### 63279 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices

1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS2011-0038. 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** 

**[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 http:// 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 http://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 § 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. 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.

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 nosignificant 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


### 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** 

**AGENCY :**  Office of the Under Secretary for Food Safety, USDA.

**ACTION :**  Notice of public meeting and request for comments.

**SUMMARY :**  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 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: http:// 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 :**  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