2020-11492. BASF Corporation; Petition for a Determination of Nonregulated Status for Plant-Parasitic Nematode-Protected and Herbicide Resistant Soybean

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 BASF Corporation seeking a determination of nonregulated status of soybean event GMB151 genetically engineered for resistance to the plant-parasitic nematode, soybean cyst nematode (Heterodera glycines), and for resistance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor herbicides. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the 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 July 27, 2020.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0023.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2020-0023, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

The petition and any comments we receive on this docket may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0023 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 (202) 7997039 before coming.

The petition is also available on the APHIS website at: https://www.aphis.usda.gov/​aphis/​ourfocus/​biotechnology/​permits-notifications-petitions/​petitions/​petition-status under APHIS petition 19-317-01p.

FOR FURTHER INFORMATION CONTACT:

Ms. Cindy Eck, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [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 (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 status must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 19-317-01p) from BASF Corporation (BASF) seeking a determination of nonregulated status of soybean event GMB151 genetically engineered for resistance to the plant-parasitic nematode, soybean cyst nematode (Heterodera glycines), and for resistance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor herbicides. The BASF petition states that information collected during field trials and laboratory analyses indicates that GMB151 soybean is not likely to be a plant pest and therefore should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, GMB151 soybean was developed through disarmed Agrobacterium-mediated transformation using the vector pSZ8832 containing the cry14Ab-1.b and hppdPf-4Pa gene cassettes. GMB151 soybean produces the Cry14Ab-1 protein, a crystal protein derived from Bacillus thuringiensis, which confers resistance to the plant-parasitic nematode, soybean cyst nematode (Heterodera glycines). GMB151 also produces a modified 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) derived from Pseudomonas fluorescens that confers resistance to HPPD-inhibitor herbicides such as isoxaflutole. Agronomic performance of GMB151 was evaluated at 11 field sites across U.S. soybean growing regions. The BASF petition states that agronomic performance of GMB151 soybean is comparable to the non-genetically modified conventional counterpart and reference varieties and that these data support the conclusion that GMB151 soybean lacks weediness potential and plant pest risk.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the likelihood of persistence in the environment after completion of the tests. 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 the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice ^[1] 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.

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 comment, 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.

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 decision-making documents. As part of our decision-making 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 the Federal Register announcing 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.

Michael Watson,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

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