[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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