[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20424-20425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06050]



[[Page 20424]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0021]


Bayer; Availability of a Draft Environmental Impact Statement and 
a Draft Plant Risk Assessment for Determination of Nonregulated Status 
for Maize Developed Using Genetic Engineering for Dicamba, Glufosinate, 
Quizalofop, and 2,4-Dichlorophenoxyacetic Acid Resistance, With Tissue-
Specific Glyphosate Resistance Facilitating the Production of Hybrid 
Maize Seed

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has prepared a draft environmental impact 
statement (EIS) and draft plant pest risk assessment (PPRA) evaluating 
the potential environmental impacts and plant pest risk that may result 
from the approval of a petition for nonregulated status for maize 
developed using genetic engineering for dicamba, glufosinate, 
quizalofop, and 2,4-dichlorophenoxyacetic resistance with tissue-
specific glyphosate resistance facilitating the production of hybrid 
maize seed. We are making the draft EIS and draft PPRA available for 
public review and comment.

DATES: We will consider all comments that we receive on or before May 
6, 2024.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2020-0021 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-2020-0021, 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 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Mr. Joseph Tangredi, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; phone (301) 851-4061; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    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 was 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 became 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 June 27, 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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    Bayer submitted a petition (APHIS Petition Number 19-316-01p) to 
APHIS seeking a determination of nonregulated status for a maize \2\ 
(identified as MON 87429) that has been developed using genetic 
engineering for dicamba, glufosinate, quizalofop, and 2,4-
dichlorophenoxyacetic acid (2,4-D) resistance with tissue-specific 
glyphosate resistance facilitating the production of hybrid maize seed. 
The Bayer petition stated that MON 87429 maize is unlikely to pose a 
plant pest risk and, therefore, should not be regulated under APHIS' 
regulations at 7 CFR part 340.
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    \2\ Maize is the common botanical term used globally for the 
cereal plant Zea mays. In the United States, maize is also referred 
to as corn. Both terms are used interchangeably in this document. 
For consistency with the common plant name and petition, APHIS uses 
the term maize, but also refers to corn in certain instances, such 
as in reference to food products.
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    According to our process \3\ for soliciting public comment when 
considering petitions for determination of nonregulated status of 
regulated organisms, APHIS accepts written comments regarding a 
petition once APHIS deems it complete. On May 8, 2020, APHIS announced 
the availability of the Bayer petition for public comment in the 
Federal Register \4\ (85 FR 27354-27355, Docket No. APHIS-2020-0021). 
APHIS solicited comments on the petition for 60 days ending July 7, 
2020, in order to help identify potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition. We received 
4,112 comments by the close of the comment period.
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    \3\ 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.
    \4\ To view the notice, its supporting documents, or the 
comments that we received, go to www.regulations.gov and enter 
APHIS-2020-0021 in the Search field.
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    Based on comments received on the petition and new information that 
APHIS became aware of after our May 8, 2020, Federal Register 
publication, we determined that an environmental impact statement 
(EIS), as opposed to an environmental assessment, was the appropriate 
National Environmental Policy Act (NEPA) analysis for the Bayer 
petition. Specifically, APHIS became aware of new information regarding 
potential issues with dicamba spray drift and volatilization and 
associated potential economic impacts, and the Environmental Protection 
Agency's (EPA) issuance of a cancellation order on June 8, 2020, for 
three products (Xtendimax with Vaporgrip Technology, EPA Reg. No. 524-6 
17, Engenia, EPA Reg. No. 7969-345, and FeXapan, EPA Reg. No. 352-9 13) 
that contain dicamba. Additionally, on October 27, 2020, the EPA 
approved limited 5-year registrations for two end-use dicamba products 
and the extension of the registration for one dicamba product

[[Page 20425]]

(EPA Reg. Nos. 100-1623, 264-1210, and 7969-472).
    On April 28, 2021, APHIS published a notice of intent (NOI) in the 
Federal Register (86 FR 22384-22386, Docket No. APHIS-2020-0021), 
announcing that as part of our evaluation of the Bayer petition, we 
planned to prepare an EIS to consider the potential impacts of a 
determination of nonregulated status for MON 87429 maize on the human 
environment.\5\
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    \5\ The National Environmental Policy Act as amended, and 
Council on Environmental Quality NEPA implementing regulations at 40 
CFR 1500-1508 require Federal agencies to thoroughly assess the 
potential environmental consequences of federal actions on the 
``human environment''. Human environment means comprehensively the 
natural and physical environment and the relationship of present and 
future generations of Americans with that environment. Impacts/
effects include ecological (such as effects on natural resources, 
and on the components, structures, and functioning of affected 
ecosystems), aesthetic, historic, cultural, economic, social, or 
health effects (see 40 CFR 1508.1).
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    APHIS solicited public comment for a period of 30 days, ending May 
28, 2021, as part of its scoping process to identify issues to address 
in the draft EIS. On June 30, 2021, APHIS announced in the Federal 
Register (86 FR 34714-34715, Docket No. APHIS-2020-0021) that the 
comment period was reopened for 30 days to allow interested persons 
additional time to prepare and submit comments until July 30, 2021. 
APHIS received a total of 3,069 comments by the end of the comment 
period.
    Comments received were from the agricultural industry, 
nongovernmental organizations, Tribal governments, and individuals. The 
most common topics and issues of concern raised in the comments 
received on the NOI for the draft EIS included: The potential for 
dicamba or 2,4-D drift to adversely impact crops not resistant to these 
herbicides, as well as adversely impact wild plants and plants on 
residential and commercial properties; the potential economic impacts 
of herbicide drift on crop and non-crop plants; herbicide-resistant 
crops and their influence on herbicide use; the potential for 
development of weed resistance to herbicides; potential effects of 
pesticides on the soil microbiome, pollinators, wildlife, biodiversity, 
and endangered species; potential effects on Tribal nations, including 
Tribal nation corn production, indigenous corn varieties, and food 
sovereignty; and potential benefits of MON 87429 corn in weed and 
herbicide resistant weed management, and U.S. corn production.
    APHIS evaluated all comments received on the NOI in developing the 
draft EIS. A summary of the comments received and APHIS response to 
comments are provided in appendix 1 of the draft EIS.
    Because the introduced trait genes in MON 87429 maize are involved 
in weed management, and considering public comments received on the 
NOI, the primary topics of focus in the draft EIS, in relation to 
potential impacts on the human environment are: (1) Weed and herbicide 
resistant weed management, (2) herbicide use with MON 87429 maize, (3) 
the potential effects of exposure to the introduced trait genes and 
gene products on human health and wildlife, (4) gene flow and potential 
weediness of MON 87429 maize, and (5) potential socioeconomic impacts.
    The draft EIS has been prepared in accordance with (1) The National 
Environmental Policy Act of 1969 (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). APHIS is making 
available the draft EIS, as well as a draft plant pest risk assessment 
(PPRA), for a 45-day public review and comment period. The draft EIS 
and draft PPRA are available as indicated under ADDRESSES and FOR 
FURTHER INFORMATION CONTACT.
    A notice of availability regarding the draft EIS will also be 
published by the Environmental Protection Agency in the Federal 
Register.

    Done in Washington, DC, this 11th day of March 2024.
Donna Lalli,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2024-06050 Filed 3-21-24; 8:45 am]
BILLING CODE 3410-34-P