[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71875-71876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25037]


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 Notices
                                                 Federal Register
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 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 
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  Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0097]


Pioneer Hi-Bred International, Inc.; Availability of a Request 
and Plant Pest Risk Similarity Assessment for an Extension of 
Determination of Nonregulated Status for Maize for Use in the Seed 
Production Technology for Africa Process

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 has received a request to extend our determination 
of nonregulated status of Pioneer Hi-Bred International, Inc.'s 
(Pioneer's) DP-32138-1 SPT maintainer maize to maize MS44 maintainer 
line DP56113 for use in the Seed Production Technology for Africa 
(SPTA) process (hereafter DP56113 SPTA maintainer maize). DP56113 SPTA 
maintainer maize has been genetically engineered for maintenance and 
recovery of male-sterile maize breeding lines using the same construct 
and method of transformation as DP-32138-1 SPT maintainer maize. We are 
making available for public comment the request and our plant pest risk 
similarity assessment and preliminary determination of nonregulated 
status.

DATES: We will consider all comments that we receive on or before 
December 14, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0097.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0097, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The Pioneer extension request, our plant pest risk similarity 
assessment and preliminary determination of nonregulated status, and 
any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0097 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) 7997039 
before coming.

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].

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 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 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, or that APHIS 
extend a determination of nonregulated status to other organisms. Such 
an extension request must include information to establish the 
similarity of the antecedent organism and the regulated article in 
question.
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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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    On June 28, 2011,\2\ APHIS announced its determination of 
nonregulated status of Pioneer Hi-Bred International, Inc.'s 
(Pioneer's) DP-32138-1 SPT maintainer maize, which was genetically 
engineered for maintenance and recovery of male-sterile maize breeding 
lines. APHIS has received a request for an extension of that 
determination of nonregulated status of DP-32138-1 SPT maintainer maize 
to maintainer maize designated as MS44 maintainer line maize event DP-
[Oslash]56113-9 and referred to as DP56113 SPTA maintainer maize (APHIS 
Petition Number 20-043-01.ext), also from Pioneer. DP56113 SPTA 
maintainer maize has also been genetically engineered for maintenance 
and recovery of male-sterile maize breeding lines. In its request, 
Pioneer stated that this maintainer maize is similar to the antecedent 
organism DP-32138-1 SPT maintainer maize and, based on the similarity 
to the antecedent organism, is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
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    \2\ https://www.regulations.gov/document?D=APHIS-2010-0041-0057.
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    As described in the extension request, DP56113 SPTA maintainer 
maize was developed using the same constructs and method of 
transformation as DP-32138-1 SPT maintainer maize. Based on the 
information in the request, we have concluded that DP56113 SPTA 
maintainer maize is similar to DP-32138-1 SPT maintainer maize. DP56113 
SPTA maintainer maize is currently regulated under 7 CFR part 340.
    As part of our decision-making process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
In section 403 of the PPA, ``plant pest'' is defined as any living 
stage of any of the following that can directly or indirectly injure, 
cause damage to, or cause disease in any plant product: A protozoan, a 
nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or 
viroid, an infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing.
    APHIS has prepared a plant pest risk similarity assessment (PPRSA) 
to compare DP56113 SPTA maintainer maize to the antecedent. As 
described in the PPRSA, the same genetic constructs used in DP56113 
SPTA maintainer maize were previously used in DP-32138-1 SPT maintainer 
maize, and APHIS has concluded that DP56113 SPTA maintainer maize is 
unlikely to

[[Page 71876]]

pose a plant health risk. Therefore, based on the similarity between 
DP56113 SPTA maintainer maize and DP-32138-1 SPT maintainer maize as 
described in the PPRSA, APHIS has concluded that DP56113 SPTA 
maintainer maize is no more likely to pose a plant pest risk than DP-
32138-1 SPT maintainer maize.
    APHIS has analyzed information submitted by Pioneer, references 
provided in the extension request, peer-reviewed publications, and 
supporting documentation prepared for the antecedent organism. Based on 
APHIS' analysis of this information and the similarity of DP56113 SPTA 
maintainer maize to the antecedent organism DP-32138-1 SPT maintainer 
maize, APHIS has determined that DP56113 SPTA maintainer maize is 
unlikely to pose a plant pest risk. We have therefore reached a 
preliminary decision to approve the request to extend the determination 
of nonregulated status of DP-32138-1 SPT maintainer maize to DP56113 
SPTA maintainer maize, whereby DP56113 SPTA maintainer maize would no 
longer be subject to our regulations governing the introduction of 
certain genetically engineered organisms.
    We are therefore publishing this notice to make available our 
evaluation and inform the public of our preliminary decision to extend 
the determination of nonregulated status of DP-32138-1 SPT maintainer 
maize to DP56113 SPTA maintainer maize.
    APHIS will accept written comments on the request for extension, 
PPRSA, and our preliminary determination for DP56113 SPTA maintainer 
maize for 30 days. These documents are available for public review as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. 
Copies of these documents may also be obtained by contacting the person 
listed under FOR FURTHER INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, if APHIS determines that no 
substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our website at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. APHIS will also 
furnish a response to the petitioner regarding our final regulatory 
determination. No further Federal Register notice will be published 
announcing the final regulatory determination regarding DP56113 SPTA 
maintainer maize.

    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 6th day of November 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-25037 Filed 11-10-20; 8:45 am]
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