
establish in the EU, under the conditions set forth in the proposal. It 
should be noted that the information and data we used for our risk 
analysis were from outbreaks that occurred in 1997-1998, which 
constituted one of the worst CSF epidemics in the EU in recent history.

CSF in Germany

    One commenter stated that no scientific justification was provided 
in the proposed rule for identifying the Kreis Vechta, the Kreis 
Warendorf, and the Kreis Altmarkkreis Salzwedel as those regions in 
which CSF is considered to exist, or for how the risk from other areas 
in Germany was assessed.
    As we explained in our proposed rule, in establishing geographic 
boundaries for the regions, we used the boundaries of the smallest 
administrative jurisdiction that has effective oversight of normal 
animal movements into, out of, and within that jurisdiction, and that, 
in association with national authorities if necessary, has the 
responsibility for controlling animal disease locally. In Germany, this 
administrative unit is a kreis.
    We proposed to continue to consider the kreis listed above as 
regions in which CSF is known to exist because each had an outbreak of 
CSF during the 6 months prior to the time we developed our proposed 
rule. In assessing the risk from the remaining areas of Germany, we 
assumed, as described above, that CSF outbreaks would continue in the 
EU, and we evaluated risk based on the length of time between the 
occurrence of infection in a region previously considered free of CSF 
by the EC and the time that control efforts took effect.

Delay in Disease Detection

    In our proposed rule, we stated that, in 1997, an estimated 103 of 
611 CSF outbreaks in the EU occurred outside any zones that were under 
restrictions because of CSF, and that, of those 103, only 1 was a swine 
semen collection center approved for export, and only 1 was a breeding 
operation that engaged in export sales. We stated further that 
epidemiological evidence suggests that the disease was present in 
various regions for 7 days to nearly 8 weeks before it was detected and 
the region was placed under restrictions. One commenter expressed 
concern that this demonstrated that several importations into the 
United States of semen and breeding stock could occur before a CSF 
outbreak is detected.
    The commenter is correct in concluding that, with unmitigated 
importation, there is a significant risk of introducing CSF into the 
United States. Our risk analysis calculated that risk as a probability, 
and also calculated the probability if mitigation measures were 
applied. We evaluated the likely volume of imported products and the 
prevalence of infected versus noninfected products in the estimate of 
the probability that infected products would be imported. The risk of 
importing CSF-infected products is not zero but, as discussed in the 
risk analysis, is quite low. Of the products evaluated, the risk 
analysis identified swine semen as presenting the greatest risk. 
Therefore, we proposed that, in addition to the EU's routine 
biosecurity measures, before swine semen can be exported to the United 
States from the region in question, the donor boar must be held at the 
semen collection center for at least 40 days following collection of 
semen, and, along with all other swine at the semen collection center, 
exhibit no clinical signs of CSF.

Compliance With Office International des Epizooties (OIE) Guidelines

    In discussing the quantitative risk analysis that we used as a 
basis for our proposed rule, we stated that one of the starting point 
assumptions we made was that OIE export guidelines are applied to the 
movement of animals and animal products within the EU. One commenter 
stated that, elsewhere in our proposal, we indicated we had to take 
into account that the EC released certain areas from restrictions prior 
to completion of a 6-month waiting period. The commenter expressed 
concern that our risk analysis appeared to be using an assumption that 
is not supported by current practice in the EU, and requested further 
documentation of adherence to the OIE standard before the proposed rule 
was made final.
    Although we stated that we expected that OIE export guidelines 
would be applied to movement of animals and animal products within the 
EU, we did not build that assumption into our quantitative risk 
assessment. The quantitative assessment was based on the waiting 
periods actually used by the EU during the 1997-1998 epidemic. With 
regard to guidelines for export to the United States, whether a region 
is certified as being free of CSF must be based on U.S. criteria (i.e., 
at least 6 months must have passed since eradication of the last 
outbreak of the disease).
    One commenter stated it was not possible to determine from the site 
visit reports done prior to the proposed rule whether movement and 
import controls complied with EU directives. Additionally, said the 
commenter, information was not presented regarding compliance with 
directives regarding truck washing.
    When conducting its site visit, the review team observed compliance 
with EC directives, truck washing, and tracking of swine movements 
through the ``SANITEL-V'' and ``ANIMO'' databases. (The SANITEL-V 
database is a computerized database in Belgium that contains 
information on animal identification, farm registration, and animal 
movements. The ANIMO database is an EU-wide database that contains 
origin, destination, and movement information regarding animal 
movements within the EU.)

Notification of Change in Disease Status

    One commenter stated that the proposed rule did not describe the 
process by which the EU would notify APHIS of a change in 
regionalization status and how timely we expected that notification to 
be. The commenter stated additionally that the proposed rule included 
no discussion of the process by which APHIS would accept or reject a 
regionalization decision and the impact of that process on EU exports 
of animals and animal products to the United States.
    The U.S.-EU Equivalency Agreement (an agreement covering sanitary 
measures affecting U.S.-EU trade in all animals and animal products) 
requires written notification, within 24 hours, of a change in disease 
status. If the EU

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recognizes a region in a previously disease-affected area to be free of 
a disease, any APHIS acceptance of the EU regionalization will be 
carried out through the rulemaking process, with an opportunity for the 
public to comment on and submit information regarding the 
regionalization.

Values Used in Our Risk Analysis

    As noted above, before developing our proposed rule, we conducted 
an analysis to determine the likelihood of the introduction of CSF from 
the EU region in question, and to determine what, if any, measures we 
considered necessary to mitigate risk. We assessed the likelihood of 
the introduction of CSF through live breeding swine, swine semen, and 
pork and pork products.
    In assessing the risk of CSF introduction, we incorporated certain 
numerical information into our mathematical model. For breeding swine, 
for example, we used input values for the following: The number of 
undetected, CSF-affected breeding farms eligible to supply animals for 
export, assuming that undetected CSF exists in the EU; the number of 
breeding herds eligible for export in the EU; the number of weeks that 
CSF remains undetected in EU breeding herds per year, assuming that 
undetected CSF exists in the EU; the number of breeding swine shipments 
per year; the number of breeding herds per shipment; the number of 
animals selected for export from any given breeding herd; and the 
probability that an individual animal is infected with CSF, assuming 
that there is infection in the herd.
    One commenter questioned some of the input values we used. The 
input values in question, the commenter's concerns, and our responses 
are as follows:
    1a. Input value: The number of undetected CSF-infected herds in the 
EU, assuming that undetected CSF exists in the EU within regions 
eligible to export breeding swine.
    1b. Comment: It is unclear whether established restriction zones in 
the EU were based on information available before 1997. If this is not 
so, the number of herds may be underestimated due to the lack of 
complete information to identify those restriction zones. In other 
words, a post hoc evaluation of regions is invalid and underestimates 
the number of infected herds. It may also be useful to give this a 
triangular distribution, because it is based on the occurrence of one 
case. If there were not this one case, the model would interpret that 
there is no risk from breeding stock.
    1c. Response: The information and data we used in the risk analysis 
for determining whether infected herds were inside established 
restriction zones were from outbreaks that occurred in 1997 and 1998. 
We obtained the information from epidemiological reports provided by 
the EU and from extensive discussions with EU representatives. The 
dates that the restriction zones were established were carefully 
compared to the dates that herds were believed to have become infected. 
Only one export-oriented swine semen center and one export-oriented 
breeding operation were identified as having become affected outside of 
established restriction zones.
    We do not agree that the data we used underestimated the potential 
disease risk. The analysis is based on data from the most severe CSF 
outbreak documented in EU history and assumes that this event is 
typical of a severe situation in the EU that might occur in the future. 
This approach likely overestimates the actual risk. We believe that if 
the EU made epidemiological data available for the several years prior 
to the 1997 to 1998 outbreaks, and if these data were incorporated into 
the risk analysis, the estimated risk levels would be lower than those 
we reported.
    With regard to the recommendation that we use a triangular 
distribution (i.e, a calculation of the minimum, most likely, and 
maximum estimate), we did sensitivity analyses (i.e., the determination 
of how variations in input data affect probability outcomes) using a 
variety of scenarios. Although the results of these multiple analyses 
were not included in the original risk analysis document, we included 
them in the revised risk analysis. The results of the multiple analyses 
did not affect the conclusions of the analysis.
    2a. Input value. The number of weeks that CSF remains undetected in 
EU breeding herds per year, assuming that undetected CSF exists in the 
EU (based on varying lengths of time in different areas of the EU).
    2b. Comment. The differentiation of detection periods among areas 
appears to be based on very limited information. It is not clear why 
the areas need to be differentiated or what the mechanical logic is for 
the wide range of detection periods.
    2c. Response. The information regarding the time that infection 
remained undetected in various locations in the EU was drawn from the 
actual outbreaks that occurred from 1997 to 1998. The rather 
substantial differences in duration among various locations (7 to 21 
days in several areas to 53 days in one area) were due in part to the 
fact that some detections occurred in areas with ongoing CSF 
eradication efforts, which included active surveillance, while other 
detections occurred in areas where only passive surveillance was being 
used. In some instances, the initial detection within a country took a 
great deal longer than subsequent detections in other parts of the 
country because the initial detection caused heightened awareness and 
surveillance.
    3a. Input value. Number of breeding herds per shipment. (The risk 
analysis used 1 for this value.)
    3b. Comment. Is it policy that only one herd will be used in a 
shipment? If not, perhaps it should be.
    3c. Response. This assumption was incorporated into some of the 
simulations we performed for the purposes of our risk analysis, 
because, historically, most shipments have involved one herd. However, 
the commenter did not provide, and we are not aware of, a disease risk 
reason to limit shipments to one herd. If all animals to be imported 
are moved in accordance with the regulations, including more than one 
herd in a shipment would not present an unacceptable increase in 
disease risk.
    4a. Input value. Number of animals selected for export from any 
given breeding herd. (The geometric mean of the distribution for the 
number of swine per shipment was 6.125. For the purposes of our risk 
analysis, we used a value of 6.)
    4b. Comment. It could be argued that using the geometric mean of 6 
probably underestimates the size of future imports. It is more likely 
that substantial portions of the line will be imported to allow rapid 
transfer of genetics.
    4c. Response. We agree that using the geometric mean could result 
in an underestimate of possible future imports. For this reason, we ran 
a simulation using an arithmetic mean (38 animals) as well, which is 
included in our revised risk analysis. We found that increasing the 
number of breeding swine in a shipment more than six-fold does not 
change our conclusion that the risk is still very low.
    5a. Input value. Probability that an individual animal is infected 
with CSF, assuming that CSF exists in the herd; or proportion of 
infected animals in a semen center in which CSF exists. The risk 
analysis used a triangular distribution of 0.05, 0.15, and 0.40 for 
each of these probabilities. We noted in our risk analysis that 
indirect reports suggest the value may be extremely variable (i.e., 25 
percent to 100 percent, depending on circumstances).
    5b. Comment. This is a subjective estimate with a value that is 
extremely variable. It is not clear why the upper

[[Page 16926]]

limit is 40 percent in this estimate. The need for the triangular 
estimate is understood, but the biological possibility of 100 percent 
is not accounted for.
    5c. Response. Despite a 40 percent upper limit suggested by EC 
officials, we performed a sensitivity analysis on this upper limit, and 
also ran simulations with an upper limit of 100 percent, although that 
analysis was not reported in the original risk analysis. Using a 40 
percent upper limit, the expected frequency of incursion was one or 
more in every 33,670 years. Using a 100 percent upper limit, the 
expected frequency of incursion was one or more in every 26,000 years, 
a 1.3-fold change. We included the results of these additional 
sensitivity analyses in our revised risk analysis.

Swine Semen Collection Centers

    In Sec.  98.38 of our proposed rule, we set forth conditions for 
the importation of swine semen from the multicountry area of the EU we 
were proposing to consider as one region. These conditions included 
origin requirements for the donor boar, requirements for isolation and 
testing prior to the boar's entry into the semen collection center, 
transportation requirements, and requirements for holding and observing 
the boar at the semen collection center for at least 40 days following 
collection of the semen. One commenter requested that an additional 
condition be included, i.e., to require that the donor boar be 
serologically tested while at the semen collection center. The 
commenter stated that observation alone might not detect very subtle 
clinical signs of CSF infection.
    We are making no changes based on this comment. All boars must be 
tested for CSF with negative results before entering the semen 
collection center. We do not consider it necessary to require 
additional testing at the center to ensure that the donor boar is not 
infected with CSF. Additionally, if an infected animal were held for at 
least 40 days at a collection center, it is very likely that the other 
animals being held at the center would provide a ``sentinel effect''-
that is, other animals exposed to the infected animal would likely show 
clinical signs of the disease while the infected animal was being held 
at the center. In developing our risk analysis, we created a scenario 
of maximum risk by not taking into account any sentinel effect. In 
actuality, it is likely that such an effect would provide a safeguard 
that an infected animal would be detected.

EU Trading Partners

    One commenter said it was not clear from the proposal if 
importation from the EU region would be dependent on the United States 
considering countries that export animals and animal products into the 
EU region as free of CSF, or if the United States would accept the EU 
designation of its trading partners' CSF status.
    Our consideration of whether to allow the importation of animals 
and animal products from a region in the EU was based on a number of 
factors. One of the factors we considered was that the exportation of 
swine into the EU from countries outside the EU is allowed under 
certain conditions if the animals are accompanied by a declaration that 
the countries are free of CSF, or if the animals were tested with 
negative results for CSF. Such movement controls are based on the 
status of countries outside the EU as recognized by the EU. 
Additionally, we considered the EU's ability to rapidly detect and 
eliminate any outbreaks of CSF that might occur within the EU. In our 
proposal, we discussed the surveillance for CSF that is carried out in 
the EU and the measures that would be taken to control and eradicate 
the disease in the event of an outbreak. After assessing these and 
other factors (as discussed in our proposed rule), we concluded that 
the conditions we proposed for importing breeding swine, swine semen, 
and pork and pork products into the United States from the EU would 
mitigate the risk of introducing CSF into this country.

CSF Outbreaks in France, Spain, Luxembourg, and Germany After June 1999

    Following publication of our June 1999 proposed rule, there were 
CSF outbreaks in domestic swine in parts of the EU, including France, 
Luxembourg, Spain, and Germany. Following those outbreaks, each of the 
affected countries took action to eradicate CSF. At this time, we are 
developing an updated evaluation of the CSF situation in France, 
Luxembourg, and Spain, and defining the jurisdictional level we could 
recognize as a region within those countries. We will publish a notice 
in the Federal Register when the updated evaluation is ready for public 
review and will accept comment on the evaluation for a specified period 
of time. Following review of any comments we receive, we will determine 
whether it is appropriate to consider: (1) France, Luxembourg, and 
Spain (or an appropriate combination of the three) as countries in 
which CSF does not exist or (2) appropriate jurisdictional units of 
France and/or Spain as regions in which CSF does not exist. If such a 
determination is made, we will publish a final rule to that effect in 
the Federal Register.
    Additionally, we anticipate developing a similar updated evaluation 
for those kreis in Germany that had CSF outbreaks after being included 
in the June 1999 proposed rule, for discussion in a separate notice in 
the Federal Register. Those areas of Germany are as follows: Kreis 
Heinsberg in the Land of Northrhine-Westphalia; Kreis Oldenberg in the 
Land of Lower Saxony; Kreis Uckermark in the Land of Brandenburg; Kreis 
Bernkastel-Wittlich in the Land of Rhineland Palatinate; Kreis Soltau-
Fallingbostel in the Land of Lower Saxony; Kreis Rhein-Hunsruche in the 
Land of Rhineland-Palatinate; Kreis Bitburg-Pr[uuml]m in the Land of 
Rhineland Palatinate; Kreis Trier-Saarburg and Kreis S[uuml]dliche 
Weinstrasse in the Land of Rhineland Palatinate; and Kreis 
Donnersbergkreis in the Land of Rhineland Palatinate.

CSF Outbreak in Spain

    One commenter expressed concern regarding the site visit report 
that APHIS completed prior to development of the proposed rule. The 
commenter noted that the site visit report indicated that no 
information was available at the time of its drafting regarding the 
source of an outbreak of CSF in the Province of Segovia in Spain. The 
commenter requested that any information that was subsequently obtained 
be made available to the public.
    All information that has been made available to us by Spain is 
posted to the APHIS Internet website.\1\ At this time, the source of 
the outbreak in Segovia has not been determined. However, the current 
epidemiological situation is being actively monitored in view of the 
recent outbreaks, and we are not relieving restrictions on imports from 
Spain at this time.
---------------------------------------------------------------------------

    \1\ The Internet address for accessing the information is http://www.aphis.usda.gov/vs/ncie/reg-request.html. At the bottom of that 
website page, click on ``Information previously submitted by Regions 
requesting export approval and their supporting documentation.'' At 
the next screen, click on the triangle beside ``European Union/Not 
Specified/Classical Swine Fever,'' then on the triangle beside 
``Information Supporting Request.''
---------------------------------------------------------------------------

Movement of Swine Within Germany

    One commenter stated that the site visit report noted that if CSF 
occurs in a district (kreis) in Germany, under EU standards, swine may 
not be exported to another country from anywhere in the State (Land) in 
which the district is located. However, districts in the State

[[Page 16927]]

other than the affected district may move swine within Germany. The 
commenter stated that there is some question whether this practice 
continues at present and, if so, questioned whether this practice 
should affect how the United States views the disease status of 
Germany.
    The type of movement within Germany that is referred to by the 
commenter is governed by a number of restrictions that reduce any 
disease risk that might otherwise be present. Swine that are moved from 
districts in a State other than an affected district must be clinically 
examined and serologically tested for CSF before being moved within 
Germany. After being moved, the swine must be held in isolation and 
clinically examined for 30 days.

Disease Surveillance in the EU

    One commenter stated that the site visit report did not provide 
information on the level of active surveillance in areas next to the 
regions in the EU in which CSF is considered to exist.
    As we stated in our proposed rule, if an outbreak of CSF occurs, 
eradication measures are conducted on the affected premises, and 
movement restrictions and active surveillance measures are implemented 
in surrounding areas. A protection zone with a radius of at least 3 
kilometers and a surveillance zone with a radius of at least 10 
kilometers are placed around the affected premises. Among the measures 
taken within the surveillance zone are the serological testing and 
clinical examination of all swine herds in the zone.

CSF Outbreaks in Previously Free Countries

    At the time we published our proposed rule, there were certain 
countries in Europe that the existing regulations listed as free of 
CSF. Because these countries were already considered free of the 
disease, we did not propose to include them in the multicountry EU 
region we identified in our proposal. One commenter questioned whether, 
in the event of a CSF outbreak in those ``free'' countries, the United 
States would accept the EU regionalization strategy in those countries, 
or would instead address the situation on an ``entire country'' basis. 
The same commenter stated that the final rule should specify when and 
how APHIS would choose to invoke safeguarding mechanisms to restrict or 
prohibit imports from the EU, rather than accept and approve EU 
regionalization strategies and requests.
    We would treat a CSF outbreak in a country we had considered free 
of the disease in the same way that we would treat an outbreak of any 
disease of concern in a ``free'' country. According to Article 12 of 
the U.S.-EU Equivalency Agreement: ``Either Party may take provisional 
measures necessary for the protection of public or animal health. These 
measures shall be notified within 24 hours to the other Party and, on 
request, consultations regarding the situation shall be held within 14 
days. The Parties shall take due account of any information provided 
through such consultations, and shall endeavor to avoid unnecessary 
disruption to trade. * * *''
    In this final rule, we are adding a new Sec.  92.3 that provides 
that whenever the EC establishes a quarantine in the EU in a region 
APHIS recognizes as one in which a disease is not known to exist, and 
the EC imposes restrictions on the movement of animals or animal 
products from the quarantined area, such animals and animal products 
are prohibited importation into the United States. If the outbreak 
appeared likely to continue in a limited part of the country, we would 
impose a ban on products from the area in question and, through 
rulemaking, would change the disease status listing of that part of the 
country. If the outbreak appeared to be spreading to other areas of the 
country, we would initiate rulemaking to change the disease status 
listing of the entire country.

FMD in Greece; SVD in Greece and Italy

    As noted above, in our proposed rule, we proposed to add Greece to 
the list of regions recognized as free of FMD. Additionally, we 
proposed to add Greece and eight Regions in northern Italy to the list 
of regions recognized as free of SVD. One commenter stated that the 
information regarding Greece upon which the proposal was based was 
collected in 1997, and expressed concern that the information did not 
address political unrest in Yugoslavia and an FMD outbreak in Turkey. 
The commenter also questioned why APHIS did not consider it necessary 
to conduct a site visit in Italy.
    As noted above, following publication of our June 1999 proposed 
rule, several outbreaks of FMD occurred in Greece in the summer of 
2000. No additional outbreaks have occurred since September 2000. In 
January 2001, APHIS representatives conducted a site visit to Greece to 
obtain evidence regarding the FMD status of that country and determined 
that a proposal to consider Greece free of FMD was warranted. In March 
2001, APHIS published in the Federal Register a proposal to consider 
Greece free of the disease, received no comments on the proposal, and 
made the proposal final in July 2002.
    With regard to SVD, we are making no changes based on the comment. 
The last outbreak of the disease in Greece was diagnosed in 1979. 
Yugoslavia is recognized as a region in which SVD does not exist. 
However, we are adding Greece to the list in Sec.  94.13 of SVD-free 
regions whose exports of pork and pork products to the United States 
are subject to certain restrictions. We are applying these restrictions 
because Greece supplements its national pork supply by importing fresh 
(chilled or frozen) pork from regions where SVD exists; has a common 
land border with certain regions where SVD exists; and imports swine 
from regions where SVD exists under conditions less restrictive than 
would be acceptable for importation into the United States.
    We did not conduct a site visit to Italy because we had conducted a 
site visit to that country 2 years previously (in March 1997) in 
connection with the Italian request to be recognized as free of African 
swine fever. That site visit gave us a clear understanding of, and 
confidence in, Italy's veterinary infrastructure, surveillance, 
diagnostic capabilities, and detection capabilities.

Noncommingling of Products

    One commenter stated that the proposed rule did not describe how 
APHIS would validate that products destined for export from Greece or 
Italy are not commingled with or exposed to products originating in 
regions where SVD exists.
    Such validation will be carried out in the same way as in other 
countries that export animals and animal products to the United States. 
We require certification by veterinary officials in those countries 
that our regulatory requirements have been met. Additionally, initial 
inspections of slaughtering and processing establishments are conducted 
by the Department's Food Safety and Inspection Service (FSIS) and 
APHIS, and periodic inspections are subsequently conducted by FSIS.

Comments Received on Revised Risk Analysis

    Of the 21 comments we received in response to our May 2002 notice 
of availability, one requested an extension of the comment period, and 
all but two of the rest of the commenters either supported the results 
of the revised risk analysis or recommended that the June 1999 proposed 
rule be made final.
    Of the remaining two commenters, one expressed the opinion that the 
risk of introducing CSF virus into the United

[[Page 16928]]

States via the import of semen is much less than the one estimated in 
the risk analysis, based on the following reasons:
    [sbull] Although the swine semen simulation model used in the risk 
analysis assumes that an outbreak of CSF occurs each 2 years in a semen 
collection center in the region being analyzed, between 1991 and 2002 
only one CSF outbreak occurred in a semen collection center in the 
region in question.
    [sbull] Although the risk analysis assumed that the ``risky 
period'' in the case of an outbreak in a semen collection center would 
last as long as in any other pig holding--i.e., 3-4 weeks on average--
this does not correspond to what actually happened in the Netherlands 
in 1997, when CSF was introduced into a swine semen center and was 
recognized in other swine holdings in the vicinity of the center well 
before confirmation of the disease in the center itself.
    [sbull] Improvements have been made through EC legislation to 
reduce the risk of spreading CSF through swine semen. This legislation 
took into account the experiences of the 1997-1998 outbreak.
    The commenter requested that APHIS eliminate the requirement that 
semen collected in the EU region in question be held for 40 days before 
being exported to the United States. The commenter further requested 
that, if APHIS believes that some mitigating measures on the 
importation of semen are necessary, it consider alternative measures 
such as the testing of semen before exportation by virological tests.
    We are making no changes based on this comment. The application of 
a 40-day hold on semen was based on the results of the risk assessment 
we conducted for the proposed rule, which indicated that, without 
mitigation, the importation of swine semen from the EU region in 
question would present a disproportionate risk of introducing CSF into 
the United States. The 40-day hold was determined to be an effective 
mitigation measure. If we receive a request from a member of the public 
to consider an alternative means of mitigation, along with supporting 
information with which to evaluate such a request, or if we receive 
information that indicates that no mitigation measures may be 
necessary, we will conduct an assessment of the risk of importing swine 
semen into the United States under the conditions suggested. If such an 
assessment indicates that the change would be appropriate, we will 
publish, in accordance with the Administrative Procedure Act (APA), a 
proposal in the Federal Register to change the regulations accordingly, 
and provide an opportunity for other members of the public to comment 
on the proposed action.
    The commenter also stated that the provisions of the final rule 
should reflect the current CSF situation in the EU, not the situation 
in 1999.
    We published our June 1999 proposal in response to a request from 
the EC that we consider a multi-country area in the EU as one region, 
and we conducted an analysis of the risk of the introduction of CSF 
from that region at that time. In accordance with the APA, we invited 
comments on the proposed rule and are addressing in this final rule the 
comments we received. We are receptive to requests for further changes 
to the regulations and will address such changes through notice and 
comment rulemaking in accordance with the APA. If the existing 
situation appears to warrant a new analysis, we will conduct one.
    One commenter raised a number of issues regarding our proposed rule 
and specific provisions of the risk analysis. We address below the 
issues raised by that commenter in a comment/response format.
    Comment: APHIS' scientific approach toward the regionalization of 
the EU and its member States and sublevels seems to differ from APHIS' 
approach to other countries or regions. Continuing outbreaks of CSF in 
the EU call into question the ability of the EU to apply appropriate 
disease control measures and how APHIS can evaluate risk in a dynamic 
situation.
    Response: We agree that the approach we proposed to regionalizing 
the EU is somewhat different from the way we have historically 
approached other regionalization actions. This is due to the nature of 
the request from the EU, which asked that multiple countries be 
considered as one region, and the infrastructure and regulatory factors 
specific to the region in question. In recognition of what the 
commenter refers to as a ``dynamic situation,'' the risk analysis we 
developed recognized the possibility of continuing sporadic CSF 
outbreaks in the EU region in question, and the risks associated with 
these outbreaks, rather than looking at a specific geographic area as 
free of the disease. Risk was defined as a quantitative probability 
based on the disease history of the region and was approached on a 
commodity basis, rather than as an evaluation of disease status. The 
approach in our risk analysis and proposed rulemaking is consistent 
with APHIS' obligation under the World Trade Organization Agreement on 
Sanitary and Phytosanitary Measures (WTO-SPS Agreement) to recognize 
not only disease-free areas, but also areas of low disease prevalence 
for which mitigations can be established to reduce risk.
    Comment: CSF has been diagnosed in numerous locations in the EU 
since the data for the revised risk analysis was collected, and these 
new data should be incorporated into a risk analysis to allow for an 
accurate conclusion. We believe an outbreak in domestic swine in France 
in 2002 due to exposure to wild boar contradicted an assumption in the 
risk analysis that CSF outbreaks in domestic swine in France do not 
occur due to exposure to wild boar. The descriptive observations in the 
risk analysis do not predict clearly where outbreaks may occur and, 
although APHIS stated in its risk analysis that an historical reduction 
in the spread of CSF from wild boar could be attributed to EU 
surveillance and control activities, those activities were considered 
inadequate by the EU to counter outbreaks that occurred after 
publication of the June 1999 proposed rule, as evidenced by the EC's 
decision in May 2002 to take further measures for the control of CSF.
    Response: Much of the data used in the risk analysis were generated 
during an extremely severe CSF epidemic that occurred in the EU in 1997 
and 1998. As discussed in the risk analysis, this CSF epidemic is 
considered the most severe the EU has ever experienced. The risk 
estimates generated in the analysis took into account the effectiveness 
of EU control measures, and where these measures failed, under these 
severe conditions. The risk analysis, therefore, anticipates future CSF 
epidemics of the same magnitude and the same level of detection and 
control failures as occurred during the 1997-98 epidemic. Given that 
recent CSF epidemics have been of a lesser magnitude and reflect fewer 
failures in detection and control, they fall within the expectations of 
the current risk analysis. Incorporating the data from these recent 
epidemics into the analysis would likely reduce the estimated risk.
    We do not agree that our risk analysis assumed that CSF outbreaks 
in domestic swine in France do not occur due to exposure to wild boar. 
The statement that, at the time of the risk analysis, there had not 
been a CSF outbreak in France was not meant to imply that outbreaks in 
domestic swine do not occur due to exposure to wild boar, but was 
simply an observation of what had or had not occurred. The risk 
analysis recognized the possibility of continuing sporadic outbreaks 
anywhere in the EU. As discussed above, given that recent CSF epidemics 
are of a lower magnitude

[[Page 16929]]

and reflect fewer failures in detection and control, they fall within 
the expectations of the risk analysis. The risk analysis was not 
intended to predict where outbreaks might occur in the EU, but simply 
to assess the risk to the United States from future situations in the 
EU where CSF epidemics reach the same magnitude and the same level of 
detection and control failures as occurred during the 1997-98 epidemic. 
Again, the 1997-98 CSF epidemic is considered the most severe the EU 
has ever experienced.
    Comment: Unless APHIS establishes what level of risk of a CSF 
incursion--as measured by ``the expected frequency of one CSF incursion 
every `x' years''--it considers acceptable, it is difficult to assess 
the different levels of risk that are calculated in the risk analysis.
    Response: Through the Animal Health Protection Act (AHPA) (7 U.S.C. 
8301-8317), Congress declared that ``the Secretary may prohibit or 
restrict the importation or entry of any animal, article, or means of 
conveyance * * * if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into or 
dissemination within the United States of any pest or disease of 
livestock'' (7 U.S.C. 8303(a)). Neither the AHPA nor the Secretary 
through regulations has delineated all the specific conditions that 
might be considered necessary to protect against the introduction of 
animal diseases or pests. This allows APHIS to evaluate the specific 
animal diseases or pests of concern and impose the specific importation 
conditions necessary to reduce sufficiently the risk of the 
introduction of such diseases and pests.
    APHIS has a long history of evaluating countries or other regions 
qualitatively for animal disease risk, including the risk of 
introducing CSF. A qualitative evaluation for this rulemaking was 
conducted in accordance with the standard approach described in 9 CFR 
92.2. The results of this evaluation are presented throughout the final 
report of the risk analysis.
    For this rulemaking, APHIS also conducted a quantitative assessment 
of the risks. APHIS estimated data parameters for input into the 
quantitative model that describe risks associated with the most severe 
outbreak of CSF that has ever occurred in the EU. APHIS reported the 
results of the assessment as the likelihood of one or more incursions 
per year or the mean time between incursions. Reporting results using 
quantitative frequency values of this type was not meant to provide, or 
imply that APHIS has identified, a precise frequency of incursion as an 
Appropriate Level of Protection or Acceptable Level of Risk (ALOP or 
ALOR). Rather, APHIS used these results to assess the probable range or 
degree of the likelihood of introducing CSF from the EU and what 
mitigating importation conditions, if any, need to be imposed to 
further decrease the degree of such likelihood. In this particular 
case, irrespective of the precise frequency of events estimated by the 
model, the numerical values suggested that the frequency of CSF 
introduction by breeding swine and pork from the EU would be extremely 
low, as would be the case with swine semen with mitigation. Using the 
information available to it, APHIS was able to determine the likelihood 
of introducing CSF from the EU, assess the different risk levels, and 
decide if any mitigation measures were necessary without having to 
pinpoint an exact ALOP or ALOR.
    Comment: The OIE Code describes four components of risk analysis-
release assessment, exposure assessment, consequence assessment, and 
risk estimation-- but APHIS did not conduct a consequence assessment 
because APHIS considered the risks estimated for release and exposure 
``very small.'' APHIS should complete all four steps in its risk 
analysis, due to the extremely wide margins around the most likely risk 
estimates, as well as different risks to the U.S. swine populations 
depending on the route of exposure (e.g., infected meat vs. infected 
semen).
    Response: OIE guidelines state that, if the release or exposure 
assessment demonstrates no significant risk, the risk assessment may 
conclude. APHIS addressed consequences in its analysis. However, 
because the risk values for both release and exposure were very small, 
it did not conduct a detailed consequence assessment. However, the risk 
analysis does address all components listed in the OIE guidelines.
    Comment: In conducting its risk analysis, did APHIS consider 
assessing CSF risk from specific discrete areas in the EU countries, 
rather than in the EU region as a whole? Perhaps this type of analysis 
would have identified specific areas with higher risk levels and the 
need for additional mitigation measures. APHIS should discuss the 
appropriateness of establishing different levels of risk for different 
areas.
    Response: The risk analysis that APHIS conducted considered 
multiple Member States of the EU as one region. This approach was in 
response to a request by the EC that the countries in question be 
considered together as one region. The approach we have taken is 
actually a conservative one with regard to disease risk, in that we are 
continuing to prohibit imports of swine and swine products from parts 
of or entire Member States that had an outbreak of CSF either shortly 
before we published our 1999 proposed rule or since that time. In those 
parts of the EU where we are removing prohibitions on imports due to 
CSF, we are also applying mitigating measures with regard to the 
importation of swine semen, in recognition of the trade practices among 
the EU Member States in the region.
    Comment: It was not clear from the risk analysis how primary and 
secondary outbreaks are factored into the evaluation of risk. It 
appears that any infected herd, regardless of whether its infection was 
considered primary or secondary, could contribute to CSF risks prior to 
detection. In the report from the APHIS 2000 site visit to the EU, it 
was not clear whether the EU was immediately notifying the United 
States of secondary outbreaks of CSF. The United States might be 
exposed to CSF from animals or products from areas of secondary 
outbreaks.
    Response: In the December 2000 risk analysis (Section II, ``Spatial 
and Temporal Considerations,'' in ``Temporal Trends in Primary versus 
Secondary Outbreaks''), we used the following definitions for primary 
and secondary outbreaks: ``For purposes of this discussion, APHIS is 
defining a primary outbreak as one that occurred in domestic swine in a 
previously free area. The smallest area under consideration by APHIS in 
this definition is a county-level equivalent (e.g., kreis) that had not 
recently reported a CSF outbreak attributed to wild boar, swill 
feeding, or any other (including unknown) cause. Secondary outbreaks 
are defined as other outbreaks and are generally attributed to causes 
such as the purchase of animals or contacts with persons or transport 
equipment from other premises with infected domesticated swine.'' The 
commenter is correct that any herd, regardless of whether it was 
considered a primary or secondary outbreak could contribute to risks 
prior to detection. However, even considering changes in the levels of 
secondary spread from recent outbreaks in areas like Germany, the 
magnitude and scope of this spread is far less than occurred in the 
Netherlands in 1997-98, which was the most severe outbreak in the 
region in question in recent history.
    The practice of the EC is to consider any disease outbreak a 
primary outbreak if it occurs outside the administrative unit where 
another primary outbreak has already occurred. Therefore,

[[Page 16930]]

notification must be given of outbreaks in any areas that are not 
currently under restriction, even if they are epidemiologically linked 
to outbreaks that have already occurred in another administrative unit. 
Where secondary outbreaks occur in areas that have already had a 
primary outbreak, movement from that area will have already been shut 
down due to the primary outbreak.
    Comment: It may be difficult to detect CSF quickly, as witnessed by 
the 1997 outbreaks in the Netherlands, where it was estimated the CSF 
virus was detected approximately 6 weeks after it was introduced. Quick 
detection may be hindered by presumption that clinical symptoms are 
caused by a disease other than CSF, such as when diagnosis of CSF in 
the United Kingdom was delayed due to confusion of CSF with Postweaning 
Multi-Systemic Wasting Syndrome (PMWS) and Porcine Dermatitis and 
Nephropathy Syndrome (PDNS).
    Response: With regard to outbreaks in the Netherlands, the risk 
analysis took into account the actual detection delays that occurred 
during the 1997-98 epidemic, including the 6-week time period the 
commenter mentioned for the Netherlands. With regard to the potential 
of misdiagnosing CSF as PMWS or PDNS, since the CSF outbreak in the 
United Kingdom, the EC has adopted a CSF Diagnostic Manual, taking into 
account the experience gained during outbreaks in the United Kingdom 
and in other EU Member States. Additionally, recent improvements in CSF 
diagnosis have been made through the development of polymerase chain 
reaction techniques, which are particularly useful in combination with 
postmortem examination and histopathology when CSF might otherwise be 
confused with other diseases.
    Comment: How does APHIS intend to enforce its prohibition on the 
importation of products and animals from EU areas that APHIS considers 
to be affected with CSF, if the EU allows movement among its member 
States from such areas before APHIS recognizes the areas as CSF-free? 
How will movements within the EU be monitored to ensure that products 
and animals are not moved from areas considered restricted regions by 
the EU?
    Response: In determining which areas in the EU are considered 
``CSF-affected,'' APHIS will apply the criterion of whether at least 6 
months have elapsed since the last incidence of CSF in the area, and 
will prohibit imports of swine and swine products from areas that APHIS 
does not consider CSF-free. This should be verifiable from the 
certification provided by the exporting region. For regions from which 
importation is not prohibited due to CSF, APHIS will require 
certification of region of origin by the exporting country.
    Comment: The proposed rule did not describe how animal products 
would be traced if there were an outbreak outside the areas in which 
CSF is considered to exist, and how such an outbreak would affect 
products already in the United States or in transit to the United 
States. How will APHIS track and keep its port inspectors notified as 
to which areas in the EU are allowed to export swine, swine products, 
and swine semen to the United States?
    Response: In the event a trading partner should have an outbreak of 
CSF, we would follow the same notification procedures that we follow 
for any disease of concern. Any prohibited or restricted articles in 
transit would be stopped at the port of importation into the United 
States. If a product had already passed through a port of entry, we 
would trace the product by means of the importer's distribution 
records.
    Comment: APHIS should discuss in the final rule any comments on its 
June 1999 risk analysis that were generated by peer review of the 
analysis.
    Response: The peer review comments focused on lack of transparency, 
identification of data sources, sensitivity analysis, listing of 
mitigation options, and conformance with OIE format. The comments 
suggested further that the analysis be revised to expand its hazard 
characterization, taking into account the spatial and temporal nature 
of the outbreaks that had occurred in the EU, including analysis of 
risk patterns, primary outbreaks versus secondary or tertiary ones, and 
pathways of disease spread.
    In response to these comments, APHIS revised the presentation of 
the quantitative model. These revisions appear in Section I of the 2000 
analysis. The document was reformatted to conform more closely with OIE 
guidelines, and includes a list of mitigation options. APHIS also 
clarified the description of the quantitative model and clearly 
identified data sources. Sensitivity analysis was conducted on some 
input values.
    In addition, APHIS requested additional data from the EU to support 
a spatial and temporal analysis. Data collected included an update of 
the epidemiological information on which the 1999 analysis was based, 
as well as new information on the origin of outbreaks in space and 
time, disease surveillance in feral swine and wild boars, patterns of 
animal movement, maps of local veterinary administrative units in areas 
where outbreaks occurred, and information on herd and animal density. 
APHIS performed a spatial and temporal analysis that was presented as 
Section II of the revised analysis.
    Comment: Will the risk analysis be reviewed and updated by APHIS in 
the event additional countries join the EU?
    Response: In the event additional countries join the EU, we will 
initiate an assessment of CSF risk from those countries upon request by 
the EC. If, based on such a risk assessment, we believe restrictions 
from those countries with regard to CSF could safely be relieved, we 
would propose such a change through notice and comment rulemaking.
    Comment: In calculating risk, the risk analysis factored in a 
``risky period'' of 35 days following an outbreak, during which the 
disease may or may not be identified. Because the clinical signs of CSF 
are the same as for a number of other swine diseases, identification of 
CSF could be delayed. How would the probabilities of CSF introduction 
into the United States change if a 42-day risky period is used?
    Response: The analysis incorporated the actual difficulties the 
Netherlands encountered in detecting CSF in 1997 as well as the actual 
detection difficulties of other EU Member States throughout the 
epidemic. The risky periods included in the analysis and described 
under variable ``b'' for each of the three models of the risk analysis 
were: (a) the Netherlands, 35 days; (b) the Lerida province in Spain, 
53 days; (c) the Segovia, Madrid, and Toledo provinces in Spain, 7 to 
21 days (most likely 10 days); (d) Belgium, 42 days; (e) Italy, 21 
days; (f) Germany, 7 to 21 days (most likely 10 days). Therefore, the 
maximum risky period considered in the analysis was 53 days based on 
Spain's experience, which is greater than the 42 days suggested by the 
commenter. The risky period for any specific Member State was not 
analyzed individually, but rather was incorporated into an overall 
probability distribution of the risky period for all of the EU Member 
States under consideration. This probability distribution and its 
derivation are described in the risk analysis document. While the 
commenter is correct that problems with detection ability could be 
compounded even further in the United States, it is only the EU's 
ability to detect CSF that is being examined in the risk analysis.
    Comment: In the EU in 1997, 611 outbreaks of CSF were confirmed, 
and 103 of the 611 were in farms outside protection zones established 
during the

[[Page 16931]]

outbreaks. Although, in its risk analysis, APHIS considered the 
remaining 508 herds as not contributing to further spread of the 
disease during the ``risky period,'' experience with disease movement 
through a variety of pathways indicates that CSF would be expected to 
spread from the protection zones.
    Response: The 103 outbreaks occurring outside protection zones 
include any spread that occurred from the 508 outbreaks inside the 
protection zones to outside the protection zones.
    Comment: APHIS stated in its risk analysis that an area can be 
designated as CSF-free if a case of CSF has not been detected for at 
least 6 months. What changes in the risk analysis would result if new 
criteria with a shorter length of time were established as the standard 
APHIS would use?
    Response: The 6-month period referred to by the commenter is longer 
than the time that actual protection zones were maintained in the EU 
after the last case of CSF occurred in the zone. The risk analysis was 
based on the actual times the protection zones were maintained. 
Therefore, if a 6-month waiting period were applied, the risk would be 
reduced to levels below those estimated in the analysis. The additional 
mitigative effect of the longer 6-month waiting period could not be 
explicitly incorporated into the risk estimates because of the lack of 
actual observations on which to base such estimates.
    Comment: In its risk model for breeding swine, APHIS assumed that 
each shipment of breeding swine for export originated from only a 
single farm. Is this a valid assumption? How would the probability of 
disease introduction change if this assumption were not made?
    Response: APHIS made the assumption based on data available from 
the United Kingdom and Denmark. Import records showed that most 
shipments from these EU Member States originated from a single herd. 
APHIS was unable to obtain specific information for other Member 
States, so we assumed for the purposes of the risk analysis that each 
shipment was represented by one breeding herd. For a given number of 
imported breeding animals, any increase in risk caused by increasing 
the number of herds would be largely offset by the decrease in risk 
resulting from decreasing the number of animals selected per herd. The 
overall effect of a small increase in the number of herds of origin 
would be expected to be negligible, given the following: (1) The low 
within-herd prevalence that is likely for an undetected infected herd; 
(2) breeding animals would not likely be shipped if there were evidence 
of any type of infection in the shipment, regardless of whether an 
animal had been specifically identified as being infected with CSF; and 
(3) the overall number of imported animals is held constant.
    Comment: Will this final rule change the quarantine and testing 
protocols for breeding swine imported into the United States?
    Response: This final rule will change the listing of regions we 
consider to be affected with CSF and will affect the requirements an 
exporting region would have to meet in the absence of any other disease 
restrictions applicable to swine and swine products. It will not affect 
the current quarantine and testing protocols for breeding swine 
imported into the United States. If breeding stock is imported into the 
United States from regions in the EU considered to be free of CSF, the 
animals would still be required to undergo preembarkation and post-
importation quarantine to ensure that they are not affected with 
brucellosis, tuberculosis, or pseudorabies.
    Comment: In its sensitivity analysis, APHIS appeared to gauge 
changes in one variable independently of changes in another. For 
instance, the analysis determined the effect of varying the proportion 
over time of infected breeding farms exporting to the United States 
independently of determining the effect of varying the probability that 
an animal in a CSF-infected herd is infected with CSF. APHIS should 
evaluate concurrently these changes to the model to determine their 
simultaneous effect on the probability of one or more CSF incursions in 
a year.
    Response: The purpose of the sensitivity analysis was to 
demonstrate the effect of changing individual input values in the 
model. The most likely risk estimates changed only minimally as a 
result of changing either of the two input values mentioned by the 
commenter, and changing both simultaneously would not be expected to 
result in a more substantial change. Although the range of uncertainty 
in the risk estimates did change substantially (a nine-fold change) by 
changing the distribution used for the input value ``Effect of varying 
the proportion over time of infected breeding swine farms exporting to 
the United States,'' this change too would not be substantively 
affected by changing both input values simultaneously.
    Comment: The beta distribution (a probability distribution that is 
used to estimate the variability around a proportion) used to describe 
the relationship of the model term g/h (the probability that a randomly 
selected breeding herd has undetected CSF) in the breeding swine model 
could be viewed as too conservative to adequately describe the expected 
outbreak frequency, and a triangular distribution (a calculation of the 
minimum, most likely, and maximum estimate) that uses a more realistic 
description of the 1997 outbreak in the Netherlands is required. The 
analysis underestimated the number of herds that would become infected 
before the disease was diagnosed. An estimate of the number of herds 
infected during this ``risky period'' should be used for ``g'' (the 
number of infected breeding herds with undetected CSF) and provide a 
basis for determining the parameters of the triangular distribution.
    Response: We disagree with the commenter's suggestion to use a 
triangular rather than a beta distribution to represent the variability 
around the proportion g/h. The use of a beta distribution to represent 
this variability is consistent with well-established statistical 
theory. A triangular distribution is generally used to represent a 
rough guess in the absence of actual observational data and has no 
theoretical foundation.
    Comment: The risk analysis indicated a ``maximum'' result of one 
CSF incursion in breeding swine every 4,880 years, but a ``most 
likely'' result of one CSF incursion every 33,700 years. How does APHIS 
view the differences in the values?
    Response: As noted above, the numerical values suggest that 
frequency of introduction by any commodity that was considered in the 
analysis, even with no import mitigations applied, was extremely low.
    Comment: What does APHIS consider the estimated sensitivity of the 
serologic assay(s) being considered in the model? If the sensitivity is 
anything less than 100 percent, it should be included in the 
development of the model.
    Response: The sensitivity of the serological assay for CSF in the 
EU is estimated at between 85 and 95 percent. However, since 
serological testing was not considered in the risk analysis as a 
potential mitigation for imported breeding swine, there was no need to 
include such an estimate in the model. If the commenter's question is 
regarding the EU's ability to detect CSF in its surveillance 
activities, it should be noted that risk analysis was based on a 
retrospective evaluation of the EU's actual detection success in the 
1997-98 epidemic. Therefore, an estimate of the sensitivity of the 
serological assay was not required. Only evidence of the

[[Page 16932]]

observed success rate in detection and control, or, in other words, the 
measurements of the risky periods, was needed.
    Comment: In its June 1999 risk analysis, APHIS stated that the 
starting risk level of CSF introduction by swine semen was 1 or more 
incursions in an average of 1,842 years, but that holding semen donor 
boars and observing them clinically for 40 days after semen collection 
reduced this likelihood to 1 or more outbreaks in 257.7 million years. 
In its December 2000 risk analysis, APHIS states that holding the swine 
for 40 days would result in a risk estimate of 1 or more incursions in 
an average of 8,090 years. How does APHIS explain the discrepancy 
between the first and the second analysis?
    Response: In the June 1999 risk analysis, the 40-day holding period 
included the additional estimated mitigative effect of multiple animals 
being held together during the 40-day period. In other words, the June 
1999 analysis incorporated a sentinel effect that required only one of 
the group of animals being held together to show observable signs of 
infection for detection to occur. In the revised December 2000 risk 
analysis, this sentinel effect was dropped from the analysis. The 
December 2000 risk analysis assumes that only one animal is held and is 
based on whether this specific animal shows observable signs. Dropping 
the sentinel effect from the analysis results in a substantial increase 
in the estimated risk. Although we believe this overestimates the risk, 
the sentinel effect was dropped from the analysis because there were no 
substantiated data available to support an estimate of the number of 
animals that might be held together. The assumption of no sentinel 
effect is described in the analysis in the discussion of variable 
``k''.
    Comment: APHIS stated in its risk analysis that additional 
mitigation could be accomplished by employing serological testing. 
APHIS, therefore, should evaluate the change in risk that would occur 
if such testing were required. During the 1997 CSF outbreak in the 
Netherlands, some boars in a semen collection center that were 
initially considered not to be infected with CSF, based on the absence 
of clinical signs, were tested the following day and found to be 
infected. It appears an outbreak of CSF in the semen collection center 
followed the transport of some boars into the center in the same means 
of conveyance used earlier for sows from a presumed infected farm. This 
apparent biosecurity problem raises questions about the assumptions 
used in the model in the risk analysis.
    Response: The risk analysis included the fact that the CSF agent 
was introduced into the semen collection center during the risky 
period-i.e., prior to CSF detection and control in the Netherlands. 
This information was incorporated into variable ``g'' (the number of 
affected swine semen collection centers with undetected CSF) in the 
swine semen model. Therefore, the breakdown in biosecurity that 
occurred and the unclear clinical signs that were presented were 
already accounted for in the risk analysis model, which prompted the 
proposed inclusion of a 40-day holding period on swine semen before 
export. Based on the reduced level of risk when such a holding period 
is required, we see no reason to additionally evaluate the effect of 
requiring the serological testing referred to by the commenter.
    Comment: Many of the approved swine semen collection centers in the 
EU are located in Spain, Germany, and France, all countries in which 
CSF outbreaks have occurred relatively recently.
    Response: As noted above, we are continuing to apply import 
prohibitions due to CSF on those parts of countries or entire countries 
where a CSF outbreak has occurred since our June 1999 proposal. As we 
discussed earlier, included in such areas are Spain, France, parts of 
Germany, and Luxembourg.
    Comment: In establishing the eligibility of the semen of a boar for 
export to the United States, is it required that no new boars enter the 
stud (the semen collection facility) during the 30-day isolation period 
and 40-day incubation period of the specific donor boar in question. Is 
serologic testing a component of the isolation and incubation protocol?
    Response: Serologic testing and isolation of boars is required by 
the EU prior to the boars entry into the semen collection center. Once 
the semen is collected, whether the boars are kept isolated will not 
have any significant effect on import risk.
    Comment: In evaluating the sensitivity of its risk model (i.e., its 
determination of how variations in input data affect probability 
outcomes), APHIS stated that it ``considered a distribution to address 
uncertainty unnecessary since the assumptions used reflected a 
situation worse than there were data to support.'' This statement seems 
to contradict itself, because a major justification for conducting a 
sensitivity analysis is the lack of a good estimate for a variable.
    Response: The statement in the risk analysis that the commenter is 
referring to was in regard to only one scenario of the sensitivity 
analysis. In that scenario, the point estimate of the number of 
infected semen centers exporting semen to the United States was doubled 
in order to see the effect on the risk estimates. This scenario was 
created to isolate the effect of altering the number of semen centers 
that were infected, which could best be accomplished by comparing the 
model results using two alternative point estimates. However, another 
scenario was also run, and is documented in the risk analysis, where a 
probability distribution (specifically a beta distribution) was used to 
represent the number of infected semen centers. We devoted attention to 
running multiple scenarios for the number of infected semen centers 
because we viewed this factor as a critical model variable.
    Comment: If the risk ``maximum result'' were selected in the 
analysis, the result would be an expected frequency of a CSF incursion 
due to imported semen every 694 years, in contrast to every 1,840 years 
for the ``most likely value.'' The sensitivity analysis varying the 
probability of an animal as CSF infected in a CSF-infected center 
results in a ``most likely value'' of one or more incursions every 903 
years, and a ``maximum value'' of one or more incursions every 278 
years, which are similar to the values for the scenario of an approved 
semen center becoming infected with CSF every year. Considering this 
level of risk, what would be the impact on risk to assume mitigation 
measures in addition to the 40-day hold on semen included in the 
proposed rule?
    Response: The value referred to by the commenter was determined 
before any mitigating measures were introduced into the risk 
calculations. With the introduction of a 40-day waiting period before 
semen may be exported, even the maximum value is no more than one or 
more incursions every 2,430 years. However, the most likely value for 
the expected frequency is one or more incursions every 8,090 years.
    Comment: Because semen seems to pose the highest risk of all swine 
commodities considered for export to the United States, it could be 
considered important to survey the U.S. industry regarding the types of 
importations that are likely in the future, in order to ensure that the 
assumptions that were used in the model are appropriate for future 
importations. The commenter suggested such survey information might 
include countries and other regions from which imports would be

[[Page 16933]]

requested, the number of doses likely, and the number of boars per 
shipment.
    Response: In compiling data for the risk analysis, APHIS contacted 
several major breeding companies regarding their plans for importation. 
Although the companies gave no indication at the time of significant 
plans for importations, the risk analysis nonetheless assumed that such 
importations would occur.
    Comment: APHIS stated that requirements for inspection by the 
Department's Food Safety and Inspection Service (FSIS) would reduce the 
risk of importing infected product into the United States even further 
than estimated in the risk analysis. Are there any rapid testing 
protocols, or pathognomonic (distinctly characteristic) lesions or 
clinical signs, that would lead an FSIS inspector to be concerned about 
CSF infection in a particular animal or pork product?
    Response: There is no commercially practical test for the CSF virus 
in meat and meat products. Our statement in the proposed rule addressed 
ante- and post-mortem inspection of animals. Such inspection evaluates 
the general health of the animal to be slaughtered. One of the common 
characteristics of CSF is a high percentage of a swine herd sick at the 
ante-mortem stage. In addition, high temperature and purplish 
discoloration of the abdominal skin may be noticed. CSF does cause 
lesions on various organs that can be detectable post-mortem. Although 
we noted the benefit of inspection, the effect of such inspection was 
not considered in our risk analysis.
    Comment: APHIS should explain why more emphasis was not applied to 
interpreting the ``maximum likelihood'' estimates regarding the risk of 
CSF introduction into the United States in addition to or rather than 
the ``most likely'' estimates. In risk evaluations, an evaluation of 
the range around the ``most likely'' estimate should carry as much 
weight as an evaluation of the ``most likely'' estimate itself.
    Response: The most likely risk estimates were highlighted as the 
central tendencies of the model output distributions. However, maximum 
risk estimates (as well as minimum, mean, and median estimates) were 
also presented as part of the output of each scenario that was run for 
each model. In this way, readers had full information about the central 
tendencies and the ranges of the model outputs. However, the maximum 
risk estimates are obtained from the extreme tail of the probability 
distribution. The tail of the distribution represents an extremely 
small area relative to the area representing the central mass of the 
distribution from which the most likely estimate is obtained.
    Comment: Given the difficulty and subjectivity involved in 
determining the value of variables for use in the risk model, and the 
magnitude of the effect of the variables on the final risk estimate, it 
may be useful to conduct a Delphi Survey (a survey of the opinions of 
experts on a particular topic) to ascertain ranges of estimates for 
prospective risk A sensitivity analysis could then be completed that 
combines the range of estimates (and the variation around the 
estimates) for the model inputs. This would allow APHIS to use data 
regarding CSF outbreaks since the December 2000 risk analysis was 
written, which would, in turn, allow the model to have more value for 
application to potential future CSF situations in the EU.
    Response: Most of the data used in the risk analysis were generated 
during an extremely severe CSF epidemic that occurred in the EU in 1997 
and 1998. As discussed in the risk analysis, this CSF epidemic is 
considered the most severe the EU has ever experienced. By using actual 
data from this epidemic rather than using estimates based on expert 
opinions obtained through a Delphi Survey, the risk assessment provides 
a more cautious estimation of the potential risk. The risk estimates 
generated in the analysis took into account the effectiveness of EU 
control measures, and if and where those measures failed, under these 
severe conditions. The risk analysis therefore anticipates future 
situations in the EU where CSF epidemics reach up to the same magnitude 
and the same level of detection and control failures as occurred during 
the 1997-98 epidemic. Given that recent CSF epidemics are of a smaller 
magnitude and have fewer failures in detection and control, they fall 
within the expectations of the current risk analysis. Incorporating the 
data from these recent epidemics into the analysis would likely reduce 
the estimated risk.
    Comment: APHIS acknowledges the impact of the sensitivity analysis 
on the models but does not present the final risk estimations resulting 
from the sensitivity analysis. APHIS should publish the final risk 
estimates for the three models.
    Response: A summary of the final risk estimates for all three 
models is presented in the executive summary of the risk analysis 
report. The full details of these estimates are presented throughout 
the text of the report. The risk estimates for each sensitivity 
analysis are reported in the sensitivity analysis section. The 
sensitivity analyses were conducted to show how the final risk 
estimates might change under alternative assumptions regarding input 
values. As such, the results of the sensitivity analyses stand alone 
rather than as adjustments to the final models.
    Commenter: The model does not account for the impact of 
intraregional spread (such as five herds being infected at one time). 
This, combined with the use of a conservative beta distribution to 
describe the proportion of infected herds from which animals are 
exported to the United States over time (g/h), biases the model toward 
underestimating the true risk to the United States. Is APHIS 
considering this aspect?
    Response: As we discussed in the sensitivity analysis section of 
the risk analysis regarding swine semen, the beta distribution for the 
input value g/h is considered conservative in the sense that it likely 
contributes to overestimating the risk. Also, as discussed in the risk 
analysis, the CSF epidemic that provided the data for the analysis is 
considered the most severe the EU has ever experienced. Incorporated 
into the risk estimates based on this epidemic are six different risky 
periods representing index cases in six discrete locations in the EU: 
the Netherlands, Italy, Belgium, Germany, and two separate locations in 
Spain (the risky period is documented under input value b in the 
models). Since the models are exclusively based on the time period 
during which this severe epidemic occurred and do not incorporate any 
``peace time'' periods, the model is actually biased toward 
overestimating the risk.
    Comment: The risk analysis report, despite referring to the 
importance of the wild boar reservoir in maintaining the CSF virus in a 
region, concludes that the ``risk of importing CSF-infected material 
from areas of the EU that are in close proximity to infected wild boar 
is not greater than the risk of importing infected material from areas 
that are geographically distant from primary outbreaks caused by wild 
boar.'' Have statistical tests been applied to the available data to 
provide a quantitative assessment of the risk posed by wild boar to EU 
herds? APHIS should review its previous assumptions about the role of 
wild boars with regard to the risk of importing infected or 
contaminated animals or products.
    Will semen be allowed to be imported into the United States from an 
area in the EU that is designated by the EU to be ``wild boar control 
area'' (i.e., an area in which CSF has been diagnosed in feral swine 
and in which domestic

[[Page 16934]]

swine have consequently been placed under surveillance and in which 
specified measures are being taken to protect domestic swine from 
infection by feral swine)? How will APHIS requirements change as EU 
wild boar control areas change?
    The site visit report notes that a seropositive wild boar was 
detected in 1999 in the Netherlands. Are there wild boar control areas 
in that country? Additionally, Italy has a significant wild boar 
population that overlays the main pig-producing areas. Although Italy 
has had no reported CSF outbreaks in 2002, it had several outbreaks 
each year previously.
    Response: Swine semen will be allowed to be imported into the 
United States from a wild boar control area. As discussed in the 
spatial and temporal section of the risk analysis, some of the 
outbreaks in domestic swine follow domestic animal movement or related 
pathways in the EU. The analysis documented that the number of 
outbreaks and the extent of undetected CSF spread associated with these 
pathways are actually greater than those that have been associated with 
disease originating from direct contact with infected wild boar and any 
associated proximity spread.
    The clearest examples of these associations are evident in the 
outbreaks that occurred in the Netherlands and in Germany. The primary 
outbreak for the epidemic in the Netherlands actually occurred in 
Paderborn, Germany. The Netherlands outbreaks were linked to infectious 
material from Germany that contaminated a Dutch lorry. The improperly 
disinfected truck carried infectious material back to the Netherlands 
after transporting pigs in the Paderborn area of Germany. In this 
epidemic, secondary spread occurred through the movement of an empty 
truck into the Netherlands, where additional spread took place from a 
variety of causes, including the movement of swine, people, equipment, 
and semen for artificial insemination. Due in part to the Netherlands' 
relatively long risky period (the period before the disease was 
detected and controls implemented), a total of 429 outbreaks occurred 
in the Netherlands during this epidemic.
    In contrast, in Germany during the same time period there were 56 
outbreaks. Fourteen of these were primary outbreaks (due to either 
contact with wild boar or unknown causes that may have been contact 
with wild boar) with very little secondary spread, in contrast to the 
enormous secondary spread that occurred in the Netherlands. The 
outbreaks in Germany occurred primarily in areas that were already 
under EU restriction because disease had been detected in wild boar. As 
discussed in the analysis, APHIS attributed the relative lack of 
disease spread in Germany to movement restrictions and increased 
surveillance and control mechanisms, which were required by EU 
legislation and also conducted in part due to the presence of infected 
wild boar. During 1997 and 1998, Germany had a much shorter risky 
period than the Netherlands, with far less undetected and uncontrolled 
secondary spread. APHIS requirements will not change as wild boar 
control areas change. In response to the commenter's question, there 
are no wild boar control areas in the Netherlands.
    All of these factors led to the conclusion that the risk to the 
United States of importing CSF-affected swine or swine products is not 
greater for imports from areas in close proximity to wild boar than it 
is from areas like the Netherlands that had more difficulty detecting a 
CSF incursion and had substantially greater secondary spread before the 
disease was detected and controls implemented. In short, CSF is found 
and controlled more quickly in areas of the EU where it is expected to 
be found, such as in close proximity to wild boar in Germany, than it 
is in areas where it is not expected to be found, such as in the 
Netherlands. The greater risk to the United States is from those areas 
with longer risky periods and substantially greater undetected 
secondary spread.
    No statistical or quantitative methods have been applied to 
estimate the risk to EU herds from wild boar, because the focus of the 
risk analysis was on the risk to U.S. herds rather than EU herds.
    Comment: Local veterinary units are important in local CSF 
eradication efforts. Are methods employed by the local veterinary units 
standardized and monitored by a central authority?
    Response: Local veterinary units are subject to the national rules 
and regulations of the EU Member State in which they are located, as 
well as the relevant EU animal health legislation. National contingency 
plans must be reviewed and approved by EC authorities. Within these 
constraints, protection zones and surveillance zones are often 
established based on the boundaries of the local veterinary units.
    Comment: Are reports from the EU Standing Veterinary Committee the 
best source of current listings of EU restrictions on swine movement 
due to a high prevalence of seropositive wild boars? What information 
will be made available to APHIS to allow it to adjust its listing of 
infected regions?
    Response: As standard practice, there is direct communication 
between the EC and APHIS within 24 hours of an outbreak. Such 
information is then compiled in the reports of the EU Standing 
Veterinary Committee.
    Comment: It would be helpful if all documentation submitted in 
support of a regionalization request that is posted to the APHIS 
Internet website be in English.
    Response: We agree with the commenter. Under Sec.  92.2, submission 
of information required by the regulations to accompany a 
regionalization request must be in English. We are encouraging 
countries requesting regionalization to provide English translations of 
all supporting documentation.
    Comment: In its site visit report, APHIS noted that detailed 
reports on six CSF outbreaks that occurred in 1999 were reviewed and 
that all six occurred within previously established protection or 
surveillance zones. The report also notes that data from 2000 was 
presented but was not detailed. Was there anything of interest in the 
information from the 2000 outbreaks?
    Response: Two CSF outbreaks occurred in domesticated swine in 
Germany in 2000. The two outbreaks were in Kreis Bernkastel-Wittlich 
(landers of Rhineland Palatinate) and were included on the maps in the 
spatial and temporal section of the risk analysis. Both outbreaks were 
situated in an area where there had been long-standing movement 
restrictions on domesticated swine due to CSF in wild boar. Therefore, 
these outbreaks would have posed no substantive risk to the United 
States.
    Comment: Since January 2002, the EU has been responding to 
continuing CSF outbreaks in Germany by increasing the size of the areas 
from which exports of live swine and semen are not allowed. In light of 
such an evolving situation, has APHIS considered conducting a ``test 
exercise'' to review how the agency would apply its import restrictions 
and procedures? Has the evolving situation altered APHIS'' view of the 
adequacy of the EU disease control procedures?
    Response: With regard to the recommendation of a ``test exercise,'' 
APHIS has ongoing experience in responding to outbreaks of animal 
diseases of concern in foreign regions, including such serious diseases 
as CSF and FMD, and will continue to take the measures necessary to 
ensure that such diseases are not introduced into the United States. 
With regard to how the evolving disease situation in the EU affects 
APHIS' conclusions regarding disease risk, as noted earlier, the risk

[[Page 16935]]

analysis upon which the June 1999 proposed rule was based took into 
consideration the most serious CSF situation in EU history. Any disease 
outbreaks since then have not been of the severity of the 1997-1998 
outbreaks.
    Comment: Although EU regulations restrict trade in domestic pigs 
from specified wild boar areas in Germany to other EU Member States, 
trade is allowed to other regions of Germany with some restrictions. 
How does the risk analysis account for the risk of the spread of CSF 
within Germany from such movement?
    Response: The risk analysis took into account all CSF outbreaks in 
Germany that occurred outside of any established restriction zones. 
Therefore, any undetected outbreaks outside such zones that resulted 
from domesticated swine movement within Germany were considered to be 
part of the population of herds from which the United States could 
potentially import. These outbreaks were included in the risk estimates 
as part of variable ``g'' in the breeding swine and swine semen models, 
and variable ``P1'' in the pork model.
    Comment: Does a 2002 outbreak in France in domestic swine exposed 
to infected wild boar change APHIS'' conclusion in the risk analysis 
that areas containing infected wild boar can be considered CSF-free for 
export? The outbreak in France additionally calls into question the 
statement made in the risk analysis report that no CSF outbreaks in 
France had been attributed to wild swine during the 7 years prior to 
development of the risk analysis.
    Response: Obviously, areas that have had recent outbreaks of CSF in 
domesticated swine, such as the area in France, would not be considered 
for recognition of CSF freedom until the waiting periods discussed in 
the proposed rule had elapsed. The risk analysis itself did not deal 
directly with declarations of disease freedom, but rather dealt with 
the risk to the United States of outbreaks that occurred outside any 
established EU restriction zones. As discussed in responses to comments 
above, the risk analysis anticipates future situations in the EU where 
CSF epidemics reach the same magnitude and the same level of detection 
and control failures as occurred during the 1997-98 epidemic. Given 
that recent CSF epidemics are of a smaller magnitude and have fewer 
failures in detection and control, they fall within the expectations of 
the current risk analysis.
    Comment: How can APHIS support its statement in the risk analysis 
that the 1997-98 CSF outbreak in the Netherlands was ``unique'' and did 
not serve as a very good model of how CSF can be introduced into or 
spread within the region? What made this situation and a 2000 outbreak 
in East Anglia in the United Kingdom unique and unlikely to recur? Many 
of the factors that APHIS considered in judging the Netherlands 
outbreak to be unique have not and will not change, such as highly 
concentrated production, dependence on pig transport between farm sites 
and regions, and insufficient rendering capacity.
    Response: The 1997-98 EU CSF epidemic is considered unique in its 
magnitude and scope because nothing comparable has occurred before or 
since. As noted above, this CSF epidemic is considered the most severe 
the EU has ever experienced. The computer model for the risk assessment 
alone is not intended to predict all possible future scenarios. APHIS 
intends to monitor the animal health situation in the EU and 
periodically review the parameters of the risk assessment model to 
determine if the situation in the EU has changed sufficiently to alter 
the findings of the assessment.
    Comment: Although the site visit report indicates the Netherlands 
has instituted additional restrictions on handling semen, transporting 
live animals, and biosecurity practices, no information was presented 
on the measures taken at semen centers in other countries or regions.
    Response: The risk analysis regarding CSF in the EU region, and the 
additional mitigations we proposed for the importation of swine semen, 
were based on the situation prior to any changes in biosecurity 
measures in the Netherlands. Any increases in biosecurity there and in 
other countries will serve to lower the assessed risk, but were not 
depended upon to bring the risk of CSF to an acceptable level.
    Comment: The site visit report noted that a surveillance zone was 
established in Luxembourg in 1999 due to CSF in a neighboring area in 
Germany. It is not clear if movement restrictions are in place for 
domestic swine in the surveillance zone.
    Response: Movement restrictions are in place for domestic pigs in 
the surveillance zone, and swine are not permitted to be moved until 
they are tested by both serology and virology.
    Comment: Although the United Kingdom had originally been considered 
a low-risk area, a CSF outbreak there in 2000, coupled with the FMD 
outbreak in 2001, indicates disease control measures there are not 
adequate.
    Response: The United Kingdom was not included in the region under 
consideration in our June 1999 proposal. We have addressed the disease 
outbreaks in the United Kingdom separately from the those in the region 
under consideration.
    Comment: The commenter stated that because of recent CSF outbreaks 
in Spain, the EU extended its implementation of restrictive measures in 
that country.
    Response: As we discussed above, CSF outbreaks in the EU region in 
question since publication of the proposed rule have been of a smaller 
magnitude, and have had fewer failures in detection and control, than 
during the 1997-1998 epidemic and fall within the expectations of our 
risk analysis. It should be noted, however, that because the outbreaks 
in Spain occurred after the publication of the proposed rule, and the 
public has not had the opportunity to formally comment on any CSF 
classification of Spain following those outbreaks, we are not including 
Spain in this final rule as a country in which CSF is not known to 
exist.
    Comment: Will any of the risk mitigation measures in the proposed 
rule be applied to countries that have already been recognized as free 
of CSF?
    Response: The scope of the risk analysis explicitly excluded those 
EU Member States that APHIS had already recognized as CSF free.
    Comment: Would APHIS prohibit imports from areas under EU 
restrictions due to wild boar infections when the EU allows trade with 
restrictions within the country in question, even though it prohibits 
trade to other Member States?
    Response: In this final rule, we are amending part 92 of the 
regulations to add a new Sec.  92.3, as proposed, that provides that 
whenever the EC establishes a quarantine for a disease in the EU in a 
region that APHIS recognizes as one in which the disease is not known 
to exist, and the EC imposes prohibitions or other restrictions on the 
movement of animals or animal products from the quarantined area in the 
EU, such animals and animal products are prohibited importation into 
the United States.

Change in Terminology

    We are making a change in this final rule to reflect current 
terminology regarding who receives certificates at the port of arrival. 
In Sec.  94.23(c), instead of referring to ``collector of customs,'' we 
refer instead to ``appropriate Customs and Border Protection Officer.''

[[Page 16936]]

    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting our June 1999 proposed rule as a final rule, 
with the changes discussed in this document.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.
    This rule recognizes a region of the EU as one in which CSF does 
not exist. Additionally, it recognizes Greece and certain regions of 
Italy as areas in which SVD does not exist. Although restrictions on 
the importation of animals and animal products from these regions may 
continue because of other diseases, a number of restrictions due to CSF 
and SVD are no longer warranted for imports from the areas. 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. The rule 
has been determined to be significant for the purposes of Executive 
Order 12866 and, therefore, has been reviewed by the Office of 
Management and Budget.
    This rule recognizes a region in the EU as one in which CSF is not 
known to exist, and from which breeding swine, swine semen, and pork 
and pork products may be imported into the United States under certain 
conditions. Additionally, it recognizes Greece and four Regions in 
Italy as free of SVD. These actions are based on a request from the 
EC's Directorate General for Agriculture and on our review of the 
supporting documentation supplied by the EC and individual EU Member 
States. These actions will relieve some restrictions on the importation 
into the United States of certain animals and animal products from 
those regions that are imposed because of CSF and SVD.
    In considering this rulemaking, we considered three options. The 
first, which we could have applied to all the diseases addressed by 
this rule, was to retain the current regulations and make no changes. 
We did not consider this an acceptable option because it was not 
warranted by the disease situation in the regions in question and such 
inaction would have been contrary to U.S. obligations under 
international trade agreements. A second option, specific to CSF, was 
to allow free movement of swine, swine semen, and pork from the region 
we are recognizing as one in which CSF does not exist. Based on our 
risk analysis, however, we concluded that adopting that option would 
lead to an unacceptable risk of introducing CSF into the United States. 
Therefore, we chose our third option, which was to adopt the provisions 
of this rule.
    Below is a summary of the economic analysis prepared for this rule. 
The economic analysis provides a cost-benefit analysis as required by 
E.O. 12866 and an analysis of impacts on small entities as required by 
the Regulatory Flexibility Act. A copy of the full economic analysis is 
available by contacting the individual listed under FOR FURTHER 
INFORMATION CONTACT.

Recognition of an EU Region as One in Which CSF Does Not Exist

    The analysis with regard to CSF examines the economic impact of the 
potential importation of fresh (chilled or frozen) pork, breeding 
swine, and swine semen from a region in the EU that this rule 
recognizes as one in which CSF is not known to exist.
    This is in accordance with the policy of ``regionalization,'' 
whereby import requirements are tailored to regions that are determined 
by science-based risk factors, rather than political boundaries.
    Five EU Member States that are already recognized in the current 
regulations as being regions in which CSF is not known to exist are 
excluded from this analysis, because the regulations governing CSF do 
not currently restrict their pork, live swine, and swine semen exports 
to the United States.

Potential Importations of Pork

    Potential exports to the United States from the seven EU Member 
States considered (Austria, Belgium, parts of Germany, Greece, parts of 
Italy, the Netherlands, and Portugal) constitute the trade volumes used 
in the analysis, assuming no risk of disease introduction. For pork, 
the import levels used in the analysis are based on the proportion of 
Denmark's global pork exports that are imported into the United States. 
It is assumed that a similar percentage of the global pork exports of 
each of the EU Member States will be exported to the United States. The 
total quantity of pork assumed is about 15,158 metric tons. For 
breeding swine and swine semen imports, the import levels used in the 
analysis are based on historical data and prior U.S. demand for EU 
swine genetic stock.
    Current U.S. pork import levels suggest that imports resulting from 
this rule are likely to be minimal. The import levels used in the 
analysis allow for an analysis of potential economic effects if market 
conditions were to change in favor of U.S. imports of EU swine and pork 
and pork products. Estimated effects on producers and consumers reflect 
the expected effects of these imports, assuming no disease risks.
    Although we expect that the economic effect of this rule will be 
minimal, we used a net trade benefit model to evaluate what would 
happen should trade occur. Benefits to the United States of pork 
imports from the EU Member States considered are calculated as the net 
change in consumer surplus and producer surplus. Assuming an import 
volume of 15,158 metric tons of pork, the annual net trade benefit is 
estimated to be about $228,000 (2001 dollars). Based on data on 
domestic pork production and prices for the period 1997 to 2001, the 
welfare changes in consumer surplus and producer surplus would reflect 
about a 0.1 percent decrease in U.S. pork production, a 0.1 percent 
increase in pork consumption, and a 0.1 percent decrease in the 
farmgate price of pork.

Potential Imports of Breeding Swine

    The marginal benefit, in terms of productivity gains, from future 
imports of EU breeding swine is expected to be minimal, given the ready 
availability of improved genetic lines in both the United States and 
Canada. Over the 8-year period from 1994-2001, over 98 percent of 
breeding swine imports into the United States came from Canada, and 
only about 1.2 percent came from the European Union. The breeding swine 
that were imported from the EU came almost entirely from Denmark and 
the United Kingdom, countries that are unaffected by this rule. We used 
the number of breeding swine imported from Denmark and the United 
Kingdom to establish a recent average and a reasonable upper bound for 
potential imports from the EU Member States of concern. The average 
number of breeding swine imported annually from Denmark and the United 
Kingdom is 440. The minimum number imported was zero in 2001, and the 
maximum was 1,299 imported in 1997. It is assumed that 200 breeding 
swine per year may be imported from the newly recognized region in 
which CSF is not known to exist.\2\
---------------------------------------------------------------------------

    \2\ Although projected import quantities for breeding swine and 
swine semen used in this analysis were approximated independently of 
those used in the risk assessment, similar assumptions were followed 
in both analyses.
---------------------------------------------------------------------------

    APHIS does not record the percentages of imported breeding swine 
that are boars and gilts. For the purposes

[[Page 16937]]

of benefits estimation, we assume that one-third of imports are boars 
and two-thirds are gilts. Therefore, the most likely future annual 
average of imported boars is assumed to be 67, and of gilts is assumed 
to be 133. Assuming minimal expected benefits from productivity gains, 
benefits to the United States from importation of EU breeding swine can 
most readily be quantified in terms of the unit values of the imports. 
It is assumed that, at a minimum, producers would expect to pay about 
$1,000 to import a single EU breeding gilt and possibly $2,800 to 
import a single EU breeding boar, including transportation and 
quarantine costs. There is a great deal of variability in both the 
prices of individual animals, due to product differentiation, and in 
the cost of transportation, which may be negotiated with individual 
contract carriers. Multiplying assumed quantities and unit values 
yields a most likely import value of $187,600 for breeding boars and a 
most likely value of $133,000 for breeding gilts imported from the EU 
region affected by this rule.

Potential Imports of Swine Semen

    During the period 1997-2001, the source countries and quantities of 
swine semen varied widely from one year to the next. The single largest 
exporter to the United States during this period was Australia, which 
averaged 1,045 doses per year, or 43 percent of the total. Canada 
supplied an average of about 672 doses per year, or 28 percent of the 
total. An average of about 680 doses were imported each year from the 
EU-28 percent of the total. In 2001, 1,736 doses came from Germany, one 
of the Member States that constitute the region affected by this rule. 
During the first 9 months of 2002, the only swine semen imports from 
the EU were 780 doses imported from Denmark.
    A wide range of prices for swine semen reflects considerable 
product differentiation in the market for swine genetics. Quoted prices 
for swine semen from a small sampling of producers range from $6 to $50 
per dose. It is presumed that the higher priced semen represents the 
greater perceived benefit to U.S. swine products. In addition to the 
price per dose, buyers must pay for packaging materials and shipping 
costs, although these costs constitute a small fraction of the overall 
cost. A typical shipment of swine semen would be 30 doses packed in a 
cooler. Packing materials, including cooler, are available for about 
$15 per shipment. A 15-pound packed cooler can be shipped between the 
United States and the EU for about $200. The value of a 30-dose 
shipment of swine semen is therefore assumed to be $1,715. Using that 
value, annual values of swine semen imported from the region affected 
by this rule are expected to be approximately $40,000.
    Regarding the effects of the rule on small entities, more than 88 
percent of all U.S. hog farms meet the U.S. Small Business 
Administration size criterion for small entities of annual revenues of 
less than $750,000. Pork, breeding swine, and swine semen imports from 
the region in question are unlikely to be significantly affected by 
this regulatory change, which could cause an average annual effect on 
small entities of less than 0.1 percent of average gross revenue.

Recognition of Greece and Certain Regions in Italy as Free of SVD

    We are also recognizing Greece and four Regions in Italy as free of 
SVD. Recognition of Greece and certain Regions in Italy as free of SVD 
will remove U.S. import restrictions because of this disease with 
respect to pork and live swine. This analysis examines potential 
effects of this rule on U.S. entities by comparing global trading 
patterns of Greece, Italy, and the United States for these commodities.
    International trade statistics for swine, pork, and pork products 
are available for Greece and the United States, but not specifically 
for the four Regions in Italy. Given the unavailability of individual 
regional trade statistics for the Regions in question, we based our 
analysis on swine, pork, and pork products for Italy as a whole. 
Because Italy has a total of 20 Regions, conclusions regarding likely 
minimal export effects for the four Regions are all the more valid.
    Both Greece's and Italy's swine, pork, and pork imports far 
outweigh their exports. During the period 1996 to 2000, the annual 
value of Italy's imports of swine, pork, and pork products averaged 
more than $1.2 billion more than the value of its exports of swine, 
pork, and pork products. For Greece, the annual value of its imports of 
swine, pork, and pork products averaged more than $250 million more 
than the value of its exports. In contrast, during the same period, the 
United States annually averaged approximately $6.2 million more in 
exports of breeding swine than in imports, and over $475 million more 
in exports of pork and pork products than imports. The United States is 
a net importer of swine other than breeding swine, with average annual 
imports, virtually all of which are supplied by Canada, valued at close 
to $274 million more than annual exports.
    Small entities that might be directly affected by the SVD 
provisions of this rule are buyers and wholesalers of swine and pork 
products, and, indirectly, U.S. pork producers. However, as discussed 
above, prevailing trade patterns indicate that this rule will have 
little economic effect on U.S. entities, large or 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.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
were prepared for this rule. The assessment provides a basis for the 
conclusion that the importation of swine, swine semen, and other swine 
products from specified regions in Europe under the conditions 
specified in this rule will not have a significant impact on the 
quality of the human environment. Based on the finding of no 
significant impact, the Administrator of the Animal and Plant Health 
Inspection Service has determined that an environmental impact 
statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were 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).
    Copies of the environmental assessment and finding of no 
significant impact are available for public inspection at USDA, room 
1141, South Building, 14th Street and Independence Avenue SW., 
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, 
except holidays. Persons wishing to inspect copies are requested to 
call ahead on (202) 690-2817 to facilitate entry into the reading room. 
In addition, copies may be obtained by contacting the individual listed 
under FOR FURTHER INFORMATION CONTACT.

[[Page 16938]]

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 0579-0218.

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

9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 92

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Region, Reporting and recordkeeping requirements.

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 94

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

9 CFR Part 98

    Animal diseases, Imports.

9 CFR Part 130

    Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry and 
poultry products, Quarantine, Reporting and recordkeeping requirements, 
Tests.

0
Accordingly, we are amending 9 CFR parts 71, 92, 93, 94, 98, and 130 as 
follows:

PART 71--GENERAL PROVISIONS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


Sec.  71.3  [Amended]

0
2. In Sec.  71.3, paragraph (b) is amended by removing the words ``hog 
cholera'' and adding the words ``classical swine fever'' in their 
place.

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS

0
3. The authority citation for part 92 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


0
4. In Sec.  92.1, a definition of European Union is added, in 
alphabetical order, to read as follows:


Sec.  92.1  Definitions.

* * * * *
    European Union. The organization of Member States consisting of 
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, 
Luxembourg, the Netherlands, Portugal, Republic of Ireland, Spain, 
Sweden, and the United Kingdom (England, Scotland, Wales, the Isle of 
Man, and Northern Ireland).
* * * * *

0
5. A new Sec.  92.3 is added to read as follows:


Sec.  92.3  Movement restrictions.

    Whenever the European Commission (EC) establishes a quarantine for 
a disease in the European Union in a region the Animal and Plant Health 
Inspection Service recognizes as one in which the disease is not known 
to exist and the EC imposes prohibitions or other restrictions on the 
movement of animals or animal products from the quarantined area in the 
European Union, such animals and animal products are prohibited 
importation into the United States.

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND 
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS 
OF CONVEYANCE AND SHIPPING CONTAINERS

0
6. The authority citation for part 93 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  93.505  [Amended]

0
7. In Sec.  93.505, paragraph (a) is amended by removing the words 
``hog cholera'' and adding the words ``classical swine fever'' in their 
place.


Sec.  93.517  [Amended]

0
8. In Sec.  93.517, paragraph (a) is amended by removing the words 
``hog cholera'' and adding the words ``classical swine fever'' in their 
place.

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
9. The title of part 94 is revised to read as above.

0
10. 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.


0
11. Section 94.9 is amended as follows:
0
a. By revising the section heading and paragraph (a) to read as set 
forth below.
0
b. By removing the words ``hog cholera'' and adding in their place the 
words ``classical swine fever'' in following places:
0
i. Paragraph (b), introductory text.
0
ii. Paragraph (b)(1)(iii)(C).
0
iii. Paragraph (b)(1)(iii)(C)(1), both times they appear.
0
iv. Paragraph (b)(1)(iii)(C)(2), both times they appear.
0
v. Paragraph (c).


Sec.  94.9  Pork and pork products from regions where classical swine 
fever exists.

    (a) Classical swine fever is known to exist in all regions of the 
world except Australia; Canada; Denmark; England, except for East 
Anglia (Essex, Norfolk, and Suffolk counties); Fiji; Finland; Iceland; 
Isle of Man; New Zealand; Northern Ireland; Norway; the Republic of 
Ireland; Scotland; Sweden; Trust Territory of the Pacific Islands; 
Wales; and a single region in the European Union consisting of Austria, 
Belgium, Germany (except for the Kreis Uckermark in the Land of 
Brandenburg; the Kreis Oldenberg, the Kreis Soltau-Fallingbostel, and 
the Kreis Vechta in the Land of Lower Saxony; the Kreis Heinsberg and 
the Kreis Warendorf in the Land of Northrhine-Westphalia; the Kreis 
Bernkastel-Wittlich, the Kreis Bitburg-Prm, the Kreis Donnersbergkreis, 
the Kreis Rhein-Hunsrche, the Kreis Sdliche Weinstrasse, and the Kreis 
Trier-Saarburg in the Land of Rhineland Palatinate; and the Kreis 
Altmarkkreis in the Land of Saxony-Anhalt); Greece; Italy (except for 
the Regions of Emilia-

[[Page 16939]]

Romagna, Piemonte, and Sardegna); the Netherlands; and Portugal.\10\
---------------------------------------------------------------------------

    \10\ See also other provisions of this part and parts 93, 95, 
and 96 of this chapter and part 327 of this title for other 
prohibitions and restrictions upon importation of swine and swine 
products.
---------------------------------------------------------------------------

* * * * *

0
12. Section 94.10 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec.  94.10  Swine from regions where classical swine fever exists.

    (a) Classical swine fever is known to exist in all regions of the 
world except Australia; Canada; Denmark; England, except for East 
Anglia (Essex, Norfolk, and Suffolk counties); Fiji; Finland; Iceland; 
Isle of Man; New Zealand; Northern Ireland; Norway; the Republic of 
Ireland; Scotland; Sweden; Trust Territory of the Pacific Islands; 
Wales; and a single region in the European Union consisting of Austria, 
Belgium, Germany (except for the Kreis Uckermark in the Land of 
Brandenburg; the Kreis Oldenberg, the Kreis Soltau-Fallingbostel, and 
the Kreis Vechta in the Land of Lower Saxony; the Kreis Heinsberg and 
the Kreis Warendorf in the Land of Northrhine-Westphalia; the Kreis 
Bernkastel-Wittlich, the Kreis Bitburg-Prm, the Kreis Donnersbergkreis, 
the Kreis Rhein-Hunsrche, the Kreis Sdliche Weinstrasse, and the Kreis 
Trier-Saarburg in the Land of Rhineland Palatinate; and the Kreis 
Altmarkkreis in the Land of Saxony-Anhalt); Greece; Italy (except for 
the Regions of Emilia-Romagna, Piemonte, and Sardegna); the 
Netherlands; and Portugal. No swine that are moved from or transit any 
region where classical swine fever is known to exist may be imported 
into the United States, except for wild swine imported into the United 
States in accordance with paragraph (b) of this section.
* * * * *

0
13. In Sec.  94.12, paragraph (a) is revised to read as follows:


Sec.  94.12  Pork and pork products from regions where swine vesicular 
disease exists.

    (a) Swine vesicular disease is considered to exist in all regions 
of the world except Australia, Austria, the Bahamas, Belgium, Bulgaria, 
Canada, Central American countries, Chile, Denmark, Dominican Republic, 
Fiji, Finland, France, Germany, Greece, Greenland, Haiti, Hungary, 
Iceland, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, 
Panama, Portugal, Republic of Ireland, Romania, Spain, Sweden, 
Switzerland, Trust Territories of the Pacific, the United Kingdom 
(England, Scotland, Wales, the Isle of Man, and Northern Ireland), 
Yugoslavia, and the Regions in Italy of Friuli, Liguria, Marche, and 
Valle d'Aosta.
* * * * *

0
14. In Sec.  94.13, the undesignated introductory text is revised to 
read as follows:


Sec.  94.13  Restrictions on importation of pork or pork products from 
specified regions.

    Austria, the Bahamas, Belgium, Bulgaria, Chile, Denmark, France, 
Germany, Hungary, Luxembourg, the Netherlands, Portugal, Republic of 
Ireland, Spain, Switzerland, the United Kingdom (England, Scotland, 
Wales, the Isle of Man, and Northern Ireland), Yugoslavia, and the 
Regions in Italy of Friuli, Liguria, Marche, and Valle d'Aosta are 
declared free of swine vesicular disease in Sec.  94.12(a) of this 
part. These regions either supplement their national pork supply by the 
importation of fresh (chilled or frozen) meat of animals from regions 
where swine vesicular disease is considered to exist, have a common 
border with such regions, or have trade practices that are less 
restrictive than are acceptable to the United States. Thus, the pork or 
pork products produced in such regions may be commingled with fresh 
(chilled or frozen) meat of animals from a region where swine vesicular 
disease is considered to exist, resulting in an undue risk of swine 
vesicular disease introduction into the United States. Therefore, pork 
or pork products and ship's stores, airplane meals, and baggage 
containing such pork, other than those articles regulated under part 95 
or part 96 of this chapter, produced in such regions shall not be 
brought into the United States unless the following requirements are 
met in addition to other applicable requirements of part 327 of this 
title:
* * * * *


Sec.  94.17  [Amended]

0
15. Section 94.17 is amended by removing the words ``hog cholera'' and 
adding in their place the words ``classical swine fever'' in the 
following places:
0
a. The section heading.
0
b. Paragraph (b).
0
c. Paragraph (c).


Sec.  94.20  [Amended]

0
16. In Sec.  94.20, paragraph (c) and the introductory text of 
paragraph (e) are amended by removing the words ``hog cholera'' and 
adding in their place the words ``classical swine fever''.

0
17. A new Sec.  94.23 is added to read as follows:


Sec.  94.23  Restrictions on the importation of swine, pork, and pork 
products from parts of the European Union.

    In addition to meeting all other applicable provisions of this 
part, live swine, pork, and pork products imported from the region of 
the European Union consisting of Austria, Belgium, Germany (except for 
the Kreis Uckermark in the Land of Brandenburg; the Kreis Oldenberg, 
the Kreis Soltau-Fallingbostel, and the Kreis Vechta in the Land of 
Lower Saxony; the Kreis Heinsberg and the Kreis Warendorf in the Land 
of Northrhine-Westphalia; the Kreis Bernkastel-Wittlich, the Kreis 
Bitburg-Prm, the Kreis Donnersbergkreis, the Kreis Rhein-Hunsrche, the 
Kreis Sdliche Weinstrasse, and the Kreis Trier-Saarburg in the Land of 
Rhineland Palatinate; and the Kreis Altmarkkreis in the Land of Saxony-
Anhalt), Greece, Italy (except for the Regions of Emilia-Romagna, 
Piemonte, and Sardegna), the Netherlands, and Portugal must meet the 
following conditions:
    (a) Pork and pork products. (1) The pork or pork products must not 
have been commingled with pork or pork products derived from swine that 
have been in any region when the region was classified in Sec.  
94.10(a) as one in which classical swine fever is known to exist;
    (2) The swine from which the pork or pork products were derived 
must not have lived in a region when the region was classified in Sec.  
94.10(a) as one in which classical swine fever is known to exist, and 
must not have transited such a region unless moved directly through the 
region in a sealed means of conveyance with the seal determined to be 
intact upon arrival at the point of destination; and
    (3) The pork and pork products must be accompanied by a certificate 
issued by an official of the national government of the region of 
origin who is authorized to issue the foreign meat inspection 
certificate required by Sec.  327.4 of this title, stating that the 
provisions of paragraphs (a)(1) and (a)(2) of this section have been 
met.\19\
---------------------------------------------------------------------------

    \19\ The certification required may be placed on the foreign 
meat inspection certificate required by Sec.  327.4 of this title or 
may be contained in a separate document.
---------------------------------------------------------------------------

    (b) Live swine. (1) The swine must be breeding swine and must not 
have lived in a region when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist, and must not 
have transited such a region unless moved directly through the region 
in a sealed means of

[[Page 16940]]

conveyance with the seal determined to be intact upon arrival at the 
point of destination;
    (2) The swine must never have been commingled with swine that were 
in a region at a time when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist;
    (3) No equipment or materials used in transporting the swine may 
have previously been used for transporting swine that do not meet the 
requirements of this section, unless the equipment or materials have 
first been cleaned and disinfected; and
    (4) The swine must be accompanied by a certificate issued by a 
salaried veterinary officer of the national government of the country 
of origin, stating that the provisions of paragraphs (b)(1) through 
(b)(3) of this section have been met.\20\
---------------------------------------------------------------------------

    \20\ The certification required may be placed on the certificate 
required by Sec.  93.505(a) of this chapter or may be contained in a 
separate document.
---------------------------------------------------------------------------

    (c) The certificates required by paragraphs (a)(3) and (b)(4) of 
this section must be presented by the importer to the appropriate 
Customs and Border Protection officer at the port of arrival, upon 
arrival of the swine, pork, or pork products at the port, for the use 
of the veterinary inspector at the port of entry.


(Approved by the Office of Management and Budget under control number 
0579-0218)

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

0
18. The authority citation for part 98 continues to read as follows:

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  98.15  [Amended]

0
19. Section 98.15 is amended by removing the words ``hog cholera'' and 
adding in their place the words ``classical swine fever'' in the 
following places:
0
a. Paragraph (a)(1)(ii).
0
b. Paragraph (a)(2)(ii).
0
c. Paragraph (a)(5)(ii)(B)
0
d. Paragraph (a)(7)(i)(B).
0
e. Paragraph (a)(8)(i)(B).


Sec.  98.34  [Amended]

0
20. Section 98.34 is amended as follows:
0
a. By removing the words ``hog cholera'' and adding in their place the 
words ``classical swine fever'' in the following places:
0
i. Paragraph (c)(7)(ii).
0
ii. Concluding text of paragraph (c)(7)(iii) (following paragraph 
(c)(7)(iii)(G)).
0
b. In paragraph (c)(7)(iii)(D), by removing the words ``Hog cholera'' 
and adding in their place the words ``Classical swine fever''.

0
21. A new Sec.  98.38 is added to read as follows:


Sec.  98.38  Restrictions on the importation of swine semen from parts 
of the European Union.

    In addition to meeting all other applicable provisions of this 
part, swine semen imported from the region of the European Union 
consisting of Austria, Belgium, Germany (except for the Kreis Uckermark 
in the Land of Brandenburg; the Kreis Oldenberg, the Kreis Soltau-
Fallingbostel, and the Kreis Vechta in the Land of Lower Saxony; the 
Kreis Heinsberg and the Kreis Warendorf in the Land of Northrhine-
Westphalia; the Kreis Bernkastel-Wittlich, the Kreis Bitburg-Prm, the 
Kreis Donnersbergkreis, the Kreis Rhein-Hunsrche, the Kreis Sdliche 
Weinstrasse, and the Kreis Trier-Saarburg in the Land of Rhineland 
Palatinate; and the Kreis Altmarkkreis in the Land of Saxony-Anhalt); 
Greece, Italy (except for the Regions of Emilia-Romagna, Piemonte, and 
Sardegna), the Netherlands, and Portugal must meet the following 
conditions:
    (a) The semen must come only from a semen collection center 
approved for export by the veterinary services of the national 
government of the country of origin;
    (b) The donor boar must not have lived in a region when the region 
was classified in Sec.  94.10(a) as one in which classical swine fever 
is known to exist, and must not have transited such a region unless 
moved directly through the region in a sealed means of conveyance with 
the seal determined to be intact upon arrival at the point of 
destination;
    (c) The donor boar must never have been commingled with swine that 
have been in a region when the region was classified in Sec.  94.10(a) 
as one in which classical swine fever is known to exist;
    (d) The donor boar must be held in isolation for at least 30 days 
prior to entering the semen collection center;
    (e) No more than 30 days prior to being held in isolation as 
required by paragraph (d) of this section, the donor boar must be 
tested with negative results with a classical swine fever test approved 
by the Office International des Epizooties;
    (f) No equipment or materials used in transporting the donor boar 
from the farm of origin to the semen collection center may have been 
used previously for transporting swine that do not meet the 
requirements of this section, unless such equipment or materials has 
first been cleaned and disinfected;
    (g) The donor boar must be observed at the semen collection center 
by the center veterinarian, and exhibit no clinical signs of classical 
swine fever;
    (h) Before the semen is exported to the United States, the donor 
boar must be held at the semen collection center for at least 40 days 
following collection of the semen, and, along with all other swine at 
the semen collection center, exhibit no clinical signs of classical 
swine fever; and
    (i) The semen must be accompanied to the United States by a 
certificate issued by a salaried veterinary officer of the national 
government of the country of origin, stating that the provisions of 
paragraphs (a) through (h) of this section have been met.\3\
---------------------------------------------------------------------------

    \3\ The certification required may be placed on the certificate 
required under Sec.  98.35(c) or may be contained in a separate 
document.

(Approved by the Office of Management and Budget under control number 
0579-0218)

PART 130--USER FEES

0
22. The authority citation for part 130 continues to read as follows:

    Authority: 5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 
136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 
2.22, 2.80, and 371.4.


Sec.  130.14  [Amended]

0
23. In Sec.  130.14, paragraph (b), the table is amended in the column 
titled ``Test'' by removing the words ``(hog cholera)'' in the entry 
for Fluorescent antibody neutralization and adding in their place the 
words ``(classical swine fever)''.

0
24. In Sec.  130.18, paragraph (b), the table is amended by removing 
the entry for Hog Cholera tissue sets and adding a new entry in 
alphabetical order to read as follows:


Sec.  130.18  User fees for veterinary diagnostic reagents produced at 
NVSL or other authorized site (excluding FADDL).

* * * * *
    (b) * * *

[[Page 16941]]



------------------------------------------------------------------------
             Reagent                 User fee              Unit
------------------------------------------------------------------------
 
                               * * * * * *
Classical swine fever tissue               81.50  Tissue set.
 sets.
 
                               * * * * * *
------------------------------------------------------------------------

* * * * *

    Done in Washington, DC, this 2nd day of April 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-8314 Filed 4-2-03; 3:00 pm]
BILLING CODE 3410-34-P