[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35850-35851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15836]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0040]


Pioneer Hi-Bred International, Inc.; Availability of Petition for 
Determination of Nonregulated Status for Enhanced Grain Yield Potential 
and Glufosinate-Ammonium Resistant DP202216 Maize

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition 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 petition has been submitted in 
accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. We are making the 
Pioneer 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 
September 23, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0040.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0040, 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-2019-0040 
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.
    The petition is also available on the APHIS website at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 19-101-01p.

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 19-101-01p) 
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 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, DP202216 maize was generated using 
Agrobacterium-mediated transformation with plasmid PHP40099 containing 
the zmm28 and mo-pat gene cassettes. Both the introduced and native 
zmm28 genes encode the ZMM28 protein, and the increased and extended 
expression of the ZMM28 protein results in plants with enhanced grain 
yield potential. DP202216 maize also contains the phosphinothricin 
acetyltransferase (PAT) protein, which confers resistance to the 
herbicidal active ingredient glufosinate-ammonium at current

[[Page 35851]]

labeled rates. DP202216 maize has been field tested in the continental 
United States and Puerto Rico over 9 years in more than 100 separate 
plantings 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.
---------------------------------------------------------------------------

    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    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 decisionmaking documents. As 
part of our decisionmaking 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 19th day of July 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-15836 Filed 7-24-19; 8:45 am]
BILLING CODE 3410-34-P