2017-24634. Verdeca LLC; Availability of a Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Increased Yield

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 Verdeca LLC seeking a determination of nonregulated status for the new plant variety HB4 soybean designated as IND-00410-5, which has been genetically engineered for increased yield. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Verdeca LLC 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 January 16, 2018.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2017-0075.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0075, 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 at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2017-0075 or 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 [phone] before coming.

The petition is also available on the APHIS Web site at http://www.aphis.usda.gov/​biotechnology/​petitions_​table_​pending.shtml under APHIS petition 17-223-01p.

FOR FURTHER INFORMATION CONTACT:

Dr. John Turner, Director, Biotechnology Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], email: [e-mail]. To obtain copies of the petition contact Ms. Cindy Eck at [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et 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 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 has received a petition (APHIS Petition Number 17-223-01p) from Verdeca LLC (Verdeca), seeking a determination of nonregulated status for the new plant variety called HB4 soybean (Glycine max) designated as event IND-00410-5 that has been genetically engineered for increased yield, stating that this soybean 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, soybean event IND-00410-5 has been genetically engineered to increase yield through the insertion of the HaHB4 transcription factor gene variant from the sunflower (Helianthus annuus). This gene improves plant fitness by reducing its sensitivity to ethylene, which would otherwise negatively impact growth, allowing the soybean to grow in a greater variety of environments with reduced negative impact on growth, development, and yield. Soybean event IND-00410-5 is currently regulated under 7 CFR part 340. Interstate movements and field tests of soybean event IND-00410-5 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 and other data are used by APHIS to determine if the new variety poses a plant pest risk.

In accordance with §  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. The petition is available for public review, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. 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 soybean 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 genetically engineered organism's regulatory status, APHIS prepares a plant pest risk assessment (PPRA) 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 publish a separate notice in the Federal Register announcing the availability of the EA and PPRA. Should we 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 8th day of November 2017.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.