[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Notices]
[Pages 69564-69566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24267]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0098]


Pioneer Hi-Bred International, Inc.: Availability of a Petition 
for the Determination of Nonregulated Status for Insect Resistant and 
Herbicide-Tolerant Maize

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition from Pioneer Hi-Bred 
International, Inc. seeking a determination of nonregulated status for 
DP23211 maize (corn). The corn is engineered for insect resistance 
against 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. We are making the petition available for review 
and comment to help us identify potential issues and impacts that APHIS 
may determine should be considered in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
January 4, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0098.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0098, Regulatory Analysis

[[Page 69565]]

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 http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0098 
or in our reading room, which is located in 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) 7997039 before coming.
    The petition is also available on the APHIS website at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS petition 20-203-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 
20737-1236; (301) 851-3892; email: [email protected]. Secondary 
contact: Dr. Subray Hegde, Director, Risk Analysis Programs, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 851-3901; email: [email protected].

SUPPLEMENTARY INFORMATION: 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, ``Introduction of Organisms and Products 
Altered or Produced Through Genetic Engineering Which Are Plant Pests 
or Which There Is Reason to Believe Are Plant Pests,'' regulate, among 
other things, the introduction (importation, interstate movement, or 
release into the environment) of organisms and products altered or 
produced through genetic engineering that are plant pests or that there 
is reason to believe are plant pests. Such organisms and products 
developed using genetic engineering are considered ``regulated 
articles.''
    Pursuant to the terms set forth in a final rule published in the 
Federal Register on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ any person may submit a petition to the Animal and Plant 
Health Inspection Service (APHIS) seeking a determination that an 
article should not be regulated under 7 CFR part 340.
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    \1\ To view the final rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
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    APHIS has received a petition (APHIS Petition Number 20-203-01p) 
from Pioneer Hi-Bred International, Inc. (Pioneer) seeking a 
determination of nonregulated status of maize (corn) designated as 
DP23211, which has been genetically engineered for insect resistance 
against corn rootworm that consists of a double-stranded RNA combined 
with a novel protein. DP23211 corn also contains the gene that codes 
for the phosphinothricin acetyltransferase (PAT) protein responsible 
for the tolerance to glufosinate-ammonium herbicides and the gene that 
encodes for phosphomannose isomerase (PMI) protein, which is used as a 
selectable marker. We are making the Pioneer petition available for 
public comment and requesting public input regarding potential issues 
and impacts that APHIS should be considering in our evaluation of the 
petition. The Pioneer petition states that information collected during 
field trials and laboratory analyses indicates that DP23211 corn is not 
likely to be a plant pest and therefore should not be a regulated 
article under APHIS' regulations in 7 CFR part 340.
    As described in the petition, DP23211 corn was genetically 
engineered to produce DvSSJ1 double-stranded ribonucleic acid (dsRNA) 
and the IPD072Aa protein for control of corn rootworm pests, the PAT 
protein for tolerance to glufosinate-ammonium herbicides, and the PMI 
protein used as a selectable marker. Agronomic performance assessments 
for DP23211 corn were conducted in replicated field studies at a total 
of 12 locations in the United States and Canada. The Pioneer petition 
states that agronomic performance of DP23211 corn is comparable to the 
non-genetically modified conventional counterpart and reference 
varieties and that these data support the conclusion that DP23211 corn 
lacks weediness potential and plant pest risk.
    Field tests conducted under APHIS oversight allowed for evaluation 
of DP23211 corn in a natural agricultural setting while imposing 
measures to minimize the likelihood of persistence in the environment 
after completion of the tests. Data are gathered on multiple parameters 
and used by the applicant to evaluate agronomic characteristics and 
product performance. These and other data are used by APHIS to 
determine if the new variety poses a plant pest risk.
    On March 6, 2012, we published in the Federal Register (77 FR 
13258-13260, Docket No. APHIS-2011-0129) a notice \2\ describing our 
process for soliciting public comment when considering petitions for 
determinations of nonregulated status for organisms developed using 
genetic engineering. In that notice we indicated that APHIS would 
accept written comments regarding a petition for 60 days once APHIS 
deemed it complete.
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    \2\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with our process for soliciting public input when 
considering petitions for determinations of nonregulated status, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and comment, and copies are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested 
in receiving comments regarding potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition. We are 
particularly interested in receiving comments regarding biological, 
cultural, or ecological issues, and we encourage the submission of 
scientific data, studies, or research to support your comments.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. Any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decision-making documents. As 
part of our decision-making process regarding an organism's regulatory 
status, APHIS prepares a plant pest risk assessment to assess its plant 
pest risk and the appropriate environmental documentation--either an 
environmental assessment (EA) or an environmental impact statement 
(EIS)--in accordance with the National Environmental Policy Act (NEPA), 
to provide the Agency with a review and analysis of any potential 
environmental impacts associated with the petition request. For 
petitions for which APHIS prepares an EA, APHIS will follow our 
published process for soliciting public comment (see footnote 2) and 
publish a separate notice in the Federal Register announcing the 
availability of APHIS' EA and plant pest risk assessment. Should APHIS 
determine that an EIS is necessary, APHIS will complete the NEPA EIS 
process in accordance with Council on Environmental Quality regulations 
(40 CFR part 1500-1508) and APHIS' NEPA implementing regulations (7 CFR 
part 372).


[[Page 69566]]


    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 28th day of October 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-24267 Filed 11-2-20; 8:45 am]
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