Monsanto Co.; Determination of Nonregulated Status of Corn Genetically Engineered for Drought Tolerance, 80869-80870 [2011-33011]

Download as PDF Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices • Due diligence procedures. Once we have made these contacts with each interested investor, USDA will hold one or more meetings, as necessary. It is expected that these meetings will occur over a one- to-two month period. USDA believes that, in order for this effort to be successful, each participating investor: • Should be a well-established investor, including, but not limited to, entities such as pension funds, commercial banking institutions, insurance investment funds, foundational endowments, or family offices; • Interested in investing in low risk, rural infrastructure as part of a larger portfolio; • Willing to commit funds for the long term (e.g., 20+ years); and • Interested in participating in a limited number of interviews and panels as we shape this initiative with USDA. Interested Entities If you are interested in the formation of, and participation in, this effort for increasing access to capital for community facility projects in rural America, please provide the following information to Doug O’Brien, as specified in the ADDRESSES section of this Notice, on or before January 26, 2012: • Name of Institution, • Headquarters Mailing Address, • Contact Name and Title, • Contact Mailing Address, • Contact Telephone Number(s), and • Contact Email Address. Thomas J. Vilsack, Secretary. [FR Doc. 2011–33111 Filed 12–23–11; 8:45 am] BILLING CODE 3410–01–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0023] sroberts on DSK5SPTVN1PROD with NOTICES Monsanto Co.; Determination of Nonregulated Status of Corn Genetically Engineered for Drought Tolerance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that a corn line developed by the Monsanto Co., designated as event MON 87460, which SUMMARY: VerDate Mar<15>2010 22:00 Dec 23, 2011 Jkt 226001 has been genetically engineered for drought tolerance, 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: December 27, 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-2011-0023. 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, email: evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734–0667, 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 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 80869 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 09–055–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of corn (Zea mays L.) designated as event MON 87460, which has been genetically engineered for drought tolerance, stating that this corn 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 May 11, 2011 (76 FR 27303– 27304, Docket No. APHIS–2011–0023), 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 corn is likely to pose a plant pest risk, the draft EA, and the PPRA for 60 days ending on July 11, 2011. On July 27, 2011, APHIS published in the Federal Register (76 FR 44891–44892, Docket No. APHIS–2011–0023) a notice announcing the extension of the public comment period for 30 days, ending on August 12, 2011. APHIS received 250 comments through the Regulations.gov Web site during the comment period, with 21 commenters expressing support of the EA’s preferred alternative to make a determination of nonregulated status and the remaining 229 commenters expressing opposition. Three of the submitted comments opposing a determination of nonregulated status included electronic attachments that consisted either of: (1) A single letter signed by numerous people (6,335 signatures), (2) many letters containing identical material (16,742 letters), or (3) a consolidated document of comments (22,500 comments). Many commenters generally expressed opposition to genetically engineered (GE) organisms 1 To view the notices mentioned in this document, the petition, the draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0023. E:\FR\FM\27DEN1.SGM 27DEN1 80870 Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices or crops but did not provide any specific disagreement with APHIS’ analysis. Several commenters questioned the performance and drought-tolerant capabilities of corn event MON 87460. Other issues raised by commenters include concerns regarding the adequacy of the analysis in the EA, effects of GE crops on biodiversity and organic agriculture, increased use of glyphosate, health and environmental effects of GE crops, and marketing and trade implications. APHIS has addressed the issues raised during the comment period and has provided responses to the comments as an attachment to the finding of no significant impact. 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 19th day of December 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–33011 Filed 12–22–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2010–0032] Notice of Determination of Pest-Free Areas in Mendoza Province, Argentina National Environmental Policy Act AGENCY: Determination sroberts on DSK5SPTVN1PROD with NOTICES To provide the public with documentation of APHIS’ review and analysis of any potential environmental impacts associated with the determination of nonregulated status of Monsanto’s corn event MON 87460, 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. Ms. Meredith C. Jones, Regulatory Coordination Specialist, Regulatory Coordination and Compliance, APHIS, 4700 River Road Unit 156, Riverdale, MD 20737; (301) 734–7467. SUPPLEMENTARY INFORMATION: Under the regulations in ‘‘Subpart— Fruits and Vegetables’’ (7 CFR 319.56– 1 through 319.56–54, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States. Section 319.56–4 of the regulations contains a performance-based process for approving the importation of commodities that, based on the findings of a pest risk analysis, can be safely 22:00 Dec 23, 2011 We are advising the public that we are recognizing the Southern and Central Oases in the southern half of Mendoza Province in Argentina as pest-free areas for Mediterranean fruit fly and South American fruit fly. Based on our site visit to the area and our review of the documentation submitted by Argentina’s national plant protection organization, which we made available to the public for review and comment through previous notices, the Administrator has determined that these areas meet the criteria in our regulations for recognition as pest-free areas for Mediterranean fruit fly and South American fruit fly. DATES: Effective Date: December 27, 2011. SUMMARY: FOR FURTHER INFORMATION CONTACT: 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 corn event MON 87460 is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the introduction of certain GE 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. VerDate Mar<15>2010 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. Jkt 226001 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. One of the designated phytosanitary measures is that the fruits or vegetables are imported from a pest-free area in the country of origin that meets the requirements of § 319.56–5 for freedom from that pest and are accompanied by a phytosanitary certificate stating that the fruits or vegetables originated in a pest-free area in the country of origin. Under the regulations in § 319.56–5, APHIS requires that determinations of pest-free areas be made in accordance with the criteria for establishing freedom from pests found in International Standards for Phytosanitary Measures (ISPM) No. 4, ‘‘Requirements For the Establishment of Pest Free Areas.’’ The international standard was established by the International Plant Protection Convention of the United Nations’ Food and Agriculture Organization and is incorporated by reference in our regulations in 7 CFR 300.5. In addition, APHIS must also approve the survey protocol used to determine and maintain pest-free status, as well as protocols for actions to be performed upon detection of a pest. Pest-free areas are subject to audit by APHIS to verify their status. In accordance with our process, we published a notice 1 in the Federal Register on June 25, 2010 (75 FR 36347– 36348, Docket No. APHIS–2010–0032), in which we announced the availability, for review and comment, of a commodity import evaluation document (CIED) that evaluates the information presented by Argentina in support of its request to recognize additional areas as pest-free areas for Mediterranean fruit fly (Ceratitis capitata) in Argentina. We solicited comments on the notice for 60 days ending on August 24, 2010. We received two comments by that date, one from a State agricultural official and the other from an official of Argentina’s national plant protection organization (NPPO). The first commenter acknowledged Argentina’s history of successful Medfly control efforts, but stated that APHIS should not relax its fruit fly-related restrictions until it can confirm that no other pest fruit flies—notably Anastrepha species fruit flies—are present in the area. The second commenter provided information to support a finding that the Mendoza Province is free of the South American 1 To view the June 2010 and August 2011 notices, the CIEDs, and the comments we received, go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2010-0032. E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80869-80870]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33011]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0023]


Monsanto Co.; Determination of Nonregulated Status of Corn 
Genetically Engineered for Drought Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a corn 
line developed by the Monsanto Co., designated as event MON 87460, 
which has been genetically engineered for drought tolerance, 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: December 27, 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-2011-0023.

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, email: 
evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, 
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 09-055-01p) from 
the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status of corn (Zea mays L.) designated 
as event MON 87460, which has been genetically engineered for drought 
tolerance, stating that this corn 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 May 11, 2011 
(76 FR 27303-27304, Docket No. APHIS-2011-0023), 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 corn is 
likely to pose a plant pest risk, the draft EA, and the PPRA for 60 
days ending on July 11, 2011. On July 27, 2011, APHIS published in the 
Federal Register (76 FR 44891-44892, Docket No. APHIS-2011-0023) a 
notice announcing the extension of the public comment period for 30 
days, ending on August 12, 2011.
---------------------------------------------------------------------------

    \1\ To view the notices mentioned in this document, the 
petition, the draft EA, the PPRA, and the comments we received, go 
to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0023.
---------------------------------------------------------------------------

    APHIS received 250 comments through the Regulations.gov Web site 
during the comment period, with 21 commenters expressing support of the 
EA's preferred alternative to make a determination of nonregulated 
status and the remaining 229 commenters expressing opposition. Three of 
the submitted comments opposing a determination of nonregulated status 
included electronic attachments that consisted either of: (1) A single 
letter signed by numerous people (6,335 signatures), (2) many letters 
containing identical material (16,742 letters), or (3) a consolidated 
document of comments (22,500 comments). Many commenters generally 
expressed opposition to genetically engineered (GE) organisms

[[Page 80870]]

or crops but did not provide any specific disagreement with APHIS' 
analysis. Several commenters questioned the performance and drought-
tolerant capabilities of corn event MON 87460. Other issues raised by 
commenters include concerns regarding the adequacy of the analysis in 
the EA, effects of GE crops on biodiversity and organic agriculture, 
increased use of glyphosate, health and environmental effects of GE 
crops, and marketing and trade implications. APHIS has addressed the 
issues raised during the comment period and has provided responses to 
the 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 the 
determination of nonregulated status of Monsanto's corn event MON 
87460, 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 corn event 
MON 87460 is unlikely to pose a plant pest risk and therefore is no 
longer subject to our regulations governing the introduction of certain 
GE 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 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33011 Filed 12-22-11; 8:45 am]
BILLING CODE 3410-34-P
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