Notice of Decision to Authorize the Importation of Shredded Lettuce From Egypt Into the Continental United States, 81468-81469 [2011-33207]
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81468
Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Notices
issuance of a finding of no significant
impact and the product meets all other
requirements for licensing.
DATES: We will consider all comments
that we receive on or before January 27,
2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2011-0114–
0001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2011–0114, 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 https://www.
regulations.gov/#!docketDetail;
D=APHIS-2011-0114 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) 6902817 before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Donna Malloy, Operational Support
Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, VS,
APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737–1231; phone (301)
734–8245, fax (301) 734–4314.
For information regarding the
environmental assessment or the risk
analysis, or to request a copy of the
environmental assessment (as well as
the risk analysis with confidential
business information removed), contact
Dr. Patricia L. Foley, Risk Manager,
Center for Veterinary Biologics, Policy,
Evaluation, and Licensing VS, APHIS,
1920 Dayton Avenue, P.O. Box 844,
Ames, IA 50010; phone (515) 337–6100,
fax (515) 337–6120.
SUPPLEMENTARY INFORMATION: Under the
Virus-Serum-Toxin Act (21 U.S.C. 151
et seq.), a veterinary biological product
must be shown to be pure, safe, potent,
and efficacious before a veterinary
biological product license may be
issued. A field test is generally
necessary to satisfy prelicensing
requirements for veterinary biological
products. Prior to conducting a field test
on an unlicensed product, an applicant
must obtain approval from the Animal
and Plant Health Inspection Service
(APHIS), as well as obtain APHIS’
authorization to ship the product for
field testing.
To determine whether to authorize
shipment and grant approval for the
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18:22 Dec 27, 2011
Jkt 226001
field testing of the unlicensed product
referenced in this notice, APHIS
conducted a risk analysis to assess the
potential effects of this product on the
safety of animals, public health, and the
environment. Based on the risk analysis,
APHIS has prepared an environmental
assessment (EA) concerning the field
testing of the following unlicensed
veterinary biological product:
Requester: Harrisvaccines, Inc.
Product: Swine Influenza Vaccine,
RNA.
Field Test Locations: North Carolina,
Illinois, and Nebraska.
The above-mentioned product
consists of propagation-defective RNA
particles that encode the hemagglutinin
protein of swine influenza virus. The
vaccine is for intramuscular use in
healthy pigs, three weeks of age or
older, as an aid in the prevention of
disease caused by swine influenza virus,
subtype H3.
The EA has been 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).
Unless substantial issues with adverse
environmental impacts are raised in
response to this notice, APHIS intends
to issue a finding of no significant
impact (FONSI) based on the EA and
authorize shipment of the above product
for the initiation of field tests following
the close of the comment period for this
notice.
Because the issues raised by field
testing and by issuance of a license are
identical, APHIS has concluded that the
EA that is generated for field testing
would also be applicable to the
proposed licensing action. Provided that
the field test data support the
conclusions of the original EA and the
issuance of a FONSI, APHIS does not
intend to issue a separate EA and FONSI
to support the issuance of the product
license, and would determine that an
environmental impact statement need
not be prepared. APHIS intends to issue
a veterinary biological product license
for this vaccine following completion of
the field test provided no adverse
impacts on the human environment are
identified and provided the product
meets all other requirements for
licensing.
Authority: 21 U.S.C. 151–159.
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Done in Washington, DC, this 19th day of
December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–33205 Filed 12–27–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2011–0078]
Notice of Decision to Authorize the
Importation of Shredded Lettuce From
Egypt Into the Continental United
States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our decision to authorize the
importation into the continental United
States of fresh shredded lettuce from
Egypt. Based on the findings of a pest
risk analysis, which we made available
to the public for review and comment
through a previous notice, we have
determined that the application of one
or more designated phytosanitary
measures will be sufficient to mitigate
the risks of introducing or disseminating
plant pests or noxious weeds via the
importation of fresh shredded lettuce
from Egypt.
DATES: Effective Date: December 28,
2011.
SUMMARY:
Mr.
Marc Phillips, Import Specialist, RCC,
RPM, PPQ, APHIS, 4700 River Road
Unit 133, Riverdale, MD 20737; (301)
734–4394.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
Under the regulations in ‘‘SubpartFruits and Vegetables’’ (7 CFR 319.56–
1 through 319.56–54, referred to below
as the regulations), the Animal and
Plant Health Inspection Service (APHIS)
of the U.S. Department of Agriculture
prohibits or restricts the importation of
fruits and vegetables into the United
States from certain parts of the world to
prevent plant pests from being
introduced into and spread within the
United States.
Section 319.56–4 of the regulations
contains a performance-based process
for approving the importation of
commodities that, based on the findings
of a pest risk analysis (PRA), can be
safely imported subject to one or more
of the designated phytosanitary
E:\FR\FM\28DEN1.SGM
28DEN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Notices
measures listed in paragraph (b) of that
section. Under that process, APHIS
publishes a notice in the Federal
Register announcing the availability of
the PRA that evaluates the risks
associated with the importation of a
particular fruit or vegetable. Following
the close of the 60-day comment period,
APHIS may begin issuing permits for
importation of the fruit or vegetable
subject to the identified designated
measures if: (1) No comments were
received on the PRA; (2) the comments
on the PRA revealed that no changes to
the PRA were necessary; or (3) changes
to the PRA were made in response to
public comments, but the changes did
not affect the overall conclusions of the
analysis and the Administrator’s
determination of risk.
In accordance with that process, we
published a notice 1 in the Federal
Register on August 17, 2011 (76 FR
50992–50993, Docket No. APHIS–2011–
0078), in which we announced the
availability, for review and comment, of
a PRA that evaluated the risks
associated with the importation into the
continental United States of fresh
shredded lettuce (Lactuca sativa L.)
from Egypt. The PRA consisted of a risk
assessment identifying pests of
quarantine significance that could
follow the pathway of importation of
fresh shredded lettuce from Egypt into
the United States and a risk
management document identifying
phytosanitary measures to be applied to
that commodity to mitigate the pest risk.
We solicited comments on the notice for
60 days ending on October 17, 2011. We
received two comments by that date.
One comment from a private citizen
who opposed the importation of
shredded lettuce from Egypt into the
United States did not address any
specific aspect of the PRA.
The other comment, submitted by an
agricultural official representing the
State of Florida, questioned the efficacy
of the post-harvest phytosanitary
measures we included in the PRA. The
commenter agreed with the PRA that
lettuce from Egypt is potentially a host
for several species of destructive leaf
miners but stated that the phytosanitary
measure of shredding lettuce does not
remove the risk of their introduction
into the United States. The commenter
requested that shipments of shredded
lettuce from Egypt not be permitted
entry into Florida until the shipping
protocol has had time to demonstrate
the effectiveness of the mitigation
measures listed in the PRA.
1 To view the notice, the PRA, and the comments
we received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2011-0078.
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18:22 Dec 27, 2011
Jkt 226001
Only commercial consignments of
shredded lettuce will be allowed to be
imported from Egypt. Commercial
consignments, as defined in § 319.56–2,
are consignments that an inspector
identifies as having been imported for
sale and distribution. Produce grown
commercially is less likely to be infested
with plant pests than noncommercial
consignments. Noncommercial
consignments are more prone to
infestations because the commodity is
often ripe to overripe, could be of a
variety with unknown susceptibility to
pests, and is often grown with little or
no pest control.
We identified in the PRA 12 pests of
quarantine significance for lettuce from
Egypt that are highly unlikely to follow
the pathway due to the standard postharvest processing practices applied to
commercial consignments of shredded
lettuce from Egypt. Although these 11
arthropods and 1 mollusk affect lettuce
leaves, we took into account the
standard commercial post-harvest
procedures of: (1) Removing outer
leaves; (2) visual inspection and culling,
with cutting; (3) shredding; and (4)
washing and centrifuging. We
concluded that these procedures
sufficiently mitigate the risk of
introducing leaf miners or other plant
pests through the importation of
shredded lettuce from Egypt. The
commenter provided no evidence to
indicate that these measures would not
effectively mitigate the pest risk.
Consignments of shredded lettuce
from Egypt will also be required to be
accompanied by a phytosanitary
certificate of inspection and pest
freedom issued by the national plant
protection organization (NPPO) of
Egypt, with an additional declaration
stating that the shredded lettuce in the
consignment had been inspected and
found free from quarantine pests. This
condition provides additional
assurances that the commercial
production process has removed
quarantine pests from the commodity.
For these reasons, APHIS has
concluded that the mitigations
described will effectively mitigate the
pest risk associated with shredded
lettuce imported from Egypt.
Accordingly, we have determined that
no changes to the PRA are necessary
based on the comment.
Therefore, in accordance with the
regulations in § 319.56–4(c)(2)(ii), we
are announcing our decision to
authorize the importation into the
continental United States of fresh
shredded lettuce from Egypt subject to
the following phytosanitary measures:
PO 00000
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Fmt 4703
Sfmt 4703
81469
• The shredded lettuce must be
imported in commercial consignments
only.
• Each consignment of shredded
lettuce leaves must be accompanied by
a phytosanitary certificate issued by the
national plant protection organization of
Egypt with an additional declaration
stating the following: ‘‘Shredded lettuce
leaves in this consignment were
inspected and found free from
quarantine pests.’’
These conditions will be listed in the
Fruits and Vegetables Import
Requirements database (available at
https://www.aphis.usda.gov/favir). In
addition to these specific measures,
shredded lettuce from Egypt will be
subject to the general requirements
listed in § 319.56–3 that are applicable
to the importation of all fruits and
vegetables.
Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 19th day of
December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–33207 Filed 12–27–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2010–0112]
Notice of Decision to Authorize
Importation of Fresh Litchi From the
Republic of South Africa Into the
Continental United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our decision to authorize the
importation of fresh litchi from the
Republic of South Africa into the
continental United States. Based on the
findings in a pest risk analysis, which
we made available to the public for
review and comment through a previous
notice, we believe that the application
of one or more designated phytosanitary
measures will be sufficient to mitigate
the risks of introducing or disseminating
plant pests or noxious weeds via the
importation of litchi from the Republic
of South Africa.
DATES: Effective Date: December 28,
2011.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Marc Phillips, Import Specialist,
E:\FR\FM\28DEN1.SGM
28DEN1
Mr.
]]>Agencies
[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Pages 81468-81469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33207]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0078]
Notice of Decision to Authorize the Importation of Shredded
Lettuce From Egypt Into the Continental United States
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our decision to authorize the
importation into the continental United States of fresh shredded
lettuce from Egypt. Based on the findings of a pest risk analysis,
which we made available to the public for review and comment through a
previous notice, we have determined that the application of one or more
designated phytosanitary measures will be sufficient to mitigate the
risks of introducing or disseminating plant pests or noxious weeds via
the importation of fresh shredded lettuce from Egypt.
DATES: Effective Date: December 28, 2011.
FOR FURTHER INFORMATION CONTACT: Mr. Marc Phillips, Import Specialist,
RCC, RPM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737;
(301) 734-4394.
SUPPLEMENTARY INFORMATION:
Background
Under the regulations in ``Subpart-Fruits and Vegetables'' (7 CFR
319.56-1 through 319.56-54, referred to below as the regulations), the
Animal and Plant Health Inspection Service (APHIS) of the U.S.
Department of Agriculture prohibits or restricts the importation of
fruits and vegetables into the United States from certain parts of the
world to prevent plant pests from being introduced into and spread
within the United States.
Section 319.56-4 of the regulations contains a performance-based
process for approving the importation of commodities that, based on the
findings of a pest risk analysis (PRA), can be safely imported subject
to one or more of the designated phytosanitary
[[Page 81469]]
measures listed in paragraph (b) of that section. Under that process,
APHIS publishes a notice in the Federal Register announcing the
availability of the PRA that evaluates the risks associated with the
importation of a particular fruit or vegetable. Following the close of
the 60-day comment period, APHIS may begin issuing permits for
importation of the fruit or vegetable subject to the identified
designated measures if: (1) No comments were received on the PRA; (2)
the comments on the PRA revealed that no changes to the PRA were
necessary; or (3) changes to the PRA were made in response to public
comments, but the changes did not affect the overall conclusions of the
analysis and the Administrator's determination of risk.
In accordance with that process, we published a notice \1\ in the
Federal Register on August 17, 2011 (76 FR 50992-50993, Docket No.
APHIS-2011-0078), in which we announced the availability, for review
and comment, of a PRA that evaluated the risks associated with the
importation into the continental United States of fresh shredded
lettuce (Lactuca sativa L.) from Egypt. The PRA consisted of a risk
assessment identifying pests of quarantine significance that could
follow the pathway of importation of fresh shredded lettuce from Egypt
into the United States and a risk management document identifying
phytosanitary measures to be applied to that commodity to mitigate the
pest risk. We solicited comments on the notice for 60 days ending on
October 17, 2011. We received two comments by that date.
---------------------------------------------------------------------------
\1\ To view the notice, the PRA, and the comments we received,
go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0078.
---------------------------------------------------------------------------
One comment from a private citizen who opposed the importation of
shredded lettuce from Egypt into the United States did not address any
specific aspect of the PRA.
The other comment, submitted by an agricultural official
representing the State of Florida, questioned the efficacy of the post-
harvest phytosanitary measures we included in the PRA. The commenter
agreed with the PRA that lettuce from Egypt is potentially a host for
several species of destructive leaf miners but stated that the
phytosanitary measure of shredding lettuce does not remove the risk of
their introduction into the United States. The commenter requested that
shipments of shredded lettuce from Egypt not be permitted entry into
Florida until the shipping protocol has had time to demonstrate the
effectiveness of the mitigation measures listed in the PRA.
Only commercial consignments of shredded lettuce will be allowed to
be imported from Egypt. Commercial consignments, as defined in Sec.
319.56-2, are consignments that an inspector identifies as having been
imported for sale and distribution. Produce grown commercially is less
likely to be infested with plant pests than noncommercial consignments.
Noncommercial consignments are more prone to infestations because the
commodity is often ripe to overripe, could be of a variety with unknown
susceptibility to pests, and is often grown with little or no pest
control.
We identified in the PRA 12 pests of quarantine significance for
lettuce from Egypt that are highly unlikely to follow the pathway due
to the standard post-harvest processing practices applied to commercial
consignments of shredded lettuce from Egypt. Although these 11
arthropods and 1 mollusk affect lettuce leaves, we took into account
the standard commercial post-harvest procedures of: (1) Removing outer
leaves; (2) visual inspection and culling, with cutting; (3) shredding;
and (4) washing and centrifuging. We concluded that these procedures
sufficiently mitigate the risk of introducing leaf miners or other
plant pests through the importation of shredded lettuce from Egypt. The
commenter provided no evidence to indicate that these measures would
not effectively mitigate the pest risk.
Consignments of shredded lettuce from Egypt will also be required
to be accompanied by a phytosanitary certificate of inspection and pest
freedom issued by the national plant protection organization (NPPO) of
Egypt, with an additional declaration stating that the shredded lettuce
in the consignment had been inspected and found free from quarantine
pests. This condition provides additional assurances that the
commercial production process has removed quarantine pests from the
commodity.
For these reasons, APHIS has concluded that the mitigations
described will effectively mitigate the pest risk associated with
shredded lettuce imported from Egypt. Accordingly, we have determined
that no changes to the PRA are necessary based on the comment.
Therefore, in accordance with the regulations in Sec. 319.56-
4(c)(2)(ii), we are announcing our decision to authorize the
importation into the continental United States of fresh shredded
lettuce from Egypt subject to the following phytosanitary measures:
The shredded lettuce must be imported in commercial
consignments only.
Each consignment of shredded lettuce leaves must be
accompanied by a phytosanitary certificate issued by the national plant
protection organization of Egypt with an additional declaration stating
the following: ``Shredded lettuce leaves in this consignment were
inspected and found free from quarantine pests.''
These conditions will be listed in the Fruits and Vegetables Import
Requirements database (available at https://www.aphis.usda.gov/favir).
In addition to these specific measures, shredded lettuce from Egypt
will be subject to the general requirements listed in Sec. 319.56-3
that are applicable to the importation of all fruits and vegetables.
Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C.
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33207 Filed 12-27-11; 8:45 am]
BILLING CODE 3410-34-P
