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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0046]

GENECTIVE SA; Availability of Petition for Determination of Nonregulated Status of Maize Genetically Engineered for Herbicide Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from GENECTIVE SA seeking a determination of nonregulated status of maize designated as VCO-O1981-5, which has been genetically engineered for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the GENECTIVE SA petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
DATES: We will consider all comments that we receive on or before September 11, 2012.
ADDRESSES: *Federal eRulemaking Portal:Go tohttp://www.regulations.gov/#!documentDetail;D=APHIS-2012-0046-0001.

*Postal Mail/Commercial Delivery:Send your comment to Docket No. APHIS-2012-0046, 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 athttp://www.regulations.gov/#!docketDetail;D=APHIS-2012-0046or 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 is also available on the APHIS Web site athttp://www.aphis.usda.gov/brs/aphisdocs/11_34201p.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:john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email:cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION: Background

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701et 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 (GE) 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 statusmust take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 11-342-01p) from GENECTIVE SA of Chappes, France, seeking a determination of nonregulated status of maize (Zea maysL.) designated as event VCO-Ø1981-5, which has been genetically engineered for tolerance to the herbicide glyphosate, stating 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, maize event VCO-Ø1981-5 has been genetically engineered to contain the stably integratedepsps grg23ace5gene expressing the EPSPS ACE5 protein, an improved EPSPS enzyme which confers tolerance to the herbicide glyphosate. The EPSPS ACE5 protein was derived from the bacteriaArthrobacter globiformis. Maize event VCO-Ø1981-5 is currently regulated under 7 CFR part 340. Interstate movements and field tests of maize event VCO-Ø1981-5 have been conducted under 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. Field tests were also conducted in Europe and Canada. 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.

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in theFederal Registerproviding 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in theFederal Register(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete.

1To view the notice, go tohttp://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.

In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, 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. The petition is available for public review, and copies are available as indicated underADDRESSESandFOR FURTHER INFORMATION CONTACTabove. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as maize growth, crop management, and crop utilization may vary considerably by geographic region.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents.

As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an Environmental Assessment (EA) or an Environmental Impact Statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in theFederal Registerannouncing the availability of APHIS' EA and plant pest risk assessment. Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' NEPA implementing regulations (7 CFR part 372).

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 9th day of July 2012. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service.