[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51706-51707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20380]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 78, No. 162 / Wednesday, August 21, 2013 / 
Notices  

[[Page 51706]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0029]


Bayer CropScience LP; Determination of Nonregulated Status of 
Soybean Genetically Engineered for Herbicide Resistance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a soybean 
line developed by Bayer CropScience LP (Bayer), designated as event 
FG72, which has been genetically engineered for resistance to the 
herbicides glyphosate and isoxaflutole, is no longer considered a 
regulated article under our regulations governing the introduction of 
certain genetically engineered organisms. Our determination is based on 
our evaluation of data submitted by Bayer in its petition for a 
determination of nonregulated status, our analysis of available 
scientific data, and comments received from the public in response to 
our previous notice announcing the availability of the petition for 
nonregulated status and its associated environmental assessment and 
plant pest risk assessment. This notice also announces the availability 
of our written determination and finding of no significant impact.

DATES: Effective Date: August 21, 2013.

ADDRESSES: You may read the documents referenced in this notice and the 
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/not_reg.html under APHIS Petition 
Number 09-328-01p and are posted with the previous notice and the 
comments we received on the Regulations.gov Web site at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0029.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Stankiewicz Gabel, Chief, 
Biotechnology Environmental Analysis Branch, Environmental Risk 
Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3927, email: 
[email protected]. To obtain copies of the 
petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    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 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 received a petition (APHIS Petition Number 09-328-01p) from 
Bayer CropScience LP (Bayer), seeking a determination of nonregulated 
status of soybean designated as event FG72, which has been genetically 
engineered for resistance to the herbicides glyphosate and 
isoxaflutole. The petition states that this soybean is unlikely to pose 
a plant pest risk and, therefore, should not be a regulated article 
under APHIS' regulations in 7 CFR part 340.
    In a notice \1\ published in the Federal Register on July 13, 2012 
(77 FR 41358-41359, Docket No. APHIS-2012-0029), APHIS announced the 
availability of the Bayer petition, a plant pest risk assessment 
(PPRA), and a draft environmental assessment (EA) for public comment. 
APHIS solicited comments on the petition, whether the subject soybean 
is likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on September 11, 2012.
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    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0029.
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    APHIS received 80 comments during the comment period. Several of 
these comments included electronic attachments consisting of a 
consolidated document of many identical or nearly identical letters, 
for a total of 5,096 comments. Issues raised during the comment period 
include the potential effects of FG72 on human health, animals, and 
nontarget organisms; herbicide use changes; and economic costs of 
herbicide-resistant weeds. APHIS has addressed the issues raised during 
the comment period and has provided responses to comments as an 
attachment to the finding of no significant impact.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status of Bayer's soybean event FG72, an 
EA has been prepared. The EA was prepared in accordance with: (1) The 
National Environmental Policy Act (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). Based on our EA, 
the response to public comments, and other pertinent scientific data, 
APHIS has reached a finding of no significant impact with regard to the 
preferred alternative identified in the EA.

[[Page 51707]]

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Bayer, references provided in the petition, peer-reviewed publications, 
information analyzed in the EA, the PPRA, comments provided by the 
public, and information provided in APHIS' response to those public 
comments, APHIS has determined that Bayer's soybean event FG72 is 
unlikely to pose a plant pest risk. We have, therefore, determined that 
Bayer's soybean event FG72 is no longer subject to our regulations 
governing the introduction of certain genetically engineered organisms.
    Copies of the signed determination document, as well as copies of 
the petition, PPRA, EA, finding of no significant impact, and response 
to comments are available as indicated in the ADDRESSES and FOR FURTHER 
INFORMATION CONTACT sections of this notice.

    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 16th day of August 2013.
Michael Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-20380 Filed 8-20-13; 8:45 am]
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