2011-16128. 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.

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 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 [phone] 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; [phone], e-mail: [e-mail]. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at [phone], e-mail: [e-mail].

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 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.

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.

Footnotes

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.