[Federal Register Volume 66, Number 214 (Monday, November 5, 2001)]
[Rules and Regulations]
[Pages 55872-55876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27719]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 01-031-2]


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.

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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; (301) 734-8083.

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

[[Page 55873]]

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 (202) 690-2817 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 55874]]

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.
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    \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.
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    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

[[Page 55875]]

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.
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    \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.
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    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.
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    \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.
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    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.

[[Page 55876]]

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.


Sec. 94.1  [Amended]

    2. In Sec. 94.1, paragraph (a)(2) is amended by adding, in 
alphabetical order, the words ``France,'' and ``Ireland,''.


Sec. 94.11  [Amended]

    3. In Sec. 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.
[FR Doc. 01-27719 Filed 11-2-01; 8:45 am]
BILLING CODE 3410-34-U