[Federal Register Volume 76, Number 1 (Monday, January 3, 2011)]
[Notices]
[Pages 83-84]
From the Federal Register Online via the Government Publishing 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.

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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:
    <bullet> Federal eRulemaking Portal: Go to http://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.
    <bullet> 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 http://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: 
<a href="/cdn-cgi/l/email-protection#8efce7ede6effceaa0fda0ede1e5ebfcceeffee6e7fda0fbfdeaefa0e9e1f8"><span class="__cf_email__" data-cfemail="3f4d565c575e4d5b114c115c50545a4d7f5e4f57564c114a4c5b5e11585049">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#fa9983948e92939bd49bd49f9991ba9b8a929389d48f899e9bd49d958c"><span class="__cf_email__" data-cfemail="8be8f2e5ffe3e2eaa5eaa5eee8e0cbeafbe3e2f8a5fef8efeaa5ece4fd">[email protected]</span></a>. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/08_33801p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dea.pdf, and http://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


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