[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60755-60756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21357]



[[Page 60755]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0037]


Westhoff Vertriebsgesellschaft mbH; Availability of Preliminary 
Plant Pest Risk Assessment, Draft Environmental Assessment, and 
Preliminary Finding of No Significant Impact for Determination of 
Nonregulated Status of Petunias Genetically Engineered for Flower Color

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, draft environmental assessment, and preliminary finding of 
no significant impact regarding a request from Westhoff 
Vertriebsgesellschaft mbH seeking a determination of nonregulated 
status of petunias containing the A1 gene from maize (A1-DFR Petunias), 
which have been genetically engineered to add a new color (orange) and 
brilliance to the flowers. We are making these documents available for 
public review and comment.

DATES: We will consider all comments that we receive on or before 
October 28, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0037.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0037, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The preliminary plant pest risk assessment, draft environmental 
assessment, and any comments we receive on this docket may be viewed at 
http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0037 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.
    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 19-099-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cynthia Eck, Team Lead, 
Communications Group, Biotechnology Regulatory Services, APHIS, 4700 
River Road Unit 146, Riverdale, MD 20737-1236; (301) 851-3892; 
[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.''
    Pursuant to the terms set forth in a final rule published in the 
Federal Register on May 17, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ 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 19-099-01p) from Westhoff 
Vertriebsgesellschaft mbH (Westhoff) seeking a determination of 
nonregulated status for petunias containing the A1 gene from maize (A1-
DFR Petunias), which have been genetically engineered to add a new 
color (orange) and brilliance to the flowers. The Westhoff petition 
stated that the plants with the new flower color and brilliance are 
unlikely to pose a plant pest risk and, therefore, should not be 
considered a regulated article under APHIS' regulations in part 340.
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    \1\ To view the final rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
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    According to our process \2\ 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, we published in the Federal 
Register (84 FR 35849-35850, Docket No. APHIS-2019-0037) a notice \3\ 
regarding the availability of the Westhoff 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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    \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 GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \3\ To view the notice, its supporting document, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0037.
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    Nine comments were received. Seven were supportive of the petition, 
while two were opposed but did not discuss the petition itself. 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 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 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.
    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 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

[[Page 60756]]

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).
    For this petition, we will be following Approach 1.
    As part of our decision-making 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 A1-DFR Petunias, which 
as stated above have been genetically engineered for the new color 
orange and brilliance are 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 Westhoff submitted, a review 
of other scientific data, field tests conducted under APHIS' oversight, 
and comments received on the petition (see footnote 3). APHIS is 
considering the following alternatives: (1) Take no action, i.e., APHIS 
would not change the regulatory status of A1-DFR Petunias, or (2) make 
a determination of nonregulated status for A1-DFR Petunias.
    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 
Westhoff, 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 petunias 
designated as event A1-DFR are unlikely to pose a plant pest risk.
    We are making available for a 30-day review period our preliminary 
determination, draft EA, preliminary FONSI, and our PPRA. The 
preliminary determination, draft EA, preliminary FONSI, and 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 16th day of September 2020.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-21357 Filed 9-25-20; 8:45 am]
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