[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Notices]
[Pages 32004-32005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11492]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0023]


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.

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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; (301) 851-3892, email: [email protected].

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 Sec.  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 Sec.  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

[[Page 32005]]

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 Sec.  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.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  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.
[FR Doc. 2020-11492 Filed 5-27-20; 8:45 am]
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