Pioneer Hi-Bred International, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce Male Sterile/Female Inbred Plants, 83-84 [2010-33083]
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Federal Register / Vol. 76, No. 1 / Monday, January 3, 2011 / Notices
Recommendation aimed at reducing
‘‘ossification’’ of the regulatory process.20 The
Conference recognizes, however, that certain
principles, including those embodied in the
preemption provisions of Executive Order
13132, are sufficiently important to warrant
systematic consideration by agencies
engaging in rulemaking. The following
Recommendation has accordingly been
structured both to encourage compliance
with existing executive directives and
increase the efficiency of internal agency
processes designed to ensure such
compliance.
Recommendation
1. The Conference reiterates its previous,
related recommendation that ‘‘Congress
should address foreseeable preemption issues
clearly and explicitly when it enacts a statute
affecting regulation or deregulation of an area
of conduct.’’ 21
jlentini on DSKJ8SOYB1PROD with NOTICES
Internal Procedures for Compliance With the
Preemption Provisions of Executive Order
13132
2. Agencies that engage in rulemaking
proceedings that may have preemptive effect
on State law should have internal written
guidance to ensure compliance with the
preemption provisions of Executive Order
13132, which should describe:
a. How the agency determines the need for
any preemption;
b. How the agency consults with State and
local officials concerning preemption; and
c. How the agency otherwise ensures
compliance with the preemption provisions
of Executive Order 13132.
3. Agencies should post their internal
guidance for compliance with the
preemption provisions of Executive Order
13132 on the Internet or otherwise make
publicly available the information contained
therein.
4. Agencies should have an oversight
procedure to improve agency procedures for
implementing the preemption provisions of
Executive Order 13132. This procedure
should include an internal process for
evaluating the authority and basis asserted in
support of a preemptive rulemaking. The
agency should provide a reasoned basis, with
such evidence as may be appropriate, that
supports its preemption conclusion.
Updated Policies To Ensure Timely
Consultation With State and Local Interests
Concerning Preemption
5. Agencies should have a consultation
process that contains elements such as the
following:
a. Agencies should use an updated contact
list for representatives of State interests,
including but not limited to the ‘‘Big Seven.’’
The Administrative Conference will maintain
such a list for use by agencies.
b. Agencies should maintain some form of
regularized personal contact in order to build
relationships with representatives of State
interests.
20 Administrative Conference of the United
States, Recommendation No. 93–4, Improving the
Environment for Agency Rulemaking (1993).
21 Administrative Conference of the United
States, Recommendation No. 84–5, Preemption of
State Regulation by Federal Agencies (1984).
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15:48 Dec 30, 2010
Jkt 223001
c. Agencies should disclose to the public
when they meet with the representatives of
State interests in the course of rulemaking
proceedings that may preempt State law. The
disclosure should include the identity of the
organization(s) or institution(s) that
participate and the subject matter of the
discussion.
d. Agencies should reach out to
appropriate State and local officials early in
the process when they are considering
preemptive rules. Such outreach should, to
the extent practicable, precede issuance of
the notice of proposed rulemaking.
6. Agencies should establish contact with
organizations and State and local regulatory
bodies and officials that have relevant
substantive expertise or jurisdiction.
7. Agencies should adopt, as one
component of their notice practice, a
procedure for notifying State attorneys
general when they are considering rules that
may have preemptive effect. This may be
achieved via direct communication with
State attorneys general and by contacting an
appropriate representative organization such
as, for example, the National Association of
Attorneys General.
Actions by OIRA/OMB To Improve the
Process
8. OIRA/OMB should request agencies to
post on their open government Web sites a
summary of the agencies’ responses to the
directive contained in the Preemption
Memorandum to conduct a 10-year
retrospective review of preemptive
rulemaking.
9. OIRA/OMB should update its
Federalism Guidelines with respect to
preemption.
10. OIRA should include reference to
Executive Order 13132 in Circular A–4.22
[FR Doc. 2010–32985 Filed 12–30–10; 8:45 am]
BILLING CODE 6110–01–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2010–0041]
Pioneer Hi-Bred International, Inc.;
Availability of Petition and
Environmental Assessment for
Determination of Nonregulated Status
for Corn Genetically Engineered To
Produce Male Sterile/Female Inbred
Plants
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
SUMMARY: We are advising the public
that the Animal and Plant Health
22 Office of Info. & Regulatory Affairs, Circular A–
4 on Regulatory Analysis (2003), available at https://
www.whitehouse.gov/sites/default/files/omb/assets/
regulatory_matters_pdf/a-4.pdf (last visited October
15, 2010).
PO 00000
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Fmt 4703
Sfmt 4703
83
Inspection Service has received a
petition from Pioneer Hi-Bred
International, Inc., seeking a
determination of nonregulated status for
corn designated as DP–32138–1, which
has been genetically engineered to
produce male sterile/female inbred
plants for the generation of hybrid corn
seed that is non-transgenic. The petition
has been submitted in accordance with
our regulations concerning the
introduction of certain genetically
engineered organisms and products. In
accordance with those regulations, we
are soliciting comments on whether this
genetically engineered corn is likely to
pose 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
that we receive on or before March 4,
2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2010-0041 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS–2010–0041,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2010–0041.
Reading Room: You may read 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.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Rick Coker, Regulatory Analyst,
Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737–1236; (301) 734–
5720, e-mail:
richard.s.coker@aphis.usda.gov. To
obtain copies of the petition, draft
environmental assessment, or plant pest
risk assessment, contact Ms. Cindy Eck
E:\FR\FM\03JAN1.SGM
03JAN1
84
Federal Register / Vol. 76, No. 1 / Monday, January 3, 2011 / Notices
at (301) 734–0667, e-mail:
cynthia.a.eck@aphis.usda.gov. Those
documents are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/08_33801p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
08_33801p_dea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs/
08_33801p_dpra.pdf.
SUPPLEMENTARY INFORMATION:
jlentini on DSKJ8SOYB1PROD with NOTICES
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
must take and the information that must
be included in the petition.
APHIS has received a petition (APHIS
Petition Number 08–338–01p) from
Pioneer Hi-Bred International, Inc.
(Pioneer) of Johnston, IA, seeking a
determination of nonregulated status for
corn (Zea mays L.) designated as DP–
32138–1, which has been genetically
engineered to produce male sterile/
female inbred plants for the generation
of hybrid corn seed that is nontransgenic, stating that corn event DP–
32138–1 is unlikely to pose a plant pest
risk and, therefore, should not be a
regulated article under APHIS’
regulations in 7 CFR part 340.
As described in the petition, the
controlled expression of a seed color
marker gene and pollen fertility and
sterility genes allows for the generation
of red transgenic seed for seed increase
of male sterile-female inbred lines and
for the production of non-transgenic
fertile pollen for use in non-transgenic
hybrid commercial seed production.
Corn event DP–32138–1 is currently
regulated under 7 CFR part 340.
Interstate movements and field tests of
corn event DP–32138–1 have been
VerDate Mar<15>2010
15:48 Dec 30, 2010
Jkt 223001
conducted under permits issued or
notifications acknowledged by APHIS.
Field tests conducted under APHIS
oversight allowed for evaluation in a
natural agricultural setting while
imposing measures to minimize the risk
of persistence in the environment after
completion of the test. Data are gathered
on multiple parameters and used by the
applicant to evaluate agronomic
characteristics and product
performance. These data are used by
APHIS to determine if the new variety
poses a plant pest risk. Pioneer has
petitioned APHIS to make a
determination that corn event DP–
32138–1 shall no longer be considered
a regulated article under 7 CFR part 340.
In section 403 of the Plant Protection
Act (7 U.S.C. 7701 et seq.), ‘‘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 has prepared a plant
pest risk assessment to determine if corn
event DP–32138–1 is unlikely to pose a
plant pest risk.
APHIS has also prepared a draft
environmental assessment (EA) in
which it presents two alternatives based
on its analyses of data submitted by
Pioneer, a review of other scientific
data, and field tests conducted under
APHIS oversight. APHIS is considering
the following alternatives: (1) Take no
action, i.e., APHIS would not change the
regulatory status of corn event DP–
32138–1 and it would continue to be a
regulated article, or (2) grant
nonregulated status to corn event DP–
32138–1 in whole.
The draft EA has been prepared to
provide the APHIS decisionmaker with
a review and analysis of any potential
environmental impacts associated with
the proposed determination of
nonregulated status for corn event DP–
32138–1. The draft 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
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
the petition for a determination of
nonregulated status from interested or
affected persons for a period of 60 days
from the date of this notice. We are also
soliciting written comments from
interested or affected persons on the
draft EA prepared to examine any
potential environmental impacts of the
proposed determination for the
deregulation of the subject corn line,
and the plant pest risk assessment. The
petition, draft EA, and plant pest risk
assessment are available for public
review, and copies of the petition, draft
EA, and plant pest risk assessment are
available as indicated under ADDRESSES
and FOR FURTHER INFORMATION CONTACT
above.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. All
comments received regarding the
petition, draft EA, and plant pest risk
assessment will be available for public
review. After reviewing and evaluating
the comments on the petition, the draft
EA, plant pest risk assessment, and
other data, APHIS will furnish a
response to the petitioner, either
approving or denying the petition.
APHIS will then publish a notice in the
Federal Register announcing the
regulatory status of corn event DP–
32138–1 and the availability of APHIS’
written environmental decision and
regulatory determination.
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 27th day of
December, 2010 .
Gregory L. Parham,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2010–33083 Filed 12–30–10; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Notice of Environmental Impact
Statement; Withdrawal
Forest Service, USDA.
Notice of withdrawal of intent
to prepare an environmental impact
statement.
AGENCY:
ACTION:
SUMMARY: The United States Department
of Agriculture, Forest Service, Prescott
National Forest, is withdrawing the
March 2, 2010, Federal Register notice
(75 FR 9388) which announced their
intent to prepare an Environmental
Impact Statement in accordance with
the National Environmental Policy Act,
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 76, Number 1 (Monday, January 3, 2011)]
[Notices]
[Pages 83-84]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33083]
=======================================================================
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0041]
Pioneer Hi-Bred International, Inc.; Availability of Petition and
Environmental Assessment for Determination of Nonregulated Status for
Corn Genetically Engineered To Produce Male Sterile/Female Inbred
Plants
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 Pioneer Hi-Bred
International, Inc., seeking a determination of nonregulated status for
corn designated as DP-32138-1, which has been genetically engineered to
produce male sterile/female inbred plants for the generation of hybrid
corn seed that is non-transgenic. The petition has been submitted in
accordance with our regulations concerning the introduction of certain
genetically engineered organisms and products. In accordance with those
regulations, we are soliciting comments on whether this genetically
engineered corn is likely to pose 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 that we receive on or before March
4, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0041 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2010-0041, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2010-0041.
Reading Room: You may read 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. Rick Coker, Regulatory Analyst,
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-5720, e-mail:
richard.s.coker@aphis.usda.gov. To obtain copies of the petition, draft
environmental assessment, or plant pest risk assessment, contact Ms.
Cindy Eck
[[Page 84]]
at (301) 734-0667, e-mail: cynthia.a.eck@aphis.usda.gov. Those
documents are also available on the Internet at https://www.aphis.usda.gov/brs/aphisdocs/08_33801p.pdf, https://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dea.pdf, and https://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dpra.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.
APHIS has received a petition (APHIS Petition Number 08-338-01p)
from Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA,
seeking a determination of nonregulated status for corn (Zea mays L.)
designated as DP-32138-1, which has been genetically engineered to
produce male sterile/female inbred plants for the generation of hybrid
corn seed that is non-transgenic, stating that corn event DP-32138-1 is
unlikely to pose a plant pest risk and, therefore, should not be a
regulated article under APHIS' regulations in 7 CFR part 340.
As described in the petition, the controlled expression of a seed
color marker gene and pollen fertility and sterility genes allows for
the generation of red transgenic seed for seed increase of male
sterile-female inbred lines and for the production of non-transgenic
fertile pollen for use in non-transgenic hybrid commercial seed
production. Corn event DP-32138-1 is currently regulated under 7 CFR
part 340. Interstate movements and field tests of corn event DP-32138-1
have been conducted under permits issued or notifications acknowledged
by APHIS.
Field tests conducted under APHIS oversight allowed for evaluation
in a natural agricultural setting while imposing measures to minimize
the risk of persistence in the environment after completion of the
test. Data are gathered on multiple parameters and used by the
applicant to evaluate agronomic characteristics and product
performance. These data are used by APHIS to determine if the new
variety poses a plant pest risk. Pioneer has petitioned APHIS to make a
determination that corn event DP-32138-1 shall no longer be considered
a regulated article under 7 CFR part 340.
In section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.),
``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 has prepared a plant pest risk
assessment to determine if corn event DP-32138-1 is unlikely to pose a
plant pest risk.
APHIS has also prepared a draft environmental assessment (EA) in
which it presents two alternatives based on its analyses of data
submitted by Pioneer, a review of other scientific data, and field
tests conducted under APHIS oversight. APHIS is considering the
following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of corn event DP-32138-1 and it would
continue to be a regulated article, or (2) grant nonregulated status to
corn event DP-32138-1 in whole.
The draft EA has been prepared to provide the APHIS decisionmaker
with a review and analysis of any potential environmental impacts
associated with the proposed determination of nonregulated status for
corn event DP-32138-1. The draft 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 or affected persons for a period of
60 days from the date of this notice. We are also soliciting written
comments from interested or affected persons on the draft EA prepared
to examine any potential environmental impacts of the proposed
determination for the deregulation of the subject corn line, and the
plant pest risk assessment. The petition, draft EA, and plant pest risk
assessment are available for public review, and copies of the petition,
draft EA, and plant pest risk assessment are available as indicated
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. All comments received regarding the petition, draft EA,
and plant pest risk assessment will be available for public review.
After reviewing and evaluating the comments on the petition, the draft
EA, plant pest risk assessment, and other data, APHIS will furnish a
response to the petitioner, either approving or denying the petition.
APHIS will then publish a notice in the Federal Register announcing the
regulatory status of corn event DP-32138-1 and the availability of
APHIS' written environmental decision and regulatory determination.
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 27th day of December, 2010 .
Gregory L. Parham,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-33083 Filed 12-30-10; 8:45 am]
BILLING CODE 3410-34-P
