[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
appearing in this section.
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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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