Verdeca LLC; Availability of a Draft Plant Pest Risk Assessment and a Draft Environmental Assessment for Determination of Nonregulated Status of Soybean Genetically Engineered for Yield Increase and Resistance to Glufosinate, 9077-9078 [2019-04537]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Notices
system. Manufacturers, wishing to sell
their products to RUS electric
borrowers, request RUS consideration
for acceptance of their products and
submit letters of request with
certifications as to the origin of
manufacture of the products and
include certified data demonstrating
their products’ compliance with RUS
specifications.
Need and Use of the Information:
Manufacturers submit certified data
demonstrating product compliance with
RUS specifications, usually in the form
of laboratory test results, catalog pages,
or drawings. RUS will evaluate the data
to determine that the quality of the
products are acceptable and that their
use will not jeopardize loan security.
The information is closely reviewed to
be certain that test data; product
dimensions and product material
compositions fully comply with RUS
technical standards and specifications
that have been established for the
particular product. Without this
information, RUS has no means of
determining the acceptability of
products for use in the rural
environment.
Description of Respondents: Business
or other for-profit.
Number of Respondents: 38.
Frequency of Responses: Reporting:
on occasion.
Total Burden Hours: 1,800.
Kimble Brown,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2019–04524 Filed 3–12–19; 8:45 am]
BILLING CODE 3410–15–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0075]
Verdeca LLC; Availability of a Draft
Plant Pest Risk Assessment and a
Draft Environmental Assessment for
Determination of Nonregulated Status
of Soybean Genetically Engineered for
Yield Increase and Resistance to
Glufosinate
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
amozie on DSK9F9SC42PROD with NOTICES
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service is making available
for public comment a draft plant pest
risk assessment (PPRA) and a draft
environmental assessment (EA) for the
new plant variety HB4 soybean
SUMMARY:
VerDate Sep<11>2014
17:45 Mar 12, 2019
Jkt 247001
designated as event IND–00410–5,
which has been genetically engineered
for increased yield and resistance to the
herbicide glufosinate. We are making
the draft PPRA and draft EA available
for public review and comment.
DATES: We will consider all comments
that we receive on or before April 12,
2019.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;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 https://
www.regulations.gov/#!docket
Detail;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 website at: https://
www.aphis.usda.gov/biotechnology/
petitions_table_pending.shtml under
APHIS petition 17–223–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
Subray Hegde, Chief, Plants Branch,
Environmental Risk Analysis Programs,
Biotechnology Regulatory Services,
APHIS, 4700 River Road, Unit 147,
Riverdale, MD 20737–1236; (301) 851–
3901; email: subray.hegde@usda.gov. To
obtain copies of the petition, contact
Ms. Cindy Eck at (301) 851–3892, email:
cynthia.a.eck@aphis.usda.gov.
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.’’
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
9077
The regulations in § 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. 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 fieldlevel resistance to the herbicide
glufosinate. APHIS reviewed the
supplemental information and has
included it in its analyses in the draft
plant pest risk assessment (PPRA) and
draft environmental assessment (EA).
We are making the supplemental
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 https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
2 To view the notice, the petition, and the
comments we received, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2017-0075.
E:\FR\FM\13MRN1.SGM
13MRN1
amozie on DSK9F9SC42PROD with NOTICES
9078
Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Notices
information available along with the
draft PPRA and draft EA for public
comment.
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 draft 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.
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 will follow Approach 2.
Under Approach 2, APHIS first solicits
written comments from the public on a
draft PPRA and draft EA for a 30-day
comment period through the
publication of a Federal Register notice.
Then, after reviewing and evaluating the
comments on the draft PPRA and draft
EA and other information, APHIS will
revise the PPRA as necessary and
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 are
using Approach 2.
APHIS has prepared a draft PPRA and
has concluded that HB4 soybean
designated as event IND–00410–5,
which has been genetically engineered
for increased yield and resistance to the
herbicide glufosinate, 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
VerDate Sep<11>2014
17:45 Mar 12, 2019
Jkt 247001
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 submitted by
Verdeca, a review of other scientific
data, field tests conducted under APHIS
oversight, and comments received on
the petition. APHIS is considering the
following alternatives: (1) Take no
action, i.e., APHIS would not change the
regulatory status of HB4 soybean
designated as event IND–00410–5, or (2)
make a determination of nonregulated
status of HB4 soybean designated as
event IND–00410–5.
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) U.S. Department
of Agriculture regulations implementing
NEPA (7 CFR part 1b), and (4) APHIS’
NEPA Implementing Procedures (7 CFR
part 372).
In accordance with 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 on our draft PPRA
and our draft EA regarding the petition
for a determination of nonregulated
status from interested or affected
persons for a period of 30 days from the
date of this notice. Copies of the draft
PPRA and the draft EA, as well as the
previously published petition, are
available as indicated under ADDRESSES
and FOR FURTHER INFORMATION CONTACT
above.
After the 30-day comment period
closes, APHIS will review and evaluate
any information received during the
comment period and any other relevant
information. After reviewing and
evaluating the comments on the draft
PPRA and the draft EA and other
information, APHIS will revise the
PPRA as necessary and prepare a final
EA. Based on the final EA, APHIS will
prepare a NEPA decision document
(either a FONSI or a notice of intent to
prepare an environmental impact
statement). If a FONSI is reached,
APHIS will furnish a response to the
petitioner, based on APHIS’ conclusions
in the PPRA, either approving or
denying the petition. APHIS will also
publish a notice in the Federal Register
announcing the regulatory status of the
GE organism and the availability of
APHIS’ final PPRA, EA, FONSI, and our
regulatory determination.
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
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 7th day of
March 2019.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2019–04537 Filed 3–12–19; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Farm Service Agency
Current and Anticipated Future
Spectrum Requirements for
Commercial Agriculture, Forestry,
Mining, and Rural Manufacturing
Farm Service Agency, USDA.
Notice of inquiry and request for
comments.
AGENCY:
ACTION:
The Farm Service Agency
(FSA), an agency of the United States
Department of Agriculture (USDA),
invites comment on the radio spectrum
requirements of commercial agriculture,
forestry, mining, and rural
manufacturing. The information
received will advise USDA regarding
non-Federal spectrum policy needs in
rural settings and offer insight into the
technology needs and potential
applications in commercial agriculture.
DATES: Comments are due on or before
5 p.m. Eastern Daylight Time on April
1, 2019.
ADDRESSES: We invite you to submit
comments on this notice. In your
comments, specify ‘‘Spectrum
Requirements.’’ You may submit
comments by the following method:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and, in the
lower ‘‘Search Regulations and Federal
Actions’’ box, select ‘‘Farm Service
Agency’’ from the agency drop-down
menu, then click on ‘‘Submit.’’
Information on using Regulations.gov,
including instructions for accessing
documents, submitting comments, and
viewing the docket after the close of the
comment period, is available through
the site’s ‘‘User Tips’’ link.
Other Information: Additional
information about Farm Service Agency
and its programs is available on the
internet at www.fsa.usda.gov.
All written comments received will be
publicly available on
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Andrew Fisher; phone: (202) 692–5298
or email: Andrew.Fisher@osec.usda.gov.
Persons with disabilities who require
alternative means for communication
SUMMARY:
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Notices]
[Pages 9077-9078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04537]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0075]
Verdeca LLC; Availability of a Draft Plant Pest Risk Assessment
and a Draft Environmental Assessment for 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.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service is making available for public comment a draft plant
pest risk assessment (PPRA) and a draft environmental assessment (EA)
for 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. We are making the draft PPRA
and draft EA available for public review and comment.
DATES: We will consider all comments that we receive on or before April
12, 2019.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://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 https://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 website at: https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under
APHIS petition 17-223-01p.
FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Chief, Plants
Branch, Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3901; email: subray.hegde@usda.gov. To obtain copies of the
petition, contact Ms. Cindy Eck at (301) 851-3892, email:
cynthia.a.eck@aphis.usda.gov.
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
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.
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 has included it in its analyses in the
draft plant pest risk assessment (PPRA) and draft environmental
assessment (EA). We are making the supplemental
[[Page 9078]]
information available along with the draft PPRA and draft EA for public
comment.
---------------------------------------------------------------------------
\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
https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
\2\ To view the notice, the petition, and the comments we
received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0075.
---------------------------------------------------------------------------
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 draft 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.
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 will follow Approach
2. Under Approach 2, APHIS first solicits written comments from the
public on a draft PPRA and draft EA for a 30-day comment period through
the publication of a Federal Register notice. Then, after reviewing and
evaluating the comments on the draft PPRA and draft EA and other
information, APHIS will revise the PPRA as necessary and 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 are
using Approach 2.
APHIS has prepared a draft PPRA and has concluded that HB4 soybean
designated as event IND-00410-5, which has been genetically engineered
for increased yield and resistance to the herbicide glufosinate, 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 submitted by Verdeca, a
review of other scientific data, field tests conducted under APHIS
oversight, and comments received on the petition. APHIS is considering
the following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of HB4 soybean designated as event IND-
00410-5, or (2) make a determination of nonregulated status of HB4
soybean designated as event IND-00410-5.
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) U.S. Department of Agriculture
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
In accordance with 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 on our draft PPRA and our draft EA
regarding the petition for a determination of nonregulated status from
interested or affected persons for a period of 30 days from the date of
this notice. Copies of the draft PPRA and the draft EA, as well as the
previously published petition, are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the 30-day comment period closes, APHIS will review and
evaluate any information received during the comment period and any
other relevant information. After reviewing and evaluating the comments
on the draft PPRA and the draft EA and other information, APHIS will
revise the PPRA as necessary and prepare a final EA. Based on the final
EA, APHIS will prepare a NEPA decision document (either a FONSI or a
notice of intent to prepare an environmental impact statement). If a
FONSI is reached, APHIS will furnish a response to the petitioner,
based on APHIS' conclusions in the PPRA, either approving or denying
the petition. APHIS will also publish a notice in the Federal Register
announcing the regulatory status of the GE organism and the
availability of APHIS' final PPRA, EA, FONSI, and our regulatory
determination.
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 7th day of March 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-04537 Filed 3-12-19; 8:45 am]
BILLING CODE 3410-34-P
