[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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