Monsanto Co.; Determination of Nonregulated Status for Soybean Genetically Engineered for Insect Resistance, 63279-63280 [2011-26351]

Download as PDF 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 63280 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices soybean event MON 87701 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 5th day of October 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–26351 Filed 10–11–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2011–0022] Codex Alimentarius Commission: Meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses Office of the Under Secretary for Food Safety, USDA. ACTION: Notice of public meeting and request for comments. AGENCY: The Office of the Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), are sponsoring a public meeting on October 20, 2011. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions that will be discussed at the 33rd Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)of the Codex Alimentarius Commission (Codex), which will be held in Bad Soden am Taunus, Germany from November 14–18, 2011. In addition, two working groups will meet on November 12 from 9 a.m. to 5:30 p.m. to discuss the Proposed Draft Revision of the Guidelines on Formulated Supplementary Foods for Older Infants and Young Children, and the Proposed Draft Revision of the Codex General Principles for the Addition of Essential Nutrients to Foods. The Under Secretary for Food Safety and the FDA recognize the importance jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 of providing interested parties the opportunity to obtain background information on the 33rd Session of the CCNFSDU and to address items on the agenda. DATES: The public meeting is scheduled for October 20, 2011 from 1 p.m.–4 p.m. ADDRESSES: The public meeting will be held in the Harvey Wiley Building, FDA, Center for Food Safety and Applied Nutrition, (CFSAN), 5100 Paint Branch Parkway, Room (1A–003) College Park, MD 20740. Parking is adjacent to this building and will be available at no charge to individuals who preregister by the date below (See Pre-Registration). In addition, the College Park metro station is across the street. Documents related to the 33rd Session of the CCNFSDU will be accessible via the World Wide Web at the following address: https:// www.codexalimentarius.net/ current.asp. Barbara Schneeman, U.S. Delegate to the 33rd Session of the CCNFSDU, invites U.S. interested parties to submit their comments electronically to the following e-mail address: CCNFSDU@fda.hhs.gov. Pre-Registration: To pre-register for this meeting, please send the following information to this e-mail address (nancy.crane@fda.hhs.gov) by October 13, 2011. —Your name —Organization —Mailing Address —Phone number —E-mail address Call-In Number If you wish to participate in the public meeting for the 33rd Session of the CCNFSDU by conference call, please use call-in number and participant code listed below. Call-in Number: 1–866–859–5767 Participant Code: 2225276 For Further Information About the 33rd Session of the CCNFSDU Contact: Nancy Crane, Senior Advisor to the U.S. CCNFSDU Delegate, Office of Nutrition, Labeling and Dietary Supplements, CFSAN (HFS–830), FDA, 5100 Paint Branch Parkway, College Park, MD 20740, telephone: (240) 402–1450, fax: (301) 436–2636, e-mail: Nancy.Crane@fda.hhs.gov. For Further Information About the Public Meeting Contact: Paulo Almeida, U.S. Codex Office, 1400 Independence Avenue, SW., Room 4861, Washington, DC 20250, telephone: (202) 205–7760, fax: (202) 720–3157, e-mail: Paulo.Almeida@fsis.usda.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 Background Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their implementation by governments, Codex seeks to protect the health of consumers and ensure that fair practices are used in trade. The CCNFSDU is responsible for: (a) Studying specific nutritional problems assigned to it by Codex and advising Codex on general nutrition issues; (b) Drafting general provisions as appropriate, concerning the nutritional aspects of all foods; (c) Developing standards, guidelines, or related texts for foods for special dietary uses, in cooperation with other committees where necessary; and (d) Considering, amending if necessary, and endorsing provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts. Issues To Be Discussed at the Public Meeting The following items on the agenda for the 33rd Session of the CCNFSDU will be discussed during the public meeting: • Matters Referred to the CCNFSDU by Codex and/or Other Codex Committees. • Matters of Interest Arising from the FAO and WHO. • Proposed Draft Additional or Revised Nutrient Reference Values (for Labeling Purposes in the Codex Guidelines on Nutrition Labeling at Step 4). • Report from FAO and WHO on Nutrient Reference Values. • Revised Draft of the General Principles for Establishing Nutrient Reference Values for labeling purposes for Nutrients Associated with Risk of Diet-Related Noncommunicable Diseases for the General Population at Step 4 (in light of comments at Step 3). • Proposed Draft Nutrient Reference Values for Nutrients Associated with Risk of Diet-Related Noncommunicable Diseases. • Proposed Draft Revision of the Codex General Principles for the Addition of Essential Nutrients to Foods at Step 4. • Proposed Draft Revision of the Guidelines on Formulated Supplementary Foods for Older Infants and Young Children at Step 4. • Proposed Draft Amendment of the Standard for Processed Cereal-Based E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63279-63280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26351]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0038]


Monsanto Co.; Determination of Nonregulated Status for Soybean 
Genetically Engineered for Insect Resistance

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 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 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.

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 09-082-01p) 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.
    In a notice\1\ 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.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0038.
---------------------------------------------------------------------------

    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 non-target 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

[[Page 63280]]

soybean event MON 87701 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 5th day of October 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-26351 Filed 10-11-11; 8:45 am]
BILLING CODE 3410-34-P
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