[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21170-21171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08065]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0084]


Agrivida, Inc.; Availability of a Petition for Determination of 
Nonregulated Status for Maize Genetically Engineered for the Production 
of Phytase Enzyme

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 Agrivida, Inc. 
(Agrivida) seeking a determination of nonregulated status for maize 
designated as Maize Event PY203, which has been genetically engineered 
for the production of phytase enzyme. The petition has been submitted 
in accordance with our regulations concerning the introduction of 
certain genetically engineered organisms and products. We are making 
the Agrivida petition available for review and comment to help us 
identify potential issues and impacts that APHIS should be considering 
in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before June 
15, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0084.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0084, 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-2019-0084 
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: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS petition 19-176-01p.

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 form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 19-176-01p) 
from Agrivida, Inc. (Agrivida) seeking a determination of nonregulated 
status for maize designated as Maize Event PY203, which has been 
genetically engineered for the production of phytase enzyme. The 
Agrivida petition states that this maize is unlikely to pose a plant 
pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
    As described in the petition, Maize Event PY203 was grown at six 
locations across the Midwestern United States including sites in Ohio, 
Indiana, Iowa, and Nebraska and at two locations in Argentina. 
Agronomic characteristics of Maize Event PY203 and near isogenic non-
transgenic control plants grown at these locations were assessed 
throughout the life cycle of the plants. These and other data are used 
by APHIS to determine if the new variety poses a plant pest risk.
    The agronomic performance and phenotypic data generated demonstrate 
that the genetic modifications introduced into Maize Event PY203 did 
not have any unintended effects on seed germination, agronomic 
characteristics, or yield. These data support the

[[Page 21171]]

conclusion that Maize Event PY203 is unlikely to develop into feral 
persistent populations or to be more weedy or invasive in the 
environment compared to conventional maize varieties.
    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 8th day of April 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-08065 Filed 4-15-20; 8:45 am]
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