This PDF is the current document as it appeared on Public Inspection on 02/26/2013 at 08:45 am.
Animal and Plant Health Inspection Service, USDA.
We are advising the public of our determination that a corn line developed by the Syngenta Biotechnology, Inc., designated as event SYN-05307-1, which has been genetically engineered for resistance to corn rootworm, an insect pest of corn, 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 Syngenta Biotechnology, 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.
Effective Date: February 27, 2013.
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) 799-7039 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-2012-0024.Start Further Info
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@example.com. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 851-3892, email: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
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 10-336-01p) from Syngenta Biotechnology, Inc., (Syngenta) of Research Triangle Park, NC, seeking a determination of nonregulated status of corn (Zea mays L.) designated as event SYN-05307-1, which has been genetically engineered for resistance to corn rootworm, an insect pest of corn. The petition states that this corn 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  published in the Federal Register on July 13, 2012 (77 FR 41366-41367, Docket No. APHIS-2012-0024), APHIS announced the availability of the Syngenta petition, a plant pest risk assessment (PPRA), 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, the draft EA, and the PPRA for 60 days ending on September 11, 2012.
APHIS received 86 comments during the comment period, with 14 commenters expressing support of the EA's preferred alternative to make a determination of nonregulated status and the remaining 72 commenters expressing opposition. One of the comments opposing a determination of nonregulated status included submitted electronic attachments that consisted of many signed letters containing identical material (4,601 letters). Issues raised during the comment period included adequacy of the EA, effects on nontarget organisms, and potential effects on human and animal health. 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 of Syngenta's corn event SYN-05307-1, 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.
Based on APHIS' analysis of field and laboratory data submitted by Syngenta, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, comments provided by the public, and information provided in APHIS' response to those public comments, APHIS has determined that Syngenta's corn event SYN-05307-1 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.Start Printed Page 13303
Copies of the signed determination document, as well as copies of the petition, PPRA, 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.Start Signature
Done in Washington, DC, this 22nd day of February 2013.
Deputy Administrator, Biotechnology Regulatory Services, Animal and Plant Health Inspection Service.
1. To view the notice, petition, draft EA, the PPRA, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0024.Back to Citation
[FR Doc. 2013-04517 Filed 2-26-13; 8:45 am]
BILLING CODE 3410-34-P