[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41351-41353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17133]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2012-0034]


Bayer CropScience LP; Availability of a Finding of No Significant 
Impact and a Preliminary Decision for an Extension of a Determination 
of Nonregulated Status of Cotton Genetically Engineered for Herbicide 
Tolerance and Insect Resistance

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 prepared a finding of no significant impact and 
a preliminary decision regarding a request from Bayer CropScience LP to 
extend to cotton event T303-3, which has been genetically engineered to 
be tolerant to the herbicide glufosinate and resistant to several 
lepidopteran pests, our determination of nonregulated status of 
TwinLinkTM cotton (event T304-40). We are making available 
for public comment our finding of no significant impact for the 
proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
August 13, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0034-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2012-0034, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The Bayer CropScience LP extension request, our finding of no 
significant impact (FONSI), our preliminary determination, and any 
comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0034 or in our reading 
room, which is located in

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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. 
Supporting documents regarding our determination of nonregulated status 
of TwinLinkTM cotton, the antecedent organism, including 
Bayer's petition, our environmental assessment, FONSI, plant pest risk 
assessment, and determination, and any comments we received regarding 
our determination of nonregulated status of TwinLinkTM 
cotton, can be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0102 or in our reading room.
    The extension request, finding of no significant impact, and 
preliminary determination for this docket, as well as Bayer's petition 
and our combined environmental assessment, FONSI, plant pest risk 
assessment, and determination for TwinLinkTM cotton, the 
antecedent organism, are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/12_03301p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/12_03301p_fonsi.pdf, http://www.aphis.usda.gov/brs/aphisdocs/12_03301p_pdet.pdf, http://www.aphis.usda.gov/brs/aphisdocs/08_34001p.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/08_34001p_com.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 supporting documents, 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 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    In a notice \1\ published in the Federal Register on October 12, 
2011 (76 FR 63278-63279, Docket No. APHIS-2010-0102), APHIS announced 
our determination of nonregulated status of TwinLinkTM 
cotton (events T304-40 and GHB119). APHIS has received a request for an 
extension of a determination of nonregulated status (APHIS Number 12-
033-01p) of TwinLinkTM cotton event T304-40 from Bayer 
CropScience LP (BCS) of Research Triangle Park, NC, seeking a 
determination of nonregulated status of cotton (Gossypium spp.) 
designated as event T303-3, which has been genetically engineered to be 
tolerant to the herbicide glufosinate and resistant to several 
lepidopteran pests. In its request, BCS stated that this cotton is 
similar to TwinLinkTM cotton (event T304-40) and, based on 
the similarity to the antecedent organism, is unlikely to pose a plant 
pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
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    \1\ To view the notice, determination, supporting documents, and 
the comments we received go to  http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0102.
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    As described in the extension request, cotton event T303-3 has been 
genetically engineered by Agrobacterium-mediated transformation 
utilizing vector pTDL004 containing a cry1Ab gene construct, encoding 
insect resistance, and the bar gene as a selectable marker conferring 
tolerance to glufosinate ammonium herbicides. The antecedent organism, 
cotton event T304-40, was also generated through Agrobacterium-mediated 
transformation utilizing a slightly different vector (pTDL008). Both 
cotton events produce the same insecticidal crystal protein (ICP) 
Cry1Ab (expression product of the cry1Ab gene) and PAT protein 
(expression product of the bar gene). Cotton event T303-3 is currently 
regulated under 7 CFR part 340. Interstate movements and field tests of 
cotton event T303-3 have been conducted under notifications 
acknowledged by APHIS.
    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.
    APHIS completed an environmental assessment (EA) and finding of no 
significant impact (FONSI) for TwinLinkTM cotton (see 
footnote 1). The EA and FONSI were prepared, in accordance with the 
National Environmental Policy Act (NEPA), to provide the APHIS 
decisionmaker with a review and analysis of any potential environmental 
impacts associated with the proposed determination of nonregulated 
status of TwinLinkTM cotton. APHIS has carefully examined 
the NEPA documentation completed for TwinLinkTM cotton and 
has concluded that the BCS extension request for a determination of 
nonregulated status of cotton event T303-3 encompasses the same scope 
of environmental analysis as TwinLinkTM cotton. Therefore, 
the existing NEPA documentation completed for TwinLinkTM 
cotton is being used to evaluate and determine if there are any 
potentially significant impacts to the human environment from APHIS' 
response to the BCS extension request for a determination of 
nonregulated status of cotton event T303-3.
    Based on APHIS' analyses of data submitted by Bayer, a review of 
other scientific data, and field tests conducted under APHIS oversight, 
the TwinLinkTM cotton EA presented two alternatives: (1) 
Take no action, i.e., APHIS would not change the regulatory status of 
TwinLinkTM cotton and it would continue to be a regulated 
article, or (2) make a determination of nonregulated status of 
TwinLinkTM cotton. Based on the similarity of cotton event 
T303-4 to the antecedent organism TwinLinkTM cotton event 
T304-40, APHIS has concluded that the alternatives considered for 
TwinLinkTM cotton are relevant to APHIS' regulatory actions 
associated with cotton event T303-3 and are therefore being used in 
their entirety.
    The EA was prepared in accordance with (1) the NEPA, as amended (42 
U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental 
Quality for implementing the procedural

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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 previous NEPA review 
completed for TwinLinkTM cotton and our conclusion that the 
BCS extension request for a determination of nonregulated status of 
cotton event T303-3 encompasses the same scope of environmental 
analysis as TwinLinkTM cotton, APHIS has reached a FONSI 
with regard to a determination of nonregulated status of cotton event 
T303-3.
    Based on APHIS' analysis of field and laboratory data submitted by 
BCS, references provided in the extension request, peer-reviewed 
publications, information analyzed in the TwinLinkTM cotton 
EA, and the similarity of cotton event T303-3 to the antecedent 
organism, cotton event T304-40, APHIS has determined that cotton event 
T303-3 is unlikely to pose a plant pest risk. We have therefore reached 
a preliminary decision to approve the request to extend the 
determination of nonregulated status of cotton event T304-40 to cotton 
event T303-3, whereby cotton event T303-3 would no longer be subject to 
our regulations governing the introduction of certain genetically 
engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of cotton event T304-40 to cotton event T303-3.
    APHIS will accept written comments on the FONSI regarding a 
determination of nonregulated status of event T303-3 for a period of 30 
days from the date of this notice. The extension request, FONSI, and 
preliminary determination for event T303-3, as well as the supporting 
documents, are available for public review 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 FONSI will be 
available for public review. After reviewing and evaluating the 
comments on the FONSI, if APHIS determines that no substantive 
information has been received that would warrant APHIS altering its 
preliminary regulatory determination or FONSI, our preliminary 
regulatory determination will become final and effective upon 
notification of the public through an announcement on our Web site at 
http://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml. APHIS 
will also furnish a response to the petitioner regarding our final 
regulatory determination. No further Federal Register notice will be 
published announcing the final regulatory determination regarding 
cotton event T303-3.

    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. 2012-17133 Filed 7-12-12; 8:45 am]
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