[Federal Register: May 10, 2004 (Volume 69, Number 90)]
[Rules and Regulations]
[Page 25817-25820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my04-1]
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Rules and Regulations
Federal Register
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[[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.
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\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).
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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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