01-27719. Change in Disease Status of France and Ireland With Regard to Foot-and-Mouth Disease

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

We are amending the regulations governing the importation of certain animals, meat, and other animal products by adding France and Ireland to the list of regions considered to be free of rinderpest and foot-and-mouth disease (FMD) and to the list of regions that are subject to certain import restrictions on meat and animal products because of their proximity to or trading relationships with rinderpest- or FMD-affected regions. This final rule follows an interim rule that removed France, Ireland, and The Netherlands from those lists due to detection of FMD in those three regions. Based on the results of an evaluation of the current FMD situation in France and Ireland, we have determined that France and Ireland meet the standards of the Office International des Epizooties for being considered free of FMD. This rule relieves certain prohibitions and restrictions on the importation of ruminants and swine and fresh (chilled or frozen) meat and other products of ruminants and swine into the United States from France and Ireland. We are still evaluating the FMD situation in The Netherlands.

EFFECTIVE DATE:

November 5, 2001.

FOR FURTHER INFORMATION CONTACT:

Dr. Anne Goodman, Senior Staff Microbiologist, Regionalization Evaluation Services Staff, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; [phone].

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease (FMD), African swine fever, hog cholera (also known as classical swine fever), 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 considered free of rinderpest or free of both rinderpest and FMD. Rinderpest or FMD is considered to exist in all parts of the world not listed. Section 94.11 of the regulations lists regions of the world that APHIS has determined to be free of rinderpest and FMD, but from which importation of meat and animal products into the United States is restricted because of the regions' proximity to or trading relationships with rinderpest- or FMD-affected regions.

In an interim rule effective February 19, 2001, and published in the Federal Register on June 1, 2001 (66 FR 29686-29689, Docket No. 01-031-1), we amended the regulations by removing France, Ireland, and The Netherlands from the list of regions considered to be free of rinderpest and FMD. This action was necessary because FMD had been confirmed in each of those regions. The effect of the interim rule was 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.

In that interim rule, we stated, “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.”

We solicited comments concerning the interim rule for 60 days ending July 31, 2001. We received four comments by that date. They were from U.S. businesses and trade associations and one Member State of the European Union. We have carefully considered these comments. They are discussed below by topic.

Status of France and Ireland

Two commenters suggested that we restore the FMD-free status of France and supplied information that supported such a change in status. No commenter supplied contradictory information or opinions. We agree that France and Ireland should have their FMD status restored. Our reasons follow.

According to the OIE, when FMD occurs in an FMD-free country or zone where vaccination is not practiced before the outbreak, the following waiting periods are required to regain FMD-free status: 3 months after the last case, where stamping-out and serological surveillance are applied; or 3 months after the slaughter of the last vaccinated animal where stamping-out, serological surveillance and emergency vaccination are applied. France and Ireland did not vaccinate animals against FMD before or after the outbreaks that occurred in France on March 23, 2001, and in Ireland on March 22, 2001. Both countries immediately destroyed affected animals and conducted serological surveillance. The last case of FMD in France occurred on March 23, 2001, and the last case of FMD in Ireland occurred on March 22, 2001. We find that France as well as Ireland meet the OIE standards for regaining FMD-free status.

We have evaluated the FMD eradication efforts in France and Ireland based on information provided to us by those regions and our own site visits. Our findings and site visit reports may be viewed on the Internet at http://www.aphis.usda.gov/​vs/​reg-request.html. You may also request paper copies of these documents by calling or writing the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to Docket No. 01-031-2 when requesting copies. These documents are also available 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.)

Based on our findings and after reviewing comments submitted to us on the interim rule, we are amending the regulations by placing France and Ireland back on the list in § 94.1(a)(2) of regions that are declared free of both rinderpest and FMD. We are also placing France and Ireland back on the list in § 94.11(a) of regions that are declared free of rinderpest and FMD but that are subject to special restrictions on the importation of their meat and other animal products into the United States. The regions listed in § 94.11(a) are subject to these special restrictions because they: (1) Supplement their national meat supply by importing fresh (chilled or frozen) meat of ruminants or swine from regions that are designated in § 94.1(a) as regions where rinderpest or FMD exists; (2) have a common land border with regions where rinderpest or FMD exists; or (3) import ruminants or swine from regions where rinderpest or FMD exists under conditions less restrictive than would be acceptable for importation into the United States.

This action relieves certain restrictions due to FMD and rinderpest on the importation into the United States of certain live animals and animal products from France and Ireland. However, because France and Ireland have certain trade practices regarding animals and animal products that are less restrictive than are acceptable for importation into the United States, the importation of meat and other products from ruminants and swine into the United States from France and Ireland continue to be subject to certain restrictions.

Status of The Netherlands

One commenter suggested that The Netherlands be recognized as FMD free, claiming that The Netherlands would be free of FMD by August 25, 2001. We are not making any changes based on this comment. We are continuing to monitor The Netherlands' progress with respect to FMD, and we are currently reevaluating the FMD status of that region. We will publish a separate document in the Federal Register with respect to the FMD status of The Netherlands when our evaluation is complete.

Notice and Comment Procedures

One commenter stated that APHIS should have followed the regulations in 9 CFR part 92 in its initial rulemaking to remove France, Ireland, and The Netherlands from the list of regions recognized as free of FMD, but not other European countries. The commenter noted that her organization had expressed the same concern in comments on previous interim rules that “regionalized” countries that had been recognized free of a disease and then experienced an outbreak (i.e., Docket 00-080-1, which established East Anglia, England, as a region affected with hog cholera, also known as classical swine fever, and continued to recognize the rest of Great Britain as free of hog cholera; Docket 00-104-1, which established KwaZulu-Natal, South Africa, as a region affected with FMD and continued to recognize the rest of the Republic of South Africa, with the exception of the already-established FMD control zone in Kruger National Park, as free of FMD; and Docket 00-111-1, which established Artigas, Uruguay, as a region affected with FMD and continued to recognize the rest of Uruguay as free of FMD).^[1] These comments, included as an attachment to the comment on this docket, also expressed concern about APHIS' statement in these interim rules that we intended to reassess the disease situations in these regions in accordance with the standards of the OIE to determine whether it is necessary to continue to prohibit or restrict the importation of animals and animal products from the regions identified in the interim rules. The commenter said that this statement suggests that APHIS intends at some future time to declare these regions free of the specified disease, again without following the process set forth in 9 CFR part 92.

The commenter identified several specific procedures set forth in 9 CFR part 92 that she believed we should be following. These are: (1) That APHIS will make information submitted in support of a request for regionalization available to the public prior to rulemaking; (2) that APHIS will publish a proposed rule for public comment; and (3) that during the comment period, the public will have access to the information upon which APHIS based its risk analysis, as well as to the methodology used to conduct the analysis.

The commenter stated that APHIS is currently applying these regulations only to countries that have had a foreign animal disease and now want the country or a region to be recognized by APHIS as free. The commenter objected to APHIS using a different process for countries that have been recognized as free by APHIS, then have an outbreak and want a region of the country to be recognized as free. The commenter noted that the procedure in these latter cases appears to be that APHIS administratively stops shipments of at-risk products, then follows with an interim rule that specifies which regions will be allowed to ship products to the United States. The commenter maintained that since at-risk shipments are immediately prohibited by administrative instruction, there appears to be no basis for issuing an emergency interim rule regionalizing a country without first providing an opportunity for public comment. In any case, the commenter also asserted that APHIS should make the information on which it bases its decisions for establishing regions via interim rules available to the public for review and comment in advance of publication.

Our response is as follows.

The regulations in 9 CFR part 92, “Importation of Animals and Animal Products; Procedures for Requesting Recognition of Regions,” were issued in November 1997 in conjunction with APHIS' policy on regionalization (Docket 94-106-8, 62 FR 56027-56033, October 28, 1997). The regulations set out the process by which a foreign government may apply to have all or part of the country recognized as a region or for approval to export animals or animal products to the United States under new conditions based on the risk associated with animals or animal products from that region. Our intention was for these regulations to tell lower risk regions within countries or extending across national boundaries how to request approval for more favorable terms than adjoining or surrounding higher risk regions for exporting animals or animal products to the United States. We did not intend for these regulations to apply in circumstances where an outbreak of a disease, or an increased incidence of disease, in a foreign region makes it necessary for the United States to take interim measures to protect its livestock from the foreign animal disease. In these cases, APHIS must take immediate action to prohibit or restrict imports from the region of concern. Such action may include publishing an interim rule to provide an appropriate basis for enforcing prohibitions or restrictions that may initially be announced administratively. In these circumstances, APHIS has a responsibility to take whatever measures appear necessary to prevent the introduction of disease. We believe that publishing a proposed rule for comment would be contrary to the public interest because doing so would delay our taking protective actions. We also believe that making the information upon which we base our decisions for establishing a region via an interim rule available to the public for comment prior to publishing the interim rule would also be contrary to the public interest for the same reason. However, we will try to make the information available as soon as possible so that the public may understand the basis for our action.

We also believe it is appropriate for us, when the disease situation warrants it, to limit prohibitions or restrictions imposed by an interim rule to a portion of a country or other region previously recognized as free of a disease. This is because we will already have extensive information about the region, including information on the authority, organization, and infrastructure of the veterinary services organization of the region; the extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity for such movements; livestock demographics and marketing practices in the region; the type and extent of disease surveillance conducted in the region; diagnostic laboratory capabilities in the region; and the region's policies and infrastructure for animal disease control, i.e., the region's emergency response capacity. This information would have provided the basis for our previous recognition of the region as free of the disease. Our obligations under international trade agreements compel us to take no more restrictive actions than necessary to prevent the introduction of disease. Unless we determine that this information is no longer reliable, it provides a rational basis for believing that the region can effectively control an outbreak within a smaller region.

As to our statement in these interim rules that we intend to reassess the disease situations in these regions in accordance with the standards of the OIE to determine whether it is necessary to retain the prohibitions or restrictions established by the interim rules, the commenter is correct that this means we may, at some future time, declare these regions free of the specified disease without following the process set forth in 9 CFR part 92. Part 92 was not intended to apply to the situations dealt with in these interim rules. An interim rule of the type we issued in this rulemaking was intended to be just that, an “interim” or “temporary” measure which would provide the immediate protection we needed for animal health purposes. It gives APHIS an opportunity to evaluate the effectiveness of emergency response measures taken in the subject region to deal with the outbreak and to determine whether the outbreak is indeed a temporary situation or indicates a fundamental change in the region's disease status. If a region takes immediate and effective steps to control and stamp out the disease and meets the minimum OIE standards for restoration of free status, the region should be promptly returned to its previous status.

In the interim rule regarding France, Ireland, and The Netherlands, we stated:

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.

We have now completed our reassessment of France and Ireland and find that these regions effectively controlled and stamped out FMD and now meet the standards of the OIE for regaining their former status as FMD-free regions. As noted earlier, we are assessing the status of The Netherlands separately. With respect to the other rulemakings that this commenter addressed, our reassessment of the disease situations in Artigas, Uruguay, and KwaZulu-Natal, South Africa, resulted in our removing, through subsequent interim rules, all of Uruguay and all of the rest of FMD-free region of South Africa from the list of FMD-free regions (see APHIS Dockets 00-111-2; and 00-122-1).^[2] We have not yet taken further action with respect to East Anglia, England. We also have not yet taken further action with regard to the FMD situation in Great Britain and Northern Ireland, which we removed from the list of regions considered free of rinderpest and FMD in an interim rule published on March 14, 2001 (66 FR 14825-14826). For final rules such as this one for France and Ireland, we will make information regarding our reassessment available to the public as soon as possible, and not later than the date of the final rule. However, we do not believe that notice and opportunity for comment on the underlying information is required or appropriate in this context. We further believe that we have an obligation under our international trade agreements to restore a region previously recognized as free to the list of free regions as soon as practicable upon its meeting OIE standards for free status. The United States would expect the same policy to be applied in the event of an outbreak of disease, and subsequent eradication of that disease, in this country.

The commenter raised one other issue, which was our statement in Docket 01-031-1 that the course of action we took with the interim rule was 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. The commenter asked whether “consistent with our obligations under [* * *] the United States-European Union Veterinary Equivalency Agreement” meant that we would allow trade to resume with European Union countries or regions that have not observed the 3 months of freedom from FMD as prescribed by the OIE. Our response is that we will not allow trade to resume with European Union countries or regions, or any other region, that does not meet the OIE standards for freedom from FMD. We will not accept less stringent measures than are provided by the OIE.

Effective Date

This is a substantive rule that relieves restrictions and, pursuant to the administrative procedure provisions in 5 U.S.C. 553, may be made effective less than 30 days after publication in the Federal Register. This rule restores France and Ireland to the list of regions considered free of FMD. Immediate action is necessary to remove restrictions on the importation of animals, meat, and other animal products that are no longer necessary. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required by Executive Order 12866.

We are amending the regulations governing the importation of certain animals, meat, and other animal products by adding France and Ireland to the list of regions considered to be free of rinderpest and FMD and to the list of regions that are subject to certain import restrictions on meat and animal products because of their proximity to or trading relationships with rinderpest-or FMD-affected regions. This final rule follows an interim rule that removed France, Ireland, and The Netherlands from those lists due to detection of FMD in those three regions. Based on the results of an evaluation of the current FMD situation in France and Ireland, we have determined that France and Ireland meet the standards of OIE for being considered free of FMD. This rule relieves certain prohibitions and restrictions on the importation of ruminants and swine and fresh (chilled or frozen) meat and other products of ruminants and swine into the United States from France and Ireland.

France and Ireland have not generally been major sources of U.S. imports of the products covered by the interim rule and this final rule, which include live ruminants, live swine, fresh (chilled or frozen) meat of ruminants and swine, processed ruminant and swine meat, some dairy products, animal feeds, and other ruminant and swine products such as semen, embryos, untanned hides and skins, unwashed wool, hair, bones, blood, and some other byproducts. Also, past imports of these products from France and Ireland represent a small fraction of the total U.S. imports or total U.S. production of these products. This final rule is not expected to alter these past trade patterns.

The majority of entities potentially affected by this final rule are considered small. For example, in 1997, approximately 97 percent (2,919 of 2,992) of meat and meat product wholesalers, 99 percent (1,490 of 1,503) of livestock wholesalers,^[3] 92 percent (79,155 of 86,022) of dairy farms, 99.3 percent (651,542 of 656,181) of cattle farms, 87 percent (40,185 of 46,353) of hog and pig farms, 99.5 percent (29,790 of 29,938) of sheep and goat farms,^[4] 98 percent (1,272 of 1,297) of slaughtering establishments, and 95 percent (1,324 of 1,393) of meat processing establishments ^[5] would be considered small entities under the criteria set by the Small Business Administration. However, these entities should be little affected by this rulemaking because of the negligible effect on imports.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

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

List of Subjects in 9 CFR Part 94

• Animal diseases
• Imports
• Livestock
• Meat and meat products
• Milk
• Poultry 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 adding, in alphabetical order, the words “France,” and “Ireland,”.

§ 94.11

[Amended]

3. In § 94.11, paragraph (a) is amended by adding, in alphabetical order, the words “France,” and “Ireland,”.

Done in Washington, DC, this 30th day of October 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  Docket 00-080-1 was published in the Federal Register on September 20, 2000, at 65 FR 56774-56775; Docket 00-104-1 was published in the Federal Register on November 2, 2000, at 65 FR 65728-65729; and Docket 00-111-1 was published in the Federal Register on December 13, 2000, at 65 FR 77771-77773.

2.  Docket 00-111-2 was published in the Federal Register on July 13, 2001, at 66 FR 36695-36697; and Docket 00-122-1 was published in the Federal Register on February 9, 2001, at 66 FR 9641-9643.

3.  1997 Economic Census, Department of Commerce, Bureau of the Census.

4.  1997 Census of Agriculture, USDA, National Agricultural Statistics Service.

5.  1997 Economic Census, Department of Commerce, Bureau of the Census.