Monsanto Co.; Determination of Nonregulated Status of Soybean Genetically Engineered To Produce Stearidonic Acid, 41350-41351 [2012-17168]

Download as PDF 41350 Notices Federal Register Vol. 77, No. 135 Friday, July 13, 2012 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 Submission for OMB Review; Comment Request srobinson on DSK4SPTVN1PROD with NOTICES July 9, 2012. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. 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Summary of Collection: The National School Lunch Program (NSLP) and the School Breakfast Program (SBP) provide federal financial assistance and commodities to schools serving lunches and breakfasts that meet required nutritional standards. The Improper Payments Information Act of 2002 (Pub. L. 107–300) requires USDA to identify and reduce erroneous payments in various programs, including the NSLP and SBP. To comply with the Improper Payments Information Act and Executive Order 13520, USDA must report on the prevalence of erroneous payments in the NSLP and SBP on an annual basis and if erroneous payments are significant, take actions to reduce improper payments and report on the efficacy of those actions. The APEC Study II will produce national estimates of erroneous payments for SY 2012–13 based on new collection of primary data. 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[FR Doc. 2012–17066 Filed 7–12–12; 8:45 am] BILLING CODE 3410–30–P PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0095] Monsanto Co.; Determination of Nonregulated Status of Soybean Genetically Engineered To Produce Stearidonic Acid 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 87769, which has been genetically engineered to produce stearidonic acid, an omega-3 fatty acid not found in conventional soybean, 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: July 13, 2012. 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 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-2011-0095. SUMMARY: E:\FR\FM\13JYN1.SGM 13JYN1 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

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41350-41351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17168]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0095]


Monsanto Co.; Determination of Nonregulated Status of Soybean 
Genetically Engineered To Produce Stearidonic Acid

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a soybean 
line developed by the Monsanto Co., designated as event MON 87769, 
which has been genetically engineered to produce stearidonic acid, an 
omega-3 fatty acid not found in conventional soybean, 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: July 13, 2012.

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 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-2011-0095.

[[Page 41351]]


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 documents referenced in this notice, contact Ms. Cindy Eck at 
(301) 851-3892, email: 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 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 omega-3 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 subject soybean 
are likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on February 27, 2012.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0095.
---------------------------------------------------------------------------

    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.

    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
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