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, 22384-22386 [2021-08879]
Download as PDF
22384
Notices
Federal Register
Vol. 86, No. 80
Wednesday, April 28, 2021
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Submission for OMB Review;
Comment Request
jbell on DSKJLSW7X2PROD with NOTICES
April 23, 2020.
The Department of Agriculture has
submitted the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13. Comments are
requested regarding: Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; the accuracy of the
agency’s estimate of burden including
the validity of the methodology and
assumptions used; ways to enhance the
quality, utility and clarity of the
information to be collected; and ways to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques and other forms of
information technology.
Comments regarding this information
collection received by May 28, 2021 will
be considered. Written comments and
recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
VerDate Sep<11>2014
19:17 Apr 27, 2021
Jkt 253001
displays a currently valid OMB control
number.
Forest Service
Title: Federal Excess Personal and
Firefighter Property Program
Administration.
OMB Control Number: 0596–0223.
Summary of Collection: Federal
Excess Personal Property (FEPP) and
Firefighter Property (FFP) programs
provide state (including US territories)
forestry agencies the opportunity to
obtain excess Department of Defense
and other Federal agencies equipment
and supplies to be used in firefighting
and emergency services. The authority
to provide excess supplies to state
agencies comes from Federal Property
and Administration Services Act of
1949, as amended, 40 U.S.C., Sec 202.
Authority to loan excess supplies comes
from 10 U.S.C., Subtitle A, Part IV,
Chapter 153, 2576b grants the authority
for the FFP.
Need and Use of the Information: The
Forest Service (FS) ‘‘Federal Excess
Property Management Information
System (FEPMIS) database allows the
FS to collect FEPP and FFP information
used to manage property inventory
electronically. Access to the database is
limited to those state employees with
access authorized by FS Management
Officers working in the fire and
Aviation staff. Each state designates an
Accountable Officer who is responsible
for the integrity of the program within
their respective state and completing the
necessary documentation for each
program in which the state participates.
For this reason FEPP and FFP collects
the state forestry agency contact
information and the information of the
Accountable Officer. Cooperative
Agreement forms FS–3100–10 and/or
FS–3100–11 are used to collect the
required information from the
participating state agency that outlines
the requirements and rules for the
cooperation. Participating state agencies
must submit separate agreements if they
desire to participate in both programs.
Description of Respondents: State and
local government.
Number of Respondents: 76.
Frequency of Responses:
Recordkeeping; Reporting: Annual.
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
Total Burden Hours: 600.
Levi S. Harrell,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2021–08821 Filed 4–27–21; 8:45 am]
BILLING CODE 3411–15–P
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 2,4Dichlorophenoxyacetic Acid
Resistance, With Tissue-Specific
Glyphosate Resistance Facilitating the
Production of Hybrid Maize Seed
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of intent to prepare an
environmental impact statement.
AGENCY:
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 2,4dichlorophenoxyacetic 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
SUMMARY:
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 86, No. 80 / Wednesday, April 28, 2021 / Notices
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.
Ms.
Cindy Eck, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit
147, Riverdale, MD 20737–1236; phone
(301) 851–3892; email: cynthia.a.eck@
aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
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
1 To view the final rule, go to
www.regulations.gov and enter APHIS–2018–0034
in the Search field.
VerDate Sep<11>2014
19:17 Apr 27, 2021
Jkt 253001
regulations at 7 CFR 340.6 (2020) as it
was received by APHIS December 11,
2019.
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 2,4dichlorophenoxyacetic 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.
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.
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
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.
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.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
22385
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 enduse 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
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 NEPAimplementing regulations (40 CFR parts
1500–1508), (3) USDA’s NEPAimplementing 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
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).
E:\FR\FM\28APN1.SGM
28APN1
22386
Federal Register / Vol. 86, No. 80 / Wednesday, April 28, 2021 / Notices
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.
jbell on DSKJLSW7X2PROD with NOTICES
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.
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
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/.
VerDate Sep<11>2014
19:17 Apr 27, 2021
Jkt 253001
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 decisionmaking, 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
COMMISSION ON CIVIL RIGHTS
Agenda and Notice of Public Meeting
of the South Dakota Advisory
Committee
Commission on Civil Rights.
Announcement of public
meeting.
AGENCY:
ACTION:
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
Notice is hereby given,
pursuant to the provisions of the rules
and regulations of the U.S. Commission
on Civil Rights (Commission), and the
Federal Advisory Committee Act
(FACA), that the South Dakota State
Advisory Committee to the Commission
will convene a meeting on May 19, 2021
at 3:00 p.m. (CT). The purpose of the
meeting is for final review and vote on
the draft report on Maternal Mortality
and Health Disparities of American
Indian Women in South Dakota.
SUMMARY:
Wednesday, May 19, 2021 at
3:00 p.m. (CT).
DATES:
Public Web Conference
Registration Link (video and audio):
https://bit.ly/3eoX6To; password, if
needed: USCCR.
If Joining by Phone Only, Dial: 1–800–
360–9505; access code: 199 390 2377.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Mallory Trachtenberg at
mtrachtenberg@usccr.gov or by phone at
(202) 809–9618.
The
meeting is available to the public
through the web link above. If joining
only via phone, callers can expect to
incur charges for calls they initiate over
wireless lines, and the Commission will
not refund any incurred charges.
Individuals who are deaf, deafblind and
hard of hearing may also follow the
proceedings by first calling the Federal
Relay Service at 1–800–877–8339 and
providing the Service with conference
details found through registering at the
web link above. To request other
accommodations, please email
mtrachtenberg@usccr.gov at least 7 days
prior to the meeting for which
accommodations are requested.
Members of the public are entitled to
make comments during the open period
at the end of the meeting. Members of
the public may also submit written
comments; the comments must be
received in the Regional Programs Unit
within 30 days following the meeting.
Written comments may be emailed to
Mallory Trachtenberg at
mtrachtenberg@usccr.gov. Persons who
desire additional information may
contact the Regional Programs Unit at
(202) 809–9618. Records and documents
discussed during the meeting will be
available for public viewing as they
become available at
www.facadatabase.gov. Persons
interested in the work of this advisory
committee are advised to go to the
Commission’s website, www.usccr.gov,
or to contact the Regional Programs Unit
at the above phone number or email
address.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28APN1.SGM
28APN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ To view the final rule, go to www.regulations.gov and enter
APHIS-2018-0034 in the Search field.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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/.
---------------------------------------------------------------------------
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