[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41358-41359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17136]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0029]


Bayer CropScience LP; Availability of Petition, Plant Pest Risk 
Assessment, and Environmental Assessment for Determination of 
Nonregulated Status of Soybean Genetically Engineered for Herbicide 
Tolerance

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 soybean designated as 
event FG72, which has been genetically engineered for 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 
soliciting comments on whether this genetically engineered soybean is 
likely to pose a plant pest risk. We are making available for public 
comment the Bayer petition, our plant pest risk assessment, and our 
draft environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments that we receive on or before 
September 11, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http:// 
www.regulations.gov/#!documentDetail;D=APHIS-2012-0029-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0029, 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-2012-
0029 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, draft environmental assessment, and plant pest risk 
assessment are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/09_32801p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/09_32801p_dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/09_32801p_dpra.pdf.

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, draft environmental assessment, or plant pest risk 
assessment, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    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

[[Page 41359]]

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 has 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 to tolerate 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.
    As described in the petition, soybean event FG72 contains the 
stably integrated 2mepsps gene, which confers tolerance to the 
herbicide glyphosate, and the hppdPfW336 gene, which confers tolerance 
to HPPD inhibitors such as the herbicide isoxaflutole.
    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 
test. 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.
    In section 403 of the Plant Protection Act, ``plant pest'' is 
defined as any living stage of any of the following that can directly 
or indirectly injure, cause damage to, or cause disease in any plant or 
plant product: A protozoan, a nonhuman animal, a parasitic plant, a 
bacterium, a fungus, a virus or viroid, an infectious agent or other 
pathogen, or any article similar to or allied with any of the 
foregoing. APHIS has prepared a plant pest risk assessment to determine 
if soybean event FG72 is unlikely to pose a plant pest risk.
    APHIS has also prepared a draft Environmental Assessment (EA) in 
which it presents two alternatives based on its analyses of data 
submitted by Bayer, a review of other scientific data, and field tests 
conducted under APHIS oversight. APHIS is considering the following 
alternatives: (1) Take no action, i.e., APHIS would not change the 
regulatory status of soybean event FG72 and it would continue to be a 
regulated article, or (2) make a determination of nonregulated status 
for soybean event FG72.
    The draft EA has been prepared to provide the APHIS decisionmaker 
with a review and analysis of any potential environmental impacts 
associated with the proposed determination of nonregulated status for 
soybean event FG72. The draft EA was 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).
    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 updated process for 
soliciting public comment when considering such petitions. As described 
in the notice, all petitions received by APHIS on or after March 6, 
2012, will be handled using the updated process, whereby APHIS will 
publish two separate notices in the Federal Register for petitions for 
which APHIS prepares an environmental assessment. For petitions 
received before this date, however, we indicated that petitions may 
follow our previous process, i.e., the petition, draft EA, and PPRA 
will be made available in a single Federal Register notice for a 60-day 
comment period. For this petition, APHIS will follow our previous 
process.
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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, 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. We are also soliciting written 
comments from interested or affected persons on the plant pest risk 
assessment and the draft EA prepared to examine any potential 
environmental impacts of the proposed determination of nonregulated 
status of the subject soybean line. The petition, draft EA, and plant 
pest risk assessment are available for public review, and copies of the 
petition, draft EA, and plant pest risk assessment are available as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments received regarding the petition, draft EA, 
and plant pest risk assessment will be available for public review. 
After reviewing and evaluating the comments on the petition, the draft 
EA, plant pest risk assessment, and other data, APHIS will furnish a 
response to the petitioner, either approving or denying the petition. 
APHIS will also publish a notice in the Federal Register announcing the 
regulatory status of soybean event FG72 and the availability of APHIS' 
written environmental decision and regulatory determination.

    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 9th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17136 Filed 7-12-12; 8:45 am]
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