Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Insect Resistant and Herbicide-Tolerant Maize, 83896-83897 [2023-26458]

Download as PDF 83896 Notices Federal Register Vol. 88, No. 230 Friday, December 1, 2023 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 Animal and Plant Health Inspection Service [Docket No. APHIS–2020–0098] Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Insect Resistant and HerbicideTolerant Maize Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that DP23211 maize (corn), which has been developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides, and also the gene that encodes for the phosphomannose isomerase protein as a selectable marker, is no longer considered regulated. Our determination is based on our evaluation of information Pioneer HiBred International, Inc. submitted in its petition for a determination of nonregulated status, our analyses, and public comments received in response to previous notices announcing the availability of the petition for nonregulated status and our associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact. DATES: This change in regulatory status will be recognized on December 1, 2023. ADDRESSES: You may read the documents referenced in this notice and the comments we received 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, lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:47 Nov 30, 2023 Jkt 262001 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. Supporting documents are also available on the APHIS website at https://www.aphis.usda.gov/aphis/ ourfocus/biotechnology/regulatoryprocesses/petitions/petition-status/ petitions-table. FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Biotechnology Regulatory Services, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, MD 20737– 1236; (301) 851–3944; email: alan.pearson@usda.gov. SUPPLEMENTARY INFORMATION: Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (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 was 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 was evaluated in accordance with the regulations at 7 CFR 340.6 (2020) as it 1 To view the final rule, go to www.regulations.gov and enter APHIS–2018–0034 in the Search field. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 was received by APHIS on July 21, 2020. Pioneer Hi-Bred International (Pioneer) submitted a petition (APHIS Petition Number 20–203–01p) to APHIS, seeking a determination of nonregulated status for DP23211 maize (corn), which was developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides. DP23211 corn also contains the gene that encodes for the phosphomannose isomerase protein, which is used as a selectable marker. The petition stated that DP23211 corn 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 2 for soliciting public comment when considering petitions for determination of nonregulated status for organisms developed using genetic engineering, APHIS accepts written comments regarding a petition once APHIS deems it complete. On November 3, 2020, APHIS published a notice in the Federal Register (85 FR 69564–69566, Docket No. APHIS–2020–0098) announcing the availability of the Pioneer petition for public comment. Four comments were received. One comment was from an individual, which stated opposition to biotechnology-derived crops in general. Three comments were received from industry organizations, which generally supported approval of the petition. APHIS evaluated the issues raised during the initial comment period and, where appropriate, incorporated a discussion of them within a draft environmental assessment (EA). A second opportunity for public involvement was provided on April 11, 2023, with a notice published in the Federal Register (88 FR 21602–21603, Docket No. APHIS–2020–0098) announcing the availability of the draft EA and draft plant pest risk assessment (PPRA) for public review and comment. That comment period closed on May 11, 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. E:\FR\FM\01DEN1.SGM 01DEN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / Notices 2023. APHIS received three comments. One commenter expressed concern that the DvSSJ1 dsRNA insect resistant trait in DP23211 corn is associated with an animal and thus presents cultural/ dietary concerns for plant-based diet adherents who may inadvertently consume DP23211 corn, and thereby DvSSJ1 dsRNA. We responded that the potential risk of exposure to insect DNA/RNA via inadvertent consumption of DP23211 corn products is not expected to appreciably increase in the event of deregulation and subsequent production of DP23211 corn, and that DvSSJ1 dsRNA poses no health risk to humans. Another commenter expressed opposition to biotechnology-derived crops, in general. A comment from a State organization representing farmers expressed support for the deregulation of DP23211 corn. APHIS provided a response to the comments in Appendix 2 of our final EA. None of the comments identified new information or data regarding the draft EA or draft PPRA. organisms developed using genetic engineering. Copies of the signed determination document, PPRA, final EA, and FONSI, as well as the previously published petition and supporting documents, are available as indicated under ADDRESSES and from the person listed under the National Environmental Policy Act After reviewing and evaluating the comments received during the comment period on the draft EA, draft PPRA, and other information, APHIS has prepared a final EA, which provides the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the determination of nonregulated status of DP23211 corn. The EA was prepared in accordance with: (1) the National Environmental Policy Act (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). Based on our EA, public comments, and other pertinent scientific data, APHIS has reached a finding of no significant impact (FONSI) with regard to the preferred alternative identified in the EA (to make a determination of nonregulated status for DP23211 corn). Proposed New Recreation Fee Sites Determination Based on APHIS’ analysis of field and laboratory data submitted by Pioneer, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, the public comments, and information provided in APHIS’ response to those public comments, APHIS has determined that DP23211 corn is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the movement of VerDate Sep<11>2014 18:47 Nov 30, 2023 Jkt 262001 FOR FURTHER INFORMATION CONTACT section in this notice. 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 27th day of November 2023. Michael Watson, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2023–26458 Filed 11–30–23; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Forest Service, Agriculture (USDA). ACTION: Notice. AGENCY: The Lassen National Forest is proposing to establish several new recreation fee sites. Recreation fee revenues collected at the new recreation fee sites would be used for operation, maintenance, and improvement of the sites. An analysis of nearby recreation fee sites with similar amenities shows the recreation fees that would be charged at the new recreation fee sites are reasonable and typical of similar recreation fee sites in the area. DATES: If approved, the new recreation fees would be implemented no earlier than six months following the publication of this notice in the Federal Register. ADDRESSES: Lassen National Forest, 2550 Riverside Drive, Susanville, CA 96130. SUMMARY: FOR FURTHER INFORMATION CONTACT: Janie Ackley, Recreation Fee Coordinator, 530–258–5165 or mary.ackley@usda.gov. SUPPLEMENTARY INFORMATION: The Federal Lands Recreation Enhancement Act (16 U.S.C. 6803(b)) requires the Forest Service to publish a six-month advance notice in the Federal Register of establishment of new recreation fee sites. In accordance with Forest Service Handbook 2309.13, chapter 30, the Forest Service will publish the proposed new recreation fee sites in local newspapers and other local publications for public comment. Most of the new PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 83897 recreation fee revenues would be spent where they are collected to enhance the visitor experience at the new recreation fee sites. An expanded amenity recreation fee of $12 per night would be charged for the Black Rock, Butte, Echo Lake, Goumaz, and Roxie Peconom Campgrounds. An expanded amenity recreation fee of $18 per night would be charged for the Bogard Campground. Expenditures from recreation fee revenues collected at the new recreation fee sites would enhance recreation opportunities, improve customer service, and address maintenance needs. Once public involvement is complete, the new recreation fees will be reviewed by a Resource Advisory Committee prior to a final decision and implementation. Reservations for Black Rock, Butte, Echo Lake, Goumaz, and Roxie Peconom, and Bogard Campgrounds could be made online at www.recreation.gov or by calling 877–444–6777. Reservations would cost $8.00 per reservation. Dated: November 28, 2023. Troy Heithecker, Associate Deputy Chief, National Forest System. [FR Doc. 2023–26442 Filed 11–30–23; 8:45 am] BILLING CODE 3411–15–P DEPARTMENT OF AGRICULTURE Forest Service Forest Service Manual 2000 National Forest Resource Management; Chapter 2040 National Forest System Monitoring Forest Service, Agriculture (USDA). ACTION: Notice of availability for public comment; extension of comment period. AGENCY: The Forest Service (Forest Service or Agency) published a notice in the Federal Register on November 28, 2023, initiating a 30-day comment period on the proposed directive contained in Forest Service manual 2000, National Forest Resource Management, chapter 2040, National Forest System Monitoring. The closing date of the original notice is scheduled for December 27, 2023. The Forest Service is extending the comment period for an additional 15 days from the previous closing date. DATES: Comments must be received in writing by January 11, 2024. ADDRESSES: Comments may be submitted electronically to https:// cara.fs2c.usda.gov/Public/Comment Input?project=ORMS-3585. Written comments may be mailed to Mara SUMMARY: E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83896-83897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26458]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 88, No. 230 / Friday, December 1, 2023 / 
Notices

[[Page 83896]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0098]


Pioneer Hi-Bred International, Inc.; Determination of 
Nonregulated Status for Insect Resistant and Herbicide-Tolerant Maize

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public of our determination that DP23211 
maize (corn), which has been developed using genetic engineering for 
insect resistance to western corn rootworm and contains the gene that 
codes for the phosphinothricin acetyltransferase protein responsible 
for tolerance to glufosinate-ammonium herbicides, and also the gene 
that encodes for the phosphomannose isomerase protein as a selectable 
marker, is no longer considered regulated. Our determination is based 
on our evaluation of information Pioneer Hi-Bred International, Inc. 
submitted in its petition for a determination of nonregulated status, 
our analyses, and public comments received in response to previous 
notices announcing the availability of the petition for nonregulated 
status and our associated environmental assessment and plant pest risk 
assessment. This notice also announces the availability of our written 
determination and finding of no significant impact.

DATES: This change in regulatory status will be recognized on December 
1, 2023.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received 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.
    Supporting documents are also available on the APHIS website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status/petitions-table.

FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Biotechnology 
Regulatory Services, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, 
MD 20737-1236; (301) 851-3944; email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (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 was 
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 was evaluated in accordance with the regulations at 
7 CFR 340.6 (2020) as it was received by APHIS on July 21, 2020.
---------------------------------------------------------------------------

    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
---------------------------------------------------------------------------

    Pioneer Hi-Bred International (Pioneer) submitted a petition (APHIS 
Petition Number 20-203-01p) to APHIS, seeking a determination of 
nonregulated status for DP23211 maize (corn), which was developed using 
genetic engineering for insect resistance to western corn rootworm and 
contains the gene that codes for the phosphinothricin acetyltransferase 
protein responsible for tolerance to glufosinate-ammonium herbicides. 
DP23211 corn also contains the gene that encodes for the phosphomannose 
isomerase protein, which is used as a selectable marker. The petition 
stated that DP23211 corn 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 \2\ for soliciting public comment when 
considering petitions for determination of nonregulated status for 
organisms developed using genetic engineering, APHIS accepts written 
comments regarding a petition once APHIS deems it complete. On November 
3, 2020, APHIS published a notice in the Federal Register (85 FR 69564-
69566, Docket No. APHIS-2020-0098) announcing the availability of the 
Pioneer petition for public comment. Four comments were received. One 
comment was from an individual, which stated opposition to 
biotechnology-derived crops in general. Three comments were received 
from industry organizations, which generally supported approval of the 
petition. APHIS evaluated the issues raised during the initial comment 
period and, where appropriate, incorporated a discussion of them within 
a draft environmental assessment (EA).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    A second opportunity for public involvement was provided on April 
11, 2023, with a notice published in the Federal Register (88 FR 21602-
21603, Docket No. APHIS-2020-0098) announcing the availability of the 
draft EA and draft plant pest risk assessment (PPRA) for public review 
and comment. That comment period closed on May 11,

[[Page 83897]]

2023. APHIS received three comments. One commenter expressed concern 
that the DvSSJ1 dsRNA insect resistant trait in DP23211 corn is 
associated with an animal and thus presents cultural/dietary concerns 
for plant-based diet adherents who may inadvertently consume DP23211 
corn, and thereby DvSSJ1 dsRNA. We responded that the potential risk of 
exposure to insect DNA/RNA via inadvertent consumption of DP23211 corn 
products is not expected to appreciably increase in the event of 
deregulation and subsequent production of DP23211 corn, and that DvSSJ1 
dsRNA poses no health risk to humans. Another commenter expressed 
opposition to biotechnology-derived crops, in general. A comment from a 
State organization representing farmers expressed support for the 
deregulation of DP23211 corn. APHIS provided a response to the comments 
in Appendix 2 of our final EA. None of the comments identified new 
information or data regarding the draft EA or draft PPRA.

National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA, draft PPRA, and other information, 
APHIS has prepared a final EA, which provides the public with 
documentation of APHIS' review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status of DP23211 corn. The EA was prepared in accordance with: (1) the 
National Environmental Policy Act (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). Based on our EA, 
public comments, and other pertinent scientific data, APHIS has reached 
a finding of no significant impact (FONSI) with regard to the preferred 
alternative identified in the EA (to make a determination of 
nonregulated status for DP23211 corn).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Pioneer, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, the public 
comments, and information provided in APHIS' response to those public 
comments, APHIS has determined that DP23211 corn is unlikely to pose a 
plant pest risk and therefore is no longer subject to our regulations 
governing the movement of organisms developed using genetic 
engineering.
    Copies of the signed determination document, PPRA, final EA, and 
FONSI, as well as the previously published petition and supporting 
documents, are available as indicated under ADDRESSES and from the 
person listed under the FOR FURTHER INFORMATION CONTACT section in this 
notice.
    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 27th day of November 2023.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2023-26458 Filed 11-30-23; 8:45 am]
BILLING CODE 3410-34-P
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