Notice2024-06050
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 22, 2024
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 57 (Friday, March 22, 2024)</title>
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[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20424-20425]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2020-0021 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> 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 <a href="http://Regulations.gov">Regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#dcb6b3afb9acb4f2a8bdb2bbaeb9b8b59ca9afb8bdf2bbb3aa"><span class="__cf_email__" data-cfemail="02686d7167726a2c76636c657067666b42777166632c656d74">[email protected]</span></a>.
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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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
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