[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43807-43809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15631]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0040]


Pioneer Hi-Bred International; Availability of a Preliminary Pest 
Risk Assessment and Draft Environmental Assessment

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 plant pest risk 
assessment and draft environmental assessment regarding a request from 
Pioneer Hi-Bred International seeking a determination of nonregulated 
status for corn designated DP202216 Maize, which has been genetically 
engineered for enhanced grain yield potential and Glufosinate-ammonium 
herbicide resistance. We are making these documents available for 
public review and comment.

DATES: We will consider all comments that we receive on or before 
August 19, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No.

[[Page 43808]]

APHIS-2019-0040, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
    The draft environmental assessment, preliminary plant pest risk 
assessment, and any comments we receive on this docket may be viewed at 
http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040 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) 
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, ``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. APHIS received a petition (APHIS Petition Number 
19-101-01p) from Pioneer Hi-Bred International, Inc. (Pioneer) seeking 
a determination of nonregulated status of a maize event designated as 
DP202216, which has been genetically engineered for enhanced grain 
yield potential and glufosinate-ammonium resistance. The Pioneer 
petition stated 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.
    According to our process \1\ for soliciting public comment when 
considering petitions for determination of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. On July 25, 2019, APHIS announced in the 
Federal Register \2\ (84 FR 35850-35851, Docket No. APHIS-2019-0040) 
the availability of the Pioneer petition for public comment. APHIS 
solicited comments on the petition for 60 days ending September 23, 
2019, in order to help identify potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition.
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    \1\ 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 GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, its supporting documents, or the 
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040.
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    Four comments were received. Two were opposed to deregulating 
DP202216 Maize, one comment was in favor of deregulation, and one 
comment was unrelated to the petition. APHIS evaluated the issues 
raised during the initial comment period and, where appropriate, 
provided a discussion of these issues in our draft environmental 
assessment (EA).
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), 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 a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS 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 preliminary 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.
    For this petition, we are following Approach 2. Under this 
approach, 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 a GE 
organism that raises substantive new issues, APHIS first solicits 
written comments from the public on a draft EA and preliminary 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 preliminary PPRA and other information, APHIS will revise the 
preliminary 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).
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA. 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 concludes in its preliminary PPRA that DP202216 Maize, which 
as stated above has been genetically engineered for increased yield and 
resistance to the herbicide glufosinate-ammonium, is unlikely to pose a 
plant pest risk. In section 403 of the Plant Protection Act, ``plant 
pest'' is defined as any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, a nonhuman animal, a parasitic 
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or 
other pathogen, or any article similar to or allied with any of the 
foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data Pioneer submitted, a review 
of other scientific data, field tests conducted under APHIS' oversight, 
and comments received on the petition (see footnote 2). APHIS is 
considering the following alternatives: (1) Take no action, i.e., APHIS 
would not change the regulatory status of DP202216 Maize, or (2) make

[[Page 43809]]

a determination of nonregulated status for enhanced grain yield and 
glufosinate-ammonium resistant DP202216 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).
    Based on APHIS' analysis of field and laboratory data submitted by 
Pioneer, references provided in the petition, peer-reviewed 
publications, information analyzed in the draft EA, the preliminary 
PPRA, comments provided by the public on the petition, and discussion 
of issues in the draft EA, APHIS has determined that corn designated as 
event DP202216 Maize is unlikely to pose a plant pest risk.
    We are making available for a 30-day review period our preliminary 
PPRA and draft EA. The draft EA and preliminary 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. 
APHIS will revise the preliminary PPRA as necessary and prepare a final 
EA and, based on the final EA, a NEPA decision document (either a FONSI 
or a notice of intent to prepare an environmental impact statement).

    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 July 2020.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-15631 Filed 7-17-20; 8:45 am]
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