[Federal Register Volume 68, Number 121 (Tuesday, June 24, 2003)]
[Proposed Rules]
[Pages 37426-37429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15907]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 121 / Tuesday, June 24, 2003 / 
Proposed Rules  

[[Page 37426]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 92

[Docket No. 02-001-1]
RIN 0579-AB53


Procedures for Reestablishing a Region as Free of a Disease

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to establish procedures that we will follow 
when a region that we recognize as free of a disease experiences an 
outbreak of that disease. The procedures include steps we would take to 
prevent the introduction of disease from that region and steps we would 
take to further assess the region's animal health status. The 
procedures would allow for timely reinstatement of the region's 
disease-free status if supported by the reassessment.

DATES: We will consider all comments that we receive on or before 
August 25, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 02-001-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 02-001-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
02-001-1'' on the subject line.
    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 
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.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Assistant Director, 
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 92, ``Importation of Animals and 
Animal Products; Procedures for Requesting Recognition of Regions'' 
(referred to below as the regulations), set out the process by which a 
foreign government may request recognition of the animal health status 
of a region or approval to export animals or animal products to the 
United States from a region based on the disease risk associated with 
animals or animal products from that region. As provided in Sec.  92.2, 
each request must include 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 disease risk, and the level of biosecurity for such movements; 
livestock demographics and marketing practices 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.
    Recognition by the Animal and Plant Health Inspection Service 
(APHIS) of a region's animal health status makes exports of animals and 
animal products from that region subject to a certain set of import 
conditions, depending on that region's animal health status. These 
import conditions are intended to ensure that animals and animal 
products imported from the region will not introduce animal diseases 
into the United States.
    Recently, we have been asked if the requirements in Sec.  92.2 
apply to regions that wish to have their previous disease-free status 
restored after they have experienced and eradicated an outbreak of the 
disease. As explained in a final rule published on November 5, 2001, 
regarding the status of France and Ireland for foot-and-mouth disease 
(66 FR 55872-55876, Docket No. 01-031-2), we do not intend for the 
regulations in Sec.  92.2 to apply in these circumstances.
    In this document, we propose to add to part 92 procedures that we 
will follow when a region recognized as free of a disease experiences 
an outbreak. The procedures include steps we will take to protect the 
United States from disease, as well as steps we will take to reassess 
the animal health status of the region and, when appropriate, to 
restore the region's previous disease-free status.
    If a region that we recognize as free of a specified animal disease 
experiences an outbreak of that disease, we will take immediate action 
to prohibit or restrict imports of animals and animal products from 
that region to protect U.S. livestock. Such action may include 
publishing an interim rule prescribing the prohibitions or restrictions 
that may initially be announced administratively. The interim rule may 
be given an effective date earlier than the date of signature or 
publication to affirm our authority for issuing previous administrative 
orders. We believe such immediate actions are necessary to prevent the 
introduction of foreign animal diseases into the United States.
    If the outbreak is confined to a limited area of the region we 
previously recognized as free of a disease, the interim rule we publish 
may impose prohibitions or restrictions on only a portion of the 
region. This is because we will already have information about the 
region, including information on the authority, organization, and 
infrastructure of the veterinary services organization of the region; 
the extent to which movements of animals and animal products are 
controlled from regions of higher risk, and the level of biosecurity 
for such movements; livestock demographics and marketing practices in 
the region; diagnostic laboratory capabilities in the region; and the 
region's policies and infrastructure

[[Page 37427]]

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 disease-free status of the region. Our 
obligations under international trade agreements compel us to take only 
actions necessary to prevent the introduction of disease; therefore, 
unless we determine that this information is no longer reliable, it 
provides a rational basis for our determination that a region can 
effectively control an outbreak within a smaller region. In these 
cases, we will provide information to the public as soon as possible 
regarding the basis for our decision to prohibit or restrict imports 
from the smaller area of a region previously recognized as free.
    Following publication of an interim rule, we will reassess the 
disease status of the region in the context of the standards of the 
Office International des Epizooties (OIE) to determine whether it is 
necessary to continue the interim prohibitions or restrictions. As part 
of the reassessment process, we will consider all public comments we 
receive on the interim rule, as well as any additional information 
relevant to a decision to change the disease status of the region, 
including information collected by or submitted to us. Prior to taking 
any action to relieve or finalize prohibitions or restrictions imposed 
by the interim rule, we will make information regarding our 
reassessment of the region's disease status available to the public for 
comment. We will announce the availability of this information by 
publishing a notice in the Federal Register. Based on the reassessment, 
including the comments we receive in response to the notice we publish, 
we will publish one of the following:
    [sbull] A final rule that reinstates the disease-free status of the 
region, or a portion of the region covered by the interim rule;
    [sbull] An affirmation of the interim rule that imposed 
prohibitions or restrictions on imports of animals and animal products 
from that region;
    [sbull] Another document in the Federal Register for comment, if 
neither a final rule or interim rule is considered appropriate at that 
time (e.g., we could publish a notice providing additional information 
for comment).
    The initial interim rule is intended solely to serve as a temporary 
measure to provide the United States immediate protection from the 
introduction of foreign animal diseases. Also, the interim rule gives 
us an opportunity to evaluate the effectiveness of the region's 
emergency response measures 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, we believe the region's 
disease-free status should be restored as quickly as possible once the 
region has met OIE requirements.
    Previously, the procedures we followed to restore the disease-free 
status of a region were lengthier. We typically did not receive adverse 
comments regarding the interim rule that revoked a region's status, so 
following the close of the comment period, we would publish an 
affirmation of the interim rule. Then, in order to restore the region's 
previous disease-free status, we would begin a new rulemaking with the 
publication of a proposed rule. After considering any comments we 
received during the comment period for the proposed rule, we would 
publish a final rule.
    We believe that we can improve the regulatory process for restoring 
a region's disease free status by using the procedures described above, 
while still providing opportunity for public participation. For 
example, we removed France, Northern Ireland, the Netherlands, and 
Ireland from the list of regions considered to be free of rinderpest 
and foot-and-mouth disease (FMD) in two interim rules published in the 
Federal Register on March 14, 2001 (66 FR 14825-14826, Docket No. 01-
018-1), and June 1, 2001 (66 FR 29686-29689, Docket No. 01-031-1). In 
those interim rules we stated that we intended to reassess the disease 
situations in these countries at a future date in accordance with OIE 
standards, and that as part of that reassessment process, we would 
consider all comments received regarding the interim rules. 
Additionally, we stated that the future reassessments would enable us 
to determine whether it was necessary to continue to prohibit or 
restrict the importation of specific regulated articles, or whether we 
could restore the disease-free status of some or all of those regions, 
or part of those regions. We subsequently reassessed the disease status 
of those regions, taking into consideration information provided to us 
by those regions, and our own site visits. We restored the disease-free 
status of France, Ireland, the Netherlands, and Northern Ireland in two 
final rules published in the Federal Register on November 5, 2001 (66 
FR 55872-55876, Docket No. 01-031-2), and January 9, 2002 (67 FR 1072-
1074, Docket No. 01-031-3). Our findings, including site visit reports, 
were made available to the public at the time the final rules were 
published.
    Based on comments we received regarding those rulemakings, we 
decided in the future to make our findings available to the public for 
comment prior to taking any final action. Recently, following our 
reassessment of the FMD-status of Great Britain, we published a notice 
of availability of our findings in the Federal Register for comment (67 
FR 54164, Docket 01-018-3, published August 21, 2002). Following the 
close of the comment period on that notice, and after considering the 
information provided by commenters, we published a final rule to 
restore the FMD-free status of Great Britain on December 17, 2002 (67 
FR 77148-77152, Docket 01-018-4).
    This proposed rule would codify in the regulations the procedures 
that we will follow to reassess the animal health status of regions 
that we recognize as free of disease, and that experience an outbreak 
of that disease. It would establish a transparent and more effective 
process for restoring the disease-free status of a region, or portion 
of that region, while acting to protect against the introduction of 
foreign animal diseases into the United States. It would also improve 
our current procedures by making information regarding our reassessment 
available for comment before taking final action.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    Below is a summary of the economic analysis for this proposal. The 
economic analysis provides a cost-benefit analysis as required by 
Executive Order 12866 and an analysis of the potential economic effects 
on small entities as required by the Regulatory Flexibility Act. A copy 
of the full economic analysis is available for review at the location 
listed in the ADDRESSES section at the beginning of this document or 
may be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    We are proposing to establish procedures that we will follow when a 
region that we recognize as free of a disease experiences an outbreak 
of that disease. The procedures include steps we would take to prevent 
the introduction of disease from that region and steps we would take to 
further

[[Page 37428]]

assess the region's animal health status. The procedures would allow 
for timely reinstatement of the disease-free status of a region, or 
portion of a region, if supported by the reassessment.
    As in the past, if a region that we recognize as free of a 
specified animal disease experiences an outbreak of that disease, we 
will take immediate action to prohibit or restrict imports of animals 
and animal products from that region to protect U.S. livestock. 
Restrictions and/or prohibitions may at first be announced 
administratively but are generally followed by an interim rule.
    Previously, following the close of the comment period on the 
interim rule, we would publish an affirmation of the interim rule. 
Then, in order to restore the region's previous disease-free status, we 
would begin a new rulemaking with the publication of a proposed rule. 
After considering any comments we received during the comment period 
for the proposed rule, we would publish a final rule.
    Under our new procedures, we will not proceed directly to an 
affirmation of the interim rule following the close of the comment 
period. Rather, we will reassess the disease status of the region in 
the context of the standards of the Office International des Epizooties 
(OIE) to determine whether it is necessary to continue the interim 
prohibitions or restrictions. As part of the reassessment process, we 
will consider all public comments we receive on the interim rule, as 
well as any additional information relevant to a decision to change the 
disease status of the region, including information collected by or 
submitted to us. Prior to taking any action to relieve or finalize 
prohibitions or restrictions imposed by the interim rule, we will make 
information regarding our reassessment of the region's disease status 
available to the public for comment. We will announce the availability 
of this information by publishing a notice in the Federal Register. 
Based on the reassessment, including the comments we receive in 
response to the notice we publish, we will publish one of the 
following:
    [sbull] A final rule that reinstates the disease-free status of the 
region, or a portion of the region covered by the interim rule;
    [sbull] An affirmation of the interim rule that imposed 
prohibitions or restrictions on imports of animals and animal products 
from that region;
    [sbull] Another document in the Federal Register for comment, if 
neither a final rule or interim rule is considered appropriate at that 
time (e.g., we could publish a notice providing additional information 
for comment).
    The new procedures will improve the process for reinstating a 
region's disease-free status while still providing an effective 
opportunity for public participation.
    U.S. entities potentially affected by these changes in procedures 
include importers, domestic producers, and consumers. In particular, 
importers and consumers could benefit because imports affected by the 
change in disease status could resume earlier than under previous 
procedures. Domestic producers of close substitutes, who may have 
benefitted during the period when imports were restricted or 
prohibited, could incur losses associated with a resumption of imports 
that could occur sooner than under past procedures. Because import 
levels of potentially regulated commodities from the majority of 
disease-free foreign regions are low relative to total imports and 
domestic availability of those commodities, the new procedures will 
likely not lead to significant benefits or losses. This projection is 
based on a review of economic analyses we prepared for recent 
rulemakings revoking and reinstating the disease-free status of foreign 
regions, as well as an analysis of the types and volumes of commodities 
currently imported from regions we currently recognize as free of 
specified diseases. We believe that the main benefits associated with 
the change in procedures will be improved trade relations between the 
U.S. and foreign governments.
    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 proposed rule has been reviewed under Executive Order 13988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed 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 92

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

    Accordingly, we propose to amend 9 CFR part 92 as follows:

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

    1. The authority citation for part 92 would continue 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.

    2. A new section 92.4 would be added to read as follows:


Sec.  92.4  Reestablishment of a region's disease-free status.

    This section applies to regions that are designated in subchapter D 
of this chapter as free of a specific animal disease and then 
experience an outbreak of that disease.
    (a) Interim designation. If a region recognized as free of a 
specified animal disease in subchapter D of this chapter experiences an 
outbreak of that disease, APHIS will take immediate action to prohibit 
or restrict imports of animals and animal products from that region. 
Such action may include publishing an interim rule that imposes 
prohibitions or restrictions that may be announced initially 
administratively. The interim rule may be given an effective date 
earlier than the date of signature or publication to affirm our 
authority for issuing previous administrative orders. The interim rule 
may impose prohibitions or restrictions on only a portion of the region 
previously recognized as free of a disease. In these cases, APHIS will 
provide information to the public as soon as possible regarding the 
basis for its decision to prohibit or restrict imports from the smaller 
area of that region previously recognized as free.
    (b) Reassessment of the disease situation. (1) Following 
publication of an interim rule as described in paragraph (a) of this 
section, APHIS will reassess the disease situation in that region in 
accordance with standards of the Office International des Epizooties to 
determine whether it is necessary to continue the interim prohibitions 
or restrictions. As part of the reassessment process, APHIS will 
consider all public comments received on the interim rule, as well as 
any other information collected by or submitted to APHIS.
    (2) Prior to taking any action to relieve or finalize prohibitions 
or restrictions imposed by the interim rule, APHIS will make 
information regarding its reassessment of the region's disease

[[Page 37429]]

status available to the public for comment. APHIS will announce the 
availability of this information by publishing a notice in the Federal 
Register.
    (c) Determination. Based on the reassessment conducted in 
accordance with paragraph (b) of this section, including comments 
regarding the reassessment information, APHIS will take one of the 
following actions:
    (1) Publish a final rule that reinstates the disease-free status of 
the region, or a portion of the region, covered by the interim rule;
    (2) Publish an affirmation of the interim rule that imposed 
prohibitions or restrictions on the imports of animals and animal 
products from that region; or
    (3) Publish another document in the Federal Register for comment.

    Done in Washington, DC, this 19th day of June, 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-15907 Filed 6-23-03; 8:45 am]
BILLING CODE 3410-34-P