Bayer CropScience LP; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to Glyphosate and Isoxaflutole, 49782-49783 [2017-23401]
Download as PDF
<![CDATA[
49782
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Regulatory Affairs, Office of
Management and Budget (OMB), New
Executive Office Building, Washington,
DC; New Executive Office Building, 725
17th Street NW., Washington, DC 20503.
Commenters are encouraged to submit
their comments to OMB via email to:
OIRA_Submission@omb.eop.gov or fax
(202) 395–5806 and to Departmental
Clearance Office, USDA, OCIO, Mail
Stop 7602, Washington, DC 20250–
7602.
Comments regarding these
information collections are best assured
of having their full effect if received by
November 27, 2017. Copies of the
submission(s) may be obtained by
calling (202) 720–8681.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
National Agricultural Statistics Service
Title: Fast Track Generic Clearance for
the Collection of Qualitative Feedback
on Customer Satisfaction Surveys.
OMB Control Number: 0535—New.
Summary of Collection: Executive
Order 12862 directs Federal agencies to
provide service to the public that
matches or exceeds the best service
available in the private sector.
Improving National Agricultural
Statistics Service (NASS) programs
requires ongoing assessment of service
delivery, by which we mean systematic
review of the operation of a program,
the quality, usability, and ease of
accessing our surveys and public
information compared to a set of
explicit or implicit standards, as a
means of contributing to the continuous
improvement of the program.
Need and Use of the Information: The
information collection activity will
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between
NASS and its customers and
stakeholders. It will allow feedback to
contribute directly to the improvement
of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: The
target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
Description of Respondents: Farms;
Business or other for-profit; Not-forprofit Institutions and State, Local or
Tribal Government.
Number of Respondents: 120,000.
Frequency of Responses: Reporting:
On occasion.
Total Burden Hours: 8,375.
Charlene Parker,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2017–23364 Filed 10–26–17; 8:45 am]
BILLING CODE 3410–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0073]
Bayer CropScience LP; Availability of
Petition for Determination of
Nonregulated Status of Cotton
Genetically Engineered for Resistance
to Glyphosate and Isoxaflutole
Animal and Plant Health
Inspection Service, USDA.
AGENCY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
ACTION:
Notice.
We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Bayer CropScience LP
seeking a determination of nonregulated
status of cotton designated as event
GHB811, which has been genetically
engineered for dual resistance to the
herbicides glyphosate and isoxaflutole.
The petition has been submitted in
accordance with our regulations
concerning the introduction of certain
genetically engineered organisms and
products. We are making the Bayer
CropScience LP petition available for
review and comment to help us identify
potential environmental and
interrelated economic issues and
impacts that the Animal and Plant
Health Inspection Service may
determine should be considered in our
evaluation of the petition.
DATES: We will consider all comments
that we receive on or before December
26, 2017.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2017-0073.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2017–0073, 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-2017-0073 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) 7997039
before coming.
The petition is also available on the
APHIS Web site at: https://
www.aphis.usda.gov/biotechnology/
petitions_table_pending.shtml under
APHIS petition 17–138–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@aphis.usda.gov. To obtain
copies of the petition, contact Ms. Cindy
Eck at (301) 851–3892, email:
cynthia.a.eck@aphis.usda.gov.
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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 § 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 § 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 17–138–01p) from
Bayer CropScience LP of Research
Triangle Park, NC (Bayer), seeking a
determination of nonregulated status of
cotton (Gossypium spp.) designated as
event GHB811, which has been
genetically engineered for dual
resistance to the herbicides glyphosate
and isoxaflutole. The Bayer petition
states that information collected during
field trials and laboratory analyses
indicates that GHB811 cotton is not
likely to be a plant pest and therefore
should not be a regulated article under
APHIS’ regulations in 7 CFR part 340.
As described in the petition, GHB811
cotton was developed through
agrobacterium-mediated transformation
using the vector pTSIH09 containing
hppdPfW336–1Pa and 2mepsps
expression cassettes. The regulatory
sequences used in this construct are
derived from common plants or plant
pathogens that are routinely used in
plant biotechnology and have a history
of safe use. GHB811 cotton is currently
regulated under 7 CFR part 340.
Interstate movements and field tests of
GHB811 cotton have been conducted
under 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 tests. Data are
gathered on multiple parameters and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
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.
Paragraph (d) of § 340.6 provides that
APHIS will publish a notice in the
Federal Register providing 60 days for
public comment for petitions for a
determination of nonregulated status.
On March 6, 2012, we published in the
Federal Register (77 FR 13258–13260,
Docket No. APHIS–2011–0129) a
notice 1 describing our process for
soliciting public comment when
considering petitions for determinations
of nonregulated status for GE organisms.
In that notice we indicated that APHIS
would accept written comments
regarding a petition once APHIS
deemed it complete.
In accordance with § 340.6(d) of the
regulations and 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 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
comment, 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.
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 GE
organism’s regulatory status, APHIS
prepares a plant pest risk assessment to
assess its plant pest risk and the
appropriate environmental
documentation—either an
1 To view the notice, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
49783
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 follow our
published process for soliciting public
comment (see footnote 1) and publish a
separate notice in the Federal Register
announcing the availability of APHIS’
EA and plant pest risk assessment.
Should APHIS 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 23rd day of
October 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2017–23401 Filed 10–26–17; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Rural Utilities Service
Information Collection Activity;
Comment Request
Rural Utilities Service, USDA.
Notice and request for
comments.
AGENCY:
ACTION:
In accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35, as amended), the
Rural Utilities Service (RUS) invites
comments on the following information
collection for which RUS intends to
request approval from the Office of
Management and Budget (OMB).
DATES: Comments on this notice must be
received by December 26, 2017.
FOR FURTHER INFORMATION CONTACT:
Thomas P. Dickson, Acting Director,
Program Development and Regulatory
Analysis, Rural Utilities Service, 1400
Independence Ave. SW., STOP 1522,
Room 5164, South Building,
Washington, DC 20250–
1522.Telephone: (202) 690–4492. Fax:
(202) 720–8435 or email
Thomas.Dickson@wdc.usda.gov
SUPPLEMENTARY INFORMATION: The Office
of Management and Budget’s (OMB)
regulation (5 CFR part 1320)
implementing provisions of the
Paperwork Reduction Act of 1995 (Pub.
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49782-49783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23401]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0073]
Bayer CropScience LP; Availability of Petition for Determination
of Nonregulated Status of Cotton Genetically Engineered for Resistance
to Glyphosate and Isoxaflutole
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Bayer CropScience LP
seeking a determination of nonregulated status of cotton designated as
event GHB811, which has been genetically engineered for dual resistance
to the herbicides glyphosate and isoxaflutole. The petition has been
submitted in accordance with our regulations concerning the
introduction of certain genetically engineered organisms and products.
We are making the Bayer CropScience LP petition available for review
and comment to help us identify potential environmental and
interrelated economic issues and impacts that the Animal and Plant
Health Inspection Service may determine should be considered in our
evaluation of the petition.
DATES: We will consider all comments that we receive on or before
December 26, 2017.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2017-0073, 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-
0073 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) 7997039 before coming.
The petition is also available on the APHIS Web site at: https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under
APHIS petition 17-138-01p.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, 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].
[[Page 49783]]
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. Paragraphs (b) and (c) of Sec. 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 17-138-01p)
from Bayer CropScience LP of Research Triangle Park, NC (Bayer),
seeking a determination of nonregulated status of cotton (Gossypium
spp.) designated as event GHB811, which has been genetically engineered
for dual resistance to the herbicides glyphosate and isoxaflutole. The
Bayer petition states that information collected during field trials
and laboratory analyses indicates that GHB811 cotton is not likely to
be a plant pest and therefore should not be a regulated article under
APHIS' regulations in 7 CFR part 340.
As described in the petition, GHB811 cotton was developed through
agrobacterium-mediated transformation using the vector pTSIH09
containing hppdPfW336-1Pa and 2mepsps expression cassettes. The
regulatory sequences used in this construct are derived from common
plants or plant pathogens that are routinely used in plant
biotechnology and have a history of safe use. GHB811 cotton is
currently regulated under 7 CFR part 340. Interstate movements and
field tests of GHB811 cotton have been conducted under 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
tests. 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.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. On March 6, 2012,
we published in the Federal Register (77 FR 13258-13260, Docket No.
APHIS-2011-0129) a notice \1\ describing our process for soliciting
public comment when considering petitions for determinations of
nonregulated status for GE organisms. In that notice we indicated that
APHIS would accept written comments regarding a petition once APHIS
deemed it complete.
---------------------------------------------------------------------------
\1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------
In accordance with Sec. 340.6(d) of the regulations and 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 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 comment, 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.
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 GE organism's regulatory
status, APHIS prepares a plant pest risk assessment 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 follow our
published process for soliciting public comment (see footnote 1) and
publish a separate notice in the Federal Register announcing the
availability of APHIS' EA and plant pest risk assessment.
Should APHIS 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 23rd day of October 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-23401 Filed 10-26-17; 8:45 am]
BILLING CODE 3410-34-P
