Monsanto Co.; Determination of Nonregulated Status for Soybean Genetically Engineered To Have a Modified Fatty Acid Profile and for Tolerance to the Herbicide Glyphosate, 78232-78233 [2011-32323]

Download as PDF 78232 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices jlentini on DSK4TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Background 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 (PRA), can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. Under that process, APHIS publishes a notice in the Federal Register announcing the availability of the PRA that evaluates the risks associated with the importation of a particular fruit or vegetable. Following the close of the 60-day comment period, APHIS may authorize the importation of the fruit or vegetable subject to the identified designated measures if: (1) No comments were received on the PRA; (2) the comments on the PRA revealed that no changes to the PRA were necessary; or (3) changes to the PRA were made in response to public comments, but the changes did not affect the overall conclusions of the analysis and the Administrator’s determination of risk. In accordance with that process, we published a notice 1 in the Federal Register on August 11, 2011 (76 FR 49726, Docket No. APHIS–2010–0023), in which we announced the availability, for review and comment, of a PRA that evaluates the risks associated with the importation into the continental United States of fresh Cape gooseberry fruit (Physalis peruviana L.) with husks from Chile. We solicited comments on the notice for 60 days ending on October 11, 2011. We did not receive any comments by that date. Therefore, in accordance with the regulations in § 319.56–4(c)(2)(ii), we are announcing our decision to authorize the importation into the continental United States of fresh Cape gooseberry fruit from Chile subject to the following phytosanitary measures: • Cape gooseberry fruit will be subject to inspection upon arrival in the United States. 1 To view the notice and the PRA, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2010-0023. VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 • Each consignment of Cape gooseberry fruit must be accompanied by a phytosanitary certificate issued by NPPO of Chile stating: ‘‘The Cape gooseberry in the consignment has been inspected and is free of pests.’’ • Cape gooseberry fruit must be imported into the United States in commercial consignments only. These conditions will be listed in the Fruits and Vegetables Import Requirements database (available at https://www.aphis.usda.gov/favir). In addition to these specific measures, fresh Cape gooseberry fruit from Chile will be subject to the general requirements listed in § 319.56–3 that are applicable to the importation of all fruits and vegetables. Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 12th day of December 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–32317 Filed 12–15–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0046] Monsanto Co.; Determination of Nonregulated Status for Soybean Genetically Engineered To Have a Modified Fatty Acid Profile and for Tolerance to the Herbicide Glyphosate 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 87705, which has been genetically engineered to have a modified fatty acid profile and for tolerance to the herbicide glyphosate, 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 SUMMARY: PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 notice also announces the availability of our written determination and finding of no significant impact. DATES: Effective Date: December 16, 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) 6902817 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-2011-0046. 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 § 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 09–201–01p) from the E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status for soybean (Glycine max) designated as event MON 87705, which has been genetically engineered to have a modified fatty acid profile and for tolerance to the herbicide glyphosate, 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. In a notice 1 published in the Federal Register on June 28, 2011 (76 FR 37771– 37772, Docket No. APHIS–2011–0046), 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 36 comments during the comment period, with 29 commenters expressing support of the EA’s preferred alternative to make a determination of nonregulated status and the remaining 7 commenters expressing opposition. Issues raised during the comment period include liability following adverse incidents, trade implications, effects of genetically engineered crops on honey bee populations, scientific peer review of safety tests, and health effects of genetically modified organisms and glyphosate. 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. jlentini on DSK4TPTVN1PROD with NOTICES 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 87705, 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 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0046. VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 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 87705 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 12th day of December 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–32323 Filed 12–15–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—WIC Breastfeeding Policy Inventory Food and Nutrition Service (FNS), USDA ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed collection. This is a new collection for the contract WIC Local Agency Breastfeeding Policy and Practices Inventory. DATES: Written comments must be received by February 14, 2012. ADDRESSES: Comments are invited on (a) whether the proposed data collection of information is necessary for the proper performance of the functions of the SUMMARY: PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 78233 agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Steven Carlson, Director, Office of Research and Analysis, U.S. Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Room 1014, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Steven Carlson at (703) 305–2576 or via email to Steve.Carlson@ fns.usda.gov. Comments will also be accepted through the Federal eRulemaking Portal. Go to https://www.regulations.gov and follow the online instruction for submitting comments electronically. All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5 p.m., Monday through Friday) at Room 1014, 3101 Park Center Drive, Alexandria, Virginia 22302. All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will also be a matter of public record. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Steven Carlson at (703) 305–2017. SUPPLEMENTARY INFORMATION: Title: WIC Breastfeeding Policy Inventory. OMB Number: 0584–NEW Expiration Date: Not yet determined. Type of Request: New information collection. Abstract: The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides supplemental foods, health care referrals, and nutrition education to nutritionally at-risk, low-income pregnant women, new mothers, their infants, and children up to age five. The Program is administered through 90 State, territorial, and Indian tribal organization (ITO) agencies. These agencies oversee approximately 2,000 local WIC agencies, which in turn operate about 10,000 clinic sites. WIC E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Pages 78232-78233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32323]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0046]


Monsanto Co.; Determination of Nonregulated Status for Soybean 
Genetically Engineered To Have a Modified Fatty Acid Profile and for 
Tolerance to the Herbicide Glyphosate

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 87705, 
which has been genetically engineered to have a modified fatty acid 
profile and for tolerance to the herbicide glyphosate, 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 16, 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) 6902817 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-2011-0046.

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 09-201-01p) from 
the

[[Page 78233]]

Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
of nonregulated status for soybean (Glycine max) designated as event 
MON 87705, which has been genetically engineered to have a modified 
fatty acid profile and for tolerance to the herbicide glyphosate, 
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.
    In a notice \1\ published in the Federal Register on June 28, 2011 
(76 FR 37771-37772, Docket No. APHIS-2011-0046), 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.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0046.
---------------------------------------------------------------------------

    APHIS received 36 comments during the comment period, with 29 
commenters expressing support of the EA's preferred alternative to make 
a determination of nonregulated status and the remaining 7 commenters 
expressing opposition. Issues raised during the comment period include 
liability following adverse incidents, trade implications, effects of 
genetically engineered crops on honey bee populations, scientific peer 
review of safety tests, and health effects of genetically modified 
organisms and glyphosate. 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 the 
determination of nonregulated status for Monsanto's soybean event MON 
87705, 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 87705 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 12th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-32323 Filed 12-15-11; 8:45 am]
BILLING CODE 3410-34-P
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