Monsanto Company; Availability of Determination of Nonregulated Status for Corn Genetically Engineered To Express High Lysine Levels, 5801-5802 [E6-1481]
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5801
Notices
Federal Register
Vol. 71, No. 23
Friday, February 3, 2006
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–112–2]
Monsanto Company; Availability of
Determination of Nonregulated Status
for Corn Genetically Engineered To
Express High Lysine Levels
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
hsrobinson on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: We are advising the public of
our determination that the Monsanto
Company corn designated as
transformation event LY038, which has
been genetically engineered to express a
lysine-insensitive dihydrodipicolinate
synthase (cDHDPS) enzyme to allow for
the accumulation of higher levels of
lysine in the germ of the seed, is no
longer considered a regulated article
under our regulations governing the
introduction of certain genetically
engineered organisms. Our
determination is based on our
evaluation of data submitted by the
Monsanto Company in their petition for
a determination of nonregulated status,
our analysis of other scientific data, and
comments received from the public in
response to a previous notice
announcing the availability of the
petition for nonregulated status and an
environmental assessment. This notice
also announces the availability of our
written determination and our finding
of no significant impact.
DATES: Effective Date: January 23, 2006.
ADDRESSES: You may read the petition,
the environmental assessment, the
determination, the finding of no
significant impact, and the comments
that we received on Docket No. 04–112–
1 in our reading room. The reading
room is located in room 1141 of the
USDA South Building, 14th Street and
Independence Avenue SW.,
VerDate Aug<31>2005
15:00 Feb 02, 2006
Jkt 208001
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.
You may also view the comments we
received on Docket No. 04–112–1 on the
Internet. Go to https://
www.regulations.gov, click on the
‘‘Advanced Search’’ tab and select
‘‘Docket Search.’’ In the Docket ID field,
enter APHIS–2005–0075 then click on
‘‘Submit.’’
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 determination, the petition, the
environmental assessment (EA), or the
finding of no significant impact
(FONSI), contact Ms. Ingrid Berlanger at
(301) 734–4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The
petition and the EA, including the
FONSI and determination, are also
available on the Internet at: https://
www.aphis.usda.gov/brs/aphisdocs/
04_22901p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
04_22901p_p.ea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs2/
04_22901p_com.pdf.
SUPPLEMENTARY INFORMATION:
Background
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 § 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
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
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.
In a notice published in the Federal
Register on September 27, 2005 (70 FR
56411-56443, Docket No. 04–112–1),
APHIS announced the availability of the
Monsanto petition and an
environmental assessment (EA). APHIS
solicited comments on whether the
subject corn would present a plant pest
risk and on the EA. APHIS received 14
comments by the close of the 60-day
comment period, which ended on
November 28, 2005. Seven of the
comments supported a determination of
nonregulated status for LY038 corn and
seven were opposed. None of the
comments addressed specific plant pest
issues. APHIS’ response to these
comments can be found in an
attachment to the finding of no
significant impact (FONSI).
Determination
Based on APHIS’ analysis of field,
greenhouse, and laboratory data
submitted by Monsanto, references
E:\FR\FM\03FEN1.SGM
03FEN1
5802
Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 / Notices
hsrobinson on PROD1PC70 with NOTICES
provided in the petition, other relevant
information as described in the EA, and
comments provided by the public,
APHIS has determined that LY038 will
not pose a plant pest risk for the
following reasons: (1) It exhibits no
plant pathogenic properties (although it
was originally engineered with
regulatory sequences derived from plant
pathogens, these plants are neither
infected nor can incite disease); (2) it
exhibits no characteristics that would
cause it to be more weedy than the nontransgenic parent corn line or other
cultivated corn; (3) gene introgression
from LY038 into wild relatives in the
United States and its territories is
extremely unlikely and is not likely to
increase the weediness potential of any
resulting progeny nor adversely affect
genetic diversity of related plants any
more than would introgression from
traditional corn hybrids; (4) disease and
insect susceptibility is similar to nontransgenic corn; (5) it exhibits no
potential to have a significant adverse
impact on organisms beneficial to
agriculture; (6) compared to current
agricultural practices, cultivation of line
LY038 and its progeny should not
reduce the ability to control insects or
weeds in corn or other crops. In
addition to our finding of no plant pest
risk, there will be no effect on
threatened or endangered species
resulting from a determination on
nonregulated status for LY038 and its
progeny.
Therefore, APHIS has concluded that
the subject corn and any progeny
derived from hybrid crosses with other
non-transformed corn varieties will be
no more of a plant pest than corn
varieties in traditional breeding
programs that are not subject to
regulation under 7 CFR part 340. The
effect of this determination is that
Monsanto LY038 corn is no longer
considered a regulated article under
APHIS’ regulations in 7 CFR part 340.
The requirements pertaining to
regulated articles under those
regulations no longer apply to the
subject corn or its progeny. However,
importation of LY038 corn and seeds
capable of propagation are still subject
to the restrictions found in APHIS’
foreign quarantine notices in 7 CFR part
319 and imported seed regulations in 7
CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any
potential environmental impacts and
plant pest risk associated with the
determination of nonregulated status for
the Monsanto LY038 corn. The EA was
prepared in accordance with: (1) The
National Environmental Policy Act of
VerDate Aug<31>2005
15:00 Feb 02, 2006
Jkt 208001
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).
Based on that EA, APHIS has reached
a FONSI with regard to the
determination that Monsanto LY038
corn and lines developed from it are no
longer regulated articles under its
regulations in 7 CFR part 340. Copies of
the EA and FONSI are available from
the individual listed under FOR FURTHER
INFORMATION CONTACT.
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
Done in Washington, DC, this 30th day of
January 2006.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E6–1481 Filed 2–2–06; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Lake Tahoe Basin Federal Advisory
Committee
Office of the Secretary, USDA.
Notice of intent to renew the
Lake Tahoe Basin Federal Advisory
Committee charter and request for
nominations.
AGENCY:
ACTION:
SUMMARY: The Secretary of Agriculture
is considering the renewal of the charter
of the Lake Tahoe Basin Federal
Advisory Committee, chartered under
the Federal Advisory Committee Act, to
provide advice to the Secretary of
Agriculture on implementing the terms
of the Federal Interagency Partnership
on the Lake Tahoe Region. Nominations
of persons to serve on the LTFAC are
invited.
Nominations for membership on
the Committee must be received in
writing by March 24, 2006.
ADDRESSES: Send nominations and
applications (Form AD–755) with
telephone numbers and e-mail
addresses for membership on the
Committee to: FACA Nomination, Lake
Tahoe Basin Management Unit, 35
College Drive, South Lake Tahoe,
California 96150.
FOR FURTHER INFORMATION CONTACT:
Terri Marceron, Forest Supervisor, or
Mark Struble, Acting Legislative &
DATES:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
Public Affairs Officer, Lake Tahoe Basin
Management Unit, telephone (530) 543–
2758.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
(5 U.S.C. App.), notice is hereby given
that the Secretary of Agriculture is
considering the renewal of the charter of
the Lake Tahoe Basin Federal Advisory
Committee. The purpose of the
Committee is to provide advice to the
Secretary of Agriculture and to the
Federal Interagency Partnership
(Partnership) on how the Partnership
can best fulfill its duties pursuant to
Executive Order 13057, issued July 26,
1997; how to facilitate the integration
and coordination of appropriate Federal
programs and funds to help achieve the
goals of the Lake Tahoe Regional
Environmental Improvement Program;
and other matters raised by the
Secretary.
The Secretary of Agriculture
established the Lake Tahoe Basin
Federal Advisory Committee
(Committee) on July 13, 1998; renewed
the Committee’s charter on June 19,
2000; amended the charter on April 17,
2001, to provide advice to the
Partnership; and renewed the charter on
June 13, 2002 and June 3, 2004. The
current charter for the Lake Tahoe Basin
Federal Advisory Committee will expire
June 7, 2006, and is currently being
considered for renewal by the Secretary
of Agriculture.
The Secretary has previously
determined that the work of the
Committee is in the public interest and
relevant to the duties of the Department
of Agriculture.
Representatives will be selected from
the following sectors: (1) Gaming, (2)
environmental, (3) national
environmental, (4) ski resorts, (5) North
Shore economic/recreation, (6) South
Shore economic/recreation, (7) resort
associations, (8) education, (9) property
rights advocates, (10) member-at-large,
(11) member-at-large, (12) science and
research, (13) California local
government, (14) Washoe Tribe, (15)
State of California, (16) State of Nevada,
(17) Tahoe Regional Planning Agency,
(18) labor, (19) transportation and (20)
Nevada local government.
Nominations to the Committee should
describe and document the proposed
member’s qualifications for membership
on the Lake Tahoe Basin Federal
Advisory Committee. The Committee
Chair will be approved by the
Designated Federal Official. Vacancies
on the Committee will be filled in the
manner in which the original
appointment was made.
Members of the Committee serve
without pay, but may be reimbursed for
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 71, Number 23 (Friday, February 3, 2006)]
[Notices]
[Pages 5801-5802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1481]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 /
Notices
[[Page 5801]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-112-2]
Monsanto Company; Availability of 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 of our determination that the
Monsanto Company corn designated as transformation event LY038, which
has been genetically engineered to express a lysine-insensitive
dihydrodipicolinate synthase (cDHDPS) enzyme to allow for the
accumulation of higher levels of lysine in the germ of the seed, is no
longer considered a regulated article under our regulations governing
the introduction of certain genetically engineered organisms. Our
determination is based on our evaluation of data submitted by the
Monsanto Company in their petition for a determination of nonregulated
status, our analysis of other scientific data, and comments received
from the public in response to a previous notice announcing the
availability of the petition for nonregulated status and an
environmental assessment. This notice also announces the availability
of our written determination and our finding of no significant impact.
DATES: Effective Date: January 23, 2006.
ADDRESSES: You may read the petition, the environmental assessment, the
determination, the finding of no significant impact, and the comments
that we received on Docket No. 04-112-1 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.
You may also view the comments we received on Docket No. 04-112-1
on the Internet. Go to https://www.regulations.gov, click on the
``Advanced Search'' tab and select ``Docket Search.'' In the Docket ID
field, enter APHIS-2005-0075 then click on ``Submit.''
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 determination, the
petition, the environmental assessment (EA), or the finding of no
significant impact (FONSI), contact Ms. Ingrid Berlanger at (301) 734-
4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. The petition and the
EA, including the FONSI and determination, are also available on the
Internet at: https://www.aphis.usda.gov/brs/aphisdocs/04_22901p.pdf,
https://www.aphis.usda.gov/brs/aphisdocs/04_22901p_p.ea.pdf, and
https://www.aphis.usda.gov/brs/aphisdocs2/04_22901p_com.pdf.
SUPPLEMENTARY INFORMATION:
Background
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.
In a notice published in the Federal Register on September 27, 2005
(70 FR 56411-56443, Docket No. 04-112-1), APHIS announced the
availability of the Monsanto petition and an environmental assessment
(EA). APHIS solicited comments on whether the subject corn would
present a plant pest risk and on the EA. APHIS received 14 comments by
the close of the 60-day comment period, which ended on November 28,
2005. Seven of the comments supported a determination of nonregulated
status for LY038 corn and seven were opposed. None of the comments
addressed specific plant pest issues. APHIS' response to these comments
can be found in an attachment to the finding of no significant impact
(FONSI).
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Monsanto, references
[[Page 5802]]
provided in the petition, other relevant information as described in
the EA, and comments provided by the public, APHIS has determined that
LY038 will not pose a plant pest risk for the following reasons: (1) It
exhibits no plant pathogenic properties (although it was originally
engineered with regulatory sequences derived from plant pathogens,
these plants are neither infected nor can incite disease); (2) it
exhibits no characteristics that would cause it to be more weedy than
the non-transgenic parent corn line or other cultivated corn; (3) gene
introgression from LY038 into wild relatives in the United States and
its territories is extremely unlikely and is not likely to increase the
weediness potential of any resulting progeny nor adversely affect
genetic diversity of related plants any more than would introgression
from traditional corn hybrids; (4) disease and insect susceptibility is
similar to non-transgenic corn; (5) it exhibits no potential to have a
significant adverse impact on organisms beneficial to agriculture; (6)
compared to current agricultural practices, cultivation of line LY038
and its progeny should not reduce the ability to control insects or
weeds in corn or other crops. In addition to our finding of no plant
pest risk, there will be no effect on threatened or endangered species
resulting from a determination on nonregulated status for LY038 and its
progeny.
Therefore, APHIS has concluded that the subject corn and any
progeny derived from hybrid crosses with other non-transformed corn
varieties will be no more of a plant pest than corn varieties in
traditional breeding programs that are not subject to regulation under
7 CFR part 340. The effect of this determination is that Monsanto LY038
corn is no longer considered a regulated article under APHIS'
regulations in 7 CFR part 340. The requirements pertaining to regulated
articles under those regulations no longer apply to the subject corn or
its progeny. However, importation of LY038 corn and seeds capable of
propagation are still subject to the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
and plant pest risk associated with the determination of nonregulated
status for the Monsanto LY038 corn. 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).
Based on that EA, APHIS has reached a FONSI with regard to the
determination that Monsanto LY038 corn and lines developed from it are
no longer regulated articles under its regulations in 7 CFR part 340.
Copies of the EA and FONSI are available from the individual listed
under FOR FURTHER INFORMATION CONTACT.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 30th day of January 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-1481 Filed 2-2-06; 8:45 am]
BILLING CODE 3410-34-P
