Notice2023-26458
Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Insect Resistant and Herbicide-Tolerant Maize
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
December 1, 2023
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 230 (Friday, December 1, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83896-83897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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.
Supporting documents are also available on the APHIS website at
<a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status/petitions-table">https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status/petitions-table</a>.
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: <a href="/cdn-cgi/l/email-protection#096865686727796c687b7a6667497c7a6d68276e667f"><span class="__cf_email__" data-cfemail="a6c7cac7c888d6c3c7d4d5c9c8e6d3d5c2c788c1c9d0">[email protected]</span></a>.
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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 1, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.