[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33208-33209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13341]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0084]


Agrivida, Inc.; Availability of a Draft Plant Pest Risk 
Assessment, Draft Environmental Assessment, Preliminary Determination, 
and Preliminary Finding of No Significant Impact for Determination of 
Nonregulated Status of Maize Developed Using Genetic Engineering 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 has prepared a preliminary determination of status, 
draft plant pest risk assessment, draft environmental assessment, and 
preliminary finding of no significant impact regarding a request from 
Agrivida, Inc., seeking a determination of nonregulated status for 
PY203 maize that has been developed using genetic engineering for the 
production of phytase enzyme. We are making these documents available 
for public review and comment.

DATES: We will consider all comments that we receive on or before July 
26, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2019-0084 in the Search field. Select the Documents tab, 
then select the Comment button in the list of documents.
     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 preliminary determination of status, draft environmental 
assessment, draft plant pest risk assessment, preliminary 
determination, preliminary finding of no significant impact, and any 
comments we receive on this docket may be viewed at 
www.regulations.gov, 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) 799-7039 before coming.
    Supporting documents for this petition 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 (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 importation, interstate movement, or release into the environment 
of organisms modified or produced through genetic engineering that are 
plant pests or pose a plausible plant pest risk.
    The petition for nonregulated status described in this notice is 
being evaluated under the version of the regulations effective at the 
time that it was received. The Animal and Plant Health Inspection 
Service (APHIS) issued a final rule, published in the Federal Register 
on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-2018-0034),\1\ 
revising 7 CFR part 340; however, the final rule is being implemented 
in phases. The new Regulatory Status Review (RSR) process, which 
replaces the petition for determination of nonregulated status process, 
became effective on April 5, 2021 for corn, soybean, cotton, potato, 
tomato, and alfalfa. The RSR process is effective for all crops as of 
October 1, 2021. However, ``[u]ntil RSR is available for a particular 
crop. . .APHIS will continue to receive petitions for determination of 
nonregulated status for the crop in accordance with the [legacy] 
regulations at 7 CFR 340.6.'' (85 FR 29815). This petition for a 
determination of nonregulated status is being evaluated in accordance 
with the regulations at 7 CFR 340.6 (2020) as it was received by APHIS 
on June 25, 2019.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    Agrivida, Inc. (Agrivida) has submitted a petition (APHIS Petition 
Number 19-176-01p) to APHIS seeking a determination of nonregulated 
status under 7 CFR part 340, for PY203 maize that has been developed 
using genetic engineering for the production of phytase enzyme. The 
petition states that such maize is unlikely to pose a plant

[[Page 33209]]

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 the petition complete. 
On April 16, 2020, APHIS announced in the Federal Register \3\ (85 FR 
21170-21171, Docket No. APHIS-2019-0084) the availability of the 
Agrivida petition for public comment. APHIS solicited comments on the 
petition for 60 days ending June 15, 2020.
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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 www.regulations.gov and enter 
APHIS-2011-0129 in the Search field.
    \3\ To view the notice, its supporting documents, and the 
comments that we received, go to www.regulations.gov and enter 
APHIS-2019-0084 in the Search field.
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    APHIS received 13 comments during the comment period. They were 
from the agricultural, academic, and private sectors. Eleven comments 
were in support of Agrivida's petition, while two expressed objections 
to crops developed or modified through genetic engineering in general.
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decision-making process. According to our 
public review process (see footnote 2), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves an organism 
that raises no substantive new issues, APHIS will follow Approach 1 for 
public involvement. Under Approach 1, APHIS prepares and announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its draft EA, preliminary finding of no 
significant impact (FONSI), and its draft plant pest risk assessment 
(PPRA) for a 30-day public review period. APHIS will evaluate any 
information received related to the petition and its supporting 
documents during the 30-day public review period. If APHIS determines 
that no substantive information has been received that would warrant 
APHIS altering its preliminary regulatory determination or FONSI, or 
substantially change the analysis of impacts in the EA, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our website. No 
further Federal Register notice will be published announcing the final 
regulatory determination.
    Under Approach 2, if APHIS decides, based on its review of the 
petition and its evaluation and analysis of comments received during 
the 60-day public comment period on the petition, that the petition 
involves an organism that raises substantive new issues, APHIS first 
solicits written comments from the public on a draft EA and draft PPRA 
for a 30-day comment period through the publication of a Federal 
Register notice. Then, after reviewing and evaluating the comments on 
the draft EA and draft PPRA and other information, APHIS will revise 
the draft PPRA as necessary. It will then prepare a final EA, and based 
on the final EA, a National Environmental Policy Act (NEPA) decision 
document (either a FONSI or a notice of intent to prepare an 
environmental impact statement).
    For this petition, we will be following Approach 1.
    As part of our decision-making process regarding an organism's 
regulatory status, APHIS prepared a PPRA to assess the plant pest risk 
of the organism, and an EA to evaluate potential impacts on the human 
environment. This will provide the Agency and the public with a review 
and analysis of any potential environmental impacts that may result if 
the petition request is approved.
    APHIS' draft PPRA compared the pest risk posed by the Maize Event 
PY203 with that of the unmodified variety from which it was derived. 
The draft PPRA concluded that PY203 maize is unlikely to pose an 
increased plant pest risk compared to the unmodified corn.\4\
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    \4\ Maize is the botanical term used globally for the cereal 
plant Zea mays. In the United States maize is commonly referred to 
as corn. Both terms are used interchangeably in this document.
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    The draft EA evaluated potential impacts that may result from the 
commercial production of PY203 maize, to include potential impacts on 
conventional and organic corn production; the acreage and area required 
for U.S. corn production; agronomic practices and inputs; the physical 
environment; biological resources; human health and worker safety; 
animal health and welfare; and socioeconomic impacts. No significant 
impacts were identified with the production and marketing of PY203 
maize.
    The draft EA was prepared in accordance with (1) NEPA, as amended 
(42 U.S.C. 4321 et 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).
    We are making available for a 30-day review period our preliminary 
determination, draft EA, preliminary FONSI, and draft PPRA. The 
preliminary determination, draft EA, preliminary FONSI, and draft PPRA 
are available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above. Copies of these documents may also be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period.

    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 15th day of June 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-13341 Filed 6-23-21; 8:45 am]
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