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[Federal Register Volume 66, Number 106 (Friday, June 1, 2001)]
[Rules and Regulations]
[Pages 29686-29689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13757]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 01-031-1]

Change in Disease Status of France, Ireland, and The Netherlands 
Because of Foot-and-Mouth Disease

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the regulations governing the importation of 
certain animals, meat, and other animal products by removing France, 
Ireland, and The Netherlands from the list of regions considered to be 
free of rinderpest and foot-and-mouth disease. We recently removed 
Great Britain and Northern Ireland from the list of regions considered 
free of rinderpest and foot-and-mouth disease because of the confirmed 
outbreak of foot-and-mouth disease in those regions. The outbreak in 
the United Kingdom has since spread elsewhere in the European Union. We 
are taking this additional action with respect to France, Ireland, and 
The Netherlands because the existence of foot-and-mouth disease has 
been confirmed there and these Member States do not yet meet the Office 
International des Epizooties criterion for freedom of foot-and-mouth 
disease (i.e., a 3-month waiting period after the last case in a region 
previously recognized as free of the disease). The effect of this 
action is to prohibit or restrict the importation of any ruminant or 
swine and any fresh (chilled or frozen) meat and other products of 
ruminants or swine into the United States from France, Ireland, and The 
Netherlands.

DATES: This interim rule was effective on February 19, 2001. We invite 
you to comment on this docket. We will consider all comments that we 
receive by July 31, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 01-031-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road, Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. 01-031-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related

[[Page 29687]]

information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    Furthermore, a risk assessment documenting the basis for including 
the designated Member States in this action is available for review in 
our reading room and on the Internet at http://www.aphis.usda.gov/vs/reg-request.html, or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Assistant Director, 
Sanitary Trade Issues, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) govern the importation of specified animals and animal 
products into the United States in order to prevent the introduction of 
various animal diseases including rinderpest, foot-and-mouth disease 
(FMD), African swine fever, hog cholera, and swine vesicular disease. 
These are dangerous and destructive communicable diseases of ruminants 
and swine. Section 94.1 of the regulations lists regions of the world 
that are declared free of rinderpest or free of both rinderpest and 
FMD. Rinderpest or FMD exists in all other regions of the world not 
listed. Section 94.11 of the regulations lists regions of the world 
that have been declared free of rinderpest and FMD, but that are 
subject to certain restrictions because of their proximity to or 
trading relationships with rinderpest- or FMD-affected regions.
    On March 14, 2001, we published in the Federal Register (66 FR 
14825-14826, Docket No. 01-018-1) an interim rule, effective January 
15, 2001, that removed Great Britain (England, Scotland, Wales, and the 
Isle of Man) and Northern Ireland from the list of regions considered 
to be free of rinderpest and FMD because the existence of FMD had been 
confirmed in both regions. Great Britain and Northern Ireland 
participate in the European Union (EU) through the individual Member 
State status of the United Kingdom. Due to the magnitude and rate of 
spread of FMD in the United Kingdom, we felt it necessary to act 
immediately to remove Great Britain and Northern Ireland from the list 
of FMD-free regions in order to safeguard the animal health status of 
the United States.
    Prior to the effective date of this interim rule, the EU Member 
States of France, Ireland, and The Netherlands were listed in 
Secs. 94.1 and 94.11 of the regulations as regions considered to be 
free of rinderpest and FMD. However, a series of FMD outbreaks have 
occurred in France, Ireland, and The Netherlands. Specifically:
     On March 13, 2001, France's Ministry of Agriculture and 
Fisheries (MAF) clinically confirmed an outbreak of FMD in the 
department of Mayenne, followed by confirmation of a second outbreak in 
the department of Seine-et-Marne on March 23, 2001;
     On March 22, 2001, Ireland's Department of Agriculture, 
Food and Rural Development (DAFRD), reported clinical confirmation of 
an outbreak of FMD in County Louth; and
     The Netherlands' Ministry of Agriculture, Nature 
Management and Fisheries (MANMF) reported clinical confirmation of FMD 
outbreaks in the provinces of Overijssel and Gelderland on March 21, 
2001, and March 24, 2001. MANMF has since confirmed a number of 
additional outbreaks in The Netherlands.
    MAF, DAFRD, and MANMF notified the Office International des 
Epizooties (OIE) and the U.S. Department of Agriculture at the time of 
clinical confirmation of these FMD diagnoses. Based on preliminary 
epidemiological studies, the sources of the outbreaks in France, 
Ireland, and The Netherlands have been traced back to the United 
Kingdom.
    Because of the close trading relationships that exist among the EU 
Member States, coupled with the speed with which FMD has spread from 
the United Kingdom to other areas of the EU, we initially believed it 
necessary to impose additional trade restrictions relating to FMD on 
the 13 EU Member States listed in our regulations as FMD-free after 
implementation of the interim rule for the United Kingdom in order to 
safeguard the animal health status of the United States. Consequently, 
on March 13, 2001, we imposed temporary import restrictions applicable 
to the EU with respect to swine and ruminants, any fresh (chilled or 
frozen) swine or ruminant meat, and other products of swine and 
ruminants. As part of this process, we also requested information from 
the European Commission and the individual Member States to justify why 
individual Member States should continue to be considered FMD-free, and 
therefore remain on our list of FMD-free regions in the regulations. We 
intended to use this information to evaluate the potential risks of 
further FMD outbreaks occurring in different regions of the EU. Any 
region for which sufficient data were not available to make such an 
evaluation would be considered to be a high FMD risk until information 
became available to support an alternative determination. We set a 
deadline of April 27, 2001, for the receipt of this information. To 
assist us in evaluating a region's level of risk relating to FMD, we 
asked that the information submitted to us address the following:
     Outbreak history in the Member State or region;
      Complete information on European Community (Community) 
legislation in force to control spread of disease among Member States, 
including information on limitations that were identified in Community 
legislation in force at the time of the outbreak, changes made to 
address these limitations, enforcement processes to implement the 
changes and enforcement of compliance;
     Information on surveillance or control measures 
implemented by individual Member States in addition to Community 
legislation;
     Statistics on trade in live animals and high-risk animal 
products within the Community since January 2001;
     Traceback results for animals moving from affected areas;
     Information on practices that might serve to introduce 
disease (e.g., garbage feeding of swine), surveillance of those 
practices, and recent or planned legislative changes that might affect 
these practices;
     Mechanisms in place to ensure compliance with Community 
and Member State legislation, as well as mechanisms to identify and 
correct failures in the safeguarding system; and
     Vaccination practices and vaccination records for the 
regions, as applicable.
    Other issues such as environmental factors (e.g., prevailing winds) 
that might contribute to disease spread may also be considered.
    Based on our evaluation of the information submitted to us by the 
European Commission and the individual Member States, published 
literature, and reports to the OIE, we are removing France, Ireland, 
and The Netherlands from the list of regions considered to be free of 
rinderpest and FMD primarily because the existence of FMD has been 
confirmed there and these Member States do not yet meet the OIE 
criterion for freedom of FMD (i.e., a 3-month waiting period after the 
last case in a region previously recognized as free of the disease). We 
have determined that the other EU Member

[[Page 29688]]

States that APHIS considers to be FMD-free represent a low risk for the 
introduction of FMD into the United States, and therefore will be 
allowed to remain on the list of free regions. The basis for our 
designation of these Member States is documented in a risk assessment 
that may be viewed on the Internet at http://www.aphis.usda.gov/vs/reg-request.html. You may also request paper copies of the risk assessment 
by calling or writing the person listed under FOR FURTHER INFORMATION 
CONTACT. Please refer to Docket No. 01-031-1 when requesting copies. 
The risk assessment is also available for review in our reading room 
(information on the location and hours of the reading room is listed 
under the heading ADDRESSES at the beginning of this document).
    We believe that this course of action is consistent with our 
obligations under the World Trade Organization in the Agreement on the 
Application of Sanitary and Phytosanitary Measures and the United 
States-European Union Veterinary Equivalency Agreement. We are imposing 
these provisional measures to safeguard the United States from FMD, but 
not before taking due account of the information and other supporting 
data provided us by the European Commission and the individual Member 
States of the EU in order to avoid any unnecessary disruption of trade.
    Therefore, we are amending the regulations in Sec. 94.1 by removing 
France, Ireland, and The Netherlands from the list of regions that have 
been declared to be free of rinderpest and FMD. We are also removing 
France, Ireland, and The Netherlands from the list in Sec. 94.11 of 
regions that are declared to be free of these diseases, but that are 
subject to certain restrictions because of their proximity to or 
trading relationships with rinderpest-or FMD-affected regions. As a 
result of this action, the importation into the United States of any 
ruminant or swine and any fresh (chilled or frozen) meat and other 
products of ruminants and swine from any part of France, Ireland, and 
The Netherlands is prohibited or restricted. We are making these 
amendments effective retroactively to February 19, 2001, because the 
disease may have been present in the affected areas of France, Ireland, 
and The Netherlands for some time before the initial outbreaks were 
clinically confirmed in each of these regions. The date of February 19, 
2001, takes into account the potential disease risk prior to discovery 
and the incubation period for FMD.
    Although we are removing France, Ireland, and The Netherlands from 
the list of regions considered to be free of rinderpest and FMD, we 
recognize that the European Commission and the regions affected by this 
action have responded to the detection of FMD by imposing restrictions 
on the movement of ruminants, swine, and ruminant and swine products 
from FMD-affected areas; by conducting heightened surveillance 
activities; and by initiating measures to eradicate the disease. We 
intend to reassess this situation at a future date in accordance with 
the standards of the OIE. As part of that reassessment process, we will 
consider all comments received on this interim rule, as well as any 
additional information or data from the European Commission or 
individual Member States that support changing the disease status of a 
given region or regions. In future reassessments, we will determine 
whether it is necessary to continue to prohibit or restrict the 
importation of ruminants or swine and any fresh (chilled or frozen) 
meat and other products of ruminants or swine from France, Ireland, and 
The Netherlands, or whether we can restore some or all of those 
countries to the list of regions in which FMD is not known to exist or 
regionalize portions of France, Ireland, and The Netherlands as FMD-
free.

Emergency Action

    This rulemaking is necessary on an emergency basis to prevent the 
introduction of FMD into the United States. Under these circumstances, 
the Administrator has determined that prior notice and opportunity for 
public comment are contrary to the public interest and that there is 
good cause under 5 U.S.C. 553 for making this rule effective less than 
30 days after publication in the Federal Register.
    We will consider comments that are received within 60 days of 
publication of this rule in the Federal Register. After the comment 
period closes, we will publish another document in the Federal 
Register. The document will include a discussion of any comments we 
receive and any amendments we are making to the rule as a result of the 
comments.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review 
process required by Executive Order 12866.
    We are amending the regulations governing the importation of 
certain animals, meat, and other animal products by removing France, 
Ireland, and The Netherlands from the list of regions considered to be 
free of rinderpest and FMD. We are taking this action because the 
existence of FMD has been confirmed there and these Member States do 
not yet meet the OIE criterion for freedom of FMD (i.e., a 3-month 
waiting period after the last case in a region previously recognized as 
free of the disease). The effect of this action is to prohibit or 
restrict the importation of any ruminant or swine and any fresh 
(chilled or frozen) meat and other products of ruminants or swine into 
the United States from France, Ireland, and The Netherlands on or after 
February 19, 2001. This action is necessary to protect the livestock of 
the United States from FMD.
    This emergency situation makes timely compliance with section 604 
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable. 
We are currently assessing the potential economic effects of this 
action on small entities. Based on that assessment, we will either 
certify that the rule will not have a significant economic impact on a 
substantial number of small entities or publish a final regulatory 
flexibility analysis.

Executive Order 12988

    This 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 retroactive 
effect to February 19, 2001; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 9 CFR Part 94

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

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

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

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

[[Page 29689]]

    Authority: 7 U.S.C. 450, 7711, 7712, 7713, 7714, 7751 and 7754; 
19 U.S.C. 1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136, 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.

Sec. 94.1  [Amended]

    2. In Sec. 94.1, paragraph (a)(2) is amended by removing the words 
``France,'', ``Ireland,'', and ``The Netherlands,''.

Sec. 94.11  [Amended]

    3. In Sec. 94.11, paragraph (a) is amended by removing the words 
``France,'', ``The Netherlands,'', and ``Republic of Ireland,''.

    Done in Washington, DC, this 25th day of May 2001.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-13757 Filed 5-31-01; 8:45 am]
BILLING CODE 3410-34-P
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