[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Notices]
[Pages 45955-45956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17558]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0023]


BASF Corporation; Availability of a Draft Plant Pest Risk 
Assessment and Draft Environmental Assessment for Determination of 
Nonregulated Status of Plant-Parasitic Nematode-Protected and Herbicide 
Tolerant 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 has prepared a draft plant pest risk assessment and 
draft environmental assessment regarding a request from BASF 
Corporation seeking a determination of nonregulated status for soybean 
event GMB151, which has been developed using genetic engineering for 
resistance to the plant-parasitic nematode, soybean cyst nematode 
(Heterodera glycines), and for tolerance to 4-hydroxyphenylpyruvate 
dioxygenase (HPPD-4) inhibitor herbicides. We are making these 
documents available for public review and comment.

DATES: We will consider all comments that we receive on or before 
September 16, 2021

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2020-0023 in the Search field. Select the Documents tab, 
then select the Comment button in the list of documents.
     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, draft environmental assessment, draft plant pest risk 
assessment, and any comments we receive on this docket may be viewed at 
www.regulations.gov, or in our reading room, which is located in Room 
1620 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.
    Supporting documents for this petition are also available on the 
APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.

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, ``Movement of Organisms Modified or 
Produced Through Genetic Engineering,'' regulate, among other things, 
the importation, interstate movement, or release into the environment 
of organisms modified or produced through genetic engineering that are 
plant pests or pose a plausible plant pest risk.
    The petition for nonregulated status described in this notice is 
being evaluated under the version of the regulations effective at the 
time that it was received. The Animal and Plant Health Inspection 
Service (APHIS) issued a final rule, published in the Federal Register 
on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-2018-0034),\1\ 
revising 7 CFR part 340; however, the final rule is being implemented 
in phases. The new Regulatory Status Review (RSR) process, which 
replaces the petition for determination of nonregulated status process, 
became effective on April 5, 2021 for corn, soybean, cotton, potato, 
tomato, and alfalfa. The RSR process is effective for all crops as of 
October 1, 2021. However, ``[u]ntil RSR is available for a particular 
crop . . . APHIS will continue to receive petitions for determination 
of nonregulated status for the crop in accordance with the [legacy] 
regulations at 7 CFR 340.6.'' (85 FR 29815). This petition for a 
determination of nonregulated status is being evaluated in accordance 
with the regulations at 7 CFR 340.6 (2020) as it was received by APHIS 
on November 13, 2019.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    BASF Corporation (BASF) has submitted a petition (APHIS Petition 
Number 19-317-01p) to APHIS seeking a determination of nonregulated 
status under 7 CFR part 340, for soybean event GMB151 which has been 
developed using genetic engineering for resistance to the plant-
parasitic nematode, soybean cyst nematode (Heterodera glycines), and 
for tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor 
herbicides. The petition states that GMB151 soybean is

[[Page 45956]]

unlikely to pose a plant pest risk and, therefore, should not be 
regulated under APHIS' regulations in 7 CFR part 340.
    According to our process \2\ for soliciting public comment when 
considering petitions for determination of nonregulated status of 
organisms developed using genetic engineering, APHIS accepts written 
comments regarding a petition once APHIS deems the petition complete. 
On May 28, 2020, APHIS announced in the Federal Register \3\ (85 FR 
32004-32005, Docket No. APHIS-2020-0023) the availability of the BASF 
petition for public comment. APHIS solicited comments on the petition 
for 60 days ending July 27, 2020.
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    \2\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for organisms developed using genetic 
engineering. To view the notice, go to www.regulations.gov and enter 
APHIS-2011-0129 in the Search field.
    \3\ To view the notice, its supporting documents, and the 
comments that we received, go to www.regulations.gov and enter 
APHIS-2020-0023 in the Search field.
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    APHIS received nine comments during the comment period. They were 
from the agricultural and private sectors. Five comments generally 
supported BASF's petition, while four expressed objections to crops 
developed or modified through genetic engineering.
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decision-making process. According to our 
public review process (see footnote 2), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves an organism 
that raises no substantive new issues, APHIS will follow Approach 1 for 
public involvement. Under Approach 1, APHIS prepares and announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its draft EA, preliminary finding of no 
significant impact (FONSI), and its draft plant pest risk assessment 
(PPRA) for a 30-day public review period. APHIS will evaluate any 
information received related to the petition and its supporting 
documents during the 30-day public review period. If APHIS determines 
that no substantive information has been received that would warrant 
APHIS altering its preliminary regulatory determination or FONSI, or 
substantially change the analysis of impacts in the EA, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our website. No 
further Federal Register notice will be published announcing the final 
regulatory determination.
    Under Approach 2, if APHIS decides, based on its review of the 
petition and its evaluation and analysis of comments received during 
the 60-day public comment period on the petition, that the petition 
involves an organism that raises substantive new issues, APHIS first 
solicits written comments from the public on a draft EA and draft PPRA 
for a 30-day comment period through the publication of a Federal 
Register notice. Then, after reviewing and evaluating the comments on 
the draft EA and draft PPRA and other information, APHIS will revise 
the draft PPRA as necessary. It will then prepare a final EA, and based 
on the final EA, a National Environmental Policy Act (NEPA) decision 
document (either a FONSI or a notice of intent to prepare an 
environmental impact statement).
    For this petition, we will be following Approach 2.
    As part of our decision-making process regarding an organism's 
regulatory status, APHIS prepared a PPRA to assess the plant pest risk 
of the organism, and an EA to evaluate potential impacts on the human 
environment. This will provide the Agency and the public with a review 
and analysis of any potential environmental impacts that may result if 
the petition request is approved.
    APHIS' draft PPRA compared the pest risk posed by soybean event 
GMB151 with that of the unmodified variety from which it was derived. 
The draft PPRA concluded that soybean event GMB151 is unlikely to pose 
an increased plant pest risk compared to the unmodified soybean.
    The draft EA evaluated potential impacts that may result from the 
commercial production of GMB151 soybean, to include potential impacts 
on conventional and organic soybean production; the acreage and area 
required for U.S. soybean production; agronomic practices and inputs; 
the physical environment; biological resources; human health and worker 
safety; animal health and welfare; and socioeconomic impacts. No 
significant impacts were identified with the production and marketing 
of GMB151 soybean.
    The draft EA was prepared in accordance with (1) 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).
    We are making available for a 30-day review period our draft EA and 
draft PPRA. These documents are available as indicated under ADDRESSES 
and FOR FURTHER INFORMATION CONTACT above. Copies of these documents 
may also be obtained from the person listed under FOR FURTHER 
INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period.
    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 11th day of August 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-17558 Filed 8-16-21; 8:45 am]
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