82 FR 49782 - Bayer CropScience LP; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to Glyphosate and Isoxaflutole

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 207 (October 27, 2017)

Page Range		49782-49783
FR Document		2017-23401

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.

Federal Register, Volume 82 Issue 207 (Friday, October 27, 2017)

[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49782-49783]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23401]


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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.

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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 http://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 http://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: http://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.
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    \1\ To view the notice, go to http://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

49782 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices

Regulatory Affairs, Office of communication, training or changes in ACTION: Notice.
Management and Budget (OMB), New operations might improve delivery of
Executive Office Building, Washington, products or services. These collections SUMMARY: We are advising the public
DC; New Executive Office Building, 725 will allow for ongoing, collaborative and that the Animal and Plant Health
17th Street NW., Washington, DC 20503. actionable communications between Inspection Service has received a
Commenters are encouraged to submit NASS and its customers and petition from Bayer CropScience LP
their comments to OMB via email to: stakeholders. It will allow feedback to seeking a determination of nonregulated
OIRA_Submission@omb.eop.gov or fax contribute directly to the improvement status of cotton designated as event
(202) 395–5806 and to Departmental of program management. GHB811, which has been genetically
Clearance Office, USDA, OCIO, Mail Feedback collected under this generic engineered for dual resistance to the
Stop 7602, Washington, DC 20250– clearance will provide useful herbicides glyphosate and isoxaflutole.
7602. information, but it will not yield data The petition has been submitted in
Comments regarding these that can be generalized to the overall accordance with our regulations
information collections are best assured population. This type of generic concerning the introduction of certain
of having their full effect if received by clearance for qualitative information genetically engineered organisms and
November 27, 2017. Copies of the will not be used for quantitative products. We are making the Bayer
submission(s) may be obtained by information collections that are CropScience LP petition available for
calling (202) 720–8681. designed to yield reliably actionable review and comment to help us identify
An agency may not conduct or results, such as monitoring trends over potential environmental and
sponsor a collection of information time or documenting program interrelated economic issues and
unless the collection of information performance. Such data uses require impacts that the Animal and Plant
displays a currently valid OMB control more rigorous designs that address: The Health Inspection Service may
number and the agency informs target population to which determine should be considered in our
potential persons who are to respond to generalizations will be made, the evaluation of the petition.
the collection of information that such sampling frame, the sample design DATES: We will consider all comments
persons are not required to respond to (including stratification and clustering), that we receive on or before December
the collection of information unless it the precision requirements or power 26, 2017.
displays a currently valid OMB control calculations that justify the proposed
number. ADDRESSES: You may submit comments
sample size, the expected response rate,
by either of the following methods:
National Agricultural Statistics Service methods for assessing potential non-
response bias, the protocols for data • Federal eRulemaking Portal: Go to
Title: Fast Track Generic Clearance for http://www.regulations.gov/
the Collection of Qualitative Feedback collection, and any testing procedures
that were or will be undertaken prior #!docketDetail;D=APHIS-2017-0073.
on Customer Satisfaction Surveys. • Postal Mail/Commercial Delivery:
OMB Control Number: 0535—New. fielding the study. Depending on the
degree of influence the results are likely Send your comment to Docket No.
Summary of Collection: Executive APHIS–2017–0073, Regulatory Analysis
Order 12862 directs Federal agencies to to have, such collections may still be
eligible for submission for other generic and Development, PPD, APHIS, Station
provide service to the public that 3A–03.8, 4700 River Road, Unit 118,
matches or exceeds the best service mechanisms that are designed to yield
quantitative results. Riverdale, MD 20737–1238.
available in the private sector.
Description of Respondents: Farms; Supporting documents and any
Improving National Agricultural
Business or other for-profit; Not-for- comments we receive on this docket
Statistics Service (NASS) programs
profit Institutions and State, Local or may be viewed at http://
requires ongoing assessment of service
Tribal Government. www.regulations.gov/
delivery, by which we mean systematic
Number of Respondents: 120,000. #!docketDetail;D=APHIS-2017-0073 or
review of the operation of a program,
Frequency of Responses: Reporting: in our reading room, which is located in
the quality, usability, and ease of
On occasion. room 1141 of the USDA South Building,
accessing our surveys and public
Total Burden Hours: 8,375. 14th Street and Independence Avenue
information compared to a set of
SW., Washington, DC. Normal reading
explicit or implicit standards, as a Charlene Parker, room hours are 8 a.m. to 4:30 p.m.,
means of contributing to the continuous Departmental Information Collection Monday through Friday, except
improvement of the program. Clearance Officer.
Need and Use of the Information: The holidays. To be sure someone is there to
[FR Doc. 2017–23364 Filed 10–26–17; 8:45 am] help you, please call (202) 7997039
information collection activity will
garner qualitative customer and
BILLING CODE 3410–P before coming.
stakeholder feedback in an efficient, The petition is also available on the
timely manner, in accordance with the APHIS Web site at: http://
DEPARTMENT OF AGRICULTURE www.aphis.usda.gov/biotechnology/
Administration’s commitment to
improving service delivery. By Animal and Plant Health Inspection petitions_table_pending.shtml under
qualitative feedback we mean Service APHIS petition 17–138–01p.
information that provides useful FOR FURTHER INFORMATION CONTACT: Dr.
[Docket No. APHIS–2017–0073]
asabaliauskas on DSKBBXCHB2PROD with NOTICES

insights on perceptions and opinions, John Turner, Director, Environmental
but are not statistical surveys that yield Bayer CropScience LP; Availability of Risk Analysis Programs, Biotechnology
quantitative results that can be Petition for Determination of Regulatory Services, APHIS, 4700 River
generalized to the population of study. Nonregulated Status of Cotton Road, Unit 147, Riverdale, MD 20737–
This feedback will provide insights into Genetically Engineered for Resistance 1236; (301) 851–3954, email:
customer or stakeholder perceptions, to Glyphosate and Isoxaflutole john.t.turner@aphis.usda.gov. To obtain
experiences and expectations, provide copies of the petition, contact Ms. Cindy
an early warning of issues with service, AGENCY: Animal and Plant Health Eck at (301) 851–3892, email:
or focus attention on areas where Inspection Service, USDA. cynthia.a.eck@aphis.usda.gov.

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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49783

SUPPLEMENTARY INFORMATION: Under the used by the applicant to evaluate environmental assessment (EA) or an
authority of the plant pest provisions of agronomic characteristics and product environmental impact statement (EIS)—
the Plant Protection Act (7 U.S.C. 7701 performance. These and other data are in accordance with the National
et seq.), the regulations in 7 CFR part used by APHIS to determine if the new Environmental Policy Act (NEPA), to
340, ‘‘Introduction of Organisms and variety poses a plant pest risk. provide the Agency with a review and
Products Altered or Produced Through Paragraph (d) of § 340.6 provides that analysis of any potential environmental
Genetic Engineering Which Are Plant APHIS will publish a notice in the impacts associated with the petition
Pests or Which There Is Reason to Federal Register providing 60 days for request. For petitions for which APHIS
Believe Are Plant Pests,’’ regulate, public comment for petitions for a prepares an EA, APHIS will follow our
among other things, the introduction determination of nonregulated status. published process for soliciting public
(importation, interstate movement, or On March 6, 2012, we published in the comment (see footnote 1) and publish a
release into the environment) of Federal Register (77 FR 13258–13260, separate notice in the Federal Register
organisms and products altered or Docket No. APHIS–2011–0129) a announcing the availability of APHIS’
produced through genetic engineering notice 1 describing our process for EA and plant pest risk assessment.
that are plant pests or that there is soliciting public comment when Should APHIS determine that an EIS
reason to believe are plant pests. Such considering petitions for determinations is necessary, APHIS will complete the
genetically engineered (GE) organisms of nonregulated status for GE organisms. NEPA EIS process in accordance with
and products are considered ‘‘regulated In that notice we indicated that APHIS Council on Environmental Quality
articles.’’ would accept written comments regulations (40 CFR part 1500–1508)
The regulations in § 340.6(a) provide regarding a petition once APHIS and APHIS’ NEPA implementing
that any person may submit a petition deemed it complete. regulations (7 CFR part 372).
to the Animal and Plant Health In accordance with § 340.6(d) of the Authority: 7 U.S.C. 7701–7772 and 7781–
Inspection Service (APHIS) seeking a regulations and our process for 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
determination that an article should not soliciting public input when 371.3.
be regulated under 7 CFR part 340. considering petitions for determinations Done in Washington, DC, this 23rd day of
Paragraphs (b) and (c) of § 340.6 of nonregulated status for GE organisms, October 2017.
describe the form that a petition for a we are publishing this notice to inform Michael C. Gregoire,
determination of nonregulated status the public that APHIS will accept Acting Administrator, Animal and Plant
must take and the information that must written comments regarding the petition Health Inspection Service.
be included in the petition. for a determination of nonregulated [FR Doc. 2017–23401 Filed 10–26–17; 8:45 am]
APHIS has received a petition (APHIS status from interested or affected
BILLING CODE 3410–34–P
Petition Number 17–138–01p) from persons for a period of 60 days from the
Bayer CropScience LP of Research date of this notice. The petition is
Triangle Park, NC (Bayer), seeking a available for public review and DEPARTMENT OF AGRICULTURE
determination of nonregulated status of comment, and copies are available as
cotton (Gossypium spp.) designated as indicated under ADDRESSES and FOR Rural Utilities Service
event GHB811, which has been FURTHER INFORMATION CONTACT above.
genetically engineered for dual We are interested in receiving Information Collection Activity;
resistance to the herbicides glyphosate comments regarding potential Comment Request
and isoxaflutole. The Bayer petition environmental and interrelated
states that information collected during Rural Utilities Service, USDA.
AGENCY:
economic issues and impacts that
field trials and laboratory analyses Notice and request for
ACTION:
APHIS may determine should be
indicates that GHB811 cotton is not comments.
considered in our evaluation of the
likely to be a plant pest and therefore petition. We are particularly interested SUMMARY: In accordance with the
should not be a regulated article under in receiving comments regarding Paperwork Reduction Act of 1995 (44
APHIS’ regulations in 7 CFR part 340. biological, cultural, or ecological issues, U.S.C. chapter 35, as amended), the
As described in the petition, GHB811 and we encourage the submission of Rural Utilities Service (RUS) invites
cotton was developed through scientific data, studies, or research to comments on the following information
agrobacterium-mediated transformation support your comments. collection for which RUS intends to
using the vector pTSIH09 containing After the comment period closes, request approval from the Office of
hppdPfW336–1Pa and 2mepsps APHIS will review all written comments
expression cassettes. The regulatory Management and Budget (OMB).
received during the comment period DATES: Comments on this notice must be
sequences used in this construct are and any other relevant information. Any
derived from common plants or plant received by December 26, 2017.
substantive issues identified by APHIS FOR FURTHER INFORMATION CONTACT:
pathogens that are routinely used in based on our review of the petition and
plant biotechnology and have a history Thomas P. Dickson, Acting Director,
our evaluation and analysis of Program Development and Regulatory
of safe use. GHB811 cotton is currently comments will be considered in the
regulated under 7 CFR part 340. Analysis, Rural Utilities Service, 1400
development of our decisionmaking Independence Ave. SW., STOP 1522,
Interstate movements and field tests of documents. As part of our
GHB811 cotton have been conducted Room 5164, South Building,
decisionmaking process regarding a GE Washington, DC 20250–
asabaliauskas on DSKBBXCHB2PROD with NOTICES

under notifications acknowledged by organism’s regulatory status, APHIS
APHIS. 1522.Telephone: (202) 690–4492. Fax:
prepares a plant pest risk assessment to (202) 720–8435 or email
Field tests conducted under APHIS assess its plant pest risk and the
oversight allowed for evaluation in a Thomas.Dickson@wdc.usda.gov
appropriate environmental
natural agricultural setting while documentation—either an SUPPLEMENTARY INFORMATION: The Office
imposing measures to minimize the risk of Management and Budget’s (OMB)
of persistence in the environment after 1 To view the notice, go to http:// regulation (5 CFR part 1320)
completion of the tests. Data are www.regulations.gov/#!docketDetail;D=APHIS- implementing provisions of the
gathered on multiple parameters and 2011-0129. Paperwork Reduction Act of 1995 (Pub.

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Document Created: 2017-10-27 02:06:11
Document Modified: 2017-10-27 02:06:11

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 December 26, 2017.
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]ov.
FR Citation		82 FR 49782

82 FR 49782 - Bayer CropScience LP; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Resistance to Glyphosate and Isoxaflutole

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 82, Issue 207 (October 27, 2017)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service