[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13312-13313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04518]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0026]
Pioneer Hi-Bred International, Inc.; Availability of Petition,
Plant Pest Risk Assessment, and Environmental Assessment for
Determination of Nonregulated Status of Maize Genetically Engineered
for Herbicide Tolerance and Insect Resistance
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., (Pioneer) seeking a determination of nonregulated
status of maize designated as maize event DP-[Oslash][Oslash]4114-3,
which has been genetically engineered to be resistant to certain
lepidopteran and coleopteran pests and tolerant to the herbicide
glufosinate. The petition has been submitted in accordance with our
regulations concerning the introduction of certain genetically
engineered organisms and products. We are soliciting comments on
whether this genetically engineered maize is likely to pose a plant
pest risk. We are making available for public comment the Pioneer
petition, our plant pest risk assessment, and our draft environmental
assessment for the proposed determination of nonregulated status.
DATES: We will consider all comments that we receive on or before April
29, 2013.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0026-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0026, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0026 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) 799-7039 before coming.
The petition, draft environmental assessment, and plant pest risk
assessment are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/11_24401p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/11_24401p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/11_24401p _dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236;
(301) 851-3954, email: [email protected]. To obtain copies
of the petition, draft environmental assessment, or plant pest risk
assessment, contact Ms. Cindy Eck at (301) 851-3892, email:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest provisions of the Plant
Protection Act (7 U.S.C. 7701 et seq.), 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 11-244-01p)
from Pioneer Hi-Bred International, Inc., (Pioneer) of Johnston, IA,
seeking a determination of nonregulated status of maize (Zea mays)
designated as maize event DP-[Oslash][Oslash]4114-3 (event 4114). Event
4114 has been genetically engineered to be resistant to certain
lepidopteran pests, including European corn borer (Ostrinia nubilalis),
and certain coleopteran pests, including western corn rootworm
(Diabrotica virgifera virgifera), and tolerant to the herbicide
glufosinate. The petition states that this maize 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, event 4114 has been genetically
engineered to produce the Cry proteins Cry1F, Cry34Ab1, and Cry35Ab1,
as well as the herbicide tolerance protein phosphinothricin
acetyltransferase (PAT). The Cry1F protein confers resistance to
certain lepidopteran pests, including European corn borer; the Cry34Ab1
and Cry35Ab1 proteins confers resistance to certain coleopteran pests,
including the western corn rootworm; and the PAT protein confers
tolerance to the herbicidal active ingredient glufosinate-ammonium at
current labeled rates. Event 4114 is currently regulated under 7 CFR
part 340. Interstate movements and field tests of event 4114 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 and other data are used by APHIS to determine if the
new variety poses a plant pest risk.
In section 403 of the Plant Protection Act, ``plant pest'' is
defined as any
[[Page 13313]]
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 event 4114 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 maize event 4114 and it would continue
to be a regulated article, or (2) make a determination of nonregulated
status of event 4114.
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 of
event 4114. 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).
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. 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 plant pest risk assessment and the draft EA
prepared to examine any potential environmental impacts of the proposed
determination of nonregulated status of the subject maize line. 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 also publish a notice in the Federal Register announcing the
regulatory status of event 4114 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 22nd day of February 2013.
Michael Gregoire,
Deputy Administrator, Biotechnology Regulatory Services, Animal and
Plant Health Inspection Service.
[FR Doc. 2013-04518 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P