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, 41351-41353 [2012-17133]

Download as PDF Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 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: john.t.turner@aphis.usda.gov. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. SUPPLEMENTARY INFORMATION: srobinson on DSK4SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: 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 § 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 § 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 09–183–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of soybean (Glycine max) designated as event MON 87769, which has been genetically engineered to produce stearidonic acid, an omega3 fatty acid not found in conventional soybean. The petition stated 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 December 27, 2011 (76 FR 80871–80872, Docket No. APHIS–2011– 0095), APHIS announced the availability of the Monsanto petition, a Plant Pest Risk Assessment (PPRA), and a draft Environmental Assessment (EA) for public comment. APHIS solicited comments on the petition, whether the 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0095. VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 subject soybean are likely to pose a plant pest risk, the draft EA, and the PPRA for 60 days ending on February 27, 2012. APHIS received 226 comments during the comment period, with 21 commenters expressing support of a determination of nonregulated status and the remaining 205 commenters expressing opposition. Issues raised during the comment period include socioeconomic impacts, changes in nutrition caused by the product, environmental impacts, changes in soybean properties, and product safety. APHIS has addressed the issues raised during the comment period and has provided responses to these 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 a determination of nonregulated status of Monsanto’s soybean event MON 87769, an EA has been prepared. The 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). 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. Determination Based on APHIS’ analysis of field and laboratory data submitted by Monsanto, 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 Monsanto’s soybean event MON 87769 is unlikely to pose a plant pest risk and therefore 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. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 41351 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. 2012–17168 Filed 7–12–12; 8:45 am] BILLING CODE 3410–34–P 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: 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 https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00340001. • 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 https://www.regulations.gov/ #!docketDetail;D=APHIS-2012-0034 or in our reading room, which is located in SUMMARY: E:\FR\FM\13JYN1.SGM 13JYN1 41352 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES 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 https://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 https://www.aphis.usda.gov/brs/ aphisdocs/12_03301p.pdf, https://www. aphis.usda.gov/brs/aphisdocs/ 12_03301p_fonsi.pdf, https://www.aphis. usda.gov/brs/aphisdocs/12_03301p_ pdet.pdf, https://www.aphis.usda.gov/ brs/aphisdocs/08_34001p.pdf, and https://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: john.t.turner@aphis.usda.gov. To obtain copies of the supporting documents, contact Ms. Cindy Eck at (301) 851– 3892, email: cynthia.a.eck@aphis.usda. gov. 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. VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 Such genetically engineered organisms and products are considered ‘‘regulated articles.’’ The regulations in § 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 § 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. 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 1 To view the notice, determination, supporting documents, and the comments we received go to https://www.regulations.gov/#!docketDetail;D= APHIS-2010-0102. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 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 E:\FR\FM\13JYN1.SGM 13JYN1 srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 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 § 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 § 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 VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 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 https://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] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2012–0046] GENECTIVE SA; Availability of Petition for Determination of Nonregulated Status of Maize Genetically Engineered for Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from GENECTIVE SA seeking a determination of nonregulated status of maize designated as VCO-;1981–5, which has been genetically engineered for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the GENECTIVE SA petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. 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: SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 41353 • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00460001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0046, 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0046 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 is also available on the APHIS Web site at https:// www.aphis.usda.gov/brs/aphisdocs/ 11_34201p.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: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov. 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 (GE) organisms and products are considered ‘‘regulated articles.’’ The regulations in § 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 § 340.6 describe the form that a petition for a determination of nonregulated status E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41351-41353]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://www.regulations.gov/#!docketDetail;D=APHIS-2012-0034 or in our reading 
room, which is located in

[[Page 41352]]

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 https://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 https://www.aphis.usda.gov/brs/aphisdocs/12_03301p.pdf, https://www.aphis.usda.gov/brs/aphisdocs/12_03301p_fonsi.pdf, https://www.aphis.usda.gov/brs/aphisdocs/12_03301p_pdet.pdf, https://www.aphis.usda.gov/brs/aphisdocs/08_34001p.pdf, and https://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: john.t.turner@aphis.usda.gov. To obtain copies 
of the supporting documents, contact Ms. Cindy Eck at (301) 851-3892, 
email: cynthia.a.eck@aphis.usda.gov.

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.
---------------------------------------------------------------------------

    \1\ To view the notice, determination, supporting documents, and 
the comments we received go to  https://www.regulations.gov/#!docketDetail;D=APHIS-2010-0102.
---------------------------------------------------------------------------

    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

[[Page 41353]]

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 
https://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]
BILLING CODE 3410-34-P
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