Monsanto Company; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Express High Lysine Levels, 56441-56443 [E5-5178]
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Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices
displays a currently valid OMB control
number.
Rural Business Service
Title: 7 CFR 4279–B, Guaranteed Loan
Making—Business and Industry Loans.
OMB Control Number: 0570–0017.
Summary of Collection: The Business
and Industry (B&I) program was
legislated in 1972 under Section 310B of
the Consolidated Farm and Rural
Development Act, as amended. The
purpose of the program is to improve,
develop, or finance businesses,
industries, and employment and
improve the economic and
environmental climate in rural
communities. This purpose is achieved
through bolstering the existing private
credit structure through the
guaranteeing of quality loans made by
lending institutions, thereby providing
lasting community benefits. The B&I
program is administered by the Rural
Business Service (RBS) through Rural
Development State and sub-State offices
serving each State.
Need and Use of the Information: RBS
will collect information to determine a
lender and borrower eligibility and
creditworthiness. The information is
used by RBS loan officers and approval
officials to determine program eligibility
and for program monitoring.
Description of Respondents: Business
or other for-profit; State, Local or Tribal
Government.
Number of Respondents: 8,544.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 19,761.
Charlene Parker,
Departmental Information Collection
Clearance Officer.
[FR Doc. 05–19219 Filed 9–26–05; 8:45 am]
BILLING CODE 3410–XT–P
DEPARTMENT OF AGRICULTURE
Agricultural Research Service
National Agricultural Library; Notice of
Intent To Seek Approval To Collect
Information
National Agricultural Library,
Agricultural Research Service, USDA.
ACTION: Notice and request for
comments.
AGENCY:
SUMMARY: In accordance with the
Paperwork Reduction Act of 1995 and
Office of Management and Budget
(OMB) regulations, this notice
announces the National Agricultural
Library’s intent to request an extension
of currently approved information
collection form related to the Animal
VerDate Aug<31>2005
14:52 Sep 26, 2005
Jkt 205001
Welfare Information Center’s (AWIC)
workshop, Meeting the Information
Requirements of the Animal Welfare
Act. This workshop registration form
requests the following information from
participants: contact information,
affiliation, and database searching
experience. Participants include
principal investigators, members of
Institutional Animal Care and Use
committees, animal care technicians,
facility managers, veterinarians, and
administrators of animal use programs.
DATES: Comments on this notice must be
received by December 1, 2005 to be
assured of consideration.
ADDRESSES: Address all comments
concerning this notice to Sandra Ball,
Program Support Assistant, USDA, ARS,
NAL Animal Welfare Information
Center, 10301 Baltimore Avenue, Room
#410, Beltsville, MD 20705–2351.
Submit electronic comments to:
sball@nal.usda.gov.
FOR FURTHER INFORMATION CONTACT:
Sandra Ball, Program Support Assistant.
Phone: 301–504–6212 or Fax: 301 504
7125.
SUPPLEMENTARY INFORMATION:
Title: Workshop Registration, Meeting
the Information Requirements of the
Animal Welfare Act.
OMB Number: 0518–033.
Expiration Date: 02/28/2006.
Type of Request: To extend currently
approved data collection form.
Abstract: This Web-based form
collects information to register
respondents in the workshop, Meeting
the Information Requirements of the
Animal Welfare Act. Information
collected includes the following:
preference of workshop date, signature,
name, title, organization name, mailing
address, phone and fax numbers, and
email address. Five questions are asked
regarding: database searching
experience, membership on an
Institutional Animal Care and Use
Committee, and goals for attending the
workshop.
Estimate of Burden: Public reporting
burden for this collection of information
is estimated to average 5 minutes per
response.
Respondents: Principal investigators,
members of Institutional Animal Care
and Use Committees, animal care
personnel, veterinarians, information
providers, and administrators of animal
use programs.
Estimated number of Respondents:
100 per year.
Estimated Total Annual Burden on
Respondents: 8.33 hours.
Comments are invited on (a) whether
the proposed collection of information
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56441
is necessary for the proper performance
of the functions of the agency, including
whether the information will have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and the assumptions used;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on those who respond, including the
use of appropriate automated,
electronic, mechanical, or other
technology. Comments should be sent to
the address in the preamble. All
responses to this notice will be
summarized and included in the request
for Office of Management and Budget
(OMB) approval. All comments will
become a matter of public record.
Dated: September 8, 2005.
Edward B. Knipling,
Administrator, ARS.
[FR Doc. 05–19197 Filed 9–26–05; 8:45 am]
BILLING CODE 3410–03–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–112–1]
Monsanto Company; Availability of
Petition and Environmental
Assessment for Determination of
Nonregulated Status for Corn
Genetically Engineered To Express
High Lysine Levels
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Monsanto Company,
seeking a determination of nonregulated
status for corn designated as
transformation event LY038, which has
been genetically engineered to express a
lysine-insensitive dihydrodipicolinate
synthase (cDHDPS) enzyme, which
allows for the accumulation of higher
levels of lysine in the germ of the seed.
Corn-soybean meal based diets
formulated for poultry and swine are
characteristically deficient in lysine and
require the addition of supplemental
lysine for optimal animal growth and
production. This corn product may
provide an alternative to
supplementation of feed with lysine.
The petition has been submitted in
accordance with our regulations
E:\FR\FM\27SEN1.SGM
27SEN1
56442
Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices
concerning the introduction of certain
genetically engineered organisms and
products. In accordance with those
regulations, we are soliciting public
comments on whether this corn presents
a plant pest risk. We are also making
available for public comment an
environmental assessment for the
proposed determination of nonregulated
status.
DATES: We will consider all comments
we receive on or before November 28,
2005.
You may submit comments
by either of the following methods:
• EDOCKET: Go to https://
www.epa.gov/feddocket to submit or
view public comments. Once you have
entered EDOCKET, click on the ‘‘View
Open APHIS Dockets’’ link to locate this
document.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. 04–112–1, Regulatory
Analysis and Development, PPD,
APHIS, Station 3C71, 4700 River Road
Unit 118, Riverdale, MD 20737–1238.
Please state that your comment refers to
Docket No. 04–112–1.
Reading Room: You may read the
petition, the environmental assessment,
and any comments that we receive on
this docket in our reading room. The
reading room is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
ADDRESSES:
Dr.
Levis Handley, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 734–5721. To obtain copies
of the petition or the environmental
assessment (EA), contact Ms. Ingrid
Berlanger at (301) 734–4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The
petition and the EA are also available on
the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/
04_22901p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
04_22901p.ea.pdf.
FOR FURTHER INFORMATION CONTACT:
The
regulations in 7 CFR part 340,
‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:52 Sep 26, 2005
Jkt 205001
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered organisms and
products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Paragraphs (b) and (c) of § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
On August 16, 2004, APHIS received
a petition (APHIS Petition Number 04–
229–01p) from Monsanto Company
(Monsanto) of St. Louis, MO, on behalf
of Renessen LLC of Deerfield, IL,
requesting a determination of
nonregulated status under 7 CFR part
340 for corn (Zea mays L.) designated as
transformation event LY038 which has
been genetically engineered to produce
higher levels of lysine in the seed than
is typically found in corn. The
Monsanto petition states that the subject
corn should not be regulated by APHIS
because it does not present a plant pest
risk.
As described in the petition, the
LY038 corn has been genetically
modified to express the cordapA gene
from Cornybacterium glutamicum. This
gene encodes for lysine-insensitive
dihydrodipicolinate synthase (cDHDPS)
enzyme. The expression of cordapA is
under the control of the maize Glb1
promoter, which directs cDHDPS
expression predominately in the germ of
the seed, resulting in accumulation of
lysine in the grain. Corn-soybean meal
based diets formulated for poultry and
swine are characteristically deficient in
lysine and require the addition of
supplemental lysine for optimal animal
growth and production. Development of
LY038 corn may provide an alternative
to direct addition of supplemental
lysine to poultry and swine diets.
Event LY038 has been considered a
regulated article under the regulations
in 7 CFR part 340 because it was
originally engineered with regulatory
sequences derived from plant
pathogens. This corn event has been
field tested since 2000 in the United
States under APHIS notifications. In the
process of reviewing the notifications
for field trials of the subject corn, APHIS
determined that the vectors and other
elements were disarmed and that the
trials, which were conducted under
conditions of reproductive and physical
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
confinement or isolation, would not
present a risk of plant pest introduction
or dissemination.
In section 403 of the Plant Protection
Act (7 U.S.C. 7702), plant pest is
defined as any living stage of any of the
following that can directly or indirectly
injure, cause damage to, or cause
disease in any plant or plant product: A
protozoan, a nonhuman animal, a
parasitic plant, a bacterium, a fungus, a
virus or viroid, an infectious agent or
other pathogen, or any article similar to
or allied with any of the foregoing.
APHIS views this definition very
broadly. The definition covers direct or
indirect injury, disease, or damage not
just to agricultural crops, but also to
plants in general, for example, native
species, as well as to organisms that
may be beneficial to plants, for example,
honeybees, rhizobia, etc.
The Food and Drug Administration
(FDA) published a statement of policy
on foods derived from new plant
varieties in the Federal Register on May
29, 1992 (57 FR 22984–23005). The FDA
statement of policy includes a
discussion of FDA’s authority for
ensuring food safety under the Federal
Food, Drug, and Cosmetic Act and
provides guidance to industry on the
scientific considerations associated with
the development of foods derived from
new plant varieties, including those
plants developed through the
techniques of genetic engineering.
Monsanto is consulting with FDA on the
subject corn event.
To provide the public with
documentation of APHIS’ review and
analysis of the environmental impacts
and plant pest risk associated with a
proposed determination of nonregulated
status for Monsanto’s event LY038 corn,
an environmental assessment (EA) has
been prepared. The EA 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).
In accordance with § 340.6(d) of the
regulations, we are publishing this
notice to inform the public that APHIS
will accept written comments regarding
the petition for a determination of
nonregulated status from interested
persons for a period of 60 days from the
date of this notice. We are also soliciting
written comments from interested
persons on the environmental
assessment prepared to examine any
E:\FR\FM\27SEN1.SGM
27SEN1
Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Notices
environmental impacts of the proposed
determination for the subject corn event.
The petition and the environmental
assessment and any comments received
are available for public review, and
copies of the petitions and the
environmental assessment are available
as indicated in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
After the comment period closes,
APHIS will review the data submitted
by the petitioner, all written comments
received during the comment period,
and any other relevant information.
After reviewing and evaluating the
comments on the petition and the
environmental assessment and other
data and information, APHIS will
furnish a response to the petitioner,
either approving the petition in whole
or in part, or denying the petition.
APHIS will then publish a notice in the
Federal Register announcing the
regulatory status of Monsanto’s high
lysine corn event LY038 and the
availability of APHIS’ written decision.
Authority: 7 U.S.C. 1622n and 7701–7772;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 21st day of
September 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–5178 Filed 9–26–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Mendocino Resource Advisory
Committee
Forest Service, USDA.
Notice of meeting.
AGENCY:
ACTION:
SUMMARY: The Mendocino County
Resource Advisory Committee will meet
October 21, 2005, (RAC) in Willits,
California. Agenda items to be covered
included: (1) Approval of minutes, (2)
Public Comment, (3) Sub-committees (4)
Discussion—items of interest (5) Next
agenda and meeting date.
DATES: The meeting will be held on
October 21, 2005, from 9 a.m. until 12
noon.
ADDRESSES: The meeting will be held at
the Mendocino County Museum,
located at 400 E. Commercial St. Willits,
California.
FOR FURTHER INFORMATION CONTACT:
Roberta Hurt, Committee Coordinator,
USDA, Mendocino National Forest,
Covelo Ranger District, 78150 Covelo
Road, Covelo CA 95428. (707) 983–
8503; e-mail rhurt@fs.fed.us.
VerDate Aug<31>2005
14:52 Sep 26, 2005
Jkt 205001
The
meeting is open to the public. Persons
who wish to bring matters to the
attention of the Committee may file
written statements with the Committee
staff by October 13, 2005. Public
comment will have the opportunity to
address the committee at the meeting.
SUPPLEMENTARY INFORMATION:
Dated: September 21, 2005.
Blaine Baker,
Designated Federal Official.
[FR Doc. 05–19240 Filed 9–26–05; 8:45 am]
BILLING CODE 3410–11–M
DEPARTMENT OF COMMERCE
International Trade Administration
[A–580–601, A–583–603]
Top–of-the–Stove Stainless Steel
Cooking Ware from the Republic of
Korea and Taiwan; Final Results of the
Expedited Sunset Reviews of the
Antidumping Duty Orders
Import Administration,
International Trade Administration,
Department of Commerce.
SUMMARY: On March 1, 2005, the
Department of Commerce (‘‘the
Department’’) initiated sunset reviews of
the antidumping duty orders on top–ofthe–stove stainless steel cooking ware
(‘‘cooking ware’’) from the Republic of
Korea (‘‘Korea’’) and Taiwan pursuant to
section 751(c) of the Tariff Act of 1930,
as amended (‘‘the Act’’). The
Department conducted expedited (120–
day) sunset reviews of these orders. As
a result of these sunset reviews, the
Department finds that revocation of the
antidumping duty orders would be
likely to lead to continuation or
recurrence of dumping. The dumping
margins are identified in the Final
Results of Reviews section of this notice.
EFFECTIVE DATE: September 27, 2005.
FOR FURTHER INFORMATION CONTACT: Zev
Primor, AD/CVD Operations, Office IV,
Import Administration, International
Trade Administration, U.S. Department
of Commerce, 14th Street & Constitution
Avenue, NW, Washington, DC 20230;
telephone: (202) 482–4114.
SUPPLEMENTARY INFORMATION:
AGENCY:
Background
On March 1, 2005, the Department
published the notice of initiation of the
second sunset reviews of the
antidumping duty orders on cooking
ware from Korea and Taiwan pursuant
to section 751(c) of the Act. See
Initiation of Five–Year (‘‘Sunset’’)
Reviews, 70 FR 9919 (March 1, 2005).
The Department received the Notice of
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56443
Intent to Participate from Regal Ware,
Inc.; Vita Craft Corporation; and Paper
Allied Industrial Chemical & Energy
Workers (Local 7–0850) (collectively
‘‘the domestic interested parties’’),
within the deadline specified in 19 CFR
351.218(d)(1)(i) (‘‘Sunset Regulations’’).
The domestic interested parties claimed
interested party status under sections
771(9)(C) and (D) of the Act, as
manufacturers of a domestic–like
product in the United States, and
unions whose workers are engaged in
the production of a domestic–like
product in the United States.
We received complete substantive
responses from the domestic interested
parties within the 30–day deadline
specified in 19 CFR 351.218(d)(3)(i). We
received no responses from respondent
interested parties with respect to any of
the orders covered by these sunset
reviews. As a result, pursuant to section
751(c)(4)(A) of the Act and 19 CFR
351.218(e)(1)(ii)(C)(2), the Department
conducted expedited (120–day) sunset
reviews of these orders for Korea and
Taiwan.
Scope of the Orders
The merchandise subject to these
antidumping orders is cooking ware
from Korea and Taiwan. The subject
merchandise is all non–electric cooking
ware of stainless steel which may have
one or more layers of aluminum, copper
or carbon steel for more even heat
distribution. The subject merchandise
includes skillets, frying pans, omelette
pans, saucepans, double boilers, stock
pots, dutch ovens, casseroles, steamers,
and other stainless steel vessels, all for
cooking on stove top burners, except tea
kettles and fish poachers. Excluded
from the scope of the orders are
stainless steel oven ware and stainless
steel kitchen ware. The subject
merchandise is currently classifiable
under Harmonized Tariff Schedule of
the United States (‘‘HTSUS’’) item
numbers 7323.93.00 and 9604.00.00.
The HTSUS item numbers are provided
for convenience and Customs purposes
only. The written description remains
dispositive.
The Department has issued several
scope clarifications for these orders. The
Department found that ‘‘universal pan
lids’’ are not within the scope of the
orders (57 FR 57420 (December 4, 1992))
and Max Burton’s StoveTop Smoker is
within the scope of the orders (60 FR
36782 (July 18, 1995)). Certain stainless
steel pasta and steamer inserts (63 FR
41545 (August 4, 1998)), certain
stainless steel eight–cup coffee
percolators (58 FR 11209, February 24,
1993), and certain stainless steel stock
pots and covers are within the scope of
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Notices]
[Pages 56441-56443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-5178]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-112-1]
Monsanto Company; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Corn
Genetically Engineered To Express High Lysine Levels
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Monsanto Company,
seeking a determination of nonregulated status for corn designated as
transformation event LY038, which has been genetically engineered to
express a lysine-insensitive dihydrodipicolinate synthase (cDHDPS)
enzyme, which allows for the accumulation of higher levels of lysine in
the germ of the seed. Corn-soybean meal based diets formulated for
poultry and swine are characteristically deficient in lysine and
require the addition of supplemental lysine for optimal animal growth
and production. This corn product may provide an alternative to
supplementation of feed with lysine. The petition has been submitted in
accordance with our regulations
[[Page 56442]]
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
public comments on whether this corn presents a plant pest risk. We are
also making available for public comment an environmental assessment
for the proposed determination of nonregulated status.
DATES: We will consider all comments we receive on or before November
28, 2005.
ADDRESSES: You may submit comments by either of the following methods:
EDOCKET: Go to https://www.epa.gov/feddocket to submit or
view public comments. Once you have entered EDOCKET, click on the
``View Open APHIS Dockets'' link to locate this document.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-112-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-112-1.
Reading Room: You may read the petition, the environmental
assessment, and any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Levis Handley, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5721. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301)
734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. The petition and
the EA are also available on the Internet at https://www.aphis.usda.gov/
brs/aphisdocs/04_22901p.pdf and https://www.aphis.usda.gov/brs/
aphisdocs/04_22901p.ea.pdf.
SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
``Introduction of Organisms and Products Altered or Produced Through
Genetic Engineering Which Are Plant Pests or Which There Is Reason to
Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
On August 16, 2004, APHIS received a petition (APHIS Petition
Number 04-229-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
on behalf of Renessen LLC of Deerfield, IL, requesting a determination
of nonregulated status under 7 CFR part 340 for corn (Zea mays L.)
designated as transformation event LY038 which has been genetically
engineered to produce higher levels of lysine in the seed than is
typically found in corn. The Monsanto petition states that the subject
corn should not be regulated by APHIS because it does not present a
plant pest risk.
As described in the petition, the LY038 corn has been genetically
modified to express the cordapA gene from Cornybacterium glutamicum.
This gene encodes for lysine-insensitive dihydrodipicolinate synthase
(cDHDPS) enzyme. The expression of cordapA is under the control of the
maize Glb1 promoter, which directs cDHDPS expression predominately in
the germ of the seed, resulting in accumulation of lysine in the grain.
Corn-soybean meal based diets formulated for poultry and swine are
characteristically deficient in lysine and require the addition of
supplemental lysine for optimal animal growth and production.
Development of LY038 corn may provide an alternative to direct addition
of supplemental lysine to poultry and swine diets.
Event LY038 has been considered a regulated article under the
regulations in 7 CFR part 340 because it was originally engineered with
regulatory sequences derived from plant pathogens. This corn event has
been field tested since 2000 in the United States under APHIS
notifications. In the process of reviewing the notifications for field
trials of the subject corn, APHIS determined that the vectors and other
elements were disarmed and that the trials, which were conducted under
conditions of reproductive and physical confinement or isolation, would
not present a risk of plant pest introduction or dissemination.
In section 403 of the Plant Protection Act (7 U.S.C. 7702), plant
pest is defined as any living stage of any of the following that can
directly or indirectly injure, cause damage to, or cause disease in any
plant or plant product: A protozoan, a nonhuman animal, a parasitic
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or
other pathogen, or any article similar to or allied with any of the
foregoing. APHIS views this definition very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
The Food and Drug Administration (FDA) published a statement of
policy on foods derived from new plant varieties in the Federal
Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of
policy includes a discussion of FDA's authority for ensuring food
safety under the Federal Food, Drug, and Cosmetic Act and provides
guidance to industry on the scientific considerations associated with
the development of foods derived from new plant varieties, including
those plants developed through the techniques of genetic engineering.
Monsanto is consulting with FDA on the subject corn event.
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for Monsanto's
event LY038 corn, an environmental assessment (EA) has been prepared.
The EA 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).
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the environmental assessment prepared to
examine any
[[Page 56443]]
environmental impacts of the proposed determination for the subject
corn event. The petition and the environmental assessment and any
comments received are available for public review, and copies of the
petitions and the environmental assessment are available as indicated
in the FOR FURTHER INFORMATION CONTACT section of this notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and the environmental
assessment and other data and information, APHIS will furnish a
response to the petitioner, either approving the petition in whole or
in part, or denying the petition. APHIS will then publish a notice in
the Federal Register announcing the regulatory status of Monsanto's
high lysine corn event LY038 and the availability of APHIS' written
decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 21st day of September 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-5178 Filed 9-26-05; 8:45 am]
BILLING CODE 3410-34-P
