[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5130-5131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00956]


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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 
 appearing in this section.
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  Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / 
Notices  

[[Page 5130]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0050]


Monsanto Company; Determination of Nonregulated Status for Insect 
Resistant Cotton

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
cotton event designated as MON 88702, which has been genetically 
engineered for resistance to certain insects, primarily Lygus spp., is 
no longer considered regulated under our regulations governing the 
introduction of certain genetically engineered organisms. Our 
determination is based on evaluation of information Monsanto Company 
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 January 19, 
2021.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050, or in our reading 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/permits-notifications-petitions/petitions/petition-status.

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, regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products modified or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests.
    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\ Although this final rule (termed the SECURE rule) published 
revisions to 7 CFR part 340 with phased effective dates beginning 
August 17, 2020 (https://www.aphis.usda.gov/brs/fedregister/BRS_2020518.pdf), the SECURE rule stated that the petition 
evaluation process found in the previous regulations would continue 
to be used for a period of time following that August 17, 2020 
effective date. This product was evaluated in accordance with that 
process.
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    APHIS received a petition (APHIS Petition Number 19-091-01p) from 
Monsanto Company (Monsanto) on May 28, 2019, seeking a determination of 
nonregulated status for a cotton event designated as MON 88702, which 
has been genetically engineered for resistance to certain insects, 
primarily Lygus spp. The Monsanto petition stated that this cotton 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 of 
organisms developed using genetic engineering, APHIS accepts written 
comments regarding a petition once APHIS deems it complete. On 
September 26, 2019, APHIS published a notice \3\ in the Federal 
Register (84 FR 50818-50819, Docket No. APHIS-2019-0050) announcing the 
availability of the Monsanto petition for public comment. Thirty-five 
comments were received. Fifteen comments from the agricultural, 
academic, and private sector were in support of Monsanto's petition. 
Fourteen comments from individuals were opposed to approval of 
Monsanto's petition. Six comments provided input on analyses to be 
considered in the environmental assessment (EA), or comments on insect-
resistant crops in general. APHIS evaluated the issues raised during 
the initial comment period and, where appropriate, incorporated a 
discussion of them within a draft EA.
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    \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 http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \3\ To view the notice, the petition, supporting documents, and 
the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
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    A second opportunity for public involvement was provided on October 
16, 2020, with a notice \4\ published in the Federal Register (85 FR 
65789-65790, Docket No. APHIS-2019-0050) announcing the availability of 
the draft EA and draft plant pest risk assessment (PPRA) for public 
review and comment. That comment period closed November 16, 2020. APHIS 
received 14 comments. Most were supportive of Monsanto's petition 
request; three were opposed. None of the comments identified new 
information or data regarding the draft EA or draft PPRA.
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    \4\ See footnote 3.
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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 MON 88702 cotton. The EA was prepared in accordance with: (1) 
the National Environmental Policy Act (NEPA), as amended (42 U.S.C. 
4321 et

[[Page 5131]]

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, 
the response to 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 of MON 88702 cotton).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Monsanto, 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 MON 88702 cotton is unlikely to 
pose a plant pest risk and therefore is no longer subject to our 
regulations governing the introduction of certain 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 12th day of January 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-00956 Filed 1-15-21; 8:45 am]
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