[Federal Register Volume 69, Number 90 (Monday, May 10, 2004)]
[Rules and Regulations]
[Pages 25817-25820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10523]



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  Federal Register / Vol. 69, No. 90 / Monday, May 10, 2004 / Rules and 
Regulations  

[[Page 25817]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 92

[Docket No. 02-001-2]
RIN 0579-AB53


Procedures for Reestablishing a Region as Free of a Disease

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

EFFECTIVE DATE: June 9, 2004.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, 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.
    While the regulations in part 92 have provided for what can be 
described as the original recognition of the animal disease status of a 
region with respect to a particular disease, they have not described 
the actions that we will take when a region that we already recognize 
as free of a disease experiences an outbreak of that disease, nor have 
they described a process by which the region's disease-free status may 
be restored following its eradication of the disease.
    To address this need, on June 24, 2003, we published in the Federal 
Register (68 FR 37426-37429, Docket No. 02-001-1) a proposal to 
establish procedures that we will follow when a region that we 
recognize as free of disease experiences an outbreak of that disease. 
Those procedures, which we proposed to set out in a new Sec.  92.4, 
included 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. We proposed this action to allow for timely 
reinstatement of the region's disease-free status if supported by the 
reassessment.
    We solicited comments concerning our proposal for 60 days ending 
August 25, 2003. We received 11 comments by that date. The comments 
were from representatives of domestic and foreign animal industry 
organizations, State veterinarians, a foreign government association, a 
representative of State government, and an individual. Most of the 
comments were generally supportive, although several asked for 
clarifications or minor adjustments to the proposed procedures. Three 
commenters did not appear to support the proposal. Their comments and 
the clarifications and adjustments requested by others are described 
below.
    One commenter who opposed the proposal objected to the concept of 
regionalization, arguing that an area smaller than an entire country 
should not be accorded a separate disease status. He expressed the 
concern that disease could spread into a regionalized area through, 
among other means, the unauthorized movement of animals into that area.
    We will not be making any changes to the final rule in response to 
these comments. International trade agreements entered into by the 
United States--specifically, the North American Free Trade Agreement 
and the World Trade Organization Agreement on Sanitary and 
Phytosanitary Measures--obligate APHIS to recognize regions, rather 
than only countries, for the purpose of regulating the importation of 
animals and animal products into the United States, and we have been 
doing so for several years. Our procedures for recognizing a region's 
disease status, including a region smaller than an entire country, are 
set out in Sec.  92.2. We consider a number of factors, including the 
extent to which movement of animals and animal products is controlled 
and the level of biosecurity regarding such movements, the extent of an 
active disease control program and disease surveillance activities in 
the region, and the authority, organization, and infrastructure of the 
veterinary services organization in the region. We believe that an 
evaluation of these factors can justify recognition of a region smaller 
than an entire country, in accordance with part 92, and provide 
assurance that the region has the means to prevent the spread of 
disease into and from that region.
    Another commenter who opposed the proposal maintained that 
reinstatement of the disease-free status of a region

[[Page 25818]]

must be done in accordance with the existing regulations in part 92. 
The commenter also maintained that any further regionalization of a 
region (e.g., recognizing a region within a country) following a 
disease outbreak should also be done in accordance with the existing 
regulations.
    We will not be making any changes to the final rule in response to 
these comments. We disagree with the commenter's assertion that 
reinstatement of disease-free status should be done in strict 
accordance with the existing regulations for original recognition of 
such status. We did not intend for the regulations in Sec.  92.2 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. An interim rule of this type is intended to 
be just that, an ``interim'' or ``temporary'' measure which would 
provide the immediate protection needed for animal health purposes. 
Such a rule 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 satisfies any other requirements 
that it may be necessary to apply to that particular region, it should 
be promptly returned to its previous status.\1\ APHIS will also take 
into consideration whether the subject region has met the minimum 
Office International des Epizooties (OIE) standards for restoration of 
free status. Our obligations under international trade agreements 
compel us to take no more restrictive actions than necessary to prevent 
the introduction of disease. Regarding the commenter's second point, in 
many cases, the evaluation of a region that led to our initial 
recognition of it as disease free also provides us with the information 
we need to determine whether an administrative unit within that region 
(e.g., a political subdivision of a country) has sufficient control 
mechanisms in place to be recognized as a region with a separate 
disease status. We are taking steps to inform the public about the 
basis for our determining the administrative unit that may be 
recognized as a region if there is an outbreak of a disease. This 
determination is country specific and based on the controls existing in 
that country. For example, a final rule recognizing regions of the 
European Union for classical swine fever (CSF) status, which was 
published in the Federal Register on April 7, 2003 (68 FR 16922-16941, 
Docket No. 98-090-5), set out what we considered to be the appropriate 
administrative units, i.e., regions, for Germany and Italy. Similarly, 
a notice of availability of our recent reassessment of the disease 
status of France and Spain for CSF, published in the Federal Register 
on November 24, 2003 (68 FR 65869-65871, Docket No. 98-090-6), set out 
the administrative units we would recognize in those countries.
---------------------------------------------------------------------------

    \1\ APHIS does not plan to use the procedures established by 
this rule to upgrade a region's status with respect to bovine 
spongiform encephalopathy (BSE).
---------------------------------------------------------------------------

    The third commenter who opposed the proposed rule represented the 
European Commission (EC). This commenter stated that, in failing to 
recognize regionalization decisions made by the EC, the proposed rule 
was inconsistent with the Veterinary Equivalency Agreement between the 
EC and the United States concerning sanitary measures in the trade of 
live animals and animal products (Council Decision 98/258/EC).
    We will not be making any changes to the final rule in response to 
this comment. Article 16 of the Veterinary Equivalency Agreement 
states, among other things, that, ``Each Party shall implement the 
commitments and obligations arising from this Agreement in accordance 
with its laws and procedures.'' APHIS' customary regulatory procedures 
involve rulemakings such as this one. However, we are working to create 
mechanisms through rulemaking that will provide us with greater 
flexibility and reduce response time. This rulemaking is one example.
    Several commenters suggested that our proposed procedures placed 
too much emphasis on the standards of the OIE, suggesting that OIE 
standards may not always reflect current science and may not be 
sufficient to protect U.S. livestock from disease. These commenters 
cited, in particular, the wording in both the preamble and rule text 
that said we intend to reassess the disease situation in a country ``in 
accordance with OIE standards.'' One commenter also cited our statement 
in the preamble that, ``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.'' That commenter noted that while OIE sets 
``standards,'' those standards are not ``requirements.''
    We agree that OIE standards are not requirements, and we did not 
intend to imply that we would base our evaluation of a region's disease 
status solely on whether the region has satisfied the criteria 
contained in those standards. APHIS uses OIE's waiting period as a 
guideline; however, APHIS' evaluation of a region's disease status will 
be based not only on whether the region has met OIE standards for 
reinstatement of disease-free status, but also on consideration of all 
relevant information, including information obtained through public 
comments on both the initial interim rule and the notice of 
availability of our reassessment and information collected by or 
submitted to us through other means. We have modified Sec.  92.4 (b)(1) 
in this final rule to clarify that all these factors will be taken into 
account when we conduct such evaluations.
    Two commenters cautioned that we should not rush the process of 
reinstating a region's disease-free status. We agree that the process 
should not be rushed; however, we will not be making any changes to the 
final rule as a result of these comments, since we continue to believe 
that the procedures originally contained in proposed Sec.  92.4 will 
give us additional flexibility in evaluating a region's disease status 
without reducing the thoroughness of the evaluation process.
    Some commenters suggested that the list of possible actions to be 
taken after the reassessment of a region's disease status should 
include a provision allowing APHIS to modify the scope of products 
affected by the initial interim rule. We believe that the proposed rule 
did include such a provision. Proposed Sec.  92.4(c) listed three 
possible actions that APHIS may take following a reassessment: (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. Under the third option, we could solicit comments on the scope 
of products to be covered in any subsequent rulemaking.

[[Page 25819]]

    One commenter questioned how APHIS will address regions that have a 
cycle of disease outbreaks. APHIS will carefully consider a pattern of 
disease outbreaks as we conduct our reassessment. A cycle of disease 
outbreaks may indicate that the region does not have the safeguards or 
resources to prevent future outbreaks. Under no circumstances will we 
reestablish a region's disease-free status when we believe that our 
reassessment does not support such a decision.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    Below is a summary of the economic analysis for this final rule. 
The economic analysis provides a cost-benefit analysis 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 may be 
obtained by contacting the person listed under FOR FURTHER INFORMATION 
CONTACT.
    This final rule establishes 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 will take to prevent 
the introduction of disease from that region and steps we will take to 
further assess the region's animal health status. The procedures will 
allow for a more 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. 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. Additionally, we will reassess the disease status of the region 
in the context of the standards of the OIE to determine whether it is 
necessary to continue the interim prohibitions or restrictions. 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:
     A final rule that reinstates the disease-free status of 
the region, or a portion of the region covered by the interim rule;
     An affirmation of the interim rule that imposed 
prohibitions or restrictions on imports of animals and animal products 
from that region;
     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 may benefit because imports affected by the 
change in disease status may resume earlier than under previous 
procedures. Domestic producers of close substitutes of the imports, who 
may have benefitted during the period when imports were restricted or 
prohibited, may 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 
United States and foreign governments.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
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 92

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


0
Accordingly, we are amending 9 CFR part 92 as follows:

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

0
1. The authority citation for part 92 continues 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.


0
2. A new section 92.4 is 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 this 
subchapter D 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

[[Page 25820]]

disease in this subchapter D 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 to 
determine whether it is necessary to continue the interim prohibitions 
or restrictions. In reassessing a region's disease status, APHIS will 
take into consideration the standards of the Office International des 
Epizooties for reinstatement of disease-free status, as well as all 
relevant information obtained through public comments on both the 
initial interim rule and the notice of availability of the reassessment 
or relevant information collected by or submitted to APHIS through 
other means.
    (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 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 4th day of May 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-10523 Filed 5-7-04; 8:45 am]
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