Federal Register, Volume 76 Issue 138 (Tuesday, July 19, 2011)

[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Proposed Rules]
[Pages 42595-42602]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18108]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 53, 71, 82, 93, 94, 95, and 104

[Docket No. APHIS-2009-0094]
RIN 0579-AD45

Importation of Live Birds and Poultry, Poultry Meat, and Poultry
Products From a Region in the European Union

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations governing the
importation of animals and animal products by recognizing 25 Member
States of the European Union as the APHIS-defined European Union
poultry trade region and adding it to the list of regions we consider
to be free of Newcastle disease. We are taking this action based on a
risk evaluation that we prepared in which we determined that the
proposed region meets our requirements for being considered free of
Newcastle disease. We also determined that the region meets our
requirements for being considered free of highly pathogenic avian
influenza. In addition, we are proposing to establish requirements
governing the importation of live birds and poultry, including hatching
eggs, and poultry meat and products from the APHIS-defined European
Union poultry trade region, and to update avian disease terms and
definitions. These actions would facilitate the importation of live
birds and poultry, and poultry meat and products, from the APHIS-
defined European Union poultry trade region while protecting the United
States from communicable avian diseases.

DATES: We will consider all comments that we receive on or before
September 19, 2011.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to (http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0094-0001).
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2009-0094, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at (http://www.regulations.gov/#!docketDetail;D=APHIS-2009-
0094) or in our reading room, which 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.

FOR FURTHER INFORMATION CONTACT: Mr. Javier Vargas, Case Manager,
National Center for Import and Export, Veterinary Services, APHIS, 4700
River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS) regulations
in title 9 of the Code of Federal Regulations (CFR), parts 93, 94, and
95, govern the importation into the United States of specified animals
and animal products and byproducts to prevent the introduction of
various animal diseases, including exotic Newcastle disease \1\

[[Page 42596]]

and highly pathogenic avian influenza (HPAI).
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\1\ For reasons explained later in this document, we propose to
replace in the regulations the term ``exotic Newcastle disease''
with ``Newcastle disease'' and revise its definition; we use the
latter term in this document when referring to the disease.
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Newcastle disease, a contagious disease of birds and poultry caused
by a paramyxovirus, is one of the most infectious diseases of poultry
in the world. Death rates of nearly 100 percent can occur in
unvaccinated poultry flocks. Newcastle disease can also infect and
cause death even in vaccinated birds and poultry.
Several strains of avian influenza (AI) virus throughout the world
can cause varying degrees of illness in many species of birds,
including chickens, turkeys, pheasants, quail, ducks, geese, and guinea
fowl. AI viruses are characterized as low pathogenicity (LP) or high
pathogenicity (HP) by their ability to produce disease or by their
molecular characteristics. The ability of the virus to cause clinical
signs may depend on the species of bird infected and may change over
time, becoming more or less pathogenic. HPAI is an extremely infectious
and potentially fatal form of AI in birds that, once established, can
spread rapidly from flock to flock. The H5 and H7 subtypes of LPAI have
the potential to mutate into HPAI. For this reason, LPAI subtypes H5
and H7 are considered along with any subtype of HPAI as notifiable
forms of AI by the World Organisation for Animal Health (OIE).\2\
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\2\ Terrestrial Animal Health Code, Chapter 10, Article 10.4.1:
(http://www.oie.int/eng/normes/mcode/en_chapitre_1.10.4.htm).
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Existing regulations in Sec. 94.6 restrict the importation of
carcasses, parts of products of carcasses, and eggs (other than
hatching eggs) \3\ of poultry, game birds, and other birds, from all
regions where Newcastle disease or any subtype of HPAI are considered
to exist.
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\3\ Regulations for importing hatching eggs are included in
Sec. Sec. 93.104, 93.205, and 93.209.
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Paragraph (a)(1) of Sec. 94.6 states that Newcastle disease is
considered to exist in all regions of the world except for the regions
listed. Paragraph (a)(2) refers readers to an APHIS Web site \4\
listing regions in the world in which any subtype of HPAI is considered
to exist. Paragraph (b) sets forth processing, handling, and shipping
requirements for importations of poultry carcasses, and parts or
products of carcasses, including meat, from regions where Newcastle
disease or HPAI is considered to exist.
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\4\ (http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_hpai.shtml.)
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Paragraph (c) of Sec. 94.6 sets forth requirements for importing
eggs (other than hatching eggs) from poultry, game birds, or other
birds if the birds or poultry are raised in any region where Newcastle
disease is considered to exist, if the eggs are imported from any
region where Newcastle disease is considered to exist, or if the eggs
are moved into or through any region where Newcastle disease is
considered to exist at any time before importation or during shipment
to the United States.
Under our regulations in 9 CFR part 92, the representative of the
national government(s) of any country or countries with the authority
to do so may request that all or part of the country or countries be
recognized as a region for animal health status purposes. In order to
consider a region for recognition, APHIS requires that the applicant
provide information about the proposed region regarding animal disease
status, diagnostic capabilities, control measures, and related subjects
listed in Sec. 92.2 of the regulations. APHIS uses this information to
help determine whether importation of specific articles can be safely
allowed, and if so, publishes a proposal stating conditions under which
imports are permitted.
The region-based model draws on the concept that restrictions on
the movement of animals and animal products for the purpose of disease
control are most effective when applied to geographically homogenous
areas with respect to disease distribution and livestock health
infrastructures. Evaluating a region spanning two or more countries, or
parts of countries, considers the risks inherent in the free trade of
animals and animal products across national borders.
In 2006, the European Commission \5\ (EC) requested recognition of
the animal health status of a region with respect to Newcastle disease
and HPAI. The region consists of the 25 European Union (EU) Member
States (EU-25) that comprised the EU in 2005.\6\ The regulations
currently list nine Member States of the EU-25 as regions in which
Newcastle disease is not known to exist.\7\ APHIS conducted a risk
evaluation of the EU-25 as a single region that would be under the
harmonized regulation and oversight of the EC, and to which we would
apply a single set of requirements for the importation of live birds
and poultry, and poultry meat and products, from the region into the
United States.\8\ As part of the risk evaluation, we conducted a site
visit to representative EU-25 Member States. We also evaluated animal
health status information submitted by the EC and consulted information
from previous APHIS evaluations.
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\5\ The European Commission (EC) is the governmental body
responsible for representing the European Union as a whole. It
proposes legislation, policies and programs of action, and
implements decisions of the EU Parliament and Council.
\6\ The Member States constituting the EU-25 are: Austria,
Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, and the United Kingdom.
\7\ Denmark, Finland, France, Great Britain, Greece, Luxembourg,
Republic of Ireland, Spain, and Sweden. These countries also meet
our requirements for HPAI freedom.
\8\ ``APHIS Risk Evaluation on the Importation of Highly
Pathogenic Avian Influenza (HPAI) and Virulent Newcastle Disease
(END) Virus from a European Union Region of Twenty-five Member
States,'' June 2009.
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We have determined that the EU-25 is free of Newcastle disease and
HPAI under our requirements and that the EC has demonstrated the
ability to rapidly detect and contain outbreaks of these diseases,
effectively limiting the need for movement restrictions to distinct
Administrative Units within the region.\9\ We also determined that the
risk of avian disease is evenly distributed across the EU-25 because of
the free trade in live birds and poultry, and poultry meat and
products, across national borders within the region, and because the EC
uniformly applies and enforces its animal disease regulations in all EU
Member States.
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\9\ Administrative Units are distinct governmental jurisdictions
such as counties and provinces. See Appendix D of the risk
evaluation document for a list of Administrative Units for each
Member State.
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Our findings are described in detail in the risk evaluation, which
may be obtained by contacting the person listed under FOR FURTHER
INFORMATION CONTACT. It may also be viewed on the Regulations.gov Web
site or in our reading room (see ADDRESSES above for a link to
Regulations.gov and information on the location and hours of the
reading room).

Proposed Changes to the Regulations

We are proposing to amend the regulations by recognizing the Member
States of the EU-25 as the APHIS-defined European Union poultry trade
region (APHIS-defined EU-PTR). We are also proposing to add this new
region to the list in Sec. 94.6(a)(1)(i) of regions we consider to be
free of Newcastle disease and to recognize the region as free of HPAI
in accordance with Sec. 94.6(a)(2)(i). Our proposed recognition of the
APHIS-defined EU-PTR as free of these diseases is modeled after an EU
region that we currently recognize as being low-risk for classical
swine fever (CSF). In response to a 1997 request from the EC, APHIS
conducted a risk analysis of a proposed region for CSF, and in a final
rule published in the Federal Register

[[Page 42597]]

and effective on April 7, 2003 (68 FR 16922-16941, Docket No. 98-090-
5), we amended the regulations in Sec. 94.24 to recognize an EU region
in which CSF is not known to exist and from which swine and pork
products may be imported into the United States under certain
conditions.\10\
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\10\ The EU Member States constituting the CSF-free region in
this rule included, with the exception of specified regions within
Germany and Italy, the countries of Austria, Belgium, Germany,
Greece, Italy, the Netherlands, and Portugal. A current list of
Member States included in the EU-CSF region is located online at:
(http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_csf.shtml).
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The April 2003 final rule also established a requirement, set forth
in Sec. 92.3, that whenever the EC establishes a quarantine for a
disease in the EU in a region that APHIS recognizes as one in which the
disease is not known to exist, and the EC imposes restrictions on the
movement of animals or animal products from that quarantined area, such
animals and animal products are prohibited importation into the United
States. This prohibition applies to the APHIS-defined EU-CSF region
when the EC imposes quarantine and movement restrictions for swine and
pork products due to outbreaks of CSF. Because we acknowledge that
limited outbreaks of Newcastle disease and HPAI will likely occur
sporadically in EU-25 Member States, the prohibitions in Sec. 92.3
would also apply to the APHIS-defined EU-PTR when the EC imposes
quarantine and movement restrictions for poultry and poultry products
due to outbreaks of Newcastle disease or HPAI.\11\
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\11\ EC regulations also require the establishment of control
measures following the detection of LPAI based on the risk that some
low pathogenic viruses may mutate into HPAI. Depending on an
assessment of the risks posed by a particular LPAI outbreak, the
control measures imposed by the EC may be less restrictive than
those applied following the detection of HPAI.
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We also propose to establish a new section, Sec. 94.28, that sets
forth import restrictions on live birds and poultry, and poultry meat
and products, from the APHIS-defined EU-PTR. These restrictions would
reduce the risk of introducing Newcastle disease or HPAI into the
United States while acknowledging the EC's ability to successfully
manage outbreaks of those diseases.

Import Restrictions for Poultry Meat and Products

Paragraph (a)(1)(i) of proposed Sec. 94.28 would require that
poultry meat and products, including eggs and egg products (other than
hatching eggs) derived from birds and poultry imported from the APHIS-
defined EU-PTR must not have been derived from birds or poultry that
were in any region when the region was classified in Sec.
94.6(a)(1)(i) as one in which Newcastle disease is considered to exist,
or any region when it was listed in accordance with Sec. 94.6(a)(2)(i)
as one in which HPAI is considered to exist, except for the APHIS-
defined EU-PTR.\12\ Under this exception, poultry meat and products
could continue to be imported from unaffected parts of the APHIS-
defined EU-PTR if a restricted zone for commercial poultry is
established elsewhere in the region because of the detection of
Newcastle disease or HPAI.
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\12\ APHIS is studying issues concerning the importation of
table eggs from regions where HPAI is considered to exist. More
information on this issue can be found in an interim rule published
and effective on January 24, 2011 (76 FR 4046-4056, Docket No.
APHIS-2006-0074).
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Paragraph (a)(1)(ii) of proposed Sec. 94.28 would require that
poultry meat and products must not have been derived from birds or
poultry that were in any restricted zone within the APHIS-defined EU-
PTR established because of detection of Newcastle disease or HPAI in
commercial poultry. While EC regulations permit lifting a restricted
zone as early as 21 days after disease control measures have been
completed, APHIS would continue to observe the 90-day restriction
periods established in Sec. 93.104 for live birds and Sec. 93.205 for
poultry and eggs for hatching. The prohibition on imports of poultry
meat and products from restricted zones imposed by the EC would
continue from the time of detection until the designation of the zone
as a restricted zone is removed by the competent veterinary authority
of the Member State, or until 3 months (90 days) following depopulation
of the poultry on affected premises in the restricted zone and the
cleaning and disinfection of the last affected premises in the zone,
whichever is later.
Paragraph (a)(1)(iii) of proposed Sec. 94.28 would prohibit
imports of poultry meat and products derived from birds and poultry
that were in a restricted zone established within the APHIS-defined EU-
PTR because of detection of Newcastle disease or HPAI in racing
pigeons, backyard flocks, or wild birds, from the time of detection
until the designation of the zone as a restricted zone is removed by
the competent veterinary authority of the Member State. We acknowledge
that in such instances a Member State may choose to lift zone
restrictions sooner than the minimum 90 days that APHIS requires for
zones established because of detection of Newcastle disease or HPAI in
commercial poultry. However, we have determined that (1) the Member
States of the EU-25 exercise sufficient biosecurity practices such that
isolated outbreaks in racing pigeons, backyard flocks, or wild birds
are less likely to infect commercial poultry, and (2) importing
commercial poultry meat and poultry products pose more of a potential
disease threat to the U.S. poultry industry than do racing pigeons,
backyard flocks, and wild birds. Whenever the EC establishes a
restricted zone for racing pigeons, backyard flocks, or wild birds and
subsequently lifts it, we would first confirm that the infection had
not been introduced into commercial poultry in the restricted zone
before we lift our import restrictions.
Paragraph (a)(2) of proposed Sec. 94.28 would require that poultry
meat and products imported from the APHIS-defined EU-PTR must not have
been commingled with poultry meat and products derived from other birds
and poultry that were in any of the regions or zones described in
proposed Sec. 94.28(a)(1)(i) through (a)(1)(iii). Additionally, we
would provide that the poultry meat and products must not have been
derived from birds and poultry that were commingled with other birds
and poultry that were in any of the regions or zones described in
proposed Sec. 94.28(a)(1)(i) through (a)(1)(iii).
Paragraph (a)(3) of Sec. 94.28 would require live birds and
poultry from which poultry meat and products are derived to originate
within the APHIS-defined EU-PTR. The farms from which they come would
not be permitted to have received birds or poultry from outside the
region.
Paragraph (a)(4) of proposed Sec. 94.28 would require any
equipment used in transporting birds and poultry from which poultry
meat and products are derived not to have been used to transport live
birds and poultry that do not meet the requirements we are proposing in
Sec. 94.28(b), unless the equipment and materials have first been
cleaned and disinfected.
Paragraph (a)(5) of proposed Sec. 94.28 would require poultry meat
and products imported from the APHIS-defined EU-PTR to be accompanied
by an inspection certificate issued by the competent veterinary
authority of the Member State. The certificate would have to state that
all applicable provisions of Sec. 94.28(a)(1) through (a)(4) have been
met.

Import Restrictions for Live Birds and Poultry, Including Hatching
Eggs

Paragraph (b)(1)(i) of proposed Sec. 94.28 would require that live
birds and

[[Page 42598]]

poultry (including hatching eggs) imported from the APHIS-defined EU-
PTR must not have been in any region when that region was classified in
Sec. 94.6(a)(1)(i) as one in which Newcastle disease is considered to
exist, or any region when the region was listed in accordance with
Sec. 94.6(a)(2)(i) as one in which HPAI is considered to exist, except
for the APHIS-defined EU-PTR. Under this exception, live birds and
poultry could continue to be imported from unaffected parts of the
APHIS-defined EU-PTR if a restricted zone for commercial poultry is
established elsewhere in the region because of the detection of
Newcastle disease or HPAI.
Paragraph (b)(1)(ii) of proposed Sec. 94.28 would require that
live birds and poultry imported from the APHIS-defined EU-PTR must not
have been in a restricted zone in the APHIS-defined EU-PTR established
because of the detection of Newcastle disease or HPAI in commercial
poultry. The prohibition on imports of live birds and poultry from a
restricted zone would continue from the time of detection until the
restricted zone designation is removed by the competent veterinary
authority of the Member State, or until 3 months (90 days) following
depopulation of the birds and poultry on affected premises in the
restricted zone and the cleaning and disinfection of the last affected
premises in the zone, whichever is later.
Paragraph (b)(1)(iii) of proposed Sec. 94.28 would prohibit
imports of live birds and poultry from a restricted zone in the APHIS-
defined EU-PTR established because of detection of Newcastle disease or
HPAI in racing pigeons, backyard flocks, and wild birds, from the time
of detection until the designation of the zone as a restricted zone is
removed by the competent veterinary authority of the Member State.
Paragraph (b)(2) of proposed Sec. 94.28 would require that live
birds and poultry offered for import not have been commingled with
other birds and poultry that have at any time been in any of the
regions or zones described in proposed Sec. 94.28(b)(1)(i) through
(b)(1)(iii).
Paragraph (b)(3) of proposed Sec. 94.28 would require live birds
and poultry offered for import to originate within the APHIS-defined
EU-PTR. Their farms of origin would not be permitted to have received
birds and poultry imported from outside the APHIS-defined EU-PTR.
Paragraph (b)(4) of Sec. 94.28 would require that no equipment and
materials used in transporting live birds and poultry have been used
previously for transporting birds and poultry that do not meet the
other requirements we are proposing in Sec. 94.28(b), unless the
equipment and materials have first been cleaned and disinfected.
Paragraph (b)(5) of proposed Sec. 94.28 would require that live
birds and poultry imported from the APHIS-defined EU-PTR be accompanied
by an inspection certificate issued by the competent veterinary
authority of the Member State. The certificate would state that all
applicable provisions of proposed Sec. 94.28(b)(1) through (b)(4) have
been met.
Paragraph (c) of Sec. 94.28 would require that the certificates
required in Sec. 94.28(a)(5) and (b)(5) be presented by the importer
to an authorized inspector at the port of arrival, upon arrival of the
live birds, poultry, hatching eggs, or bird and poultry meat and
products.
Because we are proposing to recognize the 25 Member States of the
APHIS-defined EU-PTR collectively as a single region free of Newcastle
disease and HPAI, we would remove from Sec. 94.6(a)(1)(i) the nine EU-
25 Member States individually listed as regions free of Newcastle
disease: Denmark, Finland, France, Great Britain, Greece, Luxembourg,
Ireland, Spain, and Sweden. The APHIS-defined EU-PTR would be included
in proposed Sec. 94.6(a)(1)(i) as a single region considered to be
free of Newcastle disease.

Changes to Terms and Definitions

We propose to make changes to the regulations regarding the terms
and definitions we use for Newcastle disease and HPAI. We would remove
the word ``exotic'' from the current references to ``exotic Newcastle
disease'' in 9 CFR parts 53, 82, 93, 94 and 95. We are making this
change so that our terminology for this disease is consistent with that
used in the OIE animal health standards. We also propose to update our
definition of Newcastle disease in parts 53, 82, and 94. The definition
currently included in these parts describes how a virulent strain of
the virus presents itself but does not define the technical criteria
for determining virulence. We would use the definition published in the
OIE animal health standards because it includes the technical criteria
of virulence.\13\
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\13\ Terrestrial Animal Health Code, Article 10.13.1: (http://www.oie.int/eng/normes/mcode/en_chapitre_1.10.13.htm).
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In parts 71, 93, and 104, we propose to remove the terms ``fowl
pest'' and ``fowl plague'' from the regulations and replace them with
``highly pathogenic avian influenza.'' The terms currently in the
regulations predate identification of the avian influenza virus and are
no longer commonly used in scientific discourse. This change would be
consistent with our previous efforts to replace these terms in other
parts of the regulations and reflects OIE terminology.\14\ In addition,
we propose to add a definition of HPAI to Sec. 94.0. We would use the
definition of HPAI included in Sec. 53.1 of the current regulations
because it defines all HPAI subtypes, makes the regulations more
consistent, and is consistent with the definition used by the OIE.
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\14\ Terrestrial Animal Health Code, Article 10.4.1: (http://www.oie.int/eng/normes/mcode/en_chapitre_1.10.4.htm).
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Executive Order 12866 and Regulatory Flexibility Act

This proposed 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.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
analysis is summarized below. Copies of the full analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).
The analysis examines impacts for U.S. small entities of a rule
that would amend Sec. 94.6 by establishing a region made up of 25
Member States of the EU and adding it to the list of regions considered
to be free of Newcastle disease and HPAI. This region would be
designated as the APHIS-defined EU-PTR, for which import restrictions
for live birds and poultry, including hatching eggs, poultry meat, and
poultry products would be uniformly applied. If outbreaks of either
disease were to occur, this proposed rule would facilitate the
continuation of imports from other areas within the APHIS-defined EU-
PTR that are considered to be free of Newcastle disease and HPAI.
We expect the proposed rule to have negligible economic effects for
U.S. entities, large or small. Nine EU Member States are currently
permitted to export poultry or poultry products to the United States,
but the quantities exported are small, and the quantities of birds,
poultry, and poultry products that would be imported from the EU-PTR
are not expected to be significant. EU Member States, in aggregate,
exported only 40 metric tons of poultry meat to the United States in
2009. In contrast,

[[Page 42599]]

the United States is one of the world's largest producers and exporters
of poultry meat; about 20 percent of U.S. poultry production was
exported in 2009. Over 99 percent of U.S. live poultry imports, 97
percent of poultry meat imports, and 91 percent of hatching egg imports
came from Canada in 2009. Imports from the APHIS-defined EU-PTR would
therefore face a highly competitive U.S. market.
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 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) No
retroactive effect will be given to this rule, and (2) administrative
proceedings will not be required before parties may file suit in court
challenging this rule.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with
recognition of the APHIS-defined EU poultry trade region as being free
of Newcastle disease and HPAI, we have prepared an environmental
assessment. The environmental assessment was prepared in accordance
with: (1) The National Environmental Policy Act of 1969 (NEPA), as
amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on
Environmental Quality for implementing the procedural provisions of
NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR
part 372).
The environmental assessment may be viewed on the Regulations.gov
Web site or in our reading room. (A link to Regulations.gov and
information on the location and hours of the reading room are provided
under the heading ADDRESSES at the beginning of this proposed rule.) In
addition, copies may be obtained by calling or writing to the
individual listed under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

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

List of Subjects

9 CFR Part 53

Animal diseases, Indemnity payments, Livestock, Poultry and poultry
products.

9 CFR Part 71

Animal diseases, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 82

Animal diseases, Poultry and poultry products, Quarantine,
Reporting and recordkeeping requirements, Transportation.

9 CFR Part 93

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

9 CFR Part 94

Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.

9 CFR Part 95

Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.

9 CFR Part 104

Animal biologics, Imports, Reporting and recordkeeping
requirements, Transportation.

Accordingly, we propose to amend 9 CFR parts 53, 71, 82, 93, 94,
95, and 104 as follows:

PART 53--FOOT-AND-MOUTH DISEASE, PLEUROPNEUMONIA, RINDERPEST, AND
CERTAIN OTHER COMMUNICABLE DISEASES OF LIVESTOCK OR POULTRY

1. The authority citation for part 53 continues to read as follows:

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

2. Section 53.1 is amended as follows:
a. In the definition of Disease, by removing the word ``exotic''.
b. By removing the definition of Exotic Newcastle Disease (END).
c. By adding, in alphabetical order, a definition of Newcastle
disease to read as set forth below.

Sec. 53.1 Definitions.

* * * * *
Newcastle disease. Newcastle disease is an acute, rapidly
spreading, and usually fatal viral infection of poultry caused by an
avian paramyxovirus serotype 1 that meets one of the following criteria
for virulence: The virus has an intracerebral pathogenicity index
(ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple
basic amino acids have been demonstrated in the virus (either directly
or by deduction) at the C-terminus of the F2 protein and phenylalanine
at residue 117, which is the N-terminus of the F1 protein. The term
``multiple basic amino acids'' refers to at least three arginine or
lysine residues between residues 113 and 116. In this definition, amino
acid residues are numbered from the N-terminus of the amino acid
sequence deduced from the nucleotide sequence of the F0 gene; 113-116
corresponds to residues -4 to -1 from the cleavage site. Failure to
demonstrate the characteristic pattern of amino acid residues as
described above may require characterization of the isolated virus by
an ICPI test. A failure to detect a cleavage site that is consistent
with virulent strains does not confirm the absence of a virulent virus.
* * * * *

Sec. 53.2 [Amended]

3. In Sec. 53.2, paragraph (b) is amended by removing the word
``exotic''.

PART 71--GENERAL PROVISIONS

4. The authority citation for part 71 continues to read as follows:

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

Sec. 71.3 [Amended]

5. In Sec. 71.3, paragraph (b) is amended by removing the words
``European fowl pest'' and adding the words ``highly pathogenic avian
influenza'' in their place.

PART 82--NEWCASTLE DISEASE AND CHLAMYDIOSIS

6. The authority citation for part 82 continues to read as follows:

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

7. The heading for part 82 is revised to read as set forth above.

Subpart A--Newcastle Disease

8. The heading for subpart A is revised to read as set forth above.

Subpart A--[Amended]

9. In subpart A, revise all references to ``END'' to read
``Newcastle disease''.
10. Section 82.1 is amended as follows:
a. By removing the definition of END.

[[Page 42600]]

b. By adding, in alphabetical order, a definition of Newcastle
disease to read as set forth below.

Sec. 82.1 Definitions.

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY,
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

11. The authority citation for part 93 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.

Sec. 93.101 [Amended]

12. Section 93.101 is amended as follows:
a. In paragraph (g)(2), by removing the words ``exotic Newcastle
disease (END)'' and adding the words ``Newcastle disease'' in their
place.
b. By revising all references to ``END'' in footnote 7 and
paragraphs (g)(3) and (g)(4) to read ``Newcastle disease''.

Sec. 93.106 [Amended]

13. Section 93.106 is amended as follows:
a. In paragraph (c)(5)(iii), in the Cooperative and Trust Fund
Agreement, in (A)(14), the second sentence, and in (A)(17), the first
sentence, remove the word ``exotic'' each time it occurs.
b. In paragraph (c)(5)(iii), in the Cooperative and Trust Fund
Agreement, in (B)(4) and (B)(5), revise the references to ``END'' to
read ``Newcastle disease''.

Sec. 93.205 [Amended]

14. In Sec. 93.205, paragraph (a), the fourth sentence is amended
by removing the words ``European fowl pest (fowl plague)'' and adding
the words ``highly pathogenic avian influenza'' in their place.

Sec. 93.209 [Amended]

15. In Sec. 93.209, paragraph (b), the first sentence is amended
by removing the word ``exotic''.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE,
HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL
SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM
ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

16. The authority citation for part 94 continues to read as
follows:

Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

17. The heading for part 94 is revised to read as set forth above.
18. Section 94.0 is amended as follows:
a. By removing the definition of Exotic Newcastle Disease (END).
b. By adding, in alphabetical order, definitions of APHIS-defined
EU Poultry Trade Region, Highly pathogenic avian influenza, and
Newcastle disease to read as set forth below.

Sec. 94.0 Definitions.

* * * * *
APHIS-defined EU Poultry Trade Region. The European Union Member
States of Austria, Belgium, Cyprus, the Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom
(England, Scotland, Wales, the Isle of Man, and Northern Ireland).
* * * * *
Highly pathogenic avian influenza. Highly pathogenic avian
influenza is defined as follows:
(1) Any influenza virus that kills at least 75 percent of eight 4-
to 6-week-old susceptible chickens within 10 days following intravenous
inoculation with 0.2 mL of a 1:10 dilution of a bacteria-free,
infectious allantoic fluid;
(2) Any H5 or H7 virus that does not meet the criteria in paragraph
(1) of this definition, but has an amino acid sequence at the
haemagglutinin cleavage site that is compatible with highly pathogenic
avian influenza viruses; or
(3) Any influenza virus that is not an H5 or H7 subtype and that
kills one to five chickens and grows in cell culture in the absence of
trypsin.
* * * * *
Newcastle disease. Newcastle disease is an acute, rapidly
spreading, and usually fatal viral infection of poultry caused by an
avian paramyxovirus serotype 1 that meets one of the following criteria
for virulence: The virus has an intracerebral pathogenicity index
(ICPI) in day-old chicks (Gallus gallus) of 0.7 or greater; or multiple
basic amino acids have been demonstrated in the virus (either directly
or by deduction) at the C-terminus of the F2 protein and phenylalanine
at residue 117, which is the N-terminus of the F1 protein. The term
``multiple basic amino acids'' refers to at least three arginine or
lysine residues between residues 113 and 116. In this definition, amino
acid residues are numbered from the N-terminus of the amino acid
sequence deduced from the nucleotide sequence of the F0 gene; 113-116
corresponds to residues -4 to -1 from the cleavage site. Failure to
demonstrate the characteristic pattern of amino acid residues as
described above may require characterization of the isolated virus by
an ICPI test. A failure to detect a cleavage site that is consistent
with virulent strains does not confirm the absence of a virulent virus.
* * * * *
19. Section 94.6 is amended as follows:
a. By revising the section heading to read as set forth below.
b. In the paragraph (a) heading, by removing the words ``exotic
Newcastle disease (END)'' and adding the words ``Newcastle disease'' in
their place.
c. By revising paragraph (a)(1)(i) to read as set forth below.
d. By revising all references to ``END'' to read ``Newcastle
disease''.

Sec. 94.6 Carcasses, meat, parts or products of carcasses, and eggs
(other than hatching eggs) of poultry, game birds, or other birds;
importations from regions where Newcastle disease or highly pathogenic
avian influenza is considered to exist.

(a) * * *
(1) * * *
(i) The following regions are considered to be free of Newcastle

[[Page 42601]]

disease: APHIS-defined EU Poultry Trade Region, Argentina, Australia,
Canada, Chile, Costa Rica, Fiji, Iceland, Mexico (States of Campeche,
Quintana Roo, and Yucatan), New Zealand, and Switzerland.
* * * * *

Sec. 94.23 [Amended]

20. Section 94.23 is amended by removing in paragraph (c) and
paragraph (e) introductory text the word ``exotic'' each time it
occurs.

Sec. 94.26 [Amended]

21. Section 94.26 is amended as follows:
a. In the introductory text, by removing the words ``exotic
Newcastle disease (END)'' and adding the words ``Newcastle disease'' in
their place.
b. By revising all references to ``END'' to read ``Newcastle
disease''.
22. A new Sec. 94.28 is added to read as follows:

Sec. 94.28 Restrictions on the importation of poultry meat and
products, and live birds and poultry, from the APHIS-defined EU poultry
trade region.

(a) Poultry meat and products. In addition to meeting all other
applicable provisions of this part, poultry meat and poultry products,
including eggs and egg products (other than hatching eggs) imported
from the APHIS-defined EU Poultry Trade Region must meet the following
conditions:
(1) The poultry meat and products must not have been derived from
birds and poultry that were in any of the following regions or zones,
unless the birds and poultry were slaughtered after the periods
described:
(i) Any region when the region was classified in Sec.
94.6(a)(1)(i) as one in which Newcastle disease is considered to exist,
or any region when the region was listed in accordance with Sec.
94.6(a)(2)(i) as one in which HPAI is considered to exist, except for
the APHIS-defined EU Poultry Trade Region;
(ii) A restricted zone in the APHIS-defined EU Poultry Trade Region
established because of detection of Newcastle disease or HPAI in
commercial poultry, from the time of detection until the designation of
the zone as a restricted zone is removed by the competent veterinary
authority of the Member State or until 3 months (90 days) following
depopulation of the poultry on affected premises in the restricted zone
and the cleaning and disinfection of the last affected premises in the
zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined EU Poultry Trade
Region established because of detection of Newcastle disease or HPAI in
racing pigeons, backyard flocks, or wild birds, from the time of
detection until the designation of the zone as a restricted zone is
removed by the competent veterinary authority of the Member State.
(2) The poultry meat and products must not have been commingled
with poultry meat and products derived from other birds and poultry
that were in any of the regions or zones described in paragraphs
(a)(1)(i) through (a)(1)(iii) of this section. Additionally, the
poultry meat and products must not have been derived from poultry that
were commingled with other poultry that were in any of the regions or
zones described in paragraphs (a)(1)(i) through (a)(1)(iii) of this
section.
(3) The live birds and poultry from which the poultry meat and
products were derived must only originate from within the APHIS-defined
EU Poultry Trade Region and the farms of origin must not have received
live birds or poultry imported from outside the APHIS-defined EU
Poultry Trade Region.
(4) No equipment or materials used in transporting the birds or
poultry from which the poultry meat and products were derived from the
farm of origin to the slaughtering establishment may have been used
previously for transporting live birds or poultry that do not meet the
requirements of Sec. 94.28(b), unless the equipment and materials have
first been cleaned and disinfected.
(5) The poultry meat and products, including eggs and egg products
(other than hatching eggs) must be accompanied by a certificate issued
by an official of the competent veterinary authority of the APHIS-
defined EU Poultry Trade Region Member State who is authorized to issue
the inspection certificate required by Sec. 93.205 of this subchapter,
stating that the applicable provisions of paragraphs (a)(1) through
(a)(4) of this section have been met. The certification for poultry
meat and products may be placed on the foreign meat inspection
certificate required by Sec. 381.196 of this title or may be contained
in a separate document.
(b) Live birds and poultry. In addition to meeting all other
applicable provisions of this title, live birds and poultry, including
hatching eggs, imported from the APHIS-defined EU Poultry Trade Region
must meet the following conditions:
(1) The birds and poultry must not have been in any of the
following regions or zones, unless the birds and poultry are exported
to the United States after the periods described:
(i) Any region when the region was classified in Sec.
94.6(a)(1)(i) as one in which Newcastle disease is considered to exist,
or any region when the region was listed in accordance with Sec.
94.6(a)(2)(i) as one in which HPAI is considered to exist, except for
the APHIS-defined EU Poultry Trade Region;
(ii) A restricted zone in the APHIS-defined EU Poultry Trade Region
established because of detection of Newcastle disease or HPAI in
commercial poultry, from the time of detection until the designation of
the zone as a restricted zone is removed by the competent veterinary
authority of the Member State or until 3 months (90 days) following
depopulation of the poultry on affected premises in the restricted zone
and the cleaning and disinfection of the last affected premises in the
zone, whichever is later; or
(iii) A restricted zone in the APHIS-defined EU Poultry Trade
Region established because of detection of Newcastle disease or HPAI in
racing pigeons, backyard flocks, and wild birds, from the time of
detection until the designation of the zone as a restricted zone is
removed by the competent veterinary authority of the Member State.
(2) The birds and poultry must not have been commingled with other
birds or poultry that have at any time been in any of the regions or
zones described in paragraphs (b)(1)(i) through (b)(1)(iii) of this
section.
(3) The birds and poultry must only originate from within the
APHIS-defined EU Poultry Trade Region and the farms of origin must not
have received birds or poultry imported from outside the APHIS-defined
EU Poultry Trade Region.
(4) No equipment or materials used in transporting the birds and
poultry may have been used previously for transporting birds or poultry
that do not meet the requirements of this paragraph, unless the
equipment and materials have first been cleaned and disinfected.
(5) The birds and poultry must be accompanied by a certificate
issued by an official of the competent veterinary authority of the
Member State who is authorized to issue the inspection certificate
required by Sec. 93.205 of this subchapter, stating that the
applicable provisions of paragraphs (b)(1) through (b)(4) of this
section have been met. The certification may be placed on the foreign
meat inspection certificate required by Sec. 381.196 of this title or
may be contained in a separate document.
(c) Presentation of certificates. The certificates required by
paragraphs (a)(5) and (b)(5) of this section must be

[[Page 42602]]

presented by the importer to an authorized inspector at the port of
arrival, upon arrival of the birds, poultry, hatching eggs, or poultry
meat and products at the port.

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

23. The authority citation for part 95 continues to read as
follows:

Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.4.

Sec. 95.5 [Amended]

24. In Sec. 95.5, paragraph (c) is amended by removing the words
``exotic'' and ``subtype H5N1''.

Sec. 95.6 [Amended]

25. In Sec. 95.6, paragraph (c) is amended by removing the word
``exotic''.

PART 104--PERMITS FOR BIOLOGICAL PRODUCTS

26. The authority citation for part 104 continues to read as
follows:

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

Sec. 104.2 [Amended]

27. In Sec. 104.2, paragraph (b) is amended by removing the words
``fowl pest (fowl plague)'' and adding the words ``highly pathogenic
avian influenza'' in their place.

Done in Washington, DC, this 13th day of July 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-18108 Filed 7-18-11 8:45 am]
BILLING CODE 3410-34-P