Bayer CropScience LP; Determination of Nonregulated Status for Cotton Genetically Engineered for Insect Resistance and Herbicide Tolerance, 63278-63279 [2011-26349]

Download as PDF 63278 Notices Federal Register Vol. 76, No. 197 Wednesday, October 12, 2011 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. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2010–0102] Bayer CropScience LP; Determination of Nonregulated Status for Cotton Genetically Engineered for Insect Resistance and Herbicide Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that a genetically engineered cotton developed by Bayer CropScience LP, designated as TwinLinkTM cotton (events T304–40 and GHB119), which has been genetically engineered to be tolerant to the herbicide glufosinate and resistant to several lepidopteran pests, 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 CropScience LP 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: October 12, 2011. 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 jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 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) 690–2817 before coming. Those documents are also available on the Internet at https:// www.aphis.usda.gov/biotechnology/ not_reg.html and are posted with the previous notice and the comments we received on the Regulations.gov Web site at https://www.regulations.gov/ #!docketDetail;D=APHIS–2010–0102. FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737–1236; (301) 734– 0942, e-mail: evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734–0667, e-mail: cynthia.a.eck@aphis.usda.gov. SUPPLEMENTARY INFORMATION: that TwinLinkTM cotton 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 notice1 published in the Federal Register on June 28, 2011 (76 FR 37769– 37770, Docket No. APHIS–2010–0102), 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 cotton is likely to pose a plant pest risk, the draft EA, and the PPRA for 60 days ending on August 29, 2011. APHIS received two comments during the comment period. The commenters expressed general opposition to genetically engineered crops but did not provide any specific comments regarding the petition, draft EA, or PPRA. 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 08–340–01p) from Bayer CropScience LP (Bayer), seeking a determination of nonregulated status for TwinLinkTM cotton (events T304–40 and GHB119), which has been genetically engineered to be tolerant to the herbicide glufosinate and resistant to several lepidopteran pests, stating To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the determination of nonregulated status for Bayer’s TwinLinkTM cotton, 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 and other pertinent scientific data, APHIS has reached a finding of no significant impact with regard to the preferred alternative identified in the EA. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 National Environmental Policy Act 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, and comments provided by the public, APHIS has determined that Bayer’s TwinLinkTM cotton is unlikely to pose a plant pest risk and therefore is no 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2010-0102. E:\FR\FM\12OCN1.SGM 12OCN1 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 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, and finding of no significant impact 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 5th day of October 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–26349 Filed 10–11–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service SUPPLEMENTARY INFORMATION: [Docket No. APHIS–2011–0038] Background Monsanto Co.; Determination of Nonregulated Status for Soybean Genetically Engineered for Insect Resistance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that a soybean line developed by the Monsanto Co., designated as event MON 87701, which has been genetically engineered for insect resistance, 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 the Monsanto Company 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: October 12, 2011. 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 jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 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) 690–2817 before coming. Those documents are also available on the Internet at https:// www.aphis.usda.gov/biotechnology/ not_reg.html and are posted with the previous notice and the comments we received on the Regulations.gov Web site at https://www.regulations.gov/ #!docketDetail;D=APHIS–2011–0038. FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 734– 0942, e-mail: evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734–0667, e-mail: cynthia.a.eck@aphis.usda.gov. 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 09–082–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status for soybean (Glycine max) designated as event MON 87701, which has been genetically engineered for insect resistance, stating 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. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 63279 In a notice1 published in the Federal Register on June 28, 2011 (76 FR 37770– 37771, Docket No. APHIS–2011–0038), 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 subject soybeans are likely to pose a plant pest risk, the draft EA, and the PPRA for 60 days ending on August 29, 2011. APHIS received four comments during the comment period. Two commenters referenced a different soybean line. One commenter expressed general opposition to genetically engineered crops but did not provide any specific comments on the petition, draft EA, or PPRA. One commenter suggested that APHIS should analyze the impacts of MON 87701 on bees and groundwater. APHIS has addressed the issues raised by this commenter in an attachment to the finding of no significant impact, and impacts to nontarget insects and impacts on water are both addressed in the EA. 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 for Monsanto’s soybean event MON 87701, 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 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0038. E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63278-63279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26349]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / 
Notices

[[Page 63278]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0102]


Bayer CropScience LP; Determination of Nonregulated Status for 
Cotton Genetically Engineered for Insect Resistance and Herbicide 
Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a 
genetically engineered cotton developed by Bayer CropScience LP, 
designated as TwinLinkTM cotton (events T304-40 and GHB119), 
which has been genetically engineered to be tolerant to the herbicide 
glufosinate and resistant to several lepidopteran pests, 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 
CropScience LP 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: October 12, 2011.

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) 690-2817 before coming. Those 
documents are also available on the Internet at https://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at https://www.regulations.gov/#!docketDetail;D=APHIS-2010-0102.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, e-
mail: cynthia.a.eck@aphis.usda.gov.

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 08-340-01p) from 
Bayer CropScience LP (Bayer), seeking a determination of nonregulated 
status for TwinLinkTM cotton (events T304-40 and GHB119), 
which has been genetically engineered to be tolerant to the herbicide 
glufosinate and resistant to several lepidopteran pests, stating that 
TwinLinkTM cotton 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 June 28, 2011 
(76 FR 37769-37770, Docket No. APHIS-2010-0102), 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 cotton is 
likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on August 29, 2011.
---------------------------------------------------------------------------

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

    APHIS received two comments during the comment period. The 
commenters expressed general opposition to genetically engineered crops 
but did not provide any specific comments regarding the petition, draft 
EA, or PPRA.

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 for Bayer's TwinLinkTM 
cotton, 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 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 
Bayer, references provided in the petition, peer-reviewed publications, 
information analyzed in the EA, the PPRA, and comments provided by the 
public, APHIS has determined that Bayer's TwinLinkTM cotton 
is unlikely to pose a plant pest risk and therefore is no

[[Page 63279]]

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, and finding of no significant impact 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 5th day of October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-26349 Filed 10-11-11; 8:45 am]
BILLING CODE 3410-34-P
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