[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50818-50819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20961]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0050]


Monsanto Company; Availability of Petition for Determination of 
Nonregulated Status of Cotton Genetically Engineered for Insect 
Resistance

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 Monsanto 
Company seeking a determination of nonregulated status for cotton 
designated as MON 88702, which has been genetically engineered for 
resistance to certain insects, primarily Lygus spp. The petition has 
been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are making the Monsanto petition available for review and comment to 
help us identify potential environmental and interrelated economic 
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 
November 25, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0050, Regulatory Analysis 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-2019-0050 
or in our reading room, which is located in room 1141 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: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 19-091-01p.

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].

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 genetically engineered (GE) 
organisms and products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that 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. Paragraphs (b) and (c) of Sec.  340.6 describe 
the submission procedures, format, and the information that must be 
included in the petition.
    APHIS has received a petition (APHIS Petition Number 19-091-01p) 
from Monsanto Company (Monsanto) seeking a determination of 
nonregulated status for cotton designated as MON 88702, which has been 
genetically engineered for resistance to certain insects. The Monsanto 
petition states that this cotton is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.

[[Page 50819]]

    As described in the petition, MON 88702 cotton was generated using 
Agrobacterium-mediated transformation with plasmid PV-GHIR508523 
containing the mCry51Aa2 expression cassette. The coding sequence 
mCry51Aa2 produces a modified Cry51Aa2 insecticidal crystal (Cry) 
protein derived from Bacillus thuringiensis (Bt) that protects cotton 
against feeding damage caused by targeted hemipteran (Lygus hesperus 
and Lygus lineolaris) and thysanopteran (Frankliniella spp.) insect 
pests. MON 88702 cotton has been field tested in the continental United 
States and Puerto Rico over 8 years as authorized under APHIS permits 
and notifications. Field tests conducted under APHIS oversight allowed 
for evaluation 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.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for GE organisms, 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 a GE 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 1) 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).

    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 20th day of September 2019.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-20961 Filed 9-25-19; 8:45 am]
 BILLING CODE 3410-34-P