[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37767-37768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16128]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0041]


Pioneer Hi-Bred International, Inc.; 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 of our determination that a corn 
line developed by Pioneer Hi-Bred International, Inc., designated as 
event 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, 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 Pioneer Hi-Bred International, Inc., in its petition 
for a determination of nonregulated status, our analysis of available 
scientific data, and comments received from the public in response to 
our previous notice announcing the availability of the petition for 
nonregulated status and its associated environmental assessment and 
plant

[[Page 37768]]

pest risk assessment. This notice also announces the availability of 
our written determination and finding of no significant impact.

DATES: Effective Date: June 28, 2011.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0041.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
[email protected]. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, e-
mail: [email protected].

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 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 event 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 stated 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.
    In a notice \1\ published in the Federal Register on January 3, 
2011 (76 FR 83-84, Docket No. APHIS-2010-0041), APHIS announced the 
availability of the Pioneer petition and a draft environmental 
assessment (EA) for public comment. APHIS solicited comments on the 
petition, whether the subject corn is likely to pose a plant pest risk, 
and on the draft EA for 60 days ending on March 4, 2011.
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    \1\ To view the notice, petition, draft EA, the plant pest risk 
assessment and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0041.
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    APHIS received 52 comments during the comment period, with 8 
comments providing support of the EA's preferred alternative and 43 
comments expressing general opposition. Those providing support cited 
several points regarding Pioneer's Seed Production Technology (SPT) 
process and its benefits including: (1) The SPT process does not 
introduce a new transgenic gene or trait through commercial hybrid seed 
or grain production; (2) the SPT process is used to increase 
productivity and efficiency in seed corn production; and (3) the 
transgenic material is used two generations before hybrid seed 
production occurs or three times before commercial grain production. 
The majority of those opposing expressed general opposition to GE crops 
and genetically modified organisms but did not provide any specific 
disagreement with APHIS' analysis. Commenters also expressed concern 
with genetic contamination; with the effects of GE corn pollen on 
honeybees, other insects, and/or the whole ecosystem; food and feed 
safety; and health effects. APHIS has addressed the issues raised 
during the comment period and has provided responses to these comments 
as an attachment to the finding of no significant impact.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status for Pioneer's corn event DP-32138-
1, an 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). 
Based on our EA, the response to public comments, and other pertinent 
scientific data, APHIS has reached a finding of no significant impact 
with regard to the preferred alternative identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Pioneer, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the plant pest risk 
assessment, comments provided by the public, and information provided 
in APHIS' response to those public comments, APHIS has determined that 
Pioneer's corn event DP-32138-1 is unlikely to pose a plant pest risk 
and therefore is no longer subject to our regulations governing the 
introduction of certain genetically engineered organisms.
    Copies of the signed determination document, as well as copies of 
the petition, plant pest risk assessment, EA, finding of no significant 
impact, and response to comments are available as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 June 2011.
John R. Clifford,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-16128 Filed 6-27-11; 8:45 am]
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