01-13757. 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.

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 [phone] before coming.

APHIS documents published in the Federal Register, and related 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; [phone].

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 §§ 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 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 § 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 § 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:

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.

§ 94.1

[Amended]

2. In § 94.1, paragraph (a)(2) is amended by removing the words “France,”, “Ireland,”, and “The Netherlands,”.

§ 94.11

[Amended]

3. In § 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.