[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56555-56557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22409]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0042]


Dow AgroSciences LLC; Determination of Nonregulated Status of 
Herbicide Resistant Corn and Soybeans

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that three 
varieties of herbicide resistant corn and soybeans produced by Dow 
AgroSciences LLC are no longer considered regulated articles under our 
regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by the Dow AgroSciences LLC in its three petitions for a 
determination of nonregulated status, our analysis of publically 
available scientific data, and comments received from the public on the 
petition for nonregulated status and its associated environmental 
impact statement and plant pest risk assessments. This notice also 
announces the availability of our written determination and record of 
decision.

DATES: Effective Date: September 22, 2014.

ADDRESSES: You may read the documents referenced in this notice and any 
comments we received in our reading room. The reading room 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. Those 
documents are also available on the Internet at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition 
Numbers 09-233-01p, 09-349-01p, and 11-234-01p and are posted with the 
comments we received on the Regulations.gov Web site at http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0042.

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 documents referenced in this notice, contact Ms. Cindy Eck at 
(301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant

[[Page 56556]]

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 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 received three petitions (referred to below as ``the 
petitions'') from Dow AgroSciences LLC seeking determinations of 
nonregulated status for corn and soybean cultivars genetically 
engineered to be resistant to herbicides. The first petition, APHIS 
Petition Number 09-233-01p, seeks a determination of nonregulated 
status for corn (Zea mays) designated as event DAS-40278-9, which has 
been genetically engineered for increased resistance to certain 
broadleaf herbicides in the phenoxy auxin group (particularly the 
herbicide 2,4-D) and resistance to grass herbicides in the 
aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) 
inhibitor group (i.e., ``fop'' herbicides, such as quizalofop-p-ethyl). 
The second petition, APHIS Petition Number 09-349-01p, seeks a 
determination of nonregulated status for soybean (Glycine max) 
designated as event DAS-68416-4, which has been genetically engineered 
for resistance to certain broadleaf herbicides in the phenoxy auxin 
growth regulator group (particularly the herbicide 2,4-D) and the 
nonselective herbicide glufosinate. The third petition, APHIS Petition 
Number 11-234-01p, seeks a determination of nonregulated status for 
soybean designated as event DAS-44406-6, which has been genetically 
engineered for resistance to certain broadleaf herbicides in the auxin 
growth regulator group (particularly the herbicide 2,4-D) and the 
nonselective herbicides glyphosate and glufosinate. The petitions state 
that these articles are unlikely to pose a plant pest risk and, 
therefore, should not be regulated articles under APHIS' regulations in 
7 CFR part 340.
    Notices were published \1\ in the Federal Register for each 
petition advising the public that APHIS had received the petition and 
was seeking public comments on the petition. The notices for the first 
two petitions (DAS-40278-9 corn and DAS-68416-4 soybean) additionally 
sought comment on our plant pest risk assessment (PPRA) and our draft 
environmental assessment (EA) for each petition.
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    \1\ Docket No. APHIS-2010-0103 published on December 27, 2011, 
76 FR 80872-80873; Docket No. APHIS-2012-0019 published on July 13, 
2012, 77 FR 41367-41368; and Docket No. APHIS-2012-0032 published on 
July 13, 2012, 77 FR 41361-41362. The Federal Register notices for 
the petitions and supporting and related materials, including public 
comments, are available at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103; http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0019; and http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0032.
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    Following review of public comments, we published another notice 
\2\ in the Federal Register on May 16, 2013 (78 FR 28798-28800, Docket 
No. APHIS-2013-0042), advising the public of our intent to prepare an 
environmental impact statement (EIS) for the potential determination of 
nonregulated status requested by the petitions. APHIS decided to 
prepare an EIS in order to perform a comprehensive environmental 
analysis of the potential environmental impacts that may occur as a 
result of granting a determination of nonregulated status for these 
three events.
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    \2\ To view the notice the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0042.
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National Environmental Policy Act and Record of Decision

    To provide the public with documentation of APHIS' review and 
analysis of the potential environmental impacts associated with a 
determination of nonregulated status of DAS-40278-9 corn, DAS-68416-4 
soybean, and DAS-44406-6 soybean, an EIS has been prepared in 
accordance with: (1) The National Environmental Policy Act of 1969 
(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) USDA regulations 
implementing NEPA (7 CFR part 1b); and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    A notice of availability regarding the draft EIS prepared by APHIS 
was published by the Environmental Protection Agency (EPA) in the 
Federal Register on January 10, 2014 (79 FR 1861-1862, Docket No. ER-
FRL-9012-9). Along with the draft EIS,\3\ APHIS also made available the 
PPRA for the third petition, DAS-44406-6 soybean, along with the PPRAs 
for the first two petitions (DAS-40278-9 corn and DAS-68416-4 soybean). 
APHIS reviewed and evaluated all of the public comments received on the 
draft EIS and prepared formal responses to them as part of the final 
EIS.
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    \3\ To view the draft EIS, final EIS, supporting documents, and 
the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0042.
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    A notice of availability regarding the final EIS prepared by APHIS 
was published by EPA in the Federal Register on August 8, 2014 (79 FR 
46439, Docket No. ER-FRL-9016-3). The NEPA implementing regulations in 
40 CFR 1506.10 require a minimum 30-day review period between the time 
the notice of availability of a final EIS is published and the time an 
agency makes a decision on an action covered by the EIS. APHIS has 
reviewed and evaluated the comments received during the 30-day review 
period and has concluded that it has fully and appropriately analyzed 
the relevant environmental issues covered by the final EIS and those 
comments. Based on our final EIS, the response to public comments, and 
other pertinent scientific data, APHIS has prepared a record of 
decision for the final EIS.

Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by 
Dow AgroSciences LLC, references provided in the petitions, peer-
reviewed publications, information analyzed in the EIS, the PPRAs, 
comments provided by the public, and APHIS' evaluation of and response 
to those comments, APHIS has determined that DAS-40278-9 corn, DAS-
68416-4 soybean, and DAS-44406-6 soybean are unlikely to pose a plant 
pest risk. Accordingly, the petitions requesting a determination of 
nonregulated status are approved and DAS-40278-9 corn, DAS-68416-4 
soybean, and DAS-44406-6 soybean are no longer subject to our 
regulations governing the introduction of certain genetically 
engineered organisms and to the plant pest provisions of the Plant 
Protection Act.
    Copies of the three signed determination documents for nonregulated 
status and the signed record of decision for the EIS, as well as copies 
the final EIS and the three PPRAs are available as indicated in the 
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.


[[Page 56557]]


    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 15th day of September 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-22409 Filed 9-19-14; 8:45 am]
BILLING CODE 3410-34-P