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)

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, 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.
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    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]
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