[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38587-38588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16920]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / 
Notices  

[[Page 38587]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0075]


Verdeca LLC; Determination of Nonregulated Status of Soybean 
Genetically Engineered for Yield Increase and Resistance to Glufosinate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the new 
plant variety HB4 soybean designated as event IND-00410-5, which has 
been genetically engineered for increased yield and resistance to the 
herbicide glufosinate, is no longer considered a regulated article 
under our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by Verdeca LLC in its petition for a determination of 
nonregulated status, our analysis of available scientific data, and 
comments received from the public in response to our previous notices 
announcing the availability of the petition for nonregulated status and 
its associated environmental assessment and plant pest risk assessment. 
This notice also announces the availability of our written 
determination and finding of no significant impact.

DATES: This change in regulatory status will be recognized August 7, 
2019.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0075 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 are also available on the APHIS website at 
http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml 
under APHIS Petition 17-223-01p.

FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Director, 
Biotechnology Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3901; email: [email protected]. To obtain copies of the 
supporting documents for this petition, contact Ms. Cindy Eck at (301) 
851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: 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 
17-223-01p) from Verdeca LLC (Verdeca), seeking a determination of 
nonregulated status for the new plant variety called HB4 soybean 
(Glycine max) designated as event IND-00410-5 (also OECD unique 
identifier IND-00410-5), which has been genetically engineered for 
increased yield. The Verdeca petition states that information collected 
during field trials and laboratory analyses indicates that HB4 soybean 
is not likely to be a plant pest 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 determinations of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on November 15, 2017 (82 FR 52873-52874, Docket No. APHIS-
2017-0075), APHIS announced the availability of the Verdeca petition 
for public comment. APHIS solicited comments on the petition for 60 
days ending on January 16, 2018, 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, we published in the Federal Register (77 
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our 
process for soliciting public comments and information when 
considering petitions for determinations of nonregulated status for 
GE organisms (see http://www.regulations.gov/#!docketDetail;D=APHIS-
2011-0129).
    \2\ To view the notice, the petition, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0075.
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    APHIS received five comments on the petition (a sixth comment 
addressing an entirely different topic was erroneously submitted). Of 
the five comments, four were opposed to the deregulation and one 
comment was in support. In May 2018, Verdeca provided supplemental 
information to APHIS informing us that its HB4 soybean variety also had 
field-level resistance to the herbicide glufosinate. APHIS reviewed the 
supplemental information and included it in its analyses in the draft 
plant pest risk assessment (PPRA) and draft environmental assessment 
(EA).
    APHIS decided, based on its review of the petition and its 
evaluation and analysis of the comments received during the 60-day 
public comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues. According to our public 
review process for such petitions (see footnote 1), APHIS is following 
Approach 2, where we first solicit written comments from the public on 
a draft EA and a 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 the draft PPRA and other 
information, APHIS revises the draft

[[Page 38588]]

PPRA as necessary and prepares a final EA and, based on the final EA, a 
National Environmental Policy Act (NEPA) finding document (either a 
finding of no significant impact (FONSI) or a notice of intent to 
prepare an environmental impact statement). If a FONSI is reached, 
APHIS furnishes a response to the petitioner, either approving or 
denying the petition. APHIS also publishes a notice in the Federal 
Register announcing the regulatory status of the GE organism and the 
availability of APHIS' final EA, PPRA, FONSI, and our regulatory 
determination.
    APHIS sought public comment on a draft EA, draft PPRA, and the 
supplemental information provided by Verdeca from March 13, 2019, to 
April 12, 2019.\3\ APHIS solicited comments on those documents and 
whether the subject soybean is likely to pose a plant pest risk. APHIS 
received three comments on the petition and supporting documents, all 
of which opposed a decision of nonregulated status for HB4 soybean. 
Those comments are addressed in our final EA.
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    \3\ 84 FR 9077-9078.
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National Environmental Policy Act

    After reviewing and evaluating the comments received during the 
comment period on the draft EA and draft PPRA and other information, 
APHIS has prepared a final EA. The EA has been prepared to provide the 
public with documentation of APHIS' review and analysis of any 
potential environmental impacts associated with the determination of 
nonregulated status of HB4 soybean. The 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 our EA, the response to public 
comments, and other pertinent scientific data, APHIS has reached a 
FONSI with regard to the preferred alternative identified in the EA (to 
make a determination of nonregulated status of HB4 soybean).

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Verdeca, references provided in the petition, peer-reviewed 
publications, information analyzed in the EA, the PPRA, comments 
provided by the public, and information provided in APHIS' response to 
those public comments, APHIS has determined that HB4 soybean is 
unlikely to pose a plant pest risk and therefore is no longer subject 
to our regulations governing the introduction of certain GE organisms.
    Copies of the signed determination document, PPRA, final EA, FONSI, 
and response to comments, as well as the previously published petition 
and supporting documents, are available as indicated in the ADDRESSES 
and FOR FURTHER INFORMATION CONTACT sections of this notice.

    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 1st day of August 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-16920 Filed 8-6-19; 8:45 am]
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