82 FR 52873 - Verdeca LLC; Availability of a Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Increased Yield

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 219 (November 15, 2017)

Page Range		52873-52874
FR Document		2017-24634

We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Verdeca LLC seeking a determination of nonregulated status for the new plant variety HB4 soybean designated as IND-00410-5, which has been genetically engineered for increased yield. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Verdeca LLC 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.

Federal Register, Volume 82 Issue 219 (Wednesday, November 15, 2017)

[Federal Register Volume 82, Number 219 (Wednesday, November 15, 2017)]
[Notices]
[Pages 52873-52874]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24634]


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Notices
                                                Federal Register
________________________________________________________________________

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 
appearing in this section.

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Federal Register / Vol. 82, No. 219 / Wednesday, November 15, 2017 / 
Notices

[[Page 52873]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0075]


Verdeca LLC; Availability of a Petition for Determination of 
Nonregulated Status of Soybean Genetically Engineered for Increased 
Yield

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 Verdeca LLC 
seeking a determination of nonregulated status for the new plant 
variety HB4 soybean designated as IND-00410-5, which has been 
genetically engineered for increased yield. The petition has been 
submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are making the Verdeca LLC 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 
January 16, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0075.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0075, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed 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.
    The petition is also available on the APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 17-223-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Biotechnology Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 
147, Riverdale, MD 20737-1236; (301) 851-3954, email: 
[email protected]. To obtain copies of the petition contact 
Ms. Cindy Eck at (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 
organisms and products are considered ``regulated articles.''
    The regulations in Sec.  [thinsp]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.  [thinsp]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 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 that has been genetically engineered 
for increased yield, stating that this soybean 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, soybean event IND-00410-5 has been 
genetically engineered to increase yield through the insertion of the 
HaHB4 transcription factor gene variant from the sunflower (Helianthus 
annuus). This gene improves plant fitness by reducing its sensitivity 
to ethylene, which would otherwise negatively impact growth, allowing 
the soybean to grow in a greater variety of environments with reduced 
negative impact on growth, development, and yield. Soybean event IND-
00410-5 is currently regulated under 7 CFR part 340. Interstate 
movements and field tests of soybean event IND-00410-5 have been 
conducted under permits issued or notifications acknowledged by APHIS. 
Field tests conducted under APHIS oversight allowed for evaluation in a 
natural agricultural setting while imposing measures to minimize the 
risk of persistence in the environment after completion of the test. 
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.
    In accordance with Sec.  [thinsp]340.6(d) of the regulations, 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 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. We also request that, 
when possible,

[[Page 52874]]

commenters provide relevant information regarding specific localities 
or regions as soybean growth, crop management, and crop utilization may 
vary considerably by geographic region.
    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 genetically 
engineered organism's regulatory status, APHIS prepares a plant pest 
risk assessment (PPRA) 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 publish a separate 
notice in the Federal Register announcing the availability of the EA 
and PPRA. Should we 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 8th day of November 2017.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-24634 Filed 11-14-17; 8:45 am]
 BILLING CODE 3410-34-P

52873

Notices Federal Register
Vol. 82, No. 219

Wednesday, November 15, 2017

This section of the FEDERAL REGISTER may be viewed at http:// event IND–00410–5 that has been
contains documents other than rules or www.regulations.gov/#!docketDetail;D= genetically engineered for increased
proposed rules that are applicable to the APHIS-2017-0075 or in our reading yield, stating that this soybean is
public. Notices of hearings and investigations, room, which is located in room 1141 of unlikely to pose a plant pest risk and,
committee meetings, agency decisions and the USDA South Building, 14th Street therefore, should not be a regulated
rulings, delegations of authority, filing of
petitions and applications and agency
and Independence Avenue SW., article under APHIS’ regulations in 7
statements of organization and functions are Washington, DC. Normal reading room CFR part 340.
examples of documents appearing in this hours are 8 a.m. to 4:30 p.m., Monday As described in the petition, soybean
section. through Friday, except holidays. To be event IND–00410–5 has been genetically
sure someone is there to help you, engineered to increase yield through the
please call (202) 799–7039 before insertion of the HaHB4 transcription
DEPARTMENT OF AGRICULTURE coming. factor gene variant from the sunflower
The petition is also available on the (Helianthus annuus). This gene
Animal and Plant Health Inspection APHIS Web site at http:// improves plant fitness by reducing its
Service www.aphis.usda.gov/biotechnology/ sensitivity to ethylene, which would
[Docket No. APHIS–2017–0075] petitions_table_pending.shtml under otherwise negatively impact growth,
APHIS petition 17–223–01p. allowing the soybean to grow in a
Verdeca LLC; Availability of a Petition FOR FURTHER INFORMATION CONTACT: Dr. greater variety of environments with
for Determination of Nonregulated John Turner, Director, Biotechnology reduced negative impact on growth,
Status of Soybean Genetically Risk Analysis Programs, BRS, APHIS, development, and yield. Soybean event
Engineered for Increased Yield 4700 River Road Unit 147, Riverdale, IND–00410–5 is currently regulated
MD 20737–1236; (301) 851–3954, email: under 7 CFR part 340. Interstate
AGENCY: Animal and Plant Health john.t.turner@aphis.usda.gov. To obtain movements and field tests of soybean
Inspection Service, USDA. copies of the petition contact Ms. Cindy event IND–00410–5 have been
ACTION: Notice. Eck at (301) 851–3892, email: conducted under permits issued or
cynthia.a.eck@aphis.usda.gov. notifications acknowledged by APHIS.
SUMMARY: We are advising the public Field tests conducted under APHIS
SUPPLEMENTARY INFORMATION: Under the
that the Animal and Plant Health oversight allowed for evaluation in a
Inspection Service (APHIS) has received authority of the plant pest provisions of
the Plant Protection Act (7 U.S.C. 7701 natural agricultural setting while
a petition from Verdeca LLC seeking a imposing measures to minimize the risk
determination of nonregulated status for et seq.), the regulations in 7 CFR part
340, ‘‘Introduction of Organisms and of persistence in the environment after
the new plant variety HB4 soybean completion of the test. Data are gathered
designated as IND–00410–5, which has Products Altered or Produced Through
Genetic Engineering Which Are Plant on multiple parameters and used by the
been genetically engineered for applicant to evaluate agronomic
increased yield. The petition has been Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate, characteristics and product
submitted in accordance with our performance. These and other data are
regulations concerning the introduction among other things, the introduction
(importation, interstate movement, or used by APHIS to determine if the new
of certain genetically engineered variety poses a plant pest risk.
organisms and products. We are making release into the environment) of
organisms and products altered or In accordance with § 340.6(d) of the
the Verdeca LLC petition available for regulations, we are publishing this
review and comment to help us identify produced through genetic engineering
that are plant pests or that there is notice to inform the public that APHIS
potential environmental and will accept written comments regarding
interrelated economic issues and reason to believe are plant pests. Such
genetically engineered organisms and the petition for a determination of
impacts that APHIS may determine nonregulated status from interested or
should be considered in our evaluation products are considered ‘‘regulated
articles.’’ affected persons for a period of 60 days
of the petition. from the date of this notice. The petition
The regulations in § 340.6(a) provide
DATES: We will consider all comments that any person may submit a petition is available for public review, and
that we receive on or before January 16, to the Animal and Plant Health copies are available as indicated under
2018. Inspection Service (APHIS) seeking a ADDRESSES and FOR FURTHER
ADDRESSES: You may submit comments determination that an article should not INFORMATION CONTACT above. We are
by either of the following methods: be regulated under 7 CFR part 340. interested in receiving comments
• Federal eRulemaking Portal: Go to Paragraphs (b) and (c) of § 340.6 regarding potential environmental and
http://www.regulations.gov/#!docket describe the form that a petition for a interrelated economic issues and
Detail;D=APHIS-2017-0075. determination of nonregulated status impacts that APHIS may determine
• Postal Mail/Commercial Delivery: should be considered in our evaluation
sradovich on DSK3GMQ082PROD with NOTICES

must take and the information that must
Send your comment to Docket No. be included in the petition. of the petition. We are particularly
APHIS–2017–0075, Regulatory Analysis APHIS has received a petition (APHIS interested in receiving comments
and Development, PPD, APHIS, Station Petition Number 17–223–01p) from regarding biological, cultural, or
3A–03.8, 4700 River Road Unit 118, Verdeca LLC (Verdeca), seeking a ecological issues, and we encourage the
Riverdale, MD 20737–1238. determination of nonregulated status for submission of scientific data, studies, or
Supporting documents and any the new plant variety called HB4 research to support your comments. We
comments we receive on this docket soybean (Glycine max) designated as also request that, when possible,

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52874 Federal Register / Vol. 82, No. 219 / Wednesday, November 15, 2017 / Notices

commenters provide relevant information collection associated with volunteers to carry out programs
information regarding specific localities the Volunteer Program. supported by the Department of
or regions as soybean growth, crop DATES: We will consider comments that Agriculture, therefore benefitting
management, and crop utilization may we receive by January 16, 2018. volunteers, the Department of
vary considerably by geographic region. ADDRESSES: We invite you to submit Agriculture, and the general public.
After the comment period closes, comments on this notice. In your Without the information, FSA will be
APHIS will review all written comments comment, include the volume, date, and unable to document the services
received during the comment period page number of this issue of the Federal provided by the volunteers. FSA will
and any other relevant information; any Register. You may submit comments by report the collected information to
substantive issues identified by APHIS any of the following methods: offices within the Department of
based on our review of the petition and • Federal eRulemaking Portal: Go to: Agriculture and the Office of Personnel
our evaluation and analysis of www.regulations.gov. Follow the online Management that request information
comments will be considered in the instructions for submitting comments. on the Volunteer Program.
development of our decisionmaking • Mail, Hand-Delivery or Courier: Ms. FSA continues to use forms AD–2022,
documents. Shannon (Logan) Morrison, USDA, FSA, AD–2023, AD–2024, and AD–2025 in
As part of our decisionmaking process Human Resources Division, HCSPIB, the Volunteer Program. There is no
regarding a genetically engineered 355 E Street SW., 12th Floor, change to the burden hours since the
organism’s regulatory status, APHIS Washington, DC 20024. last OMB approval. Also, FSA will
prepares a plant pest risk assessment You may also send comments to the remove the FSA-related burden for form
(PPRA) to assess its plant pest risk and Desk Officer for Agriculture, Office of OF301 from the generic information
the appropriate environmental Information and Regulatory Affairs, collection request approved under OMB
documentation—either an Office of Management and Budget, control number 0596–0080; FSA had
environmental assessment (EA) or an Washington, DC 20503. Comments will previously used form OF301, but no
environmental impact statement (EIS)— be available for inspection online at longer uses that form.
in accordance with the National http://www.regulations.gov. For the following estimated total
Environmental Policy Act (NEPA), to Copies of the information collection annual burden on respondents, the
provide the Agency with a review and may be requested by contacting formula used to calculate the total
analysis of any potential environmental Shannon (Logan) Morrison at the above burden hours is the estimated average
impacts associated with the petition address. Persons with disabilities who time per response multiplied by the
request. For petitions for which APHIS require alternative means of estimated total annual responses.
prepares an EA, APHIS will publish a communications should contact the Estimate of Average Time to Respond:
separate notice in the Federal Register USDA Target center at (202)720–2600 Public reporting burden for collecting
announcing the availability of the EA (voice). information under this notice is
and PPRA. Should we determine that an FOR FURTHER INFORMATION CONTACT: For estimated to average 15 minutes (0.25)
EIS is necessary, APHIS will complete specific questions related to collection per response for each of the 4 forms,
the NEPA EIS process in accordance activities, Ms. Shannon (Logan) including the time for reviewing
with Council on Environmental Quality Morrison; (202) 401–0165. instructions, searching existing data
regulations (40 CFR part 1500–1508) SUPPLEMENTARY INFORMATION: sources, gathering and maintaining the
and APHIS’ NEPA implementing Title: Volunteer Program. data needed, and completing and
regulations (7 CFR part 372). OMB Control Number: 0560–0232. reviewing the collection of information
Authority: 7 U.S.C. 7701–7772 and 7781– Expiration Date for Approval: January for all respondent. Therefore, it would
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 31, 2018. be an average 0.38 hours per response
371.3. Type of Request: Extension. in this collection.
Abstract: Section 1526 of the Type of Respondents: Any
Done in Washington, DC, this 8th day of
November 2017. Agriculture and Food Act of 1981 (7 individuals.
U.S.C. 2272) authorizes the Secretary of Estimated Number of Respondents:
Kevin Shea,
Agriculture to establish a program (‘‘the 20.
Administrator, Animal and Plant Health
Volunteer Program’’) to use volunteers
Inspection Service. Estimated Number of Responses per
to perform a wide range of activities to
[FR Doc. 2017–24634 Filed 11–14–17; 8:45 am] Respondent: 4.
carry out the programs of the
BILLING CODE 3410–34–P Estimated Total Annual Reponses: 80.
Department of Agriculture. In addition,
5 U.S.C. 3111 grants agencies the Estimated Average Time per
authority to establish programs designed Response: 0.38 hours.
DEPARTMENT OF AGRICULTURE Estimated Total Annual Burden on
to provide educationally-related work
assignments for students in non-pay Respondents: 30 hours.
Farm Service Agency
status. For FSA’s volunteer program, We are requesting comments on all
Information Collection Request, each volunteer must follow the same aspects of this information to help us to:
Volunteer Program responsibilities and guidelines for (1) Evaluate whether the proposed
conduct that Federal government collection of information is necessary
AGENCY: Farm Service Agency, USDA. employees are expected to follow. The for the proper performance of the
volunteers, who are mainly students functions of the agency, including
sradovich on DSK3GMQ082PROD with NOTICES

ACTION: Notice; request for comments.
participating in the sponsored volunteer whether the information will have
SUMMARY: In accordance with the program, must complete a service practical utility;
Paperwork Reduction Act of 1995, the agreement, attendance records, and (2) Evaluate the accuracy of the
Farm Service Agency (FSA) is other forms, and provide the required agency’s estimate of the burden of the
requesting comments from all interested supporting documents to FSA. The collection of information, including the
individuals and organizations on an information will allow FSA to validity of the methodology and
extension of a currently approved effectively recruit, train, and accept assumptions used;

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Document Created: 2018-10-25 10:36:41
Document Modified: 2018-10-25 10:36:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		We will consider all comments that we receive on or before January 16, 2018.
Contact		Dr. John Turner, Director, Biotechnology Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the petition contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation		82 FR 52873

82 FR 52873 - Verdeca LLC; Availability of a Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Increased Yield

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 82, Issue 219 (November 15, 2017)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service