Bayer; Notice of Intent To Prepare an Environmental Impact Statement 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
| Citation | 86 FR 22384 |
| Record Number | 2021-08879 |
| Published date | 28 April 2021 |
| Section | Notices |
| Court | Animal And Plant Health Inspection Service |
Federal Register, Volume 86 Issue 80 (Wednesday, April 28, 2021)
[Federal Register Volume 86, Number 80 (Wednesday, April 28, 2021)]
[Notices]
[Pages 22384-22386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08879]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0021]
Bayer; Notice of Intent To Prepare an Environmental Impact
Statement 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 intent to prepare an environmental impact statement.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service (APHIS) plans to prepare an environmental impact
statement (EIS) regarding a request from Bayer seeking a 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. APHIS is requesting public comment
to help identify alternatives, and relevant information, studies, and/
or analyses APHIS should consider in the EIS.
DATES: We will consider all comments that we receive on or before May
28, 2021.
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
[[Page 22385]]
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 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) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; phone (301) 851-3892; email: [email protected].
SUPPLEMENTARY INFORMATION:
Purpose and Need for the Proposed Action
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. 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
December 11, 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 has 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) which 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 in 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 GE organisms. 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 have determined that an environmental impact statement
(EIS), as opposed to an environmental assessment (EA), is 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 the active ingredient dicamba. Additionally, on
October 27, 2020, EPA approved limited 5-year registrations for two
end-use dicamba products and the extension of the registration for one
dicamba product (EPA Reg. Nos. 100-1623, 264-1210, and 7969-472).
As part of our evaluation of Bayer's petition, we are planning 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\ 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 (such as the effects on
employment), social, or health effects (see 40 CFR 1508.1).
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The EIS is being prepared in accordance with: (1) NEPA, as amended
(42 U.S.C. 4321 et seq.), (2) the Council on Environmental Quality's
NEPA-implementing regulations (40 CFR parts 1500-1508), (3) USDA's
NEPA-implementing regulations (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
Proposed Action and Alternative the EIS Will Consider
The EIS will analyze both the preferred alternative--approve
Bayer's petition for a determination of nonregulated status for MON
87429 maize--and the no action alternative--deny the petition for
nonregulated status--both of which will be fully considered. APHIS has
developed a list of topics for analysis in the EIS based on issues
identified in prior public comments on the petition, prior EAs/EISs for
maize varieties developed using genetic engineering, public comments
submitted for other EAs/EISs evaluating petitions for nonregulated
status, the scientific literature on agricultural biotechnology, and
issues identified by APHIS specific to wild and cultivated Zea mays
(maize) and Tripsacum species. The following topics were identified as
relevant to the scope of analysis: Agricultural production (acreage and
areas of U.S. corn production, agronomic practices and
[[Page 22386]]
inputs); physical environment (soils, water resources, air quality);
biological resources (soil biota, animal communities, plant
communities, herbicide-resistant weeds, gene flow and weediness,
biodiversity); public health and worker safety; animal health and
welfare; and socioeconomic considerations. In addition, potential
impacts on threatened and endangered species will be evaluated.
Summary of Potential Impacts
APHIS anticipates the primary potential impacts of the proposed
action will be on agronomic practices and inputs. Agronomic impacts may
include changes in: Herbicide use in U.S. corn crops, weed and
herbicide resistant (HR) weed management practices, and the control of
HR weeds. In recent years, the use of dicamba-based herbicides has
resulted in instances of significant economic impact on neighboring
crop and orchard fields because of unintended drift and volatilization
of the herbicide. Potential economic impacts associated with the use of
dicamba-based herbicides will also be considered.
Anticipated Permits and Authorizations
MON 87429 maize, if deregulated, could be cultivated to produce
food, feed, fuel, and industrial products, subject to any EPA and/or
U.S. Food and Drug Administration (FDA) requirements under the
Coordinated Framework.\6\ For example, any pesticide registration and
use with MON 87429 maize would be subject to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and EPA
requirements. Any human or animal food derived from MON 87429 maize
would be subject to the Federal Food, Drug, and Cosmetic Act (FFDCA; 21
U.S.C. 301 et seq.) and FDA requirements. Bayer may voluntarily consult
with the FDA to ensure compliance with the FFDCA.
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\6\ See Coordinated Framework. U.S. Department of Agriculture,
Animal and Plant Health Inspection Service, Biotechnology Regulatory
Services, https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.
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Public Scoping Process
As previously discussed, APHIS seeks public comment on petitions
deemed complete through notices published in the Federal Register. In
accordance with our process, on May 8, 2020, APHIS solicited comments
on the petition for 60 days ending July 7, 2020. We received 4,112
comments on the petition by the close of the comment period from the
academic sector, farmers, non-governmental organizations, nonprofit
organizations, industry, private citizens, and a tribal nation.
APHIS is seeking additional public comment on this notice of intent
to prepare an EIS to help identify potential alternatives, and relevant
information, studies, and/or analyses that APHIS should consider in
evaluating the potential impacts of the proposed action on the quality
of the human environment. Those who have already submitted comments on
the Bayer petition need not resubmit--APHIS will consider these
comments in development of the EIS. To promote informed NEPA analysis
and decision-making, comments should be as specific as possible and
explain why the issues raised are important for consideration in the
EIS. Comments should include, where possible, references and data
sources supporting the information provided in the comment. We
encourage the submission of scientific data, studies, or research to
support your comments.
APHIS will accept written comments regarding the EIS for the Bayer
petition for a period of 30 days from the date of this notice. The
petition is available for public review, and copies are available as
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
Schedule for the Decision-Making Process
As part of the decision-making process in responding to the
petition, APHIS is preparing an EIS and a Plant Pest Risk Assessment
(PPRA). APHIS plans to complete the PPRA within 6 months, and the EIS
and record of decision within 2 years of the date of this notice. Note
that this schedule is tentative, and the time frame could be extended.
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 23rd day of April 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-08879 Filed 4-27-21; 8:45 am]
BILLING CODE 3410-34-P
