[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15096-15097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06013]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0113]


Dow AgroSciences LLC; Availability of Petition for Determination 
of Nonregulated Status of Cotton Genetically Engineered for Resistance 
to 2,4-D and Glufosinate

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 Dow AgroSciences LLC 
(DAS) seeking a determination of nonregulated status of cotton 
designated as DAS-8191[Oslash]-7, which has been genetically engineered 
for resistance to the herbicides 2,4-D and glufosinate. The petition 
has been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms and products. 
We are making the DAS 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 May 
19, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0113-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0113, 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-2013-
0113 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 number 13-262-01p.

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].

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.''

[[Page 15097]]

    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 13-262-01p) 
from Dow AgroSciences LLC (DAS) of Indianapolis, IN, seeking a 
determination of nonregulated status of cotton (Gossypium hirsutum) 
designated as DAS-8191[Oslash]-7, which has been genetically engineered 
for resistance to certain broadleaf herbicides in the phenoxy auxin 
group (particularly the herbicide 2,4-D) and resistance to the 
herbicide glufosinate. The DAS petition states that information 
collected during field trials and laboratory analyses indicates that 
DAS-8191[Oslash]-7 cotton is not likely to be a plant pest or result in 
weediness potential and therefore should not be a regulated article 
under APHIS' regulations in 7 CFR part 340.
    As described in the petition, DAS developed DAS-8191[Oslash]-7 
cotton using Agrobacterium-mediated transformation to incorporate the 
aad-12 gene from Delftia acidovorans and the pat gene from Streptomyces 
viridochromogenes into cotton. The aad-12 gene encodes the enzyme 
aryloxyalkanoate dioxygenase-12 (AAD-12) which, when expressed in 
plants, degrades 2,4-D to herbicidally-inactive 2,4-dichlorophenol. The 
pat gene encodes the enzyme phosphinothricin acetyltransferase that 
inactivates glufosinate.
    DAS has submitted information on the use of 2,4-D on DAS-
8191[Oslash]-7 cotton to the U.S. Environmental Protection Agency 
(EPA), which is responsible for evaluating and approving the use of any 
herbicides or pesticides on plants, including GE plants.\1\
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    \1\ The roles of the Federal agencies responsible for regulating 
the safe use of GE organisms is described in a notice published in 
the Federal Register on June 26, 1986 (51 FR 23302). The notice may 
be viewed at http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
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    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 \2\ 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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    \2\ 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. We also 
request that, when possible, commenters provide relevant information 
regarding specific localities or regions as cotton 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 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 2) 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 12th day of March 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-06013 Filed 3-17-14; 8:45 am]
BILLING CODE 3410-34-P